## Ethical Issues in Research Involving Human Participants
January 1989 through November 1998

### Prepared by
Cynthia B. Love, M.L.S., National Library of Medicine
Elizabeth J. Thomson, M.S., R.N., National Human Genome Research Institute
Charmaine D. Royal, Ph.D., National Human Genome Research Institute; Howard University

> ## Current Bibliographies in Medicine 99-3

> 1999 May

> U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
> Public Health Service
> National Institutes of Health

> National Library of Medicine
> Reference Section
> 8600 Rockville Pike
> Bethesda, Maryland 20894

> - Series Note
> - Table of Contents
> - Introduction
> - Sample Citations

> Series Note

> Each bibliography in the Current Bibliographies in Medicine (CBM) series covers a distinct subject area of biomedicine and is intended to fulfill a current awareness function. Citations are usually derived from searching a variety of online databases. NLM databases utilized include MEDLINE®, LOCATORplus, BIOETHICSLINE®, HEALTHSTARtm, POPLINEtm, and TOXLINE®. The only criterion for the inclusion of a particular published work is its relevance to the topic being presented; the format, ownership, or location of the material is not considered.

> Other publications in the Current Bibliographies in Medicine series are available at no cost to anyone with Internet access through the Library's World Wide Web site at http://www.nlm.nih.gov/pubs/resources.html.

> Comments and suggestions on this series may be addressed to:

> Karen Patrias, Editor
> Current Bibliographies in Medicine
> Reference Section
> National Library of Medicine
> Bethesda, MD 20894
> Phone: 301-496-6097
> Fax: 301-402-1384
> Internet: ref@nlm.nih.gov

> PUBMEDTM AND INTERNET GRATEFUL MED®

> To make online searching easier and more efficient, the Library offers two user-friendly interfaces to its databases. Both PubMed and Internet Grateful Med are available from the World Wide Web. The user with Internet access need only point a compatible Web browser (Netscape Navigator is strongly recommended) to the NLM Web site http://www.nlm.nih.gov. No other software at the user end is required. Searching through either PubMed or Internet Grateful Med is free-of-charge. Further information on both PubMed and Internet Grateful Med may be found at the NLM Web site given above.

> For those users without access to the World Wide Web, please contact the Library's Customer Service Desk at 1-888-FINDNLM (301-594-5983 international) or send e-mail for information on alternative ways to search.

> Return to table of contents

> ### Table of Contents

> Series Note
> Introduction
> Sample Citations

> ## Part I: Bibliography

> - 1. Overview of the ethics of research involving human participants: Journal Articles; Books
> - 2. Historical perspectives on research involving human participants: Journal Articles; Books
> - 3. Informed consent: Journal Articles; Books
> - 4. Community consent: Journal Articles; Books
> - 5. Privacy and confidentiality: Journal Articles; Books
> - 6. Clinical trials: Journal Articles; Books
> - 7. Special or vulnerable populations
>   - a. Women: Journal Articles; Books
>   - b. Minorities and cross-cultural issues: Journal Articles; Books
>   - c. Children and adolescents: Journal Articles; Books
>   - d. Cognitively impaired: Journal Articles; Books
>   - e. Elderly: Journal Articles
>   - f. Prisoners: Journal Articles; Books
>   - g. Military personnel: Journal Articles; Books
>   - h. Teaching and research using newly deceased patients: Journal Articles
>   - i. Self-experimentation by researchers: Journal Articles; Books
> - 8. Special Research Topics
>   - a. Genetic research: Journal Articles; Books
>   - b. Gamete, embryo and fetal research: Journal Articles; Books
>   - c. Human cloning: Journal Articles; Books
>   - d. Research using human biological materials including fetal tissue: Journal Articles; Books
>   - e. Xenotransplantation: Journal Articles; Books
>   - f. AIDS/HIV research: Journal Articles; Books
>   - g. Cancer research: Journal Articles; Books
>   - h. Emergency medicine, acute care and critical care research: Journal Articles
>   - i. Drug and medical device research and development: Journal Articles; Books
>   - j. Institutional review boards and ethics committees: Journal Articles; Books

> ## Part II: Resources

> - 1. Bioethics education: Journal Articles; Books
> - 2. Case studies: Journal Articles; Books
> - 3. Audiovisual materials for teaching the ethics of research involving human participants.
> - 4. Bioethics journals
> - 5. Bioethics databases
> - 6. Source materials
>   - a. U.S. federal government laws, regulations, and guides concerning the protection of human research participants: Journal Articles; Books
>   - b. Guidelines for the protection of human research participants published by U.S. non-government organizations: Journal Articles; Books
>   - c. Guidelines for the protection of human research participants published by non-U.S. government and other organizations: Journal Articles; Books

> Introduction

> ETHICAL ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS

> On May 16, 1997, President Clinton apologized to the survivors and families of hundreds of men used in a research project to study the progression of untreated syphilis. These men were mainly sharecroppers from Macon County, Alabama (the area surrounding Tuskegee). They were poor, African American, and had few resources available to them. In 1932, when they were offered free medical care by physicians and researchers involved with the United States Public Health Service, they believed they had found treatment for what they had been told was "bad blood." Instead, they were enrolled in an observational research study, without their knowledge or consent. In exchange for their participation (which included agreeing to an autopsy at death), the men received free medical examinations (primarily to provide data for the study), transportation and hot meals on the days of their examinations, and $50 for burial expenses. Even though some rudimentary remedies for syphilis were available in the early years of the study, they were not offered to these men, so that the study of the natural history of the untreated disease would not be jeopardized. 1

> The study (the Tuskegee Study of Untreated Syphilis in the Male Negro 2) did not end until 1972, forty years after it had begun, and twenty years after penicillin had been identified as an effective treatment for syphilis. The New York Times headline exposing the experiment read, "Syphilis victims in U.S. study went untreated for 40 years." 3 The article revealed the details of the study and called it "the longest nontherapeutic experiment on human beings in medical history." According to the Report of the Tuskegee Syphilis Study Legacy Committee, "In the almost 25 years since its disclosure, the Study has moved from a singular historical event to a powerful metaphor. It has come to symbolize racism in medicine, ethical misconduct in human research, paternalism by physicians, and government abuse of vulnerable people." 4

> According to President Clinton, "The legacy of the study at Tuskegee has reached far and deep, in ways that hurt our progress and divide our nation. We cannot be one America when a whole segment of our nation has no trust in America. An apology is the first step, and we take it with a commitment to rebuild that broken trust. We can begin by making sure there is never again another episode like this one. We need to do more to ensure that medical research practices are sound and ethical, and that researchers work more closely with communities." 5

> In his remarks, the President promised that several steps would be taken to assure that such research tragedies would not happen again. The plan, laid out by the President, contained five elements and was designed to begin the process of restoring the public trust that had been severely damaged, particularly in the African American community. The first step was to award a planning grant to Tuskegee University so that the University could establish a Center for Bioethics in Research and Health Care. This Center will serve as a museum of the Tuskegee Syphilis Study and support the University's efforts to strengthen bioethics training. The second element was to increase community involvement in research, so that the lost trust of some segments of society could begin to be restored. A third element of the plan was to strengthen researchers' training in bioethics to help increase their understanding of the core ethical principles of respect for individuals, beneficence, and justice, as set forth in the Belmont Report. 6 Fourth, a commitment was made to provide post-graduate fellowships to train more bioethicists, especially among African Americans and other minority groups. Finally, by executive order, the President extended the charter of the National Bioethics Advisory Commission to October of 1999. 7

> Following the apology, the Department of Health and Human Services charged several of its agencies with implementing the President's plan. In support of the first two elements, funds have been awarded to Tuskegee University for the establishment of a Center for Bioethics, and several meetings have been held to explore how communities, especially minority communities, can be involved in the planning and implementation of research. In response to the third and fourth elements, interagency Program Announcements soliciting research and training grant applications have been developed, issued, and are ongoing. They are designed to: support research to examine ethical issues surrounding research involving human participants; 8 provide training opportunities in the form of mentored scientist awards in research ethics; 9 and develop short term courses in research ethics. 10

> Although regulatory safeguards for protecting research participants have improved significantly in recent years, 11 historical cases such as the Tuskegee Syphilis Study stand as examples of the potential for ethical problems in research involving human participants, and of the need for vigilance in protecting the rights and welfare of these individuals. Contemporary safeguards such as requirements that federally funded research protocols be submitted to an institutional review board (IRB) are important, but by themselves are insufficient. Educating researchers and the public about research ethics is critical for the full protection of research participants.

> To facilitate the identification and dissemination of materials to support the education of researchers on the ethics of research involving human participants, an interagency working group (the Bioethics Education Materials and Resources Subcommittee) was established. It included representatives from five Department of Health and Human Services (DHHS) agencies. The agencies co-leading this effort, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) were joined by the Food and Drug Administration (FDA), Health Resources Services Administration (HRSA), and Substance Abuse and Mental Health Services Administration (SAMHSA). This working group was charged with identifying existing bioethics educational materials and resources and making these materials more accessible to the entire research and research training community. In addition, the working group was asked to identify gaps in these resources and make recommendations about how to fill them.

> In response to this charge, the members of the Bioethics Education Materials and Resources Subcommittee have identified and drawn together this extensive bibliography of books, audiovisuals, and journal article citations. The focus of these materials is the inclusion and protection of human participants from diverse populations in biomedical research, and not on other areas of research ethics and scientific integrity. It provides information about topics critical to understanding ethical issues surrounding research involving human participants and provides resources to support the further integration of these topics into research and research training settings. These materials have been compiled and are now available in this two-part publication which will be disseminated to all DHHS-funded research and training sites. To ensure that this document is widely accessible, it is available on the Internet at the National Library of Medicine at: http://www.nlm.nih.gov/pubs/cbm/hum_exp.html.

> The first part of this publication is a citation bibliography, consisting of more than 4000 journal and book entries on topics relevant to the involvement and protection of human participants in research. The first section provides a comprehensive overview of this topic. Next is a section on historical perspectives on research ethics, which includes references to some of the most striking lapses in research ethics (e.g. the Tuskegee Syphilis Study, the Willowbrook experiment, the human radiation experiments, etc.). This section also includes a number of citations regarding the egregious Nazi "experiments," the subsequent Nuremberg Trial, the resulting Nuremberg Code, and their role in the development of protections for research participants. This is followed by sections on the fundamental research ethics topics of informed consent, including community consent, privacy and confidentiality, and clinical trials. Next, the bibliography focuses on selected populations that may be recruited for research, including: women; minorities; children; the elderly; the cognitively impaired (including those who have mental disorders and whose capacity to consent may be diminished or questionable); prisoners; military personnel; newly deceased individuals; and researchers involved in self-experimentation. The final section focuses on special research topics, including: genetics research; research on gametes, embryos, and fetuses; cloning; research involving human biological materials (including fetal tissue research); xenotransplantation; AIDS/HIV research; cancer research; emergency, acute and critical care research; drug and device development; and finally, institutional review boards and ethics committees.

> The second part of this publication provides bibliographic and other information and resources that can be used to enhance bioethics education in research and other settings. It includes over 500 journal and book citations on bioethics education, case study citations that may be useful for discussion in educational settings, and a list of audiovisual materials. It also includes a list of bioethics journals and bioethics databases, as well as relevant government and non-government documents on laws, regulations and guidelines for research.

> The journal article citations selected for this bibliography were published between 1989 and 1998 in English-language journals from around the world, in the fields of biomedicine, ethics and history. Also included, especially in the History section, are some earlier references considered to be seminal articles in the field. Books published and audiovisuals produced in English in the last 10 years were selected from the National Library of Medicine catalog (LOCATORplus). Some earlier, particularly significant, books are cited as well. Journal articles and books listed in the Source Materials sections may also be listed under another subject. Materials citing both Women and Minorities as keywords are listed under both subject headings. All other citations are listed under only one topic. Thus, if the subject of interest is, for example, HIV research involving women, it would be useful to look both in the AIDS/HIV Research section and the section on Women. Items included in the bibliography were selected solely on the basis of relevance to the subject.

> The documents cited in this bibliography provide a rich source of history as well as practical guidance for those who are involved in teaching and mentoring research trainees. They may also be of use to those who are planning or conducting research. It is our hope that this bibliography will be useful to researchers throughout the global community and to all individuals interested in teaching or learning about the ethical conduct of research.

> Members of the working group would especially like to acknowledge the leadership of Ms. Cynthia Love of the National Library of Medicine in developing this bibliography. We would also like to acknowledge the patience and support of the parent committee, the Tuskegee Follow-Up Steering Committee, especially its co-chairs Dr. Dixie E. Snider, Jr. (CDC) and Dr. Wendy Baldwin (NIH).

> The compilers of this bibliography would further like to express their gratitude to those who provided direct assistance in the production of this publication: Dr. Peggie Tillman, Ms. Twann Dailey, Ms. Karen Patrias, Mr. Adam Glazer and Ms. Jennie Hunt of the National Library of Medicine, and Ms. Susan Saylor and Ms. Leizle Talangbayan of the National Human Genome Research Institute.

> To search this web document for a particular author or keyword, begin at the top of the document. Type CTRL F or use your browser's EDIT-FIND function, type in the last name of the author or the keyword you wish to locate, hit ENTER, and the first citation that you wish to find will be located. You can then hit FIND AGAIN to search the entire document for the author or keyword of interest. To begin a new search, you must first return to the begining of the document.

> Any reproduction of this bibliography, in whole or in part, must include all credits. If you wish to cite this bibliography, the correct format is: Love, Cynthia B; Thomson, Elizabeth J.; Royal, Charmaine D., compilers. Ethical issues in research involving human participants [bibliography on the Internet]. Bethesda (MD): National Library of Medicine; 1999 April. (Current bibliographies in medicine; no. 99-3). 4621 citations from January 1989 through November 1998. Available from: http://www.nlm.nih.gov/pubs/resources.html

> Bioethics Education Materials and Resources Subcommittee

> Lead agencies and staff:

> National Institutes of Health
>   Ms. Elizabeth Thomson, Subcommittee Chair, National Human Genome Research Institute
>   Ms. Cynthia Love, National Library of Medicine
>   Dr. Charmaine Royal, National Human Genome Research Institute; Howard University
>   Ms. Joy Boyer, National Human Genome Research Institute
>   Dr. Christine Grady, Department of Clinical Bioethics, Clinical Center
>   Dr. Ruth Fischbach, Office of the Director, NIH
> Centers for Disease Control and Prevention
>   Dr. Steven Coughlin, National Center for Chronic Disease Prevention and Health Promotion
>   Dr. Andrew Dannenberg, Division of Applied Public Health Training

> Participating agencies and staff:

> Food and Drug Administration
>   Dr. Glen Drew, Office of Health Affairs
>   Dr. Stuart Nightingale, Office of Health Affairs
> Health Resources Services Administration
>   Dr. Louis Mahoney, Center for Quality
> Substance Abuse and Mental Health Services Administration
>   Dr. Dorita Sewell, Division of Extramural Activities, Policy, and Review

> References

> 1. Jones JH, Bad Blood: The Tuskegee Syphilis Experiment, new and expanded ed., New York: Free Press, 1993.

> 2. Vonderlehr RA, Clark T, Wenger OC, Heller JR Jr. Untreated syphilis in male Negro; comparative study of treated and untreated cases. Ven Dis Inform 1936 Sep;17(9):260-5. Also J Am Med Assoc 1936 Sep 12;107:856-60.

> 3. Heller J. Syphilis victims in U.S. study went untreated for 40 years. New York Times 1972 Jul 26;1, 8.

> 4. Report of the Tuskegee Syphilis Study Legacy Committee Final Report--May 20, 1996 [report on the Internet]. [place unknown]: The Committee; 1996 [cited 1999 April 29]. [8 p.]. Available from: http://www.med.virginia.edu/hs-library/historical/apology/report.html.

> 5. Remarks by President Clinton in apology for study done in Tuskegee [speech on the Internet]. Clinton WJ. Washington: The White House; 1997 May 16 [cited 1999 April 29]. [3 p.]. Available from: http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1997/5/16/11.text.1.

> 6. The Belmont report: ethical principles and guidelines for the protections of human subjects. Bethesda (MD): U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; 1978. 8 p. Also available on the Internet from: http://www.nih.gov:80/grants/oprr/humansubjects/guidance/belmont.htm.

> 7. Executive Order 13046. Further Amendment To Executive Order 12975, Extension Of The National Bioethics Advisory Commission. [file on the Internet]. Washington: The White House. Office of the Press Secretary; 1997 May 16 [cited 1999 May 10]. [1 p.]. Available from: http://bioethics.gov/about/further.htm. Also available from: http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1997/5/16/7.text.2

> 8. Research on ethical issues in human studies. PA [Program Announcement]-99-079 [announcement on the Internet]. Bethesda,(MD): National Institutes of Health; 1999 Mar 31 [cited 1999 April 29]. [15 p.] Available from: http://www.nih.gov/grants/guide/pa-files/PA-99-079.html.

> 9. Mentored scientist development award in research ethics. PA-99-050 [announcement on the Internet] Bethesda (MD): National Institutes of Health; 1999 Jan 22 [cited 1999 April 29]. [10 p.]. Available from: http://www.nih.gov/grants/guide/pa-files/PA-99-050.html.

> 10. Short-term courses in research ethics. PA-99-051 [announcement on the Internet]. Bethesda (MD): National Institutes of Health; 1999 Jan 22 [cited 1999 April 29]. [6 p.]. Available from: http://www.nih.gov/grants/guide/pa-files/PA-99-051.html.

> 11. Protection of Human Subjects-Title 45 Code of Federal Regulations Part 46, Revised June 18, 1991. Available from: http://www.nih.gov:80/grants/oprr/humansubjects/45cfr46.htm.

> Return to table of contents

> Sample Citations

> Citations are formatted according to the rules established for Index Medicus ®. Sample journal and monograph citations appear below. For journal articles written in a foreign language, the English translation of the title is placed in brackets; for monographs, the title is given in the original language. In both cases the language of publication is shown by a three letter abbreviation appearing at the end of the citation.

> Journal Article:

> Example:
> Appelbaum PS. Examining the ethics of human subjects research. Kennedy Inst Ethics J 1996 Sep;6(3):283-7.

> Order, with separating punctuation:
> Authors. Article Title. Abbreviated Journal Title Date;Volume(Issue):Pages.

> Monograph:

> Example:
> McNeill PM. The ethics and politics of human experimentation. New York: Cambridge University Press; 1993. 315 p.

> Order, with separating punctuation:
> Authors/Editors. Title. Place of Publication: Publisher; Date. Total No. of Pages.

> For details of the formats used for references, see the following publication:
> Patrias, Karen. National Library of Medicine recommended formats for bibliographic citation. Bethesda (MD): The Library; 1991 Apr. Available from: NTIS, Springfield, VA; PB91-182030.

> Return to table of contents

> ## Overview of the ethics of research involving human participants - Journal Articles

> Aarons D. Research ethics. West Indian Med J 1995 Dec;44(4):115-8.

> Abbott A. European vote raises bioethics stakes [news]. Nature 1996 Jun 13;381(6583):545.

> Ackerman TF. Balancing moral principles in federal regulations on human research. IRB Rev Hum Subj Res 1992;14(1):1-6.

> Ackerman TF. An ethical framework for the practice of paying research subjects. IRB Rev Hum Subj Res 1989 Jul-Aug;11(4):1-4.

> Alderson P. A national research ethics committee? Bull Med Ethics 1995 Apr;107:13-6.

> Aldhous P. Medical research. UK ethics guidelines [news]. Nature 1991 Aug 29;352(6338):746.

> Alecrim M das G. Ethics on malaria seroepidemiology. Rev Inst Med Trop Sao Paulo 1992 Apr;34 Suppl 9:S31-2.

> Alhous P. Ethics and research: sex, hearts and brains; animal rights; genetic engineering [news]. Nature 1990 Jan 4;343(6253):8-9.

> American Academy of Neurology Code of Professional Conduct. Neurology 1993 Jun;43(6):1257-60.

> American Hospital Association. A patient's bill of rights [monograph on the Internet]. Chicago: The Association; c1992 [cited 1998 Sep 28]. [141 lines]. Available from: http://www.aha.org/resource/pbillofrights.html.

> Anderson JR, Jameton A, Reitemeier PJ, Prentice E. The case of two devices: disclosure to subjects following Phase IV ("post-marketing") research. IRB Rev Hum Subj Res 1995 May-Jun;17(3):6-9.

> Annas GJ. Experimentation and research. J Calif Alliance Ment Ill 1994;5(1):9-11.

> Annas GJ. Questing for grails: duplicity, betrayal and self-deception in postmodern medical research. J Contemp Health Law Policy 1996 Spring;12(2):297-324.

> Annas GJ. Will the real bioethics (commission) please stand up? Hastings Cent Rep 1994 Jan-Feb;24(1):19-21.

> Annotated bibliography and appendices: international codes of ethics. Bull Pan Am Health Org 1990;24(4):582-629.

> Appelbaum PS. Examining the ethics of human subjects research. Kennedy Inst Ethics J 1996 Sep;6(3):283-7.

> Ashby D, Machin D. Stopping rules, interim analyses and data monitoring committees. Br J Cancer 1993 Dec;68(6):1047-50.

> Baer N. New draft code for research involving humans proved a major challenge. CMAJ 1996 Aug 15;155(4):442-4.

> Bailey RR. New Zealanders--why let this medical experiment proceed? [letter]. N Z Med J 1992 Jul 8;105(937):270.

> Balk DE. Bereavement research using control groups: ethical obligations and questions. Death Stud 1995 Mar-Apr;19(2):123-38.

> Bamberg M, Budwig N. Therapeutic misconceptions: when the voices of caring and research are misconstrued as the voice of curing. Ethics Behav 1992;2(3):165-84.

> Beauchamp TL, Cook RR, Fayerweather WE, Raabe GK, Thar WE, Cowles SR, Spivey GH. Ethical guidelines for epidemiologists. J Clin Epidemiol 1990;44(1 Suppl):S151-S69.

> Beauvais F. The politicizing of science: when protection of subjects' rights leads to a wrong. Subst Use Misuse 1997 Jan;32(1):77-82.

> Bebeau MJ, Davis EL. Survey of ethical issues in dental research. J Dent Res 1996 Feb;75(2):845-55.

> Bebeau MJ, Holt SC, American Association for Dental Research Ethics Committee. The role of the AADR in promoting research integrity: perspectives and consensus statements. J Dent Res 1996 Feb;75(2):856-60.

> Beeson D. Nuance, complexity, and context: qualitative methods in genetic counseling research. J Genet Couns 1997 Mar;6(1):21-43.

> Behi R, Nolan M. Ethical issues in research. Br J Nurs 1995 Jun 22-Jul 12;4(12):712-6.

> Bell R. MRC [Medical Research Council] faces negligence claims over growth hormone victims [news]. Nature 1996 Apr 25;380(6576):661.

> Benatar SR, Keet MP, Prozesky OW. Guidelines to ethics of medical research. S Afr Med J 1994 Feb;84(2):62.

> Benrubi GI. Medical ethics: what we couldn't possibly learn at our mother's knee [editorial]. Obstet Gynecol Surv 1995 Mar;50(3):163-4.

> Benster R, Pollock A, Pelerin M, Hall SM, Drury M. Ethics and multicentre research projects [letters]. BMJ 1992 Jun 27;304(6843):1696.

> Bernard J. Bioethics and knowledge. Nouv Rev Fr Hematol 1990;32(6):377-85.

> Bernard J. Ethics and haematology. Haematologia (Budap) 1991;24(4):221-7.

> Bernat JL, Beresford HR, American Academy of Neurology. The American Academy of Neurology Code of Professional Conduct. Neurology 1993 Jun;43(6):1257-60.

> Biesecker LG, DeRenzo EG. Internet solicitation of research subjects for genetics studies [letter]. Am J Hum Genet 1995 Nov;57(5):1255-6.

> Bioethics panel [news]. Science 1996 Aug 2;273(5275):583.

> Bjune G, Gedde-Dahl TW. Some problems related to risk-benefit assessments in clinical testing of new vaccines. IRB Rev Hum Subj Res 1993;15(1):1-5.

> Black KJ, Hodge MH. Protecting subjects' identity in test-retest experiments. IRB Rev Hum Subj Res 1987 Mar-Apr;9(2):10-1.

> Blanck PD, Bellack AS, Rosnow RL, Rotheram-Borus MJ, Schooler NR. Scientific rewards and conflicts of ethical choices in human subjects research. Am Psychol 1992 Jul;47(7):959-65.

> Bleich JD. Utilization of scientific data obtained through immoral experimentation--survey of recent halakhic literature. Tradition J Orthodox Jew Thought 1991 Fall;26(1):65-79.

> Blinded by science [editorial]. Lancet 1994 Mar 5;343(8897):553-4.

> Blustein J. What bioethics needs to learn about families. Theor Med Bioeth 1998 Apr;19(2):101-15.

> Bok S. The ethics of giving placebos. Sci Am 1974 Nov;231(5):17-23.

> Botkin JR. Ethics and evidence [commentary]. J Clin Ethics 1992 Spring;3(1):63-4.

> Bracken MB, Nicholas JA, O'Leary PF, Ragnarsson KT. Offering a celebrity experimental treatment [letter and response]. N Engl J Med 1993 Apr 22;328(16):1202-3.

> Brett A, Grodin M. Ethical aspects of human experimentation in health services research. JAMA 1991 Apr 10;265(14):1854-7.

> Brewer TF, Heymann SJ. Two-tiered health care: the root of ethical problems in recent clinical trials [editorial]. Int J Infect Dis 1998 Jan-Mar;2(3):123-6.

> Brewin T, Thornton H, Bradley C, McPherson K, Gore SM, Silverman WA, Altman DG. Patients' preferences and randomised trials [letters and response]. Lancet 1996 Apr 20;347(9008):1118-9.

> Brezinova V, Shaw AB. Ethical issues in randomised prevention trials [letters]. BMJ 1992 Mar 20;306(6880):790.

> Brink PJ. Writing a research grant for AFNR ethical clearance. AARN News Lett 1992 Jul-Aug;48(7):36.

> Bristol study continues to cause debate [news]. Bull Med Ethics 1995 May;108:3-5.

> British Psychological Society. Ethical research in psychology: revised ethical principles for conducting research with human participants. Bull Med Ethics 1991 May;68:8-11.

> Brodie DA, Stopani K. Experimental ethics in sports medicine research. Sports Med 1990 Mar;9(3):143-50.

> Brody BA. Research ethics: international perspectives. Camb Q Healthc Ethics 1997 Fall;6(4):376-84.

> Brody BA. When physicians go wrong. J Health Polit Policy Law 1995 Summer;20(2):503-9.

> Browner WS. Ethics, statistics, and technology assessment: the use of a stopping rule and an independent policy and data monitoring board in a cohort study of perioperative cardiac morbidity. Clin Res 1991 Feb;39(1):7-12.

> Buchanan RN. Problems related to the use of human subjects in clinical evaluation/responsibility for follow-up care. J Dent Educ 1991 Dec;55(12):797-801.

> Bulger RE. Toward a statement of the principles underlying responsible conduct in biomedical research. Acad Med 1994 Feb;69(2):102-7.

> Busch DB, Bryan GT, Easterling D, Leventhal H, Messing E M, Cummings KB. Follow-up: recontacting subjects in mutagen exposure monitoring studies [letter]. IRB Rev Hum Subj Res 1988 Sep-Oct;10(5):9-11.

> Butler D. 'Bioethics needs better input from public' [news]. Nature 1997 Oct 23;389(6653):775.

> Butler D. Europe plans convention on social impacts of biomedical technologies [news]. Nature 1994 Jul 7;370(6484):3.

> Byk C. The European Convention on bioethics. J Med Ethics 1993 Mar;19(1):13-6. Comment in: J Med Ethics 1993 Mar;19(1):3-4.

> Byk C. The European Convention on Bioethics. Med Law 1993;12(6-8):507-19.

> Byk C. Medical and biological progress and the European Convention on Human Rights. Med Law 1992;11(3-4):187-219.

> Canadian Medical Association. Code of Ethics of the Canadian Medical Association (approved by General Council, August 1996). CMAJ 1996 Oct 15;155(8):1176A-1176B. Comment in: Can Med Assoc J 1996 Oct 15;155(8):1063-5.

> Capron AM. An egg takes flight: the once and future life of the National Bioethics Advisory Commission. Kennedy Inst Ethics J 1997 Mar;7(1):63-80.

> Capron AM. Protection of research subjects: do special rules apply in epidemiology? Law Med Health Care 1991 Fall-Winter;19(3-4):184-90.

> Carico JM, Harrison ER. Ethical considerations for nurses in biomedical research. J Neurosci Nurs 1990 Jun;22(3):160-3.

> Carriero A, Spinazzi A, Bonomo L. Ethics and research. Eur Radiol 1996;6 Suppl 1:S11-5.

> Cassidy V. Ethical responsibilities in nursing: research findings and issues. J Prof Nurs 1991 Mar-Apr;7(2):112-8.

> Cattorini P, Mordacci R. The physician as caregiver and researcher. Thyroidology 1993 Dec;5(3):73-6.

> Chalmers I. Ethics, clinical research, and clinical practice in obstetric anaesthesia [letter]. Lancet 1992 Feb 22;339(8791):498.

> Chalmers I. What do I want from health research and researchers when I am a patient? BMJ 1995 May 20;310(6990):1315-8.

> Chao TC. The three dimensions in medicine: science, art and ethics. Ann Acad Med Singapore 1995 Nov;24(6):919-20.

> Charlton E. Ethical guidelines for pain research in humans. Committee on Ethical Issues of the International Association for the Study of Pain [editorial]. Pain 1995 Dec;63(3):277-8.

> Chaudhary SK, Chaudhary K. Unethical experimental studies on humans [letter]. J Indian Med Assoc 1994 Jul;92(7):241-2.

> Cheah JS. Ethical pledges, declarations and oaths of medical students and doctors [editorial]. Ann Acad Med Singapore 1995 Nov;24(6):779.

> Christakis NA, Panner MJ. Existing international ethical guidelines for human subjects research: some open questions. Law Med Health Care 1991 Fall-Winter;19(3-4):214-21.

> Clinton WJ. Executive Order 12975 of October 3, 1995: protection of human research subjects and creation of National Bioethics Advisory Commission. Fed Regist 1995 Oct 5;60(193):52063-5.

> Code of Ethics of the Canadian Medical Association. CMAJ 1996 Oct 15;155(8):1176A-1176D.

> Cohen CB, McCloskey EL. Private bioethics forums: counterpoint to government bodies. Kennedy Inst Ethics J 1994 Sep;4(3):283-9.

> Cohen P. Sugaring the pill. New Sci 1996 Jan 27;149(2014):26-9.

> Cole L, Frisina M, Sellman J. Healing or killing? [letters and responses]. Hastings Cent Rep 1991 May-Jun;21(3):37-9.

> College on Problems of Drug Dependence. College on Problems of Drug Dependence policy on administering drugs with abuse potential in human research. IRB Rev Hum Subj Res 1996 Sep-Oct;18(5):5-7.

> Collier J, Cami J, Farre M, Lamas X. Volunteering for research [letters]. Lancet 1992 Oct 31;340(8827):1103.

> Concar D. Ethics code spells disaster for Canadian psychologists [news]. New Sci 1996 Dec 7;152(2059):7.

> Connelly RJ. Deception and the placebo effect in biomedical research. IRB Rev Hum Subj Res 1987 Jul-Aug;9(4):5-7.

> Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (adopted by the Committee of Ministers on 19 November 1996). Council of Europe. Hum Reprod 1997 Sep;12(9):2076-80.

> Cook RR. Code of ethics for epidemiologists. J Clin Epidemiol 1991;44 Suppl 1:135S-139S.

> Cooley WE, Castellion AW. International regulatory aspects of clinical periodontal research. Ann Periodontol 1997 Mar;2(1):18-30.

> Coughlin SS. Advancing professional ethics in epidemiology. J Epidemiol Biostat 1996;1(2):71-7.

> Coughlin SS, Beauchamp TL. Ethics, scientific validity, and the design of epidemiologic studies. Epidemiology 1992 Jul;3(4):343-7.

> Council JR, Smith EJ, Kaster-Bundgaard J, Gladue BA. Ethical evaluation of hypnosis research: a survey of investigators and their institutional review boards. Am J Clin Hypn 1997 Apr;39(4):258-65.

> Council for International Organizations of Medical Sciences. International guidelines for ethical review of epidemiological studies. Law Med Health Care 1991 Fall-Winter;19(3-4):247-58.

> Council of Europe. Convention for protection of human rights and dignity of the human being with regard to the application of biology and biomedicine: convention of human rights and biomedicine. Kennedy Inst Ethics J 1997 Sep;7(3):277-90.

> Council of Europe. Draft convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: bioethics convention. Bull Med Ethics 1994 Jun-Jul;99:19-24.

> Council of Europe Committee of Ministers. European guidance on medical research [official statements]. Bull Med Ethics 1990 Mar;56:8-10.

> Coutts MC. Basic resources in bioethics [bibliography]. Kennedy Inst Ethics J 1991 Mar;1(1):75-90.

> Crigger BJ. A new bioethics commission [news]. Hastings Cent Rep 1994 Nov-Dec;24(6):2-3.

> Crigger BJ. New Presidential National Bioethics Advisory Commission proposed. IRB Rev Hum Subj Res 1994;16(5):10-1.

> Cunningham N, Hutchinson S. Myths in health care ethics. Image J Nurs Sch 1990 Winter;22(4):235-8.

> Dale O, Salo M. The Helsinki Declaration, research guidelines and regulations: present and future editorial aspects [editorial]. Acta Anaesthesiol Scand 1996 Aug;40(7):771-2.

> Daugherty CK, Geller G. Hope and the limits of research. Hastings Cent Rep 1996 Sep-Oct;26(5):20; discussion 20-2.

> Davies S, McDonald V, Barton S, Gazzard B, Onwude J, Thornton JG. Volunteering for research [letters]. Lancet 1992 Nov 14;340(8829):1229-30.

> Davis AJ. Ethical issues in nursing research. West J Nurs Res 1990 Jun;12(3):413-6.

> Davis DS. Legal trends in bioethics. J Clin Ethics 1997 Summer;8(2):204-7.

> Day RO, Chalmers DR, Williams KM, Campbell TJ. The death of a healthy volunteer in a human research project: implications for Australian clinical research. Med J Aust 1998 May 4;168(9):449-51.

> De Castro LD. Exploitation in the use of human subjects for medical experimentation: a re-examination of basic issues. Bioethics 1995 Jul;9(3-4):259-68.

> de Groot JM, Kennedy SH. Integrating clinical and research psychiatry. J Psychiatry Neurosci 1995 Mar;20(2):150-4.

> de Jong J, Reatig N. SAMHSA philosophy and statement of ethical principles. Ethic Behav 1998;8(4):339-43.

> de Raeve L. Ethical issues in palliative care research. Palliat Med 1994 Oct;8(4):298-305. Comment in: Palliat Med 1995 Apr;9(2):165-6.

> de Wachter MA. The European convention on bioethics. Hastings Cent Rep 1997 Jan-Feb;27(1):13-23.

> Death of a study: WHO what and why [editorial]. Lancet 1994 Apr 23;343(8904):987-8.

> Dedrick RF. Deception in diabetes research [letter]. Diabetes Care 1990 Feb;13(2):182-4. Comment on: Diabetes Care 1989 Mar;12(3):184-8.

> Demarez JP. Remuneration, freedom of choice, professional guinea pig. Fundam Clin Pharmacol 1990;4 Suppl 2:189s-196s.

> Diamond MR, Reidpath DD. Are students really human? Observations on institutional ethics committees. Aust Psychol 1994 Jul;29(2):145-6.

> Diamond MR, Reidpath DD. Psychology ethics down under: a survey of student subject pools in Australia. Ethics Behav 1992;2(2):101-8.

> Dias HP. Bioethics: implications for medical practice and deontologic and legal standards in Brazil. Bull Pan Am Health Organ 1990;24(4):491-503.

> Dickens BM. Issues in preparing ethical guidelines for epidemiological studies. Law Med Health Care 1991 Fall-Winter;19(3-4):175-83.

> Dickens BM, Gostin L, Levine RJ. Research on human populations: national and international ethical guidelines. Law Med Health Care 1991 Fall-Winter;19(3-4):157-61.

> Diers D. On mischief [editorial]. Image J Nurs Sch 1990 Fall;22(3):138. Comments in: Image J Nurs Sch 1991 Spring;23(1):62-3; Image J Nurs Sch 1991 Fall;23(3):195.

> Dillner L. GMC gets tough with fraudulent doctors [news]. BMJ 1991 Dec 14;303(6816):1493.

> Dommel FW, Alexander D. The Convention on Human Rights and Biomedicine of the Council of Europe. Kennedy Inst Ethics J 1997 Sep;7(3):259-76.

> Dooley D. Medical ethics in Ireland: a decade of change. Hastings Cent Rep 1991 Jan-Feb;21(1):18-21.

> Dunn PM, Gallagher TH, Hodges MO, Prendergast TJ, Rubenfeld GD, Tolle SW, Lo B. Medical ethics: an annotated bibliography. Ann Intern Med 1994 Oct 15;121(8):627-32.

> Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet 1991 Apr 13;337(8746):867-72.

> Easterbrook PJ, Matthews DR. Fate of research studies. J R Soc Med 1992 Feb;85(2):71-6.

> Eddie FCT. Moral and ethical dilemmas in relation to research projects. Br J Nurs 1994 Feb 24-Mar 9;3(4):182-4.

> Elizalde J. Bioethics as a new human rights emphasis in European research policy. Kennedy Inst Ethics J 1992 Jun;2(2):159-70.

> Elks ML. Conflict of interest and the physician-researcher. J Lab Clin Med 1995 Jul;126(1):19-23. Comment in: J Lab Clin Med 1995 Jul;126(1):5-6.

> Elliott C. Doing harm: living organ donors, clinical research and The Tenth Man. J Med Ethics 1995 Apr;21(2):91-6.

> Elliott D. Researchers as professionals, professionals as researchers: a context for laboratory research ethics. Prof Ethics 1995 Spring-Summer;4(3-4):5-16.

> Elliott D, Blanford P, Watson M. Scientific research ethics videography. Prof Ethics 1995 Spring-Summer;4(3-4):199-204.

> Ellis GB. Office for Protection from Research Risks (OPRR). Politic Life Sci 1994 Aug;13(2):271-3.

> Emson HE. Medicine, research and the criminal code [editorial]. CMAJ 1990 Jul 15;143(2):95-7.

> Ethical guidelines for FAPESP-sponsored research on human populations. Group on Bioethics and Population Research. Fundacao de Amparoa Pesquisa do Estado de Sao Paulo [editorial]. Braz J Med Biol Res 1994 Dec;27(12):2701-4.

> Ethical issues facing medical research in developing countries. Gambia Government/Medical Research Council Joint Ethical Committee. Lancet 1998 Jan 24;351(9098):286-7. Comment in: Lancet 1998 Jan 24;351(9098):225.

> Ethical issues in clinical research in neurology: advancing knowledge and protecting human research subjects. The Ethics and Humanities Subcommittee of the American Academy of Neurology. Neurology 1998 Mar;50(3):592-5.

> Ethics and clinical research in anaesthesia [editorial]. Lancet 1992 Feb 8;339(8789):337-8.

> Ethics of learning from patients [editorial]. Lancet 1994 Jul 9;344(8915):71-2.

> Ethics of research in relation to human subjects/patients [news]. J Med Ethics 1990 Jun;16(2):99-100.

> Evans BK. Human experimentation [letter]. Neurology 1991 Oct;41(10):1705-7. Comment on: Neurology 1991 May;41(5):697-702.

> Evans JG. Ethical problems of futile research [editorial]. J Med Ethics 1997 Feb;23(1):5-6.

> Evered DC. Deadly experiments. UK's programme was open and ethical [letter]. BMJ 1995 Jul 15;311(6998):192.

> Fabick MM. Ethical considerations for research on human subjects. Plast Surg Nurs 1995 Winter;15(4):225-7, 231.

> Faden RR. Human-subjects research today: final report of the Advisory Committee on Human Radiation Experiments. Acad Med 1996 May;71(5):482-3.

> Feinleib M. The epidemiologist's responsibilities to study participants. J Clin Epidemiol 1991;44 Suppl 1:73S-79S.

> Feinstein AR. Scientific paradigms and ethical problems in epidemiologic research. J Clin Epidemiol 1990;44(Suppl 1):119S-23S.

> Fethe C. Beyond voluntary consent: Hans Jonas on the moral requirements of human experimentation. J Med Ethics 1993 Jun;19(2):99-103.

> Fisher CB. Joining science and application: ethical challenges for researchers and practitioners. Prof Psychol Res Pract 1993 Aug;24(3):378-81.

> Fisher CB. A relational perspective on ethics-in-science decisionmaking for research with vulnerable populations. IRB Rev Hum Subj Res 1997 Sep-Oct;19(5):1-4.

> FitzGerald M. The practical implications of a critique of traditional science. Int J Nurs Pract 1995 Nov;1(1):2-11.

> Fitzpatrick JJ. Every nurse should be a patient, every researcher should be a subject [editorial]. Appl Nurs Res 1996 Feb;9(1):1.

> Fletcher JC. On restoring public bioethics. Politic Life Sci 1994 Feb;13(1):84-6. Comment on: Politic Life Sci 1993 Aug;12(2):205-19.

> Flournoy N, Hearne LB. Sharing scientific data III: planning and the research proposal. IRB Rev Hum Subj Res 1990;12(3):6-9.

> Fost N. Ethical dilemmas in medical innovation and research: distinguishing experimentation from practice. Semin Perinatol 1998 Jun;22(3):223-32.

> Fox R. What do patients want from medical research? [editorial]. J R Soc Med 1996 Jun;89(6):301-2.

> Fox RC. "Experiment Perilous": forty-five years as a participant observer of patient-oriented clinical research. Perspect Biol Med 1996 Winter;39(2):206-26.

> Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987 Jul 16;317(3):141-5.

> Freedman B. Placebo-controlled trials and the logic of clinical purpose. IRB Rev Hum Subj Res 1990;12(6):1-6.

> Freedman B. Scientific value and validity as ethical requirements for research: a proposed explication. IRB Rev Hum Subj Res 1987 Nov-Dec;9(6):7-10.

> Freedman B, Fuks A, Weijer C. Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research. Clin Res 1992 Dec;40(4):653-60.

> Friedman RJ. Scientific and ethical considerations in human clinical experimentation. South Med J 1992 Sep;85(9):917-22.

> Frommer PL, Ross J Jr, Benson JA Jr, Friedman WF, Friesinger GC 2d, Goldstein S, Huth EJ, Levine RJ, Malone TE, Quash JA, et al. Ethics in cardiovascular medicine. Task Force IV: Scientific responsibility and integrity in medical research. J Am Coll Cardiol 1990 Jul;16(1):24-9.

> Gallagher B, Creighton S, Gibbons J. Ethical dilemmas in social research: no easy solutions. Br J Soc Work 1995 Jun;25(3):295-11.

> Gardner L. Ethical questions [news]. Nurs Times 1992 May 27-Jun 2;88(22):20-1.

> Gates EA. New surgical procedures: can our patients benefit while we learn? Am J Obstet Gynecol 1997 Jun;176(6):1293-8; discussion 1298-9.

> Gavaghan H. US sets up new bioethics advisory board [news]. Nature 1995 Mar 16;374(6519):202.

> Gbolade BA. Exploitative collaborative research must be discouraged [letter]. BMJ 1997 May 3;314(7090):1347. Comment on: BMJ 1997 Feb 8;314(7078):390.

> Gellar ED. Ethics Committee report, Part 2: The Nuremberg Code. Ky Nurse 1990 Jul-Aug;38(4):16.

> Geussenhainer S. Status of the GCP guidelines in Europe. Methods Find Exp Clin Pharmacol 1993 May;15(4):223-8.

> Gilks CF. Ethical imperialism [letter]. N Engl J Med 1990 Jan 18;322(3):200-1.

> Gillett G. NZ medicine after Cartwright [news]. BMJ 1990 Apr 7;300(6729):892-4.

> Gillon R. No-fault compensation for victims of non-therapeutic research -- should government continue to be exempt? [editorial]. J Med Ethics 1992 Jun;18(2):59-60.

> Glantz L, Annas GJ, Grodin M, Mariner WK. Research in developing countries: taking benefit seriously. Hastings Cent Rep 1998 Nov-Dec;28(6):38-42.

> Goldberg HI. Ethical issues in administrative continuous improvement. Applying the concept of prior notification to the conduct of firm trials. Med Care 1990 Sep;28(9):822-33.

> Goldberg HI, McGough H. The ethics of ongoing randomization trials. Investigation among intimates. Med Care 1991 Jul;29(7 Suppl):JS41-8.

> Goldberg HI, McGough H. Testing the implementation of clinical guidelines. IRB Rev Hum Subj Res 1991 Nov-Dec;13(6):1-7.

> Goldberg JL, Phillips JO, Freedman B, Weijer C. Demarcating research and treatment interventions: a case illustration [and commentary]. IRB Rev Hum Subj Res 1992;14(4):5-8.

> Goldner JA. An overview of legal controls on human experimentation and the regulatory implications of taking Professor Katz seriously. St Louis Univ Law J 1993 Fall;38(1):63-134. Comment on: St Louis Univ Law J 1993 Fall;38(1):7-54.

> Goodkin DE, Kanoti GA. Ethical considerations raised by the approval of interferon beta-1b for the treatment of multiple sclerosis. Neurology 1994 Jan;44(1):166-70.

> Gore SM. The consumer principle of randomisation [letter]. Lancet 1994 Jan 1;343(8888):58.

> Gostin L. Ethical principles for the conduct of human subject research: population-based research and ethics. Law Med Health Care 1991 Fall-Winter;19(3-4):191-201.

> Green WP. Ethical dilemmas in perioperative research. AORN J 1990 Feb;51(2):612-3, 615.

> Grinnell F. Endings of clinical research protocols: distinguishing therapy from research. IRB Rev Hum Subj Res 1990 Jul-Aug;12(4):1-3.

> Grodin MA. The Nuremberg Code and medical research [symposium report]. Hastings Cent Rep 1990 May-Jun;20(3):4.

> Grodin MA, Annas GJ, Glantz LH. Medicine and human rights. A proposal for international action. Hastings Cent Rep 1993 Jul-Aug;23(4):8-12.

> Guest S. Compensation for subjects of medical research: the moral rights of patients and the power of research ethics committees. J Med Ethics 1997 Jun;23(3):181-5. Comment in: J Med Ethics 1997 Jun;23(3):131-2.

> Guest S. Compensation for the subjects of medical research [letter]. J Med Ethics 1997 Oct;23(5):328.

> Guidelines for medical research: [news]. Lancet 1990 Jan 20;335(8682):158.

> Gurman EB. Debriefing for all concerned: ethical treatment of human subjects. Psychol Sci 1994 May;5(3):139.

> Gwaltney JM Jr, Hendley O, Hayden FG, McIntosh K, Hollinger FB, Melnick JL, Turner RB. Updated recommendations for safety-testing of viral inocula used in volunteer experiments on rhinovirus colds. Prog Med Virol 1992;39:256-63.

> Halnan KE. Deadly experiments. No evidence of harm from tracer studies [letter]. BMJ 1995 Jul 15;311(6998):192.

> Hall AJ. Public health trials in West Africa: logistics and ethics. IRB Rev Hum Subj Res 1989 Sep-Oct;11(5):8-10.

> Halsey NA, Sommer A, Henderson DA, Black RE. Ethics and international research [editorial]. BMJ 1997 Oct 18;315(7114):965-6.

> Hanna KE, Cook-Deegan RM, Nishimi RY. Finding a forum for bioethics in U.S. public policy. Politic Life Sci 1993 Aug;12(2):205-19.

> Harrison L. Issues related to the protection of human research participants. J Neurosci Nurs 1993 Jun;25(3):187-93.

> Harth SC, Thong YH. Aftercare for participants in clinical research: ethical considerations in an asthma drug trial. J Med Ethics 1995 Aug;21(4):225-8.

> Harvey I, Chadwick R. Compensation for harm: the implications for medical research. Soc Sci Med 1992 Jun;34(12):1399-404.

> Havard JD. Ethical principles of the Commonwealth Medical Association. J Assist Reprod Genet 1997 Oct;14(9):500-2.

> Herrera CD. The other human-subject experiments. J Med Philos 1997 Apr;22(2):161-71.

> Heymann SJ. Patients in research: not just subjects, but partners. Science 1995 Aug 11;269(5225):797-8.

> Hickman JR Jr. Panel summary: from Zen riddle to the razor's edge. Aviat Space Environ Med 1991 Jul;62(7):632-7.

> Hind M. Ethical dilemmas in qualitative research: how do we respect autonomy? Br J Theatre Nurs 1993 Jan;2(10 Suppl):S1-S5.

> Hirschfeld RM, Winslade W, Krause TL. Protecting subjects and fostering research. Striking the proper balance. Arch Gen Psychiatry 1997 Feb;54(2):121-3. Comment on: Arch Gen Psychiatry 1997 Feb;54(2):105-11; Arch Gen Psychiatry 1997 Feb;54(2):113-6; Arch Gen Psychiatry 1997 Feb;54(2):117-20. Comment in: Arch Gen Psychiatry 1997 Feb;54(2):117-20.

> Hoffenberg R. Medicine and ethics [editorial]. J R Coll Physicians Lond 1990 Jan;24(1):6-7.

> Holden C. Draft research code raises hackles [news]. Science 1996 Dec 6;274(5293):1604.

> Holder AR. Can a court order participation in research? IRB Rev Hum Subj Res 1987 Jul-Aug;9(4):8-9.

> Holder AR. Medical insurance payments and patients involved in research. IRB Rev Hum Subj Res 1994;16(1-2):19-22.

> Holloway I, Wheeler S. Ethical issues in qualitative nursing research. Nurs Ethics 1995 Sep;2(3):223-32.

> Holm S. Moral reasoning in biomedical research protocols. Scand J Soc Med 1994 Jun;22(2):81-5.

> Holmes-Farley SR, Grodin MA. Foreword: law, medicine and socially responsible research. Am J Law Med 1998;24(2-3):153-62

> Hope T. Compensating subjects of medical research [editorial]. J Med Ethics 1997 Jun;23(3):131-2. Comment on: J Med Ethics 1997 Jun;23(3):181-5.

> Human guinea pigs [letter]. BMJ 1991 Feb 16;302(6773):411. Comment on: BMJ 1990 Dec 22-29;301(6766):1456-60.

> Husien AMA, Houston JG. Is it ethical to use patients to determine normal findings? [letter and response]. Clin Radiol 1993 Jul;48(1):70.

> Huston P. Ethics in evolution [editorial]. CMAJ 1996 Aug 15;155(4):363.

> International guidelines for ethical review of epidemiological studies. Law Med Health Care 1991 Fall-Winter;19(3-4):247-58.

> Is the practice of offering finder's fees for subject recruitment appropriate? Is the practice widespread or unique to my institution? What is the proper role of the IRB? What is the role of the institution? IRB Rev Hum Subj Res 1990 Jul-Aug;12(4):6.

> Is the practice of offering finder's fees for subject recruitment appropriate? Is the practice widespread or unique to my institution? What is the proper role of the IRB? What is the role of the institution? IRB Rev Hum Subj Res 1990 Jul-Aug;12(4):6.

> Iserson KV. Physician ethics in human research: the role of medical publications [editorial]. Ann Emerg Med 1990 Jul;19(7):828-30.

> Jacobsen G, Hals A. Medical investigators' views about ethics and fraud in medical research. J R Coll Physicians Lond 1995 Sep-Oct;29(5):405-9.

> Jacobson A. Human subjects used for biokinetic studies [letter]. Health Phys 1991 Oct;61(4):575-6. Comment on: Health Phys 1991 Apr;60(4):481-8.

> James FP. The experimental treatment exclusion clause: a tool for silent rationing of health care? J Leg Med 1991 Sep;12(3):359-418.

> Jones B. Ethics, morals and patient photography. J Audiov Media Med 1994 Apr;17(2):71-6.

> Jones DG. Anatomy and ethics: an exploration of some ethical dimensions of contemporary anatomy. Clin Anat 1998;11(2):100-5.

> Jones DJ. Conflict of interest in human research ethics. NCBHR Commun 1995;6(2):5-10.

> Jones R, Murphy E, Crosland A. Primary care research ethics. Br J Gen Pract 1995 Nov;45(400):623-6.

> Josefson D. New US rules could overturn Nuremberg Code [news]. BMJ 1996 Nov 16;313(7067):1223.

> Joseph KS. Ethics in clinical research: searching for absolutes [editorial]. CMAJ 1998 May 19;158(10):1303-5.

> Kaiser J. Broader oversight for research on humans? [news]. Science 1997 Jan 31;275(5300):605.

> Kass NE, Sugarman J. Are research subjects adequately protected? A review and discussion of studies conducted by the Advisory Committee on Human Radiation Experiments. Kennedy Inst Ethics J 1996 Sep;6(3):271-82. Comment in Kennedy Inst Ethics J 1996 Sep;6(3):283-7.

> Kass NE, Sugarman J, Faden R, Schoch-Spana M. Trust, the fragile foundation of contemporary biomedical research. Hastings Cent Rep 1996 Sep-Oct;26(5):25-9.

> Katz J. Do we need another advisory commission on human experimentation? Hastings Cent Rep 1995 Jan-Feb;25(1):29-31.

> Katz J. Human experimentation and human rights. St Louis Univ Law Rev 1993 Fall;38(1):7-54.

> Katz J. The regulation of human experimentation in the United States--a personal odyssey. IRB Rev Hum Subj Res 1987 Jan-Feb;9(1):1-6.

> Keatinge R, Chalmers I. Human guinea pigs [letters]. BMJ 1991 Feb 16;302(6773):411.

> Khan KS. Epidemiology and ethics: the people's perspective. Law Med Health Care 1991 Fall-Winter;19(3-4):202-6.

> Khan KS. Epidemiology and ethics: the perspective of the Third World. J Pub Health Policy 1994 Summer;15(2):218-25.

> Kiernan V. Patients confused by medical trials [news]. New Sci 1995 Jul 1;147(1984):7.

> King NM. Experimental treatment. Oxymoron or aspiration? Hastings Cent Rep 1995 Jul-Aug;25(4):6-15.

> King NMP, Henderson G. Treatments of last resort: informed consent and the diffusion of new technology. Mercer Law Rev 1991 Spring;42(3):1007-50.

> Kodish E, Stocking C, Ratain MJ, Kohrman A, Siegler M. Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. J Clin Oncol 1992 Nov;10(11):1810-6.

> Kondro W. Canada still seeking research code of ethics [news]. Lancet 1997 Sep 13;350(9080):794.

> Kondro W. Leaked document indicates Canada's future stance on human research [news]. Lancet 1998 Jun 20;351(9119):1868.

> Korgaonkar G, Tribe D. Legal implications of medical research. Br J Hosp Med 1993 Nov 3-16;50(9):551-2.

> Korn JH, Huelsman TJ, Reed CKS. Logic, ethics, and rhetoric of research on rape: a reply to Mosher and Bond. Ethics Behav 1992;2(2):123-8.

> Koschnitzke L, McCracken SC, Pranulis MF. Ethical considerations for quality assurance versus scientific research. West J Nurs Res 1992 Jun;14(3):392-6.

> Kottek SS, Lepicard E. Medical prayers and oaths in Jewish lore. Isr J Med Sci 1993 Jan;29(1):75.

> Kouri RP. The law governing human experimentation in Quebec. Rev Droit (Universite de Sherbrooke) 1990;22(1):77-108.

> Kumar S. Hope, but little cheer, for India's revised code of ethics [news]. Lancet 1998 Jan 31;351(9099):347.

> Landrum RE, Chastain G. Experiment spot-checks: a method for assessing the educational value of undergraduate participation in research. IRB Rev Hum Subj Res 1995 Jul-Aug;17(4):4-6.

> Larson E. Exclusion of certain groups from clinical research. Image J Nurs Sch 1994 Fall;26(3):185-90.

> Lasagna L. The Helsinki Declaration: timeless guide or irrelevant anachronism? [editorial]. J Clin Psychopharmacol 1995 Apr;15(2):96-8.

> Last JM. Epidemiology and ethics. Law Med Health Care 1991 Fall-Winter;19(3-4):166-74.

> Last JM. Obligations and responsibilities to research subjects. J Clin Epidemiol 1990;44(Suppl 1):95S-101S.

> Law PK, Cho M. Misrepresentation conspires against potential treatment for muscular dystrophy [letter and response]. IRB Rev Hum Subj Res 1995;17(2):4-8.

> Leffall LD Jr. Claude H Organ, Jr Honorary Sandoz Nutrition Lectureship. Ethics in research and surgical practice. Am J Surg 1997 Dec;174(6):589-91.

> Legislative roundup: protection of human subjects key issue for Congress [news]. J Natl Cancer Inst 1998 Jan 21;90(2):97-8.

> Lehrman S. Call for human subjects monitoring body [news]. Nature 1997 Jul 24;388(6640):313.

> Lemaire F, Blanch L, Cohen SL, Sprung C. Informed consent for research purposes in intensive care patients in Europe--part I. An official statement of the European Society of Intensive Care Medicine. Working Group on Ethics. Intensive Care Med 1997 Mar;23(3):338-41.

> Lemaire F, Blanch L, Cohen SL, Sprung C. Informed consent for research purposes in intensive care patients in Europe--part II. An official statement of the European Society of Intensive Care Medicine Working Group on Ethics. Intensive Care Med 1997 Apr;23(4):435-9.

> Lenoir N. Are attitudes towards bioethics entering a new era? [editorial]. J Med Ethics 1997 Apr;23(2):69-70.

> Levine RJ. New international ethical guidelines for research involving human subjects [editorial]. Ann Intern Med 1993 Aug 15;119(4):339-41.

> Levy L. "Primum non nocere", the ethics of trials of leprosy chemotherapy [editorial]. Leprosy Rev 1993 Sep;64(3):185-7.

> Levy L. Rejoinder [letter]. Indian J Lepr 1990 Jul-Sep;62(3):404-5. Comment on: Indian J Lepr 1989 Oct;61(4):419-27.

> Lewith GT. Ethical problems in evaluating complementary medicine. Bull Med Ethics 1996 Aug;120:17-20.

> Lilford R, Fetal Compromise Group. Formal measurement of clinical uncertainty: prelude to a trial in perinatal medicine. BMJ 1994 Jan 8;308(6921):111-2.

> Limits on patient and volunteer exposure during clinical magnetic resonance diagnostic procedures. Recommendations for the practical application of the Board's statement. Ann N Y Acad Sci 1992 Mar 31;649:376-98.

> Lind SE. Dilemmas in paying for clinical research: the view from the IRB. IRB Rev Hum Subj Res 1987 Mar-Apr;9(2):1-5.

> Lind SE. Innovative medical therapies: between practice and research. Clin Res Oct 1988; 36(6):546-51.

> Lindsay RCL, Adair JG. Do ethically recommended research procedures influence the perceived ethicality of social psychological research? Can J Behav Sci 1990 Jul;22(3):282-94.

> Lloyd RD. What is a radiation experiment? Health Phys 1996 Feb;70(2):147-50.

> Lock S. Fraud in medical research. J R Coll Physicians Lond 1997 Jan-Feb;31(1):90-4. Comments in: J R Coll Physicians Lond 1997 Jan-Feb;31(1):8-9; J R Coll Physicians Lond 1997 Mar-Apr;31(2):223.

> Lock S. Research misconduct: a brief history and a comparison. J Intern Med 1994 Feb;235(2):123-7.

> London L, Hoffman M, Shungking M, Midgley A, Myers J, de Pinho H, Cooper D, Morar R, Makan B, Mohamed H , Rother A, Reagon G, Sayed R. Ethics of research involving vulnerable groups [editorial]. S Afr Med J 1997 Dec;87(12):1667-8.

> Loue S, Okello D, Kawuma M. Research bioethics in the Ugandan context: a program summary. J Law Med Ethics 1996 Spring;24(1):47-53.

> Luna F. Vulnerable populations and morally tainted experiments. Bioethics 1997 Jul-Oct;11(3-4):256-64.

> Lynn J, Johnson J, Levine RJ. The ethical conduct of health services research: a case study of 55 institutions' applications to the SUPPORT project. Clin Res 1994 Feb;42(1):3-10.

> Macilwain C. US bioethics panel poised to judge local review boards [news]. Nature 1996 Oct 10;383(6600):466.

> Macklin R. Ethical principles in the conduct of menopause research. Exp Gerontol 1994 May-Aug;29(3-4):519-24.

> Macklin R. The paradoxical case of payment as benefit to research subjects. IRB Rev Hum Subj Res 1989 Nov-Dec;11(6):1-3.

> Main P, Meslin E. Ethics and dental research: mechanisms for oversight and fostering a climate for ethical research. Ont Dent 1992 Oct;69(8):12-5.

> Maloney DM. Agency will pay for care of injured research subjects [news]. Hum Res Rep 1996 Nov;11(11):3.

> Maloney DM. Federal report says protection of human subjects is threatened by numerous factors [news]. Hum Res Rep 1996 May;11(5):1-3.

> Maloney DM. Government could be sued over human experimentation problems [news]. Hum Res Rep 1996 Oct;11(10):6.

> Maloney DM. Harm to research subjects will now lead to new federal regulations [news]. Hum Res Rep 1994 Dec;9(12):1-3.

> Maloney DM. Research subject loses case against physician, IRB, and hospital [news]. Hum Res Rep 1995 Feb;10(2):4-5.

> Maloney DM. To inform or not to inform -- that is the question for researchers affected by a proposed rule. Hum Res Rep 1995 Mar;10(3):1-3.

> Maloney DM. Two agencies issue new policies on human subjects. Hum Res Rep 1995 Nov;10(11):3.

> Mandel ID. On being a scientist in a rapidly changing world. J Dent Res 1996 Feb;75(2):841-4.

> Mariner WK. Public confidence in public health research ethics. Public Health Rep 1997 Jan-Feb;112(1):33-6. Comment on: Public Health Rep 1997 Jan-Feb;112(1):29-32. Comment in: Public Health Rep 1997 Jul-Aug;112(4):266.

> Marquis D, Stephens R, Levine RJ. The doctor's unproven belief and the subject's informed choice: another commentary. IRB Rev Hum Subj Res 1989 May-Jun;11(3):8-11.

> Marshall E. Hepatitis study: drug trial deaths deemed unavoidable [news]. Science 1994 Jun 10;264(5165):1530.

> Marshall E. Political fallout: a national bioethics board? [news]. Science 1994 Jan 28;263(5146):473.

> Marshall TD. Working paper on experiments with humans useful but flawed. CMAJ 1990 May 15;142(10):1124-5.

> Martin PA. Is it research? Appl Nurs Res 1995 Nov;8(4):199-201.

> Martin PA. Responsibilities when a patient is a research subject. Applied Nurs Res 1994 Aug;7(3):158-61.

> Marwick C. Bioethics group considers transnational research [news]. JAMA 1998 May 13;279(18):1425.

> Marwick C. Compensation for injured research subjects [news]. JAMA 1998 Jun 17;279(23):1854.

> Marwick C. Ethicist faults human research subject protection [news]. JAMA 1994 Apr 27;271(16):1228-9.

> Marwick C. NCI trial hearing elicits vow of more oversight [news]. JAMA 1994 May 11;271(18):1391.

> Marwick C. Protecting human subjects of biomedical research [news]. JAMA 1997 Feb 5;277(5):369.

> McGee G. A piece of my mind. Subject to payment? JAMA 1997 Jul 16;278(3):199-200.

> McGough H. Finder's fees may compromise the provider-patient relationship [letter]. IRB Rev Hum Subj Res 1991;13(1-2):23.

> McGuire ER. The entitlement of Veterans Affairs medical patients to vulnerable population status for human medical research [note]. Health Matrix 1992 Summer;2(2):259-301.

> McLarty JW, Levine RJ. How many subjects are required for a study? [article and commentary]. IRB Rev Hum Subj Res 1987 Sep-Oct;9(5):1-3.

> McMahon FG. Reviewing subject recruitment: new rules from Rockville. IRB Rev Hum Subj Res 1988 May-Jun;10(3):6-7.

> McNeill P. Paying people to participate in research: why not? A response to Wilkinson and Moore. Bioethics 1997 Oct;11(5):390-6.

> McNeill PM. Research ethics review in Australia, Europe and North America. IRB Rev Hum Subj Res 1989 May-Jun;11(3):4-7.

> Medical ethics: should medicine turn the other cheek? [editorial]. Lancet 1990 Oct 6;336(8719):846-7. Comments in: Lancet 1990 Oct 27;336(8722):1074; Lancet 1990 Nov 17;336(8725):1261; Lancet 1991 Feb 9;337(8737):369.

> Mendelson JH. Protection of participants and experimental design in clinical abuse liability testing. Br J Addict 1991 Dec;86(12):1543-8.

> Meslin EM, Sutherland HJ, Lavery JV, Till JE. Principlism and the ethical appraisal of clinical trials. Bioethics 1995 Oct;9(5):399-418.

> Meyers K. A new problem for IRBs: screening for HIV antibodies. IRB Rev Hum Subj Res 1989 Nov-Dec;11(6):10-1.

> Middle C, Johnson A, Petty T, Sims L, Macfarlane A. Ethics approval for a national postal survey: recent experience. BMJ 1995 Sep 9;311(7006):659-60. Comments in: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Dec 9;311(7019):1571; BMJ 1995 Dec 9;311(7019):1572; BMJ 1996 Jan 6;312(7022):54.

> Mike V. Suspended judgment. Ethics, evidence, and uncertainty. Control Clin Trials 1990 Jun;11(3):153-6.

> Miller J. Towards an international ethic for research with human beings. IRB Rev Hum Subj Res 1988 Nov-Dec;10(6):9-11.

> Miller J, Crigger BJ. Ethical standards for human subject research in developing countries [article and editor's note]. IRB Rev Hum Subj Res 1992;14(3):7-8.

> Miller RL. Human guinea pigs--protecting human subjects. J Ky Med Assoc 1997 Mar;95(3):109-10.

> Milner LS, Fuster V, Califf RM, Chesebro JH. Double-blind coumadin research -- an ethical dilemma [letter and response]. Am J Cardiol 1994 Apr 1;73(9):725-6.

> Mitchell EA, Hassall IB, Scragg R, Taylor BJ, Ford RP, Allen EM. The New Zealand Cot Death Study: some legal and ethical issues. J Paediatr Child Health 1992;28 Suppl 1:S17-20.

> Mitchell L. Resources for ethical decision making. J Cardiovasc Nurs 1995 Apr;9(3):78-87.

> Moore DL. An IRB member's perspective on access to innovative therapy. Albany Law Rev 1994;57(3):559-81.

> Moreno JD. Ethical considerations of industry-sponsored research: the use of human subjects. J Am Coll Nutr 1996 Oct;15(5 Suppl):35S-40S.

> Morgan A, Harris M, Boyce P, Wilhelm K. Has social psychiatry met its Waterloo? Methodological and ethical issues in a community study. Aust N Z J Psychiatry 1993 Sep;27(3):411-21.

> Morreim EH. Patient-funded research: paying the piper or protecting the patient? IRB Rev Hum Subj Res 1991;13(3):1-6.

> Mossman KL. Radiation risk communication in human subjects research [letter]. Health Phys 1996 May;70(5):749-50. Comment on: Health Phys 1996 Jan;70(1):111-7.

> Munro AJ. Publishing the findings of clinical research. BMJ 1993 Nov 20;307(6915):1340-1.

> Nakajima H. The responsibilities of epidemiologists [foreword]. Law Med Health Care 1991 Fall-Winter;19(3-4):164-5.

> National Bioethics Advisory Commission. 1996-1997 Annual report [monograph on the Internet]. Rockville (MD): The Commission; 1998 Mar [cited 1999 May 18]. [39 p.]. Available from: http://bioethics.gov/pubs/ann_rept.pdf

> National Council for Hospice and Specialist Palliative Care Services (Great Britain). Guidelines on research in palliative care [official statement]. Bull Med Ethics 1995 Aug;(110):19-20.

> National Council on Bioethics in Human Research (Canada). The Ethics of Human Experimentation: reinventing the Research Ethics Board: Proceedings of a National Workshop held in Ottawa, Ontario, March 5-6, 1995. NCBHR Commun 1996;7(1):5-35.

> Newburg SM, Holland AE, Pearce LA. Motivation of subjects to participate in a research trial. Applied Nurs Res 1992 May;5(2):89-93.

> Newman DH. A medical school honor code: what does it mean? Pharos 1997 Spring;60(2):2-4.

> Nicoll LH, Beyea SC. The ethical conduct of research. AORN J 1998 Jun;67(6):1237-40, 1243.

> Nightingale SL. From the Food and Drug Administration. JAMA 1991 Sep 18;266(11):1482.

> Nishimi RY. From the Congressional Office of Technology Assessment: Biomedical ethics in U.S. public policy. JAMA 1993 Dec 22-29;270(24):2911.

> Nordenfelt L. Prevention and ethics in medicine: the case of diabetes prevention. J Pediatr Endocrinol Metab 1996 May-Jun;9(3):381-6.

> Norway Ministry of Education and Research. Mandate of the Norwegian National Committee for Medical Research Ethics, 16 May 1990. Bull Med Ethics 1990 Oct;62:9.

> Nuremberg Trials. The Nuremberg Code. Law Med Health Care 1991 Fall-Winter;19(3-4):266.

> Nyapadi TJ. Legal article II: legal aspects of medical research and the way forward. Cent Afr J Med 1995 Apr;41(4):127-31.

> Oddi LF, Cassidy VR. Nursing research in the United States: the protection of human subjects. Int J Nurs Stud 1990;27(1):21-33.

> Office of Science and Technology Policy (US). Federal policy for the protection of human subjects; final rule. Fed Regist 1991 Jun 18;56(117):28003-23.

> Oldham RK. Selling experiment treatment [letter]. Hastings Cent Rep 1990 Nov-Dec;20(6):43-4. Comment on: Hastings Cent Rep 1989 Sep-Oct;19(5):36-43.

> On stopping a trial before its time [editorial]. Lancet 1993 Nov 27;342(8883):1311-2.

> Palca J. Conflict over release of clinical research data [news]. Science 1991 Jan 25;251(4992):374-5.

> Parker LS, Arnold RM, Meisel A, Siminoff LA, Roth LH. Ethical factors in the allocation of experimental medical therapies: the chronic left ventricular assist system. Clin Res 1990 Oct;38(3):537-44.

> Pearn J. Publication: an ethical imperative. BMJ 1995 May 20;310(6990):1313-5. Comments in: BMJ 1995 May 20;310(6990):1277-8; BMJ 1995 Sep 9;311(7006):688.

> Pellegrino ED. Beneficence, scientific autonomy, and self-interest: ethical dilemmas in clinical research. Camb Q Healthc Ethics 1992 Fall;1(4):361-9.

> Pettit P. Instituting a research ethic. Control Clin Trials 1993 Aug;14(4):261-5.

> Pettit P. Instituting a research ethic: chilling and cautionary tales. Bioethics 1992 Apr;6(2):90-112.

> Pettit P. Suspended judgment: instituting a research ethic. Control Clin Trials 1993 Aug;14(4):261-5.

> Phillips DF. New voices ask to be heard in bioethics. Camb Q Healthc Ethics 1992 Spring;1(2):169-77.

> Phillips JM. Reducing postmortem examination refusal by families of research subjects. IRB Rev Hum Subj Res 1997 Sep-Oct;19(5):10-1.

> Pinch WJ. Research and nursing: ethical reflections. N HC Perspect Community 1996 Jan-Feb;17(1):26-31.

> Pollock RE, Curley SA, Lotzova E. Ethics of research training for NIH T32 surgical investigators. J Surg Res 1995 Feb;58(2):247-51.

> Popper SE, McCloskey K. Ethics in human experimentation: examples in aeromedical research. Mil Med 1995 Jan;160(1):12-5.

> Porter JP. The federal policy for the protection of human subjects. IRB Rev Hum Subj Res 1991 Sep-Oct;13(5):8-9.

> Porter JP. Protecting human research subjects: the Office for Protection from Research Risks. Kennedy Inst Ethics J 1992 Sep;2(3):279-82.

> Porter JP, Dustira AK. Policy development lessons from two federal initiatives: protecting human research subjects and handling misconduct in science. Acad Med 1993 Sep;68 Suppl 9:S51-5.

> Potter RL. An integrated ethics program for managed care organizations. Trends Health Care Law Ethics 1995 Winter-Spring;10(1-2):87-90.

> Pragmatism in codes of research ethics [editorial]. Lancet 1998 Jan 24;351(9098):225.

> Prentice ED, Reitemeier PJ, Antonson DL, Kelso T, et al. Bill of Rights for research subjects. IRB Rev Hum Subj Res 1993 Mar-Apr;15(2):7-9.

> Principles for the protection of patients and volunteers during clinical magnetic resonance diagnostic procedures. Ann N Y Acad Sci 1992 Mar 31;649:372-5.

> Raudonis B, Kirschling JM. Hospice research: the importance of program participation. Am J Hosp Palliat Care 1992 Jul-Aug;9(4):21-5.

> Recommendations guiding physicians in biomedical research involving human subjects. World Medical Association Declaration of Helsinki. J Med Liban 1994;42(2):88-9.

> Reiser SJ. Misconduct and the development of ethics in the biological sciences. Camb Q Healthc Ethics 1994 Fall;3(4):499-505.

> Rennie D, Yank V. Disclosure to the reader of institutional review board approval and informed consent [editorial]. JAMA 1997 Mar 19;277(11):922-3. Comment on: JAMA 1997 Mar 19;277(11):909-14; JAMA 1997 Mar 19;277(11):925-6; JAMA 1997 Mar 19;277(11):927-34; JAMA 1997 Aug 13;278(6):477.

> Resch KL, Ernst E. The ethical type II error [letter]. Lancet 1996 Jan 6;347(8993):62-3. Comment on: Lancet 1995 Oct 28;346(8983):1115-6.

> Research involving patients. Summary and recommendations of a report of the Royal College of Physicians. J R Coll Physicians Lond 1990 Jan;24(1):10-4.

> Research. The Ethics Committee of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg 1996 Sep;115(3):195-9.

> Response to ethical challenges in stroke research. The NINDS rt-PA Stroke Study Group [editorial]. Stroke 1998 Aug;29(8):1492-3. Comment on: Stroke 1998 Aug;29(8):1725-9.

> Rhein R. NIH confused about ethics rules [news]. BMJ 1991 Aug 10;303(6798):329-30.

> Ridley A. Ill-gotten gains: on the use of results from unethical experiments in medicine. Public Aff Q 1995 Jul;9(3):253-66.

> Riis P. Ethics: Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine; distributional ethics and prioritization. JAMA 1997 Jun 18;277(23):1855-6.

> Riis P. Medical ethics in the European Community. J Med Ethics 1993 Mar;19(1):7-12. Comment in: J Med Ethics 1993 Mar;19(1):3-4.

> Riis P. Research ethics--a widening of the scope and extrapolation into the future. J Intern Med 1995 Dec;238(6):521-9.

> Ringheim K. Ethical issues in social science research with special reference to sexual behaviour research. Soc Sci Med 1995 Jun;40(12):1691-7.

> Roberts FD, Newcomb PA, Fost N. Perceived risks of participation in an epidemiologic study. IRB Rev Hum Subj Res 1993;15(1):8-10.

> Robley LR. The ethics of qualitative nursing research. J Prof Nurs 1995 Jan-Feb;11(1):45-8.

> Rodney P, Starzomski R. Constraints on the moral agency of nurses. Can Nurse 1993 Oct;89(9):23-6.

> Rogero-Anaya P, Carpintero-Avellaneda JL, Vila-Blasco B. Ethics and research in nursing. Nurs Ethics 1994 Dec;1(4):216-23.

> Rogers A. Bioethics convention signed, but doubts remain [news]. Lancet 1997 Apr 12;349(9058):1079.

> Rogers A. European bioethics convention stalled again [news]. Lancet 1994 Jul 9;344(8915):117-8.

> Roila F, Tonato M, Del Favero A. Publication of unethical studies on the treatment of chemotherapy-induced emesis [letter]. J Clin Oncol 1991 May;9(5):891-3. Comment on: J Clin Oncol 1990 Oct;8(10):1721-7.

> Rosenthal E. The International Covenant on Civil and Political Rights and the rights of research subjects. Account Res 1996;4(3-4):253-60.

> Rosner F, Bennett AJ, Cassell EJ, Farnsworth PB, Halpern AL, Henry JB, Kanick V, Kark PR, Landolt AB, Loeb L, et al. The ethics of using scientific data obtained by immoral means. N Y State J Med 1991 Feb;91(2):54-9.

> Royal Australasian College of Surgeons. Code of ethics. Arch Surg 1996 Aug;131(8):900-1.

> Royal College of Physicians. Research involving patients: summary and recommendations of a report of the Royal College of Physicians. J R Coll Physicians Lond 1990 Jan ;24(1):10-4.

> Saha S, Saha PS. Biomedical ethics and the biomedical engineer: a review. Crit Rev Biomed Eng 1997;25(2):163-201.

> Sanchez-Sweatman L. Research, patients and nurses. Can Nurse 1994 Dec;90(11):53-4.

> Sass HM. Ethical considerations in phase I clinical trials. Onkologie 1990 Apr;13(2):85-8.

> Savulescu J. Commentary: safety of participants in non-therapeutic research must be ensured. BMJ 1998 Mar 21;316(7135):891-2; discussion 893-4.

> Scheuer R. Research in the hospital setting on human subjects. Protecting the patient and the institution. Mt Sinai J Med 1993 Oct;60(5):391-8.

> Schneiderman LJ, Jecker NS. Is the treatment beneficial, experimental, or futile? Camb Q Healthc Ethics 1996 Spring;5(2):248-56.

> Schulte PA. Ethical issues in the communication of results. J Clin Epidemiol 1991;44 Suppl 1:57S-61S.

> Schwartz TB. Sinful saints or saintly sinners? [editorial]. South Med J 1995 May;88(5):596-8.

> Seitz J, O'Neill P. Ethical decision-making and the Code of Ethics of the Canadian Psychological Association. Can Psychol 1996 Feb;37(1):23-30.

> Sherer DM, Abramowicz JS. Ethics in medical studies with human subjects [letter]. Am J Obstet Gynecol 1991 Dec;165(6 Pt 1):1895-6. Comment on: Am J Obstet Gynecol 1990 Oct;163(4 Pt 1):1261-3.

> Sieber JE. Ethical considerations in planning and conducting research on human subjects. Acad Med 1993 Sep;68 Suppl 9:S9-13.

> Siegler M. Ethical issues in innovative surgery: should we attempt a cadaveric hand transplantation in a human subject? Transplant Proc 1998 Sep;30(6):2779-82.

> Siegler M, Pellegrino ED, Singer PA. Clinical medical ethics. J Clin Ethics 1990 Spring;1(1):5-9.

> Skinner LJ, Berry KK, Biro M, Jackson T. Research ethicality: the perceptions of participants and their participation willingness. Curr Psychol Res Rev 1991 Spring-Summer;10(1-2):79-91.

> Skrabanek P. Why is preventive medicine exempted from ethical constraints? J Med Ethics 1990 Dec;16(4):187-90. Comments in: J Med Ethics 1990 Dec;16(4):187-90; J Med Ethics 1991 Mar;17(1):46; J Med Ethics 1991 Jun;17(2):104; J Med Ethics 1991 Sep;17(3):162-3.

> Slatkoff SF, Curtis P, Coker A. Patients as subjects for research: ethical dilemmas for the primary care clinician-investigator. J Am Board Fam Pract 1994 May-Jun;7(3):196-201. Comments in: J Am Board Fam Pract 1994 May-Jun;7(3):261-3; J Am Board Fam Pract 1994 May-Jun;7(3):263-6.

> Slyter H. Ethical challenges in stroke research. Stroke 1998 Aug;29(8):1725-9. Comment in: Stroke 1998 Aug;29(8):1491-2; Stroke 1998 Aug;29(8):1492-3; Stroke 1998 Aug;29(8):1493-4.

> Smith GP. Toward an international standard of scientific inquiry. Health Matrix 1992 Summer;2(2):167-91.

> Smith MM. Chiropractic research: the ethics [commentary]. J Manipulative Physiol Ther 1992 Oct;15(8):536-41.

> Spiro HM. Mammon and medicine: the rewards of clinical trials. JAMA 1986;255(9):1174-5.

> Squires BP. Ethics of human research [editorial]. CMAJ 1994 Oct 15;151(8):1103.

> Sriram TG, Chatterjee S, Jain S, Vergheese M, Raghavan KS, Murthy RS. Opinion survey of physicians on ethical issues in medical research. J Indian Med Assoc 1991 Jul;89(7):187-90.

> Stanton AL, Burker EJ, Kershaw D. Effects of researcher follow-up of distressed subjects: tradeoff between validity and ethical responsibility. Ethics Behav 1990;1(2):105-12.

> Steadman JH. Ethical review of human experimentation in the consumer products industry. Neth J Med 1998 Apr;52(4):138-41.

> Steinberg A. Ethical considerations in modern human experimentation. Cancer Invest 1991;9(1):99-105.

> Stone R. Eyeing a project's ethics [news]. Science 1993 Mar 26;259(5103):1820.

> Stuber ML, Reed GM. Never been done before--consultative issues in innovative therapies. Gen Hosp Psychiatry 1991 Sep;13(5):337-43.

> Suggested ethical standards for South African nurse researchers. Curationis 1990 Dec;13(3-4):91-2.

> Sutherland HJ, Meslin EM, da Cunha R, Till JE. Judging clinical research questions: what criteria are used? Soc Sci Med 1993 Dec;37(12):1427-30.

> Symposium on the Law of 20 December 1988 Concerning Biomedical Research on Human Subjects: Protection committee or ethics committee? Int J Bioethics 1993 Mar;4(Special Issue):61-4.

> Szawarski Z. Research ethics in Eastern Europe. Bull Med Ethics 1992 Oct;82:13-8.

> Tabak N. Medical experimentation on humans: a moral point of view. Med Law 1992;11(5-6):353-62.

> Tetting DW. Preparing for the human subjects review. Crit Care Nurs Q 1990 Mar;12(4):10-6.

> The Common Rule. 10 C.F.R. Sect. 745 (1991). Adopted June 18 by 16 Federal agencies.

> Thomison JB. Practice-based research [editorial]. South Med J 1991 Apr;84(4):419-20. Comment in: South Med J 1991 Nov;84(11):1414.

> Thornton H. A sacrifice for others? Ethical dilemmas surrounding the UK randomised trial for the management of screen-detected ductal carcinoma in situ of the breast. Prof Nurse 1993 Mar;8(6):402-4.

> Thornton H. Whose interests: patient's or researcher's? Bull Med Ethics 1993 Nov;93:13-9.

> Toremalm NG. Ethical problems in rhinologic research. Rhinology 1991 Dec;29(4):253-6.

> Tranoy KE. Research ethics: a European perspective. Bull Med Ethics 1993 Oct;92:28-33.

> Tranoy KE. Modern medical research ethics [editorial]. Scand J Prim Health Care 1993 Sep;11(3):161-2.

> Tuffs A. Germany: ethics of clinical experiment questions [news]. Lancet 1992 Sep 26;340(8822):782.

> Tyson JE. Use of unproven therapies in clinical practice and research: how can we better serve our patients and their families? Semin Perinatol 1995 Apr;19(2):98-111.

> van Gelderen CE, Savelkoul TJ, Sangster B. Safety studies in humans II: Human volunteer studies. Food Chem Toxicol 1990 Nov;28(11):775-8.

> van Leeuwen E. Between scientific application and therapy: the ethical consideration. Dev Biol Stand 1990;71:161-70.

> van Wyk C. Introduction to the framework and functions of law in South Africa. Med Law 1990;9(5):1110-21.

> Vennell MAM. Medical research and treatment: ethical standards in the international context. Med Law Int 1995;2(1):1-21.

> Volunteering for research [editorial]. Lancet 1992 Oct 3;340(8823):823-4. Comments in: Lancet 1992 Oct 31;340(8827):1103; Lancet 1992 Nov 14;340(8829):1229-30; Lancet 1992 Nov 14;340(8829):1230.

> Wadman M. Clinton sketches out his 'ethical guideposts' for modern biology [news]. Nature 1997 May 22;387(6631):323.

> Wadman M. National Institutes of Health sets up its own bioethics panel [news]. Nature 1997 Dec 18-25;390(6661):651.

> Wadman M. Pesticide tests on humans cause concern [news]. Nature 1998 Aug 6;394(6693):515.

> Wadman M. US research safety system 'in jeopardy' [news]. Nature 1998 Jun 18;393(6686):610.

> Wald N. Ethical issues in randomised prevention trials. BMJ 1993 Feb 27;306(6877):563-5.

> Ward CM. Surgical research, experimentation and innovation. Br J Plast Surg 1994 Mar;47(2):90-4.

> Warden J. Patients' rights in research [letter from Westminster]. BMJ 1991 Dec 14;303(6816):1498.

> Watson R. European bioethics convention signed [news]. BMJ 1997 Apr 12;314(7087):1066.

> Weed DL. Science, ethics guidelines, and advocacy in epidemiology. Ann Epidemiol 1994 Mar;4(2):166-71.

> Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10 Research ethics. CMAJ 1997 Apr 15;156(8):1153-7. Comment in: CMAJ 1997 Oct 15;157(8):1020, 1022.

> Weil V, Hollander R. Sharing scientific data II: normative issues. IRB Rev Hum Subj Res 1990 Mar-Apr;12(2):7-8.

> Weiss GB, Winslade WJ. Is post-marketing drug follow-up research or advertising? IRB Rev Hum Subj Res 1987 Jul-Aug;9(4):10-1.

> Wells F. Clinical trial compensation [letter]. Lancet 1995 Oct 28;346(8983):1164.

> Wells F. Fraud in medical research [letter]. J R Coll Physicians Lond 1997 Mar-Apr;31(2):223. Comment on: J R Coll Physicians Lond 1997 Jan-Feb;31(1):90-4.

> Wertz DC. Providers' gender and moral reasoning: a proposed agenda for research on providers and patients. Fetal Diagn Ther 1993 Apr;8(Suppl 1):81-9.

> Westrin CG. Ethical, legal, and political problems affecting epidemiology in European countries. IRB Rev Hum Subj Res 1993;15(3):6-8.

> Westrin CG, Nilstun T, Smedby B, Haglund B. Epidemiology and moral philosophy. J Med Ethics 1992 Dec;18(4):193-6.

> What's new in research ethics. Bull Med Ethics 1996 Oct;122:13-8.

> Wichman A, Carter MA. Bioethics at the National Institutes of Health. Kennedy Inst Ethics J 1991 Sep;1(3):257-62.

> Wichman A, Mills D, Sandler AL. Exempt research: procedures in the intramural research program of the National Institutes of Health. IRB Rev Hum Subj Res 1996;18(2):3-5.

> Wichman A, Smith J, Mills D, Sandler AL. Collaborative research involving human subjects: a survey of researchers using international single project assurances. IRB Rev Hum Subj Res 1997;19(1):1-6.

> Wilkie P. Ethical issues in qualitative research in palliative care. Palliat Med 1997 Jul;11(4):321-4.

> Wilkie P. Ethical issues in urology: the patient's perspective. Br J Urol 1995 Nov;76 Suppl 2:5-7.

> Wilkinson M, Moore A. Inducement in research. Bioethics 1997 Oct;11(5):373-89.

> Williams J. Ethical review of clinical research [conference report]. Bull Med Ethics 1993 Nov;93:28-30.

> Wirshing WC. In a perfect world none of this would concern us. J Calif Alliance Ment Ill 1994;5(1):30.

> World Medical Association. Declaration of Helsinki. Law Med Health Care 1991 Fall-Winter;19(3-4):264-5.

> World Medical Association declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997 Mar 19;277(11):925-6.

> World Medical Association is reanimated [news]. Bull Med Ethics 1994 Sep;101:3-5.

> Return to table of contents

> ## Overview of the ethics of research involving human participants - Books

> American Hospital Association. Directory of biomedical ethics organizations. Chicago: Hospital Ethics; 1989. 165 p.

> Annas GJ. The rights of patients: the basic ACLU guide to patient rights. Carbondale (IL): Southern Illinois University Press; 1989.

> Annas GJ. Standard of care: the law of American bioethics. New York: Oxford University Press; 1993. 291 p.

> Annual Report of the National Council on Bioethics in Human Research, Jan 1990. Ottawa: NCBHR; 1990 Jan. 60 p.

> Annual Report of the National Council on Bioethics in Human Research, Jan 1991. Ottawa: NCBHR; 1991 Jan. 53 p.

> Arras J, Steinbock B. Ethical issues in modern medicine. 4th ed. Mountain View (CA): Mayfield Pub. Co; c1995. 681 p.

> Bankowski Z, Bryant JH, Last JM, editors. Ethics and epidemiology: international guidelines: proceedings of the 25th Council for International Organization of Medical Sciences Conference; 1990 Nov 7-9; Geneva, Switzerland. Switzerland: CIOMS; 1991.

> Bankowski Z, Levine RJ. Ethics and research on human subjects: international guidelines: proceedings of the 26th Council for International Organization of Medical Sciences Conference; 1992 Feb 5-7; Geneva, Switzerland. Switzerland: CIOMS; 1993. 63 p.

> Beach D. The responsible conduct of research. New York: VCH Publishers; 1996. 161 p.

> Beauchamp TL, Childress JF. Principles of biomedical ethics. 3rd ed. New York: Oxford University Press; 1989. 470 p.

> Beauchamp TL, Childress JF. Principles of biomedical ethics. 4th ed. New York: Oxford University Press; 1994. 546 p.

> Beauchamp TL, Walters L, editors. Contemporary issues in bioethics. 3rd ed. Belmont (CA): Wadsworth Pub. Co.; 1989. 655 p.

> Beauchamp TL, Walters L, editors. Contemporary issues in bioethics. 4th ed. Belmont (CA): Wadsworth Pub. Co; c1994. 752 p.

> Bebeau MJ, Pimple KD, Muskavitch KMT, Smith DH, Borden SL. Moral reasoning in scientific research: cases for teaching and assessment. Bloomington (IN): Indiana University-Bloomington, Poynter Center for the Study of Ethics and American Institutions; c1998. 100 p.

> Beecher HK. Research and the individual; human studies. 1st ed. Boston: Little, Brown; c1970. 358 p.

> Bernard C, Nassiry L, Knoppers BM. Legal aspects of research and clinical practice with human beings: selected Canadian legal bibliography, 1980-1992. Ottawa: National Council on Bioethics in Human Research; 1992. 35 p.

> Bioethics and clinical practice: examining research outcomes and methods: a workshop sponsored by the National Center for Nursing Research. Bethesda (MD): National Institutes of Health, National Center for Nursing Research; 1990 Apr. 25 p.

> Bioethics and human rights: final report and recommendations of the International Meeting on Bioethics and the Social Consequences of Biomedical Research, 1991 May 13-15, Moscow, USSR. Paris: UNESCO; 1992. 32 p.

> Biomedical ethics in U.S. public policy. Washington: Congress of the United States, Office of Technology Assessment; 1993. 92 p. (Background paper).

> Biomedical Ethics and U.S. Public Policy. Examining the Federal Role in Addressing the Social, Legal, and Ethical Issues Raised by Advances in Biomedical Research and Technology: Hearing (1993 Oct 14). Washington: U.S. Government Printing Office; 1994. 85 p.

> Biomedical experimentation involving human subjects: Working paper 61. Ottawa: The Law Reform Commission; 1989. 142 p.

> Biotechnology related to human beings. Oslo: Ministry of Health and Social Affairs; 1993. 89 p.

> Bittar EE, Bittar N, editors. Bioethics. Greenwich (CT): Jai Press; 1994. 208 p. (Principles of medical biology; 1A).

> Blank RH, Bonnicksen AL. Emerging issues in biomedical policy: an annual review. Vol. 2, Debates over authority in medical decision making; new challenges in biomedical experimentation. New York: Columbia University Press; 1993. 273 p.

> Bloch S, Chodoff P. Psychiatric ethics. 2nd ed. New York: Oxford University Press; 1991. 556 p.

> Boyd KM, Higgs R, Pinching AJ. The new dictionary of medical ethics. London: BMJ Publishing; 1997.

> Brody BA. The ethics of biomedical research: an international perspective. New York: Oxford University Press; 1998. 386 p.

> Brody BA, editor. Moral theory and moral judgments in medical ethics. Boston: Kluwer Academic; 1988. 232 p. (Philosophy and medicine; 32).

> Brody EB. Biomedical technology and human rights. Brookfield (VT): Dartmouth Pub. Co; c1993. 312 p.

> Bulger RE, Heitman E, Reiser SJ, editors. The ethical dimensions of the biological sciences. New York: Cambridge University Press; 1993. 294 p.

> Bulger RE, Reiser SJ. Integrity in health care institutions: humane environments for teaching, inquiry, and healing. 1st ed. Iowa City: University of Iowa Press; 1990. 180 p.

> Byrne P, editor. Ethics and law in health care and research. New York: Wiley; 1990. 192 p. (King's College studies; 5th).

> Campbell A. Medical ethics. 2nd ed. New York: Oxford University Press; 1997. 228 p.

> Caplan AL. Moral matters: ethical issues in medicine and the life sciences. New York: Wiley; c1995. 198 p.

> Caplan AL. Am I my brother's keeper? The ethical frontiers of biomedicine. Bloomington (IN): Indiana University Press; 1997. 241 p.

> Carson RA, Burns C. Philosophy of medicine and bioethics: a twenty-year retrospective and critical appraisal. Boston: Kluwer Academic; c1997. 341 p. (Philosophy and medicine; 50).

> Chadwick RF. Encyclopedia of applied ethics. San Diego: Academic Press; c1998. 4 vol.

> Chapman AR, editor. Health care and information ethics: protecting fundamental human rights. Kansas City: Sheed & Ward; 1997. 482 p.

> Cheney D, editor. Ethical issues in research. Frederick (MD): University Pub. Group; c1993. 237 p.

> Childress JF. Practical reasoning in bioethics. Bloomington: Indiana University Press; c1997. 385 p. (Medical ethics series).

> Connor SS, Fuenzalida-Puelma HL, editors. Bioethics: issues and perspectives. Washington: Pan American Health Organization, Pan American Sanitary Bureau, Regional Office of the World Health Organization; c1990. 238 p. (Scientific publication; 527). Published also as a special issue of the Bull Pan Am Health Organ;24(4).

> Coughlin SS, Beauchamp TL, editors. Ethics and epidemiology. New York: Oxford University Press; 1996. 312 p.

> Coughlin SS, editor. Ethics in epidemiology and clinical research: annotated readings. 1st ed. Newton (MA): Epidemiology Resources Inc; 1995. 272 p.

> Daly J, editor. Ethical intersections: health research, methods, and researcher responsibility. Boulder (CO): Westview Press; 1996. 256 p.

> De Raeve L. Nursing research: an ethical and legal appraisal. Philadelphia: Bailliere Tindall; 1996. 194 p.

> Department of Energy, Office of Energy Research. Protecting human research subjects at the Department of Energy: human subjects handbook [loose-leaf]. Washington: Department of Energy, Assistant Secretary for Environment, Safety, and Health, Office of Energy Research, Office of Health and Environmental Research; 1992-. 1 vol.

> Developing a code of ethics in research: a guide for scientific societies. Washington: Association of American Medical Colleges; c1997. 42 p.

> Deyn PP, editor. The ethics of animal and human experimentation. London: J. Libbey; c1994. 369 p.

> DOE human subjects research handbook: protecting human research subjects [microform]. 2nd ed. Washington: Department of Energy, Office of Health and Environmental Research; 1996. Rev. ed. of: Protecting human research subjects at the Department of Energy. 1992.

> Drowatzky JN. Ethical decision making in physical activity research. Champaign (IL): Human Kinetics; c1996. 103 p.

> Dutton DB, Preston TA, Pfund NE. Worse than the disease. Pitfalls of medical progress. New York: Cambridge University Press; 1988. 528 p.

> Edwards RB, Glenn C, editors. Bioethics. San Diego: Harcourt Brace Jovanovich; c1988. 755 p. Reprinted from various sources.

> Engelhardt HT. The foundations of bioethics. 2nd ed. New York: Oxford University Press; 1996. 446 p.

> Erwin E, Gendin S, Kleiman L. Ethical issues in scientific research: an anthology. New York: Garland; 1994. 413 p.

> Europe and bioethics: Proceedings of the 1st Symposium of the Council of Europe on Bioethics, 1989 Dec 5-7, Strasbourg. Strasbourg (France): The Council; 1990. 184 p.

> European directory of bioethics, 1996. 2nd ed. Secaucus (NJ): Lavoisier; 1996. 703 p.

> Evans D, Evans M. A decent proposal: ethical review of clinical research. New York: Wiley; c1996. 218 p.

> Flynn EP. Issues in medical ethics. Kansas City (MO): Sheed & Ward; c1997. 384 p.

> Freund PA, editor. Experimentation with human subjects. New York: Braziller; c1970. 470 p. (Daedalus library).

> Furrow BR, Johnson SH, Jost TS, Schwartz RL. Bioethics: health care law and ethics. St. Paul (MN): West; 1991. 412 p.

> Gert B, Culver CM, Clouser KD. Bioethics: a return to fundamentals. New York: Oxford University Press; 1997. 320 p.

> Graber GC, Thomasma DC, editors. Theory and practice in medical ethics. New York: Continuum; 1989. 229 p.

> Greenberg J, Folger R. Controversial issues in social research methods. New York: Springer-Verlag; 1988. 237 p.

> Guidelines for the conduct of research at the National Institutes of Health. Bethesda (MD): National Institutes of Health; 1990 Mar 21. 15 p.

> Guidelines for the conduct of research involving human subjects at the National Institutes of Health. Bethesda (MD): National Institutes of Health; 1995 Apr. 21 p.

> Guidelines for the conduct of research involving human subjects at the National Institutes of Health. Research involving human subjects. Bethesda (MD): National Institutes of Health; 1993. 21 p.

> Guidelines on ethics for medical research. Rev. ed. Tygerberg: South African Medical Research Council; 1993. 119 p.

> Hanna KE. Biomedical politics. Washington: National Academy Press; 1991. 352 p.

> Heaney RP, Dougherty CJ, editors. Research for health professionals: design, analysis, and ethics. lst ed. Ames (IA): Iowa State University Press; 1988. 268 p.

> Henry C, Pashley G, editors. Community ethics and health care research. Wilts, England: Quay Books Division, Mark Allen Pub.; 1995. 193 p. Health and nursing studies for diploma and undergraduate students; v. 4.

> Hoffmaster CB, Freedman B, Fraser G, editors. Clinical ethics: theory and practice. Clifton (NJ): Humana Press; 1989. 237 p. (Contemporary issues in biomedicine, ethics, and society).

> Homan R. The ethics of social research. New York: Longman; 1991. 197 p.

> Howell JH, Sale WF, editors. Life choices: a Hastings Center introduction to bioethics. Washington: Georgetown University Press; c1995. 537 p. (Hastings Center studies in ethics).

> Institute of Medicine, Division of Health Sciences Policy, Committee on the Responsible Conduct of Research. The responsible conduct of research in the health sciences: report of a study. Washington: National Academy Press; 1989. 97 p.

> International ethical guidelines for biomedical research involving human subjects. Geneva: World Health Organization, Council for International Organizations of Medical Sciences. 1993. 63 p.

> Jecker NAS, Jonsen AR, Pearlman RA, editors. Bioethics: an introduction to the history, methods, and practice. Boston: Jones and Bartlett Publishers; c1997.

> Jonsen AR, Siegler M, Winslade WJ. Clinical ethics: a practical approach to ethical decisions in clinical medicine. 4th ed. New York: McGraw Hill, Health Professions Division; c1998. 206 p.

> Jonsen AR, Veatch RM, Walters L, editors. Source book in bioethics. Washington: Georgetown University Press; 1998.

> Kahn JP, Mastroianni AC, Sugarman J. Beyond consent: seeking justice in research. New York: Oxford University Press; 1998. 190 p.

> Kapis MB, Gad SC, editors. Non-animal techniques in biomedical and behavioral research and testing. Boca Raton: Lewis Publishers; c1993. 264 p.

> Kelley WN, Osterweis M, Rubin ER, editors. Emerging policies for biomedical research. Washington: Association of Academic Health Centers; 1993. 266 p. (Health policy annual; 3).

> Kikuchi JF, Simmons H, Romyn D, editors. Truth in nursing inquiry. Thousand Oaks (CA): Sage Publications; 1996. 172 p.

> Kimbrell A. The human body shop: the engineering and marketing of life. New York: HarperCollins; 1993. 348 p.

> Kimmel AJ. Ethical issues in behavioral research: a survey. Cambridge (MA): Blackwell Publishers; 1996. 405 p.

> Kimmel AJ. Ethics and values in applied social research. Newbury Park (CA): Sage Publications; 1988. 160 p.

> Kuczewski MG. Fragmentation and consensus: communitarian and casuist bioethics. Washington: Georgetown University Press; c1997.

> Ladimer I, editor. New dimensions in legal and ethical concepts for human research. New York [publisher unknown]: 1970. (Ann N Y Acad Sci:169 (art. 2):293-593).

> LeVay S. Queer science: the use and abuse of research into homosexuality. Cambridge (MA): MIT Press; 1996. 364 p.

> Levine RJ. Ethics and regulation of clinical research. 2nd ed. Baltimore: Urban & Schwarzenberg; 1986. 452p.

> Levine C, editor. Taking sides. Clashing views on controversial bioethical issues. 4th ed. Guilford (CT): Dushkin Pub. Group; 1991. 382 p.

> Lock S, Wells FO, editors. Fraud and misconduct in medical research. 2nd ed. London: BMJ; 1993. 202 p.

> Loewy EH, editor. Textbook of medical ethics. New York: Plenum Medical Book Co; 1989. 252 p.

> Lovat TJ, Mitchell KR, editors. Bioethics for medical and health professionals: history, principles, and case studies. Wentworth Falls (Australia): Social Science Press; 1991. 1261 p.

> Macrina FL. Scientific integrity: an introductory text with cases. Washington: ASM Press; 1995.

> McCullagh PJ. Brain dead, brain absent, brain donors: human subjects or human objects? New York: Wiley; 1993. 261 p.

> McKenny GP. To relieve the human condition: bioethics, technology, and the body. Albany (NY): State University of New York Press; c1997. 279 p.

> McNeill PM. The ethics and politics of human experimentation. New York: Cambridge University Press; 1993. 315 p.

> Miller DJ, Hersen M, editors. Research fraud in the behavioral and biomedical sciences. New York: Wiley; 1992. 251 p.

> Murphy EA, Butzow JJ, Suarez-Murias EL. Underpinnings of medical ethics. Medical ethics. Baltimore: Johns Hopkins University Press; c1997. 480 p.

> National Academy of Sciences, National Academy of Engineering, Institute of Medicine, Committee on Science, Engineering, and Public Policy, Panel on Scientific Responsibility and the Conduct of Research. Responsible science: ensuring the integrity of the research process. Vol. 2. Washington: National Academy Press; 1993. 275 p.

> National Academy of Sciences, National Academy of Engineering, Institute of Medicine, Committee on Science, Engineering, and Public Policy. On being a scientist: responsible conduct in research [booklet]. 2nd ed. Washington: National Academy Press; 1995. 27 p.

> National Academy of Sciences, National Academy of Engineering, Institute of Medicine, Committee on Science, Engineering, and Public Policy, Panel on Scientific Responsibility and the Conduct of Research. Responsible science: ensuring the integrity of the research process. Vol. 1. Washington: National Academy Press; 1992. 199 p.

> National Health and Medical Research Council (Australia). NHMRC Statement on Human Experimentation and Supplementary Notes, 1992. Canberra: Australian Government Publishing Service; 1992 Nov. 23 p.

> Nolen AL, Coutts MC, editors. International directory of bioethics organizations. Washington: Georgetown University, National Reference Center for Bioethics Literature, Kennedy Institute of Ethics; c1993. 371 p. (Bioethics resource series; 1).

> Oderberg DS, Laing JA. Human lives: critical essays on consequentialist bioethics. New York: St. Martin's Press; 1997. 244 p.

> Olson S, (National Research Council. Board on Biology). Shaping the future: biology and human values. Washington: National Academy Press; 1989. 116 p.

> Pappworth MH. Human guinea pigs; experimentation on man. London: Routledge & Paul; 1967. 228 p.

> People as products: the ethical, legal, and social issues in reproductive technologies and other procedures involving the commercialization of body parts and tissues: November 6-7, 1989. Boston: Public Responsibility in Medicine and Research; 1989. 127 p.

> Philosophy and practice of medical ethics. Rev. ed. London: British Medical Association; 1988. 139 p.

> Pincus HA, Lieberman JA, Ferris S. Ethics in psychiatric research: a resource manual on human subjects research. 1st ed. Washington: American Psychiatric Association; c1998.

> Porter RJ, Malone TE. Biomedical research: collaboration and conflict of interest. Baltimore: Johns Hopkins University Press; 1992. 230 p.

> Reich WT, editor. Encyclopedia of bioethics. Rev. ed. New York: Macmillan Library Reference; c1995.

> Research involving human subjects. Copenhagen: Ministry of Health; 1989. 111 p.

> Research involving patients: a report of the Royal College of Physicians. London: Royal College of Physicians of London; c1990. 48 p. (Medical ethics publications).

> Responsibility in investigations on human participants and material and on personal information. London: Medical Research Council; 1992 Nov. 15 p.

> RU 486: the Import Ban and its effect on Medical Research: Hearing (1990 Nov 19). Washington: U.S. Government Printing Office; 1991. 285 p.

> Scientific Misconduct in Breast Cancer Research: Hearings (1994 Apr 13, Jun 15). Washington: U.S. Government Printing Office; 1994. 219 p.

> Scientific research: continued vigilance critical to protecting human subjects. United States General Accounting Office report to the ranking minority member, Committee on Governmental Affairs, U.S. Senate. Washington: General Accounting Office; 1996. 46 p.

> Seedhouse D. Ethics: the heart of health care. 2nd ed. New York: John Wiley; 1998. 232 p.

> Shamoo AE, editor. Ethics in neurobiological research with human subjects: the Baltimore Conference on Ethics. Amsterdam: Gordon and Breach Publishers; 1997. 335 p.

> Shannon TA. An introduction to bioethics. 3rd ed., rev. and updated. New York: Paulist Press; c1997. 189 p.

> Sharpe VA, Faden AI. Medical harm: historical, conceptual, and ethical dimensions of iatrogenic illness. New York: Cambridge University Press; 1998. 280 p.

> Shrader-Frechette K. Ethics of scientific research. Lanham (MD): Rowman and Littlefield; 1994. 243 p.

> Sieber JE. Planning ethically responsible research: a guide for students and internal review boards. Newbury Park (CA): Sage Publications; 1992. 163 p.

> Siegler M, Singer PA, Schiedermayer DL, editors. Medical ethics: an annotated bibliography. Philadelphia: American College of Physicians; c1988. 42 p.

> Silva MC. Annotated bibliography: for ethical guidelines in the conduct, dissemination, and implementation of nursing research. Washington: American Nurses Association; 1995. 60 p.

> Silva MC. Ethical guidelines in the conduct, dissemination, and implementation of nursing research. Washington: American Nurses Pub.; 1995. 56 p.

> Smith T. Ethics in medical research: a handbook of good practice. New York: Cambridge University Press; 1998.

> Spece RG, Shimm DS, Buchanan AE, editors. Conflicts of interest in clinical practice and research. New York: Oxford University Press; 1996. 453 p.

> Spicker SF, editor. The use of human beings in research: with special reference to clinical trials. Dordrecht: Kluwer Academic Publishers; c1988. 291 p. (Philosophy and medicine; 28). Developed from the Fourteenth Trans-disciplinary Symposium on Philosophy and Medicine, September 5-8, 1982, at Tel Aviv University, Israel.

> Sprinkle RH. Profession of conscience: the making and meaning of life-sciences liberalism. Princeton (NJ): Princeton University Press; 1994. 257 p.

> Sproul RC. Playing God: dissecting biomedical ethics and manipulating the body. Grand Rapids (MI): Baker Books; 1997. 96 p.

> Stanley B, Sieber JE, Melton GB, editors. Research ethics: a psychological approach. Lincoln: University of Nebraska Press; c1996. 273 p.

> The Belmont report: ethical principles and guidelines for the protections of human subjects. Bethesda (MD): U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; l979. 8 p. Reprinted in numerous books and Internet web sites.

> The National Council on Bioethics in Human Research (NCBHR). Ottawa: NCBHR; 1989. 15 p.

> The responsible conduct of research in the health sciences: report of a study by the Committee on the Responsible Conduct of Research, Institute of Medicine, Division of Health Sciences Policy. Washington: National Academy Press; 1989. 97 p. (Publication IOM 89-01).

> Thomasma DC. The influence of Edmund D. Pellegrino's philosophy of medicine. Boston: Kluwer Academic Publishers; 1997.

> U.S. Congress, House, Committee on Government Operations. Are scientific misconduct and conflicts of interest hazardous to our health? Washington: U.S. Government Printing Office; 1990. 74 p.

> Van Steendam G, Van Den Berghe H, Winnacker EL. Dealing with ethical problems linked to modern biomedical research. Part one: compendium -- analytical inventory of problematic situations. Final report. Luxembourg: Office for Official Publications of the European Communities; 1993. 106 p.

> Vanderpool HY, editor. The ethics of research involving human subjects: facing the 21st century. Frederick (MD): University Pub Group; c1996. 531 p.

> Veatch RM, editor. Medical ethics. Boston: Jones and Bartlett; c1989. 372 p.

> Veatch RM. The patient as partner: a theory of human-experimentation ethics. Bloomington: Indiana Univ Press, 1987. 241 p.

> Veatch RM, editor. The patient-physician relation: the patient as partner, part 2. Bloomington (IN): Indiana University Press; c1991. 306 p. (Medical ethics series).

> Veatch RM. Medical ethics. 2nd ed. Sudbury (MA): Jones and Bartlett Publishers; c1997. 461 p. (Jones and Bartlett series in philosophy).

> Walters L. Bibliography of bioethics. Washington: Georgetown University, Center for Bioethics, Kennedy Institute for the Study of Human Reproduction and Bioethics; 1975- . Annual.

> Weisstub DN. Research on human subjects: ethics, law and social policy. New York: Elsevier-Science; 1998. 658 p.

> White GB. Ethical dilemmas in contemporary nursing practice. Washington: American Nurses Publishing; 1992. 154 p.

> Zilinskas RA. The microbiologist and biological defense research: ethics, politics, and international security. New York: New York Academy of Sciences; 1992. 249 p.

> Return to table of contents

> ## Historical perspectives on research involving human participants - Journal Articles

> Abbott A. Germany's past still casts a long shadow [news]. Nature 1997 Oct 16;389(6652):660.

> Addis GJ. The BMJ's Nuremberg issue. Force of moral duty was greater for conscientious objectors [letter]. BMJ 1997 Apr 12;314(7087):1128. Comment on: BMJ 1997 Feb 8;314(7078):440.

> Adler T. Experts debate merits of radiation studies [news]. Sci News 1994 Feb 5;145(6):87.

> Alexander L. Limitations of experimentation on human beings with special reference to psychiatric patients. Dis Nerv Syst 1966 Jul;7 Suppl(7):61-5.

> Alexander L. Medical science under dictatorship. N Engl J Med 1949;241:39-47.

> Angell M. The Nazi hypothermia experiments and unethical research today [editorial]. N Engl J Med 1990 May 17;322(20):1462-4. Comment on: N Engl J Med 1990 May 17;322(20):1435-40. Comment in: N Engl J Med 1991 Mar 21;324(12):845-7.

> Annas GJ. The changing landscape of human experimentation: Nuremberg, Helsinki, and beyond. Health Matrix 1992 Summer;2(2):119-40.

> Annas GJ. Mengele's birthmark: the Nuremberg Code in United States courts. J Contemp Health Law Policy 1991 Spring;7:17-45.

> Annas GJ, Grodin MA. The Nazi doctors and the Nuremberg Code: relevance for modern medical research. Med War 1990 Apr-Jun;6(2):120-3.

> Barondess JA. Medicine against society. Lessons from the Third Reich. JAMA 1996 Nov 27;276(20):1657-61. Comments in: JAMA 1996 Nov 27;276(20):1679-81; JAMA 1997 Mar 5;277(9):710.

> Bean WB. The Fielding H. Garrison lecture: Walter Reed and the ordeal of human experiments. Bull Hist Med 1977 Spring;51(1):75-92.

> Bean WB. Personal reflections on clinical investigations. Annu Rev Nutr 1982;2:1-20.

> Beardsley T. The cold war's dirty secrets. Radiation experiments ignored ethics guidelines [news]. Sci Am 1995 May;272(5):16.

> Beauchamp TL. Looking back and judging our predecessors. Kennedy Inst Ethics J 1996 Sep;6(3):251-70.

> Beauchamp TL. The principles approach. Hastings Cent Rep 1993 Nov-Dec;23(6 Suppl):S9.

> Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354-60.

> Benedek TG. The 'Tuskegee Study' of syphilis: analysis of moral versus methodologic aspects. J Chronic Dis 1978 Jan;31(1):35-50.

> Berger RL. Closing the door on Nazi data. Sh'ma J Jew Responsib 1995 Oct 13;26(499):7-8.

> Berger RL. Ethics in scientific communication: study of a problem case. J Med Ethics 1994 Dec;20(4):207-11.

> Berger RL. Nazi science--the Dachau hypothermia experiments. N Engl J Med 1990 May 17;322(20):1435-40. Comments in: N Engl J Med 1990 May 17;322(20):1462-4; N Engl J Med 1991 Mar 21;324(12):845-7.

> Bernstein JE. Ethical considerations in human experimentation. J Clin Pharmacol 1975 Aug-Sep;15(8-9):579-90.

> Biddiss M. Disease and dictatorship: the case of Hitler's Reich. J R Soc Med 1997 Jun;90(6):342-6. Comment in: J R Soc Med 1997 Oct;90(10):589.

> Blom K. Armauer Hansen and human leprosy transmission. Medical ethics and legal rights. Int J Lepr Other Mycobact Dis 1973 Apr-Jun;41(2):199-207.

> Boozer JS. Children of Hippocrates: doctors in Nazi Germany. Ann Am Acad Pol Soc Sci 1980 Jul;(450):83-97.

> Borelli N. The Nuremberg Code, informed consent, and involuntary treatment [letter]. JAMA 1997 Mar 5;277(9):712; discussion 713-4. Comment on: JAMA 1996 Nov 27;276(20):1682-3.

> Brandt A. Racism and research: the case of the Tuskegee Syphilis Study. Hastings Cent Rep 1978 Dec;8(6):21-9.

> Brandt AM. Polio, politics, publicity, and duplicity: ethical aspects in the development of the Salk vaccine. Int J Health Serv 1978;8(2):257-70.

> Brandt AM, Freidenfelds L. Research ethics after World War II: the insular culture of biomedicine [commentary]. Kennedy Inst Ethics J 1996 Sep;6(3):239-43.

> Brawley OW. The study of untreated syphilis in the negro male. Int J Radiat Oncol Biol Phys 1998 Jan 1;40(1):5-8. Comment in: Int J Radiat Oncol Biol Phys 1998 Jan 1;40(1):1-2.

> Buchanan A. The controversy over retrospective moral judgment. Kennedy Inst Ethics J 1996 Sep;6(3):245-50.

> Buchanan A. Judging the past. The case of the human radiation experiments. Hastings Cent Rep 1996 May-Jun;26(3):25-30.

> Burchell HB. Ethics in mid-century cardiovascular research: apologia. Perspect Biol Med 1996 Spring;39(3):327-37.

> Burt RA. The suppressed legacy of Nuremberg. Hastings Cent Rep 1996 Sep-Oct;26(5):30-3.

> Byman B. Bitterfruit. The legacy of Nazi medical experiments. Minn Med 1989 Oct;72(10):580-6. Comment in: Minn Med 1990 Feb;73(2):15.

> Callahan D. The legacy of the Nuremberg Code. Cas Lek Cesk 1998 Apr 20;137(8):244-5.

> Campbell CS. It never dies: assessing the Nazi analogy in bioethics. J Med Humanit 1992 Spring;13(1):21-9.

> Cantrell RW. A century of progress in medical ethics. Laryngoscope 1997 Apr;107(4):447-52.

> Caplan AL. Twenty years after. The legacy of the Tuskegee Syphilis Study. When evil intrudes. Hastings Cent Rep 1992 Nov-Dec;22(6):29-32.

> Capron AM. Bioethics on the congressional agenda. Hastings Cent Rep 1989 Mar-Apr;19(2):22-3.

> Chalmers TC. The clinical trial. Milbank Mem Fund Q Health Soc 1981 Summer;59(3):324-39.

> Chernin E. Richard Pearson Strong and the iatrogenic plague disaster in Bilibid Prison, Manila, 1906. Rev Infect Dis 1989 Nov-Dec;11(6):996-1004.

> Clinton to apologize for tests [news]. Indian J Med Sci 1997 Jul;51(7):240.

> Clinton WJ. Executive Order 12891 of January 15, 1994: Advisory Committee on Human Radiation Experiments. Fed Regist 1994 Jan 20;59(13):2935-7.

> Cochrane AL. Sickness in Salonica: my first, worst, and most successful clinical trial. Br Med J (Clin Res Ed) 1984 Dec 22-29;289(6460):1726-7.

> Cohen B. The ethics of using medical data from Nazi experiments. J Halacha Contemp Soc 1990 Spring;19:103-26.

> Cooper R. A note on the biologic concept of race and its application in epidemiologic research. Am Heart J 1984 Sep;108(3 Pt 2):715-22.

> Coughlin SS, Etheredge GD, Metayer C, Martin SA Jr. Remember Tuskegee: public health student knowledge of the ethical significance of the Tuskegee Syphilis Study. Am J Prev Med 1996 Jul-Aug;12(4):242-6.

> Cox JD. Paternalism, informed consent and Tuskegee [editorial]. Int J Radiat Oncol Biol Phys 1998 Jan 1;40(1):1-2. Comment on: Int J Radiat Oncol Biol Phys 1998 Jan 1;40(1):5-8.

> Crigger BJ. Daughter of the national commission [news]. Hastings Cent Rep 1994 May-Jun;24(3):3-4.

> Crigger BJ. Twenty years after: the legacy of the Tuskegee Syphilis Study [introduction to a set of four articles]. Hastings Cent Rep 1992 Nov-Dec;22(6):29.

> Cutler DS. Origins of the Pernkopf anatomy atlas [letter]. JAMA 1997 Apr 9;277(14):1122; discussion 1123-4.

> Daroff RB. Schaltenbrand and Hallervorden [editorial]. Neurology 1994 Feb;44(2):201-2. Comment on: Neurology 1994 Feb;4492):350-6. Comment in: Neurology 1995 Mar;45(3 Pt 1):601-2.

> Deaths associated with yellow fever experiments [letter]. JAMA 1983 Mar 4;249(9):1150-1.

> Deichmann U, Muller-Hill B. The fraud of Abderhalden's enzymes. Nature 1998 May 14;393(6681):109-11.

> Diamond EF. Reflections on the 50th anniversary of the Nuremberg doctors' trials. Linacre Q 1997 May;64(2):17-20.

> Dickson D. NIH censure for Dr Martin Cline: tighter rules for future research plans [news]. Nature 1981 Jun 4;291(5814):369.

> Diethelm AG. Ethical decisions in the history of organ transplantation. Ann Surg 1990 May;211(5):505-20.

> Dirckx JH. The mad doctor in fiction. Pharos 1992 Summer;55(3):27-31.

> Doctor knows best or not [editorial]. New Sci 1995 Jul 1;147(1984):3.

> Doll R. Clinical trials: retrospect and prospect. Stat Med 1982 Oct-Dec;1(4):337-44.

> Doll R. The controlled trial. Postgrad Med J 1984 Nov;60(709):719-24.

> Dowling HF. The dilemma of human experimentation with drugs: a historical perspective. J Clin Pharmacol J New Drugs 1967 Sep-Oct;7(5):248-50.

> Dowling HF. Human dissection and experimentation with drugs. Some problems and parallels. JAMA 1967 Dec 25;202(13):1132-5.

> Dowling HF. Human experimentation in infectious diseases. JAMA 1966 Nov 28;198(9):997-9.

> Dowling HF. The regulation of clinical investigations: some historical comments. Antimicrob Agents Chemother 1967;7:13-5.

> Drobniewski F. Why did Nazi doctors break their 'Hippocratic' oaths? J R Soc Med 1993 Sep;86(9):541-3.

> Edgar H. Outside the community [The legacy of the Tuskegee Syphilis Study]. Hastings Cent Rep 1992 Nov-Dec;22(6):32-5.

> Edsall G. Experiments at Willowbrook. Lancet. 1971 Jul 10;2(7715):95.

> Einhorn TA, Burstein AH, Cowell HR. Human experimentation [editorial]. J Bone Joint Surg Am 1997 Jul;79(7):959-60. Comment on: J Bone Joint Surg Am 1997 Jul;79(7):1089-98.

> Einspruch BC. United States v Karl Brandt. Forgotten? Almost. Tex Med 1997 Feb;93(2):14-5.

> Eisenberg L. The social imperatives of medical research. Science 1977 Dec 16;198(4322):1105-10.

> Ernst E. 50 years ago: the Nuremberg Doctors' Tribunal. Part 1: The descent towards medicalised murder. Wien Med Wochenschr 1996;146(21-22):574-6.

> Ernst E. 50 years ago: the Nuremberg doctors' tribunal. Part 2: Medical resistance during the Third Reich. Wien Med Wochenschr 1996;146(24):629-31.

> Ernst E. 50 years ago: the Nuremberg Doctors' Tribunal. Part 3: The failure of coming to terms with the past. Wien Med Wochenschr 1997;147(2):53-4.

> Ernst E. 50 years ago: the Nuremberg Doctors' Tribunal. Part 4: Nazi medicine's relevance today. Wien Med Wochenschr 1997;147(3):70-1.

> Ernst E. Killing in the name of healing: the active role of the German medical profession during the Third Reich. Am J Med 1996 May;100(5):579-81. Comment in: Am J Med 1997 Jan;102(1):130-1.

> Ernst E. Medicine in Germany [letter]. Lancet 1997 Feb 15;349(9050):508. Comment on: Lancet 1996 Dec 14;348(9042):1631-9.

> Ernst E. Unethical behavior of Nazi doctors [letter]. J R Soc Med 1994 Apr;87(4):246.

> Ernst E, Weindling PJ. The Nuremberg Medical Trial: have we learned the lessons? J Lab Clin Med 1998 Feb;131(2):130-5.

> Estling R. Whatever made them do it? New Sci 1995 Jan 21;145(1961):48-9.

> Ettershank K, Ranson D. Vaccine trials on orphans cause outrage in Australia [news]. Lancet 1997 Jun 21;349(9068):1817.

> Evans BK. Joseph Goldberger: unsung hero [letter]. Ann Intern Med 1995 Jan 15;122(2):157. Comment on: Ann Intern Med 1994 Sep 1;121(5):372-5.

> Faden R. The Advisory Committee on Human Radiation Experiments. Reflections on a Presidential Commission. Hastings Cent Rep 1996 Sep-Oct;26(5):5-10.

> Faden R. Chair's perspective on the work of the Advisory Committee on Human Radiation Experiments. Kennedy Inst Ethics J 1996 Sep;6(3):215-21.

> Faden RR, Lederer SE, Moreno JD. US medical researchers, the Nuremberg Doctors Trial, and the Nuremberg Code. A review of findings of the Advisory Committee on Human Radiation Experiments. JAMA 1996 Nov 27;276(20):1667-71.

> Faraone SV, Gottesman II, Tsuang MT. Fifty years of the Nuremberg Code: a time for retrospection and introspection [editorial]. Am J Med Genet 1997 Jul 25;74(4):345-7. Comment on: Am J Med Genet 1997 Jul 25;74(4):455-6; discussion 461-3.

> Feldshuh D. Miss Evers' boys [excerpt]. Harvard Med Alum Bull 1992/93 Winter;66(3):29-36.

> Ferngren GB. Roman lay attitudes towards medical experimentation. Bull Hist Med 1985 Winter;59(4):495-505.

> Fielder J. Some ethical issues in clinical trials. IEEE Eng Med Biol Mag 1993 Mar;12(1):126-7.

> Fischbach RL. The Tuskegee legacy. Harvard Med Alum Bull 1992/93 Winter;66(3):24-8.

> Flagler EA, Winkler ER. An unfortunate experiment: the New Zealand study of cancer of the cervix. Ann R Coll Physicians Surg Can 1992 Apr;25(2):124-30.

> Flanagin A. Who wrote the Declaration of Helsinki? JAMA 1997 Mar 19;277(11):926.

> Fletcher JC. Clinical bioethics at NIH: history and a new vision. Kennedy Inst Ethics J 1995 Dec;5(4):355-64.

> Fletcher JC. The evolution of the ethics of informed consent. Prog Clin Biol Res 1983;128:187-228.

> Frankel MS. The development of policy guidelines governing human experimentation in the United States: a case study of public policy-making for science and technology. Ethics Sci Med 1975 May;2(1):43-59.

> Franzblau MJ. Ethical values in health care in 1995: lessons from the Nazi period. J Med Assoc Ga 1995 Apr;84(4):161-4.

> Frenkel DA. Human experimentation: codes of ethics. Leg Med Q 1977 Mar;1(1):7-14.

> Freundel B. Using Nazi experimental data -- asking the right question. Sh'ma J Jew Responsib 1995 Mar 17;25(490):1-3.

> Friedman E. Teach your children well [Nazi medicine and research]. Health Prog 1990 Oct;71(8):20-4.

> Friedmann T. Lessons from Nuremberg: ethical and social responsibilities for health care professionals, health care organizations, and medical journals [letter]. JAMA 1997 Mar 5;277(9):710-1; discussion 711-2. Comment on: JAMA 1996 Nov 27;276(20):1693-6.

> From Nazi holocaust to nuclear holocaust [letter]. Lancet 1986 Sep 13;2(8507):632.

> Fumes from the spleen. Paediatr Perinat Epidemiol 1990 Jul;4(3):255-8.

> Fumes from the spleen [letter]. Paediatr Perinat Epidemiol 1992 Jul;6(3):316-21.

> Garver KL, Garver B. Eugenics: past, present, and the future. Am J Hum Genet 1991 Nov;49(5):1109-18. Comment in: Am J Hum Genet 1992 Jul;51(1):222-3.

> Geiger JH. Medicine, public health, and the lurid ethics of the cold war. Med Global Surv 1994 Mar;1(1):33-6.

> Geison GL. Pasteur's work on rabies: reexamining the ethical issues. Hastings Cent Rep 1978 Apr;8(2):26-33.

> Gellhorn A. Medical ethics--so what's the story? In Vitro 1977 Oct;13(10):588-94.

> Giles JP. Hepatitis research among retarded children. Lancet. 1971 May 29;1(7709):1126.

> Goldby S. Experiments at the Willowbrook State School. Lancet. 1971 Apr 10;1(7702):749.

> Goldman L. Was Dr. Krugman justified in giving children hepatitis? Med World News 1971 Oct 15:20-31.

> Grace PA. Men, medicine and machines. Ir J Med Sci 1997 Jul-Sep;166(3):152-6.

> Greenberg DS. Hidden data and abuse in research come to light in the USA [news]. Lancet 1997 Oct 11;350(9084):1083.

> Grunfeld GB. Ethics of using Nazi research [letter]. J Med Ethics 1991 Sep;17(3):162. Comment on: J Med Ethics 1991 Mar;17(1):42-4.

> Grunfeld GB. Modern medicine and the emergence of biomedical ethics. Caduceus 1992 Spring;8(1):1-22.

> Guidelines for clinical trials of psychotropic drugs June 1, 1977. Pharmakopsychiatr Neuropsychopharmakol 1977 Jul;10(4):205-31.

> Hammar L. The dark side to Donovanosis: color, climate, race and racism in American South venereology. J Med Humanit 1997 Spring;18(1):29-57.

> Hanauske-Abel HM. Not a slippery slope or sudden subversion: German medicine and national socialism in 1933. BMJ 1996 Dec 7;313(7070):1453-63. Comments in: BMJ 1997 Feb 8;314(7078):439; BMJ 1997 Feb 8;314(7078):440.

> Hanlon CR. Ethics in surgery. J Am Coll Surg 1998 Jan;186(1):41-9.

> Hannah M. The BMJ's Nuremberg issue. Use of Nazi material during medical training left an uncomfortable feeling [letter]. BMJ 1997 Feb 8;314(7078):440. Comment on: BMJ 1996 Dec 7;313(7070):1413-5.

> Harkness JM. Nuremberg and the issue of wartime experiments on US prisoners. The Green Committee. JAMA 1996 Nov 27;276(20):1672-5.

> Harkness JM. The significance of the Nuremberg Code [letter]. N Engl J Med 1998 Apr 2;338(14):995-6. Comment on: N Engl J Med 1997 Nov 13;337(20):1436-40.

> Harrington A. Unmasking suffering's masks: reflections on old and new memories of Nazi medicine. Daedalus 1996;125(1):181-205.

> Harris S. Japanese biological warfare research on humans: a case study of microbiology and ethics. Ann N Y Acad Sci 1992 Dec 31;666:21-52.

> Hawkins C. Consent and confidentiality. Trans Med Soc Lond 1986-87;103:67-81.

> Hay A, Rall DP, Pechura CM. Effects on health of mustard gas [letters]. Nature 1993 Dec 2;366(6454):398-9.

> Hayes-Bautista DE. Identifying hispanic populations: the influence of research methodology upon public policy. Am J Public Health 1980 Apr;70(4):353-6.

> Higgins GA. The Society of Surgical Oncology Lucy Wortham James Research Award--1980. Problems in clinical trials: lessons from the tuck uppers. Cancer 1981 May 1;47(9):2167-71.

> Hill AB. Suspended judgment. Memories of the British Streptomycin Trial in Tuberculosis. The first randomized clinical trial. Control Clin Trials 1990 Apr;11(2):77-9.

> Hill GB. Controlled clinical trials--the emergence of a paradigm. Clin Invest Med 1983;6(1):25-32.

> Horowitz HS. Ethical considerations of study participants in dental caries clinical trials. Community Dent Oral Epidemiol 1976 Mar;4(2):43-50.

> Horowski R. Schaltenbrand [letter]. Neurology 1995 Mar;45(3 Pt 1):601-2. Comment on: Neurology 1994 Feb;44(2):201-2; Neurology 1994 Feb;44(2):350-6.

> Howard-Jones N. Human experimentation in historical and ethical perspectives. Soc Sci Med 1982;16(15):1429-48.

> Hunter E. The snake in the caduceus: dimensions of medical and psychiatric responsibility in the Third Reich. Aust N Z J Psychiatry 1993 Mar;27(1):149-56.

> Huriet C. The French law on the protection of persons participating in biomedical research: origins and history. Int Dig Health Legis 1992;43(2):391-3.

> Janson CG. Thoughts on medical ethics and education. Pharos 1997 Fall;60(4):31-4.

> Jay Katz: authority and autonomy, power and process. Law Med Health Care 1988 Fall-Winter;16(3-4):153-273.

> Jelenko C, Jelenko JM, Mendelson JA, Buxton RW. The marfanil mystery. Surg Gynecol Obstet 1966 Jan;122(1):121-7.

> Jones AH. Literature and medicine: an evolving canon. Lancet 1996 Nov 16;348(9038):1360-2.

> Jonsen AR. The birth of bioethics. Hastings Cent Rep 1993 Nov-Dec;23(6):S1-4.

> Josefson D. US admits radiation experiments on 20,000 veterans [news]. BMJ 1997 Sep 6;315(7108):566.

> Josefson D. US compensates subjects of radiation experiments [news]. BMJ 1996 Dec 7;313(7070):1421.

> Kampmeier RH. Final report on the Tuskegee syphilis study. South Med J 1974 Nov;67(11):1349-53.

> Katz J. Ethics and clinical research revisited A tribute to Henry K Beecher. Hastings Cent Rep 1993 Sep-Oct;23(5):31-9.

> Katz J. The Nuremberg Code and the Nuremberg Trial. A reappraisal. JAMA 1996 Nov 27;276(20):1662-6. Comment in: JAMA 1997 Mar 5;277(9):709; discussion 709-10.

> Katz J. Reflections on unethical experiments and the beginnings of bioethics in the United States. Kennedy Inst Ethics J 1994 Jun;4(2):85-92.

> Kaufman SR. The World War II plutonium experiments: contested stories and their lessons for medical research and informed consent. Cult Med Psychiatry 1997 Jun;21(2):161-97.

> Keith J. Bad blood: another unfortunate experiment. N Z Nurs J 1989 Dec-Jan;81(12):20-1.

> Kenny C. Killing with care. Nurs Times 1998 Apr 1-7;94(13):16-7.

> Kevorkian J. A brief history of experimentation on condemned and executed humans. J Natl Med Assoc 1985 Mar;77(3):215-26.

> Kiernan V. Radiation doctors abused trust in the name of science [news]. New Sci 1995 Oct 14;148(1999):8.

> Kimball DG. U.S. advisory committee investigates human radiation experiments [news]. Med Global Surv 1994 Sep;1(3):180-1.

> Kmietowicz Z. MRC cleared of unethical research practices [news]. BMJ 1998 May 30;316(7145):1628.

> Knepper JD. Use of human subjects in experimentation: a review of legal and ethical issues. J Am Med Rec Assoc 1982 Aug;53(4):62-7 passim.

> Korszniak N. A review of the use of radio-isotopes in medicine and medical research in Australia (1947-73). Australas Radiol 1997 May;41(2):211-9.

> Krugman S. The Willowbrook hepatitis studies revisited: ethical aspects. Rev Infect Dis. 1986 Jan-Feb;8(1):157-62.

> Krugman S, Giles JP. Viral hepatitis. New light on an old disease. JAMA 1970 May 11;212(6):1019-29.

> Krugman S, Ward R, Giles JP, Bodansky O, Jacobs AM. Infectious hepatitis: detection of the virus during the incubation period and in clinically inapparent infection. N Engl J Med 1959;261(15):729-34.

> Kuhse H, Singer P. Questionable experiments, muddled defence [editorial]. Bioethics 1994 Oct;8(4):3-6.

> Larkins RG. Victorian orphans and clinical research [editorial]. Med J Aust 1997 Jul 21;167(2):60-1.

> Lawrence W Jr. Some problems with clinical trials. James Ewing lecture. Arch Surg 1991 Mar;126(3):370-8.

> Leaning J. War crimes and medical science [editorial]. BMJ 1996 Dec 7;313(7070):1413-5. Comments in: BMJ 1997 Feb 8;314(7078):439; BMJ 1997 Feb 8;314(7078):440.

> Lederer SE. The right and wrong of making experiments on human beings: Udo J. Wile and syphilis. Bull Hist Med 1984 Fall;58(3):380-97.

> Lerner BH, Rothman DJ. Medicine and the Holocaust: learning more of the lessons [editorial]. Ann Intern Med 1995 May 15;122(10):793-4. Comment on: Ann Intern Med 1995 May 15;122(10):793-4.

> Lifton RJ. Medicalized killing in Auschwitz. Psychiatry 1982 Nov;45(4):283-97.

> Lindee MS. Atonement: understanding the no-treatment policy of the Atomic Bomb Casualty Commission. Bull Hist Med 1994 Fall;68(3):454-90.

> Lock S. Research ethics--a brief historical review to 1965. J Intern Med 1995 Dec;238(6):513-20.

> Lockhart JD. The informed consent of Beaumont's patient. Hosp Pract 1978 May;13(5):29-35.

> Loftman B. Lessons from Nuremberg: ethical and social responsibilities for health care professionals, health care organizations, and medical journals [letter]. JAMA 1997 Mar 5;277(9):711; discussion 711-2. Comment on: JAMA 1996 Nov 27;276(20):1679-81.

> Lynoe N. Informed consent. Scand J Soc Med 1987;15(1):55-6.

> Lyon J. Experimenting with humans. Part I: History and context. Second Opin 1987 Nov;(6):62-89.

> Macilwain C. Public protests spark 'witch-hunt' fears over radiation experiments [news]. Nature 1994 Jan 27;367(6461):303.

> Macilwain C. US admits to use of humans in radiation experiments [news]. Nature 1994 Jan 6;367(6458):4.

> Macilwain C. US agencies split over inquiry into effects of radiation experiments [news]. Nature 1994 Apr 28;368(6474):781.

> Macilwain C. US radiation report fails to satisfy critics [news]. Nature 1995 Oct 12;377(6549):470.

> Macilwain C. US radiation report prompts bioethics move [news]. Nature 1995 Oct 5;377(6548):374.

> Mann CC. Radiation: balancing the record [news]. Science 1994 Jan 28;263(5146):470-3.

> Masood E. MRC rejects call for radiation tests inquiry [news]. Nature 1995 Jul 13;376(6536):107.

> Mastroianni A, Kahn J. Remedies for human subjects of cold war research: recommendations of the Advisory Committee. J Law Med Ethics 1996 Summer;24(2):118-26.

> McCally M, Cassel C, Kimball DG. U.S. government-sponsored radiation research on humans 1945-1975. Med Global Surv 1994 Mar;1(1):4-17.

> McCarthy CR. Historical background of clinical trials involving women and minorities. Acad Med 1994 Sep;69(9):695-8.

> McCarthy M. Cold war human radiation experiments in the USA [news]. Lancet 1994 Nov 26;344(8935):1498.

> McLoyd VC, Randolph SM. Secular trends in the study of Afro-American children: a review of Child Development, 1936-1980. Monogr Soc Res Child Dev 1985;50(4-5):78-92.

> Menkin A. Historical basis of medical crimes in Nazi Germany. N C Med J 1968 May;29(5):189-201.

> Merkatz RB, Junod SW. Historical background of changes in FDA policy on the study and evaluation of drugs in women. Acad Med 1994 Sep;69(9):703-7.

> Merton PA. The first Carmichael Memorial Lecture. Neurophysiology on man. J Neurol Neurosurg Psychiatry 1981 Oct;44(10):861-70.

> Meslin EM. Adding to the canon: the final report. [Review of the final report of the White House Advisory Committee on Human Radiation Experiments]. Hastings Cent Rep 1996 Sep-Oct;26(5):34-6.

> Meyer-Lindenberg J. The Holocaust and German psychiatry. Br J Psychiatry 1991 July;159:7-12.

> Miller L. Not nuclear medicine: the government's radiobiological and other experiments [news]. J Nucl Med 1994 Mar;35(3):9N-12N, 16N, 22N.

> Moe K. Should the Nazi research data be cited? Hastings Cent Rep 1984 Dec;14(6):5-7.

> Moore FD. Three ethical revolutions: ancient assumptions remodeled under pressure of transplantation. Transplant Proc 1988 Feb;20(1 Suppl 1):1061-7.

> Moreno JD. The only feasible means. The Pentagon's ambivalent relationship with the Nuremberg Code. Hastings Cent Rep 1996 Sep-Oct;26(5):11-9.

> Moreno JD. Reassessing the influence of the Nuremberg Code on American medical ethics. J Contemp Health Law Policy 1997 Spring;13(2):347-60.

> Moreno JD, Lederer SE. Revising the history of Cold War research ethics. Kennedy Inst Ethics J 1996 Sep;6(3):223-7.

> Moss R. The abuse of medicine as a political power in Nazi Germany. Med War 1987 Jan-Mar;3(1):43-7.

> Mossman KL. The human radiation experiments: the real issues [editorial]. Health Phys 1995 Jun;68(6):757-60.

> Mostow P. Like building on top of Auschwitz: on the symbolic meaning of using data from the Nazi experiments, and on nonuse as a form of memorial. J Law Relig 1993-4;10(2):403-31.

> Muller-Hill B. From Daedalus to Mengele: the dark side of human genetics. Genome 1989;31(2):876-8.

> Musto DF. Freedom of inquiry and subjects' rights: historical perspective. Am J Psychiatry 1977 Aug;134(8):893-6.

> Nazi science [letter]. N Engl J Med 1991 Mar 21;324(12):845-7. Comment on: N Engl J Med 1990 May 17;322(20):1435-40; N Engl J Med 1990 May 17;322(20):1462-4.

> Nerve gas volunteers demand follow-up study [news]. Nature 1994 Jan 27;367(6461):303.

> Neumann R. The US Advisory Committee on Human Radiation Experiments. Eur J Nucl Med 1995 Jun;22(6):589-91.

> Novak D, Weitzman M. Readers' responses [Novak's response to Weitzman's The ethics of using Nazi medical data: a Jewish perspective.] [letter and response]. Second Opin 1991 Oct;17(2):143-5.

> Novak SJ. Second thoughts on psychedelic drugs. Endeavour 1998;22(1):21-3.

> Nuremberg Military Tribunal. The Nuremberg code [reprint]. JAMA 1996 Nov 27;276(20):1691.

> Ojanuga D. The medical ethics of the 'father of gynaecology', Dr. J. Marion Sims. J Med Ethics 1993 Mar;19(1):28-31.

> Older J. Psychosurgery: ethical issues and a proposal for control. Am J Orthopsychiatry 1974 Oct;44(5):661-74.

> OReilly M. Nazi medicine: the perversion of the noblest profession. CMAJ 1993 Mar 1;148(5):819-21. Comments in: CMAJ 1993 Jun 1;148(11):1865; CMAJ 1993 Jun 1;148(11):1865-6; CMAJ 1993 Jun 1;148(11):1866.

> Pace BP, Sullivan-Fowler M. JAMA 21 years ago: Panel discusses ethics of studies on humans -- especially the poor [and] Proposed compensations for Tuskegee Study men [reprints]. JAMA 1996 Nov 27;276(20):1692.

> Pace BP, Sullivan-Fowler M. JAMA 50 years ago: the brutality of Nazi physicians [reprint]. JAMA 1996 Nov 27;276(20):1692.

> Panush RS. Upon finding a Nazi anatomy atlas: the lessons of Nazi medicine. Pharos 1996 Fall;59(4):18-22. Comment in: Pharos 1996 Fall;59(4):33.

> Pappworth MH. Human guinea pigs--a history. BMJ 1990 Dec 22-29;301(6766):1456-60. Comment in: BMJ 1991 Feb 16;302(6773):411.

> Parsons CD. Drugs, science, and ethics; lessons from the Depo-provera story. Issues Reprod Genet Eng J Int Feminist Anal 1990;3(2):101-10.

> Peiffer J. Neuropathology in the Third Reich [Memorial to those victims of National-Socialist atrocities in Germany who were used by medical science]. Brain Pathol 1991 Jan;1(2):125-31. Comment in: Brain Pathol 1991 Jul;1(4):328.

> Pellegrino ED. The Nazi doctors and Nuremberg: some moral lessons revisited [editorial]. Ann Intern Med 1997 Aug 15;127(4):307-8.

> Poma PA. Daniel A. Carrion: 1858-1885. IMJ Ill Med J 1988 Jul;174(1):27-9.

> Popper SE, McCloskey K. Ethics in human experimentation: historical perspectives. Mil Med 1995 Jan;160(1):7-11.

> Post SG. The echo of Nuremberg: Nazi data and ethics. J Med Ethics 1991 Mar;17(1):42-4. Comment in: J Med Ethics 1991 Sep;17(3):162.

> Pross C. Breaking through the postwar coverup of Nazi doctors in Germany. J Med Ethics 1991 Dec;17(Suppl):13-6.

> Reichhardt T. Energy department X-rays skeletons in Cold War closet [news]. Nature 1995 Aug 24;376(6542):627.

> Reinhardt O. The Nazi doctors debate. Med J Aust 1990 Dec 3-17;153(11-12):645-7. Comment in: Med J Aust 1991 Mar 18;154(6):428.

> Reprinted from J Lab Clin Med 39:3-9, 1952. A testament of duty. Some strictures on moral responsibilities in clinical research by William Bennett Bean MD. Arch Intern Med 1974 Nov;134(5):854-7.

> Research ethics and the medical profession. Report of the Advisory Committee on Human Radiation Experiments. JAMA 1996 Aug 7;276(5):403-9.

> Rich V. Japanese war-time experiments come to light [news]. Lancet 1995 Aug 26;346(8974):566.

> Riggs G. What should we do about Eduard Pernkopf's atlas? Acad Med 1998 Apr;73(4):380-6.

> Roberts J. A little of the Buchenwald touch [news]. BMJ 1994 Jan 22;308(6923):226.

> Roberts J. US apologises for radiation tests on unaware patients [news]. BMJ 1995 Oct 14;311(7011):970.

> Roelcke V, Hohendorf G, Rotzoll M. Psychiatric research and 'euthanasia'. The case of the psychiatric department at the University of Heidelberg, 1941-1945. Hist Psychiatry 1994 Dec;5(20 Pt 4):517-32.

> Rose RM. Informed consent: history, theory, and practice. Am J Otol 1986 Jan;7(1):82-5.

> Rosner D. Human guinea pigs: medical experimentation before World War II. [Review of: Lederer SE. Subjected to science: human experimentation in America before the Second World War. Johns Hopkins University Press, 1995]. Rev Am Hist 1996 Dec;24(4):652-6.

> Rothman DJ. Ethics and human experimentation. Henry Beecher revisited. N Engl J Med 1987 Nov 5;317(19):1195-9.

> Rothman DJ. The Nuremberg Code, German law, and prominent physician-thinkers [letter]. JAMA 1997 Mar 5;277(9):709; discussion 709-10. Comment on: JAMA 1996 Nov 27;276(20):1662-6.

> Rothman DJ. Radiation [Review of the: "Final Report" of the Advisory Committee on Human Radiation Experiments, and of the "Executive Summary of Final Report", by Ruth R. Faden, Chair]. JAMA 1996 Aug 7;276(5):421-3.

> Rothman DJ. Were Tuskegee & Willowbrook 'studies in nature'? Hastings Cent Rep. 1982 Apr;12(2):5-7.

> Roy B. The Julius Rosenwald Fund syphilis seroprevalence studies. J Natl Med Assoc 1996 May;88(5):315-22.

> Roy B. The Tuskegee Syphilis Experiment: biotechnology and the administrative state. J Natl Med Assoc 1995 Jan;87(1):56-67.

> Roy B. The Tuskegee syphilis experiment: medical ethics, constitutionalism, and property in the body. Harv J Minority Public Health 1995 Fall-Winter;1(1):11-5.

> Rudnick S, Capizzi RL. The conduct of therapeutic trials in cancer medicine. Semin Oncol 1977 Jun;4(2):255-8.

> Samei E, Kearfott KJ. A limited bibliography of the federal government-funded human radiation experiments. Health Phys 1995 Dec;69(6):885-91.

> Sass HM. The Nuremberg Code, German law, and prominent physician-thinkers [letter]. JAMA 1997 Mar 5;277(9):709; discussion 709-10. Comment on: JAMA 1996 Nov 27;276(20):1662-6.

> Sass HM. Reichsrundschreiben 1931: pre-Nuremberg German regulations concerning new therapy and human experimentation. J Med Philos 1983 May;8(2):99-111.

> Schell BH. The ominous shadow of the CIA has imprinted itself on the brain research community. J Calif Alliance Ment Ill 1994;5(1):38-40.

> Schultz MG. Daniel Carrion's experiment. N Engl J Med 1968 Jun 13;278(24):1323-6.

> Seidelman WE. Mengele medicus: medicine's Nazi heritage. Milbank Q 1988;66(2):221-39.

> Seidelman WE. Nuremberg lamentation: for the forgotten victims of medical science. BMJ 1996 Dec 7;313(7070):1463-7.

> Seidelman WE. The path to Nuremberg in the pages of JAMA, 1933-1939. JAMA 1996 Nov 27;276(20):1693-6. Comment in: JAMA 1997 Mar 5;277(9):710-1; discussion 711-2.

> Seidler E. The teaching of medical ethics in the Federal Republic of Germany. J Med Ethics 1979 Jun;5(2):76-9.

> Sellers J. Medical ethics and the civil rights movement. Why informed consent is too little, too late. Second Opin 1989 Nov;(12):46-61.

> A shedding of light. JAMA. 1970 May 11;212(6):1057-8.

> Shevell MI. Neurology's witness to history: part II. Leo Alexander's contributions to the Nuremberg Code (1946 to 1947). Neurology 1998 Jan;50(1):274-8.

> Shevell MI, Evans BK. The Schaltenbrand experiment, Wurzburg, 1940: scientific, historical, and ethical perspectives. Neurology 1994 Feb;44(2):350-6. Comments in: Neurology 1994 Feb;44(2):201-2; Neurology 1995 Mar;45(3 Pt 1):601-2.

> Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med 1997 Nov 13;337(20):1436-40.

> Shuster E. Nazi science. [letters and responses]. N Engl J Med 1991 Mar 21;324(12):845-7.

> Shuster E. The Nuremberg Code: Hippocratic ethics and human rights. Lancet 1998 Mar 28;351(9107):974-7.

> Sidel VW. The social responsibilities of health professionals. Lessons from their role in Nazi Germany. JAMA 1996 Nov 27;276(20):1679-81. Comment on: JAMA 1996 Nov 27;276(20):1657-61; JAMA 1996 Nov 27;276(20):1676-8. Comment in: JAMA 1997 Mar 5;277(9):711; discussion 711-2.

> Simmons HG. Psychosurgery and the abuse of psychiatric authority in Ontario. J Health Polit Policy Law 1987 Fall;12(3):537-50.

> Skolnick AA. Advisory committee report recommends that US make amends for human radiation experiments [news]. JAMA 1995 Sep 27;274(12):933.

> Skolnick AA. Discovery of 50-year-old naval logbook may aid follow-up study of radium-exposed veterans [news]. JAMA 1996 Nov 27;276(20):1628, 1630.

> Skolnick AA. Museum scholars to apply Holocaust experience to 1990s biomedical issues [news]. JAMA 1992 Aug 5;268(5):575-6.

> Skolnick AA. President limits secret experiments on humans [news]. JAMA 1997 May 28;277(20):1583.

> Smallwood R. Medical ethics--past and future [editorial]. Med J Aust 1993 Apr 5;158(7):444-5.

> Smith JG Jr. Yesterday's research: today's standards [editorial]. South Med J 1995 May;88(5):598-9.

> Spicer CM. Fallout from government-sponsored radiation research. Kennedy Inst Ethics J 1994 Jun;4(2):147-54.

> Spiro HM. Eppinger of Vienna: scientist and villain? J Clin Gastroenterol 1984 Dec;6(6):493-7.

> Staiman VR, O'Toole KM, Rubin MA, Lowe FC. Giant malignant fibrous histiocytoma of the testis/spermatic cord: psychologic and possible etiologic complications of unethical Nazi medical experimentation. Urology 1996 Dec;48(6):939-43.

> Steinfels P. Editorial: The National Commission and fetal research. Hastings Cent Rep 1975 Jun;5(3):11-12.

> Steppe H. Nursing in Nazi Germany. West J Nurs Res 1992 Dec;14(6):744-53.

> Steppe H. Nursing in the Third Reich. Hist Nurs J 1990;3(4):21-37.

> Talone P. Establishing trust after Tuskegee [editorial]. Int J Radiat Oncol Biol Phys 1998 Jan 1;40(1):3-4.

> The courage to ask hard questions [editorial]. New Sci 1995 Oct 14;148(1999):3.

> Time to come clean on radiation tests [editorial]. New Sci 1996 Nov 30;152(2058):3.

> Torchia MM. Tuberculosis among American Negroes: medical research on a racial disease, 1830--1950. J Hist Med Allied Sci 1977 Jul;32(3):252-79.

> Toulmin S. The tyranny of principles. Hastings Cent Rep 1981 Dec;11(6):31-9.

> Trey JS. Opening up: U.S. agencies release documents on human radiation experiments [news]. J Law Med Ethics 1994 Fall;22(3):288-91.

> Tuffs A. Nazi war crimes and medicine 50 years on [news]. Lancet 1996 Nov 2;348(9036):1234.

> Vandenbroucke JP. A short note on the history of the randomized controlled trial. J Chronic Dis 1987;40(10):985-7.

> Vessey JA, Gennaro S. The ghost of Tuskegee [editorial]. Nurs Res 1994 Mar-Apr;43(2):67. Comment in: Nurs Res 1994 May-Jun;43(3):132.

> Vinar O. Psychopharmacology research ward. Ten years' experience. Int Pharmacopsychiatry 1976;11(1):32-42.

> Vollmann J, Winau R. History of informed medical consent [letter]. Lancet 1996 Feb 10;347(8998):410. Comment on: Lancet 1995 Oct 7;346(8980):980.

> Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ 1996 Dec 7;313(7070):1445-9.

> Vollmann J, Winau R. The Prussian regulation of 1900: early ethical standards for human experimentation in Germany. IRB Rev Hum Subj Res 1996;18(4):9-11.

> Vonderlehr RA, Clark T, Wenger OC, Heller JR Jr. Untreated syphilis in male Negro; comparative study of treated and untreated cases. Ven Dis Inform 1936 Sep;17(9):260-5. Also J Am Med Assoc 1936 Sep 12;107:856-60.

> Vuylsteke KK. Lessons from Nuremberg: ethical and social responsibilities for health care professionals, health care organizations, and medical journals [letter]. JAMA 1997 Mar 5;277(9):711; discussion 711-2. Comment on: JAMA 1996 Nov 27;276(20):1679-81.

> Watson JD. Genes and politics. J Mol Med 1997 Sep;75(9):624-36. Comment in: J Mol Med 1997 Sep;75(9):615-7.

> Weimerskirch PJ, Richter GW. Hunter and venereal disease [letter]. Lancet 1979 Mar 3;1(8114):503-4.

> Weindling P. Human guinea pigs and the ethics of experimentation: the BMJ's correspondent at the Nuremberg medical trial. BMJ 1996 Dec 7;313(7070):1467-70. Comment in: BMJ 1997 Feb 8;314(7078):440.

> Weissmann G. Origins of the Pernkopf anatomy atlas [letter]. JAMA 1997 Apr 9;277(14):1122; discussion 1123-4.

> Weissmann G, Cutler DS, Israel HA, Seidelman WE, Panush RS, Ebenbauer A, Schutz W. Origins of the Pernkopf Anatomy atlas. [letters and responses]. JAMA 1997 Apr 9;277(14):1122-4.

> Weitzman M. The ethics of using Nazi medical data: a Jewish perspective. Second Opin 1990 Jul;14:27-38.

> White BC. Ethical issues surrounding informed consent. Part I. A brief history and ethical foundations surrounding informed consent. Urol Nurs 1989 Jan-Mar;9(3):11-4.

> White RM. Grand Dragon or windmill: why I opposed the Presidential apology for the Tuskegee Study [editorial]. J Natl Med Assoc 1997 Nov;89(11):719-20.

> Whymant R. The Butchers of Harbin. Experimentation on POWs--Japan, World War II. Conn Med 1983 Mar;47(3):163-5.

> Wikler D, Barondess J. Bioethics and anti-bioethics in light of Nazi medicine: what must we remember? Kennedy Inst Ethics J 1993 Mar;3(1):39-55.

> Williamson F. Man against insect. 3. Walter Reed v yellow fever. Nurs Times 1974 Aug 1;70(31):1202-3.

> Wilson W. Old ethics: new dilemmas. Ulster Med J 1982;51(1):23-34.

> Yankauer A. The neglected lesson of the Tuskegee study [letter]. Am J Public Health 1998 Sep;88(9):1406.

> Young EW. When critical illness interferes with informed consent. Prog Clin Biol Res 1989;299:235-9.

> Zinn C. Australian orphans were used as guinea pigs [news]. BMJ 1997 Jun 21;314(7097):1783.

> Ziporyn T. What the Nazis called 'medical research' haunts the scientific community to this day [news]. JAMA 1990 Feb 9;263(6):791.

> Return to table of contents

> ## Historical perspectives on research involving human participants - Books

> A report on the use of radioactive materials in human subject research that involved residents of state-operated facilities within the Commonwealth of Massachusetts from 1943 through 1973. Boston: Massachusetts Department of Mental Retardation; 1994 Apr. 290+ p.

> Advisory Committee on Human Radiation Experiments. Advisory Committee on Human Radiation Experiments: final report. Washington: The Committee; 1995. 925 p.

> Advisory Committee on Human Radiation Experiments. The human radiation experiments: final report of the Advisory Committee. New York: Oxford University Press; 1996. 620 p.

> Advisory Committee on Human Radiation Experiments. Interim report of the Advisory Committee on Human Radiation Experiments: October 21, 1994. Washington: U.S. Government Printing Office; 1994.

> Aly G, Chroust P, Pross C. Cleansing the fatherland: Nazi medicine and racial hygiene. Cooper B, translator. Baltimore: Johns Hopkins University Press; 1994. 295 p. Consists primarily of edited translations of articles which originally appeared in German in the journal: Beitrage zur nationalsozialistischen Gesundheits- und Sozialpolitik.

> Annas GJ, Grodin MA, editors. The Nazi doctors and the Nuremberg Code: human rights in human experimentation. New York: Oxford University Press; 1992. 371 p.

> Beecher H. Research and the individual: human studies. Boston: Little, Brown. 1970.

> Caplan AL. When medicine went mad: bioethics and the Holocaust. Papers from a conference; 1989 May 17-19; University of Minnesota. Totowa (NJ): Humana Press; 1992. 359 p. (Contemporary issues in biomedicine, ethics, and society).

> Cold War Era Human Subject Experimentation: Hearing Before the Legislation and National Security Subcomm. of the House Comm. on Government Operations, 103rd Cong., 2nd Sess. (1994 Sep 28) [microform]. Washington: U.S. Government Printing Office; 1994. 213 p.

> Cole LA. Clouds of secrecy: the Army's germ warfare tests over populated areas. Totowa (NJ): Rowman and Littlefield; 1988. 188 p.

> Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women's Hospital (New Zealand). Report of the Cervical Cancer Inquiry (Cartwright report). Auckland: Government Printing Office; 1988 Jul. 288 p.

> Coney S. The unfortunate experiment. New York: Penguin Books; 1988. 287 p.

> Deichmann U. Biologists under Hitler. Cambridge (MA): Harvard University Press; 1996. 468 p.

> Dell'Oro R, Viafora C. History of bioethics: international perspectives. San Francisco: International Scholars Publications; 1996. 313 p.

> Department of Defense Mustard Gas Testing: Hearing (1993 Mar 10). Washington: U.S. Government Printing Office; 1993. 117 p.

> Documents on origin and development of the Tuskegee syphilis study, 1973. 4 manuscript boxes (12 v.). Bethesda (MD): National Library of Medicine, History of Medicine Division.

> Feldshuh D. Miss Evers' boys. New York: Dramatists Play Service; 1995. 101 p.

> Final report of the Advisory Committee on Human Radiation Experiments. Supplemental vol. 1: Ancillary materials. Washington: U.S. Government Printing Office; 1995 Oct. 840 p.

> Final report of the Advisory Committee on Human Radiation Experiments. Supplemental vol. 2: Sources and documentation, Supplemental vol. 2a: Sources and documentation -- Appendices. Washington: U.S. Government Printing Office; 1995 Oct.

> Friedlander H. The origins of Nazi genocide: from euthanasia to the final solution. Chapel Hill: University of North Carolina Press; 1995. 421 p.

> Gallagher HG, editor. By trust betrayed: patients, physicians, and the license to kill in the Third Reich. Rev. ed. Arlington (VA): Vandamere Press; 1995. 318 p.

> Geiger HJ, Rush D. Dead reckoning: a critical review of the Department of Energy's epidemiologic research. Washington: Physicians for Social Responsibility, Physicians Task Force on the Health Risks of Nuclear Weapons Production; 1992. 96 p.

> Geison GL. The private science of Louis Pasteur. Princeton (NJ): Princeton University Press; 1995. 378 p.

> Glass JM. "Life unworthy of life": racial phobia and mass murder in Hitler's Germany. New York: Basic Books; 1997. 252 p.

> Government-Sponsored Testing on Humans: Hearing (1994 Feb 3). Washington: U.S. Government Printing Office; 1994. 289 p.

> Gray FD. The Tuskegee Syphilis Study: the real story and beyond. Montgomery (AL): Black Belt Press, c1998. 175 p.

> Hamilton D. The monkey gland affair. London: Chatto & Windus; 1986. 155 p.

> Harris SH. Factories of death: Japanese biological warfare 1932-45 and the American cover-up. New York: Routledge; 1994. 297 p.

> Hoedeman P, translation from Dutch by Ralph de Rijke. Hitler or Hippocrates: medical experiments and euthanasia in the Third Reich. Sussex (England): Book Guild; 1991. 260 p.

> Human Radiation and other Scientific Experiments: the Federal Government's Role: Hearing Before the Senate Committee on Governmental Affairs, 103rd Cong. 2nd Sess. (1994 Jan 25) [microform]. Washington: U.S. Government Printing Office; 1995. 176 p.

> Human Radiation Experimentation, Ethics, and Gene Therapy: Hearing (1994 Feb 10). Washington: U.S. Government Printing Office; 1994. 145 p.

> Human radiation experiments associated with the U.S. Department of Energy and its predecessors [microform]. Washington: Department of Energy, Assistant Secretary for Environment, Safety, and Health; 1995. 213 p.

> Human Radiation Experiments: Hearing Before the Senate Comm. on Governmental Affairs, 104th Cong. 2nd Sess. (1996 Mar 12) [microform]. Washington: U.S. Government Printing Office; 1996. 434 p. (Senate hrg; 104-588).

> Human radiation experiments: the Department of Energy roadmap to the story and the records. Washington: Departmeny of Energy, Assistant Secretary for Environment, Safety and Health; 1995. 302 p.

> Human Subject Radiation Experiments: Progress on Records Search and Ethical Evaluation: Hearing Before the Senate Comm. on Governmental Affairs, 103rd Cong. 2nd Sess. (1994 Dec) [microform]. Washington: U.S. Government Printing Office; 1995. 44 p. (Senate hrg.; 103-1060).

> Hunt L, editor. Secret agenda: the United States government, Nazi scientists, and Project Paperclip, 1945 to 1990. 1st ed. New York: St. Martin's Press; 1991. 340 p.

> International Auschwitz Committee. Nazi medicine: doctors, victims, and medicine in Auschwitz. New York: Howard Fertig; 1986. 227 p. Reproduced from an original copy in the YIVO Institute for Jewish Research Library.

> Jones JH. Bad blood: the Tuskegee syphilis experiment. New and expanded ed. New York: Free Press; c1993. 297 p.

> Jones S. Race, prejudice and health care: the lessons of the Tuskegee Syphilis Experiment, and Critical condition: African Americans in the health care system -- a dual conference report. Minneapolis (MN): Illusion Theater; 1992. 51 p.

> Jonsen AR. The birth of bioethics. New York: Oxford University Press; 1998. 431 p.

> Kater MH, editor. Doctors under Hitler. Chapel Hill: University of North Carolina Press; c1989. 426 p.

> Katz J. Experimentation with human beings: the authority of the investigator, subject, profession, and state in the human experimentation process. New York: Russell Sage Foundation, 1972.

> Lagnado LM, Dekel SC, editors. Children of the flames: Dr. Josef Mengele and the untold story of the twins of Auschwitz. 1st ed. New York: Morrow; c1991. 320 p.

> Lederer SE. Subjected to science: human experimentation in America before the Second World War. Baltimore: Johns Hopkins University Press; 1995. 192 p. (The Henry E. Sigerist series in the history of medicine).

> Lederer SM. Human experimentation and antivivisection in turn-of-the-century America [photocopy]. Ann Arbor (MI): U.M.I. Dissertation Information Service; 187. 268 p.

> Lifton RJ. The Nazi doctors : medical killing and the psychology of genocide. New York: Basic Books; c1986. 561 p.

> Lindee MS. Suffering made real: American science and the survivors at Hiroshima. Chicago: University of Chicago Press; 1994. 287 p.

> Maranto G. Quest for perfection: the drive to breed better human beings. New York: Scribner; 1996. 335 p.

> Marks HM. The progress of experiment: science and therapeutic reform in the United States, 1900-1990. New York: Cambridge University Press; 1997. 258 p. (Cambridge history of medicine).

> McCullough LB. John Gregory and the invention of professional medical ethics and the profession of medicine. Boston: Kluwer Academic; c1998. 347 p. (Philosophy and medicine; 56).

> Michalczyk JJ, editor. Medicine, ethics, and the Third Reich: historical and contemporary issues. Kansas City: Sheed & Ward; c1994. 258 p.

> National Research Council, Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine 131. The Arctic Aeromedical Laboratory's thyroid function study: a radiological risk and ethical analysis. Washington: National Academy Press; 1996. 104 p.

> Pence GE. Classic cases in medical ethics: accounts of cases that have shaped medical ethics, with philosophical, legal, and historical backgrounds. 2nd ed. New York: McGraw-Hill; c1995. 504 p.

> Proctor R, editor. Racial hygiene: medicine under the Nazis. Cambridge (MA): Harvard University Press; 1988. 414 p.

> Public Health Service (US), Tuskegee Syphilis Study Ad Hoc Advisory Panel. Final report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel. Washington: Public Health Service; 1973. 47 p.

> Radiation Experiments Conducted by the University of Cincinnati Medical School with Department of Defense Funding: Hearing (1994 Apr 11). Washington: U.S. Government Printing Office; 1994. 389 p.

> Radiation Research in the VA Involving Human Subjects: Hearing Before the House Comm. on Veteran's Affairs, 103rd Cong. 2nd Sess. (1994 Feb 8) [microform]. Washington: U.S. Government Printing Office; 1994. 190 p. (Serial no. 103-37).

> Radiation Testing on Humans: Hearing (1994 Jan 18). Washington: U.S. Government Printing Office; 1994. 109 p.

> Ramsey P. The patient as person: explorations in medical ethics. New Haven: Yale University Press, 1970.

> Shelley L. Criminal experiments on human beings in Auschwitz and war research laboratories: twenty women prisoners' accounts. San Francisco: Mellen Research University Press; c1991. 402 p.

> Staff of the Subcommittee on Investigations and Oversight transmitted to the House Committee on Science, Space, and Technology, 103rd Cong., 2nd Sess. Ethics and the atom: the use of radioisotopes in medical research at Charity Hospital of New Orleans, 1945-60: report [microform]. Washington: U.S. Government Printing Office; 1995. 97 p.

> The thyroid studies: a follow-up report on the use of radioactive materials in human subject research that involved residents of state-operated facilities within the Commonwealth of Massachusetts from 1943 through 1973. Boston: Massachusetts Department of Mental Retardation; 1994 Jun. 23 p.

> Thomas G. Journey into madness: the true story of secret CIA mind control and medical abuse. New York: Bantam Books; 1989. 388 p.

> Ward R, Krugman S, Giles JP, Jacobs M, Bodansky O. Infectious hepatitis: studies of its natural history and prevention. N Engl J Med 1958;258(9):407-16.

> Weindling P. Health, race, and German politics between National Unification and Nazism, 1870-1945. New York: Cambridge University Press; 1989. 641 p.

> Weinstein HM. Psychiatry and the CIA: victims of mind control. Washington: American Psychiatric Press; 1990. 312 p.

> Williams P, Wallace D. Unit 731: The Japanese Army's secret of secrets. London: Hodder and Stoughton; 1989. 366 p.

> Wright S. Molecular politics: developing American and British regulatory policy for genetic engineering, 1972-1982. Chicago: University of Chicago Press; 1994. 591 p.

> Return to table of contents

> ## Informed consent - Journal Articles

> Aaronson NK, Visser-Pol E, Leenhouts GH, Muller MJ, van der Schot AC, van Dam FS, Keus RB, Koning CC, ten Bokkel Huinink WW, van Dongen JA, Dubbelman R. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol 1996 Mar;14(3):984-96.

> Abrams FR. Commentary on ACOG Committee Opinion #108, May 1992; ethical dimensions of informed consent. Womens Health Issues 1993 Spring;3(1):27-8.

> Adedeji OA. Informed consent in clinical trials. Raise public awareness... [letter]. BMJ 1993 Dec 4;307(6917):1495-6. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

> Agencies look to improve informed consent [news]. Science 1996 Aug 2;273(5275):567.

> Alderson P. Nursing ethics. Consent to research: the role of the nurse. Nurs Stand 1995 May 31-Jun 6;9(36):28-31.

> American Public Health Association. Worker notification and institutional review for privately funded research in occupational health and safety. [Policy statement 9503]. Am J Public Health 1996 Mar;86(3):432-3.

> American Society of Human Genetics. ASHG report: statement on informed consent for genetic research. Am J Hum Genet 1996 Aug;59(2):471-4.

> Ana JN. Informed consent in medical research. South African study raises the ghosts of Nuremberg and apartheid [letter]. BMJ 1997 May 17;314(7092):1479-80. Comment on: BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

> Anderson WF. Big changes at the RAC [editorial]. Hum Gene Ther 1994 Nov;5(11):1309-10.

> Andrews LB. Genetics and informed consent [letter]. Science 1996 Mar 8;271(5254):1346-7. Comment on: Science 1996 Jan 26;271(5248):440. Comment in: Science 1996 May 31;272(5266):1248-9.

> Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 1987 Apr;17(2):20-4.

> Ashcroft R, Toth B. Informed consent. Research suffers if patients suspect that their rights may be breached [letter]. BMJ 1997 Jul 26;315(7102):252. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

> Bagley G. Informed consent: the FDA's perspective. Food Drug Law J 1993;48(2):181-6.

> Bang O. EC proposal for directive can destroy the possibilities of cancer research. Eur J Cancer 1992;28A(6-7):1012-3.

> Barer D. Informed consent. Respect for autonomy may conflict with principle of beneficence [letter]. BMJ 1997 Jul 26;315(7102):254. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1107-11.

> Barker EM. Informed consent in medical research: the ethics committee's view [letter]. BMJ 1998 Jan 31;316(7128):392-3.

> Bartolo [pseud]. Tales of informed consent: four years on an institutional review board. Health Matrix 1992 Summer;2(2):193-245.

> Baum M. Clinical trials--a brave new partnership: a response to Mrs. Thornton. J Med Ethics 1994 Mar;20(1):23-5.

> Baum M. Informed consent in medical research. The whole population must be mobilised in the war against cancer [letter]. BMJ 1997 May 17;314(7092):1482. Comment on: BMJ 1997 Apr 12;314(7087):1107-11; BMJ 1997 Apr 12;314(7087):1111-4.

> Baum M. Informed consent. Reactionary approach inhibits progress [letter]. BMJ 1994 Jan 22;308(6923):271.

> Bebout RR, Becker DR, Drake RE. A research induction group for clients entering a mental health research project: a replication study. Community Ment Health J 1998 Jun;34(3):289-95.

> Belizan JM, Carroli G. Eclampsia studies in developing countries [letter]. Lancet 1998 Sep 26;352(9133):1067.

> Benatar D, Benatar SR. Informed consent and research. BMJ 1998 Mar 28;316(7136):1008.

> Benatar SR. Informed consent in Africa [editorial]. S Afr Med J 1992 May 16;81(10):489-90.

> Benoit G, Spira A, Nicoulet I, Moukarzel M. Presumed consent law: results of its application/outcome from an epidemiologic survey. Transplant Proc 1990 Apr;22(2):320-2.

> Bergmann JF, Chassany O, Gandiol J, Deblois P, Kanis JA, Segrestaa JM, Caulin C, Dahan R. A randomised clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain. Clin Trials Metaanal 1994 Apr;29(1):41-7.

> Bernhardt BA, Geller G, Strauss M, Helzlsouer KJ, Stefanek M, Wilcox PM, Holtzman NA. Toward a model informed consent process for BRCA1 testing: a qualitative assessment of women's attitudes. J Genet Couns 1997 Jun;6(2):207-22.

> Berry DL, Dodd MJ, Hinds PS, Ferrell BR. Informed consent: process and clinical issues. Oncol Nurs Forum 1996 Apr;23(3):507-12.

> Birley JL. Informed consent in clinical trials [letter]. Lancet 1991 Jun 1;337(8753):1353.

> Bland M. Informed consent in medical research. Let readers judge for themselves [letter]. BMJ 1997 May 17;314(7092):1477-8. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

> Blichert-Toft M, Mouridsen H, Andersen KW. Clinical trials. Semin Surg Oncol 1996 Jan-Feb;12(1):32-8.

> Bok S. Informed consent in tests of patient reliability [editorial]. JAMA 1992 Feb 26;267(8):1118-9. Comment on: JAMA 1992 Feb 26;267(8):1106-8. Comment in: JAMA 1992 Aug 12;268(6):790-1; JAMA 1992 Nov 4;268(17):2373-4; discussion 2375-6.

> Bok S. Shading the truth in seeking informed consent for research purposes. Kennedy Inst Ethics J 1995 Mar;5(1):1-17.

> Bracken MB, Shepard MJ. Informed consent [letter]. J Neurosurg 1997 Aug;87(2):336.

> Bratt DE. Informed consent in medical research. Doctors are arrogant to think they need to debate issue of patient consent [letter]. BMJ 1997 May 17;314(7092):1477. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Breast cancer: research without consent [news]. J Med Ethics 1997 Dec;23(6):372.

> Brent NJ. Legal issues in research: informed consent. J Neurosci Nurs 1990 Jun;22(3):189-91.

> Brewin T. Informed consent. Blanket consent to trials would be a good idea [letter]. BMJ 1997 Jul 26;315(7102):253. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Brodeur D. Considering experimentation and elusive truth: informed consent made difficult. Issues Crit Exam Contemp Ethical Issues Health Care 1992 Mar-Apr;7(2):1-8.

> Bromhead HJ, Goodman NW. CONSORT statement on the reporting standards of clinical trials. Reporting of refusal of consent to take part in clinical trials is still poor [letter]. BMJ 1997 Apr 12;314(7087):1126-7. Comment on: BMJ 1996 Sep 7;313(7057):570-1.

> Brushwood DB. Hospital's independent responsibility to obtain informed consent. Am J Hosp Pharm 1994 Sep 1;51(17):2176-8.

> Butler DJ. Informed consent for videotaping [letter]. Acad Med 1996 Dec;71(12):1276-7. Comment on: Acad Med 1996 Jul;71(7):744-8.

> Cacciatore G. Tailoring consent for innovative therapies. Am J Health Syst Pharm 1995 Mar 15;52(6):600-1.

> Campbell H, Boyd KM, Surry SA. Informed consent. Journals should require routine reporting of consent rates [letter]. BMJ 1997 Jul 26;315(7102):247. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Cardinal BJ, Martin JJ, Sachs ML. Readability of written informed consent forms used in exercise and sport psychology research. Res Q Exerc Sport 1996 Sep;67(3):360-2.

> Castronovo FP Jr. An attempt to standardize the radiodiagnostic risk statement in an institutional review board consent form. Invest Radiol 1993 Jun;28(6):533-8.

> Chanter DO. Informed consent in medical research. Risk of bias may be another reason not to seek consent [letter]. BMJ 1997 May 17;314(7092):1478. Comment on: BMJ 1997 Apr 12;314(7087):1107-11.

> Clarke H. Nursing research and patients' rights. Nurs BC 1992 Jul-Aug;24(4):19-20.

> Cocking D, Oakley J. Medical experimentation, informed consent and using people. Bioethics 1994 Oct;8(4):293-311.

> Counsell CE, Sandercock PA. Informed consent in medical research. Failure to publish completed randomised controlled trials is unethical in itself [letter]. BMJ 1997 May 17;314(7092):1481. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Cowell HR. Ethics of medical authorship [editorial]. J Bone Joint Surg Am 1998 Feb;80(2):151-3. Comment on: J Bone Joint Surg Am 1998 Feb;80(2):198-206.

> Cox C, Macpherson CNL. Modified informed consent in a viral seroprevalence study in the Caribbean. Bioethics 1996 Jul;10(3):222-32.

> Cox NH, Wells F. Informed consent to postmarketing research [letters]. BMJ 1995 Sep 9;311(7006):692.

> Culliton BJ. Illuminating informed consent [editorial]. Nat Med 1995 Nov;1(11):1099.

> Dal-Re R. Elements of informed consent in clinical research with drugs: a survey of Spanish clinical investigators. J Intern Med 1992 Apr;231(4):375-9.

> Dal-Re R. Informed consent in clinical research with drugs in Spain: perspective of clinical trials committee members. Eur J Clin Pharmacol 1990;38(4):319-24.

> Daly MB. Informed consent. Research studies in diving medicine are considered by Ministry of Defence research ethics committee [letter]. BMJ 1997 Jul 26;315(7102):248. Comment on: BMJ 1997 May 17;314(7092):1481.

> Daniels RW. For nonscientists and subjects, consent forms are too technical [letter]. IRB Rev Hum Subj Res 1990;12(4):7.

> Daugherty CK, Ratain MJ, Minami H, Banik DM, Vogelzang NJ, Stadler WM, Siegler M. Study of cohort-specific consent and patient control in phase I cancer trials. J Clin Oncol 1998 Jul;16(7):2305-12.

> Daugherty CK, Ratain MJ, Siegler M. Pushing the envelope: informed consent in phase I trials [editorial]. Ann Oncol 1995 Apr;6(4):321-3. Comment on: Ann Oncol 1995 Apr;6(4):363-9.

> Daugherty CK, Siegler M, Ratain MJ, Zimmer G. Learning from our patients: one participant's impact on clinical trial research and informed consent. Ann Intern Med 1997 Jun 1;126(11):892-7.

> Davis AJ. Informed consent process in research protocols: dilemmas for clinical nurses. West J Nurs Res 1989 Aug;11(4):448-57.

> Davis TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst 1998 May 6;90(9):668-74. Comment in: J Natl Cancer Inst 1998 May 6;90(9):644-5.

> DeCherney GS. Actionable medical ethics: informed consent (Part II--Research subjects). Del Med J 1993 Nov;65(11):727-9.

> DeLuca SA, Korcuska LA, Oberstar BH, Rosenthal ML, Welsh PA, Topol EJ. Are we promoting true informed consent in cardiovascular clinical trials? J Cardiovasc Nurs 1995 Apr;9(3):54-61.

> Dicker BG, Kent DL. Physician consent and researchers' access to patients. Epidemiology 1990 Mar;1(2):160-3.

> Douglas S, Briones J, Chronister C. The incidence of reporting consent rates in nursing research articles. Image J Nurs Sch 1994 Spring;26(1):35-40.

> Dowd SB, Wilson B. Informed patient consent: a historical perspective. Radiol Technol 1995 Nov-Dec;67(2):119-24.

> Doyal L. Informed consent -- a response to recent correspondence. BMJ 1998 Mar 28;316(7136):1000-1.

> Doyal L. Informed consent in medical research. Journals should not publish research to which patients have not given fully informed consent--with three exceptions. BMJ 1997 Apr 12;314(7087):1107-11. Comment in: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 May 17;314(7092):1477; BMJ 1997 May 17;314(7092);1478; BMJ 1997 May 17;314(7092):1480; BMJ 1997 May 17;314(7092);1480-1; BMJ 1997 May 17;314(7092):1481; BMJ 1997 May 17;314(7092):1482; BMJ 1997 Jul 26;315(7102):247; BMJ 1997 Jul 26;315(7102):248; BMJ 1997 Jul 26;315(7102):250; BMJ 1997 Jul 26;315(7102):253; BMJ 1997 Jul 26;315(7102):254

> Doyal L, Tobias JS, Warnock M, Power L, Goodare H. Informed consent in medical research. BMJ 1998 Mar 28;316(7136):1000-5. Comment in: BMJ 1998 Mar 28;316(7136):949-51.

> Dudley HA. Informed consent--issues for the 1990s. Br J Urol 1991 Dec;68(6):561-4.

> Edmond MB, Wenzel RP. Ethical considerations in the use of subliminal stimulation to improve handwashing compliance: scientific utility versus autonomy of the individual. Infect Control Hosp Epidemiol 1993 Feb;14(2):107-9.

> Elbourne D, Snowdon C, Garcia J. Informed consent. Subjects may not understand concept of clinical trials [letter]. BMJ 1997 Jul 26;315(7102):248-9. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Ellenberg SS. Informed consent: protection or obstacle? Some emerging issues. Control Clin Trials 1997 Dec;18(6):628-36; discussion 661-6.

> Ellenberg SS. Randomized consent designs for clinical trials: an update [letter]. Stat Med 1992 Jan 15;11(1):131-2. Comment on: Stat Med 1990 Jun;9(6):645-56.

> Emberton M, Wood C, Meredith P. Informed consent in clinical trials. Should be comprehensive...[letter]. BMJ 1993 Dec 4;307(6917):1494. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

> Emberton M, Wood C, Meredith P, Gerlis L, Wong JG, Walsworth-Bell JP, Modi N, Adedeji OA, Thornton H, Chinnery P, Asimakopoulos G, Kenny RA, McIntosh N, Keatinge R, Kanis JA, Bergmann JF. Informed consent in clinical trials [letters]. BMJ 1993 Dec 4;307(6917):1494-7.

> Epstein K, Sloat B. Informed consent. Informed consent is not always obtained in United States [letter]. BMJ 1997 Jul 26;315(7102):249. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Ethical dimensions of informed consent ACOG Committee Opinion: Committee on Ethics Number 108--May 1992. Int J Gynaecol Obstet 1992 Dec;39(4):346-55.

> Euretig JG. Legal and ethical aspects of deliberate G-induced loss of consciousness experiments. Aviat Space Environ Med 1991 Jul;62(7):628-31.

> Faden R. Informed consent and clinical research. Kennedy Inst Ethics J 1996 Dec;6(4):356-9.

> Finkel MJ. Should informed consent include information on how research is funded? IRB Rev Hum Subj Res 1991;13(5):1-3.

> Flegel KM. Physicians, finder's fees and free, informed consent [editorial]. CMAJ 1997 Nov 15;157(10):1373-4.

> Fligner DJ, Spivey WH, Runge JW. Informed consent and the regulation of research (SAEM position paper). Acad Emerg Med 1994 Nov-Dec;1(6):561-2.

> Food and Drug Administration (US). Informed consent for human drugs and biologics; determination that informed consent is not feasible; interim rule and opportunity for public comment. Fed Regist 1990 Dec 21;55(246):52814-7.

> Food and Drug Administration (US). Protection of human subjects; informed consent; proposed rule. Fed Regist 1995 Sep 21;60(183):49086-103.

> Foster C. Commentary: ethics of clinical research without patients' consent. BMJ 1996 Mar 30;312(7034):817.

> Freedman B. Cohort-specific consent: an honest approach to phase 1 clinical cancer studies. IRB Rev Hum Subj Res 1990 Jan-Feb;12(1):5-7.

> Freeman JM, Weil W, Berris RF, Veatch RM. Abandoning informed consent? [letters and response]. Hastings Cent Rep 1996 Jan-Feb;26(1):2-4.

> Friedlander WJ. The evolution of informed consent in American medicine. Perspect Biol Med 1995 Spring;38(3):498-510.

> Fumes from the spleen [letter]. Paediatr Perinat Epidemiol 1998 Jan;12(1):2-4.

> Fureman I, Meyers K, McLellan AT, Metzger D, Woody G. Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV vaccine efficacy trials. AIDS Educ Prev 1997 Aug;9(4):330-41.

> Gallo C, Perrone F, De PS, Giusti C. Informed versus randomised consent to clinical trials. Lancet 1995 Oct 21;346(8982):1060-4.

> Geller G, Strauss M, Bernhardt BA, Holtzman NA. Decoding informed consent: insights from women regarding breast cancer susceptibility testing. Hastings Cent Rep 1997 Mar-Apr;27(2):28-33.

> Geller JL, Lidz CW, Pattulo EL. When the subjects are hospital staff, is it ethical (or possible) to get informed consent? [case study and commentary]. IRB Rev Hum Subj Res 1987 Sep-Oct;9(5):4-8.

> Gene Therapy Advisory Committee (Great Britain). Writing information leaflets for patients participating in gene therapy research. Bull Med Ethics 1995 Oct;112:18-21.

> Gluck JP, Hahn-Smith S. Deception in psychological research [letter]. Kennedy Inst Ethics J 1995 Dec;5(4):386-8.

> GMC guidance on videos of patients [news]. Bull Med Ethics 1994 Aug;100:5-6.

> Gold RL, Lebel RR, Mearns EA, Dworkin RB, Hadro T, Burns JK. Model consent forms for DNA linkage analysis and storage. Am J Med Genet 1993 Dec 1;47(8):1223-4.

> Goldhammer M, Altman J. Ensuring that nonscientists and subjects understand research protocols [letter]. IRB Rev Hum Subj Res 1990;12(5):10-11.

> Goldstein AO, Frasier P, Curtis P, Reid A, Kreher NE. Consent form readability in university-sponsored research. J Fam Pract 1996 Jun;42(6):606-11.

> Goldworth A. Informed consent in the human genome enterprise. Camb Q Healthc Ethics 1995 Summer;4(3):296-303.

> Goodare H. Studies that do not have informed consent from participants should not be published. BMJ 1998 Mar 28;316(7136):1004-5.

> Green Lane Hospital (Auckland) Consultant Staff. Informed consent: discussion paper by the New Zealand Health Council's working party. N Z Med J 1990 Jul 25;103(894):348-51.

> Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 1994 Oct;12(10):2211-5.

> Gunderson M. Justifying a principle of informed consent: a case study in autonomy-based ethics. Public Aff Q 1990 Jul;4(3):249-65.

> Gunn AE. Risk-benefit ratio: the soft underbelly of patient autonomy. Issues Law Med 1991 Fall;7(2):139-53.

> Haddad A. Ethics in action. A cardiac patient has just signed a consent form agreeing to participate in a clinical trial. RN 1996 Mar;59(3):17-9.

> Hadfield P. Tokyo perspective: informed consent [news]. Lancet 1993 May 1;341(8853):1141.

> Hamajima N, Yuasa H, Nakamura M, Tajima K, Tominaga S. Nested consent design for clinical trials. Jpn J Clin Oncol 1998 May;28(5):329-32.

> Hammerschmidt DE, Keane MA. Institutional review board (IRB) review lacks impact on the readability of consent forms for research. Am J Med Sci 1992 Dec;304(6):348-51.

> Heinze-Lacey B, Saunders C, Sugar A. Improving the readability of informed consent documents [letter]. IRB Rev Hum Subj Res 1993;15(3):10-11.

> Hewlett S. Consent to clinical research--adequately voluntary or substantially influenced? J Med Ethics 1996 Aug;22(4):232-7.

> Hewlett SE. Is consent to participate in research voluntary? Arthritis Care Res 1996 Oct;9(5):400-4.

> Hochhauser M. Some overlooked aspects of consent form readability. IRB Rev Hum Subj Res 1997 Sep-Oct;19(5):5-9.

> Hodges C. Consent checklist for investigators. Bull Med Ethics 1991 Apr;67:3-4.

> Holditch-Davis D, Conway A. Consent: where research design meets reality. Neonatal Netw 1992 Jun;11(4):65-8.

> Homan R. The ethics of open methods. Br J Sociol 1992 Sep;43(3):321-32.

> Hood CA, Hope T, Dove P. Videos, photographs, and patient consent. BMJ 1998 Mar 28;316(7136):1009-11.

> Hooker EZ. Can your research subjects read your study's informed consent form? SCI Nursing 1995 Jun;12(2):57-8.

> Hooker EZ. Informed consent. SCI Nurs 1992 Aug;9(3):86-91.

> Horton R. The context of consent [commentary]. Lancet 1994 Jul 23;344(8917):211-2.

> House A, Knapp P. Informed consent. Trials that use Zelen's procedure should be acceptable [letter]. BMJ 1997 Jul 26;315(7102):251. Comment on: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7.

> Howe EG. The Nuremberg Code, informed consent, and involuntary treatment [letter]. JAMA 1997 Mar 5;277(9):713; discussion 713-4. Comment on: JAMA 1996 Nov 27;276(20):1682-3.

> Hunter D, Caporaso N. Informed consent in epidemiologic studies involving genetic markers. Epidemiology 1997 Sep;8(5):596-9.

> Informed consent: how informed? [editorial]. Lancet 1991 Sep 14;338(8768):665-6. Comment in: Lancet 1991 Oct 12;338(8772):952.

> Isaacman SH. HIV surveillance testing: taking advantage of the disadvantaged [letter]. Am J Public Health 1993 Apr;83(4):597-8. Comment in: Am J Public Health 1993 Apr;83(4):496-7; Am J Public Health 1994 Feb;84(2):319-20.

> Isaacman SH, Miller LA. Neonatal HIV seroprevalence studies. A critique of national and international practices. J Leg Med 1993 Sep;14(3):413-61.

> Issues in nursing and health. Research trials: advice for nurses. Nurs Stand 1992 Feb 5-11;6(20):35.

> Jimison HB, Sher PP, Appleyard R, LeVernois Y. The use of multimedia in the informed consent process. J Am Med Inform Assoc 1998 May-Jun;5(3):245-56.

> Johnson CD. Informed consent in surgical research. Br J Surg 1992 Feb;79(2):116.

> Johnson M. A silent conspiracy: some ethical issues of participant observation in nursing research. Int J Nurs Stud 1992 May;29(2):213-23.

> Kachoyeanos MK. Elements of informed consent. MCN Am J Matern Child Nurs 1996 Jul-Aug;21(4):205.

> Kachoyeanos MK. Principles of informed consent. MCN Am J Matern Child Nurs 1996 May-Jun;21(3):131.

> Kanis JA, Bergmann JF. Informed consent in clinical trials. Full consent may bias outcome of trials [letter]. BMJ 1993 Dec 4;307(6917):1497. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

> Katz J. Reflections on informed consent: 40 years after its birth. J Am Coll Surg 1998 Apr;186(4):466-74.

> Kee C. Nurses' perceptions of informed consent. AARN News Lett 1995 Feb;51(2):23-7.

> Kiernan V. Measles trial broke consent rules [news]. New Sci 1996 Jun 29;150(2036):8.

> Klepp KI. Nonresponse bias due to consent procedures in school-based, health-related research. Scand J Soc Med 1995 Mar;23(1):53-9.

> La Puma J, Kraut J. How much do you get paid if I volunteer? Suggested institutional policy on reward, consent, and research. Hosp Health Serv Adm 1994 Summer;39(2):193-203.

> Lai KK. Consent to treatment with zidovudine among HIV-infected patients. Cleve Clin J Med 1992 Jan-Feb;59(1):45-7.

> Lantos J. Informed consent. The whole truth for patients? Cancer 1993 Nov 1;72(9 Suppl):2811-5.

> Lara MC, de la Fuente JR. On informed consent. Bull Pan Am Health Organ 1990;24(4):419-24.

> Laurence DR. Informed consent [letter]. Lancet 1993 Jun 5;341(8858):1479. Comment on: Lancet 1993 May 1;341(8853):1141.

> Lawson C. Research participation as a contract. Ethics Behav 1995;5(3):205-15.

> Lawson SL, Adamson HM. Informed consent readability: subject understanding of 15 common consent form phrases. IRB Rev Hum Subj Res 1995 Sep-Dec;17(5-6):16-9.

> LeBlang TR. Medical battery and failure to obtain informed consent: Illinois court decision suggests potential for IRB liability. IRB Rev Hum Subj Res 1995;17(3):10-1.

> Leino-Kilpi H, Nyrhinen T, Katajisto J. Patients' rights in laboratory examinations: do they realize? Nurs Ethics 1997 Nov;4(6):451-64.

> Levine RJ. Informed consent: some challenges to the universal validity of the Western model. Law Med Health Care 1991 Fall-Winter;19(3-4):207-13.

> Li FP, Polli AM. Informed consent for genetic research [letter]. JAMA 1996 Apr 10;275(14):1085-6. Comment on: JAMA 1995 Dec 13;274(22):1786-92.

> Lippman A. Nonconsensual participation in genetic studies [letter]. Am J Public Health 1996 Jul;86(7):1030.

> Little P, Williamson I. Informed consent in medical research. Ethics committees and BMJ should continue to consider the overall benefit to patients [letter]. BMJ 1997 May 17;314(7092):1478. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7.

> LoVerde ME, Prochazka AV, Byyny RL. Research consent forms: continued unreadability and increasing length. J Gen Intern Med 1989 Sep-Oct;4(5):410-2.

> Lustig BA, Coverdale J, Bayer T, Chiang E. Attitudes toward the use of deception in psychologically induced pain. IRB Rev Hum Subj Res 1993 Nov-Dec;15(6):6-8.

> Lynoe N, Sandlund M, Dahlqvist G, Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ 1991 Sep 14;303(6803):610-3. Comment in: BMJ 1991 Nov 2;303(6810):1138.

> Lynoe N, Sandlund M, Jacobsson L. Clinical cancer research--some aspects on doctors' attitudes to informing participants. Acta Oncol 1996;35(6):749-54.

> MacKinnon B. How important is consent for controlled clinical trials? Camb Q Healthc Ethics 1996 Spring;5(2):221-7.

> Malin A, Lockwood D. Informed consent. Study in which patients had HIV tests could have been designed differently [letter]. BMJ 1997 Jul 26;315(7102):251-2. Comment on: BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

> Maloney DM. Court tells jury to ignore human subject protection regulations [news]. Hum Res Rep 1995 Mar;10(3):4-5.

> Maloney DM. Federal agency's final rule says informed consent forms must be dated [news]. Hum Res Rep 1996 Dec;11(12):1-2.

> Maloney DM. If a subject incurs obligations and carries them out, then consent is a contract: Dahl vs HEM Pharmaceuticals (Part II). Hum Res Rep 1996 Jan;11(1):4-5.

> Maloney DM. Informed consent is binding contract: Dahl vs HEM Pharmaceuticals. Hum Res Rep 1995 Dec;10(12):4-5.

> Maloney DM. Informed consent process and document is criticized in court [news]. Hum Res Rep 1994 Dec;9(12):4-5.

> Maloney DM. Informed consent process is deemed legally and ethically invalid by witness [news]. Hum Res Rep 1995 Jan;10(1):4-5.

> Maloney DM. Special informed consent requirements are included in protocol review procedures [news]. Hum Res Rep 1995 Jul;10(7):1-2.

> Maltby JR, Eagle CJ. Informed consent for clinical anaesthesia research. Can J Anaesth 1993 Sep;40(9):891-6.

> Maltby JR, Eagle CJ. Patient recruitment for clinical research [letter]. Can J Anaesth 1993 Sep;40(9):897-8. Comment on: Can J Anaesth 1993 Mar;40(3):287-8.

> Mander R. Seeking approval for research access: the gatekeeper's role in facilitating a study of the care of the relinquishing mother. J Adv Nurs 1992 Dec;17(12):1460-4.

> Mant J, Winner S, Carter J, Wade DT. Informed consent. Patients' knowledge that they are participating in trial may not bias results [letter]. BMJ 1997 Jul 26;315(7102):252-3. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7.

> Marsh BT. Informed consent--help or hindrance [editorial]. J R Soc Med 1990 Oct;83(10):603-6. Comment in: J R Soc Med 1991 Mar;84(3):182.

> Marshall E. Panel faults research consent process [news]. Science 1995 Oct 6;270(5233):25.

> Marshall S. How to get patients consent to enter clinical trials. Participants should be given feedback about the trial [letter]. BMJ 1996 Jan 20;312(7024):186. Comment on: BMJ 1995 Sep 16;311(7007):734-7.

> Marwick C. Improved protection for human research subjects [news]. JAMA 1998 Feb 4;279(5):344-5.

> McIntosh N. Informed consent in clinical trials. Strengthen ethical committees' role [letter]. BMJ 1993 Dec 4;307(6917):1496. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

> McLean P. Biomedical research and the law of informed consent. Can Nurse 1996 Nov;92(10):49-50.

> Meade CD, Howser DM. Consent forms: how to determine and improve their readability. Oncol Nurs Forum 1992 Nov-Dec;19(10):1523-8.

> Meisel A. Informed consent [editorial]. Arthritis Rheum 1992 Nov;35(11):1264-6. Comment on: Arthritis Rheum 1992 Nov;35(11):1257-63.

> Melby T, Mendelson JE, Jones RT. Patients' understanding of consent form should be checked before participation in trial [letter]. BMJ 1996 Mar 30;312(7034):847. Comment on: BMJ 1995 Sep 16;311(7007):734-7.

> Merrell J, Williams A. Participant observation and informed consent: relationships and tactical decision-making in nursing research. Nurs Ethics 1994 Sep;1(3):163-72.

> Meyers K, Dunton AW. Applying "an ethical framework" to a proposed HIV antibody screening program. IRB Rev Hum Subj Res 1988 Jan-Feb;10(1):6-8.

> Miller CK, O'Donnell DC, Searight HR, Barbarash RA. The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects. Pharmacotherapy 1996 Sep-Oct;16(5):872-8.

> Minogue BP, Palmer-Fernandez G, Udell L, Waller BN. Individual autonomy and the double-blind controlled experiment: the case of desperate volunteers. J Med Philos 1995 Feb;20(1):43-55.

> Montague J. Balancing caution & courage. Physicians and regulators weigh informed consent issues in clinical research. Hosp Health Netw 1994 Sep 20;68(18):50, 52-4.

> Montgomery C, Lydon A, Lloyd K. Informed consent in medical research. Patients may not understand enough to give their informed consent [letter]. BMJ 1997 May 17;314(7092):1482. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Montgomery JE, Sneyd JR. Consent to clinical trials in anaesthesia. Anaesthesia 1998 Mar;53(3):227-30.

> Moorhouse A, Weisstub DN. Advance directives for research: ethical problems and responses. Int J Law Psychiatry 1996 Spring;19(2):107-41.

> Mosher DL, Bond SB. Ethics -- perceived or reasoned from principles?: a rejoinder to Korn, Huelsman, and Reed. Ethics Behav 1992;2(3):203-14.

> Mosher DL, Bond SB. Little rapes, specious claims, and moral hubris: a reply to Korn, Huelsman, Reed, and Aiello. Ethics Behav 1992;2(2):109-21.

> Mountford PJ, Nunan TO. Radiation risk and ethical consent [editorial]. Nucl Med Commun 1995 Jan;16(1):1-3.

> Murgatroyd RJ, Cooper RM. Readability of informed consent forms. Am J Hosp Pharm 1991 Dec;48(12):2651-2.

> Murphy J, Gamble G, Sharpe N. Readability of subject information leaflets for medical research. N Z Med J 1994 Dec 14;107(991):509-10.

> Newman AM. Drug trials, doctors, and developing countries: toward a legal definition of informed consent. Camb Q Healthc Ethics 1996 Summer;5(3):387-99.

> Newton LH. Ethical imperialism and informed consent. IRB Rev Hum Subj Res 1990;12(3):10-1.

> Novick A. May a human subject waive the right to be treated as a human subject? AIDS Public Policy J 1990 Winter;5(1):45-8.

> Nylenna M. Details of patients' consent in studies should be reported [letter]. BMJ 1997 Apr 12;314(7087):1127-8. Comment on: BMJ 1996 Nov 2;313(7065):1117.

> Nylenna M, Riis P. Identification of patients in medical publications: need for informed consent. BMJ 1991 May 18;302(6786):1182.

> O'Neil TJ, Goldberg H, McGough H. Minimal risk, administrative firm trials, and informed consent [letter]. IRB Rev Hum Subj Res 1992;14(3):9-10, 12.

> Ockene IS, Miner J, Shannon TA, Gore JM, Weiner BH, Ball SP. The consent process in the Thrombolysis in Myocardial Infarction (TIMI--phase I) trial. Clin Res 1991 Feb;39(1):13-7.

> Oddens BJ, Algra A, van Gijn J. Informing patients about clinical trials [editorial]. Clin Investig 1993 Jul;71(7):572-3.

> Ogloff JRP, Otto RK. Are research participants truly informed? Readability of informed consent forms used in research. Ethics Behav 1990;1(4):239-52.

> Oldham RK. Is informed consent a function of who pays? [editorial]. Mol Biother 1991 Mar;3(1):2-5.

> Oliansky A. A confederate's perspective on deception. Ethics Behav 1990;1(4):253-8.

> Olson CM, Jobe KA. Reporting institutional review board approval and patient consent [letter]. JAMA 1997 Aug 13;278(6):477. Comment on: JAMA 1997 Mar 19;277(11):909-14; JAMA 1997 Mar 19;277(11):922-3.

> Olver IN, Buchanan L, Laidlaw C, Poulton G. The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Oncol 1995 Nov;6(9):867-70.

> Padberg RM. Sources of information about consent in cancer research. Cancer Pract 1996 Sep-Oct;4(5):281-4.

> Past radiation experiments may lead to new efforts for informed consent [news]. Hosp Ethics 1994 Mar-Apr;10(2):13-5.

> Pellegrino ED. Autonomy, beneficence, and the experimental subject's consent: a response to Jay Katz. St Louis Univ Law J 1993 Fall;38(1):55-62. Comment on: St Louis Univ Law J 1993 Fall;38(1):7-54.

> Peterson BT, Clancy SJ, Champion K, McLarty JW. Improving readability of consent forms: what the computers may not tell you. IRB Rev Hum Subj Res 1992 Nov-Dec;14(6):6-5.

> Pfeffer N. How to get patients consent to enter clinical trials. Information and consent forms should use short words and sentences [letter]. BMJ 1996 Jan 20;312(7024):186. Comment on: BMJ 1995 Sep 16;311(7007):734-7.

> Pfeffer N, Alderson P. Informed consent. The central problem is often poor design and conduct of trials [letter]. BMJ 1997 Jul 26;315(7102):247. Comment on: BMJ 1997 Apr 12;314(7087):1107-11; BMJ 1997 Apr 12;314(7087):1111-4.

> Philipson SJ, Doyle MA, Gabram SG, Nightingale C, Philipson EH. Informed consent for research: a study to evaluate readability and processability to effect change. J Investig Med 1995 Oct;43(5):459-67.

> Power L. Trial subjects must be fully involved in design and approval of trials. BMJ 1998 Mar 28;316(7136):1003-4.

> Porter JP. Informed consent issues in international research concerns. Camb Q Healthc Ethics 1996 Spring;5(2):237-43.

> Preziosi MP, Yam A, Ndiaye M, Simaga A, Simondon F, Wassilak SG. Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Engl J Med 1997 Jan 30;336(5):370-3.

> Priestley KA, Campbell C, Valentine CB, Denison DM, Buller NP. Are patient consent forms for research protocols easy to read? BMJ 1992 Nov 21;305(6864):1263-4. Comment in: BMJ 1992 Nov 21;305(6864):1242.

> Pritchard KI. Informed consent in compliance studies [letter]. J Clin Oncol 1993 Dec;11(12):2457-8. Comment on: J Clin Oncol 1993 Jun;11(6):1189-97.

> Proposed requirements for informed consent go beyond current federal regulations [news]. Hum Res Rep 1994 Jul;9(7):1-3.

> RAGE (Radiotherapy Action Group Exposure) National [Great Britain]. All treatment and trials must have informed consent. BMJ 1997 Apr 12;314(7087):1134-5.

> Raloff J. Tamoxifen and informed consent/dissent. Sci News 1992 Nov 28;142(22):378-80.

> Rankine JJ. Most patients don't read the BMJ. BMJ 1998 Mar 28;316(7136):1026-7.

> Rempusheski VF. Elements, perceptions, and issues of informed consent. Appl Nurs Res 1991 Nov;4(4):201-4.

> Research without consent in South Africa [news]. BMJ 1997 Jun 28;314(7098):1850.

> Riecken HW, Ravich R. Informed consent to biomedical research in Veterans Administration Hospitals. JAMA 1982 Jul 16;248(3):344-8.

> Riis P, Nylenna M. Patients have a right to privacy and anonymity in medical publication [editorial]. JAMA 1991 May 22-29;265(20):2720. Comment on: JAMA 1991 May 22-29;265(20):2697-8.

> Riordan F, Thomson AP. How to get patients' consent to enter clinical trials. Reports of trials should state proportion of people who refuse to participate [letter]. BMJ 1996 Jan 20;312(7024):185-6. Comment on: BMJ 1995 Sep 16;311(7007):734-7.

> Rivera R, Reed JS, Menius D. Evaluating the readability of informed consent forms used in contraceptive clinical trials. Int J Gynaecol Obstet 1992 Jul;38(3):227-30.

> Roberts J. US researchers fail to get informed consent [news]. BMJ 1994 Mar 19;308(6931):739.

> Robinson P, Vandenburg M, Dews I. Informed consent [letter]. BMJ 1991 Nov 2;303(6810):1138. Comment on: BMJ 1991 Sep 14;303(6803):610-3.

> Rogers CG, Tyson JE, Kennedy KA, Broyles RS, Hickman JF. Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. J Pediatr 1998 Apr;132(4):606-11. Comment in: J Pediatr 1998 Apr;132(4):567-8.

> Ross LF, Veatch RM. Consent for clinical research. [letter]. N Engl J Med 1997 Jul 24;337(4):282.

> Rubenstein LS. Standards of accountability for consent in research. Account Res 1996;4(3-4):197-206.

> Schaeffer MH, Krantz DS, Wichman A, Masur H, Reed E, Vinicky JK. The impact of disease severity on the informed consent process in clinical research. Am J Med 1996 Mar;100(3):261-8.

> Schultz AL, Pardee GP, Ensinck JW. Are research subjects really informed? West J Med 1975 Jul;123(1):76-80.

> Searight HR, Miller CK. Remembering and interpreting informed consent: a qualitative study of drug trial participants. J Am Board Fam Pract 1996 Jan-Feb;9(1):14-22.

> Senn S. The ignoble lie [letter]. J Clin Epidemiol 1992 Nov;45(11):1338-40. Comment on: J Clin Epidemiol 1991;44(4-5):339-41; J Clin Epidemiol 1991;44(4-5):343-5.

> Sheldon T. Consent is not always essential, say Dutch experts [news]. BMJ 1995 May 27;310(6991):1355-6.

> Shimm DS, Spece RG. Rate of refusal to participate in clinical trials. IRB Rev Hum Subj Res 1992 Mar-Apr;14(2):7-9.

> Shimm DS, Spece RG Jr. Conflict of interest and informed consent in industry-sponsored clinical trials. J Leg Med 1991 Dec;12(4):477-513.

> Shore D. Ethical principles and informed consent: an NIMH perspective. Psychopharmacol Bull 1996;32(1):7-10.

> Sikich N, Lerman J. Obtaining informed consent for anesthesia research [letter]. Anesth Analg 1996 Aug;83(2):438. Comment on: Anesth Analg 1996 Feb;82(2):332-7.

> Sikich N, Lerman J. Same day consent for anaesthesia research [letter]. Can J Anaesth 1994 Dec;41(12):1234.

> Silva MC, Sorrell JM. Enhancing comprehension of information for informed consent: a review of empirical research. IRB Rev Hum Subj Res 1988 Jan-Feb;10(1):1-5.

> Silverman HJ. Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients. Am J Respir Crit Care Med 1996 Sep;154(3 Pt 1):582-6.

> Sim J. Nursing research: is there an obligation on subjects to participate? J Adv Nurs 1991 Nov;16(11):1284-9.

> Simel DL, Feussner JR. A randomized controlled trial comparing quantitative informed consent formats. J Clin Epidemiol 1991 Aug;44(8):771-7.

> Simel DL, Feussner JR. Suspended judgment. Clinical trials of informed consent. Control Clin Trials 1992 Oct;13(5):321-4.

> Sloan J, Resnick GD. The consent form revisited. Arch Intern Med 1993 May 24;153(10):1170-3. Comment in: Arch Intern Med 1994 Apr 11;154(7):824.

> Smith ML. Power, advocacy, and informed consent forms. J Calif Alliance Ment Ill 1994;5(1):25-7.

> Smith R. Commentary: the importance of patients' consent for publication. BMJ 1996 Jul 6;313(7048):16.

> Smith R. Informed consent: edging forwards (and backwards) [editorial]. BMJ 1998 Mar 28;316(7136):949-51. Comment on: BMJ 1998 Mar 28;316(7136):955; BMJ 1998 Mar 28;316(7136):1000-5.

> Smith R. Informed consent: the intricacies [editorial]. BMJ 1997 Apr 12:314(7087)1059-60. Comment on: BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1107-11; BMJ 1997 Apr 12;314(7087):1111-4. Comments in: BMJ 1997 May 17;314(7092):1477; BMJ 1997 May 17;314(7092):1479; BMJ 1997 May 17;314(7092):1480; BMJ 1997 May 17;314(7092):1480-1; BMJ 1997 May 17;314(7092):1481; BMJ 1997 May 17;314(7092):1482; BMJ 1997 May 17;314(7092):1482-3; BMJ 1997 Jul 26;315(7102):247; BMJ 1997 Jul 26;315(7102):248; BMJ 1997 Jul 26;315(7102):248-9; BMJ 1997 Jul 26;315(7102):249; BMJ 1997 Jul 26;315(7102):249-50; BMJ 1997 Jul 26;315(7102):250; BMJ 1997 Jul 26;315(7102):250-1; BMJ 1997 Jul 26;315(7102):251; BMJ 1997 Jul 26;315(7102):253.

> Smith R. Publishing information about patients: time to change from guarding anonymity to getting consent [editorial]. BMJ 1995 Nov 11;311(7015):1240-1.

> Soloniuk LJ. All subjects of a study should provide informed consent [letter]. Anesthesiology 1990 Mar;72(3):577-8. Comment on: Anesthesiology 1989 Sep;71(3):385-90.

> Sorscher EJ, Logan JJ, Frizzell RA, Lyrene RK, Bebok Z, Dong JY, Duvall MD, Felgner PL, Matalon S, Walker L, Wiatrak BJ. Informed consent to participate in a research study -- gene therapy for cystic fibrosis using cationic liposome mediated gene transfer: a phase I trial of safety and efficacy in the nasal airway. Hum Gene Ther 1994 Oct;5(10):1271-7.

> Souhami RL, Tobias JS, Baum M, Marteau T. Informed consent [letters]. BMJ 1994 Jan 22;308(6923):271-2.

> Soutter P. Informed consent in medical research. No one has a monopoly on deciding what is ethical [letter]. BMJ 1997 May 17;314(7092):1477. Comment on: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7; BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4; BMJ 1997 Apr 12;314(7087):1107-11; BMJ 1997 Apr 12;314(7087):1111-4.

> Speck P. Consideration of consent in clinical research. Palliat Med 1996 Apr;10(2):163-4.

> Spivey WH. Questions & answers: statistical tests & consent [letter]. Ann Emerg Med 1991 Dec;20(12):1396. Comment on: Ann Emerg Med 1990 Nov;19(11):1280-7.

> Springate R. Respecting patient consent [letter]. Can Fam Physician 1995 Nov;41:1850, 1852. Comment on: Can Fam Physician 1995 Aug;41:1367-72.

> Squire SB, Gray N, Hawley R, Hayward C, Ali A, Macfarlane S, Bianco AE, Beeching NJ, Taylor M, Agbaje S, Brabin B, Wyatt GB, Coulter JB, De Koning K. Informed consent. British institutions collaborating in projects overseas may face dilemma [letter]. BMJ 1997 Jul 26;315(7102):248. Comment on: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4; BMJ 1997 Apr 12;314(7087):1107-11.

> Stern PN. Horror story [editorial]. Health Care Women Int 1990;11(2):v-vii.

> Stewart-Brown S. Informed consent in medical research. Clinicians are being disingenuous with themselves [letter]. BMJ 1997 May 17;314(7092):1478-9.

> Sugarman J, McCrory DC, Powell D, Krasny A, Adams B, Ball E, Cassell C. Empirical research on informed consent. An annotated bibliography. Hastings Cent Rep 1999 Jan-Feb;29(1):S1-42.

> Summers S. The research process: informed consent. J Post Anesth Nurs 1993 Dec;8(6):406-9.

> Sutherland HJ, Lockwood GA, Till JE. Are we getting informed consent from patients with cancer? J R Soc Med 1990 Jul;83(7):439-43.

> Tankanow RM, Sweet BV, Weiskopf JA. Patients' perceived understanding of informed consent in investigational drug studies. Am J Hosp Pharm 1992 Mar;49(3):633-5.

> Taub HA, Sturr JF. Evaluating informed consent for research: a methodological study with older adults. Educ Gerontol 1990;16(3):273-81.

> Temmerman M, Ndinya-Achola J, Ambani J, Piot P. The right not to know HIV-test results. Lancet 1995 Apr 15;345(8955):969-70.

> Thar WE. The epidemiologist's responsibilities to research subjects in the occupational setting. J Clin Epidemiol 1991;44 Suppl 1:91-4S.

> Thong YH, Harth SC. The social filter effect of informed consent in clinical research. Pediatrics 1991 Apr;87(4):568-9.

> Thornton H. Clinical trials--a brave new partnership? J Med Ethics 1994 Mar;20(1):19-22; discussion 23-5. Comment in: J Med Ethics 1994 Mar;20(1):3-4.

> Thornton H. Informed consent in medical research. We all have a responsibility to contribute to research [letter]. BMJ 1997 May 17;314(7092):1479. Comment on: BMJ 1997 Apr 12;314(7087):1111-4.

> Thornton H. Understanding informed consent. Lancet 1995 Oct 21;346(8982):1047-8. Comment on: Lancet 1995 Oct 21;346(8982):1060-4.

> Tindall B, Forde S, Ross MW, Goldstein D, Barker S, Cooper DA. Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine. Patient Educ Couns 1994 Dec;24(3):261-6.

> Titus SL, Keane MA. Do you understand?: an ethical assessment of researchers' description of the consenting process. J Clin Ethics 1996 Spring;7(1):60-8.

> Tobias JS. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997 Apr 12;314(7087):1111-4. Comment in: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 May 17;314(7092):1477; BMJ 1997 May 17;314(7092);1479; BMJ 1997 May 17;314(7092):1480-1; BMJ 1997 May 17;314(7092);1481; BMJ 1997 May 17;314(7092);1482; BMJ 1997 Jul 26;315(7102):247; BMJ 1997 Jul 26;315(7102):253.

> Tobias JS. Changing the BMJ's position on informed consent would be counterproductive. BMJ 1998 Mar 28;316(7136):1001-2.

> Tobias JS, Houghton J. Is informed consent essential for all chemotherapy studies? [editorial]. Eur J Cancer 1994;30A(7):897-9.

> Tognoni G, Geraci E. Approaches to informed consent. Control Clin Trials 1997 Dec;18(6):621-7; discussion 661-6.

> Tomamichel M, Sessa C, Herzig S, de Jong J, Pagani O, Willems Y, Cavalli F. Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients. Ann Oncol 1995 Apr;6(4):363-9. Comment in: Ann Oncol 1995 Apr;6(4):321-3.

> Tooley PJ. Informed consent: the law [letter]. Med Sci Law 1992 Jul;32(3):272. Comment on: Med Sci Law 1992 Jan;32(1):35-42.

> Tregillus EV. Informed consent for trial of elective ventilation will not be forthcoming [letter]. BMJ 1995 Dec 2;311(7018):1502. Comment on: BMJ 1995 Oct 7;311(7010):950.

> Tuthill KA. Human experimentation. Protecting patient autonomy through informed consent. J Leg Med 1997 Jun;18(2):221-50.

> Vansweevelt T. Medical experimentation and informed consent [editorial]. Acta Clin Belg 1995;50(1):1-3.

> Verdun-Jones S, Weisstub DN. Consent to human experimentation in Quebec: the application of the Civil Law principle of personal inviolability to protect special populations. Int J Law Psychiatry 1995 Spring;18(2):163-82.

> Verheggen FW, Jonkers R, Kok G. Patients' perceptions on informed consent and the quality of information disclosure in clinical trials. Patient Educ Couns 1996 Nov;29(2):137-53.

> Verheggen FW, van Wijmen FC. Myth and reality of informed consent in clinical trials. Med Law 1997;16(1):53-69.

> Vollmann J, Helmchen H. Publishing information about patients. Obtaining consent to publication may be unethical in some cases [letter]. BMJ 1996 Mar 2;312(7030):578.

> Voluntary consent goes down [editorial]. Lancet 1996 Nov 16;348(9038):1323. Comment in: Lancet 1997 Feb 8;349(9049):436-7.

> Wager E, Tooley PJ, Emanuel MB, Wood SF. How to do it. Get patients' consent to enter clinical trials. BMJ 1995 Sep 16;311(7007):734-7. Comments in: BMJ 1996 Jan 20;312(7024):185-6; BMJ 1996 Jan 20;312(7024):186; BMJ 1996 Mar 30;312(7034):847.

> Wager E, Tooley PJH, Emanuel MB, Wood SF. Get patients' consent to enter clinical trials. BMJ 1995 Sep 16;311(7007):734-37.

> Waggoner WC, Mayo DM. Who understands? A survey of 25 words or phrases commonly used in proposed clinical research consent forms. IRB Rev Hum Subj Res 1995 Jan-Feb;17(1):6-9.

> Waggoner WC, Sherman BB. Who understands? II: a survey of 27 words, phrases, or symbols used in proposed clinical research consent forms. IRB Rev Hum Subj Res 1996;18(3):8-10.

> Warnock M. Informed consent -- a publisher's duty. BMJ 1998 Mar 28;316(7136):1002-3.

> Watson R, Wilson P. Informed consent. Rigorous studies are needed to determine values of interventions [letter]. BMJ 1997 Jul 26;315(7102):250-1. Comment on: BMJ 1997 Apr 12;314(7087):1059-60; BMJ 1997 Apr 12;314(7087):1071-6; discussion 1076-7.

> Weiss AH. Asking about asking: informed consent in organ donation research. IRB Rev Hum Subj Res 1996;18(1):6-10.

> Wendler D. Deception in medical and behavioral research: is it ever acceptable? Milbank Q 1996;74(1):87-114.

> Wenger NS, Shapiro MF. Consent and discontent. CMAJ 1997 Dec 15;157(12):1691-2.

> Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 1997 Mar;30(3):239-45.

> White LJ, Jones JS, Felton CW, Pool LC. Informed consent for medical research: common discrepancies and readability. Acad Emerg Med 1996 Aug;3(8):745-50.

> Whitney J. Notes on methodology. Participation of human subjects in studies. J Wound Ostomy Continence Nurs 1997 May;24(3):165. Comment on: J Wound Ostomy Continence Nurs 1997 May;24(3):163-71.

> Williams BF, French JK, White HD. Is our method of obtaining consent appropriate for randomised controlled trials in acute myocardial infarction? N Z Med J 1997 Aug 8;110(1049):298-9.

> Williams CJ, Zwitter M. Informed consent in European multicentre randomised clinical trials -- are patients really informed? Eur J Cancer 1994;30A(7):907-10.

> Williamson C. Not gaining patients' consent in trials is deceitful [letter]. BMJ 1996 Jun 8;312(7044):1479. Comment on: BMJ 1996 Feb 24;312(7029):508-9; discussion 509-10. Comment in: BMJ 1996 Aug 10;313(7053):362-3.

> Wilmshurst P. Informed consent in medical research. Subjects may be coerced into participating in studies [letter]. BMJ 1997 May 17;314(7092):1481. Comment on: BMJ 1997 Apr 12;314(7087):1059-60. Comment in: BMJ 1997 Jul 26;315(7102):248.

> Wiltshire C. Informed consent in medical research. Communication with potential subjects needs to be effective [letter]. BMJ 1997 May 17;314(7092):1482. Comment on: BMJ 1997 Apr 12;314(7087):1107-11; BMJ 1997 Apr 12;314(7087):1111-4.

> Winkens RA, Knottnerus JA, Kester AD, Grol RP, Pop P. Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent? J Clin Epidemiol 1997 Apr;50(4):435-9.

> Wirshing DA, Wirshing WC, Marder SR, Liberman RP, Mintz J. Informed consent: assessment of comprehension. Am J Psychiatry 1998 Nov;155(11):1508-11.

> Wise J. Patients do not read consent forms [news]. BMJ 1996 Dec 7;313(7070):1421.

> Wollin DA, Avanzato J. Informed consent: a primer for health care practitioners. Med Health R I 1996 Apr;79(4):155-7.

> Woodcock T, Norman J. Informed consent. Explicit guidance is required on valid exemptions for need for ethical review [letter]. BMJ 1997 Jul 26;315(7102):250. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB Rev Hum Subj Res 1990;12(3):1-5.

> Zelen M. Randomised consent trials [letter]. Lancet 1992 Aug 8;340(8815):375. Comment on: Lancet 1992 Jun 27;339(8809):1574-5.

> Zelen M. Randomized consent designs for clinical trials: an update. Stat Med 1990 Jun;9(6):645-56. Comment in: Stat Med 1992 Jan 15;11(1):131-2.

> Return to table of contents

> ## Informed consent - Books

> Alderson P. Consent to health treatment and research: differing perspectives. London: University of London, Institute of Education, Social Science Research Unit, 1992. 56 p.

> Brazier M. Protecting the vulnerable: autonomy and consent in health care. New York: Routledge; 1991. 183 p. (Social ethics and policy series).

> Buchanan AE, Brock DW. Deciding for others: the ethics of surrogate decision making. New York: Cambridge University Press; 1989. 422 p. (Studies in philosophy and health policy).

> Close B, editor. Volunteers in research and testing. Bristol (PA): Taylor & Francis; c1997. 198 p.

> Faden RR, Beauchamp TL, King NMP. A history and theory of informed consent. New York: Oxford University Press; 1986. 392 p.

> Hirsch SR, Harris J, editors. Consent and the incompetent patient: ethics, law, and medicine. Proceedings of a meeting held at the Royal Society of Medicine; 1986 Dec 9. London: Gaskell; 1988. 101 p. (Gaskell psychiatry series).

> Palmer RN. Consent and confidentiality. London: Medical Protection Society; 1991. 26 p.

> Rowland HF, Rowland AB. Hospital consents manual. Gaithersburg (MD): Aspen Publishers; 1992.

> Rozovsky LE. The Canadian law of consent to treatment. 2nd ed. Toronto: Butterworths; c1997. 166 p.

> Tomes JP. Informed consent: a guide for the healthcare professional. Chicago: Probus Pub. Co.; c1993. 164 p.

> Van Oosten F, editor. The doctrine of informed consent in medical law. New York: P. Lang; c1991. 495 p. (Recht & Medizin; 23).

> Wear S. Informed consent: patient autonomy and clinician beneficence within health care. 2nd ed. Washington: Georgetown University Press; 1998.

> White BC. Competence to consent. Washington: Georgetown University Press; c1994. 209 p.

> Return to table of contents

> ## Community consent - Journal Articles

> Abbott K, Blair F, Duncan S. Participatory research. Can Nurse 1993 Jan;89(1):25-7.

> Abeliovich D, Quint A, Weinberg N, Verchezon G, Lerer I, Ekstein J, Rubinstein E. Cystic fibrosis heterozygote screening in the Orthodox Community of Ashkenazi Jews: the Dor Yesharim approach and heterozygote frequency. Eur J Hum Genet 1996;4(6):338-41.

> Alderete E. The formulation of a health research agenda by and for indigenous peoples: contesting the Western scientific paradigm. J Altern Complement Med 1996 Fall;2(3):377-85.

> Banner RO, DeCambra H, Enos R, Gotay C, Hammond OW, Hedlung N, Issell BF, Matsunaga DS, Tsark JA. A breast and cervical cancer project in a native Hawaiian community: Wai'anae cancer research project. Prev Med 1995 Sep;24(5):447-53.

> Boston P, Jordan S, MacNamara E, Kozolanka K, Bobbish-Rondeau E, Iserhoff H, Mianscum S , Mianscum-Trapper R, Mistacheesick I, Petawabano B, Sheshamush-Masty M, Wapachee R, Weapenicappo J. Using participatory action research to understand the meanings aboriginal Canadians attribute to the rising incidence of diabetes. Chronic Dis Can 1997;18(1):5-12.

> Burnett L, Proos AL, Chesher D, Howell VM, Longo L, Tedeschi V, Yang VA, Siafakas N, Turner G. The Tay-Sachs disease prevention program in Australia: Sydney pilot study. Med J Aust 1995 Sep 18;163(6):298-300.

> Cadwell K, White E. Global participatory action research (GLOPAR) [letter]. J Hum Lact 1995 Dec;11(4):262.

> Chen AM, Wismer BA, Lew R, Kang SH, Min K, Moskowitz JM, Tager IB. Health is strength: a research collaboration involving Korean Americans in Alameda County. Am J Prev Med 1997 Nov-Dec;13(6 Suppl):93-100.

> Chesler MA. Participatory action research with self-help groups: an alternative paradigm for inquiry and action. Am J Community Psychol 1991 Oct;19(5):757-68.

> Coggan C, Disley B, Patterson P. Community based intervention on adolescent risk taking: using research for community action. Inj Prev 1998 Mar;4(1):58-61.

> Colen BD. Proceedings of the Workshop on Inherited Breast Cancer in Jewish Women: Ethical, Legal, and Social Implications. LawMed News 1996 Summer;2(1):1-4.

> Corcega TF. Participatory research: getting the community involved in health development. Int Nurs Rev 1992 Nov-Dec;39(6):185-8.

> Cornwall A, Jewkes R. What is participatory research? Soc Sci Med 1995 Dec;41(12):1667-76.

> Dorff EN. Jewish theological and moral reflections on genetic screening: the case of BRCA1. Health Matrix 1997 Winter;7(1):65-96.

> Drevdahl D. Coming to voice: the power of emancipatory community interventions. ANS Adv Nurs Sci 1995 Dec;18(2):13-24.

> Enquselassie F, Nokes J, Cutts F. Ethics committees. Communities' confidentiality should be maintained and community consent sought [letter]. BMJ 1996 Jan 6;312(7022):54-5. Comment on: BMJ 1995 Sep 9;311(7006):639-40.

> Foster MW, Bernsten D, Carter TH. A model agreement for genetic research in socially identifiable populations. Am J Hum Genet 1998 Sep;63(3):696-702.

> Foster MW, Eisenbraun AJ, Carter TH. Communal discourse as a supplement to informed consent for genetic research. Nat Genet 1997 Nov;17(3):277-9.

> Gallagher EM, Scott VJ. The STEPS Project: participatory action research to reduce falls in public places among seniors and persons with disabilities. Can J Public Health 1997 Mar-Apr;88(2):129-33.

> Geller G, Bernhardt BA, Helzlsouer K, Holtzman NA, Stefanek M, Wilcox PM. Informed consent and BRCA1 testing [letter]. Nat Genet 1995 Dec;11(4):364.

> Gibson RS, Yeudall F, Drost N, Mtitimuni B, Cullinan T. Dietary interventions to prevent zinc deficiency. Am J Clin Nutr 1998 Aug;68(2 Suppl):484S-487S.

> Grams GD, Herbert C, Heffernan C, Calam B, Wilson MA, Grzybowski S, Brown D. Haida perspectives on living with non-insulin-dependent diabetes. CMAJ 1996 Dec 1;155(11):1563-8.

> Green LW, O'Neill M, Westphal M, Morisky D. The challenges of participatory action research for health promotion [editorial]. Promot Educ 1996 Dec;3(4):3-5.

> Hagey RS. The use and abuse of participatory action research [editorial]. Chronic Dis Can 1997;18(1):1-4.

> Hamet P, Petrasovits A. How to translate science into community action. J Hum Hypertens 1996 Feb;10 Suppl 1:S89-92.

> Hecker R. Participatory action research as a strategy for empowering aboriginal health workers. Aust N Z J Public Health 1997 Dec;21(7):784-8.

> Henderson DJ. Consciousness raising in participatory research: method and methodology for emancipatory nursing inquiry. ANS Adv Nurs Sci 1995 Mar;17(3):58-69.

> Herbert CP. Community-based research as a tool for empowerment: the Haida Gwaii Diabetes Project example. Can J Public Health 1996 Mar-Apr;87(2):109-12.

> Juengst ET. Groups as gatekeepers to genomic research: conceptually confusing, morally hazardous, and practically useless. Kennedy Inst Ethics J 1998 June;8(2):183-200.

> Kirkpatrick SM. Participatory nursing research. A promising methodology in Third World countries. West J Nurs Res 1990 Jun;12(3):282-92.

> Kirkwood M, Simmons D, Weblemoe T, Voyle J, Richards D. Perceptions of diabetes among rural Maori elders and spokespersons. N Z Med J 1997 Nov 14;110(1055):415-7.

> Labonte R, Robertson A. Delivering the goods, showing our stuff: the case for a constructivist paradigm for health promotion research and practice. Health Educ Q 1996 Nov;23(4):431-47.

> Laurell AC, Noriega M, Martinez S, Villegas J. Participatory research on workers' health. Soc Sci Med 1992 Mar;34(6):603-13.

> Lehrman S. Jewish leaders seek genetic guidelines...[news]. Nature 1997 Sep 25;389(6649):322.

> Liberati A. Consumer participation in research and health care [editorial]. BMJ 1997 Aug 30;315(7107):499. Comment in: BMJ 1998 Jan 10;316(7125):148.

> Lindsey E, Stajduhar K. From rhetoric to action: establishing community participation in AIDS-related research. Can J Nurs Res 1998 Spring;30(1):137-52.

> Macaulay AC, Delormier T, McComber AM, Cross EJ, Potvin LP, Paradis G, Kirby RL, Saad-Haddad C, Desrosiers S. Participatory research with native community of Kahnawake creates innovative Code of Research Ethics. Can J Public Health 1998 Mar-Apr;89(2):105-8.

> Macaulay AC, Paradis G, Potvin L, Cross EJ, Saad-Haddad C, McComber A, Desrosiers S, Kirby R, Montour LT , Lamping DL, Leduc N, Rivard M. The Kahnawake Schools Diabetes Prevention Project: intervention, evaluation, and baseline results of a diabetes primary prevention program with a native community in Canada. Prev Med 1997 Nov-Dec;26(6):779-90.

> Macilwain C. Tribal groups attack ethics of genome diversity project [news]. Nature 1996 Sep 19;383(6597):208.

> Macleod C. Research as intervention within community mental health. Curationis 1997 Jul;20(2):53-6.

> Matsunaga DS, Enos R, Gotay CC, Banner RO, DeCambra H, Hammond OW, Hedlund N, Ilaban EK, Issell BF, Tsark JA. Participatory research in a Native Hawaiian community. The Wai'anae Cancer Research Project. Cancer 1996 Oct 1;78(7 Suppl):1582-6.

> Nelson NJ. Ashkenazi community is not unwilling to participate in genetic research [news]. J Natl Cancer Inst 1998 Jun 17;90(12):884-5.

> Nkozo-Mtembu LL. Participatory research in psychiatric nursing. Curationis 1996 Sep;19(3):57-9.

> Oliver S. The progress of lay involvement in the NHS Research and Development Programme. J Eval Clin Pract 1996 Nov;2(4):273-80.

> Piercy FP, Thomas V. Participatory evaluation research: an introduction for family therapists. J Marital Fam Ther 1998 Apr;24(2):165-76.

> Rains JW, Ray DW. Participatory action research for community health promotion. Public Health Nurs 1995 Aug;12(4):256-61.

> Richardson M. Participatory research methods: people with learning difficulties. Br J Nurs 1997 Oct 23-Nov 12;6(19):1114-21.

> Robinson A. Transformative 'cultural shifts' in nursing: participatory action research and the 'project of possibility'. Nurs Inq 1995 Jun;2(2):65-74.

> Rothenberg KH. Breast cancer, the genetic quick fix, and the Jewish community: ethical, legal, and social challenges. Health Matrix 1997 Winter;7(1):97-124.

> Schell LM, Tarbell AM. A partnership study of PCBs and the health of Mohawk youth: lessons from our past and guidelines for our future. Environ Health Perspect 1998 Jun;106 Suppl 3:833-40.

> Scott K, Receveur O. Ethics for working with communities of Indigenous Peoples. Can J Physiol Pharmacol 1995 Jun;73(6):751-3.

> Seeley JA, Kengeya-Kayondo JF, Mulder DW. Community-based HIV/AIDS research--whither community participation? Unsolved problems in a research programme in rural Uganda. Soc Sci Med 1992 May;34(10):1089-95.

> Seng JS. Praxis as a conceptual framework for participatory research in nursing. ANS Adv Nurs Sci 1998 Jun;20(4):37-48.

> Setton GC, Garvican L, Wilson R. Informed consent. Ethical principles may need to be adapted when research subject is not an individual subject [letter]. BMJ 1997 Jul 26;315(7102):251.

> Smith SE, Pyrch T, Lizardi AO. Participatory action-research for health. World Health Forum 1993;14(3):319-24.

> Soltis-Jarrett V. The facilitator in participatory action research: les raisons d'etre. ANS Adv Nurs Sci 1997 Dec;20(2):45-54.

> Sperber AD, Henkin Y, Shany S. Methodological issues in conducting a community-based clinical drug trial. Fam Pract Res J 1993 Dec;13(4):311-21.

> Spiers HR. Community consultation and AIDS clinical trials: I. IRB Rev Hum Subj Res 1991 May-Jun;13(3):7-10.

> Spiers HR. Community consultation and AIDS clinical trials: II. IRB Rev Hum Subj Res 1991 Jul-Aug;13(4):1-6.

> Spiers HR. Community consultation and AIDS clinical trials: III. IRB Rev Hum Subj Res 1991 Sep-Oct;13(5):3-7.

> Thompson JL. Exploring gender and culture with Khmer refugee women: reflections on participatory feminist research. ANS Adv Nurs Sci 1991 Mar;13(3):30-48.

> Travers KD. Reducing inequities through participatory research and community empowerment. Health Educ Behav 1997 Jun;24(3):344-56.

> Travers KD. The social organization of nutritional inequities. Soc Sci Med 1996 Aug;43(4):543-53.

> Wadman M. 'Group debate' urged for gene studies [news]. Nature 1998 Jan 22;391(6665):314. Comment in: Nature 1998 Mar 5;392(6671):14; Nature 1998 Apr 16;392(6677):646.

> Wadman M. Jewish leaders meet NIH chiefs on genetic stigmatization fears [news]. Nature 1998 Apr 30;392(6679):851.

> Westphal MF, da Silva NN, Maciel MG. Participatory research as social mobilization for health. Promot Educ 1996 Dec;3(4):21-4.

> Willms D, Bhatia R, Lowe J, Niemi F, Stewart D, Westmoreland-Traore J. Five conversations: reflections of stakeholders on the impact of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S44-8, S49-53.

> Willms D, Singer SM, Adrien A, Godin G, Maticka-Tyndale E, Cappon P. Participatory aspects in the qualitative research design of phase II of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S15-25, S16-27.

> Wismer BA, Moskowitz JM, Chen AM, Kang SH, Novotny TE, Min K, Lew R, Tager IB. Rates and independent correlates of Pap smear testing among Korean-American women. Am J Public Health 1998 Apr;88(4):656-60.

> Return to table of contents

> ## Community consent - Books

> De Koning K, Martin M. Participatory research in health: issues and experiences. Johannesburg: Zed Books; 1996. 242 p.

> Return to table of contents

> ## Privacy and confidentiality - Journal Articles

> American Psychiatric Association resource document on preserving patient confidentiality in the era of information technology. J Am Acad Psychiatry Law 1997;25(4):551-9.

> American Public Health Association. Protecting confidential data in disease registries. [Policy statement 9515]. Am J Public Health 1996 Mar;86(3):443-4.

> Andrews G, Wittchen HU. Clinical practice, measurement and information technology [editorial]. Psychol Med 1995 May;25(3):443-6.

> Annas GJ. Genetic prophecy and genetic privacy--can we prevent the dream from becoming a nightmare? [editorial]. Am J Public Health 1995 Sep;85(9):1196-7. Comment on: Am J Public Health 1995 Sep;85(9):1280-4.

> Annas GJ. A national bill of patients' rights. N Engl J Med 1998 Mar 5;338(10):695-9.

> ASHG statement. Professional disclosure of familial genetic information. The American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure. Am J Hum Genet 1998 Feb;62(2):474-83.

> Avins AL, Woods WJ, Lo B, Hulley SB. A novel use of the link-file system for longitudinal studies of HIV infection: a practical solution to an ethical dilemma. AIDS 1993 Jan;7(1):109-13.

> Bain MR, Chalmers JW, Brewster DH. Routinely collected data in national and regional databases--an under-used resource. J Public Health Med 1997 Dec;19(4):413-8.

> Bakker AR, Barber B, Pellikka RT. Overall observations, conclusions and recommendations. Int J Biomed Comput 1996 Oct;43(1-2):149-52.

> Baram M. The laws of genetics. Environ Health Perspect 1997 May;105(5):488-91.

> Barratt K. Reviewing gag clauses in managed care contracts. Wis Med J 1996 Apr;95(4):249-50.

> Bellach B, Schon D. Legislation to protect individual confidentiality: the case of cancer registration in Germany. Sci Total Environ 1996 May 17;184(1-2):33-6.

> Bentley-Cooper JE. Protecting human research from an invasion of privacy: the unintended results of the Commonwealth Privacy Act 1988. Aust J Public Health 1991 Sep;15(3):228-34.

> Berry RM. The genetic revolution and the physician's duty of confidentiality. The role of the old Hippocratic virtues in the regulation of the new genetic intimacy. J Leg Med 1997 Dec;18(4):401-41.

> Beto JA, Geraci MC, Marshall PA, Bansal VK. Pharmacy computer prescription databases: methodologic issues of access and confidentiality. Ann Pharmacother 1992 May;26(5):686-91.

> Bharucha-Reid R, Schork MA, Schwartz SA. Data linkage and subject anonymity for HIV testing. AIDS Public Policy J 1990 Winter;5(4):189-90.

> Birkett N. Confidentiality and research [letter]. CMAJ 1993 Feb 15;148(4):486-7.

> Black B. Subpoenas and science--when lawyers force their way into the laboratory. N Engl J Med 1997 Mar 6;336(10):725-7. Comments in: N Engl J Med 1997 Jul 24;337(4):282-3; N Engl J Med 1997 Jul 24;337(4):283.

> Black D. Access to records for epidemiological research [letter]. BMJ 1992 Apr 11;304(6832):987.

> Black D. Personal health records [editorial]. J Med Ethics 1992 Mar;18(1):5-6.

> Blandino DA. Adolescents and confidentiality. J Fam Pract 1998 Jan;46(1):15-6.

> Botkin JR, McMahon WM, Smith KR, Nash JE. Privacy and confidentiality in the publication of pedigrees: a survey of investigators and biomedical journals. JAMA 1998 Jun 10;279(22):1808-12.

> Bracken MB. Alarums false, alarums real: challenges and threats to the future of epidemiology. Ann Epidemiol 1998 Feb;8(2):79-82.

> Brahams D. Who owns patients' data? [news]. Lancet 1990 Jan 6;335(8680):39-40.

> Brase T. Privacy and medical-records research [letter]. N Engl J Med 1998 Apr 9;338(15):1076-7; discussion 1077-8. Comment on: N Engl J Med 1997 Nov 13;337(20):1466-70.

> Brennan TA. Ethics of confidentiality: the special case of quality assurance research. Clin Res 1990 Oct;38(3):551-7.

> Brenner H, Schmidtmann I, Stegmaier C. Effects of record linkage errors on registry-based follow-up studies. Stat Med 1997 Dec 15;16(23):2633-43.

> Buchan H, Paul C. When important social interests compete with privacy. N Z Med J 1992 Dec 9;105(947):492-3.

> Bullimore D. Publication of pictures of patient on BMJ's website was mistake [letter]. BMJ 1998 Mar 28;316(7136):1022.

> Butler D. BSE researchers bemoan 'ministry secrecy' [news]. Nature 1996 Oct 10;383(6600):467-8.

> Byers PH, Ashkenas J. Pedigrees-publish? or perish the thought? Am J Hum Genet 1998 Sep;63(3):678-81.

> Chamberlayne R, Green B, Barer ML, Hertzman C, Lawrence WJ, Sheps SB. Creating a population-based linked health database: a new resource for health services research. Can J Public Health 1998 Jul-Aug;89(4):270-3.

> Clarke EA, Darlington G, Holowaty EJ, Kreiger N, Marrett LD, McLaughlin J, Parkes R, Sloan M, Theis E. Confidentiality and research [letter]. CMAJ 1993 Sep 15;149(6):792-3.

> Clarke J. Moral dilemmas in nursing research. Nurs Pract 1991;4(4):22-5.

> Clough J. The Disability Discrimination Act 1995--an OHP challenge. Occup Health (Lond) 1997 Feb;49(2):62-3.

> Cole D, Graf HP. Database consultation for phase I studies in Europe. Eur J Med 1993 Jun-Jul;2(6):358-62.

> Coleman MP, Muir CS, Menegoz F. Confidentiality in the cancer registry. Br J Cancer 1992 Dec;66(6):1138-49.

> Conference of Medical Royal Colleges and Their Faculties in the United Kingdom Audit Working Group. Access to medical records for the purposes of medical audit [statement]. BMJ 1993 Apr 3;306(6882):896-7.

> Cooper JE. Balancing the scales of public interest: medical research and privacy. Med J Aust 1991 Oct 21;155(8):556-60.

> Cuatrecasas P. Industry-university alliances in biomedical research. J Clin Pharmacol 1992 Feb;32(2):100-6.

> Cushman R. Serious technology assessment for health care information technology. J Am Med Inform Assoc 1997 Jul-Aug;4(4):259-65.

> Dahl R. The right to the research. Environ Health Perspect 1997 Dec;105(12):1306-8.

> Dannenberg AL, Vernick JS, Kirk GD. AIDS and confidentiality: making exemptions to encourage research [letter]. JAMA 1993 Jan 6;269(1):47-8.

> Davis T, King KM. Accessing patients, patient records, and patient databases: the confidentiality-access maze, Part I. Can J Cardiovasc Nurs 1997;8(2):35-8.

> Detmer DE. Improving health and reducing costs through information technology. Acad Med 1998 Mar;73(3):286-7.

> Detmer DE, Steen EB. The computer-based record: patient moving from concept toward reality. Int J Biomed Comput 1996 Jul;42(1-2):9-19.

> Dierks C. Medical confidentiality and data protection as influenced by modern technology. Med Law 1993;12(6-8):547-51.

> Donaldson MS, Lohr KN, Bulger RJ. From the Institute of Medicine. JAMA 1994 May 4;271(17):1308.

> Donaldson MS, Lohr KN, Bulger RJ. From the Institute of Medicine. JAMA 1994 May 11;271(18):1392.

> Dovey SM, Tilyard MW. The computer research network of the Royal New Zealand College of General Practitioners: an approach to general practice research in New Zealand. Br J Gen Pract 1996 Dec;46(413):749-52.

> Doyal L. Data from patient records [letter]. Br Dent J 1995 Jun 24;178(12):448. Comment on: Br Dent J 1995 Apr 22;178(8):286.

> Earley CL, Strong LC. Certificates of confidentiality: a valuable tool for protecting genetic data. Am J Hum Genet 1995 Sep;57(3):727-31. Comment in: Am J Hum Genet 1996 Feb;58(2):436-8.

> Edouard L, Rawson NS. Use of personal records for research purposes. Identification numbers help maintain confidentiality [letter]. BMJ 1995 Jan 28;310(6974):257-8. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

> Elwood JM. Scientific and ethical issues of computer-linked records [letter]. Int J Cancer 1996 Aug 7;67(4):586-7. Comment on: Int J Cancer 1995 May 16;61(4):485-90.

> Emson HE. Guidelines on ethical and legal considerations in anonymous unlinked HIV seroprevalence research [letter]. CMAJ 1991 Dec 1;145(11):1418-9. Comment on: CMAJ 1991 Jun 15;144(12):1603-4.

> Emson HE. Minimal breaches of confidentiality in health care research: a Canadian perspective. J Med Ethics 1994 Sep;20(3):165-8. Comment in: J Med Ethics 1995 Apr;21(2):117.

> Erlen JA. The inadvertent breach of confidentiality. Orthop Nurs 1998 Mar-Apr;17(2):47-50.

> Fisher CB, Higgins-D'Alessandro A, Rau JM, Kuther TL, Belanger S. Referring and reporting research participants at risk: views from urban adolescents. Child Dev 1996 Oct;67(5):2086-100.

> Fitzgerald J, Hamilton M. The consequences of knowing: ethical and legal liabilities in illicit drug research. Soc Sci Med 1996 Dec;43(11):1591-600.

> Fitzgerald JL, Hamilton M. Confidentiality, disseminated regulation and ethico-legal liabilities in research with hidden populations of illicit drug users. Addiction 1997 Sep;92(9):1099-107.

> Flawed US proposals on patients' privacy [editorial]. Lancet 1997 Sep 20;350(9081):823.

> Foster MW, Freeman WL. Naming names in human genetic variation research.[editorial]. Genome Res 1998 Aug;8(8):755-7.

> Frisch SR, Fowler-Graham D, Shannon V, Dembeck P. Maintaining the anonymity of vulnerable subjects. Can J Nurs Res 1990 Winter;22(4):51-60.

> Furnell SM, Sanders PW. Security management in the healthcare environment. Medinfo 1995;8 (Pt 1):675-8.

> Gabbard GO. Case histories and confidentiality [letter]. Int J Psychoanal 1997 Aug;78 ( Pt 4):820-1. Published erratum appears in 1997 Oct;78(Pt 5):1020. Comment on: Int J Psychoanal 1997 Jun;78( Pt 3):435-8.

> Gabriel SE. Threats to population-based research [editorial]. Curr Opin Rheumatol 1997 Mar;9(2):87-9. Comment on: Curr Opin Rheumatol 1997 Mar;9(2):90-4; Curr Opin Rheumatol 1997 Mar;9(2):95-101; Curr Opin Rheumatol 1997 Mar;9(2):102-5; Curr Opin Rheumatol 1997 Mar;9(2):106-11; Curr Opin Rheumatol 1997 Mar;9(2):118-25; Curr Opin Rheumatol 1997 Mar;9(2):126-32.

> Galbraith RA, Sobel BE. Patient information and confidentiality: a compelling conundrum [editorial]. Coron Artery Dis 1997 Jan;8(1):59-60.

> Garber JE, Patenaude AF. Ethical, social and counselling issues in hereditary cancer susceptibility. Cancer Surv 1995;25:381-97.

> Genetic(al) correctness [editorial]. Nat Genet 1997 Dec;17(4):363-4.

> Genetic testing and insurance. The Ad Hoc Committee on Genetic Testing/Insurance Issues. Am J Hum Genet 1995 Jan;56(1):327-31.

> Goldberg A. Ethics and drugs. Ir J Med Sci 1990 Aug;159(8):242-3.

> Goldberg A. Writing case histories [editorial]. Int J Psychoanal 1997 Jun;78(Pt 3):435-8. Comment in: Int J Psychoanal 1997 Aug;78( Pt 4):820-1.

> Goodman KW. Critical care computing: outcomes, confidentiality, and appropriate use. Crit Care Clin 1996 Jan;12(1):109-22.

> Goodman KW. Ethics, genomics, and information retrieval. Comput Biol Med 1996 May;26(3):223-9.

> Goodman NW. Secrecy in research [letter]. N Engl J Med 1996 Jul 11;335(2):134-5; discussion 135-6. Comment on: N Engl J Med 1996 Feb 8;334(6):392-4.

> Goodwin C. Personal privacy vs. public health. New Sci 1993 Dec 11;140(1903):25-7.

> Gordis L. Ethical and professional issues in the changing practice of epidemiology. J Clin Epidemiol 1991;44 Suppl 1:9S-13S.

> Gorelick DA. Subpoenas and science [letter]. N Engl J Med 1997 Jul 24;337(4):282-3. Comment on: N Engl J Med 1997 Mar 6;336(10):725-7.

> Gostin LO, Lazzarini Z, Neslund VS, Osterholm MT. The public health information infrastructure. A national review of the law on health information privacy. JAMA 1996 Jun 26;275(24):1921-7.

> Guenin LM. Confidentiality [letter]. Science 1996 Mar 29;271(5257):1790.

> Haddow JE, Palomaki GE. Use of personal records for research purposes. Restrictions unnecessary and obstructive [letter]. BMJ 1995 Jan 28;310(6974):258. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

> Hancock B. Research: your secrets are safe with us. Nurs Stand 1994 Aug 31-Sep 6;8(49):44-5.

> Hawkins MM, Craft AW. Use of personal records for research purposes. Records prematurely destroyed [letter]. BMJ 1995 Jan 28;310(6974):258. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

> Hertz-Picciotto I, Lee LW, Hoyo C. HIV test-seeking before and after the restriction of anonymous testing in North Carolina. Am J Public Health 1996 Oct;86(10):1446-50. Comment in: Am J Public Health 1998 Apr;88(4):683.

> Hoge SK. Proposed federal legislation jeopardizes patient privacy. Bull Am Acad Psychiatry Law 1995;23(4):495-500.

> Holder AR. Research records and subpoenas: a continuing issue. IRB Rev Hum Subj Res 1993 Jan-Feb;15(1):6-7.

> Holder AR. Researchers and subpoenas: the troubling precedent of the Selikoff case. IRB Rev Hum Subj Res 1989 Nov-Dec;11(6):8-10.

> Horner JS. Research, ethics and privacy: the limits of knowledge. Public Health 1998 Jul;112(4):217-20.

> Human genome--any questions? Med Leg J 1991;59(Pt 1):41-9.

> Independent ethical review of studies involving personal medical records. Report of a working group to the Royal College of Physicians Committee on Ethical Issues in Medicine. J R Coll Physicians Lond 1994 Sep-Oct;28(5):439-43. Comment in: J R Coll Physicians Lond 1995 Sep-Oct;29(5):446.

> International Committee of Medical Journal Editors. Protection of patients' rights to privacy [guidelines]. BMJ 1995 Nov 11;311(7015):1272.

> Isaacs P, Anand JK, Myles JW. Pictures in the "BMJ" [letters and editor's response]. BMJ 1993 Apr 17;306(6884):1067-8.

> Iversen KR, Grotan TO. Socio-technical aspects of the use of health related personal information for management and research. Int J Biomed Comput 1996 Oct;43(1-2):83-91.

> Iversen T. Health registries. Ethics and security. Acta Obstet Gynecol Scand 1996 Nov;75(10):875-6.

> Jaillon P. Healthy volunteers data bank: where and how? Fundam Clin Pharmacol 1990;4(2 Suppl):177S-81S.

> Jones TL, George T. Private matters. Will electronic medical records doom confidentiality? Tex Med 1996 May;92(5):46-50.

> Kaiser J. Privacy rules set no new research curbs [news]. Science 1997 Sep 19;277(5333):1757.

> Keppel S. Use of personal health information by third parties for research purposes. Auckland Univ Law Rev 1992 Aug;7(1):1-26.

> Kern DG. Confidentiality agreements and scientific independence [letter]. Med Decis Making 1998 Apr-Jun;18(2):239.

> King KM, Davis T. Accessing patients, patient records, and patient databases: the confidentiality-access maze. Part II. Can J Cardiovasc Nurs 1997;8(3):31-5.

> Kottow MH. Confidentiality as fair agreement [letter]. J Med Ethics 1995 Apr;21(2):117. Comment on: J Med Ethics 1994 Sep;20(3):165-8.

> Lane MJ. Privacy protection: implications for public health researchers. Med J Aust 1991 Dec 2-16;155(11-12):831-3.

> Lane MJ. Privacy protection: implications for public health researchers [letter]. Med J Aust 1992 Mar 16;156(6):438.

> Lehrman S. University blocks efforts to reveal researchers' identity [news]. Nature 1995 Mar 9;374(6518):109.

> Leigh WA. Participant protection with the use of records: ethical issues and recommendations. Ethic Behav 1998;8(4):305-19.

> Lincoln TL. Privacy: a real-world problem with fuzzy boundaries [editorial]. Methods Inf Med 1993 Apr;32(2):104-7. Comment on: Methods Inf Med 1993 Apr;32(2):95-103.

> Lowden JA. Certificates of confidentiality [letter]. Am J Hum Genet 1996 Feb;58(2):436-8. Comment on: Am J Hum Genet 1995 Sep;57(3):727-31.

> Loxley W, Hawks D, Bevan J. Protecting the interests of participants in research into illicit drug use: two case studies. Addiction 1997 Sep;92(9):1081-5.

> Lynge E. European directive on confidential data: a threat to epidemiology [editorial]. BMJ 1994 Feb 19;308(6927):490. Comment on: BMJ 1994 Feb 19;308(6927):522-3.

> Lynge E. New draft on European directive on confidential data [editorial]. BMJ 1995 Apr 22;310(6986):1024.

> Maloney DM. Institutional review boards, genetic research, and privacy. Hum Res Rep 1996 Sep;11(9):6.

> Mann RD. Selling patients' data [letter]. Lancet 1990 Feb 24;335(8687):478.

> Marshall E. Publishing sensitive data: who calls the shots? Secretiveness found widespread in life sciences [news]. Science 1997 Apr 25;276(5312):525.

> McCarthy CR, Porter JP. Confidentiality: the protection of personal data in epidemiological and clinical research trials. Law Med Health Care 1991 Fall-Winter;19(3-4):238-41.

> McClintock T, Friendship C. Ethics committees. Information that can be given to researchers over the telephone needs to be clarified [letter]. BMJ 1996 Jan 6;312(7022):54. Comment on: BMJ 1995 Sep 9;311(7006):659-60.

> McCormick WC. Impact of a change in confidentiality law on enrollment of persons with AIDS in a clinical research study. Clin Res 1990 Oct;38(3):545-50.

> McLean SA. Mapping the human genome--friend or foe? Soc Sci Med 1994 Nov;39(9):1221-7.

> Melton GB. Certificates of confidentiality under the Public Health Service Act: strong protection but not enough. Violence Vict 1990 Spring;5(1):67-71.

> Melton LJ 3rd. The threat to medical-records research. N Engl J Med 1997 Nov 13;337(20):1466-70. Comments in: N Engl J Med 1998 Apr 9;338(15):1076; discussion 1077-8; N Engl J Med 1998 Apr 9;338(15):1076-7; discussion 1077-8; N Engl J Med 1998 Apr 9;338(15):1077; discussion 1077-8.

> Meux E. Encrypting personal identifiers. Health Serv Res 1994 Jun;29(2):247-56.

> Michaelis J, Miller M, Pommerening K, Schmidtmann I. A new concept to ensure data privacy and data security in cancer registries. Medinfo 1995;8 (Pt 1):661-5.

> Milholland DK. Privacy and confidentiality of patient information. Challenges for nursing. J Nurs Adm 1994 Feb;24(2):19-24.

> Miller SK. Genetic privacy makes strange bedfellows [news]. Science 1990 Sep 21;249(4975):1368.

> Mills ME. Data privacy and confidentiality in the public arena. Proc AMIA Annu Fall Symp 1997:42-5

> Monahan J, Appelbaum PS, Mulvey EP, Robbins PC, Lidz CW. Ethical and legal duties in conducting research on violence: lessons from the MacArthur Risk Assessment Study. Violence Vict 1993 Winter;8(4):387-96.

> New bills seek to prevent misuse of medical data [news]. Nat Biotechnol 1997 May;15(5):398.

> Newcombe HB. When privacy threatens public health. Can J Public Health 1995 May-Jun;86(3):188-92.

> Newcombe HB, Cavoukian A. Cohorts and privacy [article and response]. Cancer Causes Control 1994 May;5(3):287-92.

> Nicholl D, Winters G, Davies D. Publishing information about patients: GMC's guidelines should be followed before information is put on Internet [letter]. BMJ 1996 Mar 2;312(7030):578-9.

> Nicholson RH. Divide and rule [news]. Hastings Cent Rep 1992 Jul-Aug;22(4):5.

> Olsen J, Breart G, Feskens E, Grabauskas V, Noah N, Olsen J, Porta M, Saracci R. Directive of the European Parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The International Epidemiological Association-IEA European Epidemiological Group [letter]. Int J Epidemiol 1995 Apr;24(2):462-3.

> Paddison J. Ethical issues in qualitative studies. Mod Midwife 1995 May;5(5):23-5.

> Pejovich RJ. Critical aspects of conducting and auditing GLP studies--the practical perspective. Qual Assur 1995 Mar;4(1):87-90.

> Pommerening K, Miller M, Schmidtmann I, Michaelis J. Pseudonyms for cancer registries. Methods Inf Med 1996 Jun;35(2):112-21.

> Prentnieks M, Qual S. Protecting the privacy of computerized health information. The Kassabaum-Kennedy Act. Minn Med 1996 Nov;79(11):47-51.

> Reilly P. ASHG statement on genetics and privacy: testimony to United States Congress. Am J Hum Genet 1992 Mar;50(3):640-2.

> Robinson I. Confidentiality for whom? Soc Sci Med 1991;32(3):279-86.

> Rosenberg SA. Secrecy in medical research. N Engl J Med 1996 Feb 8;334(6):392-4. Comments in: N Engl J Med 1996 Jul 11;335(2):134-5; discussion 135-6: N Engl J Med 1996 Jul 11;335(2):135; discussion 135-6.

> Rosenberg SA. Secrecy in research: cooperation and costimulation in immunology [editorial]. Curr Opin Immunol 1996 Oct;8(5):611-2.

> Rossiter BJ, Caskey CT. The human genome project. Clin Obstet Gynecol 1993 Sep;36(3):466-75.

> Roush W. Publishing sensitive data: who calls the shots? Secrecy dispute pits Brown researcher against company [news]. Science 1997 Apr 25;276(5312):523-4.

> Royal College of Physicians Committee on Ethical Issues in Medicine. Independent ethical review of studies involving personal medical records. J R Coll Physicians Lond 1994 Sep-Oct;28(5):439-43.

> Ruffin M. Developing and using a data repository for quality improvement: the genesis of IRIS. Jt Comm J Qual Improv 1995 Oct;21(10):512-20.

> Schulte PA. Biomarkers in epidemiology: scientific issues and ethical implications. Environ Health Perspect 1992 Nov;98:143-7.

> Schulte PA, Hunter D, Rothman N. Ethical and social issues in the use of biomarkers in epidemiological research. IARC Sci Publ 1997;(142):313-8.

> Sieber JE. Sharing scientific data: I. New problems for IRBs. IRB Rev Hum Subj Res 1989 Nov-Dec;11(6):4-7.

> Slack WV. Private information in the hands of strangers. MD Comput 1997 Mar-Apr;14(2):83-6.

> Smee PH. Should insurance companies have access to patients' medical records? Denying access would do more harm than good. BMJ 1996 Aug 3;313(7052):287. Comment on: BMJ 1996 Aug 3;313(7052):286-7. Comments in: BMJ 1996 Nov 16;313(7067):1261; BMJ 1996 Nov 16;313(7067):1261-2.

> Smith GP. Accessing genomic information or safeguarding genetic privacy. J Law Health 1994-5;9(1):121-34.

> Smith J. Keeping confidences in published papers [editorial]. BMJ 1991 May 18;302(6786):1168. Comment on: BMJ 1991 May 18;302(6786):1182.

> Smith MF. Data protection, health care, and the new European directive: extension of data protection to paper records is logical but problematic [editorial]. BMJ 1996 Jan 27;312(7025):197-8.

> Stark AN. Use of personal records for research purposes. Guidelines may affect audit [letter]. BMJ 1995 Jan 28;310(6974):258. Comment on: BMJ 1994 Nov 26;309(6966):1422-4.

> Statements from the International Committee of Medical Journal Editors. JAMA 1991 May 22-29;265(20):2697-8. Comment in: JAMA 1991 May 22-29;265(20):2720.

> Statements from the International Committee of Medical Journal Editors [editorial]. Ann Intern Med 1991 Jun 1;114(11):989.

> Stern SB. Privileged communication: an ethical and legal right of psychiatric clients. Perspect Psychiatr Care 1990;26(4):22-5.

> Stevens S. Patients' rights and publication [letter]. J Med Ethics 1993 Mar;19(1):50-1.

> Stiller CA. Cancer registration: its uses in research, and confidentiality in the EC. J Epidemiol Community Health 1993 Oct;47(5):342-4.

> Sweeney L. Privacy and medical-records research [letter]. N Engl J Med 1998 Apr 9;338(15):1077; discussion 1077-8. Comment on: N Engl J Med 1997 Nov 13;337(20):1466-70.

> Taube DO, Burkhardt S. Ethical and legal risks associated with archival research. Ethics Behav 1997;7(1):59-67.

> Thacker SB, Stroup DF. Future directions for comprehensive public health surveillance and health information systems in the United States. Am J Epidemiol 1994 Sep 1;140(5):383-97.

> The hazards of government data [editorial]. Nature 1996 Oct 10;383(6600):463.

> Thomas SP. Issues in data management and storage. J Neurosci Nurs 1993 Aug;25(4):243-5.

> Users and uses of patient records. Report of the Council on Scientific Affairs. Council on Scientific Affairs, American Medical Association. Arch Fam Med 1993 Jun;2(6):678-81.

> Vanchieri C. New EC privacy directive worries European epidemiologists [news]. J Natl Cancer Inst 1993 Jul 7;85(13):1022-3.

> Vandenbroucke JP. Privacy, confidentiality and epidemiology: the Dutch ordeal [letter]. Int J Epidemiol 1992 Aug; 21(4):825-6.

> Vehvilainen-Julkunen K. Ethical considerations in qualitative nursing research. Vard Nord Utveckl Forsk 1993 Summer;13(2):23-5.

> vonKoss Krowchuk H, Moore ML, Richardson L. Using health care records as sources of data for research. J Nurs Meas 1995 Summer;3(1):3-12.

> Wadman M. US to tighten protection of medical data [news]. Nature 1997 Aug 14;388(6643):611.

> Wald N, Law M, Meade T, Miller G, Alberman E, Dickinson J. Use of personal medical records for research purposes. BMJ 1994 Nov 26;309(6966):1422-4. Comment in: BMJ 1995 Jan 28;310(6974):257-8; BMJ 1995 Jan 38;310(6974):258.

> Whitaker VB, Whitaker R Jr. Ethics: issues of concern. Insight 1991 Dec;16(6):30-1.

> Whose right to genetic knowledge? [editorial]. Nature 1996 Feb 1;379(6564):379.

> Wolffers I. Confidentiality in research [letter]. Lancet 1996 Mar 2;347(9001):620. Comment on: Lancet 1995 Nov 11;346(8985):1303.

> Woodward B. Privacy and medical-records research [letter]. N Engl J Med 1998 Apr 9;338(15):1076; discussion 1077-8. Comment on: N Engl J Med 1997 Nov 13;337(20):1466-70.

> Zimmerli WC. Who has the right to know the genetic constitution of a particular person? Ciba Found Symp 1990;149:93-102; discussion 102-10.

> Return to table of contents

> ## Privacy and confidentiality - Books

> Bruce JAC. Privacy and confidentiality of health care information. 2nd ed. Chicago: American Hospital Publishing; 1988. 209 p.

> Confidentiality: a guide to the federal law and regulations. New York: Legal Action Center; 1995.

> Confidentiality, use, and disclosure of personal health information. London: Great Britain, Department of Health; 1994 Aug 10. 23 p. Draft guidance.

> CPRI Work Group on Confidentiality, Privacy, and Security. Sample confidentiality statements and agreements for organizations using computer-based patient record systems. Schaumburg (IL): Computer-Based Patient Record Institute; c1996. 29 p.

> Donaldson MS. Regional health databases, health services research, and confidentiality: summary of an invitational workshop at the Institute of Medicine, national implications of the development of regional health database organizations, January 31-February 1, 1994. Washington: Institute of Medicine; 1994.

> Donaldson MS, Lohr KN, editors. Health data in the information age: use, disclosure, and privacy. Washington: National Academy Press; 1994. 257 p.

> Goldman J, Mulligan D. Privacy and health information systems: a guide to protecting patient confidentiality. Washington: Center for Democracy & Technology; c1996. 46 p.

> Lowrance WW. Privacy and health research: a report. Washington: Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation; 1997. 80 p.

> Saunders JM. Patient confidentiality. 4th ed. Salt Lake City: Medicode, Inc.; 1998. 107 p.

> Tomes JP. Healthcare privacy and confidentiality: the complete legal guide. Chicago: Probus; 1994. 236 p.

> Return to table of contents

> ## Clinical trials - Journal Articles

> Ahmad I. Clinical trials in surgery. JPMA J Pak Med Assoc 1991 Sep;41(9):235-8.

> Alderson P. Equipoise as a means of managing uncertainty: personal, communal and proxy. J Med Ethics 1996 Jun;22(3):135-9.

> Alibhai SM. The placebo effect [letter]. CMAJ 1997 Oct 15;157(8):1020, 1022. Comment on: CMAJ 1997 Apr 15;156(8):1153-7.

> Allen ME. Good Clinical Practice: current state of the art for clinical trial documentation. Med Leg J 1998;66(Pt 2):61-4.

> Altman DG, Whitehead J, Parmar MK, Stenning SP, Fayers PM, Machin D. Randomised consent designs in cancer clinical trials. Eur J Cancer 1995 Nov;31A(12):1934-44.

> Alves WA, Macciocchi SN. Ethical considerations in clinical neuroscience. Current concepts in neuroclinical trials. Stroke 1996 Oct;27(10):1903-9.

> Ashcroft RE, Chadwick DW, Clark SR, Edwards RH, Frith L, Hutton JL. Implications of socio-cultural contexts for the ethics of clinical trials. Health Technol Assess 1997;1(9):1-65.

> Barer D, Finch E, Gossop M, Hankinson L, Taylor C, Farrell M, Strang J, Thornton H. Patients' preferences and randomised trials. Lancet 1994 Sep 3;344(8923):688-9.

> Bartelink H, Jassem J. Early presentation of results in clinical trials: an ethical dilemma for medicine and science. Eur J Cancer 1990 Apr;26(4):419-20.

> Barton JM, Macmillan MS, Sawyer L. The compensation of patients injured in clinical trials. J Med Ethics 1995 Jun;21(3):166-9.

> Basch PF. Antischistosomal vaccines: beyond the laboratory. Trans R Soc Trop Med Hyg 1993 Sep-Oct;87(5):589-92.

> Baum M. The ethics of clinical trials. Isr J Med Sci 1995 Feb-Mar;31(2-3):197-200. Comment in: Isr J Med Sci 1995 Sep;31(9):580-2.

> Baum M. The ethics of randomized controlled trials. Eur J Surg Oncol 1995 Apr;21(2):136-7.

> Beran RG, Tilley M. Clinical trials of antiepileptic drugs performed in the private practice setting. Epilepsia 1994 Jan-Feb;35(1):101-6.

> Bleich HL. The science and ethics of the randomized clinical trial [editorial]. MD Comput 1995 Jan-Feb;12(1):5-6. Comment on: MD Comput 1995 Jan-Feb;12(1):36-44.

> Boissel JP, Haugh MC. Clinical trial registries and ethics review boards: the results of a survey by the FICHTRE project. Fundam Clin Pharmacol 1997;11(3):281-4.

> Bolton WK. The nature of clinical trials in nephrology [editorial]. Kidney Int 1992 Nov;42(5):1061-9.

> Bone HG, Chavkin W, Fox H, Chalmers TC. Ethical implications of rejecting patients for clinical trials [letters and response]. JAMA 1990 Aug 22;264(8):973-4.

> Bornman PC. The clinical researcher--present and future prospective. S Afr J Surg 1992 Sep;30(3):118-23.

> Brandon S. Ethics, economics and science [editorial]. J R Soc Med 1991 Oct;84(10):575-7.

> Buck BA. Ethical issues of randomized clinical trials. Radiol Technol 1990 Jan-Feb;61(3):202-5.

> Burchell HB. Vicissitudes in clinical trial research. Subjects, participants, patients. Control Clin Trials 1992 Jun;13(3):185-9.

> Cappelleri JC, Trochim WM. Ethical and scientific features of cutoff-based designs of clinical trials: a simulation study. Med Decis Making 1995 Oct-Dec;15(4):387-94.

> Chalmers TC. Ethical implications of rejecting patients for clinical trials [editorial]. JAMA 1990 Feb 9;263(6):865. Comment on: JAMA 1990 Feb 9;263(6):825-30. Comment in: JAMA1990 Aug 22-29;264(8):973-4.

> Chen MJ, Scarth BJ, Slack CJ. Good clinical research practice in Canada. CMAJ 1994 Nov 1;151(9):1255-7.

> Citron ML. Placebos and principles: a trial of ondansetron [editorial]. Ann Intern Med 1993 Mar 15;118(6):470-1. Comment on: Ann Intern Med 1993 Mar 15;118(6):407-13.

> Claessens MT, Bernat JL, Baron JA. Ethical issues in clinical trials. Br J Urol 1995 Nov;76 Suppl 2:29-36.

> Clark PI, Leaverton PE. Scientific and ethical issues in the use of placebo controls in clinical trials. Annu Rev Public Health 1994;15:19-38.

> Cleophas TJ. Clinical trials: specific problems associated with the use of a placebo-control group. J Mol Med 1995 Aug;73(8):421-4.

> Cleophas TJ. Is selective reporting of well-designed clinical research unethical as well as unscientific? [letter]. Ned Tijdschr Geneeskd 1996 Mar 2;140(9):509-10. Comment on: Ned Tijdschr Geneeskd 1996 Jan 27;140(4):220-1.

> Cohen-Haguenauer O. Safety and regulation at the leading edge of biomedical biotechnology. Curr Opin Biotechnol 1996 Jun;7(3):265-72.

> Cohen J. Clinical trial monitoring: hit or miss? [news]. Science 1994 Jun 10;264(5165):1534-7.

> Collier J. Confusion over use of placebos in clinical trials [editorial]. BMJ 1995 Sep 30;311(7009):821-2. Comment on: BMJ 1995 Sep 30;311(7009):844-6.

> Connolly CK, Trewby PN. Per capita payments for clinical trials [letter]. J R Coll Physicians Lond 1992 Oct;26(4):457.

> Corbett F, Oldham J, Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants. J Med Ethics 1996 Aug;22(4):227-31.

> CQ sources. Camb Q Healthc Ethics 1994 Fall;3(4):574-7.

> CQ sources/bibliography. Camb Q Healthc Ethics 1996 Summer;5(3):422-4.

> Cramer JA. Ethical issues in the planning and conduct of clinical trials of anti-epileptic drugs. Med Law 1997;16(2):209-14.

> Dahlqvist G. Epidemiological and ethical considerations on trials with immunotherapy in pre-type 1 (insulin-dependent) diabetes mellitus [letter]. Diabetologia 1991 Jul;34(7):536. Comment on: Diabetologia 1990 Dec;33(12):741.

> De Deyn PP, D'Hooge R. Placebos in clinical practice and research. J Med Ethics 1996 Jun;22(3):140-6.

> de Zoysa I, Elias CJ, Bentley ME. Ethical challenges in efficacy trials of vaginal microbicides for HIV prevention. Am J Public Health 1998 Apr;88(4):571-5.

> DeMets DL , Fleming TR, Whitley RJ, Childress JF, Ellenberg SS, Foulkes M, Mayer KH, O'Fallon J, Pollard RB, Rahal JJ, et al. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials 1995 Dec;16(6):408-21.

> Dennison DK. Components of a randomized clinical trial. J Periodontal Res 1997 Jul;32(5):430-8.

> Deo MG. Leprosy vaccines [letter]. Natl Med J India 1992 May-Jun;5(3):143-4.

> Deutsch E, von Eickstedt KW, Frolich JC, Schneider B. Monitors and European Community guideline on clinical trials [letter]. Lancet 1991 Nov 2;338(8775):1151.

> Devlin HB. Clinical trials and clinical practice [letter]. Lancet 1993 Nov 27;342(8883):1367-8.

> Downs FS. Clinical trials revisited [editorial]. Nurs Res 1994 May-Jun;43(3):132.

> Durant JR. Overview. Current status of clinical trials. Cancer 1990 May 15;65(10 Suppl):2371-5.

> Early termination of clinical trials: causes, consequences and control. With special reference to trials in the field of arrhythmias and sudden death. Task Force of the Working Group on Arrhythmias of the European Society of Cardiology. Eur Heart J 1994 Jun;15(6):721-38.

> Easterbrook P, Houghton J. Informing patients about clinical trials [letter]. BMJ 1993 Jan 23;306(6872):273.

> Edwards SJ, Lilford RJ, Braunholtz D, Jackson J. Why underpowered trials are not necessarily unethical. Lancet 1997 Sep 13;350(9080):804-7.

> Einhorn LH. Curable neoplasms and the ethics of clinical trials [editorial]. J Clin Oncol 1993 Apr;11(4):593-5. Comment on: J Clin Oncol 1993 Apr;11(4):598-606.

> Elander G, Hermeren G. Placebo effect and randomized clinical trials. Theor Med 1995 Jun;16(2):171-82.

> Ellis PM, Coates AS. Ethics of randomized clinical trials [letter]. J Clin Oncol 1998 Jul;16(7):2570. Comment on: J Clin Oncol 1998 Jan;16(1):365-6; discussion 366-71.

> Emanuel EJ, Patterson WB, Hellman S. Ethics of randomized clinical trials. J Clin Oncol 1998 Jan;16(1):365-71. Comment in: J Clin Oncol 1998 Apr;16(4):1637; J Clin Oncol 1998 Jul;16(7):2570.

> Emerson SS, Fleming TR. Interim analyses in clinical trials. Oncology (Huntingt) 1990 Mar;4(3):126-33; discussion 134, 136.

> Engelking C. Facilitating clinical trials. The expanding role of the nurse. Cancer 1991 Mar 15;67(6 Suppl):1793-7.

> Ethical implications of rejecting patients for clinical trials [letter]. JAMA 1990 Aug 22-29;264(8):973-4. Comment on: JM1990 Feb 9;263(6):865.

> Fahy TJ. The ethics of prophylactic trials of depression [letter]. Br J Psychiatry 1990 Apr;156:585-6. Comment on: Br J Psychiatry Suppl 1988 Sep;(3):69-76.

> Finder's fees for research subjects [letter]. N Engl J Med 1990 Dec 13;323(24):1710-1. Comment on: N Engl J Med 1990 Jul 19;323(3):192-5.

> Fleming ID. Clinical trials for cancer patients. The community practicing physician's perspective. Cancer 1990 May 15;65(10 Suppl):2388-90.

> Fleming TR, DeMets DL. Monitoring of clinical trials: issues and recommendations. Control Clin Trials 1993 Jun;14(3):183-97.

> Freedman B. Ethics and placebo-controlled thrombolytic trials: the future [editorial]. Coron Artery Dis 1991 Sep;2(7):849-52.

> Freedman B. A response to a purported ethical difficulty with randomized clinical trials involving cancer patients. J Clin Ethics 1992 Fall;3(3):231-4.

> Garner P, Torres TT, Alonso P. Trial design in developing countries [editorial]. BMJ 1994 Oct 1;309(6958):825-6.

> Giertz G. When medical science conflicts with clinical medicine. Scand J Urol Nephrol Suppl 1991;138:9-10.

> Gifford F. Community-equipoise and the ethics of randomized clinical trials. Bioethics 1995 Apr;9(2):127-48.

> Gillett GR. Ethics and dental research. J Dent Res 1994 Nov;73(11):1766-72.

> Gillon R. Recruitment for clinical trials: the need for public-professional co-operation [editorial]. J Med Ethics 1994 Mar;20(1):3-4. Comment on: J Med Ethics 1994 Mar;20(1):19-22; discussion 23-5.

> Glass KC. Toward a duty to report clinical trials accurately: the clinical alert and beyond. J Law Med Ethics 1994 Winter;22(4):327-38. Comment in: J Law Med Ethics 1995 Summer;23(2):211-2.

> Glass KC, Freedman B. Legal liability for injury to research subjects. Clin Invest Med 1991 Apr;14(2):176-80.

> Goodare H, Smith R. The rights of patients in research [editorial]. BMJ 1995 May 20;310(6990):1277-8. Comment on: BMJ 1995 May 20;310(6990):1279; BMJ 1995 May 20;310(6990):1305-6; BMJ 1995 May 20;310(6990):1313-5; BMJ 1995 May 20;310(6990):1315-8; BMJ 1995 May 20;310(6990):1318-20. Comment in: BMJ 1995 Dec 9;311(7019):1570.

> Gordon J, Tucker RM, Newcomer LN, Poland RL. Randomized clinical trials [letters]. N Engl J Med 1991 Nov 21;325(21):1513.

> Gotay CC. Accrual to cancer clinical trials: directions from the research literature. Soc Sci Med 1991;33(5):569-77.

> Goyot P. Ethics and clinical trials [letter]. Trans R Soc Trop Med Hyg 1992 Sep-Oct;86(5):571.

> Grady C. Ethical issues in clinical trials. Semin Oncol Nurs 1991 Nov;7(4):288-96.

> Greco D, Salinaso S, Mastrantonio S, Pertosse P. The Italian pertussis vaccine trial: ethical issues [letter]. JAMA 1994 Dec 28;272(24):1898-9. Comment on: JAMA 1994 Apr 27;271(16):1228-9.

> Groudine S, Lumb PD. First, do no harm. J Med Ethics 1997 Dec;23(6):377-8.

> Guttmann RD. Some words on clinical trials. Transplant Proc 1996 Dec;28(6):3016.

> Hellman S, Hellman DS. Of mice but not men. Problems of the randomized clinical trial. N Engl J Med 1991 May 30;324(22):1585-9. Comment in: N Engl J Med 1991 Nov 21;325(21):1513-5.

> Helmchen H. Ethical problems and design of controlled clinical trials. Psychopharmacol Ser 1990;8:82-7.

> Hermans M. Clinical research versus evaluation. Nurs RSA 1993 Feb;8(2):26-9.

> Herschel M, Beck J. Negative attitudes to clinical trials are not an external problem for clinical trials [letter]. Pharmacopsychiatry 1991 May;24(3):103. Comment on: Pharmacopsychiatry 1990 Jul;23(4):164-70. Comment in: Pharmacopsychiatry 1992 May;25(3):167.

> Herxheimer A. Clinical trials: two neglected ethical issues. J Med Ethics 1993 Dec;19(4):211, 218.

> Hilden J, Habbema JD. The marriage of clinical trials and clinical decision science. Stat Med 1990 Nov;9(11):1243-57.

> Hill TP. The patient-physician relationship in clinical trials: an ethical dilemma? Mak Rounds Health Faith Ethics 1996 Jun 3;1(19):5-7.

> Hope T. Evidence based medicine and ethics [editorial]. J Med Ethics 1995 Oct;21(5):259-60. Comments in: J Med Ethics 1996 Feb;22(1):55-6; J Med Ethics 1996 Feb;22(1):56.

> Horaud F. Ethical and safety considerations for the use in clinical trials of new attenuated poliovirus strains. Dev Biol Stand 1993;78:149-54; discussion 154-5.

> Hughes MD. Stopping guidelines for clinical trials with multiple treatments. Stat Med 1993 May 30;12(10):901-15.

> Hutton JL. The ethics of randomised controlled trials: a matter of statistical belief? Health Care Anal 1996 May;4(2):95-102.

> Irwig L, Glasziou P, March L. Ethics of n-of-1 trials. Lancet 1995 Feb 25;345(8948):469. Comment in: Lancet 1995 Apr 15;345(8955):989.

> Johnson N, Lilford RJ, Brazier W. At what level of collective equipoise does a clinical trial become ethical? J Med Ethics 1991 Mar;17(1):30-4.

> Joseph RR. Viewpoints and concerns of a clinical trial participant. Cancer 1994 Nov 1;74 Suppl 9:2692-3.

> Kaptchuk TJ. Concerns about run-in periods in randomized trials [letter]. JAMA 1998 May 20;279(19):1526-7. Comment on: JAMA 1998 Jan 21;279(3):222-5.

> Karlawish Jason HT, Lantos John. Community equipoise and the architecture of clinical research. Camb Q Healthc Ethics 1997 Fall;6(4):385-396.

> Kerridge I, Lowe M, Henry D. Ethics and evidence based medicine. BMJ 1998 Apr 11;316(7138):1151-3.

> Kirsch I, Rosadino MJ. Do double-blind studies with informed consent yield externally valid results? An empirical test. Psychopharmacology (Berl) 1993;110(4):437-42.

> Kishon Y. Clinical trials in Israel--facts and dilemmas. Med Law 1996;15(4):663-70.

> Klein DF. Response to Rothman and Michels on placebo-controlled clinical trials. Psychiatr Ann 1995 Jul;25(7):401-3.

> Klocke RA. Ethics of monitoring patient adherence. An evolving dilemma [editorial]. Am J Respir Crit Care Med 1994 Feb;149(2 Pt 1):286. Comment on: Rev Respir Dis 1992 Dec;146(6):1559-64; Am J Respir Crit Care Med 1994 Feb;149(2 Pt 1):287-8.

> Kluge EH. Placebos: some ethical considerations [editorial]. CMAJ 1990 Feb 15;142(4):293-5. Comment in: CMAJ 1990 May 1;142(9):925, 928.

> Koch HJ. The concept of balanced autonomy in therapeutic and nontherapeutic trials [letter]. Control Clin Trials 1995 Jun;16(3):182-4. Comment on: Control Clin Trials 1994 Apr;15(2):154-9.

> Kodish E, Lantos JD, Siegler M. Ethical considerations in randomized controlled clinical trials. Cancer 1990 May 15;65(10 Suppl):2400-4.

> Kodish E, Lantos JD, Siegler M. The ethics of randomization. CA Cancer J Clin 1991 May-Jun;41(3):180-6.

> Kuhse H, Singer P. Randomization in controlled trials [editorial]. Bioethics 1996 Apr;10(2):3-5.

> Langer A. Early stopping of trials [letter]. Lancet 1997 Sep 20;350(9081):890-1. Comment on: Lancet 1997 Jul 19;350(9072):155; Lancet 1997 Jul 19;350(9072):214-5.

> Lantos J. Ethical issues. How can we distinguish clinical research from innovative therapy? Am J Pediatr Hematol Oncol 1994 Feb;16(1):72-5.

> Lawrence W Jr. Patient selection for clinical trials. Risks versus benefits and quality of life issues. Cancer 1993 Nov 1;72(9 Suppl):2798-800.

> Lawrence W Jr, Antman K, Freeman HP, Huber SL, Kaufman D, Lantos J, Lenhard RE Jr, Levine RJ, McKenna RJ Sr, Young FE. The impact of clinical trial protocols on patient care systems. Cancer 1993 Nov 1;72(9 Suppl):2839-41.

> Lawrence W Jr, Bear HD. Is there really an ethical conflict in clinical trials? Cancer 1995 May 15;75(10):2407-9; discussion 2410-1. Comment on: Cancer 1995 May 15;75(10):2403-6.

> Lennard-Jones JE. Evolution of the controlled clinical trial. Mt Sinai J Med 1993 May;60(3):180-5.

> Levine RJ. Clinical trials and physicians as double agents. Yale J Biol Med 1992 Mar-Apr;65(2):65-74.

> Levine RJ. Ethics of clinical trials. Do they help the patient? Cancer 1993 Nov 1;72(9 Suppl):2805-10.

> Levine RJ. The impact of HIV infection on society's perception of clinical trials. Kennedy Inst Ethics J 1994 Jun;4(2):93-8.

> Levine RJ. Monitoring for adherence: ethical considerations [editorial]. Am J Respir Crit Care Med 1994 Feb;149(2 Pt 1):287-8. Comment on: Am J Respir Crit Care Med 1992 Dec;146(6):1559-64; Am Rev Respir Dis 1993 Apr;147(4):887-95; Am Rev Respir Dis 1994 Feb;149(2 Pt 1):286;: Am J Respir Crit Care Med 1994 Feb;149(2 Pt 1):289-90. Comment in: Am J Respir Crit Care Med 1994 Feb;149(2 Pt 1):291-2

> Lewis JP. Clinical studies with make-believe drugs. West J Med 1992 Dec;157(6):677-8.

> Liberati A. The relationship between clinical trials and clinical practice: the risks of underestimating its complexity. Stat Med 1994 Jul 15-30;13(13-14):1485-91.

> Lichter PR. Paying bounty for patients [editorial]. Ophthalmology 1990 Sep;97(9):1097-8.

> Lilford RJ. The substantive ethics of clinical trials. Clin Obstet Gynecol 1992 Dec;35(4):837-45.

> Lind SE. Finder's fees for research subjects. N Engl J Med 1990 Jul 19;323(3):192-5. Comment in: N Engl J Med 1990 Dec 13;323(24):1710-1.

> Lisook AB. FDA audits of clinical studies: policy and procedure. J Clin Pharmacol 1990 Apr;30(4):296-302.

> Llewellyn-Thomas HA, McGreal MJ, Thiel EC, Fine S, Erlichman C. Patients' willingness to enter clinical trials: measuring the association with perceived benefits and preference for decision participation. Soc Sci Med 1991;32(1):35-42.

> Logue G, Wear S. A desperate solution: individual autonomy and the double-blind controlled experiment. J Med Philos 1995 Feb;20(1):57-64.

> Lucas BD Jr, Hilleman DE. Media sensationalism of clinical trials: freedom of information or potential for causing patient harm? [editorial]. Ann Pharmacother 1995 Jun;29(6):629-31.

> Lumley J, Bastian H. Competing or complementary? Ethical considerations and the quality of randomized trials. Int J Technol Assess Health Care 1996 Spring;12(2):247-63.

> Macciocchi SN, Alves WA. Ethical considerations in neuroclinical trials. Neurosurg Rev 1997;20(3):161-70.

> Maher EA. An analysis of finder's fees in clinical research. CMAJ 1994 Jan 15;150(2):252-6.

> Makuch RW, Johnson MF. Dilemmas in the use of active control groups in clinical research. IRB Rev Hum Subj Res 1989 Jan-Feb;11(1):1-5.

> Maloney DM. Encouraging more subjects to participate in clinical trials. Hum Res Rep 1996 Jun;11(6):6.

> Mansour EG. Barriers to clinical trials Part III: Knowledge and attitudes of health care providers. Cancer 1994 Nov 1;74(9 Suppl):2672-5.

> Markman M. When regulatory requirements conflict with ethical study design: the case of oral ondansetron. Cancer Invest 1994;12(6):654-6.

> Marks J. The placebo shrine. J Clin Pharm Ther 1991 Aug;16(4):225-30.

> Marwick C. Clinical trial investigators talk about getting the data [news]. JAMA 1997 Jun 18;277(23):1833-6.

> Marwick C. Questions raised about measles vaccine trial [news]. JAMA 1996 Oct 23-30;276(16):1288-9.

> McKenna RJ Sr. The impact of clinical trial protocols on patient care in a community hospital. Cancer 1993 Nov 1;72(9 Suppl):2828-33.

> McNeil C. Why patients enroll in clinical trials: physicians play a key role [news]. J Natl Cancer Inst 1996 Jun 5;88(11):709-11.

> Meinert CL. Comments on NIH clinical trials valid analysis requirement. Control Clin Trials 1995 Oct;16(5):304-6.

> Meinert CL. Toward prospective registration of clinical trials. IRB Rev Hum Subj Res 1988 Mar-Apr;10(2):6-7.

> Melink TJ, Whitacre MY. Planning and implementing clinical trials. Semin Oncol Nurs 1991 Nov;7(4):243-51.

> Moher D. Clinical-trial registration: a call for its implementation in Canada [editorial]. CMAJ 1993 Dec 1;149(11):1657-8. Comment in: CMAJ 1994 Jun 15;150(12):1939-40.

> Moher D. Trial registration: a new standard for REBs. NCBHR Commun 1993 Nov-Dec;4(2):6-7.

> Molin C. The special case of clinical trials. Eur J Cancer Care (Engl) 1996 Mar;5 Suppl 1:5-6.

> Mueller CB. Ethics of medicine and science [letter]. CMAJ 1994 Jul 1;151(1):11.

> Nicholson RH. Paternalism no problem. Hastings Cent Rep 1992 Mar-Apr;22(2):4-5.

> Novick A. Noncompliance in clinical trials: I. Subjects. AIDS Public Policy J 1990 Spring;5(2):94-6.

> Nowak R. Research methods: problems in clinical trials go far beyond misconduct. Science 1994 Jun 10;264(5165):1538-41.

> Onwude J, Thornton JG. Volunteering for research [letter]. Lancet 1992 Nov 14;340(8829):1230. Comment on: Lancet 1992 May 26;300(6736):1372-5; Lancet 1992 Oct 3;340(8823):832-4.

> Orr RD. Guidelines for the use of placebo controls in clinical trials of psychopharmacologic agents. Loma Linda University Institutional Review Board. Psychiatr Serv 1996 Nov;47(11):1262-4.

> Palter SF. Ethics of clinical trials. Semin Reprod Endocrinol 1996 May;14(2):85-92.

> Papers from the Conference on Methodological and Ethical Issues in Clinical Trials. 27-28 June 1991. Stat Med 1993 Aug;12(15-16):1373-534.

> Pearn J, Chalmers I. Is selective reporting of well-designed clinical research unethical as well as unscientific? [letter]. Ned Tijdschr Geneeskd 1996 Jan 27;140(4):220-1. Comment on: Ned Tijdschr Geneeskd 1995 Jul 22;139(29):1476-7. Comment in: Ned Tijdschr Geneeskd 1996 Mar 2;140(9):509-10.

> Piantadosi S, Wittes J. Politically correct clinical trials [letter]. Control Clin Trials 1993 Dec;14(6):562-7.

> Pocock SJ. Statistical and ethical issues in monitoring clinical trials. Stat Med 1993 Aug;12(15-16):1459-69; discussion 1471-5.

> Pocock SJ. When to stop a clinical trial. BMJ 1992 Jul 25;305(6847):235-40. Comment in: BMJ 1992 Aug 22;305(6851):475.

> Pollock A. When to stop a clinical trial [letter]. BMJ 1992 Aug 22;305(6851):475. Comment on: BMJ 1992 Jul 25;305(6847):235-40.

> Powell JT, Greenhalgh RM, Ruckley CV, Fowkes FG. Prologue to a surgical trial. Lancet 1993 Dec 11;342(8885):1473-4.

> Poy E. Objectives of QC systems and QA function in clinical research. Qual Assur 1993 Dec;2(4):326-31.

> Price JR. The placebo effect. Use outside trials may be unethical [letter]. BMJ 1994 Sep 10;309(6955):667. Comment on: BMJ 1994 Jul 9;309(6947):69-70.

> Promotion of ethics in gastroenterology. Joint meeting of the members of the Japanese Society of Gastroenterology and the World Organization of Gastroenterology. Gastroenterol Jpn 1993 Jul;28 Suppl 6:45-54.

> Prorok P. The National Cancer Institute Multi-Screening Trial. Can J Oncol 1994 Nov;4 Suppl 1:98-9; discussion 100-1.

> Psillidis L, Flach J, Padberg RM. Participants strengthen clinical trial research: the vital role of participant advisors in the Breast Cancer Prevention Trial. J Womens Health 1997 Apr;6(2):227-32.

> Quality of life and clinical trials [editorial]. Lancet 1995 Jul 1;346(8966):1-2.

> Ratain MJ, Mick R, Schilsky RL, Siegler M. Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J Natl Cancer Inst 1993 Oct 20;85(20):1637-43. Comment in: J Natl Cancer Inst 1993 Oct 20;85(20):1618-9.

> Reynolds DJ. Safer use of traditional medicines. Clinical trials may fail to get ethical approval [letter]. BMJ 1994 Apr 16;308(6935):1043. Comment on: BMJ 1994 Mar 12;308(6930):673-4.

> Ridsdale L. Use and abuse of placebos. Practitioner 1990 Dec;234(1497):1028, 1031.

> Rimer BK. Participant enrollment, participation, and compliance in chemoprevention trials. Adv Exp Med Biol 1992;320:111-7.

> Robinson J. A lay person's perspective on starting and stopping clinical trials. Stat Med 1994 Jul 15-30;13(13-14):1473-7.

> Rogers A. European drug industry concerned over proposed clinical-trial legislation [news]. Lancet 1997 Nov 29;350(9091):1609.

> Rosenberg LT. We have a prejudice against ourselves -- sentiment, ethics, and reason. J Med Humanit 1993 Spring;14(1):5-14.

> Rosenberg LT. Weighing community and individual needs: use of placebos in clinical testing. R I Med 1992 Dec;75(12):585-7.

> Rosenberger WF, Lachin JM. The use of response-adaptive designs in clinical trials. Control Clin Trials 1993 Dec;14(6):471-84.

> Rosner F. Human experimentation and clinical trials [correction of trails] [letter]. Isr J Med Sci 1995 Sep;31(9):580-2. Comment on: Isr J Med Sci 1995 Feb-Mar;31(2-3):197-200.

> Rothman KJ. Placebo mania [editorial]. BMJ 1996 Jul 6;313(7048):3-4. Comment on: BMJ 1996 Jul 6;313(7048):36-9. Comments in: BMJ 1996 Oct 19;313(7063):1008; BMJ 1996 Oct 19;313(7063):1008-9; BMJ 1996 Oct 19;313(7063):1009.

> Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med 1994;331(6):394-8. Comments in N Engl J Med 1995 Jan 5;332(1):60-2.

> Royall RM. Ignorance and altruism [editorial]. J Clin Ethics 1992 Fall;3(3):229-30. Comment in: J Clin Ethics 1992 Fall;3(3):193-5.

> Royall RM, Bartlett RH, Cornell RG, Byar DP, Dupont WD, Levine RJ, Lindley F, Simes RJ, Zelen M. Ethics and statistics in randomized clinical trials [article, seven commentaries, and rejoinder]. Stat Sci 1990;6(1):52-88.

> Rutan RL, Deitch EA, Waymack JP. Academic surgeons' knowledge of Food and Drug Administration regulations for clinical trials. Arch Surg 1997 Jan;132(1):94-8.

> Schain WS. Barriers to clinical trials Part II: Knowledge and attitudes of potential participants. Cancer 1994 Nov 1;74(9 Suppl):2666-71.

> Schechter C. The use of placebo controls [letter]. N Engl J Med 1995 Jan 5;332(1):60; discussion 62. Comment on: N Engl J Med 1994 Aug 11;331(6):394-8.

> Schmidt M. Inspection of clinical investigations by the German health authorities. Methods Find Exp Clin Pharmacol 1993 May;15(4):229-31.

> Schron EB, Wassertheil-Smoller S, Pressel S. Clinical trial participant satisfaction: survey of SHEP enrollees. SHEP Cooperative Research Group. Systolic Hypertension in the Elderly Program. J Am Geriatr Soc 1997 Aug;45(8):934-8.

> Scoles L, Silagy C. Are clinical trials in general practice ethical? Aust Fam Physician 1993 Feb;22(2):182-3.

> Segelov E, Tattersall MHN, Coates AS. Redressing the balance: the ethics of "not" entering an eligible patient on a randomised clinical trial. Ann Oncol 1992 Feb;3(2):103-5.

> Senn S. Are placebo run ins justified? BMJ 1997 Apr 19;314(7088):1191-3.

> Shatz D. Randomized clinical trials and the problem of suboptimal care: an overview of the controversy. Cancer Invest 1990;8(2):191-205.

> Shaw AB. Ethical issues in randomised prevention trials [letter]. BMJ 1993 Mar 20;306(6880):790. Comment on: BMJ 1993 Feb 27;306(6877):563-5.

> Shimm DS, Spece RG. Ethical issues and clinical trials. Drugs 1993 Oct;46(4):579-84.

> Shimm DS, Spece RG Jr. Industry reimbursement for entering patients into clinical trials: legal and ethical issues. Ann Intern Med 1991 Jul 15;115(2):148-51.

> Should I enroll in a randomized clinical trial? Excerpts from a patient's guide. IRB Rev Hum Subj Res 1988 Mar-Apr;10(2):10-1.

> Silagy CA, Jewell D, Mant D. An analysis of randomized controlled trials published in the US family medicine literature, 1987-1991. J Fam Pract 1994 Sep;39(3):236-42. Comment in: J Fam Pract 1994 Sep;39(3):221-4.

> Silverman WA. The most noble goal of medicine. Control Clin Trials 1991 Dec;12(6):723-6. Comment in: Control Clin Trials 1993 Apr;14(2):174-5.

> Silverman WA. Patient preferences and randomised trials [letter]. Lancet 1994 Oct 8;344(8928):1023. Comment on: Lancet 1994 Sep 3;344(8923):688.

> Silverman WA, Altman DG. Patients' preferences and randomised trials. Lancet 1996 Jan 20;347(8995):171-4. Comment in: Lancet 1996 Apr 20;347(9008):1118; discussion 1119; Lancet 1996 Apr 20;347(9008):1118-9; Lancet 1996 Apr 20;347(9008):1119.

> Simberkoff MS, Hartigan PM, Hamilton JD. Clinical trials: to terminate or not to terminate. The VA Cooperative Studies Group on AIDS [letter]. Ann Intern Med 1992 Apr 15;116(8):699-700. Comment on: Ann Intern Med 1991 Nov 15;115(10):818-22.

> Smeltz KJ. Bill promotes Medicare coverage of clinical trials [news]. J Natl Cancer Inst 1997 Apr 16;89(8):546-7.

> Sniderman AD. The governance of clinical trials. Lancet 1996 May 18;347(9012):1387-8.

> Spilker B. Methods of assessing and improving patient compliance in clinical trials. IRB Rev Hum Subj Res 1992 May-Jun;14(3):1-6.

> Streiner DL. The ethics of placebo-controlled trials [editorial]. Can J Psychiatry 1995 May;40(4):165-6.

> Surgical Infection Society statement by the Council of the Surgical Infection Society regarding data derived from clinical trials. Arch Surg 1992 Jul;127(7):764.

> Sutherland HJ, Meslin EM, Till JE. What's missing from current clinical trial guidelines? A framework for integrating science, ethics, and the community context. J Clin Ethics 1994 Winter;5(4):297-303.

> Swinbanks D. Deaths bring clinical trials under scrutiny in Japan [news]. Nature 1994 Jun 30;369(6483):697.

> Taubes G. Use of placebo controls in clinical trials disputed [news]. Science 1995 Jan 6;267(5194):25-6.

> Taylor KM. Integrating conflicting professional roles: physician participation in randomized clinical trials. Soc Sci Med 1992 Jul;35(2):217-24.

> Teehan M, Canadian Psychiatric Association. Guidelines for Phase IV clinical trials. Can J Psychiatry 1994 Dec;39(10):629-30.

> Thornton H. U.K. DCIS Trial--time for review? Eur J Cancer 1993;29A(3):428-9. Comment on: Eur J Cancer 1992;28(2-3):626-9. Comment in: Eur J Cancer 1993;29A(3):295-6.

> Tomatis L. Ethical aspects of prevention. Scand J Work Environ Health 1995 Aug;21(4):245-51.

> Torgerson DJ, Roland M. What is Zelen's design? BMJ 1998 Feb 21;316(7131):606.

> Truog RD. Randomized controlled trials of innovative therapies: are they ethical? [editorial]. J Nephrol 1995 Nov-Dec;8(6):285-6.

> Truog RD. Randomized controlled trials of potentially life-saving therapies: are they ethical? [editorial]. Coron Artery Dis 1993 Sep;4(9):835-6.

> Truog RD, Arnold JH. The ethics of evidence and randomized controlled trials [commentary]. J Clin Ethics 1992 Spring;3(1):65-7.

> Ubel PA, Merz JF, Shea J, Asch DA. How preliminary data affect people's stated willingness to enter a hypothetical randomized controlled trial. J Investig Med 1997 Dec;45(9):561-6.

> Vander Stichele R. Measurement of patient compliance and the interpretation of randomized clinical trials. Eur J Clin Pharmacol 1991;41(1):27-35.

> Veatch RM. Ethical perspectives on the FDA and ADA evaluation of dental products. J Public Health Dent 1992;52(6):387-90.

> Veatch RM. Should I enroll in a randomized clinical trial? A critical commentary. IRB Rev Hum Subj Res 1988 Sep-Oct;10(5):7-8.

> Vere DW. Payments to healthy volunteers--ethical problems [editorial]. Br J Clin Pharmacol 1991 Aug;32(2):141-2.

> Weijer C. Evolving ethical issues in selection of subjects for clinical research. Camb Q Healthc Ethics 1996 Summer;5(3):334-45.

> Weijer C, Fuks A. The duty to exclude: excluding people at undue risk from research. Clin Invest Med 1994 Apr;17(2):115-22.

> Weijer C, Shapiro S, Fuks A, Glass KC, Skrutkowska M. Monitoring clinical research: an obligation unfulfilled. CMAJ 1995 Jun 15;152(12):1973-80.

> Weiss RB, Vogelzang NJ, Peterson BA, Panasci LC, Carpenter JT, Gavigan M, Sartell K, Frei E 3d, McIntyre OR. A successful system of scientific data audits for clinical trials. A report from the Cancer and Leukemia Group B. JAMA 1993 Jul 28;270(4):459-64. Comments in: JAMA 1993 Jul 28;270(4):495-6; JAMA 1993 Dec 8;270(22):2685.

> Wells F. Fraud and misconduct in clinical research: is it prejudicial to patient safety? Adverse Drug React Toxicol Rev 1992 Winter;11(4):241-55.

> Wells FO. Good clinical research practice in Europe. J R Coll Physicians Lond 1991 Oct;25(4):329.

> Wells RJ. Secrecy for data monitoring committees: inferior ethics, bad policy [letter]. J Clin Oncol 1998 Jan;16(1):390-1. Comment on: J Clin Oncol 1997 Jul;15(7):2736-43.

> Weymuller EA Jr. A consideration of ethical issues in the design of clinical trials. Am J Otolaryngol 1996 Jan-Feb;17(1):2-11.

> Widder J. Randomising means, not aims in clinical trials [letter]. Lancet 1994 Feb 5;343(8893):359.

> Zwitter M. Communication with the patient in clinical research. Ann N Y Acad Sci 1997 Feb;20(809):83-96.

> Return to table of contents

> ## Clinical trials - Books

> Clinical Research: Hearing Before a Subcomm. of the Senate Comm. on Appropriations. 104th Cong. 2nd Sess. [microfiche]. Washington: U.S. Government Printing Office; 1996. 59 p. (Senate hrg; 104-559).

> Current issues in human subject protection: an FDA perspective: proceedings of a meeting, 1996 Sep 13, National Institutes of Health. Bethesda MD. Rockville (MD): Food and Drug Administration; 1996. 1 vol.

> Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 3rd ed. St. Louis: Mosby; c1996. 361 p.

> Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 4th ed. New York: Springer; c1998.

> Giffels JJ. Clinical trials: what you should know before volunteering to be a research subject. New York: Demos Vermande; c1996. 48 p.

> Kadane JB, editor. Bayesian methods and ethics in a clinical trial design. New York: J. Wiley & Sons; c1996. 318 p. (Wiley series in probability and statistics. Applied probability and statistics).

> Mann RD. Risk and consent to risk in medicine: the proceedings of a conference. Park Ridge (NJ): Parthenon Pub. Group; 1989. 224 p.

> Perman JA, Rey J. Clinical trials in infant nutrition: methodology, statistics, and ethicial issues. Philadelphia: Lippincott-Raven; c1998. 281 p. (Nestle Nutrition Workshop series; vol. 40).

> Spilker B, Cramer JA. Patient recruitment in clinical trials. New York: Raven Press; c1992. 346 p.

> Walker SR, Lumley CE, McAuslane JAN. The relevance of ethnic factors in the clinical evaluation of medicines. Boston: Kluwer Academic; c1994. 262 p. (CMR workshop series).

> Return to table of contents

> ## Special or vulnerable populations - Women - Journal Articles

> Aldhous P. Boost for women's health [news]. Nature 1991 Jul 18;352(6332):180.

> Allen A, Ross RL, Payer L, Angell M. Women's health [letters and response]. N Engl J Med 1993 Dec 9;329(24):1816-7.

> American College of Clinical Pharmacy Task Force on Women's Health and Research Issues. Women as research subjects. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):534-42.

> Anderson C. Clinical research: panel backs pregnant women in trials [news]. Science 1994 Mar 4;263(5151):1216.

> Anderson C. Panel backs pregnant women in trials [news]. Science 1994 Mar 4;263(5151):1216.

> Anderson C. A woman's place [news]. Nature 1990 Sep 27;347(6291):321.

> Angell M. Caring for women's health--what is the problem? [editorial]. N Engl J Med 1993 Jul 22;329(4):271-2. Comment on: N Engl J Med 1993 Jul 22;329(4):247-56; N Engl J Med 1993 Jul 22;329(4):288-92; N Engl J Med 1993 Jul 22;329(4):292-6. Comment in: N Engl J Med 1993 Dec 9;329(24):1816; discussion 1817; N Engl J Med 1993 Dec 9;329(24):1816-7; N Engl J Med 1993 Dec 9;329(24):1817.

> Assaf AR, Carleton RA. The Women's Health Initiative Clinical Trial and Observational Study: history and overview. R I Med 1994 Dec;77(12):424-7.

> Auerbach JD, Figert AE. Women's health research: public policy and sociology. J Health Soc Behav 1995;Spec No:115-31.

> Baum M. New approach for recruitment into randomised controlled trials. Lancet 1993 Mar 27;341(8848):812-3. Comment in: Lancet 1993 Mar 27;341(8848):795-6; Lancet 1993 Jun 12;341(8859):1539.

> Baylis F. Women and health research: working for change. J Clin Ethics 1996 Fall;7(3):229-42.

> Becker RC. Education and clinical research issues in women's health. Cardiology 1995;86(4):270-1.

> Bennett JC. Inclusion of women in clinical trials--policies for population subgroups. N Engl J Med 1993 Jul 22;329(4):288-92. Comment in: N Engl J Med 1993 Jul 22;329(4):271-2.

> Berg MJ. Status of research on gender differences. J Am Pharm Assoc (Wash) 1997 Jan-Feb;NS37(1):43-56.

> Berglund CA. Women's views of consent procedures for a cervical cytology register [letter]. Med J Aust 1995 Aug 21;163(4):222. Comment on: Med J Aust 1995 Apr 17;162(8):443.

> Berkowitz RL, Berkowitz GS. Invasive studies during normal pregnancy [editorial]. Obstet Gynecol 1990 Jun;75(6):1041-2.

> Birmingham K. Women in trials: clinical hold or stranglehold? [news]. Nat Med 1997 Nov;3(11):1179-80.

> Bone CR, Higgins MW, Hurd SS, Reynolds HY. NHLBI workshop summary. Research needs and opportunities related to respiratory health of women. Am Rev Respir Dis 1992 Aug;146(2):528-35.

> Brink PJ. Feminist research [editorial]. West J Nurs Res 1991 Jun;13(3):304-5.

> Bruce SL. Coronary artery disease in women [letter]. J Cardiovasc Nurs 1991 Jan;5(2):9. Comment on: J Cardiovasc Nurs 1990 Aug;4(4):35-50.

> Buc NL. Women in clinical trials: concluding remarks. Food Drug Law J 1993;48(2):223-6.

> Bunkle P. Women and power: how can we change the system? Health Care Women Int 1991 Oct-Dec;12(4):379-91.

> Burge SK. Incorporating feminist perspectives into family medicine research [editorial]. Fam Pract Res J 1991 Dec;11(4):349-55.

> Bush JK. The industry perspective on the inclusion of women in clinical trials. Acad Med 1994 Sep;69(9):708-15.

> Byman B. Less than equal treatment. Women battle sex bias in the health care arena. Minn Med 1992 Jan;75(1):16-21.

> Caschetta MB, Chavkin W, McGovern T. FDA policy on women in drug trials [letter]. N Engl J Med 1993 Dec 9;329(24):1815-6. Comment on: N Engl J Med 1993 Jul 22;329(4):292-6.

> Cassel CK. Policy implications of the Human Genome Project for women. Womens Health Issues 1997 Jul-Aug;7(4):225-9.

> Centers for Disease Control and Prevention (US), Agency for Toxic Substances and Disease Registry. Policy on the inclusion of women and racial and ethnic minorities in externally awarded research; notice. Fed Regist 1995 Sep 15;60(179):47947-51.

> Charo RA. Protecting us to death: women, pregnancy, and clinical research trials. St Louis Univ Law J 1993 Fall;38(1):135-87.

> Chavkin W. Women and clinical research [editorial]. J Am Med Womens Assoc 1994 Jul-Aug;49(4):99-100.

> Cotton DJ, Finkelstein DM, He W, Feinberg J. Determinants of accrual of women to a large, multicenter clinical trials program of human immunodeficiency virus infection. The AIDS Clinical Trials Group. J Acquir Immune Defic Syndr 1993 Dec;6(12):1322-8.

> Cotton P. FDA lifts ban on women in early drug tests, will require companies to look for gender differences [news]. JAMA 1993 Apr 28;269(16):2067.

> Cotton P. Is there still too much extrapolation from data on middle-aged white men? [news]. JAMA 1990 Feb 23;263(8):1049-50.

> Cotton P. Women's health initiative leads way as research begins to fill gender gaps [news]. JAMA 1992 Jan 22-29;267(4):469-70, 473.

> Culliton BJ. Critics condemn NIH women's study [news]. Nature 1993 Nov 4;366(6450):11. Comment in: Nature 1994 Feb 3;367(6462):404.

> Culliton BJ. NIH push for women's health [news]. Nature 1991 Oct 3;353(6343):383.

> Cummings NB. Choices: biomedical ethics and women's health. Ethical issues and dilemmas. J Womens Health 1998 Mar;7(2):173-6.

> Cummings NB. Women's health and nutrition research: US governmental concerns. J Am Coll Nutr 1993 Aug;12(4):329-36.

> DeBruin DA. Justice and the inclusion of women in clinical studies: an argument for further reform. Kennedy Inst Ethics J 1994 Jun;4(2):117-46.

> Denmark FL. Engendering psychology. Am Psychol 1994 Apr;49(4):329-34.

> Donahue AH. Women's health: a national plan for action. J Dent Educ 1993 Oct;57(10):738-41.

> Dresser R. Wanted. Single, white male for medical research. Hastings Cent Rep 1992 Jan-Feb;22(1):24-9.

> Dubois MY, Burris JF. Inclusion of women in clinical research. Acad Med 1994 Sep;69(9):693-4.

> Erikson J. Breast cancer activists seek voice in research decisions [news]. Science 1995 Sep 15;269(5230):1508-9.

> Fabrizio T. Have women patients been treated differently from men? Nord Med 1991;106(10):276-8.

> FDA and women's health. J Am Med Womens Assoc 1998 Spring;53(2):105-7.

> Finnegan LP. The NIH Women's Health Initiative: its evolution and expected contributions to women's health. Am J Prev Med 1996 Sep-Oct;12(5):292-3.

> Food and Drug Administration (US). Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice. Fed Regist 1993 Jul 22;58(139):39406-16.

> Freda MC. Childbearing, reproductive control, aging women, and health care: the projected ethical debates. J Obstet Gynecol Neonatal Nurs 1994 Feb;23(2):144-52.

> Frederiksen MC. Clinical trials in pregnancy. Food Drug Law J 1993;48(2):195-203.

> Freedman L, Anderson G, Kipnis V, Prentice R, Wang CY, Rossouw J, Wittes J, DeMets D. Approached to monitoring the results of long-term disease prevention trials: examples from the Women's Health Initiative. Control Clin Trials 1996 Dec;17(6):509-25.

> Freedman LS, Simon R, Foulkes MA, Friedman L, Geller NL, Gordon DJ, Mowery R. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993--the perspective of NIH clinical trialists. Control Clin Trials 1995 Oct;16(5):277-85; discussion 286-9, 293-309.

> Gamble VN. The Tuskegee Syphilis Study and women's health. J Am Med Womens Assoc 1997 Fall;52(4):195-6.

> Gannon L, Luchetta T, Rhodes K, Pardie L, Segrist D. Sex bias in psychological research. Progress or complacency? Am Psychol 1992 Mar;47(3):389-96.

> Gender gap in research hit by ANA. Pa Nurse 1991 Aug;46(8):24.

> Gershon D. Drugs tested for women [news]. Nature 1992 Jan 23;355(6358):287.

> Gibaldi M. Drug development and women: an overview. Pharmacotherapy 1992;12(5):365-8.

> Gibbons A. Women's health issues take center stage at the IOM [news]. Science 1992 Oct 30;258(5083):733.

> Gift HC. Needed: a research agenda for women's oral health [editorial]. J Dent Res 1993 Feb;72(2):552-3.

> Goldmann BJ. A drug company report: what is the same and what is changing with respect to inclusion/exclusion of women in clinical trials. Food Drug Law J 1993;48(2):169-74.

> Goldsmith MF. Heart research efforts aim at fairness to women in terms of causes, care of cardiac disorders [news]. JAMA 1990 Dec 26;264(24):3112-3.

> Gore SM. Inclusion of women and minorities in clinical trials. Control Clin Trials 1995 Oct;16(5):290-2.

> Gorenberg H, White A. Off the pedestal and into the arena: toward including women in experimental protocols. Rev Law Soc Change 1991-2;19(1):205-46.

> Gray C. US resistance to Canadian mammogram study not only about data. CMAJ 1993 Feb 15;148(4):622-3.

> Griffin E. Disadvantaged women [letter]. Nature 1998 Jan 8;391(6663):118. Comment on: Nature 1997 Dec 4;390(6659):431; Nature 1997 Dec 4;390(6659):438.

> Gryniewicz EH. Methodology of food-supplemented detoxification study debated [letter]. Altern Ther Health Med 1996 Mar;2(2):17-8.

> Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA 1992 Sep 16;268(11):1417-22. Comment in: JAMA 1992 Sep 16;268(11):1460-7.

> Haffner ME. Studies involving orphan products for treating/diagnosing women's diseases. Food Drug Law J 1993;48(2):205-11.

> Hall JK. Exclusion of pregnant women from research protocols: unethical and illegal. IRB Rev Hum Subj Res 1995 Mar-Apr;17(2):1-3.

> Harlow SD, Ephross SA. Epidemiology of menstruation and its relevance to women's health. Epidemiol Rev 1995;17(2):265-86.

> Hayunga EG, Rothenberg KH, Pinn VW. Women of childbearing potential in clinical research: perspectives on NIH policy and liability issues. Food Drug Cosmet Med Device Law Dig 1996 Jan;13(1):7-11.

> Healy B. Women's health, public welfare [editorial]. JAMA 1991 Jul 24-31;266(4):566-8. Comment in: JAMA 1991 Dec 4;266(21):2984; discussion 2984-5.

> Healy B. The Yentl syndrome [editorial]. N Engl J Med 1991 Jul 25;325(4):274-6.

> Heiberg AN. Access to the world's resources: women's health. Bull Med Libr Assoc 1996 Jan;84(1):91-5.

> Henderson MM. Priorities for research to meet women's health needs. Ann Epidemiol 1994 Mar;4(2):172-3.

> Herz SE. Don't test, do sell: legal implications of inclusion and exclusion of women in clinical drug trials. Epilepsia 1997;38 Suppl 4:S42-9.

> HHS calls for inclusion of pregnant women [news]. Am J Nurs 1998 Sep;98(9):10.

> HIV studies target women. AORN J 1991 Jul;54(1):80.

> Hohmann AA, Parron DL. How the new NIH Guidelines on Inclusion of Women and Minorities apply: efficacy trials, effectiveness trials, and validity. J Consult Clin Psychol 1996 Oct;64(5):851-5.

> Holden C. Women not shortchanged in trials? [news]. Science 1997 Mar 14;275(5306):1571-3.

> Horton R. Trials of women. Lancet 1994 Mar 26;343(8900):745-6.

> Hospital put on probation for tests on pregnant women [news]. Hosp Ethics 1994 Nov-Dec;10(6):6.

> Ickovics JR, Epel ES. Women's health research: policy and practice. IRB Rev Hum Subj Res 1993 Jul-Aug;15(4):1-7.

> Jennings C. Raising consciousness about women's health issues. J Am Acad Nurse Pract 1991 Apr-Jun;3(2):92-4.

> Jensvold MF, Hamilton JA, Mackey B. Including women in clinical trials: how about the women scientists? J Am Med Womens Assoc 1994 Jul-Aug;49(4):110-2.

> Jevne R, Oberle K. Enriching health care and health care research: a feminist perspective. Humane Med 1993 Jul;9(3):201-6.

> Kelly PJ, Cordell JR. Recruitment of women into research studies: a nursing perspective. Clin Nurse Spec 1996 Jan;10(1):25-8. Comment in: Clin Nurse Spec 1996 Jan;10(1):20.

> Keville TD. The invisible woman: gender bias in medical research. Womens Rights Law Rep 1994;15:123-42.

> Khaw KT. Where are the women in studies of coronary heart disease? White middle aged men are not necessarily representative of all humankind [editorial]. BMJ 1993 May 1;306(6886):1145-6.

> Kirschstein R. From the National Institutes of Health. JAMA 1993 Oct 6;270(13):1521.

> Kirschstein RL. Research on women's health. Am J Public Health 1991 Mar;81(3):291-3.

> Kitler ME. Coronary disease: are there gender differences? Eur Heart J 1994 Mar;15(3):409-17.

> Kornblum A. What's good for the gander may not be good for the goose. Environ Health Perspect 1993 Jun;101(2):121-2.

> Kraynak MA. The women's health movement: political, social, and medical issues. Am Pharm 1994 Dec;NS34(12):30-5.

> Lakhani ZM. Racism, sexism and trials. Ann R Coll Physicians Surg Can 1990 Dec;23(7):509-10.

> Langer AS. The role of advocacy in cancer research: not a monster. Cancer Invest 1997;15(5):500-2.

> LaRosa JH. Office of Research on Women's Health. National Institutes of Health and the women's health agenda. Ann N Y Acad Sci 1994 Dec 30;736:196-204.

> LaRosa JH. Women's health: science and politics. Ann Epidemiol 1994 Mar;4(2):84-8.

> Lechky O. Toronto-based foundation tries to combat underfunding in women's health research. Can Med Assoc J 1992 Jan 15;146(2):261-4.

> Levey BA. Bridging the gender gap in research [editorial]. Clin Pharmacol Ther 1991 Dec;50(6):641-6.

> Levine C. Ethics, epidemiology, and women's health. Ann Epidemiol 1994 Mar;4(2):159-65.

> Levine C. Women and HIV/AIDS research: the barriers to equity. IRB Rev Hum Subj Res 1991;13(1-2):18-22.

> Litt IF. Double standard, double jeopardy: research on health problems of adolescent women [editorial]. J Adolesc Health 1991 Jul;12(5):361.

> Little MO. Why a feminist approach to bioethics? Kennedy Inst Ethics J 1996 Mar;6(1):1-18.

> Low KG, Joliceour MR, Colman RA, Stone LE, Fleisher CL. Women participants in research: assessing progress. Women Health 1994;22(1):79-98.

> Macklin R. Reversing the presumption: the IOM report on women in health research. J Am Med Womens Assoc 1994 Jul-Aug;49(4):113-6, 121.

> Macklin R. Women's health: an ethical perspective. J Law Med Ethics 1993 Spring;21(1):23-9.

> Mahowald MB. The Human Genome Project and women. Womens Health Issues 1997 Jul-Aug;7(4):204-5.

> Malterud K. Strategies for empowering women's voices in the medical culture. Health Care Women Int 1993 Jul-Aug;14(4):365-73.

> Mangino JE, Fass RJ. Inclusion of women in clinical trials of antiretroviral agents for HIV/AIDS during pregnancy [letter]. Lancet 1997 Jul 12;350(9071):150.

> Mann C. Women's health research blossoms [news]. Science 1995 Aug 11;269(5225):766-70. Comment in: Science 1995 Nov 3;270(5237):719-20.

> Manolio TA, Harlan WR. Research on coronary disease in women: political or scientific imperative? [editorial]. Br Heart J 1993 Jan;69(1):1-2.

> Marshall E. Women's health initiative draws flak [news]. Science 1993 Nov 5;262(5135):838.

> Marwick C. Women's health action plan sees first anniversary [news]. JAMA 1992 Oct 14;268(14):1816-7, 1821.

> Mason JO. From the Assistant Secretary for Health, US Public Health Service. JAMA 1992 Jan 22-29;267(4):482. Comment in: JAMA 1992 Nov 18;268(19):2647; discussion 2647-8; JAMA 1992 Nov 18;268(19):2647-8.

> Mastroianni A, Faden R, Federman D. Women and health research: a report from the Institute of Medicine. Kennedy Inst Ethics J 1994 Mar;4(1):55-62.

> Maxwell L. Feminist critique of cardiovascular research. Can J Cardiovasc Nurs 1994;5(1):26-7.

> Maynard C, Selker HP, Beshansky JR, Griffith JL, Schmid CH, Califf RM, D'Agostino RB, Laks MM, Lee KL , Wagner GS, et al. The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database. Med Decis Making 1995 Jan-Mar;15(1):38-43.

> McBride AB. From gynecology to GYN-ecology: developing a practice-research agenda for women's health. Health Care Women Int 1993 Jul-Aug;14(4):315-25.

> McDermott MM, Lefevre F, Feinglass J, Reifler D, Dolan N, Potts S, Senger K. Changes in study design, gender issues, and other characteristics of clinical research published in three major medical journals from 1971 to 1991. J Gen Intern Med 1995 Jan;10(1):13-8.

> McGoldrick KE. Women's health: is anatomy still destiny? [editorial]. J Am Med Womens Assoc 1990 Nov-Dec;45(6):211-2.

> McGovern T, Davis M, Caschetta MB. Inclusion of women in AIDS clinical research: a political and legal analysis [published erratum appears in J Am Med Wom Assoc 1994 Sep-Oct;49(5):149]. J Am Med Womens Assoc 1994 Jul-Aug;49(4):102-4, 109. Comment in: J Am Med Wom Assoc 1995 Jan-Feb;50(1):2.

> Meinert CL. The inclusion of women in clinical trials. Science 1995 Aug 11;269(5225):795-6.

> Melnick SL, Wertheimer WJ, Pinn VW. Women and HIV/AIDS research in the United States. J Am Med Womens Assoc 1995 May-Aug;50(3-4):137-8.

> Merkatz R. Progress notes on women's health. Am J Nurs 1993 Nov;93(11):75-80.

> Merkatz RB. Inclusion of women in clinical trials: a historical overview of scientific, ethical, and legal issues. J Obstet Gynecol Neonatal Nurs 1998 Jan-Feb;27(1):78-84.

> Merkatz RB. Women in clinical trials: an introduction. Food Drug Law J 1993;48(2):161-6.

> Merkatz RB, Summers EI, Toigo TA. FDA: making a difference for women and HIV/AIDS. J Am Med Womens Assoc 1995 May-Aug;50(3-4):108, 120.

> Merkatz RB, Temple R. Women in clinical trials. Oncology (Huntingt) 1994 Jun;8(6):52, 57.

> Merkatz RB, Temple R, Subel S, Feiden K, Kessler DA. Women in clinical trials of new drugs. A change in Food and Drug Administration policy. The Working Group on Women in Clinical Trials. N Engl J Med 1993 Jul 22;329(4):292-6. Comment in: N Engl J Med 1993 Jul 22;329(4):271-2; N Engl J Med 1993 Dec 9;329(24):1815-6.

> Merton V. The exclusion of pregnant, pregnable, and once-pregnable people (a.k.a. women) from biomedical research. Am J Law Med 1993;19(4):369-451.

> Merton V. Review essay: "Women and Health Research" [Institute of Medicine report, edited by A.C. Mastroianni, R. Faden, and D. Federman]. J Law Med Ethics 1994 Fall;22(3):272-9.

> Merton V. Women and health research. J Law Med Ethics 1994 Fall;22(3):272-9.

> Messing K. Women's occupational health: a critical review and discussion of current issues. Women Health 1997;25(4):39-68.

> Millner L, Widerman E. Women's health issues: a review of the current literature in the social work journals, 1985-1992. Soc Work Health Care 1994;19(3-4):145-72.

> Minkoff H, Moreno JD, Powderly KR. Fetal protection and women's access to clinical trials. J Women Health 1992 Summer;1(2):137-40.

> Mitchell JL, Tucker J, Loftman PO, Williams SB. HIV and women: current controversies and clinical relevance. J Women Health 1992 Spring;1(1):35-9.

> Mohanna K. Informed consent. Research in pregnancy brings special considerations [letter]. BMJ 1997 Jul 26;315(7102):249-50. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Moore DL, Bernard S. The impact of managed care on women's health research: innovation versus renovation. J Am Med Womens Assoc 1997 Spring;52(2):83-4.

> Morrell MJ. Issues for women in antiepileptic drug development. Adv Neurol 1998 1998;76:149-59.

> Morrell MJ. Maximizing the health of women with epilepsy: science and ethics in new drug development. Epilepsia 1997;38 Suppl 4:S32-41.

> Morrell MJ. The new antiepileptic drugs and women: efficacy, reproductive health, pregnancy, and fetal outcome. Epilepsia 1996;37 Suppl 6:S34-44.

> Mudur G. Indian study of women with cervical lesions called unethical [news]. BMJ 1997 Apr 12;314(7087):1065.

> Murphy D. Women in clinical trials: HIV-infected women. Food Drug Law J 1993;48(2):175-9.

> Neill KM, Chessa F. Recruitment and retention of women in nontherapeutic clinical trials. Appl Nurs Res 1998 Aug;11(3):148-51.

> Ness RB, Kuller LH. Women's health as a paradigm for understanding factors that mediate disease. J Womens Health 1997 Jun;6(3):329-36.

> New FDA policy encourages inclusion of women in clinical trials [news]. Clin Pharm 1993 Oct;12(10):712-3.

> NIEHS to play unique role in women's health research effort [news]. Environ Health Perspect 1993 Jun;101(2):112.

> Nightingale SL, US Food and Drug Administration. FDA guideline on women in clinical trials. JAMA 1993 Sep 15;270(11):1290.

> Nunnelee JD. The inclusion of women in clinical trials of antihypertensive medications: a review of twenty-four trials in one pharmacology journal. J Vasc Nurs 1995 Jun;13(2):41-9.

> Palca J. NIH unveils plan for women's health project [news]. Science 1991 Nov 8;254(5033):792.

> Palca J. Women left out at NIH [news]. Science 1990 Jun 29;248(4963):1601-2.

> Parkinson C, Thomas KE, Lumley CE. Reproductive toxicity testing of pharmaceutical compounds to support the inclusion of women in clinical trials. Hum Exp Toxicol 1997 May;16(5):239-46.

> Patterson WB, Emanuel EJ. The eligibility of women for clinical research trials [case presentation and discussion]. J Clin Oncol 1995 Jan;13(1):293-9.

> Pfafflin SM. Future directions for women's health. Ann N Y Acad Sci 1994 Dec 30;736:217-22

> Pinch WJ. Women and research. News Views 1995 Spring:5-7

> Pinn VW. Commentary: women, research, and the National Institutes of Health. Am J Prev Med 1992 Sep-Oct;8(5):324-7. Published erratum appears in Am J Prev Med 1992 Nov-Dec;8(6):399.

> Pinn VW. Equity in biomedical research [editorial]. Science 1995 Aug 11;269(5225):739.

> Pinn VW. The NIH agenda for women's health [editorial]. J Natl Med Assoc 1993 Jul;85(7):511-5.

> Pinn VW. The NIH Office of Research on Women's Health: goals and recent activities. J Am Med Womens Assoc 1998 Winter;53(1):35-7.

> Pinn VW. The role of the NIH's Office of Research on Women's Health. Acad Med 1994 Sep;69(9):698-702.

> Pinn VW. Women's health research: prescribing change and addressing the issues [editorial]. JAMA 1992 Oct 14;268(14):1921-2.

> Pinn VW, Chunko MT, Cooper Z. Setting the research agenda for the 21st century. J Womens Health 1997 Oct;6(5):517-20.

> Prentice R, Henderson M, Furberg C, Kuller L. Women's health and diet [letter]. Nature 1994 Feb 3;367(6462):404. Comment on: Nature 1993 Nov 4;366(6450):11.

> Pronsati MP. Women's health is no fad [editorial]. Adv Nurse Pract 1997 Nov;5(11):8.

> Raloff J. Tamoxifen turmoil: new issues emerge as healthy women volunteer to take a potent drug [news]. Sci News 1994 Oct 31;146(17):268-9.

> Rathgeber EM, Vlassoff C. Gender and tropical diseases: a new research focus. Soc Sci Med 1993 Aug;37(4):513-20.

> Rechner S. Research about women's health. An outrageous act or an everyday rebellion? [editorial]. Can Fam Physician 1994 May;40:859-61, 867-9. Comment on: Can Fam Physician 1994 May;40:900-5. Comment in: Can Fam Physician 1994 Sep;40:1509, 1511-2.

> Repper J, Perkins R, Owen S, Deighton D, Robinson J. Evaluating services for women with serious and ongoing mental health problems: developing an appropriate research method. J Psychiatr Ment Health Nurs 1996;3(1):39-46.

> Roberts J. Hospital accused of experiments on pregnant women [news]. BMJ 1994 Jan 29;308(6924):291-2.

> Rodges J. Clinical trials for diet and hypolipidemic therapy have generally included few female subjects [letter]. Crit Care Nurse 1997 Oct;17(5):18. Comment on: Crit Care Nurse 1997 Apr;17(2):45-53.

> Rosser SV. AIDS and women. AIDS Educ Prev 1991 Fall;3(3):230-40.

> Rothenberg KH. The Institute of Medicine's report on women and health research: implications for IRBs and the research community. IRB Rev Hum Subj Res 1996;18(2):1-3.

> Rothenberg KH, Hayunga EG, Rudick JE, Pinn VW. The NIH inclusion guidelines: challenges for the future. IRB Rev Hum Subj Res 1996;18(3):1-4, 12.

> Ruiz MT, Verbrugge LM. A two way view of gender bias in medicine [editorial]. J Epidemiol Community Health 1997 Apr;51(2):106-9.

> Runowicz CD, Berman ML. Access to cancer care and clinical trials: a time for reappraisal [editorial]. Womens Health Issues 1996 Mar-Apr;6(2):112-3.

> Sandomire H. Women in clinical trials: are sponsors liable for fetal injury? J Law Med Ethics 1993 Summer;21(2):217-30.

> Schmucker DL, O'Mahony MS, Vesell ES. Women in clinical drug trials. An update. Clin Pharmacokinet 1994 Dec;27(6):411-7.

> Schmucker DL, Vesell ES. Underrepresentation of women in clinical drug trials. Clin Pharmacol Ther 1993 Jul;54(1):11-5.

> Schoepf BG. AIDS action-research with women in Kinshasa, Zaire. Soc Sci Med 1993 Dec;37(11):1401-13.

> Sherman LA, Temple R, Merkatz RB. Women in clinical trials: an FDA perspective. Science 1995 Aug 11;269(5225):793-5.

> Sherman SS. Gender, health, and responsible research. Clin Geriatr Med 1993 Feb;9(1):261-9.

> Sherwin S. Women in clinical studies: a feminist view. Camb Q Healthc Ethics 1994 Fall;3(4):533-8.

> Shuster E. For her own good: protecting (and neglecting) women in research. Camb Q Healthc Ethics 1996 Summer;5(3):346-61.

> Skolnick AA. At third meeting, menopause experts make the most of insufficient data [news]. JAMA 1992 Nov 11;268(18):2483-5.

> Stauning I. Women, health, and technology. Health Care Women Int 1993 Jul-Aug;14(4):355-63.

> Steimle S. Women still face many hurdles to clinical trial participation [news]. J Natl Cancer Inst 1997 Apr 16;89(8):545-6.

> Steingart RM, Forman S, Coglianese M, Bittner V, Mueller H, Frishman W, Handberg E, Gambino A, Knatterud G , Conti CR. Factors limiting the enrollment of women in a randomized coronary artery disease trial. The Asymptomatic Cardiac Ischemia Pilot Study (ACIP) Investigators. Clin Cardiol 1996 Aug;19(8):614-8.

> Stotland NL. If a little knowledge is a dangerous thing, what about a lot of knowledge: what have we learned from Pandora? [editorial]. Womens Health Issues 1997 Jul-Aug;7(4):201-3.

> Stuber J. Women and HIV: a new agenda [news]. Hastings Cent Rep 1995 May-Jun;25(3):51-2.

> Sutherland HJ, Carlin K, Harper W, Martin LJ, Greenberg CV, Till JE, Boyd NF. A study of diet and breast cancer prevention in Canada: why healthy women participate in controlled trials. Cancer Causes Control 1993 Nov;4(6):521-8.

> Taylor C. Gender equity in research. J Women Health 1994 Jun;3(3):143-53.

> Thornton H. A ladyplan for trial recruitment? -- everyone's business. Lancet 1993 Mar 27;341(8848):795-6. Comment Lancet 1993 Mar 27;314(8848);812-3.

> UBINIG. Research report: Norplant, the five year needle -- an investigation of the Norplant trial in Bangladesh from the user's perspective. Issues Reprod Genet Eng J Int Feminist Anal 1990;3(3):211-28.

> Varricchio CG. Issues to consider when planning cancer control interventions for women. Womens Health Issues 1995 Summer;5(2):64-72.

> Vlassoff C. Gender inequalities in health in the Third World: uncharted ground. Soc Sci Med 1994 Nov;39(9):1249-59.

> Ward JE, Proude EM, Osborn M. Women's views of consent procedures for a cervical cytology register [letter]. Med J Aust 1995 Apr 17;162(8):443. Comment in: Med J Aust 1995 Aug 21;163(4):222.

> Watson T. FDA wants to invite women into drug trials earlier [news]. Nature 1992 Nov 26;360(6402):289.

> Wenger NK. Cardiovascular drugs: the urgent need for studies in women. J Am Med Womens Assoc 1991 Jul-Aug;46(4):117-20.

> Wenger NK. Exclusion of the elderly and women from coronary trials. Is their quality of care compromised? [editorial]. JAMA 1992 Sep 16;268(11):1460-1. Comment on: JAMA 1992 Sep 16;268(11):1417-22.

> Wentz AC. Women's health issues. Adv Intern Med 1995;40:1-30.

> Wermeling DP, Selwitz AS. Current issues surrounding women and minorities in drug trials. Ann Pharmacother 1993 Jul-Aug;27(7-8):904-11. Comment in: Ann Pharmacother 1993 Jul-Aug;27(7-8):972-3.

> Women as research subjects. American College of Clinical Pharmacy. Pharmacotherapy 1993 Sep-Oct;13(5):534-42.

> Women promoting women's health. J Am Med Womens Assoc 1993 Jan-Feb;48(1):12-3, 18.

> Women's health research at NIEHS [news]. Environ Health Perspect 1993 Jun;101(2):110.

> Woods NF. The United States women's health research agenda analysis and critique. West J Nurs Res 1994 Oct;16(5):467-79.

> Wysocki S. Women's health care: equality for the 90s. Nurse Pract Forum 1991 Mar;2(1):8-10.

> Yi JK. Are Asian/Pacific Islander American women represented in women's health research? [letter]. Womens Health Issues 1996 Jul-Aug;6(4):237-8.

> Yonkers KA, Harrison W. The inclusion of women in psychopharmacologic trials [editorial]. J Clin Psychopharmacol 1993 Dec;13(6):380-2. Comment in: J Clin Psychopharmacol 1994 Aug;14(4):288.

> Zahm SH, Pottern LM, Lewis DR, Ward MH, White DW. Inclusion of women and minorities in occupational cancer epidemiologic research. J Occup Med 1994 Aug;36(8):842-7.

> Zinn C. Australia launches major study of women's health [news]. BMJ 1995 Apr 22;310(6986):1026.

> Return to table of contents

> ## Special or vulnerable populations - Women - Books

> Beauregard L, Haseltine F, Jacobson BG. Women's health research: a medical and policy primer. 1st ed. Washington: Health Press International; c1997. 364 p.

> Clinical research and products liability issues: use of women of childbearing potential in drug trials. Meeting, 1995 Oct 30, New York City. Albany: New York State Bar Association; 1995. 122 p.

> Comprehensive report of the Office of Research on Women's Health: fiscal year 1991-1992. Bethesda (MD): National Institutes of Health, Office of the Director; 1993? 127 p. (NIH publication; no.93-3455).

> Implementation of the NIH guidelines on the inclusion of women and minorities as subjects in clinical research, FY 1995-1996: advisory council reports certifying compliance. Bethesda (MD): National Institutes of Health, Office of Research on Women's Health, NIH Tracking/Inclusion Committee; 1997.

> Institute of Medicine, Board on Health Sciences Policy. Inclusion of women in clinical trials: policies for population subgroups. Washington: National Academy Press; 1993. 11 p.

> Komesaroff PA. Troubled bodies: critical perspectives on postmodernism, medical ethics, and the body. Durham: Duke University Press; 1995. 241 p.

> Laurence L, Weinhouse B. Outrageous practices: the alarming truth about how medicine mistreats women. New York: Fawcett Columbine; 1994. 434 p.

> Mastroianni AC, Faden R, Federman D. Women and health research: ethical and legal issues of including women in clinical studies. Vol. 2, Workshop and commissioned papers. Washington: National Academy Press; 1994. 247 p.

> Mastroianni AC, Faden R, Federman D. Women and health research: ethical and legal issues of including women in clinical studies. Vol. 1. Washington: National Academy Press; 1994. 271 p.

> Moss KL. Man-made medicine: women's health, public policy, and reform. Durham (NC): Duke University Press; 1996. 288 p.

> National Institutes of Health, NIH Advisory Committee on Women's Health Issues. NIH support for research on women's and men's health issues. Bethesda (MD): National Institutes of Health; 1991-.

> Nechas E, Foley D. Unequal teatment: what you don't know about how women are mistreated by the medical community. New York: Simon and Schuster; 1994. 272 p.

> Outreach notebook for the NIH guidelines on inclusion of women and minorities as subjects in clinical research. Bethesda (MD): National Institutes of Health, 1994. 37 p.

> Ragavan VV. Drug development for women. New York: J. Wiley; 1998. 480 p.

> Recruitment and Retention of Women in Clinical Studies. Bethesda (MD): National Institutes of Health, Office of the Director, Office of Research on Women's Health; 1994. 104 p. (NIH publication; no. 95-3756).

> Research to improve women's health: an agenda for equity: a preliminary report, presented to Ruth Kirschstein, Acting Deputy Director, Office of Research on Women's Health, National Institutes of Health. [Washington?]: National Women's Health Network; 1990. 18 p.

> Rosser SV. Women's health-- missing from U.S. medicine. Bloomington: Indiana University Press; c1994. 213 p. (Race, gender, and science).

> Sechzer JA, Griffin A, Pfafflin SM. Forging a women's health research agenda: policy issues for the 1990s. New York: New York Academy of Sciences; 1994. 223 p.

> Smith JM. Women and doctors: a physician's explosive account of women's medical treatment -- and mistreatment -- in America today and what you can do about it. New York: Atlantic Monthly Press; 1992. 241 p.

> Treichler PA, Cartwright L, Penley C, editors. The visible woman: imaging technologies, gender, and science. New York: New York University Press; 1998. 400 p.

> Wolf SM. Feminism and bioethics: beyond reproduction. New York: Oxford University Press; 1996. 398 p.

> Women Health Care Consumers: Short-Changed on Medical Research and Treatment: Hearing Before the Subcomm. on Housing and Consumer Interests of the Select Committee on Aging, 101st Cong., 2nd Sess. (1990 July 24). Washington: U.S. Government Printing Office; 1991. 174 p.

> Return to table of contents

> ## Special or vulnerable populations - Minorities and cross-cultural issues - Journal Articles

> Adebimpe VR. Race, racism, and epidemiological surveys. Hosp Community Psychiatry 1994 Jan;45(1):27-31.

> Agosti V, Nunes E, Ocepeck-Welikson K. Patient factors related to early attrition from an outpatient cocaine research clinic. Am J Drug Alcohol Abuse 1996 Feb;22(1):29-39.

> Allen M. The dilemma for women of color in clinical trials. J Am Med Womens Assoc 1994 Jul-Aug;49(4):105-9.

> Alvidrez J, Azocar F, Miranda J. Demystifying the concept of ethnicity for psychotherapy researchers. J Consult Clin Psychol 1996 Oct;64(5):903-8.

> Anderson MR, Moscou S. Race and ethnicity in research on infant mortality. Fam Med 1998 Mar;30(3):224-7.

> Andrews MM, Krouse SA. Research on excess deaths among American Indians and Alaska Natives: a critical review. J Cult Divers 1995 Winter;2(1):8-15.

> Arean PA, Gallagher-Thompson D. Issues and recommendations for the recruitment and retention of older ethnic minority adults into clinical research. J Consult Clin Psychol 1996 Oct;64(5):875-80.

> Azuonye IO. Describing race, ethnicity, and culture in medical research. Guidelines will encourage the thinking that underpins racism in medicine [letter]. BMJ 1996 Aug 17;313(7054):426. Comment on: BMJ 1996 Apr 27;312(7038):1054; BMJ 1996 Apr 27;312(7038):1094.

> Bagley C. A plea for ignoring race and including insured status in American research reports on social science and medicine [editorial]. Soc Sci Med 1995 Apr;40(8):1017-9.

> Ballard EL, Nash F, Raiford K, Harrell LE. Recruitment of black elderly for clinical research studies of dementia: the CERAD experience. Gerontologist 1993 Aug;33(4):561-5.

> Barry M, Molyneux M. Ethical dilemmas in malaria drug and vaccine trials: a bioethical perspective. J Med Ethics 1992 Dec;18(4):189-92.

> Bauer BA. Race and ethnicity: a compelling research agenda [letter]. Ann Intern Med 1997 Feb 1;126(3):252. Comment on: Ann Intern Med 1996 Aug 1;125(3):237-9.

> Bauman LJ, Adair EG. The use of ethnographic interviewing to inform questionnaire construction. Health Educ Q 1992 Spring;19(1):9-23.

> Bayer R. The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and the Caribbean: racist exploitation or exploitation of racism? Am J Public Health 1998 Apr;88(4):567-70.

> Beatty LA. Issues in drug abuse prevention intervention research with African Americans. NIDA Res Monogr 1994;139:171-201.

> Bedolla MA. The principles of medical ethics and their application to Mexican-American elderly patients. Clin Geriatr Med 1995 Feb;11(1):131-7.

> Bell CC. Race as a variable in research: being specific and fair [editorial]. Hosp Community Psychiatry 1994 Jan;45(1):5. Comment in: Hosp Community Psychiatry 1994 May;45(5):498-9; Psychiatr Serv 1995 Jul;46(7):731.

> Bennett T, Bhopal R. US health journal editors' opinions and policies on research in race, ethnicity, and health. J Natl Med Assoc 1998 Jul;90(7):401-8.

> Bhopal R. Is research into ethnicity and health racist, unsound, or important science? BMJ 1997 Jun 14;314(7096):1751-6. Comment in: BMJ 1997 Jun 14;314(7096):1703-4; BMJ 1997 Nov 15;315(7118):1309.

> Bhopal R, Donaldson L. White, European, Western, Caucasian, or what? Inappropriate labeling in research on race, ethnicity, and health. Am J Public Health 1998 Sep;88(9):1303-7. Comment in: Am J Public Health 1998 Sep;88(9):1297-8.

> Bhopal R, Kohli H, Rankin J. Editors' practice and views on terminology in ethnicity and health research. Ethn Health 1997 Aug;2(3):223-7.

> Bhopal RS, Phillimore P, Kohli HS. Inappropriate use of the term 'Asian': an obstacle to ethnicity and health research. J Public Health Med 1991 Nov;13(4):244-6.

> Biggins DR. Ethics of health research [letter]. Aust J Public Health 1992 Mar;16(1):107-8.

> Bleyer WA. Re: recruiting minorities into clinical trials: toward a participant-friendly system [letter]. J Natl Cancer Inst 1996 Mar 20;88(6):377. Comment on: J Natl Cancer Inst 1995 Dec 6;87(23):1747-59.

> Bleyer WA, Tejeda HA, Murphy SB, Brawley OW, Smith MA, Ungerleider RS. Equal participation of minority patients in U.S. national pediatric cancer clinical trials. J Pediatr Hematol Oncol 1997 Sep-Oct;19(5):423-7.

> Blumenthal DS, Sung J, Coates R, Williams J, Liff J. Recruitment and retention of subjects for a longitudinal cancer prevention study in an inner-city black community. Health Serv Res 1995 Apr;30(1 Pt 2):197-205.

> Bonner GJ, Miles TP. Participation of African Americans in clinical research. Neuroepidemiology 1997;16(6):281-4.

> Brawley OW, Tejeda H. Minority inclusion in clinical trials issues and potential strategies. J Natl Cancer Inst Monogr 1995;(17):55-7.

> Brown LS Jr. Enrollment of drug abusers in HIV clinical trials: a public health imperative for communities of color. J Psychoact Drugs 1993 Jan-Mar;25(1):45-52.

> Burish TG. Behavioral and psychosocial cancer research. Building on the past, preparing for the future. Cancer 1991 Feb 1;67 Suppl 3:865-7.

> Butler D. Genetic diversity proposal fails to impress international ethics panel [news]. Nature 1995 Oct 5;377(6548):373. Comment in: Nature 1996 Jan 4;379(6560):11.

> Byman B. Out from the shadow of Tuskegee. Fighting racism in medicine. Minn Med 1991 Aug;74(8):15-20.

> Caban CE. Hispanic research: implications of the National Institutes of Health guidelines on inclusion of women and minorities in clinical research. J Natl Cancer Inst Monogr 1995;(18):165-9.

> Campbell A. Ethics in a bicultural context -- a report from New Zealand. Bioethics 1995 Apr;9(2):149-54.

> Cancer research in Hispanic populations in the United States. J Natl Cancer Inst Monogr 1995;(18):1-169.

> Cassidy CM. Walk a mile in my shoes: culturally sensitive food-habit research. Am J Clin Nutr 1994 Jan;59(1 Suppl):190S-197S.

> Castaneda DM. A research agenda for Mexican-American adolescent mental health. Adolescence 1994 Spring;29(113):225-39.

> Castro FG, Harmon MP, Coe K, Tafoya-Barraza HM. Drug prevention research with Hispanic populations: theoretical and methodological issues and a generic structural model. NIDA Res Monogr 1994;139:203-33.

> Chavez EL, Oetting ER. A critical incident model for considering issues in cross-cultural research. Failures in cultural sensitivity. Int J Addict 1995 May;30(7):863-74.

> Cheung YW. Ethnicity and alcohol/drug use revisited: a framework for future research. Int J Addict 1990-91;25(5A-6A):581-605.

> Chiodo GT, Tolle SW. Informed consent across cultures. Gen Dent 1997 Sep-Oct;45(5):421-4.

> Christakis NA. Ethics are local: engaging cross-cultural variation in the ethics for clinical research. Soc Sci Med 1992 Nov;35(9):1079-91.

> Coghlan A. Gene treaty promises rewards for unique peoples [news]. New Sci 1996 Nov 2;152(2054):8.

> Cohen GD. African American issues in geriatric psychiatry: a perspective on research opportunities. J Geriatr Psychiatry Neurol 1993 Oct-Dec;6(4):195-9.

> Coleman EA, Tyll L, LaCroix AZ, Allen C, Leveille SG, Wallace JI, Buchner DM, Grothaus LC, Wagner EH. Recruiting African-American older adults for a community-based health promotion intervention: which strategies are effective? Am J Prev Med 1997 Nov-Dec;13(6 Suppl):51-6.

> Coreil J, Losikoff P, Pincu R, Mayard G, Ruff AJ, Hausler HP, Desormeau J, Davis H, Boulos R, Halsey NA. Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. AIDS Educ Prev 1998 Feb;10(1):46-62.

> Crews DE, Bindon JR. Ethnicity as a taxonomic tool in biomedical and biosocial research. Ethn Dis 1991 Winter;1(1):42-9.

> De Bono D. Describing race, ethnicity, and culture in medical research. White populations also need to be accurately described [letter]. BMJ 1996 Aug 17;313(7054):425; discussion 426. Comment on: BMJ 1996 Apr 27;312(7038):1054.

> Delgado JL, Johnson CL, Roy I, Trevino FM. Hispanic Health and Nutrition Examination Survey: methodological considerations. Am J Public Health 1990 Dec;Suppl 80:6-10.

> Des Jarlais DC, Stepherson B. History, ethics, and politics in AIDS prevention research [editorial]. Am J Public Health 1991 Nov;81(11):1393-4. Comment on: Am J Public Health 1991 Nov;81(11):1498-505; Am J Public Health 1991 Nov;81(11):1506-17.

> Donovan RJ, Spark R. Towards guidelines for survey research in remote Aboriginal communities. Aust N Z J Public Health 1997 Feb;21(1):89-95. Comment in: Aust N Z J Public Health 1997 Feb;21(1):96-7.

> Dula A. African American suspicion of the healthcare system is justified: what do we do about it? Camb Q Healthc Ethics 1994 Summer;3(3):347-57.

> Edgar H. Twenty years after. The legacy of the Tuskegee Syphilis Study. Outside the community. Hastings Cent Rep 1992 Nov-Dec;22(6):32-5.

> Edwards NC. Important considerations in the use of ethnicity as a study variable. Can J Public Health 1992 Jan-Feb;83(1):31-3.

> el-Sadr W, Capps L. The challenge of minority recruitment in clinical trials for AIDS. JAMA 1992 Feb 19;267(7):954-7.

> Ellison GT, de Wet T, IJsselmuiden CB, Richter LM. Desegregating health statistics and health research in South Africa. S Afr Med J 1996 Oct;86(10):1257-62. Comment in: S Afr Med J 1996 Dec;86(12):1559; S Afr Med J 1997 Mar;87(3):329-31.

> Ethnicity, race and culture guidelines for research audit and publication. BMJ 1996 Apr 27;312(7038):1094. Comment in: BMJ 1996 Apr 27;312(7038):1054; BMJ 1996 Aug 17;313(7054):425-6; BMJ 1996 Aug 17;313(7054):426; discussion 426; BMJ 1996 Aug 17;313(7054):426.

> Feinleib M, Hancoff LD, Phillips M, Osborne NG, Feit MD. The use of race in medical research [letters and response]. JAMA 1992 Jun 17;267(23):3150-1.

> Fernando S. Racial stereotypes [letter]. Br J Psychiatry 1991 Feb;158:289-90. Comment on: Br J Psychiatry 1990 Sep;157:410-5.

> Francis CK. Research in coronary heart disease in blacks: issues and challenges. J Health Care Poor Underserved 1997 Aug;8(3):250-69.

> Freeman HP. The impact of clinical trial protocols on patient care systems in a large city hospital. Access for the socially disadvantaged. Cancer 1993 Nov 1;72(9 Suppl):2834-8.

> Freeman HP. The meaning of race in science--considerations for cancer research: concerns of special populations in the National Cancer Program. Cancer 1998 Jan 1;82(1):219-25.

> Fulwood R. Setting the agenda for research and education on coronary heart disease. J Health Care Poor Underserved 1997 Aug;8(3):247-9.

> Gamble VN. A legacy of distrust: African Americans and medical research. Am J Prev Med 1993 Nov-Dec;9(6 Suppl):35-8.

> Gamble VN. The Tuskegee Syphilis Study and women's health. J Am Med Womens Assoc 1997 Fall;52(4):195-6.

> Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health 1997 Nov;87(11):1773-8. Comment in: Am J Public Health 1997 Nov;87(11):1765-6.

> Gavaghan H. Clinical trials face lack of minority group volunteers [news]. Nature 1995 Jan 19;373(6511):178.

> Geis SB, Fuller RL. Inadvertent discrimination in medical research. J Relig Health 1990 Fall;29(3):207-17.

> Gibson RC. The age-by-race gap in health and mortality in the older population: a social science research agenda. Gerontologist 1994 Aug;34(4):454-62.

> Gore SM. Inclusion of women and minorities in clinical trials. Control Clin Trials 1995 Oct;16(5):290-2.

> Gorelick PB, Harris Y, Burnett B, Bonecutter FJ. The recruitment triangle: reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial. An interim report from the African-American Antiplatelet Stroke Prevention Study (AAASPS). J Natl Med Assoc 1998 Mar;90(3):141-5.

> Gorelick PB, Richardson D, Hudson E, Perry C, Robinson D, Brown N, Harris Y. Establishing a community network for recruitment of African Americans into a clinical trial. The African-American antiplatelet stroke Prevention Study (AAASPS) experience [editorial]. J Natl Med Assoc 1996 Nov;88(11):701-4.

> Grunbaum JA, Labarthe DR, Ayars C, Harrist R, Nichaman MZ. Recruitment and enrollment for Project HeartBeat. Achieving the goals of minority inclusion. Ethn Dis 1996 Autumn;6(3-4):203-12.

> Guralnik JM, Leveille SG. Race, ethnicity, and health outcomes--unraveling the mediating role of socioeconomic status. Am J Public Health 1997 May;87(5):728-30. Comment on: Am J Public Health 1997 May;87(5):805-10.

> Hardy K. Clinical trials need more ethnic balance [news]. J Natl Cancer Inst 1997 May 21;89(10):686.

> Harris Y, Gorelick PB, Samuels P, Bempong I. Why African Americans may not be participating in clinical trials. J Natl Med Assoc 1996 Oct;88(10):630-4.

> Haynes MA, Bernard LJ. Drew/Meharry/Morehouse Consortium Cancer Center: an approach to targeted research in minority institutions. J Natl Med Assoc 1992 Jun;84(6):505-11.

> Hohmann AA, Parron DL. How the new NIH Guidelines on Inclusion of Women and Minorities apply: efficacy trials, effectiveness trials, and validity. J Consult Clin Psychol 1996 Oct;64(5):851-5.

> Holder B, Turner-Musa J, Kimmel PL, Alleyne S, Kobrin S, Simmens S, Cruz I, Reiss D. Engagement of African American families in research on chronic illness: a multisystem recruitment approach. Fam Process 1998 Summer;37(2):127-51.

> Houston S, Legge D. Aboriginal health research and the National Aboriginal Health Strategy [editorial]. Aust J Public Health 1992 Jun;16(2):114-5.

> Hughes AO, Fenton S, Hine CE, Pilgrim S, Tibbs N. Strategies for sampling black and ethnic minority populations. J Public Health Med 1995 Jun;17(2):187-92. Published erratum appears in J Public Health Med 1995 Sep;17(3):375.

> Huttlinger K, Drevdahl D. Increasing minority participation in biomedical and nursing research. J Prof Nurs 1994 Jan-Feb;10(1):13-21.

> Jones JH. The Tuskegee legacy. AIDS and the black community. Hastings Cent Rep 1992 Nov-Dec;22(6):38-40.

> Kaluzny A, Brawley O, Garson-Angert D, Shaw J, Godley P, Warnecke R, Ford L. Assuring access to state-of-the-art care for U.S. minority populations: the first 2 years of the Minority-Based Community Clinical Oncology Program. J Natl Cancer Inst 1993 Dec 1;85(23):1945-50.

> Kaufert JM, O'Neil JD, Koolage WW. The cultural and political context of informed consent for Native Canadians. Arctic Med Res 1991;Suppl:181-4.

> King PA. The dangers of difference. [The legacy of the Tuskegee Syphilis Study]. Hastings Cent Rep 1992 Nov-Dec;22(6):35-8.

> Kitler ME. Clinical trials and transethnic pharmacology. Drug Saf 1994 Nov;11(5):378-91.

> Krieger N, Sidney S, Coakley E. Racial discrimination and skin color in the CARDIA study: implications for public health research. Coronary Artery Risk Development in Young Adults. Am J Public Health 1998 Sep;88(9):1308-13.

> Kristal AR, Feng Z, Coates RJ, Oberman A, George V. Associations of race/ethnicity, education, and dietary intervention with the validity and reliability of a food frequency questionnaire: the Women's Health Trial Feasibility Study in Minority Populations. Am J Epidemiol 1997 Nov 15;146(10):856-69.

> Kuramoto FH. Drug abuse prevention research concerns in Asian and Pacific Islander populations. NIDA Res Monogr 1994;139:249-72.

> Lakhani ZM. Racism, sexism and trials. Ann R Coll Physicians Surg Can 1990 Dec;23(7):509-10.

> Landrine H, Klonoff EA. Conclusions: the future of research on black women's health. Womens Health 1997 Fall-Winter;3(3-4):367-81.

> Lehrman S. Coalition to pursue ethnic concerns over gene research [news]. Nature 1998 Apr 2;392(6675):428. Comment in: Nature 1998 Jun 18;393(6686):618.

> Lenfant C. Enhancing minority participation in research. The NHLBI experience [news]. Circulation 1995 Aug 1;92(3):279-80.

> Lewis MA, Rachelefsky G, Lewis CE, Leake B, Richards W. The termination of a randomized clinical trial for poor Hispanic children. Arch Pediatr Adolesc Med 1994 Apr;148(4):364-7.

> Lin KM. Ethical aspects of psychopharmacological studies in different ethnic groups. Clin Neuropharmacol 1992 1992;15 (Suppl 1 Pt A):483A-484A.

> Macaulay AC. Ethics of research in Native communities [editorial]. Can Fam Physician 1994 Nov;40:1888-90, 1894-7.

> Maddocks I. Ethics in aboriginal research. A model for minorities or for all? Med J Aust 1992 Oct 19;157(8):553-5. Comment in: Med J Aust 1993 Apr 5;158(7):508.

> Marin G, Amaro H, Eisenberg C, Opava-Stitzer S. The development of a relevant and comprehensive research agenda to improve Hispanic health. Public Health Rep 1993 Sep-Oct;108(5):546-50.

> Marshall SL, While AE. Interviewing respondents who have English as a second language: challenges encountered and suggestions for other researchers. J Adv Nurs 1994 Mar;19(3):566-71.

> Mathews J, Currie B. Ethics in aboriginal research [letter]. Med J Aust 1993 Apr 5;158(7):508. Comment on: Med J Aust 1992 Oct 19;157(8):553-5.

> Mathews J, Currie B, Maddocks I. Ethics in Aboriginal research [letter and response]. Med J Aust 1993 Apr 5;158(7):508.

> McAuley J, De Souza L, Sharma V, Robinson I, Main CJ, Frank AO. Describing race, ethnicity, and culture in medical research. Self defined ethnicity is unhelpful [letter]. BMJ 1996 Aug 17;313(7054):425-6. Comment on: BMJ 1996 Apr 27;312(7038):1054; BMJ 1996 Apr 27;312(7038):1094.

> McGinnis JM, Ballard-Barbash RM. Obesity in minority populations: policy implications of research. Am J Clin Nutr 1991 Jun;53(6 Suppl):1512S-1514S.

> McGraw SA, McKinlay JB, Crawford SA, Costa LA, Cohen DL. Health survey methods with minority populations: some lessons from recent experience. Ethn Dis 1992 Summer;2(3):273-87.

> McKenzie K, Crowcroft NS. Describing race, ethnicity, and culture in medical research [editorial]. BMJ 1996 Apr 27;312(7038):1054. Comment on: BMJ 1996 Apr 27;312(7038):1080-2; BMJ 1996 Apr 27;312(7038):1094. Comment in: BMJ 1996 Aug 17;313(7054):425; discussion 426; BMJ 1996 Aug 17;313(7054):425-6; BMJ 1996 Aug 17;313(7054):426; discussion 426; BMJ 1996 Aug 17;313(7054):426.

> McLaughlin LA, Braun KL. Asian and Pacific Islander cultural values: considerations for health care decision making. Health Soc Work 1998 May;23(2):116-26.

> McMasters A. Research from an aboriginal health worker's point of view. Aust N Z J Public Health 1996 Jun;20(3):319-20. Comment in: Aust N Z J Public Health 1996 Jun;20(3):227-9.

> Mhlongo SW, Mdingi GV. Informed consent. Informed consent is light years away for black African patients [letter]. BMJ 1997 Jul 26;315(7102):252. Comment on: BMJ 1997 Apr 12;314(7087):1077-81; discussion 1081-4.

> Miller P, Rainow S. Commentary: don't forget the plumber: research in remote Aboriginal communities. Aust N Z J Public Health 1997 Feb;21(1):96-7. Comment on: Aust N Z J Public Health 1997 Feb;21(1):89-95.

> Millon-Underwood S, Sanders E, Davis M. Determinants of participation in state-of-the-art cancer prevention, early detection/screening, and treatment trials among African-Americans. Cancer Nurs 1993 Feb;16(1):25-33.

> Minority health research [news]. Environ Health Perspect 1993 Jun;101(2):112-3.

> Modan B, Kovar MG, Weeks JA. Health policy for the aged. We don't study the right people. Aging (Milano) 1998 Feb;10(1):1-4.

> Modiano MR, Villar-Werstler P, Meister J, Figueroa-Valles N. Cancer in Hispanics: issues of concern. J Natl Cancer Inst Monogr 1995;(18):35-9.

> Mohiuddin SM, Hilleman DE. Gender and racial bias in clinical pharmacology trials [editorial]. Ann Pharmacother 1993 Jul-Aug;27(7-8):972-3. Comment on: Ann Pharmacother 1993 Jul-Aug;27(7-8):904-11.

> Moody LE, Gregory SJ, Bocanegra T, Vasey F. Factors influencing post-menopausal African-American women's participation in a clinical trial. J Am Acad Nurse Pract 1995 Oct;7(10):483-8.

> Morris RD, Munasinghe RL. Aggregation of existing geographic regions to diminish spurious variability of disease rates. Stat Med 1993 Oct;12(19-20):1915-29.

> Mosby JA. Relevance of race or ethnic group in case reports [letter]. Am Fam Physician 1996 Apr;53(5):1530.

> Moulton LH, Wolff MC, Brenneman G, Santosham M. Case-cohort analysis of case-coverage studies of vaccine effectiveness. Am J Epidemiol 1995 Nov 1;142(9):1000-6.

> Mouton CP, Harris S, Rovi S, Solorzano P, Johnson MS. Barriers to black women's participation in cancer clinical trials. J Natl Med Assoc 1997 Nov;89(11):721-7.

> Nacif de Brey V, Gonzalez VM. Recruiting for arthritis studies in hard-to-reach populations: a comparison of methods used in an urban Spanish-speaking community. Arthritis Care Res 1997 Feb;10(1):64-71.

> Naranjo LE, Dirksen SR. The recruitment and participation of Hispanic women in nursing research: a learning process. Public Health Nurs 1998 Feb;15(1):25-9.

> Nelson C. Cancer screening, clinical trials for African Americans still problematic [news]. J Natl Cancer Inst 1994 Dec 7;86(23):1753-4.

> Ness RB, Nelson DB, Kumanyika SK, Grisso JA. Evaluating minority recruitment into clinical studies: how good are the data? Ann Epidemiol 1997 Oct;7(7):472-8.

> Norton IM, Manson SM. Research in American Indian and Alaska Native communities: navigating the cultural universe of values and process. J Consult Clin Psychol 1996 Oct;64(5):856-60.

> Novick A. One small ethical issue arising in ethnographic research. AIDS Public Policy J 1996 Fall;11(3):115-7.

> Olivier S. Informed consent and transcultural research [editorial]. S Afr Med J 1995 Oct;85(10):984-5.

> Osborne NG, Feit Marvin D. The use of race in medical research. JAMA 1992 Jan 8;267(2):275-9.

> Padgett DK. Consideration of the ethnic factor in aging research--the time has never been better [editorial]. Gerontologist 1990 Dec;30(6):723-4.

> Paskett ED, DeGraffinreid C, Tatum CM, Margitic SE. The recruitment of African-Americans to cancer prevention and control studies. Prev Med 1996 Sep-Oct;25(5):547-53.

> Pavlik VN, Hyman DJ, Vallbona C, Dunn JK , Louis K, Dewey CM, Wieck L, Toronjo C. Response rates to random digit dialing for recruiting participants to an onsite health study. Public Health Rep 1996 Sep-Oct;111(5):444-50.

> Payne-Johnson JC. Communications and aging. A case for understanding African Americans who are elderly. ASHA 1992 Jan;34(1):41-4. Published erratum appears in ASHA 1992 Apr;34(4):15.

> Pettiway LE. Identifying, gaining access to, and collecting data on African-American drug addicts. NIDA Res Monogr 1993;130:258-79.

> Phillips JM. Research for improving the health and well-being of the black community: implications for shaping a research agenda. J Natl Black Nurses Assoc 1994 Fall-Winter;7(2):21-8.

> Pinn VW. The status of women's health research: where are African American women? J Natl Black Nurses Assoc 1996 Spring-Summer;8(1):8-19.

> Pollard RQ. Cross-cultural ethics in the conduct of deafness research. Rehabil Psychol 1992 Summer;37(2):87-101.

> Porter TL. The use of race in case presentations [letter]. Am J Psychiatry 1993 Jul;150(7):1129.

> Powless Sage G. Drug prevention research with Native-American populations: some considerations. NIDA Res Monogr 1994;139:235-48.

> Prince CS. Research on Indian reserves--an Indian perspective. Arctic Med Res 1991;Suppl:185-7.

> Raine CS. What's in a name? [letter]. Can J Neurol Sci 1995 Aug;22(3):247.

> Ramirez AG, McAlister A, Gallion KJ, Villarreal R. Targeting Hispanic populations: future research and prevention strategies. Environ Health Perspect 1995 Nov;103 Suppl 8:S287-90.

> Recruiting black men to a clinical trial to evaluate prostate cancer screening--Detroit Michigan 1998. MMWR Morb Mortal Wkly Rep 1998 Aug 28;47(33):694-6.

> Reynolds T. Panel grapples with the legacy of race medicine in research [news]. J Natl Cancer Inst 1997 Jun 4;89(11):758-61.

> Reynolds T. Screening and prevention trials step up minority recruitment [news]. J Natl Cancer Inst 1996 Sep 18;88(18):1265-7.

> Roberson NL. Clinical trial participation. Viewpoints from racial/ethnic groups. Cancer 1994 Nov 1;74(9 Suppl):2687-91.

> Robinson SB, Ashley M, Haynes MA. Attitude of African-Americans regarding prostate cancer clinical trials. J Community Health 1996 Apr;21(2):77-87.

> Rosenberg L, Adams-Campbell L, Palmer JR. The Black Women's Health Study: a follow-up study for causes and preventions of illness. J Am Med Womens Assoc 1995 Mar-Apr;50(2):56-8.

> Rosenbloom AL, House DV, Winter WE. Non-insulin dependent diabetes mellitus (NIDDM) in minority youth: research priorities and needs. Clin Pediatr (Phila) 1998 Feb;37(2):143-52.

> Sano M, Mackell JA, Ponton M, Ferreira P, Wilson J, Pawluczyk S, Pfeiffer E, Thomas RG, Jin S, Schafer K , Schittini M, Grundman M, Ferris SH , Thal LJ. The Spanish Instrument Protocol: design and implementation of a study to evaluate treatment efficacy Instruments for Spanish-speaking patients with Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11 Suppl 2:S57-64.

> Sasao T, Sue S. Toward a culturally anchored ecological framework of research in ethnic-cultural communities. Am J Community Psychol 1993 Dec;21(6):705-27.

> Saunders E. Recruitment of African-American patients for clinical trials--the Allhat challenges. Antihypertensive and Lipid-lowering Trial to Prevent Heart Attack. J Natl Med Assoc 1995 Aug;87(8 Suppl):627-9.

> Savage PJ, Harlan WR. Racial and ethnic diversity in obesity and other risk factors for cardiovascular disease: implications for studies and treatment. Ethn Dis 1991 Spring;1(2):200-11.

> Sawyer L, Regev H, Proctor S, Nelson M, Messias D, Barnes D, Meleis AI. Matching versus cultural competence in research: methodological considerations. Res Nurs Health 1995 Dec;18(6):557-67.

> Sayers S, Powers J. Missing values ignored [letter]. J Paediatr Child Health 1997 Apr;33(2):174; discussion 174-5. Comment on: J Paediatr Child Health 1996 Apr;32(2):99-102.

> Scrimgeour D. Ethics are local: engaging cross-cultural variation in the ethics for clinical research [letter]. Soc Sci Med 1993 Oct;37(7):957-8. Comment on: Soc Sci Med 1992 Nov;35(9):1079-91.

> Serrano LaVertu D, Linares AM. Ethical principles of biomedical research on human subjects: their application and limitations in Latin America and the Caribbean. Bull Pan Am Health Organ 1990;24(4):469-79.

> Shavers-Hornaday VL, Lynch CF, Burmeister LF, Torner JC. Why are African Americans under-represented in medical research studies? Impediments to participation. Ethn Health 1997 Mar-Jun;2(1-2):31-45.

> Sheldon TA, Parker H. Race and ethnicity in health research. J Public Health Med 1992 Jun;14(2):104-10.

> Silva MC. The ethics of cultural diversity and culturally competent nursing education, practice, and research. NursingConnections 1994 Summer;7(2):52-6.

> Singer M. Knowledge for use: anthropology and community-centered substance abuse research. Soc Sci Med 1993 Jul;37(1):15-25.

> Smith R. Deception in research, and racial discrimination in medicine [editorial]. BMJ 1993 Mar 13;306(6879):668-9.

> Snowden LR. Ethnic minority populations and mental health outcomes. New Dir Ment Health Serv 1996 Fall;(71):79-87.

> Swanson GM, Ward AJ. Recruiting minorities into clinical trials: toward a participant-friendly system. J Natl Cancer Inst 1995 Dec 6;87(23):1747-59. Comment in: J Natl Cancer Inst 1996 Mar 20;88(6):377.

> Tejeda HA, Green SB, Trimble EL, Ford L, High JL, Ungerleider RS, Friedman MA, Brawley OW. Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst 1996 Jun 19;88(12):812-6.

> Thomas CR Jr, Pinto HA, Roach M 3rd, Vaughn CB. Participation in clinical trials: is it state-of-the-art treatment for African Americans and other people of color? [editorial]. J Natl Med Assoc 1994 Mar;86(3):177-82.

> Thompson EE, Neighbors HW, Munday C, Jackson JS. Recruitment and retention of African American patients for clinical research: an exploration of response rates in an urban psychiatric hospital. J Consult Clin Psychol 1996 Oct;64(5):861-7.

> Torzillo PJ. Politicised Aborigine health research [letter]. Med J Aust 1997 Nov 17;167(10):555-6.

> Trimble JE. Ethnic specification, validation prospects, and the future of drug use research. Int J Addict 1990-91;25(2A):149-68; discussion 168-70.

> Tseng AL. Anonymous HIV testing in the Canadian aboriginal population. Can Fam Physician 1996 Sep;42:1734-40. Comment in: Can Fam Physician 1996 Dec;42:2341-2, 2344.

> Turbott J. Who should do cross-cultural research? [letter]. Aust N Z J Psychiatry 1998 Apr;32(2):302-3. Comment on: Aust N Z J Psychiatry 1997 Aug;31(4):496-503.

> Centers for Disease Control and Prevention (US), Agency for Toxic Substances and Disease Registry. Policy on the inclusion of women and racial and ethnic minorities in externally awarded research; notice. Fed Regist 1995 Sep 15;60(179):47947-51.

> van Wissen K, Williams C, Siebers R, Maling T. Maori health research. N Z Med J 1994 Apr 13;107(975):134-6.

> Wagener DK. Ethical considerations in the design and execution of the National and Hispanic Health and Nutrition Examination Survey (HANES). Environ Health Perspect 1995 Apr;103 Suppl 3:75-80.

> Walker AR. Desegregating health statistics: what should be done? [news]. Natl Med J India 1998 May-Jun;11(3):146-7.

> Walker AR. Race, ethnicity, and health: how can greater understanding be attained? [letter]. Am J Clin Nutr 1997 Dec;66(6):1481-3. Comment on: Am J Clin Nutr 1997 Mar;65(3):831-6; Am J Clin Nutr 1997 Mar;65(3):887-8.

> Walker AR, Sitas F, Cleaton-Jones PE, Vorster HH, Whittaker DE. Desegregating health statistics and health research in South Africa [letter]. S Afr Med J 1997 Mar;87(3):329-31 Published erratum appears in S Afr Med J 1997 Apr;87(4):478. Comment on: S Afr Med J 1996 Oct;86(10):1257-62. Comment in: S Afr Med J 1997 Dec;87(12):1701-4.

> Walker AR, Sitas P, Cleaton-Jones PE, Vorster HH, Whittaker DE, Segal I. Desgregrating health statistics and health research in South Africa [letter]. S Afr Med J 1997 Dec;87(12):1701-4. Comment on: S Afr Med J 1997 Mar;87(3):329-31.

> Wallace RW. The Human Genome Diversity Project: medical benefits versus ethical concerns. Mol Med Today 1998 Feb;4(2):59-62.

> Warnecke RB, Johnson TP, Chavez N, Sudman S, O'Rourke DP, Lacey L, Horm J. Improving question wording in surveys of culturally diverse populations. Ann Epidemiol 1997 Jul;7(5):334-42.

> Watson T. Affirmative action for clinical trials [news]. Science 1993 May 7;260(5109):746.

> Wax ML. The ethics of research in American Indian communities. Am Indian Q 1991 Fall;15(4):431-56.

> Weissman A. Race and phobia [letter]. J Nerv Ment Dis 1991 May;179(5):305. Comment on: J Nerv Ment Dis 1990 Jul;178(7):434-41.

> Welsh KA, Ballard E, Nash F, Raiford K, Harrell L. Issues affecting minority participation in research studies of Alzheimer disease. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:38-48.

> Wermeling DP, Selwitz AS. Current issues surrounding women and minorities in drug trials. Ann Pharmacother 1993 Jul-Aug;27(7-8):904-11. Comment in: Ann Pharmacother 1993 Jul-Aug;27(7-8):972-3.

> Whelton PK, Lee JY, Kusek JW, Charleston J, DeBruge J, Douglas M, Faulkner M, Greene PG, Jones CA, Kiefer S , Kirk KA, Levell B, Norris K, Powers SN, Retta TM, Smith DE, Ward H. Recruitment experience in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. Control Clin Trials 1996 Aug;17(4 Suppl):17S-33S.

> White LL, Goldberg HI, Gilbert TJ, Ballew C, Mendlein JM, Peter DG, Percy CA, Mokdad AH. Rationale, design and methodology for the Navajo Health and Nutrition Survey. J Nutr 1997 Oct;127(10 Suppl):2078S-2084S.

> Williams DR. The concept of race in Health Services Research: 1966 to 1990. Health Serv Res 1994 Aug;29(3):261-74.

> Williams DR. Race/ethnicity and socioeconomic status: measurement and methodological issues. Int J Health Serv 1996;26(3):483-505.

> Williams LM. Ethics and nursing research: meeting the needs of indigenous peoples. Nurs Inq 1998 Mar;5(1):25-31.

> Wolinsky H. Steps still being taken to undo damage of America's Nuremberg [news]. Ann Intern Med 1997 Aug 15;127(4):I43-4.

> Yeo G. Ethical considerations in Asian and Pacific Island elders. Clin Geriatr Med 1995 Feb;11(1):139-52.

> Young TK. Ethical issues in health research among circumpolar indigenous populations [editorial]. Arctic Med Res 1995 Jul;54(3):114-5.

> Yu ES, Liu WT. US National Health Data on Asian Americans and Pacific Islanders: a research agenda for the 1990s. Am J Public Health 1992 Dec;82(12):1645-52.

> Zahm SH, Pottern LM, Lewis DR, Ward MH, White DW. Inclusion of women and minorities in occupational cancer epidemiologic research. J Occup Med 1994 Aug;36(8):842-7.

> Zambrana RE. The role of Latino/Hispanic communities in health services research: strategies for a meaningful partnership. J Med Syst 1996 Oct;20(5):317-28.

> Return to table of contents

> ## Special or vulnerable populations - Minorities and cross-cultural issues - Books

> A partnership for health. Minorities and biomedical research. Bethesda (MD): National Institutes of Health, National Institute of Allergy and Infectious Diseases; 1992. 25 p.

> Duster T. Backdoor to eugenics. New York: Routledge; 1990. 201 p.

> Flack H, Pellegrino ED, editors. African-American perspectives on biomedical ethics. Washington: Georgetown University Press; c1992. 203 p.

> Implementation of the NIH guidelines on the inclusion of women and minorities as subjects in clinical research, FY 1995-1996: advisory council reports certifying compliance. Bethesda (MD): National Institutes of Health, Office of Research on Women's Health, NIH Tracking/Inclusion Committee; 1997. 1 vol.

> Kirmayer LJ. Emerging trends in research on mental health among Canadian aboriginal peoples: a report prepared for the Royal Commission on Aboriginal Peoples. Rev. final version. Montreal: Sir Mortimer B. Davis-Jewish General Hospital, Institute of Community & Family Psychiatry, Culture & Mental Health Research Unit; 1994? 119 p. (Report. Culture & Mental Health Research Unit; no. 2).

> Outreach notebook for the NIH guidelines on inclusion of women and minorities as subjects in clinical research. Bethesda (MD): National Institutes of Health, 1994. 37 p.

> Pellegrino ED, Mazzarella P, Corsi P, editors. Transcultural dimensions in medical ethics. Papers based on proceedings of the Transcultural Dimensions in Medical Ethics Symposium held at the National Academy of Sciences; 1990 Apr 26-27; Washington, DC. Frederick (MD): University Pub Group; 1992. 221 p.

> Pletsch PK. Cultural values and health research: a methods conference. Milwaukee: University of Wisconsin; 1994.

> Tucker WH. The science and politics of racial research. Urbana: University of Illinois Press; 1994. 371 p.

> Walker SR, Lumley CE, McAuslane JAN. The relevance of ethnic factors in the clinical evaluation of medicines. Boston: Kluwer Academic; c1994. 262 p. (CMR workshop series).

> Return to table of contents

> ## Special or vulnerable populations - Children and adolescents - Journal Articles

> Abramovitch R, Freedman JL, Henry K, Van Brunschot M. Children's capacity to agree to psychological research: knowledge of risks and benefits and voluntariness. Ethics Behav 1995;5(1):25-48.

> Ackerman TF. The ethics of phase I pediatric oncology trials. IRB Rev Hum Subj Res 1995 Jan-Feb;17(1):1-5.

> Ackerman TF. Nontherapeutic research procedures involving children with cancer. J Pediatr Oncol Nurs 1994 Jul;11(3):134-6.

> Ackerman TF. Phase I pediatric oncology trials. J Pediatr Oncol Nurs 1995 Jul;12(3):143-5.

> Ackerman TF. Protectionism and the new research imperative in pediatric AIDS. IRB Rev Hum Subj Res 1990 Sep-Oct;12(5):1-5.

> Akers JA, Bell SK. Should children be used as research subjects? Nurs Forum 1994 Jul-Sep;29(3):28-33.

> Alcaraz R, Klonoff EA, Landrine H. The effects on children of participating in studies of minors' access to tobacco. Prev Med 1997 Mar-Apr;26(2):236-40.

> Alderson P. Did children change, or the guidelines? Bull Med Ethics 1992 Aug:21-8.

> Alderson P. 'Will you help us with our research?'. Arch Dis Child 1995 Jun;72(6):541-2.

> Aman MG, Wolford PL. Consumer satisfaction with involvement in drug research: a social validity study. J Am Acad Child Adolesc Psychiatry 1995 Jul;34(7):940-5.

> American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995 Feb;95(2):286-94.

> Anderson B, Hall B. Parents' perceptions of decision making for children. J Law Med Ethics 1995 Spring;23(1):15-9.

> Arnold LE, Stoff DM, Cook E Jr, Cohen DJ, Kruesi M, Wright C, Hattab J, Graham P, Zametkin A, Castellanos FX, et al. Ethical issues in biological psychiatric research with children and adolescents. J Am Acad Child Adolesc Psychiatry 1995 Jul;34(7):929-39.

> Autret E, Dutertre JP, Barbier P, Jonville AP, Pierre F, Berger C. Parental opinions about biomedical research in children in Tours, France. Dev Pharmacol Ther 1993;20(1-2):64-71.

> Beardsmore CS. Ethical aspects of respiratory research in infancy and early childhood. Pediatr Pulmonol 1998 Jul;26(1):64-8.

> Belzer EG, McIntyre L, Simpson C, Officer S, Stadey N. A method to increase informed consent in school health research. J Sch Health 1993 Sep;63(7):316-7.

> Berglund CA. Children in medical research: Australian ethical standards. Child Care Health Dev 1995 Mar;21(2):149-59.

> Bjune G, Arnesen O. Problems related to informed consent from young teenagers participating in efficacy testing of a new vaccine. IRB Rev Hum Subj Res 1992;14(5):6-9.

> Brooks-Gunn J, Rotheram-Borus MJ. Rights to privacy in research: adolescents versus parents. Ethics Behav 1994;4(2):109-21.

> Bulford R. Children have rights too. BMJ 1997 May 10;314(7091):1421-2.

> Butler D. French suspend child research pending review [news]. Nature 1993 Feb 11;361(6412):481.

> Capron C. Consent laws [letter]. Nature 1993 Mar 11;362(6416):102. Comment on: Nature 1993 Jan 14;361(6408):102.

> Chan KW, Gajewski JL, Supkis D Jr, Pentz R, Champlin R, Bleyer WA. Use of minors as bone marrow donors: current attitude and management. A survey of 56 pediatric transplantation centers. J Pediatr 1996 May;128(5 Pt 1):644-8.

> Choudhry S. Review of legal instruments and codes on medical experimentation with children. Camb Q Healthc Ethics 1994 Fall;3(4):560-72.

> Consent form for paediatric research [news]. Bull Med Ethics 1992 Nov;93:6.

> Crigger BJ. You read it first here. IRB Rev Hum Subj Res 1992;14(5):10-1.

> Cunningham N, Hutchinson S. Neonatal nurses and issues in research ethics. Neonatal Netw 1990 Apr;8(5):29-48.

> de Martino M, Galli L, Guarino Amato A, Vierucci A. Human immunodeficiency virus type 1 infection, clinical trials and ethics in paediatrics. Acta Paediatr Suppl 1997 Jun;421:78-85.

> Dogramaci I. Ethics in pediatric research. Turk J Pediatr 1993 Oct-Dec;35(4):245-7.

> Evans D. The investigation of life-threatening child abuse and Munchausen syndrome by proxy. J Med Ethics 1995 Feb;21(1):9-13. Comment in: J Med Ethics 1995 Jun;21(3):131-2.

> Evans M. Conflicts of interest in research on children. Camb Q Healthc Ethics 1994 Fall;3(4):549-59.

> Field D. Ethics of consent for babies in randomised clinical trials. The Steering Committee of the Collaborative UK ECMO Trial [letter]. Lancet 1995 May 27;345(8961):1370. Comment on: Lancet 1995 Apr 1;345(8953):805-6.

> Fisher CB. Integrating science and ethics in research with high-risk children and youth. Soc Policy Rep Soc Res Child Dev 1993 Winter;7(4):1-27.

> Freedman B, Fuks A, Weijer C. In loco parentis. Minimal risk as an ethical threshold for research upon children. Hastings Cent Rep 1993 Mar-Apr;23(2):13-9.

> Freeman WL. Research with radiation and healthy children: greater than minimal risk. IRB Rev Hum Subj Res 1994;16(5):1-5.

> Friman PC. Take away their hammer: logical and ethical problems in Range and Cotton's Reports of assent and permission in research with children: illustrations and suggestions. Ethics Behav 1995;5(4):349-53.

> Gamble SA. The ethics of research in the neonatal intensive care unit. Nurs Prax N Z 1996 Nov;11(3):47-9.

> Gans JE, Brindis CD. Choice of research setting in understanding adolescent health problems. J Adolesc Health 1995 Nov;17(5):306-13.

> Garralda E. Venepuncture distress and research in childhood [letter]. Lancet 1993 Mar 27;341(8848):832.

> Gidding SS, Camp D, Flanagan MH, Kowalski JA, Lingl LL, Silverman BL, Langman CB. A policy regarding research in healthy children. J Pediatr 1993 Dec;123(6):852-5.

> Gillon R. Covert surveillance by doctors for life-threatening Munchausen's syndrome by proxy [editorial]. J Med Ethics 1995 Jun;21(3):131-2. Comment on: J Med Ethics 1995 Feb;21(1):9-13; J Med Ethics 1995 Apr;21(2):104-5, 115.

> Glantz LH. Conducting research with children: legal and ethical issues. J Am Acad Child Adolesc Psychiatry 1996 Oct;35(10):1283-91.

> Glantz LH. Research with children. Am J Law Med. 1998;24(2-3):213-44

> Goodman GS, Tobey AE. Ethical issues in child witness research [letter]. Child Abuse Negl 1994 Mar;18(3):290-3.

> Gordon B, Prentice E, Reitemeier P. The use of normal children as participants in research on therapy. IRB Rev Hum Subj Res 1996;18(3):5-8.

> Gordon VM, Bonkovsky FO. Family dynamics and children in medical research. J Clin Ethics 1996 Winter;7(4):349-54; discussion 362-4. Comment in: J Clin Ethics 1996 Winter;7(4):355-61.

> Grodin MA, Sassower R. Whose patient is this, anyway? [case study]. IRB Rev Hum Subj Res 1987 Mar-Apr;9(2):6-7.

> Guidelines for adolescent health research. Society for Adolescent Medicine. J Adolesc Health 1995 Nov;17(5):264-9. Comment in: J Adolesc Health 1995 Nov;17(5):259.

> Guidelines for the ethical conduct of medical research involving children. BPA Ethics Advisory Committee. Bull Med Ethics 1992 Aug:13-20.

> Hall D. Reviewing research involving children: the practice of British research ethics committees. IRB Rev Hum Subj Res 1988 Mar-Apr;10(2):1-5.

> Harth SC, Johnstone RR, Thong YH. The psychological profile of parents who volunteer their children for clinical research: a controlled study. J Med Ethics 1992 Jun;18(2):86-93.

> Harth SC, Thong YH. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 1995 Jun;40(11):1573-7.

> Harth SC, Thong YH. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 1995 Dec;41(12):1647-51.

> Harth SC, Thong YH. Sociodemographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study. BMJ 1990 May 26;300(6736):1372-5.

> Hoagwood K. The certificate of confidentiality at the National Institute of Mental Health: discretionary considerations in its applicability in research on child and adolescent mental disorders. Ethics Behav 1994;4(2):123-31.

> Jacqz-Aigrain E. Ethical aspects of pediatric therapeutic clinical trials. Acta Gastroenterol Belg 1998 Apr-Jun;61(2):243-4.

> Kachoyeanos MK. Ethical perspectives on research involving healthy children. MCN Am J Matern Child Nurs 1995 Sep-Oct;20(5):285.

> Kauffman RE. Drug trials in children: ethical, legal, and practical issues. J Clin Pharmacol 1994 Apr;34(4):296-9.

> Kauffman RE, Kearns GL. Pharmacokinetic studies in paediatric patients. Clinical and ethical considerations. Clin Pharmacokinet 1992 Jul;23(1):10-29. Comment in: Clin Pharmacokinet 1992 Jul;23(1):1-9.

> Keens TG, Oki GSF, Gilsanz V, Roe TF, Goodman W, Tsang RC, Specker BL, Saenger EL. Does radiation research in healthy children pose greater than minimal risk? IRB Rev Hum Subj Res 1994;16(5):5-10. Commentaries on W.L. Freeman, p. 1-5.

> Kent G. Volunteering children for bone marrow donation. Studies show large discrepancies between views of surrogate decision makers and patients [letter]. BMJ 1996 Jul 6;313(7048):49-50.

> Kodish ED, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BJ. Informed consent in the Childrens Cancer Group: results of preliminary research. Cancer 1998 Jun 15;82(12):2467-81.

> Koren G. Ethical boundaries of medical research in infants and children in the 80s: analysis of rejected protocols and a new solution for drug studies. Dev Pharmacol Ther 1990;15(3-4):130-41.

> Koren G. The eutectic mixture of local anesthetics: changing the risk-benefit ratio in pediatric research. IRB Rev Hum Subj Res 1992 Mar-Apr;14(2):4-6.

> Koren G, Carmeli DB, Carmeli YS, Haslam R. Maturity of children to consent to medical research: the babysitter test. J Med Ethics 1993 Sep;19(3):142-7.

> Koren G, Pastuszak A. Medical research in infants and children in the eighties: analysis of rejected protocols. Pediatr Res 1990 May;27(5):432-5.

> Lantos JD. Was the UK collaborative ECMO trial ethical? Paediatr Perinat Epidemiol 1997 Jul;11(3):264-8.

> Lantos JD, Frader J. Extracorporeal membrane oxygenation and the ethics of clinical research in pediatrics. N Engl J Med 1990 Aug 9;323(6):409-13.

> Lau YL, Yeung CY. Parental perception of the effect of venepuncture in preschool children in non-therapeutic research. J Paediatr Child Health 1992 Aug 4;28(4):294-6.

> Laughren TP. Regulatory issues in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry 1996 Oct;35(10):1276-82.

> Lee L. Ethical issues related to research involving children. J Pediatr Oncol Nurs 1991 Jan;8(1):24-9.

> Leikin S. Minors' assent, consent, or dissent to medical research. IRB Rev Hum Subj Res 1993 Mar-Apr;15(2):1-7.

> Leikin S. The role of adolescents in decisions concerning their cancer therapy. Cancer 1993 May 15;71(10 Suppl):3342-6.

> Levene M, Wright I, Griffiths G. Is informed consent in neonatal randomised controlled trials ritual? [letter]. Lancet 1996 Feb 17;347(8999):475.

> Levine C. Children in HIV/AIDS clinical trials: still vulnerable after all these years. Law Med Health Care 1991 Fall-Winter;19(3-4):231-7.

> Levine RJ. Adolescents as research subjects without permission of their parents or guardians: ethical considerations. J Adolesc Health 1995 Nov;17(5):287-97.

> Lilleyman JS. Informed consent: how informed and consent to what? [editorial]. Pediatr Hematol Oncol 1995 Nov-Dec;12(6):xiii-xvi.

> Liss MB. Child abuse: is there a mandate for researchers to report? Ethics Behav 1994;4(2):133-46.

> Litt IF. Ethics and research on adolescents [editorial]. J Adolesc Health 1992 Dec;13(8):640. Comment in: J Adolesc Health 1995 Nov;17(5):259.

> Lowes L. Paediatric nursing and research ethics: is there a conflict? J Clin Nurs 1996 Mar;5(2):91-7.

> Lynch A. Ethics of research involving children. Ann R Coll Physicians Surg Can 1992 Oct;25(6):371-2.

> Maloney DM. Bill requires express written consent, not passive consent [news]. Hum Res Rep 1995 Jul;10(7):6.

> Maloney DM. Law would remove ability of institutional review boards to waive written consent [news]. Hum Res Rep 1996 Aug;11(8):1-2.

> Mammel KA, Kaplan DW. Research consent by adolescent minors and institutional review boards. J Adolesc Health 1995 Nov;17(5):323-30.

> Mason S. Obtaining informed consent for neonatal randomised controlled trials--an elaborate ritual? Arch Dis Child Fetal Neonatal Ed 1997 May;76(3):F143-5. Comment in: Arch Dis Child Fetal Neonatal Ed 1998 Mar;78(2):F156-7.

> Mason S, Brown J, Levene M. What is this thing called randomise? Lancet 1997 Nov 15;350(9089):1416. Comment in: Lancet 1998 Feb 14;351(9101):530.

> McCormick MC. Ethics of consent for babies in randomised clinical trials [letter]. Lancet 1995 May 27;345(8961):1370-1. Comment on: Lancet 1995 Apr 1;345(8953):805-6.

> McLean S. Medical experimentation with children. Int J Law Fam 1992 Apr;6(1):173-91.

> McNutt B. The under-enrollment of HIV-infected foster children in clinical trials and protocols and the need for corrective state action. Am J Law Med 1994;20(3):231-49.

> Medical Research Council (Great Britain). MRC guidance on research ethics. Bull Med Ethics 1992 Mar;76:8-10.

> Medical Research Council (Great Britain). MRC guidance on research ethics: children and the mentally incapacitated. Int J Bioethics 1992 Sep;3(3):185-6.

> Meran JG. Ethics of consent for babies in randomised clinical trials [letter]. Lancet 1995 May 27;345(8961):1370. Comment on: Lancet 1995 Apr 1;345(8953):805-6.

> Miller SK. Ethics lobby forces rethink on growth hormones [news]. New Sci 1992 Aug 15;135(1834):9.

> Modi N. Clinical trials and neonatal intensive care [letter]. Arch Dis Child Fetal Neonatal Ed 1994 May;70(3):F231-2. Comment in: Arch Dis Child Fetal Neonatal Ed 1995 Jan;72(1):F79.

> Modi N. Informed consent in clinical trials. Informed consent difficult in paediatric intensive care [letter]. BMJ 1993 Dec 4;307(6917):1495. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

> Modi N. Neonatal research [letter]. Lancet 1998 Feb 14;351(9101):530. Comment on: Lancet 1997 Nov 15;350(9089):1416.

> Modi N, Carr R. Informed consent for observational research in children [letter]. Lancet 1996 Jul 6;348(9019):68. Comment on: Lancet 1996 May 25;347(9013):1423.

> Morton CT. Is research in normal and ill children involving radiation exposure ethical? [letter]. Arch Gen Psychiatry 1996 Nov;53(11):1059-61. Comment on: Arch Gen Psychiatry 1993 May;50(5):333-40.

> Mott MG, Chambers TL. Distress due to venepuncture [letter]. Lancet 1993 Feb 6;341(8841):373.

> Munir K, Earls F. Ethical principles governing research in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry 1992 May;31(3):408-14. Comment in: J Am Acad Child Adolesc Psychiatry 1993 Mar;32(2):471-2.

> Nahata MC. Conducting pediatric research. Ann Pharmacother 1994 Sep;28(9):1105-8. Comment in: Ann Pharmacother 1995 Oct;29(10):1052.

> Nassiry L. Health science research ethics and the law: research involving children. NCBHR Commun 1993 Nov-Dec;4(2):11-3.

> National Council on Bioethics in Human Research (Canada). Ethics of research involving children: proceedings of a national workshop. NCBHR Commun 1993 Apr-May;4(1):12-41.

> National Council on Bioethics in Human Research (Canada). Revised recommendations of the NCBHR "Report on Research Involving Children". NCBHR Commun 1993 Apr-May;4(1):8-11.

> Neargarder T. Informed consent and use of artificial baby milk [letter]. J Hum Lact 1993 Mar;9(1):6-7. Comment on: J Hum Lact 1992 Jun;8(2):61-2; J Hum Lact 1992 Jun;8(2):67-72.

> Oberman M. Minor rights and wrongs. J Law Med Ethics 1996 Summer;24(2):127-38.

> Oesterheld JR, Fogas B, Rutten S. Ethical standards for research on children [letter]. J Am Acad Child Adolesc Psychiatry 1998 Jul;37(7):684-5.

> Olds RS, Symons CW. Recommendations for obtaining cooperation to conduct school-based research. J Sch Health 1990 Mar;60(3):96-8.

> Orr RD, Perkin RM. Clinical ethics consultations with children. J Clin Ethics 1994 Winter;5(4):323-8.

> Osmun WE. Volunteering children for bone marrow donation. Children's views should have been represented in discussion [letter]. BMJ 1996 Jul 6;313(7048):50.

> Paavilainen E, Astedt-Kurki P, Paunonen M. Ethical problems in research on families who are abusing children. Nurs Ethics 1998 May;5(3):200-5.

> Paul M. Informed consent in medical research. Children from the age of 5 should be presumed competent [letter]. BMJ 1997 May 17;314(7092):1480. Comment on: BMJ 1997 Apr 12;314(7087):1107-11.

> Pellegrino ED. Commentary. Clinical judgment, scientific data, and ethics: antidepressant therapy in adolescents and children. J Nerv Ment Dis 1996 Feb;184(2):106-8.

> Phillips SR. Asking the sensitive question: the ethics of survey research and teen sex. IRB Rev Hum Subj Res 1994 Nov-Dec;16(6):1-7.

> Pierro A, Spitz L. Informed consent in clinical research: the crisis in paediatrics [letter]. Lancet 1997 Jun 7;349(9066):1703.

> Pilpel D, Leavitt FJ, Elizur-Leiberman E. Ethical and cross cultural questions concerning pediatric clinical trials. Control Clin Trials 1996 Jun;17(3):201-8.

> Postlethwaite RJ, Reynolds JM, Wood AJ, Eminson DM. Recruiting patients to clinical trials: lessons from studies of growth hormone treatment in renal failure [letter]. Arch Dis Child 1996 Jan;74(1):91. Comment on: Arch Dis Child 1995 Jul;73(1):30-5.

> Postlethwaite RJ, Reynolds JM, Wood AJ, Evans JH, Lewis MA, Eminson DM. Recruiting patients to clinical trials: lessons from studies of growth hormone treatment in renal failure. Arch Dis Child 1995 Jul;73(1):30-5. Comment in: Arch Dis Child 1996 Jan;74(1):91.

> Pratt CB. The conduct of phase I-II clinical trials in children with cancer. Med Pediatr Oncol 1991;19(4):304-9.

> Prentice ED, Antonson DL, Jameton A, Graber B, Sears T. Can children be enrolled in a placebo-controlled randomized clinical trial of synthetic growth hormone? IRB Rev Hum Subj Res 1989 Jan-Feb;11(1):6-10.

> Proposed regulations would mandate pediatric testing for many drugs [news]. Am J Health Syst Pharm 1997 Oct 1;54(19):2152.

> Prows CA, McCain GC. Parental consent for bone marrow transplantation in the case of genetic disorders. J Soc Pediatr Nurs 1997 Jan-Mar;2(1):9-18; quiz 19-20.

> Puskar KR, Weaver PL, DeBlassio K. Nursing research in a school setting. J Sch Nurs 1994 Dec;10(4):8, 10-4.

> Range LM, Cotton CR. Assent and permission rejoinder. Ethics Behav 1995;5(4):345-7. Comment on: Ethics Behav 1995;5(4):333-4.

> Range LM, Cotton CR. Reports of assent and permission in research with children: illustrations and suggestions. Ethics Behav 1995;5(1):49-66.

> Rhodes AM. Curran v. Bosze: bone marrow donation. MCN Am J Matern Child Nurs 1992 Mar-Apr;17(2):67.

> Roberts MC, Buckloh LM. Five points and a lament about Range and Cotton's Reports of assent and permission in research with children: illustrations and suggestions. Ethics Behav 1995;5(4):333-44.

> Robinson W. Commentary on family dynamics and children in medical research. J Clin Ethics 1996 Winter;7(4):362-4. Comment on: J Clin Ethics 1996 Winter;7(4);349-54.

> Rogers AS, D'Angelo L, Futterman D. Guidelines for adolescent participation in research: current realities and possible resolutions. IRB Rev Hum Subj Res 1994 Jul-Aug;16(4):1-6.

> Rowell M, Zlotkin S. The ethical boundaries of drug research in pediatrics. Pediatr Clin North Am 1997 Feb;44(1):27-40.

> Salva P, Aguado MA. Clinical trials in paediatrics [letter]. Lancet 1990 Dec 15;336(8729):1513.

> Santelli J. Human subjects protection and parental permission in adolescent health research. J Adolesc Health 1997 Dec;21(6):384-7. Comment on: J Adolesc Health 1997 Dec;21(6):376-83.

> Santelli JS, Rosenfeld WD, DuRant RH, Dubler N, Morreale M, English A, Rogers AS. Guidelines for adolescent health research: a position paper of the Society for Adolescent Medicine. J Adolesc Health 1995 Nov;17(5):270-6.

> Scarr S. Ethical problems in research on risky behaviors and risky populations. Ethics Behav 1994;4(2):147-55.

> Scott-Jones D. Ethical issues in reporting and referring in research with low-income minority children. Ethics Behav 1994;4(2):97-108.

> Sheldon M. Adolescent medicine: introduction [to a set of articles by S.E. Zinner, R.E. Ladd and E.N. Forman, and R.F. Weir and J.R. Horton]. Theor Med 1995 Dec;16(4):321-22.

> Should deaths of neonates in trial have been more openly reported? [news]. Bull Med Ethics 1993;93:3-5.

> Sieber JE. Issues presented by mandatory reporting requirements to researchers of child abuse and neglect. Ethics Behav 1994;4(1):1-22.

> Sikand A, Schubiner H, Simpson PM. Parent and adolescent perceived need for parental consent involving research with minors. Arch Pediatr Adolesc Med 1997 Jun;151(6):603-7.

> Silverman WA. The future of clinical experimentation in neonatal medicine. Pediatrics 1994 Dec;94(6 Pt 1):932-8.

> Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997 Nov;45(9):1337-55.

> Stephenson T, Walker DA. Gaining patients' consent. Telling parents all relevant details might reduce recruitment of children to trials [letter]. BMJ 1996 Aug 10;313(7053):362-3. Comment on: BMJ 1996 Jun 8;312(7044);1479. Comment in: BMJ 1997 Jan 4;314(7073):74-5.

> Stone R. Clinical research: NIH adds an extra layer of review for sensitive grants [news]. Science 1993 Mar 26;259(5103):1820-1.

> Strasburger VC. Parental permission in adolescent health research [letter]. J Adolesc Health 1998 May;22(5):362. Comment on: J Adolesc Health 1997 Dec;21(6):376-83; J Adolesc Health 1997 Dec;21(6):384-7.

> Susman EJ, Dorn LD, Fletcher JC. Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 1992 Oct;121(4):547-52.

> Tait AR, Voepel-Lewis T, Siewert M, Malviya S. Factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research. Anesth Analg 1998 Jan;86(1):50-3.

> Tarnowski KJ, Allen DM, Mayhall C, Kelly PA. Readability of pediatric biomedical research informed consent forms. Pediatrics 1990 Jan;85(1):58-62.

> Tauer CA. The NIH trials of growth hormone for short stature. IRB Rev Hum Subj Res 1994 May-Jun;16(3):1-9.

> Thompson RA. Behavioral research involving children: a developmental perspective on risk. IRB Rev Hum Subj Res 1990 Mar-Apr;12(2):1-6.

> Thompson RA. Vulnerability in research: a developmental perspective on research risk. Child Dev 1990 Feb;61(1):1-16.

> Thurber FW, Deatrick JA, Grey M. Children's participation in research: their right to consent. J Pediatr Nurs 1992 Jun;7(3):165-70.

> Truog RD. Randomized controlled trials: lessons from ECMO. Clin Res 1992;40(3):519-27.

> Visser HK. Paediatrics in The Netherlands: challenges for today and tomorrow. Arch Dis Child 1993 Aug;69(2):251-5.

> Walterspiel JN. Informed consent: influence on patient selection among critically ill premature infants. Pediatrics 1990 Jan;85(1):119-21.

> Weimer D. Beyond parens patriae: assuring timely, informed, compassionate decisionmaking for HIV-positive children in foster care. Univ Miami Law Rev 1991 Nov;46(2):379-402.

> Weir RF, Horton JR. Genetic research, adolescents, and informed consent. Theor Med 1995 Dec;16(4):347-73.

> Weisz V, Robbennolt JK. Risks and benefits of pediatric bone marrow donation: a critical need for research. Behav Sci Law 1996 Autumn;14(4):375-91.

> Westcott HL. On sensitivity and ethical issues in child witness research [letter]. Child Abuse Negl 1994 Mar;18(3):287-90. Comment on: Child Abuse Negl 1992 Nov-Dec;16(6):779-96.

> White GB. Human growth hormone: the dilemma of expanded use in children. Kennedy Inst Ethics J 1993 Dec;3(4):401-9.

> White RJ. Ethical issues in pediatric surgical research. America 1997 Feb 8;176(4):17-20.

> Williams PC. Ethical principles in federal regulations: the case of children and research risks. J Med Philos 1996 Apr;21(2):169-86.

> Your baby is in a trial [editorial]. Lancet 1995 Apr 1;345(8953):805-6.

> Zinner SE. The elusive goal of informed consent by adolescents. Theor Med 1995 Dec;16(4):323-31.

> Return to table of contents

> ## Special or vulnerable populations - Children and adolescents - Books

> Alderson P, Mayall B. Children's decisions in health care and research. London: University of London, Institute of Education, Social Science Research Unit; 1994 Jul. 63 p.

> Bernard C. Legal aspects of research and clinical practice with children. Questions de droit touchant la recherche et la pratique clinique aupres des enfants. Canada: The National Council on Bioethics in Human Research; 1992. 15 p.

> Burgess MM, Woodrow BE. Contemporary issues in paediatric ethics. Lewiston (NY): E. Mellen Press; 1991. 109 p.

> English A. State minor consent statutes: a summary. Cincinnati: Children's Hospital Medical Center, Division of Adolescent Medicine, National Center for Youth Law for the Center for Continuing Education in Adolescent Health; 1995. 197 p.

> Grodin MA, Glantz LH, editors. Children as research subjects: science, ethics, and law. New York: Oxford University Press; 1994. 258 p.

> Guidelines for the ethical conduct of medical research involving children. London: British Paediatric Association, Ethics Advisory Committee; 1992 Aug. 18 p.

> Hoagwood K, Jensen PS, Fisher CB, editors. Ethical issues in mental health research with children and adolescents. Mahwah (NJ): Erlbaum Associates; 1996. 313 p.

> Koren G, editor. Textbook of ethics in pediatric research. Ethics in pediatric research. Original ed. Malabar (FL): Krieger Pub. Co.; 1993. 336 p.

> Miller JN. Reflections on research involving children. Ottawa (Canada): The Council on Bioethics in Human Research; 1993.

> Report on research involving children. Ottawa: National Council on Bioethics in Human Research; 1992. 64 p. Prepared by the Consent Panel Task Force of the National Council on Bioethics in Human Research with the support of the Canadian Paediatric Society.

> Stanley B, Sieber JE. Social research on children and adolescents: ethical issues. Newbury Park (CA): Sage Publications; 1992. 205 p.

> The ethical conduct of research on children. London: Medical Research Council, Working Party on Research on Children; 1991 Dec. 21 p.

> Return to table of contents

> ## Special or vulnerable populations - Cognitively impaired - Journal Articles

> Abbing HDCR. Medical research involving incapacitated persons: what are the standards? Eur J Health Law 1994;1(2):147-60.

> Addington D, Williams R, Lapierre Y, el-Guebaly N. Placebos in clinical trials of psychotropic medication. Can J Psychiatry 1997 Apr;42(3):6.

> Adelman LS. The ethics of research in incurable disease. R I Med 1992 Mar;75(3):133-5.

> Adler MW. Human subject issues in drug abuse research. College on Problems of Drug Dependence. Drug Alcohol Depend 1995 Feb;37(2):167-75.

> Angrist B. Ethical issues regarding prospective studies of amphetamine psychosis. J Calif Alliance Ment Ill 1994;5(1):32-5.

> Appelbaum PS. Consent and coercion: research with involuntarily treated persons with mental illness or substance abuse. Account Res 1995;4(1):69-79.

> Appelbaum PS. Drug-free research in schizophrenia: an overview of the controversy. IRB Rev Hum Subj Res 1996;18(1):1-5.

> Appelbaum PS. Patients' competence to consent to neurobiological research. Account Res 1996;4(3-4):241-51.

> Appelbaum PS. Psychiatric research and the incompetent subject. Psychiatr Serv 1997 Jul;48(7):873-4.

> Appelbaum PS. Rethinking the conduct of psychiatric research. Arch Gen Psychiatry 1997 Feb;54(2):117-20. Comment on: Arch Gen Psychiatry 1997 Feb;54(2):105-11; Arch Gen Psychiatry 1997 Feb;54(2):113-6; Arch Gen Psychiatry 1997 Feb;54(2):121-3. Comment in: Arch Gen Psychiatry 1997 Feb;54(2):121-3.

> Arboleda-Florez J, Weisstub DN. Ethical research with the mentally disordered. Can J Psychiatry 1997 Jun;42(5):485-91.

> Armstrong E. Safety of patients participating in drug trials. Use of placebo in trials of drugs for mental illness should be debated [letter]. BMJ 1998 Sep 19;317(7161):818.

> Backlar P. Advance directives for subjects of research who have fluctuating cognitive impairments due to psychotic disorders (such as schizophrenia). Community Ment Health J 1998 Jun;34(3):229-40.

> Baskin SA, Morris J, Ahronheim JC, Meier DE, Morrison RS. Barriers to obtaining consent in dementia research: implications for surrogate decision-making. J Am Geriatr Soc 1998 Mar;46(3):287-90.

> Baudouin JL. Biomedical experimentation on the mentally handicapped: ethical and legal dilemmas. Med Law 1990;9(4):1052-61.

> Becker D, Kahana Z. Informed consent in demented patients: a question of hours. Med Law 1993;12(3-5):271-6.

> Becker JC. A mother's testimony. J Calif Alliance Ment Ill 1994;5(1):17.

> Bein PM. Surrogate consent and the incompetent experimental subject. Food Drug Cosmet Law J 1991 Sep;46(5):739-71.

> Beltran JE. Response to special section: ethical decision making and persons with mental retardation (CQ vol 3, no 2). Camb Q Healthc Ethics 1995 Winter;4(1):100-2.

> Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines. J Law Med Ethics 1996 Spring;24(1):18-35.

> Berghmans RL. Advance directives for non-therapeutic dementia research: some ethical and policy considerations. J Med Ethics 1998 Feb;24(1):32-7.

> Berghmans RLP, ter Meulen RHJ. Ethical issues in research with dementia patients. Int J Geriatr Psychiatry 1995 Aug;10(8):647-51.

> Bergsma J. Response to ethical concerns about relapse studies by Adil E Shamoo and Timothy J Keay (CQ Vol 5, No 3). Research with vulnerable subjects [letter]. Camb Q Healthc Ethics 1997 Spring;6(2):233-4. Comment on: Camb Q Healthc Ethics 1996 Summer;5(3):373-86.

> Birenbaum R. Doctor proposes new ethics protocol for Alzheimer's research. CMAJ 1991 Feb 1;144(3):335, 338.

> Bonkovsky FO. Helping Ken and Marie Pines. J Clin Ethics 1994 Summer;5(2):126; discussion 127-8. Comment in: J Clin Ethics 1994 Summer;5(2):129-31.

> Bonnie RJ. Research with cognitively impaired subjects. Unfinished business in the regulation of human research. Arch Gen Psychiatry 1997 Feb;54(2):105-11. Comments in: Arch Gen Psychiatry 1997 Feb;54(2):117-20; Arch Gen Psychiatry 1997 Feb;54(2):121-3.

> Candilis PJ, Wesley RW, Wichman A. A survey of researchers using a consent policy for cognitively impaired human research subjects. IRB Rev Hum Subj Res 1993;15(6):1-4.

> Caplan AL. Are existing safeguards adequate? J Calif Alliance Ment Ill 1994;5(1):36-8.

> Capron AM. Incapacitated research. Hastings Cent Rep 1997 Mar-Apr;27(2):25-7.

> Carpenter WT Jr. The risk of medication-free research. Schizophr Bull 1997;23(1):11-8.

> Carpenter WT Jr, Schooler NR, Kane JM. The rationale and ethics of medication-free research in schizophrenia. Arch Gen Psychiatry 1997 May;54(5):401-7. Comment in: Arch Gen Psychiatry 1997 May;54(5):412-3; Arch Gen Psychiatry 1997 May;54(5):415-6; Arch Gen Psychiatry 1998 Mar;55(3):280-1; discussion 283; Arch Gen Psychiatry 1998 Mar;55(3):281-3.

> Chinnery P, Asimakopoulos G, Kenny RA. Informed consent in clinical trials. Consent may not be possible [letter]. BMJ 1993 Dec 4;307(6917):1496. Comment on: BMJ 1993 Nov 6;307(6913):1199-201.

> Clinical development of atypical antipsychotics: research design and evaluation. Collaborative Working Group on Clinical Trial Evaluations. J Clin Psychiatry 1998;59(Suppl 12):10-6.

> Cognitively impaired subjects. American College of Physicians. Ann Int Med 1989 Nov 15;111(10):843-8.

> College on Problems of Drug Dependence. Policy on Administering Drugs with Abuse Potential in Human Research [news]. Drug Alcohol Depend 1996 Dec 2;43(1-2):115-7.

> Convit A, Levine S, Berns S, Evangelista C. Type of symptomatology as a form of volunteer bias. Bull Am Acad Psychiatry Law 1991;19(2):185-91.

> Corrigan PW, Garman AN. Considerations for research on consumer empowerment and psychosocial interventions. Psychiatr Serv 1997 Mar;48(3):347-52.

> Cusveller BS, Jochemsen H. The new Dutch 'medical experimentation bill' and incompetent patients. Ethics Med 1993 Summer;9(2):18-20.

> Cutler NR, Sramek JJ. Scientific and ethical concerns in clinical trials in Alzheimer's patients: the bridging study. Eur J Clin Pharmacol 1995;48(6):421-8. Comment in: Eur J Clin Pharmacol 1996;50(3):245-6.

> De Deyn PP. On the ethical acceptability of placebo application in neuropsychiatric research. Acta Neurol Belg 1995;95(1):8-17.

> Delano SJ, Zucker JL. Protecting mental health research subjects without prohibiting progress. Hosp Community Psychiatry 1994 Jun;45(6):601-3.

> DeRenzo E. Surrogate decision making for severely cognitively impaired research subjects: the continuing debate. Camb Q Healthc Ethics 1994 Fall;3(4):539-48.

> DeRenzo EG. The ethics of involving psychiatrically impaired persons in research. IRB Rev Hum Subj Res 1994;16(6):7-9, 11.

> Dilonardo JD, Kendrick KA, Vivaldi KB. Chronic or long-term psychiatric patients: potential subjects for longitudinal research. Issues Ment Health Nurs 1993 Apr-Jun;14(2):109-18.

> Dolinsky ZS, Babor TF. Ethical, scientific and clinical issues in ethanol administration research involving alcoholics as human subjects. Addiction 1997 Sep;92(9):1087-97.

> Dresser R. Mentally disabled research subjects. The enduring policy issues. JAMA 1996 Jul 3;276(1):67-72.

> du Plessis AD, van Heerden FJ, Oosthuizen H. Informed consent: research and the psychotic patient. Med Law 1996;15(3):493-7.

> Dukoff R, Sunderland T. Durable power of attorney and informed consent with Alzheimer's disease patients: a clinical study. Am J Psychiatry 1997 Aug;154(8):1070-5.

> Elliott C. Caring about risks. Are severely depressed patients competent to consent to research? Arch Gen Psychiatry 1997 Feb;54(2):113-6. Comments in: Arch Gen Psychiatry 1997 Feb;54(2):117-20; Arch Gen Psychiatry 1997 Feb;54(2):121-3.

> Ethical issues concerning research in patients with dementia. Societa Italiana di Neurologia (SIN)--Working Group Bioethics and Neurology. Ital J Neurol Sci 1996 Oct;17(5):371-5. Published erratum appears in Ital J Neurol Sci 1997 Feb;18(1):68.

> Fins JJ, Miller FG. The call of the sirens. Navigating the ethics of medication-free research in schizophrenia. Arch Gen Psychiatry 1997 May;54(5):415-6. Comment on: Arch Gen Psychiatry 1997 May;54(5):401-7.

> Fitten LJ. The ethics of conducting research with older psychiatric patients. Int J Geriatr Psychiatry 1993 Jan;8(1):33-9.

> Fletcher JC. Ethical aspect of research involving elderly subjects [commentary]. J Clin Ethics 1990 Winter;1(4):285-6.

> Frese FJ. Informed consent and the right to refuse or participate. J Calif Alliance Ment Ill 1994;5(1):56-7.

> Fulford KW, Howse K. Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers. J Med Ethics 1993 Jun;19(2):85-91.

> Gallant D. Ethical considerations of alcohol administration in human research studies. Alcohol Clin Exp Res 1993 Dec;17(6):1345-6.

> Gaughwin PC. The ACT heroin trial proposal: an overview [letter]. Med J Aust 1997 Feb 17;166(4):221-2. Comment on: Med J Aust 1996 Jun 3;164(11):690-2.

> Geiselmann B, Helmchen H. Demented subjects' competence to consent to participate in field studies: the Berlin Ageing Study. Med Law 1994;13(1-2):177-84.

> Ghaemi SN, Hundert EM. The ethics of research in mental illness. J Calif Alliance Ment Ill 1994;5(1):47-9.

> Gift AG. Informed consent and vulnerable subjects. Clin Nurse Spec 1993 Jul;7(4):183.

> Glass KC, Speyer-Ofenberg M. Incompetent persons as research subjects and the ethics of minimal risk. Camb Q Healthc Ethics 1996 Summer;5(3):362-72.

> Goodwin FK. Questions and answers [about National Institute of Mental Health-funded studies]. J Calif Alliance Ment Ill 1994;5(1):45-7.

> Green RM, Pascual LA, Wasserman EM. Ethical guidelines for rTMS research. IRB Rev Hum Subj Res 1997 Mar-Apr;19(2):1-7.

> Haimowitz S, Delano SJ, Oldham JM. Uninformed decision making: the case of surrogate research consent. Hastings Cent Rep 1997 Nov-Dec;27(6):9-16.

> Hale B. Mentally incapacitated adults and decision-making: the English perspective. Int J Law Psychiatry 1997 Winter;20(1):59-75.

> Hassner V. What is ethical? What is not? Where do you draw the line? J Calif Alliance Ment Ill 1994;5(1):4-5.

> Helmchen H. The problem of informed consent in dementia research. Med Law 1990;9(6):1206-13.

> Henn FA, Lader M. Medication-free research with schizophrenic patients. A European perspective. Arch Gen Psychiatry 1997 May;54(5):412-3. Comment on: Arch Gen Psychiatry 1997 May;54(5):401-7.

> High DM. Advancing research with Alzheimer disease subjects: investigators' perceptions and ethical issues. Alzheimer Dis Assoc Disord 1993 Fall;7(3):165-78.

> High DM. Research with Alzheimer's disease subjects: informed consent and proxy decision making. J Am Geriatr Soc 1992 Sep;40(9):950-7.

> High DM, Post SG, Whitehouse PJ. Ethical and legal issues in Alzheimer disease research. Introduction. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:1-4.

> High DM, Whitehouse PJ, Post SG, Berg L. Guidelines for addressing ethical and legal issues in Alzheimer disease research: a position paper. National Institute on Aging. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:66-74.

> Hope T. Aging, research and families [editorial]. J Med Ethics 1997 Oct;23(5):267-8.

> Hoppe SK. Institutional review boards and research on individuals with mental disorders. Account Res 1996;4(3-4):187-95.

> Howe EG. Deceiving patients for their own good. J Clin Ethics 1997 Fall;8(3):211-6.

> Irving DN. Psychiatric research: reality check. J Calif Alliance Ment Ill 1994;5(1):42-4.

> Jonas C, Soutoul JH. Biomedical research on incapacitated people according to French law. Med Law 1993;12(6-8):567-72.

> Kaminski R. The importance of maintaining patient's continued and informed consent. J Calif Alliance Ment Ill 1994;5(1):57-8.

> Kane JM. Enormous ethical challenges. J Calif Alliance Ment Ill 1994;5(1):28-9.

> Kane JM. Obstacles to clinical research and new drug development in schizophrenia. Schizophr Bull 1991;17(2):353-6.

> Kapp MB. Proxy decision making in Alzheimer disease research: durable powers of attorney, guardianship, and other alternatives. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:28-37.

> Katz J. Ethics in neurobiological research with human subjects -- final reflections. Account Res 1996;4(3-4):277-83.

> Kay B. Grasping the research nettle in learning disabilities nursing. Br J Nurs 1995 Jan 28-Feb 8;4(2):96-8.

> Keyserlingk EW, Glass K, Kogan S, Gauthier S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 1995 Winter;38(2):319-61.

> King EM, Smith A, Jobst KA. Autopsy: consent, completion and communication in Alzheimer's disease research. Age Ageing 1993 May;22(3):209-14.

> Kristjanson LJ, Hanson EJ, Balneaves L. Research in palliative care populations: ethical issues. J Palliat Care 1994 Autumn;10(3):10-5.

> Kunjukrishnan R. RE: The need for research and ethical safeguards in special populations [letter]. Can J Psychiatry 1995 Mar;40(2):110. Comment on: Can J Psychiatry 1993 Dec;38(10):681-90.

> Lazarus J. Critical ethical issues and conflicts. J Calif Alliance Ment Ill 1994;5(1):20-1.

> Lehrman NS, Sharav VH. Ethical problems in psychiatric research. J Ment Health Adm 1997 Spring;24(2):227-50.

> Levine RH. A researcher's concern with ethics in human research. J Calif Alliance Ment Ill 1994;5(1):6-8.

> Levine RJ. Proposed regulations for research involving those institutionalized as mentally infirm: a consideration of their relevance in 1995. Account Res 1996;4(3-4):177-86.

> Lieberman Jeffrey A, Sloan Judith. The moral imperatives of medical research in human subjects. J Calif Alliance Ment Ill 1994;5(1):40-42.

> Lynn J. Ethical concerns about research on incompetent persons [letter]. J Am Geriatr Soc 1998 May;46(5):660. Comment on: J Am Geriatr Soc 1997 Aug;45(8):929-33.

> Maciunas KA, Moss AH. Learning the patient's narrative to determine decision-making capacity: the role of ethics consultation. J Clin Ethics 1992 Winter;3(4):287-9.

> Marshall E. NIH examines standards for consent [news]. Science 1998 Jun 12;280(5370):1688.

> Marson DC, Schmitt FA, Ingram KK, Harrell LE. Determining the competency of Alzheimer patients to consent to treatment and research. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:5-18.

> Marwick C. Bioethics Commission examines informed consent from subjects who are 'decisionally incapable' [news]. JAMA 1997 Aug 27;278(8):618-9.

> McGee G. Subject to payment? JAMA 1997 Jul 16;278(3):199-200.

> McGovern TF. Vulnerability: reflection on its ethical implications for the protection of participants in SAMHSA programs. Ethic Behav 1998;8(4):293-304.

> Medical Research Council (Great Britain). MRC guidance on research ethics. Bull Med Ethics 1992 Mar;76:8-10.

> Medical Research Council (Great Britain). MRC guidance on research ethics: children and the mentally incapacitated. Int J Bioethics 1992 Sep;3(3):185-6.

> Meier DE. Voiceless and vulnerable: dementia patients without surrogates in an era of capitation [editorial]. J Am Geriatr Soc 1997 Mar;45(3):375-7. Comment on: J Am Geriatr Soc 1997 Mar;45(3):369-74.

> Miller FG, Rosenstein DL. Psychiatric symptom-provoking studies: an ethical appraisal. Biol Psychiatry 1997 Sep 1;42(5):403-9.

> Milliken AD. The need for research and ethical safeguards in special populations. Can J Psychiatry 1993 Dec;38(10):681-90. Comment in: Can J Psychiatry 1995 Mar;40(2):110.

> Modell JG, Glaser FB, Mountz JM. The ethics and safety of alcohol administration in the experimental setting to individuals who have chronic, severe alcohol problems. Alcohol Alcohol 1993 Mar;28(2):189-97.

> Moline ML, Aisen MW. Perspectives of protocol reviewers. J Calif Alliance Ment Ill 1994;5(1):59-60.

> Morris JC. Conflicts of interest: research and clinical care. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:49-57.

> Nahas GG. The experimental use of cocaine in human subjects. Bull Narc 1990;42(1):57-62.

> NAMI outlines national standards for protecting research subjects with serious mental illness [news]. Psychiatr Serv 1995 Apr;46(4):419-20.

> National Bioethics Advisory Commission. Research involving persons with mental disorders that may affect decisionmaking capacity [monograph on the Internet]. [place unknown]: The Commission; 1998 Dec [cited 1999 May 18]. Available from: http://bioethics.gov/capacity/TOC.htm

> Neylan TC, Wright BA, Shelton MD, van Kammen DP. More on ethics of drug discontinuation studies in schizophrenia [letter]. Arch Gen Psychiatry 1990 Feb;47(2):192.

> Oosthuizen H, Fick G, Els C. Legal status of the mentally disabled person in South African law. Med Law 1995;14(7-8):601-9.

> Ostini R, Bammer G, Dance PR, Goodin RE. The ethics of experimental heroin maintenance. J Med Ethics 1993 Sep;19(3):175-82.

> Pellegrino ED. Emerging ethical issues in palliative care. JAMA 1998 May 20;279(19):1521-2.

> Pinals DA, Malhotra AK, Breier A, Pickar D. Informed consent in schizophrenia research [letter]. Psychiatr Serv 1998 Feb;49(2):244.

> Post SG, Ripich DN, Whitehouse PJ. Discourse ethics: research, dementia, and communication. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:58-65.

> Prentice ED, Antonson DL, Leibrock LG, Prabhu VC, Kelso TK, Sears TD. An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements. IRB Rev Hum Subj Res 1994;16(1-2):16-8.

> Puglisi JT, Ellis GB. Neurobiological research involving human subjects: perspectives from the Office for Protection from Research Risks. Account Res 1996;4(3-4):261-5.

> Ryan AJ. True protection for persons with severe mental disabilities, such as schizophrenia, involved as subjects in research? A look and consideration of the Protection of Human Subjects. J Law Health 1994-5;9(2):349-76.

> Sachs GA. Advance consent for dementia research. Alzheimer Dis Assoc Disord 1994;8 Suppl 4:19-27.

> Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res 1994 Oct;42(3):403-12.

> Shamoo AE. Human rights in reference to persons with mental illness. Account Res 1996;4(3-4):207-16.

> Shamoo AE. Our responsibilities toward persons with mental illness as human subjects. J Calif Alliance Ment Ill 1994;5(1):14-6.

> Shamoo AE, Irving DN. Accountability in research using persons with mental illness. Account Res 1993;3:1-17.

> Shamoo AE, Keay TJ. Ethical concerns about relapse studies. Camb Q Healthc Ethics 1996 Summer;5(3):373-86. Comment in: Camb Q Healthc Ethics 1997 Spring;6(2):233-4.

> Shore D, Berg K, Mullican C. Ethical issues in clinical neurological research. J Calif Alliance Ment Ill 1994;5(1):61-2.

> Sigmon ST. Ethical practices and beliefs of psychopathology researchers. Ethics Behav 1995;5(4):295-309.

> Skolnick AA. Evaluating estrogen for Alzheimer disease poses ethical and logistical challenges [news]. JAMA 1997 Jun 18;277(23):1831-3.

> Smith L. Ethical issues in interviewing. J Adv Nurs 1992 Jan;17(1):98-103.

> Stricker G. Ethical concerns in alcohol research. J Consult Clin Psychol 1991 Apr;59(2):256-7. Comment on: J Consult Clin Psychol 1991 Feb;59(1):176-81; discussion 183.

> Sunderland T, Dukoff R. Informed consent with cognitively impaired patients: an NIMH perspective on the durable power of attorney. Account Res 1996;4(3-4):217-26.

> Swartz MS, Burns BJ, George LK, Swanson J, Hiday VA, Borum R, Wagner HR. The ethical challenges of a randomized controlled trial of involuntary outpatient commitment. J Ment Health Admin 1997 Winter;24(1):35-43.

> Thomasma DC. A communal model for presumed consent for research on the neurologically vulnerable. Account Res 1996;4(3-4):227-39.

> Thomasma DC. Obtaining consent for research in the neurobiologically impaired. J Calif Alliance Ment Ill 1994;5(1):54-5.

> Tomossy GF, Weisstub DN. The reform of adult guardianship laws: the case of non-therapeutic experimentation. Int J Law Psychiatry 1997 Winter;20(1):113-39.

> Trickett EJ. Prevention ethics: explicating the context of prevention activities. Ethics Behav 1992;2(2):91-100.

> Wadman M. Ethical protection for subjects 'could stifle psychiatric research' [news]. Nature 1998 Aug 20;394(6695):713.

> Wadman M. Mentally disabled research subjects 'need protection' [news]. Nature 1997 Oct 16;389(6652):652.

> Walsh JH. The substance-abusing family: consideration for nursing research. J Pediatr Nurs 1991 Feb;6(1):49-56.

> Warren CAB, Karner TX. Permissions and the social context. Am Sociol 1990 Summer;21(2):116-35.

> Watson R. Practical ethical issues related to the care of elderly people with dementia. Nurs Ethics 1994 Sep;1(3):151-62.

> Weijer C, Appelbaum P. Placebo controls are not good science [letter and response]. IRB Rev Hum Subj Res 1996;18(5):8-10.

> Weisstub DN, Arboleda-Florez J. Ethical research with the developmentally disabled. Can J Psychiatry 1997 Jun;42(5):492-6.

> Wichman A, Sandler AL. Research involving subjects with dementia and other cognitive impairments: experience at the NIH, and some unresolved ethical considerations. Neurology 1995 Sep;45(9):1777-8.

> Willwerth James. How to tell if the men in white coats are lying to you (investigative journalism and research abuse). Account Res 1997;5(1-3):51-8.

> Wilson JR. Source data verification in clinical trials involving the temporarily incapacitated subject: is there a missing link in the notion of proxy consent? IRB Rev Hum Subj Res 1992 Jul-Aug;14(4):8-10.

> Wyatt RJ. Research in schizophrenia and the discontinuation of antipsychotic medications. Schizophr Bull 1997;23(1):3-9.

> Young SN, Annable L, Canadian College of Neuropsychopharmacology. The use of placebos in psychiatry: a response to the draft document prepared by the Tri-Council Working Group. J Psychiatry Neurosci 1996 Jul;21(4):235-8.

> Zeph LA. Are we allowing our science to interfere with our ethics? A response to Mulick and Kedesdy. Ment Retard 1990 Apr;28(2):122-3. Comment on: Ment Retard 1988 Aug;26(4):223-9. Comment in: Ment Retard 1990 Aug;28(4):245.

> Zipursky RB. Re: The use of placebos in clinical trials for acute schizophrenia [letter]. Can J Psychiatry 1995 Sep;40(7):425-6. Comment on: Can J Psychiatry 1995 May;40(4):171-6.

> Return to table of contents

> ## Special or vulnerable populations - Cognitively impaired - Books

> Alderson P. Disabled people and consent to medical treatment and research. London: University of London, Institute of Education, Social Science Research Unit, 1993 Mar. 62 p.

> Berg JM, Karlinsky H, Lowy FH. Alzheimer's disease research: ethical and legal issues. Toronto: Carswell; 1991. 366 p.

> Colloquy in research ethics: issues in biomedical research involving cognitively impaired subjects. Washington: U.S. Government Printing Office; 1995. 47 p. Edited transcript of the proceedings of a meeting held in August 1993.

> Hertzman M, Feltner DE. The handbook of psychopharmacology trials: an overview of scientific, political, and ethical concerns. New York: New York University Press; c1997. 454 p.

> Mentally incapacitated adults and decision-making: medical treatment and research. London: Her Majesty's Stationery Office; 1993. 139 p.

> Moorhouse JA. Autonomy and beneficence: striking a balance in Alzheimer's Disease research. 2 vol. Ann Arbor (MI): University Microfilms International; 1991. 513 p.

> Prien RF, Robinson DS. Clinical evaluation of psychotropic drugs: principles and guidelines. New York: Raven Press; c1994. 728 p.

> Roth J, editor. The disturbed subject: epistemological and ethical implications of reactivity in videotape research. New York: Peter Lang; c1990. 134 p. (American university studies. Series 8, Psychology; 20).

> Sramek JJ. Optimizing the development of antipsychotic drugs. New York: John Wiley & Sons; 1997. 204 p.

> The ethical conduct of research on the mentally incapacitated. London: Medical Research Council, Working Party on Research on the Mentally Incapacitated; 1991 Dec. 23 p.

> Return to table of contents

> ## Special or vulnerable populations - Elderly - Journal Articles

> Alt-White AC. Obtaining informed consent from the elderly. West J Nurs Res 1995 Dec;17(6):700-5.

> Applegate WB, Curb JD. Designing and executing randomized clinical trials involving elderly persons. J Am Geriatr Soc 1990 Aug;38(8):943-50.

> Avorn J. Including elderly people in clinical trials: better information could improve the effectiveness and safety of drug use [editorial]. BMJ 1997 Oct 25;315(7115):1033-4.

> Brod MS, Feinbloom RI. Feasibility and efficacy of verbal consents. Res Aging 1990 Sep;12(3):364-72.

> Christensen K, Haroun A, Schneiderman LJ, Jeste DV. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatr Law 1995;23(3):353-65.

> Good BA, Rodrigues-Fisher L. Vulnerability: an ethical consideration in research with older adults. West J Nurs Res 1993 Dec;15(6):780-3.

> Kaye JM, Lawton P, Kaye D. Attitudes of elderly people about clinical research on aging. Gerontologist 1990 Feb;30(1):100-6.

> Lane LW, Cassel CK, Bennett W. Ethical aspects of research involving elderly subjects: are we doing more than we say? J Clin Ethics 1990 Winter;1(4):278-85; discussion 285-6. Published erratum appears in J Clin Ethics 1991 Spring;2(1):4.

> McNeely EA, Clements SD. Recruitment and retention of the older adult into research studies. J Neurosci Nurs 1994 Feb;26(1):57-61.

> Miller J, Evans T. Some reflections on ethical dilemmas in nursing home research. West J Nurs Res 1991 Jun;13(3):375-81.

> Patriarca PA. A randomized controlled trial of influenza vaccine in the elderly: scientific scrutiny and ethical responsibility [editorial]. JAMA 1994 Dec 7;272(21):1700-1.

> Rapp CG, Topps-Uriri J, Beck C. Obtaining and maintaining a research sample with cognitively impaired nursing home residents. Geriatr Nurs 1994 Jul-Aug;15(4):193-6.

> Rikkert MG, van den Bercken JH, ten Have HA, Hoefnagels WH. Experienced consent in geriatrics research: a new method to optimize the capacity to consent in frail elderly subjects. J Med Ethics 1997 Oct;23(5):271-6.

> Sachs GA, Cassel CK. Biomedical research involving older human subjects. Law Med Health Care 1990 Fall;18(3):234-43.

> Sachs GA, Rhymes J, Cassel CK. Biomedical and behavioral research in nursing homes: guidelines for ethical investigations. J Am Geriatr Soc 1993 Jul;41(7):771-7.

> Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Geriatr Soc 1998 Apr;46(4):517-24.

> Tymchuk AJ. An alternative conceptualization of informed consent with people who are elderly. Educ Gerontol 1992 Mar;18(2):135-47.

> Uman GC, Urman HN. The challenges of conducting clinical nursing research with elderly populations. AORN J 1990 Aug;52(2):400-6.

> Williams SG. Research considerations: family opinions about elderly relatives in research. J Gerontol Nurs 1992 Dec;18(12):3-8.

> Return to table of contents

> ## Special or vulnerable populations - Prisoners - Journal Articles

> Arboleda-Florez J. Ethical issues regarding research on prisoners [editorial]. Int J Offender Ther Comp Criminol 1991 Mar;35(1):1-5.

> Bailey RC, Berg D. The Behavioral and Attitudinal Modification Project (BAM): a failed experiment using a classical experimental research design in a closed institutional setting for drug addicts. Int J Addict 1994 Aug;29(10):1315-45.

> Behrendt C, Kendig N, Dambita C, Horman J, Lawlor J, Vlahov D. Voluntary testing for human immunodeficiency virus (HIV) in a prison population with a high prevalence of HIV. Am J Epidemiol 1994 May 1;139(9):918-26.

> Bellin E. Non-placebo controlled HIV experimental trials in prisoners [letter]. J Acquir Immune Defic Syndr Hum Retrovirol 1995 Jul 1;9(3):315-6. Comment on: J Acquir Immune Defic Syndr 1994 Oct;7(10):1086-94.

> Boudreau D. A question of ethics? International medical community condemns death row donations in China. Nephrol News Issues 1995 Aug;9(8):29.

> Brakel SJ. Considering behavioral and biomedical research on detainees in the mental health unit of an urban mega-jail. N Engl J Crim Civil Confine 1996 Winter;22(1):1-27.

> Briggs JD. The use of organs from executed prisoners in China [editorial]. Nephrol Dial Transplant 1996 Feb;11(2):238-40.

> Callender CO, Kelly BS, Rivadeneira DA. Medical utility versus legal justice: a proposal for the ethical use of prisoner-donated organs. Transplant Proc 1996 Feb;28(1):374.

> Campbell KA. Knots in the fabric: Richard Pearson Strong and the Bilibid Prison vaccine trials, 1905-1906. Bull Hist Med 1994 Winter;68(4):600-38.

> Collins A, Baumgartner D, Henry K. US prisoners' access to experimental HIV therapies. Minn Med 1995 Nov;78(11):45-8.

> Fletcher BW, Tims FM. Methodological issues: drug abuse treatment research in prisons and jails. NIDA Res Monogr 1992;118:246-60.

> Gore SM, Basson J, Bird AG, Goldberg DJ. Uptake of confidential, named HIV testing in Scottish prisons [letter]. Lancet 1992 Oct 10;340(8824):907-8.

> Gore SM, Jolliffe DW, Bird AG. Prisoners' uptake of confidential, named HIV testing [letter]. Lancet 1992 Jun 13;339(8807):1491-2.

> Harkness JM. Prisoners and pellagra. Public Health Rep 1996 Sep-Oct;111(5):463-7.

> Hornblum AM. They were cheap and available: prisoners as research subjects in twentieth century America. BMJ 1997 Nov 29;315(7120):1437-41.

> Hsieh H, Yu TJ, Yang WC, Chu SS, Lai MK. The gift of life from prisoners sentenced to death: preliminary report. Transplant Proc 1992 Aug;24(4):1335-6.

> Human rights begin at home [editorial]. BMJ 1997 Nov 29;315(7120):1387.

> In the name of consent [editorial]. New Sci 1994 Feb 19;141(1913):3.

> Kuvin SF. AIDS and malaria experiments [letter]. Nature 1992 Jan 23;355(6358):305. Comment on: Nature 1991 Nov 28;354(6351):262.

> Leukefeld CG, Tims FM. Directions for practice and research. NIDA Res Monogr 1992;118:279-93.

> Liebling A, Ward T. Prison doctors and prison suicide research. Clio Med 1995;34:118-29; discussion 130-3.

> Mason JK. Recording HIV status on police computers [editorial]. BMJ 1992 Apr 18;304(6833):995-6. Comment in: BMJ 1992 May 9;304(6836):1243; BMJ 1992 Jun 20;304(6842):1635-6.

> Moore J. Informed consent with prisoners in research: issues, dilemmas and regulations. Correctcare 1995 Jun-Jul;9(2):14-5, 18.

> New rule for vulnerable research subjects has some special provisions [news]. Hum Res Rep 1994 Jun;9(6):1-2.

> Potler C, Sharp VL, Remick S. Prisoners' access to HIV experimental trials: legal, ethical, and practical considerations. J Acquir Immune Defic Syndr 1994 Oct;7(10):1086-94. Comment in: J Acquir Immune Defic Syndr Hum Retrovirol 1995 Jul 1;9(3):315-6.

> Siegal HA, Carlson RG, Falck R, Reece RD, Perlin T. Conducting HIV outreach and research among incarcerated drug abusers: a case study of ethical concerns and dilemmas. J Subst Abuse Treat 1993 Jan-Feb;10(1):71-5.

> Stein GL, Headley LD. Forum on prisoners' access to clinical trials: summary of recommendations. AIDS Public Policy J 1996 Spring;11(1):3-20.

> Return to table of contents

> ## Special or vulnerable populations - Prisoners - Books

> Gordner RL. Prison health care: January 1986 through September 1990: 1132 citations. Bethesda (MD): National Library of Medicine, Reference Section; 1990. 77 p. (Current bibliographies in medicine; no. 90-12).

> Hornblum AM. Acres of skin: human experiments at Holmesburg Prison: a true story of abuse and exploitation in the name of medical science. New York: Routledge; 1998. 297 p.

> Return to table of contents

> ## Special or vulnerable populations - Military personnel - Journal Articles

> Annas GJ. Changing the consent rules for Desert Storm. N Engl J Med 1992 Mar 12;326(11):770-3. Comments in: N Engl J Med 1992 Oct 8;327(15):1096; discussion 1098; N Engl J Med 1992 Oct 8;327(15):1096-7; N Engl J Med 1992 Oct 8;327(15):1097; discussion 1098; N Engl J Med 1992 Oct 8;327(15):1097-8; N Engl J Med 1992 Oct 8;327(15):1098.

> Annas GJ. Protecting soldiers from friendly fire: the consent requirement for using investigational drugs and vaccines in combat. Am J Law Med 1998;24(2-3):245-60

> Berezuk GP, McCarty GE. Investigational drugs and vaccines fielded in support of Operation Desert Storm. Mil Med 1992 Aug;157(8):404-6. Comment in: Mil Med 1992 Dec;157(12):A8.

> Birmingham K. Pentagon breaks FDA rules [news]. Nat Med 1998 Mar;4(3):255.

> Butler D. Admission on Gulf War vaccines spurs debate on medical records [news]. Nature 1997 Nov 6;390(6655):3-4.

> Cooper RM. Military medical research: proving the safety and effectiveness of a nerve gas antidote -- a legal view. IRB Rev Hum Subj Res 1989 Jul-Aug;11(4):7-9.

> Cotton P. Veterans seeking answers to syndrome suspect they were goats in Gulf War [news]. JAMA 1994 May 25;271(20):1559-61.

> Dudley HA. Research ethics committees and military defence. J R Coll Physicians Lond 1994 May-Jun;28(3):237-41.

> FDA seeks public comment on informed consent rules in combat situations [news]. Hastings Cent Rep 1997 Sep-Oct;27(5):43.

> Gunby P. Informing troops of investigational drugs, devices [news]. JAMA 1995 Jan 25;273(4):276.

> Hickman JR. Panel [on deliberate G-LOC] summary: from Zen riddle to the razor's edge. Aviat Space Environ Med 1991 Jul;62(7):632-7.

> Howe EG, Martin ED. Treating the troops. Hastings Cent Rep 1991 Mar-Apr;21(2):21-4; discussion 24-9.

> Levine C. Military medical research: are there ethical exceptions? IRB Rev Hum Subj Res 1989 Jul-Aug;11(4):5-7.

> Milner CA. Gulf War guinea pigs: is informed consent optional during war? J Contemp Health Law Policy 1996 Fall;13(1):199-232.

> Moran PJ. A military exception to informed consent: "Doe v. Sullivan" [comment]. St.Johns Law Rev 1993 Fall-Winter;66(3):847-63.

> Morris CE, Briggs J, Popper SE. Human subject research at Armstrong Laboratory, 1973-93: medical and musculoskeletal disqualifications. Aviat Space Environ Med 1997 May;68(5):378-83.

> Pearson GS. Experiments and volunteers [letter]. Nature 1994 Feb 24;367(6465):676.

> Poikonen J, McCart GM, Veatch RM. Waivers for military use of investigational agents. Am J Hosp Pharm 1991 Jul;48(7):1525; discussion 1525-9.

> Rall DP, Pechura CM. Effects on health of mustard gas [letter]. Nature 1993 Dec 2;366(6454):398-9.

> Schuchardt EJ. Walking a thin line: distinguishing between research and medical practice during Operation Desert Storm. Columbia J Law Soc Probl 1992 Autumn;26(1):77-115.

> Soldiers as experimental animals [editorial]. Nature 1993 Feb 11;361(6412):479.

> Summers C. Militarism, human welfare, and the APA Ethical Principles of Psychologists. Ethics Behav 1992;2(4):287-310.

> Tiedt TN. The Nuremberg Code, informed consent, and involuntary treatment [letter]. JAMA 1997 Mar 5;277(9):712-3; discussion 713-4. Comment on: JAMA 1996 Nov 27;276(20):1682-3.

> Vander Hamm DG. Human subjects research [letter]. Science 1997 Apr 4;276(5309):17.

> Vlassov V. Experimenting on the vulnerable [letter]. Nature 1994 Oct 27;371(6500):734.

> Return to table of contents

> ## Special or vulnerable populations - Military personnel - Books

> Is Military Research Hazardous to Veterans' Health? Lessons from World War II, the Persian Gulf, and Today: Hearing (1994 May 6). Washington: U.S. Government Printing Office; 1995. 474 p.

> Pechura CM, Rall DP. Veterans at risk: the health effects of mustard gas and lewisite. Washington: National Academy Press; 1993. 427 p.

> Return to table of contents

> ## Teaching and research using newly deceased patients - Journal Articles

> Ardagh M. May we practise endotracheal intubation on the newly dead? J Med Ethics 1997 Oct;23(5):289-94.

> Ashby R. Teaching resuscitation on the newly deceased: do we want to know? [editorial]. Med J Aust 1996 Oct 21;165(8):412-3. Comment on: Med J Aust 1996 Oct 21;165(8):445-7.

> Benfield DG, Flaksman RJ, Lin TH, Kantak AD, Kokomoor FW, Vollman JH. Teaching intubation skills using newly deceased infants. JAMA 1991 May 8;265(18):2360-3. Comment in: JAMA 1991 Sep 25;266(12):1649-51.

> Brattebo G, Wisborg T. Consent for invasive procedures in the newly deceased [letter]. JAMA 1995 Jul 12;274(2):128-9. Comment on: JAMA 1995 Jan 25;273(4):310-2.

> Brattebo G, Wisborg T. Teaching and training of emergencies on 'newly dead' patients: national experiences from Norway [letter]. Arch Emerg Med 1990 Sep;7(3):237-8.

> Brattebo G, Wisborg T. Teaching procedures on the newly dead [letter]. Ann Emerg Med 1995 Aug;26(2):242. Comment on: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):91-4; Ann Emerg Med 1995 Jan;25(1):99-100.

> Brattebo G, Wisborg T, Oyen N. Using newly deceased patients in teaching procedures [letter]. N Engl J Med 1995 May 25;332(21):1445; discussion 1446-7. Comment on: N Engl J Med 1994 Dec 15;331(24):1652-5.

> Brattebo G, Wisborg T, Solheim K, Oyen N. Public opinion on different approaches to teaching intubation techniques. BMJ 1993 Nov 13;307(6914):1256-7.

> Burns JP, Reardon FE, Truog RD. Using newly deceased patients to teach resuscitation procedures. N Engl J Med 1994 Dec 15;331(24):1652-5. Comments in: N Engl J Med 1995 May 25;332(21):1445; discussion 1446-7; N Engl J Med 1995 May 25;332(21):1445-6; discussion 1446-7; N Engl J Med 1995 May 25;332(21):1446; discussion 1446-7.

> Catalano JT. The ethics of cadaver experimentation. Crit Care Nurse 1994 Dec;14(6):82-5.

> Fernandes CM. Practice of procedures on the newly dead [letter]. Ann Emerg Med 1995 Jul;26(1):106-7. Comment on: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):91-4.

> Ginifer C, Kelly AM. Teaching resuscitation skills using the newly deceased. Med J Aust 1996 Oct 21;165(8):445-7. Comment in: Med J Aust 1996 Oct 21;165(8):412-2.

> Goldblatt AD. Don't ask, don't tell: practicing minimally invasive resuscitation techniques on the newly dead. Ann Emerg Med 1995 Jan;25(1):86-90. Comment on: Ann Emerg Med 1995 Jan;25(1):91-4. Comments in: Ann Emerg Med 1995 Jan;25(1):99-100; Ann Emerg Med 1995 Jul;26(1):106-7; Ann Emerg Med 1995 Aug;26(2):242.

> Hayes GJ. Issues of consent: the use of the recently deceased for endotracheal intubation training. J Clin Ethics 1994 Fall;5(3):211-6. Comments in: J Clin Ethics 1994 Fall;5(3):256-60; J Clin Ethics 1994 Fall;5(3):261-40; J Clin Ethics 1994 Fall;5(3):264-6.

> Intubation training: an ethical practice? Nurs Stand 1993 Jul 21-27;7(44):38-9.

> Iserson KV. Law versus life: the ethical imperative to practice and teach using the newly dead emergency department patient. Ann Emerg Med 1995 Jan;25(1):91-4. Comments in: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):99-100; Ann Emerg Med 1995 Jul;26(1):106-7; Ann Emerg Med 1995 Aug;26(2):242.

> Iserson KV. Life versus death: exposing a misapplication of ethical reasoning [editorial]. J Clin Ethics 1994 Fall;5(3):261-4. Comment on: J Clin Ethics 1994 Fall;5(3):211-6.

> Iserson KV. Postmortem procedures in the emergency department: using the recently dead to practise and teach. J Med Ethics 1993 Jun;19(2):92-8.

> Iserson KV. Requiring consent to practice and teach using the recently dead [editorial]. J Emerg Med 1991 Nov-Dec;9(6):509-10. Comment on: J Emerg Med 1991 Nov-Dec;9(6):515-8.

> Kerns AF. Better to lay it out on the table rather than do it behind the curtain: hospitals need to obtain consent before using newly deceased patients to teach resuscitation procedures. J Contemp Health Law Policy 1997 Spring;13(2):581-612.

> King AI, Viano DC, Mizeres N, States JD. Humanitarian benefits of cadaver research on injury prevention. J Trauma 1995 Apr;38(4):564-9.

> Knopp R. Bioethics and health policy section: practicing procedures on the newly dead [editorial]. Ann Emerg Med 1995 Jan;25(1):99-100. Comment on: Ann Emerg Med 1995 Jan;25(1):86-90; Ann Emerg Med 1995 Jan;25(1):91-4. Comment in: Ann Emerg Med 1995 Aug;26(2):242.

> Knopp RK. Practicing cricothyrotomy on the newly dead [editorial]. Ann Emerg Med 1995 May;25(5):694-5. Published erratum appears in Ann Emerg Med 1995 Jul;26(1):109. Comment on: Ann Emerg Med 1995 May;25(5):660-5.

> Lurie KG, Benditt D. Regulated to death: the matter of informed consent for human experimentation in emergency resuscitation research. Pacing Clin Electrophysiol 1995 Jul;18(7):1443-7.

> McNamara RM, Monti S, Kelly JJ. Requesting consent for an invasive procedure in newly deceased adults. JAMA 1995 Jan 25;273(4):310-2. Comment in: JAMA 1995 Jul 12;274(2):128-9.

> Morhaim DK, Heller MB. The practice of teaching endotracheal intubation on recently deceased patients. J Emerg Med 1991 Nov-Dec;9(6):515-8. Comment in: J Emerg Med 1991 Nov-Dec;9(6):509-8.

> Nelson MS. Models for teaching emergency medicine skills. Ann Emerg Med 1990 Mar;19(3):333-5.

> Olsen J, Spilger S, Windisch T. Feasibility of obtaining family consent for teaching cricothyrotomy on the newly dead in the emergency department. Ann Emerg Med 1995 May;25(5):660-5. Comment in: Ann Emerg Med 1995 May;25(5):694-5.

> Olsen JC, Buenefe ML, Falco WD. Death in the emergency department. Ann Emerg Med 1998 Jun;31(6):758-65.

> Orlowski JP. Politically correct ethical thinking and intubation practice on cadavers [editorial]. J Clin Ethics 1994 Fall;5(3):256-60. Comment on: J Clin Ethics 1994 Fall;5(3):211-6.

> Orlowski JP, Kanoti GA, Mehlman MJ. The ethical dilemma of permitting the teaching and perfecting of resuscitation techniques on recently expired patients. J Clin Ethics 1990 Fall;1(3):201-5.

> Perkins HS, Gordon AM. Should hospital policy require consent for practicing invasive procedures on cadavers? The arguments, conclusions, and lessons from one ethics committee's deliberations. J Clin Ethics 1994 Fall;5(3):204-10.

> Rosner F. Research and/or training on the newly dead: the Jewish perspective. Mt Sinai J Med 1997 Mar;64(2):120-4.

> Rosner F. Research and training on the newly dead [letter]. Arch Pathol Lab Med 1997 Oct;121(10):1029.

> Teaching intubation skills using newly deceased infants [letter]. JAMA 1991 Sep 25;266(12):1649-51. Comment on: JAMA 1991 May 8;265(18):2360-3.

> Tonks A. Intubation practice on cadavers should stop [news]. BMJ 1992 Aug 8;305(6849):332.

> Return to table of contents

> ## Special or vulnerable populations - Self-experimentation by researchers - Journal Articles

> Altman LK. Auto-experimentation. An unappreciated tradition in medical science. N Engl J Med 1972 Feb 17;286(7):346-52.

> Batchelor JA, Briggs C. Subject, project or self? Thoughts on ethical dilemmas for social and medical researchers. Soc Sci Med 1994;39(7):949-54.

> Burchell HB. The investigator as volunteer subject. Mayo Clin Proc 1982 Jul;57 Suppl:28-33.

> Fontenot C, O'Leary JP. Dr. Werner Forssman's self-experimentation. Am Surg 1996 Jun;62(6):514-5.

> Forrester JM. Using oneself as one's only experimental subject. Lancet 1990 Sep 29;336(8718):798-9. Comments in: Lancet 1990 Nov 10;336(8724):1200; Lancet 1990 Dec 8;336(8728):1448.

> Frayn KN. Nutritionists as guinea-pigs [editorial]. Br J Nutr 1996 Aug;76(2):157-9.

> Garcia-Caceres U, Garcia FU. Bartonellosis. An immunodepressive disease and the life of Daniel Alcides Carrion. Am J Clin Pathol 1991 Apr;95(4 Suppl 1):S58-66.

> Goldman L. History of self-experimentation in dermatology: should we go first--sometimes? Cutis 1991 Oct;48(4):338-41.

> Josefson D. Doctors volunteer to be guinea pigs for AIDS vaccine [news]. BMJ 1997 Oct 4;315(7112):833.

> London NL, London WT. A case of self-experimentation [editorial]. Cancer Epidemiol Biomarkers Prev 1997 Jul;6(7):475-6.

> Marino D. Doctors plan to inject themselves with live AIDS vaccine [news]. Dent Today 1997 Nov;16(11):27, 29.

> Murley R. Guilty of perpetuating the myth that John Hunter suffered from syphilis after inoculating himself from a chancre [letter]. World J Surg 1994 Mar-Apr;18(2):290. Comment on: World J Surg 1993 Jul-Aug;17(4):563-5.

> van Everdingen JJ, Cohen AF. Self-experimentation by doctors [letter]. Lancet 1990 Dec 8;336(8728):1448. Comment on: Lancet 1990 Sep 29;336(8718):798-9.

> Wright AJ. Self-experimentation in anesthesia. A preliminary inventory. Middle East J Anesthesiol 1994 Jun;12(5):431-42.

> Zorgniott AW. Self-experimentation [letter]. Lancet 1990 Nov 10;336(8724):1200. Comment on: Lancet 1990 Sep 29;336(8718):798-9.

> Return to table of contents

> ## Special or vulnerable populations - Self-experimentation by researchers - Books

> Altman LK. Who goes first? the story of self-experimentation in medicine. Berkeley: University of California Press; 1998. Originally published: New York: Random House; 1987.

> Franklin J, Sutherland J. Guinea pig doctors: the drama of medical research through self-experimentation. New York: Morrow; 1984. 317 p.

> Return to table of contents

> ## Genetic Research - Journal Articles

> Abbott A. German physicians warn of genetics risks [news]. Nature 1996 Nov 7;384(6604):5.

> Agarwal S, Khardori R, Khardori N. Gene therapy: a status report. J Assoc Physicians India 1992 Feb;40(2):95-8. Comment in: J Assoc Physicians India 1992 Oct;40(10):706-7.

> Alcolado JC, Rees JA, Owens DR. Selection of control subjects in genetic studies of diabetes mellitus [letter]. Diabetologia 1994 Jun;37(6):639-40. Comment on: Diabetologia 1993 Nov;36(11):1208-9.

> Alexander JR, Lerer B, Baron M. Ethical issues in genetic linkage studies of psychiatric disorders. Br J Psychiatry 1992 Jan;160:98-102.

> Anderson C. Gene therapy: a speeding ticket for NIH's controversial cancer star [news]. Science 1993 Mar 5;259(5100):1391-2.

> Anderson FW. Reflections: of hope and of concern [editorial]. Hum Gene Ther 1991 Fall;2(3):193-4.

> Anderson WF. Compassionate exemptions [editorial]. Hum Gene Ther 1993 Apr;4(2):125-6.

> Anderson WF. Genetic engineering and our humanness. Hum Gene Ther 1994 Jun;5(6):755-9; discussion 759-60.

> Anderson WF. Genetics and human malleability. Hastings Cent Rep 1990 Jan-Feb;20(1):21-4.

> Anderson WF. Human gene therapy. Science 1992 May 8;256(5058):808-13.

> Anderson WF. Human gene therapy. Nature 1998 Apr 30;392(6679 Suppl):25-30.

> Anderson WF. RAC approves accelerated review [editorial]. Hum Gene Ther 1994 Jun;5(6):665-6.

> Anderson WF. September 14, 1990: the beginning [editorial]. Hum Gene Ther 1990 Winter;1(4):371-2.

> Anderson WF. Uses and abuses of human gene transfer [editorial]. Hum Gene Ther 1992 Feb;3(1):1-2.

> Anderson WF, Blaese RM, Culver K. The ADA human gene therapy clinical protocol: Points to Consider response with clinical protocol, July 6, 1990. Hum Gene Ther 1990 Fall;1(3):331-62.

> Areen J, King P. Legal regulation of human gene therapy. Hum Gene Ther 1990 Summer;1(2):151-61.

> ASHG report. Statement on informed consent for genetic research. The American Society of Human Genetics. Am J Hum Genet 1996 Aug;59(2):471-4.

> Bader JM. UNESCO declaration on genetic research [news]. Lancet 1994 Oct 1;344(8927):946.

> Bailey K, Ridgway A. A rational approach to regulation of gene therapy in Canada. Transfus Sci 1996 Mar;17(1):197-202.

> Baird PA. Altering human genes: social, ethical, and legal implications. Perspect Biol Med 1994 Summer;37(4):566-75.

> Bard TR. Ethical considerations regarding potentials of human gene therapy: ethical dilemmas in serendipity. Prog Clin Biol Res 1990;352:355-64.

> Barker S. Guidelines may boost gene therapy in Japan [news]. Nature 1995 Nov 23;378(6555):327.

> Baskerville G. Human gene therapy: application, ethics and regulation. Dickinson Law Rev 1992 Summer;96(4):733-63.

> Bayertz K, Paslack R, Schmidt KW. Summary of gene transfer into human somatic cells. State of the technology, medical risks, social and ethical problems: a report. Hum Gene Ther 1994 Apr;5(4):465-8.

> Bekelman D. Human germ-line gene therapy: new territory? Pharos 1993 Fall;56(4):15-9.

> Bell H. Bringing bioethics theory to the bedside. Minn Med 1997 Nov;80(11):20-5.

> Berger EM, Gert BM. Genetic disorders and the ethical status of germ-line gene therapy. J Med Philos 1991 Dec;16(6):667-83.

> Bondy M, Mastromarino C. Ethical issues of genetic testing and their implications in epidemiologic studies. Ann Epidemiol 1997 Jul;7(5):363-6.

> Bonvicini KA. The art of recruitment: the foundation of family and linkage studies of psychiatric illness. Fam Process 1998 Summer;37(2):153-65.

> Botkin JR. Ethical issues in human genetic technology. Pediatrician 1990;17(2):100-7.

> Brahams D. Human genetic information: the legal implications. Ciba Found Symp 1990;149:111-9; discussion 119-32.

> Brower V. Mining the genetic riches of human populations. Nat Biotechnol 1998 Apr;16(4):337-40.

> Brown P. Britain dithers over gene therapy [news]. New Sci 1992 Dec 12;136(1851):4.

> Butler D. Ethics treaty to target genome implications [news]. Nature 1994 Sep 29;371(6496):369.

> Carmen IH. Debates, divisions, and decisions: Recombinant DNA Advisory Committee (RAC) authorization of the first human gene transfer experiments. Am J Hum Genet 1992 Feb;50(2):245-60.

> Caulfield T. The commercialization of human genetics: profits and problems. Mol Med Today 1998 Apr;4(4):148-50.

> Chase GA, DeLeon PA, Dronamraju KR, Erickson RP, Glorioso JC, Hirschhorn R, Lysaught MT, McGraw KM, Meyers AS, Miller AD, Ross GS, Rothenberg KH, Saha BK, Secundy MG, Straus SE. Regulation of human gene therapy [letter]. Science 1995 Jul 7;269(5220):14-5.

> Cohen-Haguenauer O. Gene therapy: regulatory issues and international approaches to regulation. Curr Opin Biotechnol 1997 Jun;8(3):361-9.

> Cohen-Haguenauer O. Overview of regulation of gene therapy in Europe: a current statement including reference to US regulation. Hum Gene Ther 1995 Jun;6(6):773-85.

> Cohen-Haguenauer O. Regulation of gene therapy in Europe: a current statement including reference to US regulation. Eur J Cancer 1994;30A(8):1193-201.

> Collins BA. Ethical issues in conducting clinical nursing research. AWHONNS Clin Issues Perinat Womens Health Nurs 1993;4(4):620-33.

> Coney S. Gene trial causes ethical storm in New Zealand [news]. Lancet 1996 Jun 22;347(9017):1759.

> Crigger BJ. The quality of mercy [news]. Hastings Cent Rep 1993 May-Jun;23(3):3.

> Crimes against genetics [editorial]. Nat Genet 1995 Nov;11(3):223-4.

> Culliton BJ. Conflict at the RAC [news]. Science 1990 Apr 13;298(4952):159.

> Culver KW. Splice of life: genetic therapy comes of age. Sciences 1993 Jan-Feb;33(1):18-24.

> Davis BD. Limits to genetic intervention in humans: somatic and germline. Ciba Found Symp 1990;149:81-6; discussion 87-92.

> Dickens BM. Legal and ethical challenges in gene therapy. Transfus Sci 1996 Mar;17(1):191-6.

> Dickson D. Britain plans broad strategy on genome, approves therapy [news]. Nature 1993 Feb 4;361(6411):387.

> Dickson D. British research council jumps at gene therapy [news]. Nature 1993 Jul 1;364(6432):8.

> Dickson D. HUGO approves ethics code for genomics [news]. Nature 1996 Mar 28;380(6572):279.

> Dickson D. MPs challenge rejection of genetics panel [news]. Nature 1996 Jan 18;379(6562):195.

> Dickson D. Panel urges caution on genetic testing for mental disorders [news]. Nature 1998 Sep 24;395(6700):309. Comment on: Nature 1998 Sep 24;395(6700):317.

> Dickson D. UK to set up advisory panel on genetic data [news]. Nature 1995 Jun 29;375(6534):714.

> Dimond B. Gene therapy and genetic screening. Mod Midwife 1995 Aug;5(8):31-3.

> Dimond B. Laws needed to control gene therapy [editorial]. Br J Nurs 1993 Mar 25-Apr 7;2(6):304.

> Downey R. Redesigning life [news]. Nurs Times 1993 Sep 29-Oct 5;89(39):16-7.

> Durfy SJ, Peters JA. For the benefit of all. Hastings Cent Rep 1993 Sep-Oct;23(5):28-9; discussion 29-30. Comment in: Hastings Cent Rep 1994 Sep-Oct;24(5):46.

> Elks ML. The right to participate in research studies. J Lab Clin Med 1993 Aug;122(2):130-6.

> Epstein SL. Regulatory concerns in human gene therapy. Hum Gene Ther 1991 Fall;2(3):243-9.

> Ethical issues in research into prevention of insulin-dependent diabetes mellitus (IDDM) [editorial]. Diabet Med 1996 May;13(5):399-400.

> European Parliament. European Parliament on genetics [Resolution of 16 Mar 1989, slightly abridged]. Bull Med Ethics 1990 Apr;57:8-10.

> Fishman RHB. Jerusalem: flourishing legal environment nurtures protected genetic inquiry [news]. Lancet 1998 Jun 27;351(9120):1939.

> Fletcher JC. Controversies in research ethics affecting the future of human gene therapy. Hum Gene Ther 1990 Fall 1990;1(3):307-24.

> Fletcher JC. Gene therapy in mental retardation: ethical considerations. Ment Retard Dev Disabil Res Rev 1995;1:7-13.

> Fletcher JC, Richter G. Ethical issues of perinatal human gene therapy. J Matern Fetal Med 1996 Sep-Oct;5(5):232-44.

> Fletcher JC, Wertz DC. Ethics, law, and medical genetics: after the human genome is mapped. Emory Law J 1990 Summer;39(3):747-9.

> Fost N. Ethical issues in genetics. Pediatr Clin North Am 1992 Feb;39(1):79-89.

> Foundation on Economic Trends. Petition to amend the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules to establish a public policy advisory committee, 18 Sep 1990 [and] Proposed amendment to the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules to establish a public policy advisory committee. Hum Gene Ther 1991 Summer;2(2):131-4.

> Fox JL. The ethical roar of germ-line gene therapy. Biotechnology (N Y) 1995 Jan;13(1):18-9.

> Fox JL. Green light for gene therapy in healthy volunteers [news]. Nat Biotechnol 1997 Apr;15(4):314.

> Freeman JW. Medicine and life [editorial]. S D J Med 1992 Jun;45(6):159. Comment on: S D J Med 1992 Jun;45(6):161-2.

> Friedmann T. The evolving concept of gene therapy. Hum Gene Ther 1990 Summer;1(2):175-81.

> Friedmann T. Milestone and events in the early development of human gene therapy. Mol Genet Med 1993;3:1-32.

> Friedmann T. Rigor in gene therapy studies [editorial]. Gene Ther 1995 Aug;2(6):355-6.

> From genetics to revelation? [editorial]. Nat Genet 1992 May;1(2):77-8.

> Garver KL, Garver B. The Human Genome Project and eugenic concerns. Am J Hum Genet 1994 Jan;54(1):148-58.

> Gavaghan H. Gene advisory group switches focus to ethical issues [news]. Nature 1994 Oct 6;371(6497):468.

> Gavaghan H. Gene therapy approval may be rocky road for industry [news]. Nature 1995 Mar 16;374(6519):202.

> Gene Therapy Advisory Committee (Great Britain). Guidance on making proposals to conduct gene therapy research on human subjects. Gene Ther 1994 Nov;1(6):343-63.

> Gene Therapy Advisory Committee (Great Britain). Second annual report, [for] January 1995-December 1995, Health Departments of the United Kingdom, May 1996. Hum Gene Ther 1996 Oct 1;7(15):1915-22.

> Genetics and the public interest [editorial]. Nature 1992 Apr 2;356(6368):365-6.

> Genome diversity alarms. Nature 1995 Oct 5;377(6548):372. Comment in: Nature 1996 Jan 4;379(6560):11.

> Genome research risks abuse panel warns [news]. Nature 1995 Dec 7;378(6557):529.

> Gershon D. Genetic engineering: cracks in the RAC [news]. Nature 1991 Oct 17;353(6345):591.

> Gershon D. RAC defers to NIH director on some gene therapy cases [news]. Nature 1993 Jan 21;361(6409):196.

> Glass KC, Weijer C, Palmour RM, Shapiro SH, Lemmens TM, Lebacqz K. Structuring the review of human genetics protocols: gene localization and identification studies. IRB Rev Hum Subj Res 1996;18(4):1-9.

> Glass RM. AAAS conference explores ethical aspects of large pedigree genetic research [news]. JAMA 1992 Apr 22;267(16):2158.

> Goodman L. Crime and genetics conference breeds further controversy [news]. Nature 1995 Sep 28;377(6547):276.

> Gray J. Genetic advances raise ethical issues [news]. Nurs Stand 1995 Jun 7-13;9(37):16-7.

> Great Britain Committee on the Ethics of Gene Therapy (Chairman: Cecil Clothier). Report of the Committee on the Ethics of Gene Therapy: recommendations [partial report]. Hum Gene Ther 1992 Oct;3(5):519-23.

> Grundfast KM, Rosen J. Ethical and cultural considerations in research on hereditary deafness. Otolaryngol Clin North Am 1992 Oct;25(5):973-8.

> Gustafson JM. A Christian perspective on genetic engineering. Hum Gene Ther 1994 Jun;5(6):747-54.

> Gustafson JM. Genetic therapy: ethical and religious reflections. J Contemp Health Law Policy 1992 Spring;8:183-200.

> Hamilton M. Genetics and heavenly intervention [editorial]. Hum Gene Ther 1994 Dec;5(12):1433-5.

> Harper P. Ethical issues in genetic testing for Huntington's disease: lessons for the study of familial cancers. Dis Markers 1992 Jul-Aug;10(4):189-93; discussion 211-28.

> Harper P. Science and Technology Committee's report on genetics [editorial]. BMJ 1995 Jul 29;311(7000):275-6.

> Harry D. The Human Genome Diversity Project and its implications for indigenous peoples. GeneWATCH 1996 Oct;10(2-3):8-9.

> Hasty compassion [editorial]. Lancet 1993 Mar 13;341(8846):663. Comment in: Lancet 1993 May 1;341(8853):1157-8.

> Healy B. Documents relating to the Recombinant DNA Advisory Committee meeting on 14 Jan 1993 concerning compassionate use exemption for gene therapy [title supplied]. Hum Gene Ther 1993 Apr;4(2):195-203.

> Healy B. From the National Institutes of Health: the pace of human gene transfer research quickens [news]. JAMA 1993 Feb 3;269(5):567.

> Healy B. Hearing on the possible uses and misuses of genetic information: testimony before the House Subcommittee on Government Information, Justice, and Agriculture, 17 Oct 1991. Hum Gene Ther 1992 Feb;3(1):51-6.

> High-level ethics committee 'needed to guide genetics policy' [news]. Nature 1997 Feb 27;385(6619):756.

> Hillman AL, Brenner MK, Caplan AL, Carey J, Champey Y, Culver KW, Drummond MF, Freund DA, Holmes EW, Kelley WN, Kolata G, Levine MN, Levy E, Schondelmeyer SW, Velu T, Wilson JM. Gene therapy: socioeconomic and ethical issues. A roundtable discussion. Hum Gene Ther 1996 Jun 10;7(9):1139-44.

> Hodgson J. UK rules out new gene therapy laws [news]. Nature 1993 Nov 18;366(6452):194.

> Holtug N. Altering humans--the case for and against human gene therapy. Camb Q Healthc Ethics 1997 Spring;6(2):157-74.

> Holtug N. Human gene therapy: down the slippery slope? Bioethics 1993 Oct;7(5):402-19.

> Hoose B. Gene therapy: where to draw the line. Hum Gene Ther 1990 Fall;1(3):299-306.

> Hoshino K. Gene therapy in Japan: current trends. Camb Q Healthc Ethics 1995 Summer;4(3):367-70.

> Howell JD. The history of eugenics and the future of gene therapy. J Clin Ethics 1991 Winter;2(4):274-8.

> Howse JL. New genetic medicine and public opinion. Forum Appl Res Public Policy 1993 Fall;8(3):29-33.

> Human Genetics Advisory Commission meets [news]. Gene Ther 1997 Apr;4(4):271.

> Institute of Medical Ethics (Great Britain). Gene therapy. Briefings Med Ethics 1990 Dec;7:4. Mailed with J Med Ethics;16(4).

> International Workshop on Legal Aspects of the Human Genome Project (Bilbao 24-26 May 1993) adopts Bilbao Declaration. Int Dig Health Legis 1994;45(2):234-7.

> Japan edges cautiously towards gene therapy [news]. Nature 1994 Jul 28;370(6487):243.

> Jayaraman KS. Indian guidelines allow limited gene screening [news]. Nature 1998 Jan 8;391(6663):115.

> Jenks S. Genes to order: regulators struggle against future abuses [news]. J Natl Cancer Inst 1997 Oct 15;89(20):1478-9.

> Jochemsen H. Medical genetics: its presuppositions, possibilities and problems. Ethics Med 1992 Summer;8(2):18-31.

> Juengst ET. Germ-line gene therapy: back to basics. J Med Philos 1991 Dec;16(6):587-92.

> Juengst ET. The human genome project and bioethics. Kennedy Inst Ethics J 1991 Mar;1(1):71-4.

> Juengst ET. Human genome research and the public interest: progress notes from an American science policy experiment. Am J Hum Genet 1994 Jan;54(1):121-8.

> Juengst ET. The NIH Points to Consider and the limits of human gene therapy. Hum Gene Ther 1990 Winter;1(4):425-33.

> Juengst ET. Self-critical federal science? The ethics experiment within the U.S. Human Genome Project. Soc Philos Policy 1996 Summer;13(2):63-95.

> Kaiser J. Controls on DNA could impact research [news]. Science 1996 Jul 19;273(5273):299.

> Kaiser J. UNESCO drafts bioethics declaration [news]. Science 1997 Oct 3;278(5335):23.

> Kaplan SR. Germ-line genetic engineering revisited. Pharos 1997 Fall;60(4):21-5.

> Karjala DS. A legal research agenda for the Human Genome Initiative. Jurimetrics J 1992 Winter;32(2):121-2.

> Karpati G, Lochmuller H. The scope of gene therapy in humans: scientific, safety and ethical considerations. Neuromuscul Disord 1997 Jul;7(5):273-6.

> Kass NE. Participation in pedigree studies and the risk of impeded access to health insurance. IRB Rev Hum Subj Res 1993;15(5):7-10.

> Kaura DR. Drawing the line on genetic intervention in humans. CMAJ 1996 Mar 15;154(6):927-9. Published erratum appears in CMAJ 1996 Jun 1;154(11):1625.

> Keenan JF. What is morally new in genetic manipulation? Hum Gene Ther 1990 Fall;1(3):289-98.

> Keeping faith in gene manipulation [editorial]. Nature 1996 Jul 18;382(6588):191.

> Kenan PD. Could history repeat itself? [letter]. N C Med J 1994 Aug;55(8):326. Comment on: N C Med J 1994 May;55(5):188-92.

> Kent A. Genetic watch. Nurs Stand 1997 Apr 9;11(29):18.

> Kessler DA, Siegel JP, Noguchi PD, Zoon KC, Feiden KL, Woodcock J. Regulation of somatic-cell therapy and gene therapy by the Food and Drug Administration. N Engl J Med 1993 Oct 14;329(16):1169-73.

> Kielstein R. Cultural and individual risk perception in human germ-line gene therapy research [symposium: regulating germ-line gene therapy]. Politic Life Sci 1994 Aug;13(2):241-3.

> Kiernan V. Fears mount for gene scrutiny as watchdog faces axe [news]. New Sci 1996 Jun 8;150(2033):10.

> Kiernan V. Panel hears conflicting views on biology of violence [news]. New Sci 1993 Jun 12;138(1877):7.

> Kleiner K. Genocide row at gene conference [news]. New Sci 1995 Sep 30;147(1997):6.

> Knoppers BM, Chadwick R. The Human Genome Project: under an international ethical microscope. Science 1994 Sep 30;265(5181):2035-6.

> Kodish E, Murray TH, Shurin S. Cancer risk research: what should we tell subjects? Clin Res 1994 Oct;42(3):396-402.

> Korn D. Dangerous intersections. Issues Sci Technol 1996 Fall;13(1):55-62.

> Kutukdjian GB. UNESCO and bioethics. UNESCO Courier 1994 Sep;23-5.

> Langfelder EJ, Juengst ET. Social policy issues in genome research. Forum Appl Res Public Policy 1993 Fall;8(3):14-8.

> Lappe M. Ethical issues in manipulating the human germ line. J Med Philos 1991 Dec;16(6):621-39.

> Lebo RV, Golbus MS. Scientific and ethical considerations in human gene therapy. Baillieres Clin Obstet Gynaecol 1991 Sep;5(3):697-713.

> Lecomte V, Taylor A. Trends in gene therapy regulation. Gene Ther 1997 Feb;4(2):77-8.

> Ledley FD. After gene therapy: issues in long-term clinical follow-up and care. Adv Genet 1995;32:1-16.

> Ledley FD. Are contemporary methods for somatic gene therapy suitable for clinical applications? Clin Invest Med 1993 Feb;16(1):78-88.

> Ledley FD. Clinical considerations in the design of protocols for somatic gene therapy. Hum Gene Ther 1991 Spring;2(1):77-83.

> Ledley FD. Distinguishing genetics and eugenics on the basis of fairness. J Med Ethics 1994 Sep;20(3):157-64.

> Ledley FD, Brody B, Kozinetz CA, Mize SG. The challenge of follow-up for clinical trials of somatic gene therapy. Hum Gene Ther 1992 Dec;3(6):657-63.

> Lehrman S. Genome ethics panel comes under the microscope at NIH [news]. Nature 1996 May 30;381(6581):357.

> Lessick M, Faux S. Implications of genetic testing of children and adolescents. Holist Nurs Pract 1998 Apr;12(3):38-46.

> Lloyd J, Taylor AJ. UK guidelines for gene therapy [editorial]. Gene Ther 1994 Nov;1(6):341-2.

> Lock M. Interrogating the Human Diversity Genome Project [editorial]. Soc Sci Med 1994 Sep;39(5):603-6.

> Mac Kay CR. Discussion points to consider in research related to the human genome. Hum Gene Ther 1993 Aug;4(4):477-95.

> Macer D. Universal bioethics and the human germ-line. Politic Life Sci 1994 Aug;13(2):243-5.

> Macer D. Whose genome project? Bioethics 1991 Jul;5(3):183-211.

> Macer D, Balk RA, Freedman B, Goulet MC. New creations? Hastings Cent Rep 1991 Jan-Feb;21(1):32; discussion 32-5. Published erratum appears in Hastings Cent Rep 1991 Mar-Apr;21(2):32.

> Maloney DM. Federal agency keeps review committee after public comments support continuation. Hum Res Rep 1997 Jan;12(1):1-2.

> Markel H. Di Goldine Medina (the Golden Land): historical perspectives of eugenics and the East European (Ashkenazi) Jewish-American community, 1880-1925. Health Matrix 1997 Winter;7(1):49-64.

> Markel H. The stigma of disease: implications of genetic screening. Am J Med 1992 Aug;93(2):209-15.

> Marshall E. Gene therapy's growing pains [news]. Science 1995 Aug 25;269(5227):1050-5.

> Marshall E. The genome project's conscience [news]. Science 1996 Oct 25;274(5287):488-90. Published erratum appears in Science 1996 Nov 15;274(5290):1069.

> Marshall E. Molecular medicine: one less hoop for gene therapy [news]. Science 1994 Jul 29;265(5172):599.

> Marshall E. National Institutes of Health: Varmus orders up a review of the science of gene therapy [news]. Science 1995 Mar 17;267(5204):1588.

> Marshall E. NIH's gay gene study questioned [news]. Science 1995 Jun 30;268(5219):1841.

> Marshall E. Panel approves gene trial for normals [news]. Science 1997 Mar 14;275(5306):1561. Published erratum appears in Science 1997 Apr 11;276(5310):185.

> Marshall E. Whose genome is it, anyway? [news]. Science 1996 Sep 27;273(5283):1788-9. Comment in: Science 1996 Nov 8;274(5289):903-4; Science 1996 Nov 8;274(5289):904.

> Marwick C. 'Desperate use' gene therapy guidelines ready [news]. JAMA 1993 Feb 17;269(7):843.

> Masters RD. Neuroscience, genetics, and society: is the biology of human social behavior too controversial to study? Politic Life Sci 1996 Mar;15(1):103-4.

> Mauron A, Thevoz JM. Germ-line engineering: a few European voices. J Med Philos 1991 Dec;16(6):649-66.

> McCarthy M. US panel urges caution in study of human genetic differences [news]. Lancet 1997 Nov 1;350(9087):1306.

> McCrary SV, Allen B, Moseley R, Crandall LA, Ostrer H, Curry RW, Dewar MA, Nye D. Ethical and practical implications of the Human Genome Initiative for family medicine. Arch Fam Med 1993 Nov;2(11):1158-63.

> McGarrity GJ, Anderson WF. Human gene therapy protocols: RAC review [letter]. Science 1995 Jun 2;268(5215):1261.

> McGee G. Parenting in an era of genetics. Hastings Cent Rep 1997 Mar-Apr;27(2):16-22.

> McGleenan T. Human gene therapy and slippery slope arguments. J Med Ethics 1995 Dec;21(6):350-5.

> McLean SAM, Giesen D. Legal and ethical considerations of the Human Genome Project. Med Law Int 1994;1(2):159-75.

> McPherson EC. Ethical implications of the Human Genome Diversity Project. Nursingconnections 1995 Spring;8(1):36-43.

> Merz JF. Is genetics research minimal risk? IRB Rev Hum Subj Res 1996 Nov-Dec;18(6):7-8.

> Miller HI. Gene therapy for enhancement. Lancet 1994 Jul 30;344(8918):316-7.

> Miller HI. Overregulation is an unnecessary hindrance to human gene therapy [editorial]. Hum Gene Ther 1995 Nov;6(11):1361-2.

> Mitchell CB. Genetic engineering: bane or blessing? [commentary]. Ethics Med 1994 Autumn;10(3):50-5.

> Moseley R. Commentary: maintaining the somatic/germ-line distinction: some ethical drawbacks. J Med Philos 1991 Dec;16(6):641-7.

> Murray TH. Ethical issues in human genome research. FASEB J 1991 Jan;5(1):55-60.

> Murray TH, Livny E. The Human Genome Project: ethical and social implications. Bull Med Libr Assoc 1995 Jan;83(1):14-21.

> Nairne P. Demystifying bioethics--a lay perspective [editorial]. J Med Ethics 1993 Dec;19(4):197-9.

> National Human Genome Research Institute (US). The use of human subjects in large-scale DNA sequencing [monograph on the Internet]. [Bethesda (MD)]: The Institute. [date unknown; cited 1998 Sep 28]. Update of NHGRI policy for the use of human subjects in large-scale sequencing: April 27, 1998; [57 lines]. Available from: http://www.nhgri.nih.gov/Grant_info/Funding/Statements/RFA/human_subjects.html.

> National Human Genome Research Institute (US). The use of human subjects in large-scale DNA sequencing [monograph on the Internet]. [Bethesda (MD)]: The Institute. [date unknown; cited 1998 Sep 28]. NHGRI-DOE guidance on human subjects issues in large-scale DNA sequencing: August 17, 1996; [7 p.]. Available from: http://www.nhgri.nih.gov/Grant_info/Funding/Statements/RFA/human_subjects.html.

> National Institutes of Health. Recombinant DNA research; actions under guidelines; notice. Fed Regist 1990 Sep 12;55(177):37565-7.

> National Institutes of Health. Recombinant DNA research; actions under guidelines; notice -- E. Points to consider for protocols for the transfer of recombinant DNA into the genome of human subjects. Fed Regist 1990 Mar 1;55(41):7443-7.

> National Institutes of Health. Recombinant DNA research: notice of intent to propose amendments to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) regarding enhanced mechanisms for NIH oversight of recombinant DNA activities. Fed Regist 1996 Jul 8;61(131):35774-7.

> National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines; notice. Fed Regist 1996 Nov 22;61(227):59726-42.

> National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines; notice. Fed Regist 1997 Feb 14;62(31):7108-23.

> National Institutes of Health Recombinant DNA Advisory Committee. Minutes of meeting, 30-31 May 1991. Hum Gene Ther 1992 Feb;3(1):95-121.

> National Institutes of Health Recombinant DNA Advisory Committee. Minutes of meeting, 4 Feb 1991. Hum Gene Ther 1991 Winter;2(4):397-413.

> National Institutes of Health Recombinant DNA Advisory Committee. Minutes of meeting, 7-8 Oct 1991. Hum Gene Ther 1992 Jun;3(3):341-56.

> National Institutes of Health Recombinant DNA Advisory Committee. Minutes of meeting of the Recombinant DNA Advisory Committee, 30 Mar 1990. Hum Gene Ther 1990 Winter;1(4):493-501.

> National Institutes of Health Recombinant DNA Advisory Committee. Minutes of meetings, 31 Jul 1990 [and] 16 Oct 1990. Hum Gene Ther 1991 Summer;2(2):177-91.

> National Institutes of Health Recombinant DNA Advisory Committee. Procedures to be followed for expedited review of single patient protocols -- recommendations of the RAC, March 2, 1993. Hum Gene Ther 1993 Jun;4(3):307.

> National Institutes of Health Recombinant DNA Advisory Committee. Recombinant DNA Advisory Committee: minutes of meeting, 1-2 Dec 1994 -- Parts VII and XV: ethical considerations relative to "in utero" somatic cell and gene therapies (discussion and presentation). Hum Gene Ther 1995 Aug;6(8):1065, 1077-8, 1095-7.

> National Institutes of Health Recombinant DNA Advisory Committee. Recombinant DNA Advisory Committee: minutes of meeting, 10-11 Feb 1992. Hum Gene Ther 1992 Oct;3(5):563-91.

> National Institutes of Health Recombinant DNA Advisory Committee. Recombinant DNA Advisory Committee: minutes of meeting, 12-13 Sep 1994. Hum Gene Ther 1995 Apr;6(4):481-525.

> National Institutes of Health Recombinant DNA Advisory Committee. Recombinant DNA Advisory Committee: minutes of meeting, 14 Jan 1993. Hum Gene Ther 1993 Aug;4(4):529-44.

> National Institutes of Health Recombinant DNA Advisory Committee. Recombinant DNA Advisory Committee: minutes of meeting, 3-4 Mar 1994. Hum Gene Ther 1994 Nov;5(11):1401-25.

> National Institutes of Health Recombinant DNA Advisory Committee. Recombinant DNA Advisory Committee: minutes of meeting, 9-10 Jun 1994. Hum Gene Ther 1995 Feb;6(2):233-62.

> National Institutes of Health Recombinant DNA Advisory Committee Human Gene Therapy/Points to Consider Subcommittee. The revised Points to Consider document. Hum Gene Ther 1990 Spring;1(1):93-103.

> National Institutes of Health Recombinant DNA Advisory Committee Human Gene Therapy Subcommittee. Human Gene Therapy Subcommittee: minutes of meeting, 5 Apr 1991. Hum Gene Ther 1992 Apr;3(2):233-48.

> National Institutes of Health Recombinant DNA Advisory Committee Human Gene Therapy Subcommittee. Human Gene Therapy Subcommittee: minutes of meeting, 29-30 Jul 1991. Hum Gene Ther 1992 Aug;3(4):439-55.

> National Institutes of Health Recombinant DNA Advisory Committee Human Gene Therapy Subcommittee. Human Gene Therapy Subcommittee: minutes of meeting, 30 Jul 1990. Hum Gene Ther 1991 Summer;2(2):161-76.

> National Institutes of Health Recombinant DNA Advisory Committee Human Gene Therapy Subcommittee. Human Gene Therapy Subcommittee: minutes of meeting, 1 Jun 1990. Hum Gene Ther 1991 Spring;2(1):87-96.

> National Institutes of Health Recombinant DNA Advisory Committee Human Gene Therapy Subcommitttee. Minutes of meeting of the Human Gene Therapy Subcommittee, 30 Mar 1990. Hum Gene Ther 1990 Winter;1(4):481-91.

> Neal DE. Ethical issues and molecular biology in urology. Br J Urol 1995 Nov;76(Suppl 2):65-70.

> NIH-DOE Working Group on Ethical Legal and Social Issues (ELSI). Statement: "The Bell Curve". J Med Ethics 1996 Jun;22(3):190.

> Nolan K. Commentary: how do we think about the ethics of human germ-line genetic therapy? J Med Philos 1991 Dec;16(6):613-9.

> Omenn GS. Comment: genetics and public health. Am J Public Health 1996 Dec;86(12):1701-4. Comment on: Am J Public Health 1996 Dec;86(12):1717-22.

> Osterlund K. Gene manipulation [letter]. Nature 1991 Mar 28;350(6316):268.

> Palca J. Changes ahead for gene therapy review process? [news]. Science 1991 Aug 9;253(5020):624-5.

> Parker LS. Bioethics for human geneticists: models for reasoning and methods for teaching. Am J Hum Genet 1994 Jan;54(1):137-47.

> Parker LS, Lidz CW. Familial coercion to participate in genetic family studies: Is there cause for IRB intervention? IRB Rev Hum Subj Res 1994 Jan-Apr;16(1-2):6-12.

> Paul DB, Spencer HG. The hidden science of eugenics [commentary]. Nature 1995 Mar 23;374(6520):302-4.

> Penticuff J. Ethical issues in genetic therapy. J Obstet Gynecol Neonatal Nurs 1994 Jul-Aug;23(6):498-501.

> Peters T. Genome project forces new look at ethics, law. Forum Appl Res Public Policy 1993 Fall;8(3):5-13.

> Peters T. Playing God and germline intervention. J Med Philos 1995 Aug;20(4):365-86. Comment in: J Med Philos 1995 Aug;20(4):341-6.

> Phan KLD, Doukas DJ, Fetters MD. Religious leaders' attitudes and beliefs about genetics research and the Human Genome Project. J Clin Ethics 1995 Fall;6(3):237-46.

> Points to consider in human somatic cell therapy and gene therapy (1991). Hum Gene Ther 1991 Fall;2(3):251-6.

> Porter J. What is morally distinctive about genetic engineering? Hum Gene Ther 1990 Winter;1(4):419-24.

> Powers M. Publication-related risks to privacy: ethical implications of pedigree studies. IRB Rev Hum Subj Res 1993;15(4):7-11.

> Regulating genetic manipulation. Bull Med Ethics 1990 May;58:13-4.

> Reilly PR. Rethinking risks to human subjects in genetic research [editorial]. Am J Hum Genet 1998 Sep;63(3):682-5.

> Reilly PR. Reviewing proposals to study biological correlates of criminality. IRB Rev Hum Subj Res 1991 Nov-Dec;13(6):8-9.

> Reilly PR, Boshar MF, Holtzman SH. Ethical issues in genetic research: disclosure and informed consent. Nat Genet 1997 Jan;15(1):16-20.

> Report of the Committee on the Ethics of Gene Therapy. Hum Gene Ther 1992 Oct;3(5):519-23.

> Resnik D. Debunking the slippery slope argument against human germ-line gene therapy. J Med Philos 1994 Feb;19(1):23-40.

> Roberts R, Ryan TJ. Task force 3: clinical research in a molecular era and the need to expand its ethical imperatives. J Am Coll Cardiol 1998 Apr;31(5):942-9.

> Robinson A. The ethics of gene research. CMAJ 1994 Mar 1;150(5):721-7.

> Robinson KD, Abernathy E, Conrad KJ. Gene therapy of cancer. Semin Oncol Nurs 1996 May;12(2):142-51.

> Rolleston FS. Canadian guidelines for research on somatic cell gene therapy in humans (1). Int J Bioethics 1991 Dec;2(4):241-4.

> Rosenberg SA. Gene therapy of cancer. Important Adv Oncol 1992:17-38.

> Rosenberg SA. TNF/TIL Human Gene Therapy Clinical Protocol: memo to the RAC, July 6, 1990; original protocol, April 23, 1990; addendum to protocol, May 24, 1990; and response to Points to Consider, July 9, 1990. Hum Gene Ther 1990 Winter;1(4):441-80.

> Rosner F. Genetic susceptibility testing: a therapeutic illusion?--reply [letter]. Cancer 1998 Jan 1;82(1):232-4. Comment on: Cancer 1997 Jun 1;79(11):2063-5; discussion 2066.

> Ross G, Erickson R, Knorr D, Motulsky AG, Parkman R, Samulski J, Straus SE, Smith BR. Gene therapy in the United States: a five-year status report. Hum Gene Ther 1996 Sep 10;7(14):1781-90.

> Russel S. Regulation of human gene therapy in Australia. Int J Bioethics 1991 Apr-Jun;2(2):87-93.

> Schenker JG. FIGO News. Report of the FIGO Committee for the Study of Ethical Aspects of Human Reproduction. International Federation of Gynecologists and Obstetrics [news]. Int J Gynaecol Obstet 1997 Jun;57(3):333-7.

> Seydel FD. Human gene therapy--playing God? Prog Clin Biol Res 1990;352:339-46.

> Sher G, Feinman MA. The day-to-day realities: commentary on The new eugenics and medicalized reproduction. Camb Q Healthc Ethics 1995 Summer;4(3):313-15. Comment on: Camb Q Healthc Ethics 1995 Summer;4(3);304-12.

> Shore D, Berg K, Wynne D, Folstein MF. Legal and ethical issues in psychiatric genetic research. Am J Med Genet 1993 May 1;48(1):17-21.

> Silverman PH. The human genome project: prospects and politics. Am Biotechnol Lab 1990 Apr;8(5):4, 6, 8.

> Small step for gene therapy [editorial]. Nat Genet 1994 Apr;6(4):323-4.

> Smith JE. Ethical issues raised by the Human Genome Project. Am J Hosp Pharm 1993 Sep;50(9):1945-50.

> Stephenson J. Ethics group drafts guidelines for control of genetic material and information [news]. JAMA 1998 Jan 21;279(3):184.

> Stewart AC. Ethical and social implications of the Human Genome Project: the issues in the UK. Sci Public Policy 1991 Apr;18(2):123-9.

> Stoianoff N. Legal rights and genetic engineering. Australas Biotechnol 1993 Sep-Oct;3(5):288-9.

> Stone R. Congressman ties genome bucks to ethics [news]. Science 1995 Mar 31;267(5206):1895.

> Suter SM. Whose genes are they anyway? Familial conflicts over access to genetic information [note]. Mich Law Rev 1993 Jun;91(7):1854-1908.

> Swinbanks D. Gene therapists face double check [news]. Nature 1994 May 5;369(6475):5.

> Swinbanks D. Gene therapy gets double dose of screening [news]. Nature 1994 Feb 3;367(6462):399.

> Swinbanks D. Gene therapy trial passed in Japan [news]. Nature 1995 Feb 9;373(6514):464.

> Swinbanks D. Japan reviews first guidelines for gene therapy trials [news]. Nature 1993 Apr 22;362(6422):684.

> Swinbanks D. Japan sets up gene therapy panel [news]. Nature 1994 Feb 10;367(6463):502.

> Tannsjo T. Should we change the human genome? Theor Med 1993 Sep;14(3):231-47.

> Tauer CA. Does human gene therapy raise new ethical questions? Hum Gene Ther 1990 Winter;1(4):411-8.

> Tauer CA. Human growth hormone: a case study in treatment priorities. Hastings Cent Rep 1995 May-Jun;25(3 Suppl):S18-S20.

> Taylor R. NIH review to suggest streamlined handling of gene therapy bids [news]. Nature 1995 Jun 29;375(6534):713.

> Temple MJ. An ethical analysis of gene therapy as molecular surgery. Prog Clin Biol Res 1990;352:347-53.

> Texas Medical Center Institute of Religion [and] Baylor College of Medicine Genetics Religion and Ethics Project. Summary reflection statement. Hum Gene Ther 1992 Oct;3(5):525-7.

> Thomas SM, Davies ARW, Birtwistle NJ, Crowther SM, Burke JF. Ownership of the human genome. Nature 1996 Apr 4;380(6573):387-8.

> Thompson L. Gene therapy: Harkin seeks compassionate use of unproven treatments [news]. Science 1992 Dec 11;258(5089):1728.

> Thompson L. Gene therapy: Healy approves an unproven treatment [news]. Science 1993 Jan 8;259(5092):172.

> Thompson L. Should dying patients receive untested genetic methods? [news]. Science 1993 Jan 22;259(5094):452.

> Thomson HJ. Medical ethics and evolution [letter]. J R Soc Med 1994 Dec;87(12):797. Comment on: J R Soc Med 1994 May;87(5):250-2. Comment in: J R Soc Med 1995 Apr;88(4):240.

> Time to act on gene therapy [editorial]. New Sci 1992 Dec 12;136(1851):3.

> Torres JM. On the limits of enhancement in human gene transfer: drawing the line. J Med Philos 1997 Feb;22(1):43-53.

> Food and Drug Administration (US). Addendum to the Points to Consider in Human Somatic Cell and Gene Therapy (1991). Hum Gene Ther 1996 Jun 10;7(9):1181-90.

> US Joint Working Group on Ethical Legal and Social Issues in Human Genome Research (ELSI). Statement of recommendations concerning genetic discrimination and ADA implementation. Hum Genome News 1991 Sep;3(3):12-3.

> Uzych L. The Human Genome project: an overview of ethical issues and public policy concerns [letter]. Nurs Outlook 1996 May-Jun;44(3):150-1. Comment on: Nurs Outlook 1995 Sep-Oct;43(5):228-31.

> Vallance P. Genetic testing [letter]. Lancet 1996 Mar 9;347(9002):685. Comment on: Lancet 1996 Jan 20;347(8995):133.

> van Tongeren PJ. Ethical manipulations: an ethical evaluation of the debate surrounding genetic engineering. Hum Gene Ther 1991 Spring;2(1):71-5.

> Vines G. Gene police frozen out. New Sci 1996 Feb 10;149(2016):12-3.

> Voelker R. The genetic revolution: despite perfection of elegant techniques, ethical answers still elusive [meeting summary]. JAMA 1993 Nov 17;270(19):2273, 2277.

> Vogel G. Genetic enhancement: from science fiction to ethics quandary [news]. Science 1997 Sep 19;277(5333):1753-54.

> Wadman M. Genome panel defends researchers'--and families'--interests [news]. Nature 1998 Feb 26;391(6670):826.

> Wadman M. Germline gene therapy 'must be spared excessive regulation' [news]. Nature 1998 Mar 26;392(6674):317. Comment in: Nature 1998 Apr 16;392(6677):645.

> Wadman M. Review panel cancels meeting as gene therapy proposals fall [news]. Nature 1996 Feb 22;379(6567):668.

> Wadman M. Senate bill seeks controls on genetic data [news]. Nature 1997 Mar 20;386(6622):203.

> Wadman M. US plan to scrap DNA panel splits genetic researchers [news]. Nature 1996 Jul 18;382(6588):197.

> Walters L. Ethical issues in human gene therapy. J Clin Ethics 1991 Winter;2(4):267-74; discussion 274-8.

> Wasserman D. Genetic influence [letter]. Nature 1992 Sep 24;359(6393):266.

> Wasserman D. Research into genetics and crime: consensus and controversy. Politic Life Sci 1996 Mar;15(1):107-9.

> Wasserman David. Science and social harm: genetic research into crime and violence. Philos Publ Policy 1995 Winter;15(1):14-9.

> Watson R. EU approves rights to genetic material [news]. BMJ 1997 Dec 6;315(7121):1487.

> Watson R. Europe cautious over genetics trials [news]. BMJ 1995 Jan 28;310(6974):213-4.

> Wells RJ, Biesecker LG, Wilfond BS, Elias S, Annas GJ. Generic consent for genetic screening [letters and response]. N Engl J Med 1994 Oct 13;331(15):1024-5.

> Wertz DC. Ethical and legal implications of the new genetics: issues for discussion. Soc Sci Med 1992;35(4):495-505.

> Williamson R. Testing for Huntington's disease: early clinical studies suggest uptake is low [editorial]. BMJ 1992 Jun 20;304(6842):1585-6.

> Wilson DJ. NIH guidelines for research involving recombinant DNA molecules. Account Res 1993;3(2-3):177-85.

> Zallen DT. Public oversight is necessary if human gene therapy is to progress [editorial]. Hum Gene Ther 1996 May 1;7(7):795-7. Comment on: Hum Gene Ther 1995 Nov;6(11):1361-2.

> Zimring FE. The genetics of crime: a skeptic's vision of the future. Politic Life Sci 1996 Mar;15(1):105-6.

> Zylke JW. Examining life's (genomic) code means reexamining society's long-held codes [news]. JAMA 1992 Apr 1;267(13):1715-6.

> Return to table of contents

> ## Genetic Research - Books

> Agius E. Germ-line intervention and our responsibilities to future generations. Boston: Kluwer Academic Publishers; c1998. 174 p. (Philosophy and medicine; 55).

> Annas GJ, Elias S. Gene mapping. Using law and ethics as guides. New York: Oxford University Press; 1992.

> Bagness C. Genetics, the fetus, and our future. 1st ed. Hale (Cheshire, UK): Hochland and Hochland; c1998. 105 p.

> Bankowski Z, Capron AM. Genetics, ethics, and human values: human genome mapping, genetic screening and gene therapy. Proceedings of the 24th CIOMS Conference; 1990 Jul 22-27; Tokyo and Inuyama City, Japan. Geneva: Council for International Organizations of Medical Sciences; 1990. 200 p.

> Chadwick RF, Levitt M, Shickle D. The right to know and the right not to know. Brookfield (VT): Avebury; c1997. 101 p. (Avebury series in philosophy).

> Davis J, editor. Mapping the code: the Human Genome Project and the choices of modern science. New York: Wiley; c1990. 294 p. (Wiley science editions).

> de Wachter MA. Experimental somatic gene therapy: ethical concerns and control. Maastricht: Institute for Bioethics; 1993. 146 p.

> Doherty P, Sutton A. Man-made man: ethical and legal issues in genetics. Dublin: Open Air; 1997. 116 p.

> Eijk WJ. The ethical problems of genetic engineering of human beings. Rome: Kerkrade; 1990. 313 p.

> European Parliament, Committee on Legal Affairs and Citizens' Rights. Ethical and legal problems of genetic engineering and human artificial insemination. Luxembourg: Office for Official Publications of the European Communities; 1990. 137 p.

> Frankel MS, Teich AH, editors. Ethical and legal issues in pedigree research: report on a conference sponsored by the AAAS Committee on Scientific Freedom and Responsibility and the AAAS-ABA National Conference of Lawyers and Scientists. Washington: American Association for the Advancement of Science, Directorate for Science and Policy Programs; 1993. 216 p.

> Frankel MS, Teich AH, editors. The genetic frontier: ethics, law, and policy. Washington: American Association for the Advancement of Science, Directorate for Science and Policy Programs; c1994. 240 p. (AAAS publication; no. 93-27S).

> Fujiki N, Macer DRJ, editors. Human genome research and society: proceedings of the 2nd International Bioethics Seminar; 1992 Mar 20-21; Fukui. Christchurch [New Zealand]: Eubios Ethics Institute; 1992. 227 p.

> Gene Therapy: Status, Prospects for the Future, and Government Policy Implications: Hearing (1994 Sep 28). Washington: U.S. Government Printing Office; 1994. 160 p.

> Genetic intervention on human subjects: the report of a working party. London: Catholic Bishops' Joint Committee on Bioethical Issues; 1996. 80 p. Distributed by the Linacre Centre.

> Genome analysis: legal rules -- practical application. Reports of the workshop, 1992 Jun 11-14. Coimbra (Portugal): Livraria Almedina; 1994. 447 p. Under the auspices of the Commission of the European Communities.

> Grace ES. Biotechnology unzipped: promises & realities. Toronto: Trifolium Books; c1997. 248 p.

> Guidelines for research on somatic cell gene therapy in humans. Ottawa: Minister of Supply and Services; 1990. 44 p.

> Human genetics: choice and responsibility. New York: Oxford University Press; 1998.

> Kevles DJ. In the name of eugenics: genetics and the uses of human heredity. Cambridge (MA): Harvard University Press; 1995. 426 p.

> Kevles DJ, Hood L. The code of codes: scientific and social issues in the Human Genome Project. Cambridge (MA): Harvard University Press; 1992. 397 p.

> Kilner JF, Pentz RD, Young FE. The Center for Bioethics and Human Dignity presents genetic ethics. Genetic ethics: do the ends justify the genes? Grand Rapids (MI): W.B. Eerdmans Pub. Co.; 1997. 291 p. (Horizons in bioethics series).

> Knoppers BM. Human dignity and genetic heritage: study paper. Ottawa: Law Reform Commission of Canada; 1991. 93 + 103 p.

> Knoppers BM, Laberge CM, Hirtle M. Human DNA: law and policy: international and comparative perspectives. Boston: Kluwer Law International; c1997. 455 p. Contains the proceedings of the 1st International Conference on DNA Sampling & Human Genetic Research: Ethical, Legal, and Policy Aspects; 1996 Sep 6-8; Montreal.

> Macer DRJ. Shaping genes: ethics, law and science of using genetic technology in medicine and agriculture. Christchurch (New Zealand): Eubios Ethics Institute; 1990. 421 p.

> Macer D, Bezar H, Gough J. Genetic engineering in New Zealand: science, ethics and public policy. Canterbury (New Zealand): Lincoln University, Centre for Resource Management; 1991 Jun. 87 p.

> Man and biotechnology: Report of the Ethics Committee. Oslo: Ministry of Health and Social Affairs. Ethics Committee; 1991. 8 p. Summary.

> Marteau T, Richards M. The troubled helix: social and psychological implications of the new human genetics. New York: Cambridge University Press; 1996. 359 p.

> McGee G. The perfect baby: a pragmatic approach to genetics. Lanham (MD): Rowman & Littlefield Publishers; c1997. 166 p.

> Muller S, Simon JW, Vesting JW. Interdisciplinary approaches to gene therapy: legal, ethical, and scientific aspects. New York: Springer; c1997. 292 p. Collection of papers from the Luneburg Symposium on Interdisciplinary Approaches to Gene Therapy, University of Luneburg, Germany, held Mar. 25-6, 1996.

> National Health and Medical Research Council (Australia). Round Table conference on gene therapy. Canberra: The Council; 1988. 73 p.

> National Research Council, Committee for the study of inborn errors of metabolism. Genetics screening. Programs, principles, and research. Washington: National Academy of Sciences; 1975.

> Neuhaus RJ. Guaranteeing the good life: medicine and the return of eugenics. Grand Rapids (MI): W.B. Eerdmans; 1990. 360 p. Published in cooperation with the Rockford Center on Religion and Society.

> NH & MRC Medical Research Ethics Committee (Australia). Guidelines for the use of genetic registers in medical research. Canberra: Australian Government Pub Service; c1991. 18 p.

> Nichols EK. Human gene therapy. Cambridge (MA): Harvard University Press; 1988. 251 p.

> Okamoto M, Fujiki N, Macer DRJ. Protection of the human genome and scientific responsibility: proceedings of the 1995 MURS-Japan/UNESCO IBC Seminars. Christchurch (New Zealand): Eubios Ethics Institute; 1996. 107 p.

> Pearson R. Heredity and humanity: race, eugenics and modern science. Washington: Scott-Townsend; 1996. 162 p.

> Prior L. Somatic and germline gene therapy: current status and prospects. Ottawa: Royal Commission on New Reproductive Technologies; 1992 Mar. 29 p.

> Proposed international guidelines on ethical issues in medical genetics and genetic services: report of a WHO meeting on ethical issues in medical genetics, 1997 Dec 15-16, Geneva. Geneva: World Health Organization, Human Genetics Programme; c1998. 15 p.

> Report of the Committee on the Ethics of Gene Therapy. London: Her Majesty's Stationery Office; 1992 Jan. 41 p.

> Roberts DF. Ethical, legal, and social issues of the Human Genome Project: report of a WHO temporary adviser. Geneva: World Health Organization, Hereditary Diseases Programme, Division of Noncommunicable Diseases; 1992.

> Roleff TL. Biomedical ethics: opposing viewpoints. San Diego: Greenhaven Press; c1998. 252 p. (Opposing viewpoints series).

> Rothblatt MA. Unzipped genes: taking charge of baby-making in the new millennium. Philadelphia: Temple University Press; 1997. 201 p. (American in transition).

> Rothstein MA, editor. Legal and ethical issues raised by the Human Genome Project: proceedings of the conference; 1991 Mar 7-9; Houston, Texas. Houston (TX): University of Houston, Health Law and Policy Institute; c1991. 449 p.

> Rothstein MA. Genetic secrets: protecting privacy and confidentiality in the genetic era. New Haven: Yale University Press; c1997. 511 p.

> Smith DH. Early warning: cases and ethical guidance for presymptomatic testing in genetic diseases. Bloomington: Indiana University Press; 1998. (Medical ethics series).

> Smith EJ, Sapp WJ. Plain talk about the Human Genome Project: a Tuskegee University conference on its promise and perils-- and matters of race. Tuskegee (AL): Tuskegee University; c1997. 292 p. The Tuskegee University Conference on the Human Genome Project was held September 26-28, 1996 at Tuskegee University.

> Spallone P. Generation games: genetic engineering and the future for our lives. Philadelphia: Temple University Press; 1992. 343 p.

> Statement of WHO Expert Advisory Group on Ethical Issues in Medical Genetics, 1997 Dec 15-16, Geneva. Geneva: World Health Organization, Human Genetics Programme, Division of Noncommunicable Diseases; c1998. 7 p.

> Suzuki DT, Knudtson P, editors. Genethics: the clash between the new genetics and human values. Cambridge (MA): Harvard University Press; 1989. 384 p.

> The human genome sequencing: ethical issues. Brescia (Italy): Clas International; 1989. 292 p.

> Thompson L. Correcting the code: inventing the genetic cure for the human body. New York: Simon and Schuster; 1994. 378 p.

> Walters L, Palmer JG. The ethics of human gene therapy. New York: Oxford University Press; 1997. 209 p.

> Weatherall DJ, Shelley JH, editors. Social consequences of genetic engineering: proceedings of the 6th Boehringer Ingelheim Symposium; 1988 Jun 12-14; Kronberg, Taunus. New York: Excerpta Medica; 1989. 223 p. (International congress series; 820).

> Wingerson L. Mapping our genes: the Genome Project and the future of medicine. New York: Dutton; 1990. 338 p.

> Yesley M S, Ossorio PN, compilers. ELSI bibliography. Ethical, legal & social implications of the Human Genome Project 1994 supplement (Sept. 1, 1994). Washington: Department of Energy, Office of Energy Research; 1994. 88 p.

> Yesley MS, compiler. Bibliography--ethical, legal, and social implications of the Human Genome Project. Washington: Department. of Energy, Office of Energy Research: 1992; 145 p.

> Yesley MS, Roth MRJ, compilers. ELSI bibliography: ethical legal & social implications of the Human Genome Project. 2nd ed. Washington: Department of Energy, Office of Energy Research; 1993. 265 p.

> Return to table of contents

> ## Gamete, embryo and fetal research - Journal Articles

> Abbot A. European convention allows use of human embryos [news]. Nature 1996 Nov 28;384(6607):298.

> Aldhous P. Pressure stepped up on embryo research [news]. Nature 1990 Apr 19;344(6268):691.

> American College of Obstetricians and Gynecologists, Committee on Ethics. Preembryo research: history, scientific background, and ethical considerations. ACOG Committee Opinion 136, Apr 1994. Int J Gynaecol Obstet 1994 Jun;45(3):291-301.

> American Medical Association, Board of Trustees. Frozen pre-embryos [report]. JAMA 1990 May 9;263(18):2484-7.

> Andrews L, Elster N. Embryo research in the US. Hum Reprod 1998 Jan;13(1):1-4.

> Andrews LB. Regulation of experimentation on the unborn. J Leg Med 1993 Mar;14(1):25-56.

> Appleton T. Ethical issues in assisted reproductive medicine: a pragmatic approach. Br J Urol 1995 Nov;76 Suppl 2:85-92.

> Bahadur G, Steele SJ. Ovarian tissue cryopreservation for patients. Hum Reprod 1996 Oct;11(10):2215-6.

> Baird P. Proceed with care: new reproductive technologies and the need for boundaries. J Assist Reprod Genet 1995 Sep;12(8):491-8.

> Balter M. France: researchers nervous about bioethics bill [news]. Science 1994 Jan 28;263(5146):463-4.

> Beier HM, Beckman JO. Implications and consequences of the German Embryo Protection Act. Hum Reprod 1991 Apr;6(4):607-8.

> Benzie RJ, Hughes-Benzie RM. Fetal therapy. Baillieres Clin Obstet Gynaecol 1991 Sep;5(3):715-29.

> Berkowitz JM. Mummy was a fetus: motherhood and fetal ovarian transplantation. J Med Ethics 1995 Oct;21(5):298-304. Published erratum appears in J Med Ethics 1996 Apr;22(2):77.

> Biggin S. Italian bioethics: embryo report opens old wounds [news]. Science 1996 Jul 12;273(5272):177.

> Bonnicksen AL. Fetal motherhood: toward a compulsion to generate lives? Camb Q Healthc Ethics 1997 Winter;6(1):19-30.

> Brennan SR. Black looks at when life begins [letter]. J R Coll Physicians Lond 1990 Jul;24(3):250. Comment on: J R Coll Physicians Lond 1990 Jan;24(1):8-9.

> Bromham DR. Attitudes toward embryo research. J Assist Reprod Genet 1992 Apr;9(2):90-3.

> Buckle S. Response to Oderberg [letter]. J Med Ethics 1990 Jun;16(2):110. Comment on: J Med Ethics 1989 Sep;15(3):166.

> Butler D. Ethics bill prompts second thoughts among scientists [news]. Nature 1994 Jan 20;367(6460):209.

> Butler D. France is urged to loosen ban on embryo research [news]. Nature 1997 May 15;387(6630):218.

> Byk JC. A proposed draft protocol for the European Convention on Biomedicine relating to research on the human embryo and fetus. J Med Ethics 1997 Feb;23(1):32-7.

> Callahan D. The puzzle of profound respect. Hastings Cent Rep 1995 Jan-Feb;25(1):39-40.

> Campbell CS. Awe diminished. Hastings Cent Rep 1995 Jan-Feb;25(1):44-6.

> Centre For Bioethics and Public Policy (London). Response to the Human Fertilisation and Embryology Authority's consultation document on research and fertility treatment using human ova and ovarian tissue obtained from live women, cadavers or fetuses. Ethics Med 1995;11(2):33-6.

> Cole AP, Duddington AJ, Duddington JG, Sayer GS. Human embryo research [letter]. Lancet 1990 Apr 28;335(8696):1040.

> Corrigan E, Mumford SE, Hull MG. Posthumous storage and use of sperm and embryos: survey of opinion of treatment centres. BMJ 1996 Jul 6;313(7048):24. Comment in: BMJ 1996 Jul 6;313(7048):1-2.

> Craft I, Shapland D, Fincham E, al-Shawaf T. Research on human embryos, cryopreservation, and the HFEA [letter]. Lancet 1991 Oct 5;338(8771):888.

> Culliton BJ, Ivinson AJ. Expect more from embryos [editorial]. Nat Med 1996 Sep;2(9):947. Comment in: Nat Med 1996 Dec;2(12):1280.

> Dalton R. Researchers 'duped' over use of embryos without consent [news]. Nature 1996 Feb 29;379(6568):756.

> Davis JH. Frozen pre-embryos [letters and responses]. JAMA 1990 Nov 14;264(18):2382-3.

> Dawson KJ. The storage of human embryos. Hum Reprod 1997 Jan;12(1):6.

> Deutsch E. Fetus in Germany: the Fetus Protection Law of 12.13.1990. Int J Bioethics 1992 Jun;3(2):85-93.

> Dickenson DL. Procuring gametes for research and therapy: the argument for unisex altruism--a response to Donald Evans. J Med Ethics 1997 Apr;23(2):93-5. Comment on: J Med Ethics 1995 Oct;21(5):261-4. Comment in: J Med Ethics 1997 Apr;23(2):67-8.

> Dickman S. Embryo research: Germany turns clock back [news]. Nature 1990 Nov 1;348(6296):8.

> Dickson D. UK parliament passes surprise ban on fetal embryos in IVF [news]. Nature 1994 Apr 21;368(6473):676.

> Dickson D. Use of fetal eggs in research to be debated [news]. Nature 1993 Jul 29;364(6436):372.

> Dijon X. Abortion and genetic manipulation: breaking with reasoning founded on disrespect for life and human dignity. Med Law 1993;12(1-2):85-92.

> Donated ovarian tissue in embryo research and assisted conception: public consultation document. UK Human Fertilisation and Embryo Authority. Hum Reprod 1994 May;9(5):931-5.

> Edwards JH, Benham JD. Views on donated ovarian tissue [letter]. Lancet 1994 Sep 17;344(8925):824. Comment on: Lancet 1994 Jul 16;344(8916):204.

> Edwards RG, Beard HK. Destruction of cryopreserved embryos. UK law dictated the destruction of 3000 cryopreserved human embryos. Hum Reprod 1997 Jan;12(1):3-5; discussions 5-6.

> Eisenberg VH, Schenker JG. Preembryo research: medical aspects and ethical considerations. Obstet Gynecol Surv 1997 Sep;52(9):565-74.

> Embryo research [editorial]. Nature 1990 Apr 19;344(6268):690.

> Eser A. The legal status of the embryo in comparative perspective. Med Law 1992;11(7-8):579-90.

> Ewing C. Australian perspectives on embryo experimentation: an update. Issues Reprod Genet Eng J Int Feminist Anal 1990;3(2):119-23.

> Fackelmann KA. Embryo research panel ignites debate [news]. Sci News 1994 Oct 1;146(14):212.

> Fasouliotis SJ, Schenker JG. Cryopreservation of embryos: medical, ethical, and legal issues. J Assist Reprod Genet 1996 Nov;13(10):756-61.

> Ferguson-Smith ME. Ethical and legal implications in IVF and prenatal diagnosis in the UK. Prenat Diagn 1991 Aug;11(8):661-70.

> Fletcher JC. Women's and fetal rights and interests: ethical aspects. Food Drug Law J 1993;48(2):213-21.

> Fletcher JC, Richter G. Human fetal gene therapy: moral and ethical questions. Hum Gene Ther 1996 Aug 20;7(13):1605-14.

> Franco JG Jr. Frozen embryos in Brazil. Hum Reprod 1995 Dec;10(12):3082-3.

> Freeman JS. Arguing along the slippery slope of human embryo research. J Med Philos 1996 Feb;21(1):61-81.

> German Embryo Protection Act. October 24th, 1990. Hum Reprod 1991 Apr;6(4):605-6.

> Gershon D. NIH panel opens debate on ethics of embryo research [news]. Nature 1994 Feb 10;367(6463):502.

> Goldbeck-Wood S. Europe is divided on embryo regulations [news]. BMJ 1996 Aug 31;313(7056):512.

> Green RM. The Human Embryo Research Panel: lessons for public ethics. Camb Q Healthc Ethics 1995 Fall;4(4):502-15.

> Handyside A. Sex and the single cell [news]. New Sci 1990 Apr 21;126(1713):34-5.

> Hersey J. Enigma of the unborn mother: legal and ethical considerations of aborted fetal ovarian tissue and ova transplantations. UCLA Law Rev 1995 Oct;43(1):159-207.

> Holt E, Maddison J, Sidebotham M. Views on donated ovarian tissue [letter]. Lancet 1994 Sep 17;344(8925):824-5.

> Holzgreve W, Garritsen HS, Tercanli S, Miny P, Nippert I, Ganshirt D. Noninvasive prenatal diagnosis. Strategy for a clinical trial. Ann N Y Acad Sci 1994 Sep 7;731:253-6.

> Human experimentation: United States and Canada decide to slow down human reproduction research [news]. Hosp Ethics 1994 Jan-Feb;10(1):10-2.

> Kazem R, Thompson LA, Hamilton MP, Templeton A. Current attitudes towards egg donation among men and women. Hum Reprod 1995 Jun;10(6):1543-8.

> Klein RD. IVF research: a question of feminist ethics. Issues Reprod Genet Eng J Int Feminist Anal 1990;3(3):243-51.

> Krimsky S, Hubbard R. The business of research. Hastings Cent Rep 1995 Jan-Feb;25(1):41-3. Published erratum appears in Hastings Cent Rep 1995 May-Jun;25(3):2.

> Lappert PW. Scarless fetal skin repair: unborn patients and fetal material [letter]. Plast Reconstr Surg 1996 Nov;98(6):1125.

> Laruelle C, Englert Y. Psychological study of in vitro fertilization-embryo transfer participants' attitudes toward the destiny of their supernumerary embryos. Fertil Steril 1995 May;63(5):1047-50. Comment in: Fertil Steril 1996 Jan;65(1):205-6.

> Lornage J, Chorier H, Boulieu D, Mathieu C, Czyba JC. Six year follow-up of cryopreserved human embryos. Hum Reprod 1995 Oct;10(10):2610-6.

> Lyall H, Murray E, Glasier A, Baird DT. Donated ovarian tissue in embryo research and assisted conception--the view of women of reproductive age. Hum Reprod 1995 May;10(5):1242-5.

> Marshall E. Embryologists dismayed by sanctions against geneticist [news]. Science 1997 Jan 24;275(5299):472.

> Martin PA, Lagod ML. The human preembryo, the progenitors, and the state: toward a dynamic theory of status, rights, and research policy. High Technol Law J 1990 Fall;5(2):257-310.

> McCormick RA. The preembryo as potential: a reply to John A. Robertson. Kennedy Inst Ethics J 1991 Dec;1(4):303-5.

> Minkoff HL, Moreno JD. Paternal consent for fetal research [letter]. N Engl J Med 1993 Jul 22;329(4):278.

> More fuss about genetics and embryos [editorial]. Nature 1994 Jan 13;367(6459):99-100.

> Mulkay M. Women in the parliamentary debate over embryo research. Sci Tech Hum Values 1994 Winter;19(1):5-22.

> Multhaupt S, Kloth K. In-vitro fertilization and embryo research: the necessity of statutory regulations. Med Law 1991;10(6):565-73.

> Nathanson B. Of pre-embryos and Bourbon kings. Ethics Med 1992 Spring;8(1):1-3.

> Ohlendorf-Moffat P. Surgery before birth. Discover 1991 Feb;12(2):58-65.

> Penn ZJ, Steer PJ. Reasons for declining participation in a prospective randomized trial to determine the optimum mode of delivery of the preterm breech. Control Clin Trials 1990 Aug;11(4):226-31.

> Quintavalle J. Case for reforming Human Fertilisation and Embryology Authority [letter]. Lancet 1996 Sep 14;348(9029):758.

> Quintavalle J. What to do with spare embryos [letter]. Lancet 1996 May 25;347(9013):1489. Comment on: Lancet 1996 Apr 13;347(9007):983.

> Robertson JA. Legal and ethical issues arising with preimplantation human embryos. Arch Pathol Lab Med 1992 Apr;116(4):430-5.

> Robertson JA. What we may do with preembryos: a response to Richard A. McCormick. Kennedy Inst Ethics J 1991 Dec;1(4):293-302.

> Rogers A. European data protection to give unborn children rights? [news]. Lancet 1997 Feb 22;349(9051):550.

> Rosenwaks Z, Davis OK. On the disposition of cryopreserved human embryos: an opinion. Hum Reprod 1997 Jun;12(6):1121.

> Sams L. Ethical dilemmas in maternal-fetal research. MCN Am J Matern Child Nurs 1997 Mar-Apr;22(2):67-71.

> Samuels A, Barrister JP. Embryo research: the significance of the new law. Med Sci Law 1991 Apr;31(2):115-8.

> Saunders DM, Bowman MC, Grierson A, Garner F. Frozen embryos: too cold to touch? The dilemma ten years on. Hum Reprod 1995 Dec;10(12):3081-2.

> Schafer D, Kettner M. Moral concern over cryopreserved human embryos: too much or too little? Hum Reprod 1997 Jan;12(1):10-1.

> Schenker JG. Research on human embryos. Eur J Obstet Gynecol Reprod Biol 1990 Sep;36(3):267-73.

> Sperber GH. The ethics of embryo experimentation [editorial]. Cleft Palate Craniofac J 1995 Jul;32(4):269-70.

> Sullivan L. Embryo experimentation and the murder prohibition: a casuistic examination of the utilitarian and pro-life positions on the moral status of the embryo. Med Law 1995;14(5-6):369-86.

> Tauer CA. Embryo research and public policy: a philosopher's appraisal. J Med Philos 1997 Oct;22(5):423-39.

> Thomas AK. Human embryo experimentation and surrogacy. Med J Aust 1990 Oct 1;153(7):369-71.

> Waldschmidt A. The embryo as a legal entity -- woman as a fetal environment: the new German laws on reproductive engineering and embryo research. Issues Reprod Genet Eng J Int Feminist Anal 1991;4(3):209-22.

> Warnock M. Ethical challenges in embryo manipulation. BMJ 1992 Apr 18;304(6833):1045-9.

> Warnock M. Green College Lecture. Ethical challenges in embryo manipulation. BMJ 1992 Apr 18;304(6833):1045-9. Comment in: BMJ 1992 May 30;304(6839):1446.

> Warren MA. Embryo manipulation and experimentation. Baillieres Clin Obstet Gynaecol 1991 Sep;5(3):591-609.

> Yding AC, Westergaard LG, Grinsted J, Petersen K, Nyboe AA. Frozen embryos: too cold to touch? Frozen pre-embryos in Denmark. Hum Reprod 1996 Apr;11(4):703.

> Return to table of contents

> ## Gamete, embryo and fetal research - Books

> Annual Report 1989 and 1990. The Hague: Health Council of the Netherlands; 1991 Sep 2. 32 p.

> Annual Report 1992. London: The Human Fertilisation and Embryology Authority; 1992. 36 p.

> Bertazzoni U, et al., editors. Human embryos and research: proceedings of the European Bioethics Conference; 1988 Nov 7-9; Mainz. New York: Campus Verlag; 1990. 258 p. (Gentechnologie; 25).

> Code of practice: consultation document. London: Human Fertilisation and Embryology Authority; 1991. 37 p.

> Ethics and mapping of the human genome: protection of sensitive personal information, genetic screening, and genetic testing in appointments, etc.: Reports [and] fifth annual report. 1992. Copenhagen: Danish Council of Ethics; 1993. 115 p.

> Evans D. Conceiving the embryo: ethics, law and practice in human embryology. Boston: Martinus Nijhoff; 1996. 358 p.

> Evans MI, editor. Fetal diagnosis and therapy: science, ethics, and the law. Philadelphia: Lippincott; c1989. 592 p.

> Fetal diagnosis and ethics: a report [and] third annual report, 1990. Copenhagen: Danish Council of Ethics; 1991. 82 p.

> Human Fertilisation and Embryology Authority (Great Britain). Statutory storage period for embryos. London: Department of Health; 1995 Jul. 13 p. Report by the Human Fertilisation and Embryology Authority to the Health Ministers of the United Kingdom.

> Humber JM, Almeder RF. Biomedical ethics reviews, 1991. Bioethics and the fetus: medical, moral and legal issues. Totowa (NJ): Humana Press; 1991. 190 p.

> Kolata G. The baby doctors: probing the limits of fetal medicine. New York: Delacorte Press; 1990. 213 p.

> Manual for centres. London: The Human Fertilisation and Embryology Authority; 1991 Jun. 1 vol. Looseleaf.

> Mulkay MJ. The embryo research debate: science and the politics of reproduction. New York: Cambridge University Press; 1997. 212 p. (Cambridge cultural social studies).

> Nimrod C, Griener G. Biomedical ethics and fetal therapy. Waterloo (Ontario): Wilfred Laurier University Press; 1988. 122 p. Published for the Calgary Institute for the Humanities.

> Protection of human gametes, fertilized ova, embryos and fetuses: a report [and] second annual report, 1989. Copenhagen: Danish Council of Ethics; 1990. 147 p.

> Rini SM, editor. Beyond abortion: a chronicle of fetal experimentation. Avon-by-the-Sea (NJ): Magnificat Press; c1988. 186 p.

> Singer P, editor. Embryo experimentation. New York: Cambridge University Press; 1990. 263 p.

> Steinberg DL. Bodies in glass: genetics, eugenics, embryo ethics. Manchester (England): Manchester University Press; 1997. 224 p.

> Steinbock B. Life before birth: the moral and legal status of embryos and fetuses. New York: Oxford University Press; 1992. 256 p.

> Swedish act concerning use of gene technology on human beings and experiments with fertilised ova. Stockholm: Ministry of Health and Social Affairs; 1991. 17 p.

> Washington M, editor. Fetal research: a survey of state law. Washington: Library of Congress; 1988. 15 p. (CRS report for Congress; 88-198 A).

> Return to table of contents

> ## Human cloning - Journal Articles

> Adult cloning marches on [editorial]. Nature 1998 Jul 23;394(6691):303. Comment on: Nature 1998 Jul 23;394(6691):315-6; Nature 1998 Jul 23;394(6691):329-30; Nature 1998 Jul 23;394(6691):369-74.

> Andrews LB. Mom, dad, clone: implications for reproductive privacy. Camb Q Healthc Ethics 1998 Spring;7(2):176-86.

> Andrews LB, Rothstein MA, Latham SR, Garfinkel MD, Charo RA. The clone age. ABA J Lawyers Mag 1997 Jul;83:68-73.

> Annas GJ. Regulatory models for human embryo cloning: the free market, professional guidelines, and government restrictions. Kennedy Inst Ethics J 1994 Sep;4(3):235-49.

> Annas GJ. Why we should ban human cloning. N Engl J Med 1998 Jul 9;339(2):122-5.

> Annas GJ, Robertson JA. Human cloning: should the United States legislate against it? Yes, individual dignity demands nothing less; No the potential for good is too compelling. ABA J Lawyers Mag 997 May;1(83):80-1.

> Benatar D. Cloning and ethics. QJM 1998 Feb;91(2):165-6.

> Blacksher E. Cloning human beings. Responding to the National Bioethics Advisory Commission's Report. Hastings Cent Rep 1997 Sep-Oct;27(5):6-9.

> Bloom FE. Breakthroughs 1997 [editorial]. Science 1997 Dec 19;278(5346):2029.

> Bower H. Public consultation on human cloning launched [news]. BMJ 1998 Feb 7;316(7129):411.

> Boyd KM. Little lamb, who made thee? A letter from Edinburgh [letter]. Camb Q Healthc Ethics 1998 Spring;7(2):199-202.

> Buck G. An open letter to Dr. Seed [satire]. JAMA 1998 Apr 1;279(10):977.

> Buehler DA. CQ sources/bibliography. Camb Q Healthc Ethics 1998 Spring;7(2):203-5.

> Bulfield G, Campbell K, James R, Wilmut I. Voices from Roslin: the creators of Dolly discuss science, ethics, and social responsibility [interview by Arlene Judith Klotzko]. Camb Q Healthc Ethics 1998 Spring;7(2):121-40.

> Burke MB. NABER on embryo splitting [letter]. Kennedy Inst Ethics J 1996 Jun;6(2):210-1.

> Butler D. Calls for human cloning ban 'stem from ignorance' [news]. Nature 1997 May 22;387(6631):324. Comment in: Nature 1997 Jul 24;388(6640):320.

> Butler D. Europe brings in first international ban [news]. Nature 1998 Jan 15;391(6664):219.

> Butler D. European ethics advisers back cloning ban [news]. Nature 1997 Jun 5;387(6633):536.

> Butler D, Schiermeier Q. Ruttgers and Chirac seek cloning ban [news]. Nature 1997 May 8;387(6629):111.

> Butler D, Wadman M. Calls for cloning ban sell science short [news]. Nature 1997 Mar 6;386(6620):8-9.

> Cahill LS. The status of the embryo and policy discourse. J Med Philos 1997 Oct;22(5):407-14.

> Callahan D. Cloning: the work not done. Hastings Cent Rep 1997 Sep-Oct;27(5):18-20.

> Callahan D. Cloning: then and now. Camb Q Healthc Ethics 1998 Spring;7(2):141-4.

> Campbell CS. Prophecy and policy. Hastings Cent Rep 1997 Sep-Oct;27(5):15-7.

> Caplan A, Venter C. Using one's head [letter]. Science 1997 Nov 28;278(5343):1547-8. Comment on: Science 1997 Oct 31;278(5339):798.

> Capron AM. Inside the Beltway again: a sheep of a different feather. Kennedy Inst Ethics J 1997 Jun;7(2):171-9.

> Capron AM. Is it time to clone a bioethics commission? Hastings Cent Rep 1994 Jan-Feb;24(1):29-30.

> Childress JF. The challenges of public ethics: reflections on NBAC's report. Hastings Cent Rep 1997 Sep-Oct;27(5):9-11.

> Cimons M. Cloning research a possibility [news]. Nat Med 1997 Jul;3(7):710.

> Clone encounters [editorial]. Nat Genet 1997 Apr;15(4):323-4.

> Cloning: realising the benefits while minimising the risks [news]. Vet Rec 1997 Mar 29;140(13):323-4.

> Coghlan A. One small step for a sheep [news]. New Sci 1997 Mar 1;153(2071):4.

> Coghlan A. Will cloned cows rise from the dead? [news]. New Sci 1997 Mar 8;153(2072):5.

> Cohen CB. Future directions for human cloning by embryo splitting: after the hullabaloo. Kennedy Inst Ethics J 1994 Sep;4(3):187-92.

> Cohen J, Tomkin G. The science, fiction, and reality of embryo cloning. Kennedy Inst Ethics J 1994 Sep;4(3):193-203.

> Cole-Turner R. Human cloning research [letter]. N Engl J Med 1998 Jun 11;338(24):1770-1. Comment on: N Engl J Med 1998 Mar 26;338(13):905-6.

> Conley JJ. Narcissus cloned. America 1994 Feb 12;170(5):15-7.

> Cooling down over cloning [editorial]. Lancet 1998 Jan 17;351(9097):151.

> Council for Responsible Genetics. Position statement on cloning. Bull Med Ethics 1997 Sep;131:10-1.

> de Grouchy J. The ethician's puzzle. Biomed Pharmacother 1997;51(9):365-6.

> Dickson D. UK consults public on clones for research [news]. Nature 1998 Feb 5;391(6667):523.

> Double trouble [editorial]. Nature 1997 Aug 7;388(6642):501. Comment on: Nature 1997 Aug 7;388(6642):508.

> Drury KC. Viable offsprings derived from fetal and adult mammalian cells. J Womens Health 1998 May;7(4):475-6.

> Ethical aspects of cloning techniques. Advisers to the President of the European Commission on the Ethical Implications of Biotechnology. J Med Ethics 1997 Dec;23(6):349-52.

> Ethical aspects of cloning techniques: opinion of the Group of Advisers on the Ethical Implications of Biotechnology of the European Commission. Camb Q Healthc Ethics 1998 Spring;7(2):187-91; discussion 192-3.

> Ethical aspects of genetic modification of animals: opinion of the Group of Advisers on the Ethical Implications of Biotechnology of the European Commission. Camb Q Healthc Ethics 1998 Spring;7(2):194-6; discussion 196-8.

> European Parliament. Cloning animals and human beings. [Resolution of 12 March 1997]. Bull Med Ethics 1997 May;128:10-1.

> Fainzilber M. Advantage of knowing nature's secrets [letter]. Nature 1997 Apr 3;386(6624):431. Comment on: Nature 1997 Feb 27;385(6619):757. Comment in: Nature 1997 May 8;387(6629):119.

> Fielding EW. Fear of cloning. Hum Life Rev 1997 Spring;23(2):15-22.

> FitzGerald KT. Human cloning: analysis and evaluation. Camb Q Healthc Ethics 1998 Spring;7(2):218-22.

> Fox JL. Bioethicists ruminate separately on clones, gene 'enhancements' [news]. Nat Biotechnol 1997 May;15(5):406-7.

> Fox JL. US bioethicists say continue human cloning moratorium [news]. Nat Biotechnol 1997 Jul;15(7):609.

> French Academy split on cloning policy [news]. Nature 1997 Jul 3;388(6637):11.

> Galton DJ, Kay A, Cavanna JS. Human cloning: safety is the issue [letter]. Nat Med 1998 Jun;4(6):644.

> Greenberg DS. Much ado about mutton? Lancet 1997 Jun 21;349(9068):1850.

> Greenberger P. Research funding and cloning: top recent policy agenda [news]. J Womens Health 1998 Jun;7(5):501-3.

> Griffin H, Wilmut I. Seven days that shook the world. New Sci 1997 Mar 22;153(2074):49.

> Group of Advisers to the President of the European Commission on the Ethical Implications of Biotechnology. Ethical aspects of cloning techniques. J Med Ethics 1997 Dec;23(6):349-52.

> Haglund K. Ninety-day wonder [editorial]. J NIH Res 1997 Jul;9(7):10.

> Harris J. Cloning and bioethical thinking [letter]. Nature 1997 Oct 2;389(6650):433. Comment on: Nature 1997 Jul 24;388(6640):320.

> Harris J. Cloning and human dignity. Camb Q Healthc Ethics 1998 Spring;7(2):163-7.

> Harris J. Goodbye Dolly? The ethics of human cloning. J Med Ethics 1997 Dec;23(6):353-60.

> Harris J. Is cloning an attack on human dignity? [letter]. Nature 1997 Jun 19;387(6635):754. Comment on: Nature 1997 Feb 27;385(6619):810-3; Nature 1997 Mar 13;386(6621):119. Comment in: Nature 1997 Jul 3;388(6637):15; Nature 1997 Jul 24;388(6640):320.

> Healy BP. The asexual revolution of Dolly the lamb [editorial]. J Womens Health 1998 Feb;7(1):1-2.

> Hodgson J. Dolly opens a farm full of possibilities [news]. Nat Biotechnol 1997 Apr;15(4):306.

> Holden C. Scholars' group defends cloning [news]. Science 1997 May 30;276(5317):1341.

> Holden C. UN weighs in on cloning [news]. Science 1997 Nov 21;278(5342):1407.

> Holm S. A life in the shadow: one reason why we should not clone humans. Camb Q Healthc Ethics 1998 Spring;7(2):160-2.

> Hopkins PD. Bad copies. How popular media represent cloning as an ethical problem. Hastings Cent Rep 1998 Mar-Apr;28(2):6-13.

> Hoyle R. Arrogance on human cloning may pose a threat to biotechnology. Nat Biotechnol 1998 Jan;16(1):6.

> Hubris, benefits and minefields of human cloning. Editorial. Nature 1998 Jan 15;391(6664):211.

> Husted GL, Husted JH. An ethical defense against the plague of cloning. Adv Pract Nurs Q 1997 Fall;3(2):82-4.

> Husted GL, Husted JH. An ethical examination of cloning. AORN J 1997 Jun;65(6):1112-3.

> Husted GL, Husted JH. Is cloning moral? N HC Perspect Community 1997 May-Jun;18(3):168-9.

> Jones HW. Reflections on the usefulness of embryo cloning. Kennedy Inst Ethics J 1994 Sep;4(3):205-7.

> Jones HW, Edwards RG, Seidel GE. On attempts at cloning in the human [editorial]. Fertil Steril 1994 Mar;61(3):423-6.

> Jones S. Send in the clones. Nurs Times 1997 Mar 19-25;93(12):24.

> Josefson D. US scientist plans human cloning clinic [news]. BMJ 1998 Jan 17;316(7126):167.

> Kahn A. Clone mammals... clone man? Nature 1997 Mar 13;386(6621):119. Comment on: Nature 1997 Feb 27;385(6619):810-3. Comment in: Nature 1997 Jun 19;387(6635):754.

> Kahn A. Cloning, dignity and ethical revisionism [letter]. Nature 1997 Jul 24;388(6640):320. Comment on: Nature 1997 May 22;387(6631):321; Nature 1997 May 22;387(6631):324; Nature 1997 Jun 19;387(6635):754. Comment in: Nature 1997 Aug 7;388(6642):511; Nature 1997 Oct 2;389(6650):433.

> Kassirer JP, Rosenthal NA. Should human cloning research be off limits? [editorial]. N Engl J Med 1998 Mar 26;338(13):905-6. Comment in: N Engl J Med 1998 Jun 11;338(24):1770; discussion 1771; N Engl J Med 1998 Jun 11;338(24):1770-1.

> Kestenbaum D. Cloning plan spawns ethics debate [news]. Science 1998 Jan 16;279(5349):315.

> Kim JH. Human cloning and the digital revolution. MD Comput 1998 Jul-Aug;15(4):215-6.

> Kitcher P. Quality, not quantity. New Sci 1997 Mar 15;153(2073):47.

> Klotzko AJ. The debate about Dolly. Bioethics 1997 Oct;11(5):427-38.

> Klotzko AJ. Dolly, cloning, and the public misunderstanding of science: a challenge for us all [editorial]. Camb Q Healthc Ethics 1998 Spring;7(2):115-6.

> Klotzko AJ. An embryonic dilemma. Nurs Times 1997 Oct 22-28;93(43):38-9.

> Kolberg R. Human embryo cloning reported [news]. Science 1993 Oct 29;262(5134):652-3.

> Kuhse H, Singer P. Cloning our way to Armageddon? [editorial]. Bioethics 1997 Oct;11(5):3-5.

> Macilwain C. Cloning of human embryos draws fire from critics [news]. Nature 1993 Oct 28;365(6449):778.

> Macklin R. Cloning without prior approval: a response to recent disclosures of noncompliance. Kennedy Inst Ethics J 1995 Mar;5(1):57-60.

> Macklin R. Splitting embryos on the slippery slope: ethics and public policy. Kennedy Inst Ethics J 1994 Sep;4(3):209-25.

> MacQuitty JJ. The real implications of Dolly. Nat Biotechnol 1997 Apr;15(4):294.

> Marshall E. Biomedical groups derail fast-track anticloning bill [news]. Science 1998 Feb 20;279(5354):1123-4.

> Marshall E. Clinton urges outlawing human cloning [news]. Science 1997 Jun 13;276(5319):1640.

> Marshall E. Mammalian genome debate heats up [news]. Science 1997 Mar 21;275(5307):1733.

> Marshall E. Panel weighs a law against cloning [news]. Science 1997 May 23;276(5316):1185-6.

> Marwick C. Put human cloning on hold, say bioethicists [news]. JAMA 1997 Jul 2;278(1):13-4.

> McClenahan JL. Anyone for cloning? Va Med Q 1998 Spring;125(2):110-1.

> McCormick RA. Blastomere separation: some concerns. Hastings Cent Rep 1994 Mar-Apr;24(2):14-6.

> Meyer JR. Cloning human embryos: why artificial human procreation is immoral. Linacre Q 1995 May;62(2):22-9.

> Michael A. Europe/Japan face up to legal hurdles to cloning [news]. Nat Biotechnol 1997 Jul;15(7):609-10.

> Miller FG, Caplan AL, Fletcher JC. Dealing with Dolly: inside the National Bioethics Advisory Commission. Health Aff (Millwood) 1998 May-Jun;17(3):264-7.

> Miller SK, Vines G. Human clones split fertility experts [news]. New Sci 1993 Oct 30;140(1897):7.

> More ado about cloning [news]. Nat Biotechnol 1998 Mar;16(3):219.

> Morton O, Williams N. First Dolly, now headless tadpoles [news]. Science 1997 Oct 31;278(5339):798. Comment in: Science 1997 Nov 28;278(5343):1547-8.

> National Advisory Board on Ethics in Reproduction (NABER). Report on human cloning through embryo splitting: an amber light. Kennedy Inst Ethics J 1994 Sep;4(3):251-82.

> Nelkin D, Lindee MS. Cloning in the popular imagination. Camb Q Healthc Ethics 1998 Spring;7(2):145-9.

> Nestle N. Cloning humans [letter]. Nature 1997 May 8;387(6629):119. Comment on: Nature 1997 Apr 3;386(6624):431.

> Newman SA. Cloning our way to the next level. Nat Biotechnol 1997 Jun;15(6):488.

> Newman SA. Human cloning and the family: reflections on cloning existing children. N Y Law Sch J Hum Rights 1997 Spring;13(3):523-30.

> Nicholson R. Two of a kind--or none? [news]. Hastings Cent Rep 1997 May-Jun;27(3):5.

> O'Brien C. Cloned sheep rekindles ethical debate [news]. Mol Med Today 1997 Apr;3(4):140.

> O'Connor J. Human cloning: efficiency vs. ethics. Origins 1997 Apr 10;26(42):681, 683-4.

> Opposition to human cloning [news]. JAMA 1997 Apr 9;277(14):1105.

> Parens E. Tools from and for democratic deliberations. Hastings Cent Rep 1997 Sep-Oct;27(5):20-2.

> Pennisi E. The lamb that roared [news]. Science 1997 Dec 19;278(5346):2038-9. Comment on: Science 1997 Dec 19;278(5346):2130-3.

> Post SG. The Judeo-Christian case against human cloning. America 1997 Jun 21;176(21):19-22.

> Report on cloning by the US Bioethics Advisory Commission: ethical considerations. Hum Reprod Update 1997 Nov-Dec;3(6):629-41.

> Rhodes R. Clones, harms, and rights. Camb Q Healthc Ethics 1995 Summer;4(3):285-90.

> Roberts MA. Human cloning: a case of no harm done? J Med Philos 1996 Oct;21(5):537-54.

> Robertson JA. Human cloning and the challenge of regulation. N Engl J Med 1998 Jul 9;339(2):119-22.

> Robertson JA. Liberty, identity, and human cloning. Texas Law Rev 1998 May;76(6):1371-456.

> Robertson JA. The question of human cloning. Hastings Cent Rep 1994 Mar-Apr;24(2):6-14.

> Rogers A. Britain denies prevarication over human-cloning ban [news]. Lancet 1997 Oct 18;350(9085):1151.

> Rogers A. Europe takes steps to outlaw human cloning [news]. Lancet 1997 Oct 4;350(9083):1012.

> Rovner J. USA to think again about ban on human cloning [news]. Lancet 1998 Feb 21;351(9102):578.

> Saegusa A. Japan gears up to debate brake on human cloning [news]. Nature 1998 Jan 22;391(6665):313.

> Saegusa A. Japanese fear that new publicity rules could hinder their research [news]. Nature 1998 Jul 30;394(6692):408.

> Shapiro D. Cloning, dignity and ethical reasoning [letter]. Nature 1997 Aug 7;388(6642):511. Comment on: Nature 1997 Jul 24;388(6640):320.

> Shapiro HT. Ethical and policy issues of human cloning. Science 1997 Jul 11;277(5323):195-6.

> Short-circuit to be avoided by bioethics committees [editorial]. Nature 1997 May 22;387(6631):321.

> Silberner J. Seeding the cloning debate. Hastings Cent Rep 1998 Mar-Apr;28(2):5.

> Silva YJ. Cloning: the cataclysmic human challenge [news]. Natl Med J India 1998 Mar-Apr;11(2):92.

> Silver LM. Cloning, ethics, and religion. Camb Q Healthc Ethics 1998 Spring;7(2):168-72.

> Soldini M. Human cloning research [letter]. N Engl J Med 1998 Jun 11;338(24):1770; discussion 1771.

> Solter D. Dolly is a clone--and no longer alone [news]. Nature 1998 Jul 23;394(6691):315-6. Comment on: Nature 1998 Jul 23;394(6691):329-30; Nature 1998 Jul 23;394(6691):369-74. Comment in: Nature 1998 Jul 23;394(6691):303.

> SoRelle R. Legislation of human cloning in the United States [news]. Circulation 1998 May 19;97(19):1889.

> Stephenson J. Threatened bans on human cloning research could hamper advances [news]. JAMA 1997 Apr 2;277(13):1023, 1025-6.

> Strong C. Cloning and infertility. Camb Q Healthc Ethics 1998 Summer;7(3):279-93.

> Sylvester R. No more cloning around [news]. Nurs Times 1997 Oct 22-28;93(43):24.

> Taggart MJ. Advantage of knowing nature's secrets [letter]. Nature 1997 Apr 3;386(6624):431. Comment on: Nature 1997 Feb 27;385(6619):810-3.

> Tanos V, Schenker JG. Reproductive health care policies around the world. Is human cloning justified? J Assist Reprod Genet 1998 Jan;15(1):1-9.

> The point of no return [editorial]. New Sci 1997 Mar 1;153(2071):3.

> Triumph of hope [editorial]. New Sci 1997 May 31;154(2084):3.

> Trounson AO. Cloning: potential benefits for human medicine [editorial]. Med J Aust 1997 Dec 1-15;167(11-12):568-9.

> van der Linde I. The gynaecologist who started all the fuss [news]. S Afr Med J 1998 Apr;88(4):420.

> Verhey AD. Cloning: revisiting an old debate. Kennedy Inst Ethics J 1994 Sep;4(3):227-34.

> Voelker R. Opposition to human cloning grows [news]. JAMA 1997 Jun 11;277(22):1750.

> Vogel G. From science fiction to ethics quandary [news]. Science 1997 Sep 19;277(5333):1753-4.

> Wadman M. Backing for anti-cloning bill reopens embryo debate [news]. Nature 1997 Aug 7;388(6642):505.

> Wadman M. Cloned mice fail to rekindle ethics debate [news]. Nature 1998 Jul 30;394(6692):408-9.

> Wadman M. Cloning for research 'should be allowed' [news]. Nature 1997 Jul 3;388(6637):6.

> Wadman M. Seed sows further doubts on cloning [news]. Nature 1998 Jan 15;391(6664):218-9.

> Wadman M. US biologists adopt cloning moratorium [news]. Nature 1997 Sep 25;389(6649):319.

> Wadman M. US panel to back longer cloning ban, ducks thornier questions [news]. Nature 1997 May 15;387(6630):217-8.

> Wadman M. US sees flurry of bills in bids to legislate [news]. Nature 1998 Feb 5;391(6667):523.

> Wadman M. US Senate bills on cloning under fire from researchers [news]. Nature 1998 Feb 12;391(6668):623.

> Wadman M. US senators urge caution on cloning ban [news]. Nature 1997 Mar 20;386(6622):204.

> Wadman M. White House bill would ban human cloning [news]. Nature 1997 Jun 12;387(6634):644.

> Warnock M. The regulation of technology. Camb Q Healthc Ethics 1998 Spring;7(2):173-5.

> Watson R. European parliament wants world ban on human cloning [news]. BMJ 1997 Mar 22;314(7084):847.

> Watson R. The [European] Union gets interested in ethics [news]. BMJ 1997 Jun 28;314(7098):1854.

> Watt H. What moral status has a human clone? [letter]. Bull Med Ethics 1993 Nov;93 :2.

> White RJ. Human cloning research [letter]. N Engl J Med 1998 Jun 11;338(24):1770; discussion 1771.

> Wilkie T, Graham E. Power without responsibility: media portrayals of Dolly and science. Camb Q Healthc Ethics 1998 Spring;7(2):150-9.

> Williams N. Cloning sparks calls for new laws [news]. Science 1997 Mar 7;275(5305):1415.

> Winston R. The promise of cloning for human medicine [editorial]. BMJ 1997 Mar 29;314(7085):913-4. Comment in: BMJ 1997 Jul 26;315(7102):255.

> Wolf DP, Meng L, Ely JJ, Stouffer RL. Recent progress in mammalian cloning. J Assist Reprod Genet 1998 May;15(5):235-9.

> Wolf PL, Liggins G, Mercola D. The cloning debates and progress in biotechnology [editorial]. Clin Chem 1997 Nov;43(11):2019-20.

> Wolf SM. Ban cloning? Why NBAC is wrong. Hastings Cent Rep 1997 Sep-Oct;27(5):12-5.

> Return to table of contents

> ## Human cloning - Books

> Biotechnology and the Ethics of Cloning: How Far Should We Go? Hearing (1997 Mar 5). Washington: U.S. Government Printing Office; 1997. 59 p.

> Cloning human beings: report and recommendations of the National Bioethics Advisory Commission. Rockville (MD): The Commission; 1997.

> Harris J. Clones, genes, and immortality: ethics and the genetic revolution. New York: Oxford University Press; 1998. 328 p. Originally published as: Wonderwoman and superman. 1992.

> Kass LR. Ethics of human cloning. Washington: American Enterprise Institute for Public Policy Research; 1998.

> Kolata G. Clone: the road to Dolly, and the path ahead. New York: William Morrow; 1998. 276 p.

> Nussbaum MC, Sunstein CR, editors. Clones and clones. Facts and fantasies about human cloning. New York: W. W. Norton & Co.; 1998. 288 p.

> Pence GE. Flesh of my flesh: the ethics of cloning humans: a reader. Lanham (MD): Rowman and Littlefield; 1998. 154 p.

> Scientific Discoveries in Cloning: Challenges for Public Policy: Hearing (1997 Mar 12). Washington: U.S. Government Printing Office; 1997. 87 p.

> Silver LM. Remaking Eden: cloning and beyond in a brave new world. 1st ed. New York: Avon Books; c1997. 317 p.

> Winters PA. Cloning. San Diego (CA): Greenhaven Press; c1998. 89 p.

> World Health Organization, Fiftieth World Health Assembly. Cloning in human reproduction. Geneva: World Health Organization; 1997 May 14. 10 p.

> Return to table of contents

> ## Research using human biological materials including fetal tissue - Journal Articles

> Adams B. Restoring hope: lifting the ban on fetal tissue transplantation research. Acad Med 1992 Apr;67(4):246-7.

> Adams M, Prentice ED, Oki GS. Ethical considerations in informed consent for potential future use of human tissue samples. IRB Rev Hum Subj Res 1996 Mar-Apr;18(2):6-7.

> Alexander D. It's time to get on with it [editorial]. Fetal Diagn Ther 1994 May-Jun;9(3):139-41.

> Allmers H. Ethics of cloning [letter]. Lancet 1997 May 10;349(9062):1401. Comment on: Lancet 1997 Mar 8;349(9053):661.

> American College of Medical Genetics Storage of Genetics Materials Committee. Statement on storage and use of genetic materials. Am J Hum Genet 1995 Dec;57(6):1499-500.

> American Medical Association, Council on Scientific Affairs and Council on Ethical and Judicial Affairs. Medical applications of fetal tissue transplantation. JAMA 1990 Jan 26;263(4):565-70.

> Ammann AJ, Bertolini F, Robustelli della Cuna G, Locatelli F, Maccario R, Zecca M, Abecasis MM, Guimaraes A, Machado A, Kurtzberg J, Rubenstein P, Stevens CE, Jefferies LC, Silberstein LE. Placental-blood transplantation [letters and response]. N Engl J Med 1997 Jan 2;336(1):68-70.

> Anderson C. Fetal tissue research. Tissue ban under fire [news]. Nature 1991 Apr 18;350(6319):543.

> Anderson F, Glasier A, Ross J, Baird DT. Attitudes of women to fetal tissue research. J Med Ethics 1994 Mar;20(1):36-40.

> Andrews L, Nelkin D. Whose body is it anyway? Disputes over body tissue in a biotechnology age. Lancet 1998 Jan 3;351(9095):53-7.

> Annas GJ. Privacy rules for DNA databanks. Protecting coded 'future diaries'. JAMA 1993 Nov 17;270(19):2346-50.

> Asano S, Nakahata T, Takahashi TA. Application for patent opposed [letter]. Nature 1996 Sep 5;383(6595):17. Comment on: Nature 1996 Jul 11;382(6587):108.

> Ashwood-Smith MJ. Frozen Canadian zygotes. Hum Reprod 1995 Dec;10(12):3082.

> Bain L. Fetal tissue transplantation in Parkinson's disease. Br J Nurs 1993 Nov 11-24;2(20):1012-6.

> Barrad CMV. Genetic information and property theory. Northwest Univ Law Rev 1993 Spring;87(3):1037-86.

> Barry R, Kesler D. Pharaoh's magicians: the ethics and efficacy of human fetal tissue transplants. Thomist 1990 Oct;54(4):575-607.

> Bauer AR. Fetal tissue transplantation: legal and ethical implications of a magic bullet. Leg Med 1991:245-67.

> Beardsley T. Aborting research [news]. Sci Am 1992 Aug;267(2):17-8. Comment in: Sci Am 1992 Dec;267(6):10.

> Beecham L. BMA says fetal tissue should not be used for treatment [news]. BMJ 1994 May 21;308(6940):1375.

> Beecham L, Smith J. Fetal tissue may be used for research not infertility treatment [news]. BMJ 1994 Jul 16;309(6948):200.

> Bell NM. Regulating transfer and use of fetal tissue in transplantation procedures: the ethical dimensions. Am J Law Med 1994;20(3):277-94.

> Benbassat J, Levy M. Researchers' access to stored medical data: the Israeli experience. IRB Rev Hum Subj Res 1988 May-Jun;10(3):1-3.

> Bergman HR. Case comment: Moore v. Regents of the University of California. Am J Law Med 1992;18(1-2):127-45.

> Bianchi DW, Bernfield M, Nathan DG. A revived opportunity for fetal research. Nature 1993 May 6;363(6424):12. Comment in: Nature 1993 Aug 19;364(6439):665.

> Biesecker LG. In response to 'Molecular pathology, informed consent, and the paraffin block' [letter]. Diagn Mol Pathol 1996 Mar;5(1):74-5.

> Boer GJ. Ethical guidelines for the use of human embryonic or fetal tissue for experimental and clinical neurotransplantation and research. Network of European CNS Transplantation and Restoration (NECTAR). J Neurol 1994 Dec;242(1):1-13.

> Boyer KL, Bakay RA. The history, theory, and present status of brain transplantation. Neurosurg Clin N Am 1995 Jan;6(1):113-25.

> Brahams D. Body parts as property [editorial]. Med Leg J 1998;66(Pt 2):45-7.

> Brahams D. Brain banks. Lancet 1990 Feb 3;335(8684):282-3.

> Brody EB. Women's rights and the medical use of fetal tissue: an international perspective. R I Med J 1990 Feb;73(2):53-8; discussion 59-67.

> Brower V. The FDA reinvents human cell and tissue regulations [news]. Nat Biotechnol 1997 May;15(5):411.

> Brundin P, Bjorklund A, Lindvall O. Practical aspects of the use of human fetal brain tissue for intracerebral grafting. Prog Brain Res 1990;82:707-14.

> Burd L, Gregory JM, Kerbeshian J. The brain-mind quiddity: ethical issues in the use of human brain tissue for therapeutic and scientific purposes. J Med Ethics 1998 Apr;24(2):118-22.

> Burgio GR, Locatelli F. Transplant of bone marrow and cord blood hematopoietic stem cells in pediatric practice, revisited according to the fundamental principles of bioethics. Bone Marrow Transplant 1997 Jun;19(12):1163-8.

> Burn J, Strachan T. Human embryo use in developmental research [news]. Nat Genet 1995 Sep;11(1):3-6.

> Burrows B. Second thoughts about U.S. Patent #4,438,032. Bull Med Ethics 1997 Jan;124:11-4.

> Burtchaell JT. The moral defect in fetal tissue research. J Christ Nurs 1990 Spring;7(2):40.

> Burtchaell JT. University policy on experimental use of aborted fetal tissue: case study. IRB Rev Hum Subj Res 1988 Jul-Aug;10(4):7-11.

> Burtchaell JT. The use of aborted fetal tissue in research: a rebuttal. IRB Rev Hum Subj Res 1989 Mar-Apr;11(2):9-12.

> Butler D. Tensions grow over access to DNA bank [news]. Nature 1998 Feb 19;391(6669):727.

> Butler D. US company comes under fire over patent on umbilical cord cells [news]. Nature 1996 Jul 11;382(6587):99.

> Caplan AL. The short, exceedingly strange debate over fetal tissue transplant research. Am J Ethics Med 1994 Fall;3(1):24-7.

> Carroll VS. The cutting edge: neurotransmitters and brain tissue transplant. AACN Clin Issues Crit Care Nurs 1991 Nov;2(4):699-705.

> Casper MJ. At the margins of humanity: fetal positions in science and medicine. Sci Tech Hum Values 1994 Summer;19(3):307-23.

> Cefalo RC, Berghmans RLP, Hall SP. The bioethics of human fetal tissue research and therapy: moral decision making of professionals. Am J Obstet Gynecol 1994 Jan;170(1 Pt 1):12-9.

> Chadwick R. The spare embryo -- a response. Health Care Anal 1993 Jun;1(1):67-8.

> Chase DS, Tawn EJ, Parker L, Jonas P, Parker CO, Burn J. The North Cumbria Community Genetics Project. J Med Genet 1998 May;35(5):413-6.

> Childress JF. Disassociation from evil: the case of human fetal tissue transplantation research. Soc Responsib Bus J Law Med 1990;16:32-49.

> Childress JF. Ethics, public policy, and human fetal tissue transplantation research. Kennedy Inst Ethics J 1991 Jun;1(2):93-121.

> Chisholm AH. Fetal tissue transplantation for the treatment of Parkinson's disease: a review of the literature. J Neurosci Nurs 1996 Oct;28(5):329-38.

> Cho MK. Are clinical trials of cell transplantation for Duchenne muscular dystrophy ethical? IRB Rev Hum Subj Res 1994;16(1-2):12-5.

> Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ, Kopelman LM, Weiss JO. Informed consent for genetic research on stored tissue samples. JAMA 1995;274(22):1786-92. Comments in: JAMA 1995 Dec 13;274(22):1806-7; JAMA 1996 Apr 10;275(14):1085-6.

> Coghlan A. Organs for research are on the cards [news]. New Sci 1997 Apr 5;154(2076):5.

> Coghlan A. Spare parts ... but not for surgery [news]. New Sci 1996 Jun 22;150(2035):6.

> Cohen J. New fight over fetal tissue grafts [news]. Science 1994 Feb 4;263(5147):600-1.

> Cohen LG. Before their time: fetuses and infants at risk. Monogr Am Assoc Ment Retard 1990;(16):1-118.

> Cohen P. Los Alamos faces 'bodysnatch' lawsuit [news]. New Sci 1996 Nov 2;152(2054):110.

> Coles P. French fetal cell transplant operations [news]. Nature 1990 Dec 20-27;348(6303):667.

> Coutts MC. Fetal tissue research [bibliography]. Kennedy Inst Ethics J 1993 Mar;3(1):81-101.

> Crigger BJ. The Research Freedom Act [news]. Hastings Cent Rep 1991 Jan-Feb;21(1):2.

> Crutcher KA. Fetal tissue research: the cutting edge? Linacre Q 1993 May;60(2):10-19.

> Culliton BJ. Needed: fetal tissue research [news]. Nature 1992 Jan 23;355(6358):295.

> Davis DS. Embryos created for research purposes. Kennedy Inst Ethics J 1995 Dec;5(4):343-54.

> de Gorgey A. The advent of DNA databanks: implications for information privacy. Am J Law Med 1990;16(3):381-98.

> de St Jean van der Reit F. Establishment of human DNA and plasma or serum banks for research purposes--a proposal [letter]. S Afr Med J 1997 May;87(5):622-3.

> de Witte JI, ten Have H. Ownership of genetic material and information. Soc Sci Med 1997 Jul;45(1):51-60.

> de Witte JI, Welie JV. The status of genetic material and genetic information in The Netherlands. Soc Sci Med 1997 Jul;45(1):45-9.

> Denman C. Ethics of 'brain transplants' [letter]. Br J Psychiatry 1990 Oct;157:625. Comment on: Br J Psychiatry 1990 Aug;157:302.

> DeRenzo EG, Biesecker LG, Meltzer N. Genetics and the dead: implications for genetics research with samples from deceased persons. Am J Med Genet 1997 Mar 31;69(3):332-4.

> Deutsch E. The use of human tissue, particularly foetal tissue, in neurosurgery. Med Law 1990;9(1):671-4.

> Dickens BM. The ethics of fetal-tissue donation: consensus and contradiction [editorial]. CMAJ 1994 Aug 1;151(3):279-82. Comment on: CMAJ 1994 Aug 1;151(3):325-30.

> Dickens BM. Living tissue and organ donors and property law: more on "Moore". J Contemp Health Law Policy 1992 Spring;8:73-93.

> Donovan P. Funding restrictions on fetal research: the implications for science and health. Fam Plann Perspect 1990 Sep-Oct;22(5):224-31.

> Dracker RA. Cord blood stem cells: how to get them and what to do with them. J Hematother 1996 Apr;5(2):145-8.

> Dunnett SB, Kendall AL, Watts C, Torres EM. Neuronal cell transplantation for Parkinson's and Huntington's diseases. Br Med Bull 1997;53(4):757-76.

> Dyer O. Non-transplanted organs can be used for research [news]. BMJ 1996 Jun 29;312(7047):1631.

> Dyer O. Working party speaks out on use of human tissue [news]. BMJ 1995 May 6;310(6988):1159.

> Easton S, Lamb D. Transplanting fetal tissue. Nurs Times 1991 Jul 31-Aug 6;87(31):39-40.

> Edwards RG. Human embryo as a source of cells. Bone Marrow Transplant 1992;9 Suppl 1:90-2.

> Elsner R. Tissues not for sale [news]. Nature 1990 Jul 19;346(6281):208. Comment in: Nature 1990 Oct 4;347(6292):419.

> Elsom MK. Fetal tissue transplants. Can Nurse 1992 Jun;88(6):31-2.

> European Association of Tissue Banks. New rules proposed for tissue banks. Official statement. Bull Med Ethics 1994 May;98:10-1.

> Evans D. Procuring gametes for research and therapy [editorial]. J Med Ethics 1995 Oct;21(5):261-4. Comment in: J Med Ethics 1997 Apr;23(2):93-5.

> Evans DW. Use of fetal eggs for research [letter]. BMJ 1994 Oct 15;309(6960):1018.

> Evered D. Human tissues: legal and ethical issues [editorials]. J R Coll Physicians Lond 1996 Jan-Feb;30(1):6-7.

> Farnam CR. Fetal tissue transplant research: ethical dilemmas. Todays Surg Nurse 1996 Sep-Oct;18(5):9-15.

> Fennell S, Jones DG. The bequest of human bodies for dissection: a case study in the Otago Medical School. N Z Med J 1992 Nov 25;105(946):472-4.

> Ferry G. Parkinson's: a suitable case for treatment? New Sci 1994 Dec 3;144(1954):36-40.

> Fetal tissue debate on complicity [letter]. Hastings Cent Rep 1990 Mar-Apr;20(2):50-1. Comment on: Hastings Cent Rep 1988 Dec;18(6):5-12.

> Fine A. Human fetal tissue research: practice, prospects, and policy. Cell Transplant 1994 Mar-Apr;3(2):113-45.

> Flake AW, Zanjani ED. In utero hematopoietic stem cell transplantation. A status report. JAMA 1997 Sep 17;278(11):932-7.

> Fletcher JC. Fetal therapy, ethics and public policies. Fetal Diagn Ther 1992;7(2):158-68.

> Fletcher JC. Fetal tissue transplantation research and federal policy: a growing wall of separation. Fetal Diagn Ther 1990;5(3-4):211-25.

> Fletcher JC, Anderson WF. Germ-line gene therapy: a new stage of debate. Law Med Health Care 1992 Spring-Summer;20(1-2):26-39.

> Fletcher S. Innovative treatment or ethical headache? Fetal transplantation in Parkinson's disease. Prof Nurse 1992 Jun;7(9):592-5.

> Forrest AR. Some patients may want to retain ownership of tissue removed from them [letter]. BMJ 1997 Apr 19;314(7088):1201-2. Comment on: BMJ 1996 Nov 30;313(7069):1366-8.

> Fraser JK, Sugarman J, McCurdy PR, Martin NL, Ammann AJ. Scientific, logistical, and ethical issues related to creation of a stem cell repository for use in experimental trials of gene therapy for AIDS. AIDS Res Hum Retroviruses 1997 Jul 20;13(11):905-7.

> Freedman B. The ethics of using human fetal tissue -- a response to Burtchaell: I. IRB Rev Hum Subj Res 1988 Nov-Dec;10(6):1-4.

> Freeman TB. From transplants to gene therapy for Parkinson's disease. Exp Neurol 1997 Mar;144(1):47-50.

> Freeman TB, Sanberg PR. Peer review for fetal tissue transplantation research [editorial]. Cell Transplant 1992;1(4):271-3.

> Frozen pre-embryos. JAMA 1990 May 9;263(18):2484-7. Comment in: JAMA 1990 Nov 14;264(18):2382-3.

> Frozen pre-embryos [letter]. JAMA 1990 Nov 14;264(18):2382-3. Comment on: JAMA 1990 May 9;263(18):2484-7.

> Furman J, Murphy WM, Rice L, Drew PA, Narayan P. Prostatectomy tissue for research: balancing patient care and discovery. Am J Clin Pathol 1998 Jul;110(1):4-9. Comment in: Am J Clin Pathol 1998 Jul;110(1):1-2.

> Garry DJ. The use of human fetal tissue in research and transplantation: sources of human fetal tissue. Med Trial Tech Q 1993;39:264-85.

> Garry DJ, Caplan AL, Vawter DE, Kearney W. Are there really alternatives to the use of fetal tissue from elective abortions in transplantation research? N Engl J Med 1992 Nov 26;327(22):1592-5.

> Gavaghan H. NIH gets the green light on embryo research [news]. Nature 1994 Sep 29;371(6496):370.

> Gelfand G, Levin TR. Fetal tissue research: legal regulation of human fetal tissue transplantation. Wash Lee Law Rev 1993 Spring;50(2):647-94.

> Geller SA. Guardians of the wax [letter]. Am J Clin Pathol 1996 Mar;105(3):371.

> Gene donors' rights at risk [editorial]. Nature 1996 May 2;381(6577):1.

> Gero E, Giordano J. Ethical considerations in fetal tissue transplantation. J Neurosci Nurs 1990 Feb;22(1):9-12.

> Gershon D. Fetal tissue research. New panel for ethical issues [news]. Nature 1991 Jan 17;349(6306):184.

> Gershon D. US panel firms up views on embryo research [news]. Nature 1994 Jul 7;370(6484):8.

> Gillam L. Arguing by analogy in the fetal tissue debate. Bioethics 1997 Oct;11(5):397-12.

> Gillon R. Brain transplantation, personal identity and medical ethics [editorial]. J Med Ethics 1996 Jun;22(3):131-2. Comment on: J Med Ethics 1996 Jun;22(3):174-80.

> Gluckman E. European organization for cord blood banking. Blood Cells 1994;20(2-3):601-8. Comment in: Blood Cells 1994;20(2-3):627-9.

> Golde DW, Rodwin MA. Commercial development of human cell lines -- property, ethics, and conflict of interest [letter and response]. N Engl J Med 1991 Jun 13;324(24):1745-6.

> Gollin MA. Biological materials transfer agreements. Biotechnology (NY) 1995 Mar;13(3):243-4.

> Gosden RG. Transplantation of fetal germ cells. J Assist Reprod Genet 1992 Apr;9(2):118-23.

> Green RM. At the vortex of controversy: developing guidelines for human embryo research. Kennedy Inst Ethics J 1994 Dec;4(4):345-56.

> Greenberg DS. When science and politics collide [news]. Lancet 1992 Jun 13;339(8807):1469-70.

> Greenberg W, Kamin D. Property rights and payment to patients for cell lines derived from human tissues: an economic analysis. Soc Sci Med 1993 Apr;36(8):1071-6.

> Grody WW. Molecular pathology, informed consent, and the paraffin block. Diagn Mol Pathol 1995 Sep;4(3):155-7.

> Grody WW, Sobel ME. Update on informed consent for stored tissue research. Diagn Mol Pathol 1996 Jun;5(2):79-80.

> Haglund K. Timing is everything for tissue-sample genetics [editorial]. J NIH Res 1997 Jan;9(1):10.

> Haley R, Harvath L, Sugarman J. Ethical issues in cord blood banking: summary of a workshop. Transfusion 1998 Sep;38(9):867-73. Comment in: Transfusion 1998 Sep;38(9):807-9.

> Hall J, Hamerton J, Hoar D, Korneluk R, Ray P, Rosenblatt D, Wood S, Canadian College of Medical Geneticists. Policy statement concerning DNA banking and molecular genetic diagnosis. Clin Invest Med 1991 Aug;14(4):363-5.

> Hamilton DP. The tissue bank's shaky underpinnings. Science 1992 Aug 14;257(5072):869.

> Hannig VL, Clayton EW, Edwards KM. Whose DNA is it anyway? Relationships between families and researchers. Am J Med Genet 1993 Aug 15;47(2):257-60.

> Harby K. Using fetus-derived tissues for molecular medicine: tension between research and ethics. Mol Med Today 1996 Aug;2(8):326-9.

> Harper PS. Research samples from families with genetic diseases: a proposed code of conduct. BMJ 1993 May 22;306(6889):1391-4.

> Hartman RG. Beyond Moore: issues of law and policy impacting human cell and genetic research in the age of biotechnology. J Leg Med 1993 Sep;14(3):463-77.

> Hartshorne G, Sargent I, Barlow D. In-vitro maturation as a source of human oocytes and embryos for research. Hum Reprod 1994 Jun;9(6):970-2.

> Hayflick L. Anomalies of tissue research [letter]. Nature 1992 Apr 23;356(6371):652.

> Healey JM. The Moore case and the doctor patient relationship. Conn Med 1991 Aug;55(8):496.

> Healey JM, Dowling KL. Controlling conflicts of interest in the doctor-patient relationship: lessons from "Moore v. Regents of the University of California". Mercer Law Rev 1991 Spring;42(3):989-1005.

> Heyd D. Experimenting with embryos: can philosophy help? Bioethics 1996 Oct;10(4):292-309.

> HFEA rules on donated ovarian tissue [news]. Bull Med Ethics.1994 Jun-Jul;(99):4-6.

> Hicks SC. Law, policy and personhood in the context of the techniques of human experimentation in modern medicine. Cap Univ Law Rev 1990;19(2):255-99.

> Hitchcock ER. Fetal transplantation in Parkinson's disease [letter]. Br J Hosp Med 1990 Feb;43(2):106. Comment on: Br J Hosp Med 1989 Oct;42(4):261, 263.

> Hoffer BJ, Olson L. Ethical issues in brain-cell transplantation. Trends Neurosci 1991 Aug;14(8):384-8.

> Holden C. Tricky ethics of tissue samples [news]. Science 1998 Mar 13;279(5357):1621.

> Holder AR. Consent to use of discarded tissues: another impact of AIDS. IRB Rev Hum Subj Res 1987 Sep-Oct;9(5):10-1.

> Holder AR. What is a contract of adhesion? IRB Rev Hum Subj Res 1991;13(4):10-1.

> Holm S. The spare embryo -- a red herring in the embryo experimentation debate. Health Care Anal 1993 Jun;1(1):63-6.

> Hurd RE. Ethical issues surrounding the transplantation of human fetal tissues. Clin Res 1992 Dec;40(4):661-6.

> Implications of fetal cell transplantation. Nurs Stand 1992 Jan 29-Feb 4;6(19):35.

> Informed consent and the use of gametes and embryos for research. The Ethics Committee of the American Society for Reproductive Medicine. Fertil Steril 1997 Nov;68(5):780-1.

> Jochemsen H. Transplantation of fetal tissue: a medical and ethical assessment, with special attention for the treatment of patients with Parkinson's disease. Ethics Med 1994 Autumn;10(3):56-7.

> Jones D. Halifax hospital first in Canada to proceed with controversial fetal-tissue transplant [news]. CMAJ 1992 Feb 1;146(3):389-91.

> Jones D. Hospital's decision to pursue fetal transplantation upsets anti-abortionists [news]. CMAJ 1990 Jun 1;142(11):1274-5, 1277.

> Jones DG. Fetal neural transplantation: placing the ethical debate within the context of society's use of human material. Bioethics 1991 Jan;5(1):23-43.

> Jones DG, Harris RJ. Neural transplantation. N Z Med J 1996 Oct 11;109(1031):369-71.

> Kassirer JP, Angell M. The use of fetal tissue in research on Parkinson's disease [editorial]. N Engl J Med 1992 Nov 26;327(22):1591-2. Comment on: N Engl J Med 1992 Nov 26;327(22):1541-8; N Engl J Med 1992 Nov 26;327(22):1549-55; N Engl J Med 1992 Nov 26;327(22):1556-63. Comment in: N Engl J Med 1993 Nov 18;329(21):1579; discussion 1580.

> Kearney W, Vawter DE, Gervais KG. Fetal tissue research and the misread compromise. Hastings Cent Rep 1991 Sep-Oct;21(5):7-12.

> Kemmy J. Ownership rights to tissue specimens. AORN J 1992 Dec;56(6):1115-21.

> Keown J. The Polkinghorne Report on Fetal Research: nice recommendations, shame about the reasoning. J Med Ethics 1993 Jun;19(2):114-20.

> Khushf G. Embryo research: the ethical geography of the debate. J Med Philos 1997 Oct;22(5):495-519.

> King PA. Embryo research: the challenge for public policy. J Med Philos 1997 Oct;22(5):441-55.

> Kingman S. Fetal tissue research around the world [news]. BMJ 1992 Mar 7;304(6827):591-3.

> Kinney JH. Restricting donative choice: fetal tissue transplantation and respect for human life. J Law Health 1995-6;10(2):259-85.

> Kischer CW. A new wave dialectic: the reinvention of human embryology. Linacre Q 1994 Nov;61(4):66-81.

> Kite CH. Fetal tissue grafting with the central nervous system: yesterday, today, and tomorrow [letter]. Neurosurgery 1994 Jun;34(6):1101-2. Comment on: Neurosurgery 1993 Oct;33(4):645-7.

> Klen R, Jebavy J. Fetal tissue banks need ethical code. Bull Med Ethics 1995 Jan;104:18-20.

> Knoppers BM, Hirtle M, Lormeau S, Laberge CM, Laflamme M. Control of DNA samples and information. Genomics 1998 Jun 15;50(3):385-401.

> Knoppers BM, Laberge CM. Research and stored tissues. Persons as sources, samples as persons? [editorial]. JAMA 1995 Dec 13;274(22):1806-7. Comment on: JAMA 1995 Dec 13;274(22):1783-6; JAMA 1995 Dec 13;274(22):1786-92.

> Kopelman LM. Informed consent and anonymous tissue samples: the case of HIV seroprevalence studies. J Med Philos 1994 Dec;19(6):525-52.

> Koshland DE Jr. Fetal tissue research [editorial]. Science 1992 Jun 26;256(5065):1741. Comment in: Science 1992 Aug 21;257(5073):1027.

> Kurtzberg J. Umbilical cord blood: a novel alternative source of hematopoietic stem cells for bone marrow transplantation [editorial]. J Hematother 1996 Apr;5(2):95-6.

> Leadbeatter S. Human tissue research: is legislation needed? [letter]. Br J Hosp Med 1994 Feb 2-15;51(3):132-3. Comment on: Br J Hosp Med 1993 Aug 18-31;50(4):157-9.

> Lehrman S. US court challenge may limit use of data in DNA banks [news]. Nature 1996 Feb 1;379(6564):385.

> Levine RJ. An IRB-approved protocol on the use of human fetal tissue. IRB Rev Hum Subj Res 1989 Mar-Apr;11(2):7-8.

> Lin MMJ. Conferring a federal property right in genetic material: stepping into the future with the Genetic Privacy Act [note]. Am J Law Med 1996;22(1):109-34.

> Lind SE. Ethical considerations related to the collection and distribution of cord blood stem cells for transplantation to reconstitute hematopoietic function. Transfusion 1994 Sep;34(9):828-34. Comment in: Transfusion 1995 Nov-Dec;35(11):967-8.

> Liskowsky DR. From the Congressional Office of Technology Assessment: neural grafting. JAMA 1991 Jun 26;265(24):3225.

> LiVolsi VA. Use of human tissue blocks for research. Association of Directors of Anatomic and Surgical Pathology. Hum Pathol 1996 Jun;27(6):519-20.

> LiVolsi VA. Use of human tissue blocks for research [editorial]. Mod Pathol 1996 May;9(5):467-8.

> MacDonald AS. Foetal neuroendocrine tissue transplantation for Parkinson's disease: an institutional review board faces the ethical dilemma. Transplant Proc 1990 Jun;22(3):1030-2.

> Macilwain C. US military tightens rules on DNA records [news]. Nature 1996 Apr 18;380(6575):570.

> Maguire PJ. Quo vadis? J Okla State Med Assoc 1994 Oct;87(10):467-8.

> Mahaney FX Jr. California court decision has major impact on informed consent [news]. J Natl Cancer Inst 1990 Sep 19;82(18):1453-4. Published erratum appears in J Natl Cancer Inst 1990 Nov 21;82(22):1745.

> Maloney DM. Possible protection for researchers who maintain genetic data records [news]. Hum Res Rep 1996 Apr;11(4):6.

> Markowitz MS. Human fetal tissue: ethical implications for use in research and treatment. AWHONNS Clin Issues Perinat Womens Health Nurs 1993;4(4):578-88.

> Maroney HM. Bioethical catch-22: the moratorium on federal funding of fetal tissue transplantation research and the NIH revitalization amendments [comment]. J Contemp Health Law Policy 1993 Spring;9:485-519.

> Marshall E. Clinical promise, ethical quandary [news]. Science 1996 Feb 2;271(5249):586-8.

> Marshall E. Whose DNA is it, anyway? [news]. Science 1997 Oct 24;278(5338):564-7.

> Martin DK. Abortion and fetal tissue transplantation. IRB Rev Hum Subj Res 1993 May-Jun;15(3):1-4.

> Martin DK, Maclean H, Lowy FH, Williams JI, Dunn EV. Fetal tissue transplantation and abortion decisions: a survey of urban women. CMAJ 1995 Sep 1;153(5):545-52.

> Marwick C. Feds may fund study of existing embryos only [news]. JAMA 1995 Jan 11;273(2):97-8.

> Marwick C. With fetal tissue moratorium lifted, applications begin reaching National Institutes of Health [news]. JAMA 1993 Mar 3;269(9):1086.

> Mason JO. Fetal tissue transplantation research. In support of the moratorium. Fetal Diagn Ther 1990;5(1):2-3.

> McCarthy CR. When OPRR comes calling: enforcing federal research regulations. Kennedy Inst Ethics J 1995 Mar;5(1):51-5.

> McCaskie AW, Roberts M, Gregg PJ. Human tissue retrieval at post-mortem for musculoskeletal research. Br J Biomed Sci 1995 Sep;52(3):222-4.

> McCauley C. Fetal tissue: a medicolegal predicament. Med Trial Tech Q 1994;40:230-43.

> McConnell J. Prison cell to pixel. Lancet 1994 Dec 10;344(8937):1632.

> McCullough J, Clay ME, Fautsch S, Noreen H, Segall M, Perry E, Stroncek D. Proposed policies and procedures for the establishment of a cord blood bank. Blood Cells 1994;20(2-3):609-26. Comment in: Blood Cells 1994;20(3):627-9.

> McEwen JE, Reilly PR. Setting standards for DNA banks: toward a model code of conduct. Microb Comp Genomics 1996;1(3):165-77.

> McEwen JE, Reilly PR. Stored Guthrie cards as DNA banks. Am J Hum Genet 1994 Jul;55(1):196-200.

> McEwen JE, Reilly PR. A survey of DNA diagnostic laboratories regarding DNA banking. Am J Hum Genet 1995 Jun;56(6):1477-86.

> McGleenan T. Back to basics on fetal ovarian tissue. Bull Med Ethics 1994 Jun-Jul;99:13-8.

> McIntosh H. Researchers coping with sensitive patent issues [news]. J Natl Cancer Inst 1996 Sep 4;88(17):1180-2.

> McLean S. Human tissue: ethical and legal issues -- the report from the Nuffield Council on Bioethics provides a coherent legal and ethical approach [editorial]. BMJ 1995 Jun 3;310(6992):1423-4.

> McMillan MP. Banking on cord blood [editorial]. J Obstet Gynecol Neonatal Nurs 1996 Feb;25(2):115.

> Meng GM. Issues in the development of a local cord blood bank. J Hematother 1996 Apr;5(2):129-33.

> Menitove JE. Cord blood banking: blood banking, ethical, and related issues. Curr Probl Obstet Gynecol Fertil 1996 Mar-Apr;19(2):70-3.

> Merz JF, Sankar P, Taube SE, Livolsi V. Use of human tissues in research: clarifying clinician and researcher roles and information flows. J Investig Med 1997 Jun;45(5):252-7.

> Mestel R. Russia provides fetal tissue for American transplants [news]. New Sci 1993 Apr 24;138(1870):7.

> Mills SE, Kempson RL, Fechner RE, Frierson HF Jr, Wick MR, Dehner LP, Swanson PE, Humphrey PA. Guardians of the wax ... and the patient. Mod Pathol 1995 Sep;8(7):699-700. Comment in: Mod Pathol 1996 Apr;9(4):457.

> Mnookin S. Department of Defense DNA registry raises legal, ethical issues. GeneWATCH 1996 Aug;10(1):1, 3, 11.

> Morgan G. The regulation of fetal tissue transplantation. Univ New South Wales Law J 1990;14(2):283-301.

> Mullen MA, Lowy FH. Physician attitudes toward the regulation of fetal tissue therapies: empirical findings and implications for public policy. J Law Med Ethics 1993 Summer;21(2):241-50.

> Mullen MA, Williams JI, Lowy FH. Transplantation of electively aborted human fetal tissue: physicians' attitudes. CMAJ 1994 Aug 1;151(3):325-30. Comment in: CMAJ 1994 Aug 1;151(3):279-82.

> NABER analyzes uses of human fetal oocytes and ovarian tissue. NABER Rep 1995;1(3):2-4.

> Nelkin D, Andrews L. Do the dead have interests? Policy issues for research after life. Am J Law Med 1998;24(2-3):261-91

> Nelkin D, Andrews L. Homo economicus: commercialization of body tissue in the age of biotechnology. Hastings Cent Rep 1998 Sep-Oct;28(5)30-9

> Nelson RM. A policy concerning the therapeutic use of human fetal tissue in transplantation. West J Med 1990 Apr;152(4):447-8.

> Nicholson RH. The good received, the giver is forgot [news]. Hastings Cent Rep 1994 Jul-Aug;24(4):5.

> Nolan K. The use of embryo or fetus in transplantation: what there is to lose. Transplant Proc 1990 Jun;22(3):1028-9.

> Northoff G. Do brain tissue transplants alter personal identity? Inadequacies of some standard arguments. J Med Ethics 1996 Jun;22(3):174-80. Comment in: J Med Ethics 1996 Jun;22(3):131-2.

> O'Brien C. U.K. panel weighs tissue ownership [news]. Science 1995 Apr 28;268(5210):492.

> O'Neill O. Medical and scientific uses of human tissue [editorial]. J Med Ethics 1996 Feb;22(1):5-7.

> Owens RG. Ethics of executed person on Internet [letter]. Lancet 1995 Mar 11;345(8950):653.

> Palca J. Fetal research ban on shaky ground? [news]. Science 1990 Feb 9;247(4943):629.

> Palca J. Fetal tissue. Banking for transplantation research [news]. Science 1992 May 29;256(5061):1274. Comment in: Science 1992 Jul 17;257(5068):310.

> Patel T. French law clamps down on tissue traders [news]. New Sci 1994 Jul 2;143(1932):6.

> Perley SN. From control over one's body to control over one's body parts: extending the doctrine of informed consent [note]. N Y Univ Law Rev 1992 May;67(2):335-65.

> Potts J. Moore vs Regents of the University of California: expanded disclosure, limited property rights [note]. Northwest Univ Law Rev 1992 Winter;86(2):453-96.

> Powledge TM. Springtime for fetal research? [news]. Hastings Cent Rep 1991 Mar-Apr;21(2):5-6.

> Prentice ED, Wiltse JC, Sharp JG, Antonson DL. An institutional policy on the right to benefit from the commercialization of human biological material. Law Med Health Care 1990 Spring-Summer;18(1-2):162-7.

> Prowda JB. Moore vs The Regents of the University of California: an ethical debate on informed consent and property rights in a patient's cells. J Pat Trademark Off Soc 1995 Aug;77(8):611-39.

> Quinn N, Brown R, Craufurd D, Goldman S, Hodges J, Kieburtz K, Lindvall O, MacMillan J, Roos R. Core Assessment Program for Intracerebral Transplantation in Huntington's Disease (CAPIT-HD). Mov Disord 1996 Mar;11(2):143-50.

> Rae SB, DeGiorgio CM. Ethical issues in fetal tissue transplants. Linacre Q 1991 Aug;58(3):12-32.

> Ramsay S. Ovarian tissue donation in UK [news]. Lancet 1994 Jul 30;344(8918):323.

> Randal J. Presidential bioethics subcommittee wrestles with confidentiality of tissue donors [news]. J Natl Cancer Inst 1997 Dec 17;89(24):1837-8.

> Rankin JC, Liebman MH, Robertson JA. The fetal tissue debate on complicity [letters and responses]. Hastings Cent Rep 1990 Mar-Apr;20(2):50-1.

> Regulating embryology [editorial]. Nature 1994 Jul 28;370(6487):236.

> Rehncrona S. A critical review of the current status and possible developments in brain transplantation. Adv Tech Stand Neurosurg 1997;23:3-46.

> Reid MM. Research on leukaemia cells surplus to diagnostic needs in children. J Med Ethics 1994 Dec;20(4):225-8.

> Reilly PR. DNA banking [letter]. Am J Hum Genet 1992 Nov;51(5):1169-70.

> Resnik DB. The morality of human gene patents. Kennedy Inst Ethics J 1997 Mar;7(1):43-61.

> Riis P. The Danish Brain Collection and its important potentials for future research. IRB Rev Hum Subj Res 1993 Nov-Dec;15(6):5-6.

> Roberts SL. With federal funding ban lifted, fetal tissue research will continue in earnest. Diabetes Care 1993 Apr;16(4):668-9.

> Robertson JA. The ethical acceptability of fetal tissue transplants. Transplant Proc 1990 Jun;22(3):1025-7.

> Robertson JA. Fetal tissue transplant research is ethical -- a response to Burtchaell: II. IRB Rev Hum Subj Res 1988 Nov-Dec;10(6):5-8.

> Roeggla G, Landesmann U, Roeggla M. Ethics of executed person on Internet [letter]. Lancet 1995 Jan 28;345(8944):260. Comment on: Lancet 1994 Dec 10;344(8937):1632. Comment in: Lancet 1995 Mar 11;345(8950):653.

> Roessler MA. Fetal tissue transplantation: an ethical analysis. Linacre Q 1993 Aug;60(3):60-74.

> Rojansky N, Schenker JG. The use of fetal tissue for therapeutic applications. Int J Gynaecol Obstet 1993 Jun;41(3):233-40.

> Rosner F, Risemberg HM, Kark PR, Sordillo PP, Bennett AJ, Buscaglia A, Cassell EJ, Farnsworth PB, Halpern AL , Henry JB, et al. Fetal tissue research and transplantation. N Y State J Med 1993 Mar;93(3):174-7.

> Rowe PM. NIH report on human embryo research [news]. Lancet 1994 Oct 8;344(8928):1009.

> Rubinstein P, Taylor PE, Scaradavou A, Adamson JW, Migliaccio G, Emanuel D, Berkowitz RL, Alvarez E , Stevens CE. Unrelated placental blood for bone marrow reconstitution: organization of the placental blood program. Blood Cells 1994;20(2-3):587-96; discussion 596-600. Comment in: Blood Cells 1994;20(2-3):627-9.

> Ruffing JA. Fetal tissue implants: it's time for legislation. Trends Health Care Law Ethics 1993 Summer;8(3):49-52, 48.

> Ryan KJ. Fetal tissue transplantation research. Against the moratorium. Fetal Diagn Ther 1990;5(1):3-4.

> Ryan KJ. Tissue transplantation from aborted fetuses, organ transplantation from anencephalic infants and keeping brain-dead pregnant women alive until fetal viability. So Calif Law Rev 1991 Nov;65(1):683-96.

> Sanberg PR. Students' views on fetal neural tissue transplantation [letter]. Lancet 1990 Jun 30;335(8705):1594.

> Sanberg PR, Koutouzis TK, Freeman TB, Cahill DW, Norman AB. Behavioral effects of fetal neural transplants: relevance to Huntington's disease. Brain Res Bull 1993;32(5):493-6.

> Sanders LM, Giudice L, Raffin TA. Ethics of fetal tissue transplantation. West J Med 1993 Sep;159(3):400-7.

> Sanders LM, Raffin TA. Ethical ground rules for fetal tissue research in the postmoratorium era [editorial]. Chest 1994 Jul;106(1):2-4.

> Sarkos CB. The fetal tissue transplant debate in the United States: where is King Solomon when you need him? [note]. J Law Politics 1991 Winter;7(2):379-416.

> Schmidtke J. Who owns the human genome? Ethical and legal aspects. J Pharm Pharmacol 1992 Feb;44(Suppl 1):205-10.

> Schoenfeld MR. Whose tissues are they anyway? A proposal for state ownership of the human body and its parts [editorial]. J Cardiovasc Diagn Proc 1994-5;12(3):145-49.

> Schulte PA, Sweeney MH. Ethical considerations, confidentiality issues, rights of human subjects, and uses of monitoring data in research and regulation. Environ Health Perspect 1995 Apr;103 Suppl 3:69-74.

> Shannon KM, Kordower JH. Neural transplantation for Huntington's disease: experimental rationale and recommendations for clinical trials. Cell Transplant 1996 Mar-Apr;5(2):339-52.

> Shapiro ED, Weinberg Michelle L. DNA data banking: the dangerous erosion of privacy. Cleveland State Law Rev 1990;38(3):455-86.

> Shaw PJ. Transplantation of cord-blood cells [letter]. N Engl J Med 1995 Jul 6;333(1):67-8; discussion 68-9. Comment on: N Engl J Med 1995 Feb 9;332(6):392-4.

> Shorr AF. Abortion and fetal tissue research: some ethical concerns. Fetal Diagn Ther 1994 May-Jun;9(3):196-203.

> Skett P, Tyson C, Guillouzo A, Maier P. Report on the international workshop on the use of human in vitro liver preparations to study drug metabolism in drug development. Held at Utrecht, The Netherlands, 6-8 September 1994. Biochem Pharmacol 1995 Jul 17;50(2):280-5.

> Sokalska ME. Removal and transplantation of cells, tissues and organs. Eur J Health Law 1996 Mar;3(1):92-4.

> Spalding BJ. Fetal-tissue research: abortion politics slow advances to a crawl. Biotechnology (NY) 1991 Jul;9(7):615-8.

> Start RD, Brown W, Bryant RJ, Reed MW, Cross SS, Kent G, Underwood JC. Ownership and uses of human tissue: does the Nuffield bioethics report accord with opinion of surgical inpatients? BMJ 1996 Nov 30;313(7069):1366-8. Comment in: BMJ 1997 Apr 19;314(7088):1201-2.

> Steinberg KK, Sanderlin KC, Ou CY, Hannon WH, McQuillan GM, Sampson EJ. DNA banking in epidemiologic studies. Epidemiol Rev 1997;19(1):156-62.

> Stephenson J. Pathologists enter debate on consent for genetic research on stored tissue. JAMA 1996 Feb 21;275(7):503-4.

> Strauss E. The tissue issue: losing oneself to science? Sci News 1997 Sep 20;152(12):190-1.

> Strong C. Fetal tissue transplantation: can it be morally insulated from abortion? J Med Ethics 1991 Jun;17(2):70-6.

> Sugarman J, Kaalund V, Kodish E, Marshall MF, Reisner EG, Wilfond BS, Wolpe PR. Ethical issues in umbilical cord blood banking. Working Group on Ethical Issues in Umbilical Cord Blood Banking. JAMA 1997 Sep 17;278(11):938-43.

> Sugarman J, Reisner EG, Kurtzberg J. Ethical aspects of banking placental blood for transplantation. JAMA 1995 Dec 13;274(22):1783-5. Comment in: JAMA 1995 Dec 13;274(22):1806-7; JAMA 1996 Mar 27;275(12):910.

> Swain MS, Marusyk RW. An alternative to property rights in human tissue. Hastings Cent Rep 1990 Sep-Oct;20(5):12-5.

> Tedeschi CM. Foetal tissue transplantation research: scientific progress and the role of special interest groups. Minerva 1995 Spring;33(1):45-66.

> The rights of the many? [editorial]. New Sci 1994 Jan 15;141(1908):3.

> Tichtchenko P, Yudin B. The moral status of fetuses in Russia. Camb Q Healthc Ethics 1997 Winter;6(1):31-8.

> Tomaszewski JE, LiVolsi VA. Striking a balance: tissue harvesting for prostate cancer research [editorial]. Am J Clin Pathol 1998 Jul;110(1):1-2. Comment on: Am J Clin Pathol 1998 Jul;110(1):4-9.

> Trounson A, Dawson K. Storage and disposal of embryos and gametes [editorial]. BMJ 1996 Jul 6;313(7048):1-2. Comment on: BMJ 1996 Jul 6;313(7048):24. Comment in: BMJ 1996 Oct 26;313(7064):1079.

> Tuch BE. Human fetal tissue for medical research. Med J Aust 1993 May 3;158(9):637-9. Comment in: Med J Aust 1993 Jul 19;159(2):143; discussion 143-4.

> Tuch BE, Dunn SM, de Vahl Davis V. The effect on researchers of handling human fetal tissue. Transplant Proc 1990 Oct;22(5):2109-10.

> Tuch BE, Dunn SM, de Vahl Davis V. The effect on researchers of handling human fetal tissue. J Clin Ethics 1993 Winter;4(4):319-26. Comment in: J Clin Ethics 1993 Winter;4(4):356-8.

> Turner DA, Kearney W. Scientific and ethical concerns in neural fetal tissue transplantation. Neurosurgery 1993 Dec;33(6):1031-7.

> US squeamishness [editorial]. Nature 1991 Jan 17;349(6306):181.

> Uzych L. Cells, research, and informed consent [letter]. J Natl Cancer Inst 1991 Mar 6;83(5):368.

> Vanchieri C. Researchers struggle to get fetal tissue for cancer research [news]. J Natl Cancer Inst 1992 Mar 18;84(6):382-4.

> Varadi G, Elchalal U, Shushan A, Schenker JG, Nagler A. Umbilical cord blood for use in transplantation. Obstet Gynecol Surv 1995 Aug;50(8):611-7.

> Vawter DE. Fetal tissue transplantation policy in the United States. Politic Life Sci 1993 Feb;12(1):79-85.

> Vawter DE, Caplan A. Strange brew: the politics and ethics of fetal tissue transplant research in the United States. J Lab Clin Med 1992 Jul;120(1):30-4.

> Vawter DE, Gervais KG. Comment on "Abortion and fetal tissue transplantation.". IRB Rev Hum Subj Res 1993 May-Jun;15(3):4-5.

> Vawter DE, Gervais KG. Ethical and policy issues in human fetal tissue transplants. Cell Transplant 1995 Sep-Oct;4(5):479-82.

> Verklan MT. The ethical use of fetal tissue for transplantation and research. J Adv Nurs 1993 Aug;18(8):1172-7.

> Voelker R. A clone by any other name is still an ethical concern [news]. JAMA 1994 Feb 2;271(5):331-2.

> Wade R. Human fetal tissue for medical research [letter]. Med J Aust 1993 Jul 19;159(2):143; discussion 143-4. Comment on: Med J Aust 1993 May 3;158(9):637-9.

> Wadman M. Ethics worries over execution twist to Internet's 'visible man' [news]. Nature 1996 Aug 22;382(6593):657. Comment in: Nature 1996 Oct 3;383(6599):381.

> Wadman M. Rival Parkinson's bills focus US debate on fetal tissue [news]. Nature 1996 Jul 25;382(6589):286.

> Weber-Nordt RM, Schott E, Finke J, Henschler R, Schulz G, Mertelsmann R. Umbilical cord blood: an alternative to the transplantation of bone marrow stem cells. Cancer Treat Rev 1996 Sep;22(5):381-91.

> Weir R, Horton J. DNA banking and informed consent - part 1. IRB Rev Hum Subj Res 1995 Jul-Aug;17( 4):1-4.

> Weir R, Horton J. DNA banking and informed consent - part 2. IRB Rev Hum Subj Res 1995 Sep-Dec;17(5-6):1-8.

> White GB, O'Connor KW. Rights, duties, and commercial interests: John Moore versus the regents of the University of California. Cancer Invest 1990;8(1):65-70.

> Widner H. NIH neural transplantation funding [letter]. Science 1994 Feb 11;263(5148):737.

> Williams D. Human tissue research: is legislation needed? [letter]. Br J Hosp Med 1994 Feb 2-15;51(3):132-3. Comment on: Br J Hosp Med 1993 Aug 18-31;50(4):157-9.

> Youngner SJ. The psychological and moral consequences of participating in human fetal-tissue research [editorial]. J Clin Ethics 1993 Winter;4(4):356-8. Comment on: J Clin Ethics 1993 Winter;4(4):319-26.

> Zilberstein M, Feingold M, Seibel MM. Umbilical-cord-blood banking: lessons learned from gamete donation. Lancet 1997 Mar 1;349(9052):642-3.

> Return to table of contents

> ## Research using human biological materials including fetal tissue - Books

> Background and current practice of fetal tissue and embryo research in Canada. Ottawa: Royal Commission on New Reproductive Technologies; 1993. 288 p. (Research studies; 15).

> Bauer AR. Legal and ethical aspects of fetal tissue transplantation. Austin (TX): R.G. Landes; 1994. 124 p.

> Cataldo PJ, Moraczewski AS. The fetal tissue issue: medical and ethical aspects. Braintree (MA): Pope John XXIII Medical-Moral Research and Education Center, Task Force on Human Fetal Tissue Transplantation; 1994. 191 p.

> College of American Pathologists. Minutes of the Board of Governors meeting; 1995 Aug 2. [Northfield (IL)]: The College; [1995]. Statement on the utilization of stored tissues.

> Committee to Review the Guidance on the Research Use of Fetuses and Fetal Material (Great Britain). Review of the guidance on the research use of fetuses and fetal material. London: Her Majesty's Stationery Office; 1989 Jul. 30 p.

> Council of Europe, Parliamentary Assembly. Recommendation 1100 (1989): On the use of human embryos and foetuses in scientific research. Strasbourg: The Council; 1989. 10 p.

> Dickens BM. Legal issues in embryo and fetal tissue research and therapy. Ottawa: Royal Commission on New Reproductive Technologies; 1991 Dec. 11 p.

> Donated ovarian tissue in embryo research and assisted conception: public consultation document. London: The Human Fertilisation and Embryology Authority; 1994. 12 p. Reprinted in Hum Reprod 1994 May;9(5):931-5.

> Donated ovarian tissue in embryo research and assisted conception: report. London: The Human Fertilisation and Embryology Authority; 1994 Jul. 13 p.

> Gold ER. Body parts: property rights and the ownership of human biological materials. Washington: Georgetown University Press; 1996. 223 p.

> Gunning J. Human IVF, embryo research, fetal tissue for research and treatment, and abortion: international information. London: Her Majesty's Stationery Office; 1990 Feb. 44 p.

> Human fetal tissue transplantation research: report of the Advisory Committee to the Director, National Institutes of Health. December 14, 1988, Bethesda, Maryland. Bethesda: The Institutes; 1988. 49 p.

> Human tissue: ethical and legal issues. London: Nuffield Council on Bioethics; 1995 Apr. 153 p.

> Institute of Medicine, Conference Committee on Fetal Research and Applications. Fetal research and applications: a conference summary. Washington: National Academy Press; 1994. 105 p. Based on the Conference on Fetal Research and Applications, held June 20-2, 1993 in Irvine, Calif.

> Jones DG. Brain grafts: Parkinson's disease, fetuses and ethics. Bramcote (Nottingham, England): Grove Books; 1989. 27 p.

> Langston JW, Palfreman J. The case of the frozen addicts: working at the edge of the mysteries of the human brain. New York: Vintage Books; 1996. 309 p.

> Lehrman D. Fetal research and fetal tissue research: summary. Washington: The Association of American Medical Colleges; 1988 Jun. 34 p.

> Maynard-Moody S. The dilemma of the fetus: fetal research, medical progress, and moral politics. 1st ed. New York: St. Martin's Press; 1995. 235 p.

> Meetings of the Human Fetal Tissue Transplantation Research Panel. Bethesda (MD): National Institutes of Health, Human Fetal Tissue Transplantation Research Panel; 1988. 4 vol. 876 p. Transcript.

> Morgan D, Lee RG. Blackstone's guide to the Human Fertilisation and Embryology Act 1990: abortion and embryo research -- the new law. London: Blackstone Press; 1991. 261 p.

> Mullen MA. The use of human embryos and fetal tissues: a research architecture. Ottawa: Royal Commission on New Reproductive Technologies; 1992 Jan. 41 p.

> National Bioethics Consultative Committee (Australia), Working Group on Embryo Experimentation. Embryo experimentation: report. Canberra: The Committee. 1991. 350 p.

> NIH reauthorization: Hearings: 1991 Apr 15 -- Fetal tissue transplantation research (H.R. 1532), 1991 Apr 16 -- Health Sciences (H.R. 1161 and H.R. 1819). Washington: U.S. Government Printing Office; 1991. 643 p.

> Report of the Human Embryo Research Panel, September 27, 1994. Bethesda (MD): National Institutes of Health, Human Embryo Research Panel; 1994 Sep 27. 111 p.

> Report of the Human Fetal Tissue Transplantation Research Panel. 2 vol. Bethesda (MD): National Institutes of Health. Human Fetal Tissue Transplantation Research Panel; 1988 Dec.

> Report, vol. 1. Bethesda (MD): National Institutes of Health, Human Embryo Research Panel; 1994 Sep. 145 p.

> Report, vol. 2: Papers commissioned for the Human Embryo Research Panel. Bethesda (MD): National Institutes of Health, Human Embryo Research Panel; 1994 Sep. 407 p.

> Research on fetuses. Oslo: National Committee for Medical Research Ethics; 1990 Nov. 29 p.

> Sorsa M. Human biobanks: ethical and social issues. Copenhagen: Nordic Committee on Bioethics; c1997. 147 p.

> Stith-Coleman I. Human fetal research and tissue transplantation. Washington: Library of Congress, Congressional Research Service; 1991. 14 p. (CRS issue brief).

> The Genome Project: the Ethical Issues of Gene Patenting: Hearing Before the Subcomm. on Patents, Copyrights and Trademarks of the Senate Comm. on the Judiciary (1992 Sep 22). Washington: U.S. Government Printing Office; 1993. 240 p.

> Vas CJ, de Souza EJ. Brain transplantation -- ethical concerns: report of a consultation workshop. Bombay: Mrs. P. Rodrigues for Rodrigo Enterprises; FIAMC Bio-Medical Ethics Centre; 1990. 86 p.

> Vawter DE, et al, editors. The use of human fetal tissue: scientific, ethical, and policy concerns: a report of phase I of an interdisciplinary research project conducted by the Center for Biomedical Ethics. Minneapolis: University of Minnesota; c1990. 1 vol.

> Return to table of contents

> ## Xenotransplantation - Journal Articles

> Advisory committee urges caution on xenotransplantation [news]. Vet Rec 1997 Jan 25;140(4):78-9.

> Allan JS. Xenotransplantation at a crossroads: prevention versus progress. Nat Med 1996 Jan;2(1):18-21.

> Andrews J. Animal donors. Nurs Stand 1996 Mar 6;10(24):16.

> Arnold RM, Dresser R, Hefner P, Offner SK. Baboon-to-human transplants: should we proceed? Mak Rounds Health Faith Ethics 1995 Oct 9;1(3):1, 3-4, 8.

> Auchincloss H. Literature update 1997, part 3. Xenotransplantation. 1998 May;5(2):164-7.

> Baboon marrow transplant given OK [news]. Hastings Cent Rep 1995 Sep-Oct;25(5):47.

> Bach FH. Xenotransplantation: problems and prospects. Annu Rev Med 1998;49:301-10.

> Bach FH, Fineberg HV. Call for moratorium on xenotransplants [letter]. Nature 1998 Jan 22;391(6665):326. Comment in: Nature 1998 Mar 5;392(6671):11-2.

> Bach FH, Fishman JA, Daniels N, Proimos J, Anderson B, Carpenter CB, Forrow L, Robson SC, Fineberg HV. Uncertainty in xenotransplantation: individual benefit versus collective risk. Nat Med 1998 Feb;4(2):141-4. Comment in: Nat Med 1998 Feb;4(2):131; Nat Med 1998 Feb;4(2):135-6; Nat Med 1998 Apr;4(4):372-3.

> Bailey LL, Gundry SR. Evolving status of xenotransplantation: introduction. World J Surg 1997 Nov-Dec;21(9):899-900.

> Bayever E. Xenotransplantation: a bold step forward [editorial]. Ann Allergy Asthma Immunol 1995 Dec;75(6 Pt 1):461-2.

> Britain plays it cautious on animal-human transplants [news]. Nature 1997 Jan 23;385(6614):285.

> Bronsther O. The dialectic nature of xenotransplantation. J Am Coll Surg 1998 Apr;186(4):397-401.

> Brower V. Xenotransplantation under FDA spotlight [news]. Nat Med 1998 Feb;4(2):135-6. Comment on: Nat Med 1998 Feb;4(2):131; Nat Med 1998 Feb;4(2):141-4.

> Butler D. Last chance to stop and think on risks of xenotransplants [news]. Nature 1998 Jan 22;391(6665):320-4. Comment in: Nature 1998 Mar 5;392(6671):11; Nature 1998 Mar 5;392(6671):12; Nature 1998 Apr 16;392(6677):646.

> Calne R. Animal organ transplants [editorial]. Br J Hosp Med 1997 Feb 5-18;57(3):66-7.

> Caplan AL. Is xenografting morally wrong? Transplant Proc 1992 Apr;24(2):722-7.

> Chapman LE, Folks TM, Salomon DR, Patterson AP, Eggerman TE, Noguchi PD. Xenotransplantation and xenogeneic infections. N Engl J Med 1995 Nov 30;333 (22):1498-501.

> Chiche L, Adam R, Caillat-Zucman S, Castaing D, Bach JF, Bismuth H. Xenotransplantation: baboons as potential liver donors? Scientific and ethical issues. Transplantation 1993 Jun;55(6):1418-21.

> Coffman KL, Sher L, Hoffman A, Rojter S, Folk P, Cramer DV, Vierling J, Villamel F, Podesta L, Demetriou A, Makowka L. Survey results of transplant patients' attitudes on xenografting. Psychosomatics 1998 Jul-Aug;39(4):379-83.

> Cooper DK. The safety of xenotransplantation. Transplant Proc 1998 Aug;30(5):2461-2.

> Cooper DK. Xenotransplantation: benefits, risks and regulation. Ann R Coll Surg Engl 1996 Mar;78(2):92-6.

> Cortesini R. Ethical aspects in xenotransplantation. Transplant Proc 1998 Aug;30(5):2463-4.

> Culliton BJ. There's a xeno in your future [editorial]. Nat Med 1995 Sep;1(9):847.

> Currie R. UK moves ahead on the xenotransplantation issue [news]. Nat Med 1998 Sep;4(9):988.

> Daar AS. Ethics of xenotransplantation: animal issues, consent, and likely transformation of transplant ethics. World J Surg 1997 Nov-Dec;21(9):975-82.

> Daar AS. Xenotransplants: proceed with caution [letter]. Nature 1998 Mar 5;392(6671):11. Comment on: Nature 1998 Jan 22;391(6665):320-4.

> Dickson D. As ethics report clears xenografts. Nature 1996 Mar 7;380(6569):6.

> Dickson D. Pig heart transplant 'breakthrough' stirs debate over timing of trials [news]. Nature 1995 Sep 21;377(6546):185-6.

> Dillner L. Pig organs approved for human transplants [news]. BMJ 1996 Mar 16;312(7032):657. Comment in: BMJ 1996 Mar 16;312(7032):651-2.

> Does biomedical research need another moratorium? [editorial]. Nat Med 1998 Feb;4(2):131. Comment on: Nat Med 1998 Feb;4(2):141-4. Comment in: Nat Med 1998 Feb;4(2):135-6.

> Downie R. Xenotransplantation [editorial]. J Med Ethics 1997 Aug;23(4):205-6.

> Duprez C, Duprez A. Are grafts of parts of human embryos resulting from requested legal abortions on to nude mice licit? Med Law 1993;12(6-8):657-61.

> Eyskens E. Ethics in actual surgery. Ethics and organ transplantation. Acta Chir Belg 1994 May-Jun;94(3):185-8.

> Federal guidelines needed to ensure safety in animal-human transplants [news]. Public Health Rep 1997 Jan-Feb;112(1):2-3.

> First MR. Xenotransplantation: social, ethical, religious, and political issues. Kidney Int 1997 Mar;Suppl 58:S46-7.

> Fox JL. Analyzing the science and ethics of xenografts. Biotechnology (NY) 1995 Aug;13(8):737, 739.

> Fox JL. FDA seeks comfort factors before removing hold on porcine xenotransplantation trials [news]. Nat Biotechnol 1998 Mar;16(3):224.

> Francione GL. Xenografts and animal rights. Transplant Proc 1990 Jun;22(3):1044-6.

> Fullbrook SD, Wilkinson BM. Xenotransplantation and the law. Br J Theatre Nurs 1997 May;7(2):21-3.

> Fullbrook SD, Wilkinson MB. Animal to human transplants: the ethics of xenotransplantation (1). Br J Theatre Nurs 1996 May;6(2):28-30, 32.

> Fullbrook SD, Wilkinson MB. Animal to human transplants: the ethics of xenotransplantation (2). Br J Theatre Nurs 1996 Jun;6(3):13-5, 18.

> Fung J. Xenotransplantation. Subhuman primates as donors. Pathol Biol (Paris) 1994 Mar;42(3):221-3.

> Gurland HJ, Mujais SK. The future of artificial organs [editorial]. Int J Artif Organs 1995 Feb;18(2):64-8.

> Halt the xeno-bandwagon [editorial]. Nature 1998 Jan 22;391(6665):309.

> Hammer C, Molloy B. Ethical aspects in xenotransplantation. Transplant Proc 1993 Aug;25(4 Suppl 3):38-40.

> Hanson MJ. Not just for breakfast anymore [news]. Hastings Cent Rep 1997 Jan-Feb;27(1):49.

> Hanson MJ. The seductive sirens of medical progress. The case of xenotransplantation. Hastings Cent Rep 1995 Sep-Oct;25(5):5-6.

> Hastillo A, Hess ML. Heart xenografting: a route not yet to trod [editorial]. J Heart Lung Transplant 1993 Jan-Feb;12(1 Pt 1):3-4. Comment in: J Heart Lung Transplant 1993 Sep-Oct;12(5):876-8; J Heart Lung Transplant 1993 Sep-Oct;12(5):878.

> Have a pig's heart? [editorial]. Lancet 1997 Jan 25;349(9047):219. Comment in: Lancet 1997 Mar 8;349(9053):735-6; Lancet 1997 Apr 5;349(9057):1031.

> Hobbs MN. US Public Health Service sets out plan for xenotransplantation [news]. Lancet 1998 Jan 31;351(9099):343.

> Hughes J. Xenografting: ethical issues. J Med Ethics 1998 Feb;24(1):18-24.

> Ildstad ST. Xenotransplantation for AIDS [letter]. Lancet 1996 Mar 16;347(9003):761. Comment on: Lancet 1995 Aug 5;346(8971):369-70.

> Jayaraman KS. Pig heart transplant surgeon held in jail [news]. Nature 1997 Jan 30;385(6615):378.

> Kaiser J. Xenotransplants. IOM backs cautious experimentation [news]. Science 1996 Jul 19;273(5273):305-6.

> Kauffman HM JR, Ellison MD, Pierce GA, Graham WK, Daily OP. Increasing donor-recipient imbalance justifies xenograft research. Transplant Proc 1996 Apr;28(2):849-50.

> Kennedy I. Xenotransplantation: ethical acceptability. Transplant Proc 1997 Sep;29(6):2729-30.

> Kennedy I, Sewell H. Xenotransplantation moratorium [letter]. Nat Biotechnol 1998 Feb;16(2):120.

> Kielstein R, Sass HM. From wooden limbs to biomaterial organs: the ethics of organ replacement and artificial organs. Artif Organs 1995 May;19(5):475-80.

> Klotzko AJ. The beast inside. Nurs Times 1998 Aug 5-11;94(31):34-5.

> Lehrman S. Trans-species transplants raise virus fears [news]. Nature 1995 Jul 6;376(6535):8. Comment in: Nature 1995 Sep 14;377(6545):98; Nature 1995 Nov 30;378(6556):434.

> Macilwain C. FDA seeks to close xenotransplant gap [news]. Nature 1997 Jul 31;388(6641):411.

> Malouin R. Surgeons' quest for life: the history and the future of xenotransplantation. Perspect Biol Med 1994 Spring;37(3):416-28.

> Mandel TE. Future directions in transplantation. Med J Aust 1993 Feb 15;158(4):269-73.

> Marcelleti C. Bioethics and medicine. Med Law 1995;14(1-2):9-12.

> Martin DK, Singer PA, Siegler M. Ethical considerations in liver transplantation. Prog Liver Dis 1994;12:215-29.

> Marwick C. British, American reports on xenotransplantation [news]. JAMA 1996 Aug 28;276(8):589-90.

> Masood E. Xenotransplant experts face good and bad news [news]. Nature 1998 Aug 6;394(6693):513.

> Mepham TB, Moore CJ, Crilly RE. An ethical analysis of the use of xenografts in human transplant surgery. Bull Med Ethics 1996 Mar;116:13-8.

> Morgan F. Babe the magnificent organ donor? The perils and promises surrounding xenotransplantation. J Contemp Health Law Policy 1997 Fall;14(1):127-60.

> Morris K. No early rejection of animal organs in UK [news]. Lancet 1997 Jan 25;349(9047):257.

> Murphy FA. The public health risk of animal organ and tissue transplantation into humans. Science 1996 Aug 9;273(5276):746-7.

> Nasto B. Xenotransplantation: proceed with caution [news]. Nat Biotechnol 1996 Apr;14(4):424, 426.

> Nelson JL. Moral sensibilities and moral standing: Caplan on xenograft donors. Bioethics 1993 Jul;7(4):315-22.

> Nelson JL. Transplantation through a glass darkly. Hastings Cent Rep 1992 Sep-Oct;22(5):6-8.

> Newman JS. Xenografting: ethical, clinical problems present obstacles. Nephrol News Issues 1993 Jan;7(1):39, 42, 46.

> Nicholson R. If pigs could fly. Nurs Times 1997 Feb 5-11;93(6):20.

> Nicholson RH. This little pig went to market [news]. Hastings Cent Rep 1996 Jul-Aug;26(4):3.

> Novak K. US FDA to issue new rules on xenotransplantation [news]. Nat Med 1998 Aug;4(8):876.

> Nowak R. FDA puts the brakes on xenotransplants [news]. Science 1995 May 5;268(5211):630-1. Published erratum appears in Science 1995 May 19;268(5213):961.

> Nowak R. Pig transplants offer hope in diabetes [news]. Science 1994 Nov 25;266(5189):1323.

> Nowak R. Xenotransplants set to resume [news]. Science 1994 Nov 18;266(5188):1148-51.

> Nuffield Council cautiously approves xenotransplantation using pigs [news]. Vet Rec 1996 Mar 16;138(11):242-3.

> O'Brien C. Yellow light for pig-human transplants [news]. Science 1996 Mar 8;271(5254):1357.

> Palca J. Animal organs for human patients? Hastings Cent Rep 1995 Sep-Oct;25(5):4.

> Pearson ML, Jarvis WR, Folks TM, Chapman LE. Xenotransplantation: Is the future upon us? [editorial]. Infect Control Hosp Epidemiol 1998 May;19(5):305-7. Comment on: Infect Control Hosp Epidemiol 1998 May;19(5):355-65.

> Pierson RN 3d, White DJ, Wallwork J. Ethical considerations in clinical cardiac xenografting [letter]. J Heart Lung Transplant 1993 Sep-Oct;12(5):876-8. Comment on: J Heart Lung Transplant 1992 Mar-Apr;11(2 Pt 1):393-7; J Heart Lung Transplant 1993 Jan-Feb;12(1 Pt 1):3-4.

> Post SG. Baboon livers and the human good. Arch Surg 1993 Feb;128(2):131-3.

> Public Health Service (US). Draft Public Health Service guideline on infectious disease. Issues in xenotransplantation (August 1996); notice. Fed Regist 1996 Sep 23;61(185):49919-32.

> Ramsay S. UK bioethics council wants stricter controls on xenotransplantation [news]. Lancet 1996 Mar 9;347(9002):683.

> Rapaport FT. Alternative sources of clinically transplantable vital organs. Transplant Proc 1993 Feb;25(1 Pt 1):42-4.

> Rapaport FT. Continuing dilemma of organ procurement for clinical transplantation. Transplant Proc 1993 Aug;25(4):2494-5.

> Reemtsma K. Ethical aspects of xenotransplantation. Transplant Proc 1990 Jun;22(3):1042-3.

> Sachs DH, Colvin RB, Cosimi AB, Russell PS, Sykes M, McGregor CG, Platt JL. Xenotransplantation--caution, but no moratorium [letter]. Nat Med 1998 Apr;4(4):372-3. Comment on: Nat Med 1998 Feb;4(2):141-4.

> Sass HM. Ethics of the allocation of highly advanced medical technologies. Artif Organs 1998 Mar;22(3):263-8.

> Shapiro D. Xenotransplantation [letter]. Lancet 1997 Mar 8;349(9053):735-6. Comment on: Lancet 1997 Jan 25;349(9047):219.

> Singer P. Xenotransplantation and speciesism. Transplant Proc 1992 Apr;24(2):728-32.

> Stephenson J. Xenotransplantation workshop ponders science, safety of animal tissue grafts [news]. JAMA 1995 Jul 26;274(4):285, 287-8.

> Thomas G, Ryall M, Taber SM. Ethical dilemmas in transplantation. Transplant Proc 1992 Oct;24(5):2099.

> Thompson C. No cheers for baboon to AIDS patient xenotransplant [news]. Lancet 1995 Aug 5;346(8971):369-70. Published erratum appears in Lancet 1995 Sep 2;346(8975):650. Comment in: Lancet 1996 Mar 16;347(9003):761.

> Travis J. The xeno-solution: perils and promise of transplanting animal organs into people. Sci News 1995 Nov 4;148(19):298-301.

> Vanderpool HY. Critical ethical issues in clinical trials with xenotransplants. Lancet 1998 May 2;351(9112):1347-50. Published erratum appears in Lancet 1998 Jun 27;351(9120):1968.

> Vogel G. Xenotransplants: no moratorium on clinical trials [news]. Science 1998 Jan 30;279(5351):648.

> Wadman M. FDA turns down moratorium demand on xenotransplants [news]. Nature 1998 Jan 29;391(6666):423.

> Wadman M. Xenotransplantation trials 'should proceed but need guidelines' [news]. Nature 1996 Jul 18;382(6588):197.

> Webster NR. Animal tissues into humans [editorial]. Br J Anaesth 1998 Mar;80(3):281-2.

> Wilkinson M. Transplants. At the edge of knowledge. Nurs Times 1996 Oct 23-29;92(43):26-8.

> Williams N. Paving the way for British xenotransplants [news]. Science 1998 Aug 7;281(5378):767.

> Williams N. Pig-human transplants barred for now [news]. Science 1997 Jan 24;275(5299):473.

> Xenotransplantation. Alternative ways of meeting demand [news]. Nature 1998 Jan 22;391(6665):325.

> Xenotransplantation and the yuk factor [editorial]. Nat Biotechnol 1996 Apr;14(4):403-4.

> Return to table of contents

> ## Xenotransplantation - Books

> Animal tissue into humans: a report by the Advisory Group on the Ethics of Xenotransplantation, 1996. London: Her Majesty's Stationery Office; 1997. 258 p.

> Animal-to-human transplants: the ethics of xenotransplantation. London: Nuffield Council on Bioethics; 1996 Mar. 147 p.

> Institute of Medicine, Committee on Xenograft Transplantation: Ethical Issues and Public Policy. Xenotransplantation: science, ethics, and public policy. Washington: National Academy Press; 1996. 126 p.

> Return to table of contents

> ## AIDS/HIV research - Journal Articles

> Abdool K. Placebo controls in HIV perinatal transmission trials: a South African's viewpoint. Am J Public Health 1998 Apr;88(4):564-6.

> AIDS, ethics and clinical trials. Institute of Medical Ethics Working Party on the Ethical Implications of AIDS. BMJ 1992 Sep 19;305(6855):699-701. Comment in: BMJ 1992 Nov 7;305(6862):1159.

> Aldhous P. Clinical trails [trials]: blazing an ethical trail [news]. Nature 1991 Sep 5;353(6339):4.

> Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med 1988 Oct 20;319(16):1081-3.

> Angell M. The ethics of clinical research in the Third World [editorial]. N Engl J Med 1997 Sep 18;337(12):847-9. Comment on: N Engl J Med 1997 Sep 18;337(12):801-8; N Engl J Med 1997 Sep 18;337(12):853-6. Comment in: N Engl J Med 1998 Mar 19;338(12):841-2.

> Annas GJ, Grodin MA. Human rights and maternal-fetal HIV transmission prevention trials in Africa. Am J Public Health 1998 Apr;88(4):560-3.

> Barker S, Tindall B, Carballo M. Quality of life and clinical trials in HIV infection [letter]. Lancet 1990 Apr 28;335(8696):1045.

> Barry M. Ethical considerations of human investigation in developing countries: the AIDS dilemma. N Engl J Med 1988 Oct 20;319(16):1083-6.

> Barry M. Ethical dilemmas with studies in less-developed countries: AIDS research trials. IRB Rev Hum Subj Res 1991;13(4):8-9.

> Bartholow BN, MacQueen KM, Douglas JM Jr, Buchbinder S, McKirnan D, Judson FN. Assessment of the changing willingness to participate in phase III HIV vaccine trials among men who have sex with men. J Acquir Immune Defic Syndr Hum Retrovirol 1997 Oct 1;16(2):108-15.

> Bayer R. The ethics of blinded HIV surveillance testing. Am J Public Health 1993 Apr;83(4):496-7.

> Bayer R. The ethics of research on HIV/AIDS in community-based settings [editoria]. AIDS 1990 Dec;4(12):1287-8. Comment on: AIDS 1990 Dec;4(12):1189-96. Comment in: Adv Ophthalmic Plast Reconstr Surg 1991 Sep;5(9):1150-1.

> Bayer R, Lumey LH, Wan L. The American, British and Dutch responses to unlinked anonymous HIV seroprevalence studies: an international comparison. Law Med Health Care 1991 Fall-Winter;19(3-4):222-30.

> Blanche S. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):837-8; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> Bloom BR. The highest attainable standard: ethical issues in AIDS vaccines. Science 1998 Jan 9;279(5348):186-8. Comment in: Science 1998 Mar 6;279(5356):1433-4; Science 1998 May 29;280(5368):1329-30; discussion 1330-1; Science 1998 May 29;280(5368):1330; discussion 1330-1.

> Chesney MA, Lurie P, Coates TJ. Strategies for addressing the social and behavioral challenges of prophylactic HIV vaccine trials. J Acquir Immune Defic Syndr Hum Retrovirol 1995 May 1;9(1):30-5. Comment in: J Acquir Immune Defic Syndr Hum Retrovirol 1995 May 1;9(1):26-9.

> Chopra M. Preventing perinatal HIV transmission--does the end justify the means? [letter]. S Afr Med J 1998 Jul;88(7):810. Comment on: S Afr Med J 1998 Apr;88(4):431-2.

> Christakis NA, Lynn LA, Castelo A. Clinical AIDS research that evaluates cost effectiveness in the developing world. IRB Rev Hum Subj Res 1991;13(4):6-8.

> Cotton P. International disunity on HIV vaccine efficacy trials [news]. JAMA 1994 Oct 12;272(14):1090-1.

> Cleaton-Jones PE. An ethical dilemma. Availability of antiretroviral therapy after clinical trials with HIV infected patients are ended. BMJ 1997 Mar 22;314(7084):887-8. Comments in: BMJ 1997 Mar 22;314(7084):840-1; BMJ 1997 Mar 22;314(7084):888-9; BMJ 1997 Mar 22;314(7084):889; BMJ 1997 Mar 22;314(7084):890; BMJ 1997 Mar 22;314(7084):890-1.

> Cohen J. AIDS vaccines. Will media reports KO upcoming real-life trials? [news]. Science 1994 Jun 17;264(5166):1660.

> Cohen J. Army clears Redfield -- but fails to resolve controversy [news]. Science 1993 Aug 13;261(5123):824-5.

> Cohen J. Did liability block AIDS trial? [news]. Science 1992 Jul 17;257(5068):316-7.

> Cohen J. Medical ethics. No consensus on rules for AIDS vaccine trials [news]. Science 1998 Jul 3;281(5373):22-3.

> Coles P, Anderson C. AIDS research. Inquiry launched into ethical procedures [news]. Nature 1991 Mar 21;350(6315):179.

> Coughlin SS, Rabin DL, Boekeloo BO, Beauchamp TL. Ethical issues in the design of a randomized trial for the prevention of HIV infection. Hum Res Rep 1992 Jul;7(7):2-3.

> Crouch RA, Arras JD. AZT trials and tribulations. Hastings Cent Rep 1998 Nov-Dec;28(6):26-34.

> Crumbo CL, Rybczyk GK, Wagner LJ. Characteristics of volunteer participants in phase I HIV vaccine trials. J Assoc Nurses AIDS Care 1997 Sep-Oct;8(5):59-65.

> Culliton BJ. Human experimentation. AIDS trials questioned [news]. Nature 1991 Mar 28;350(6316):263.

> Des Jarlais DC, Friedman SR. AIDS prevention among IV drug users: potential conflicts between research design and ethics. IRB Rev Hum Subj Res 1987 Jan-Feb;9(1):6-8.

> Des Jarlais DC, Vanischseni S, Marmor M, Kitayaporn D. HIV vaccine trials [letter]. Science 1998 Mar 6;279(5356):1433-4. Comment on: Science 1998 Jan 9;279(5348):186-8.

> Diaz T, Chu SY, Sorvillo F, Mokotoff E, Davidson AJ, Samuel MC, Herr M, Doyle B, Frederick M, Fann SA , et al. Differences in participation in experimental drug trials among persons with AIDS. J Acquir Immune Defic Syndr Hum Retrovirol 1995 Dec 15;10(5):562-8.

> Dickens M. Research ethics and HIV/AIDS. Med Law 1997;16(1):187-97.

> Enel P, Charrel J, Larher MP, Reviron D, Manuel C, San Marco JL. Ethical problems raised by anti-HIV vaccination. Eur J Epidemiol 1991 Mar;7(2):147-53.

> Enel P, Charrel J, Reviron D, Manuel C, Larher MP, Auquier P, San Marco JL. HIV vaccination: the ethical issues. AIDS Public Policy J 1992 Spring;7(1):50-5.

> Esparza J, Osmanov S, Kallings LO, Wigzell H. Planning for HIV vaccine trials: the World Health Organization perspective. AIDS 1991;5 Suppl 2:S159-63.

> Faden R, Kass N. HIV research, ethics, and the developing world [editorial]. Am J Public Health 1998 Apr;88(4):548-50.

> Fast PE, Mathieson BJ, Schultz AM. Efficacy trials of AIDS vaccines: how science can inform ethics [editorial]. Curr Opin Immunol 1994 Oct;6(5):691-7.

> Flap on NEJM board over ethics articles [news]. Science 1997 Oct 10;278(5336):211.

> Francis DP. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):837; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> Freedman B. Suspended judgment. AIDS and the ethics of clinical trials: learning the right lessons. Control Clin Trials 1992 Feb;13(1):1-5.

> Gaskins S, Sowell R, Gueldner S. Overcoming methodological barriers to HIV/AIDS nursing research. J Assoc Nurses AIDS Care 1991;2(4):33-7.

> Gill MJ, Burgess MM, Kinsella TD. Ethical modifications of the Emergency Drug Release Program for AIDS: a proposal [editorial]. CMAJ 1992 May 1;146(9):1541-5.

> Glantz LH, Grodin MA. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):839; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> Grady C. HIV preventive vaccine research: selected ethical issues. J Med Philos 1994 Dec;19(6):595-612.

> Grady C. Science in the service of healing. Hastings Cent Rep 1998 Nov-Dec;28(6):34-8.

> Grunfeld GB. Dissimilarities between Tuskegee Study and HIV/AIDS programs emphasized [letter]. Am J Public Health 1992 Aug;82(8):1176.

> Hamilton H. The road to nowhere--ACT drug trial [editorial]. Collegian 1997 Oct;4(4):5.

> Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol 1995 Nov 1;10(3):386-90.

> Haynes BF. Scientific and social issues of human immunodeficiency virus vaccine development. Science 1993 May 28;260(5112):1279-86.

> Herrington D. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):838-9; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> HIV vaccines get the green light for Third World trials [news]. Nature 1994 Oct 20;371(6499):644.

> Hodel D. HIV preventive vaccine efficacy trials in the United States: an overview of target communities' concerns. AIDS Res Hum Retroviruses 1994;10 Suppl 2:S255-6.

> Hutchins SA, Eckes R. HIV infection. Clinical research. Considerations for prospective participants. Nurs Clin North Am 1996 Mar;31(1):125-35.

> IJsselmuiden CB. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):838; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> IJsselmuiden CB, Faden RR. Research and informed consent in Africa--another look. N Engl J Med 1992 Mar 19;326(12):830-3. Comment in: N Engl J Med 1992 Oct 8;327(15):1101-2; discussion 1103.

> Ivinson AJ. Hard-won consensus on AIDS vaccine trial guidelines [news]. Nat Med 1998 Aug;4(8):874.

> Jenkins RA, Chinaworapong S, Morgan PA, Ruangyuttikarn C, Sontirat A, Chiu J, Michael RA, Nitayaphan S, Khamboonruang C. Motivation, recruitment, and screening of volunteers for a phase I/II HIV preventive vaccine trial in Thailand. J Acquir Immune Defic Syndr Hum Retrovirol 1998 Jun 1;18(2):171-7.

> Josefson D. US journal attacks unethical HIV trials [news]. BMJ 1997 Sep 27;315(7111):765.

> Kaiser J. Flap on NEJM board over ethics articles [news]. Science 1997 Oct 10;278(5336):211.

> Kaiser J. UNAIDS to weigh vaccine ethics [news]. Science 1997 Sep 19;277(5333):1751.

> Karzon DT, Bolognesi DP, Koff WC. Development of a vaccine for the prevention of AIDS, a critical appraisal. Vaccine 1992;10(14):1039-52.

> Kass NE, Taylor HA, King PA. Harms of excluding pregnant women from clinical research: the case of HIV-infected pregnant women. J Law Med Ethics 1996 Spring;24(1):36-46.

> Katongole-Mbidde E. Preparations for AIDS vaccine trials. Respecting concerns of international host countries. AIDS Res Hum Retroviruses 1994;10 Suppl 2:S187-9.

> Kim RJ. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):838; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> King E. AIDS, ethics, and clinical trials [letter]. BMJ 1992 Nov 7;305(6862):1159. Comment on: BMJ 1992 Sep 19;305(6855):699-701.

> Lallemant M, McIntosh K, Jourdain G, Le Coeur S, Vithayasai V, Lee TH, Hammer S, Prescott N, Essex M. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):839-40; discussion 840-1.

> Levine C. Placebos and HIV: lessons learned. Hastings Cent Rep 1988 Nov-Dec;28(6):43-8.

> Levine C, Dubler NN, Levine RJ. Building a new consensus: ethical principles and policies for clinical research on HIV/AIDS. IRB Rev Hum Subj Res 1991 Jan-Apr;13(1-2):1-17.

> Levine MM. Non-target effects of live vaccines: myth, reality and demagoguery. Dev Biol Stand 1995;84:33-8.

> Lo B. Clinical ethics and HIV-related illnesses: issues in treatment and health services research. Medical Care Rev 1990 Spring;47(1):15-32.

> Lo B. Ethical dilemmas in HIV infection: what have we learned? Law Med Health Care 1992 Spring-Summer;20(1-2):92-103.

> Lurie P, Bishaw M, Chesney MA, Cooke M, Fernandes MEL, Hearst N, Katongole-Mbidde E, Koetsawang S, Lindan CP, Mandel J, Mhloyi M, Coates TJ. Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries. JAMA 1994 Jan 26;271(4):295-01.

> Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997 Sep 18;337(12):853-6. Comment in: N Engl J Med 1997 Sep 18;337(12):847-9.

> Lynn LA. AIDS clinical trials. Is there access for all? [editorial]. J Gen Intern Med 1997 Mar;12(3):198-9. Comment on: J Gen Intern Med 1997 Mar;12(3):150-7.

> Magnusson RS. Testing for HIV without specific consent: a short review. Aust N Z J Public Health 1996 Feb;20(1):57-60.

> Mann J, Chin J. AIDS: a global perspective [editorial]. N Engl J Med 1988 Aug 4;319(5):302.

> Mariner WK. The ethical conduct of clinical trials of HIV vaccines. Evaluation Rev 1990 Oct;14(5):538-64.

> Mariner WK. New FDA drug approval policies and HIV vaccine development. Am J Public Health 1990 Mar;80(3):336-41.

> Marks ES, Derderian SS, Wray HL. Guidelines for conducting HIV research with human subjects at a U.S. military medical center. IRB Rev Hum Subj Res 1992 Jan-Feb;14(1):7-10.

> Martin JM, Sacks HS. Do HIV-infected children in foster care have access to clinical trials of new treatments? AIDS Public Policy J 1990 Winter;5(1):3-8.

> Marwick C. NIH also takes further protective steps [news]. JAMA 1991 Jul 24-31;266(4):466, 469.

> Marwick C. NIH collaboration with French AIDS vaccine researcher put on hold pending investigation [news]. JAMA 1991 May 22-29;265(20):2648, 2650.

> Marwick C. Two governments act on one controversial study [news]. JAMA 1991 Jul 24-31;266(4):466.

> Mbidde E. Bioethics and local circumstances [editorial]. Science 1998 Jan 9;279(5348):155. Comment in: Science 1998 Mar 6;279(5356):1434-6.

> McLean GR. A case for goodwill. BMJ 1997 Mar 22;314(7084):890. Comment on: BMJ 1997 Mar 22;314(7084):887-8; BMJ 1997 Mar 22;314(7084):890-1.

> Morrison C. The HIV epidemic. Ethical issues for the next decade. Crit Care Nurs Clin North Am 1992 Sep;4(3):421-8.

> Murphy TF. Women and drug users: the changing faces of HIV clinical drug trials. QRB Qual Rev Bull 1991 Jan;17(1):26-32.

> Merson MH. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):836; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> Moodley K. Preventing perinatal HIV transmission--does the end justify the means? [letter]. S Afr Med J 1998 Jul;88(7):808, 810. Comment on: S Afr Med J 1998 Apr;88(4):431-2.

> Nitayaphan S, Brown AE. Preventive HIV vaccine development in Thailand. AIDS 1998;12(Suppl B):S155-61.

> Nowack R. Staging ethical AIDS trials in Africa [news]. Science 1995 Sep 8;269(5229):1332-5.

> Nzila N. Remarks spoken before the audience at the final conference plenary session, entitled: future directions, at the International Conference on Advances in AIDS Vaccine Development Fourth annual meeting of the National Cooperative Vaccine Development Groups for AIDS. AIDS Res Hum Retroviruses 1992 Aug;8(8):1521-2.

> Pellegrino ED. Ethics. JAMA 1990 May 16;263(19):2641-2.

> Perry SW. Pharmacological and psychological research on AIDS: some ethical considerations. IRB Rev Hum Subj Res 1987 Sep-Oct;9(5):8-10.

> Phanuphak P. Ethical issues in studies in Thailand of the vertical transmission of HIV. N Engl J Med 1998 Mar 19;338(12):834-5. Comment in: N Engl J Med 1998 Mar 19;338(12):843-4; N Engl J Med 1998 Mar 19;338(12):844.

> Phanuphak P, Vermund SH. Ethical issues for perinatal HIV trials in developing countries [editorial]. Pediatr AIDS HIV Infect 1996 Aug;7(4):236-8.

> Piot P. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):839; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> Piot P. The science of AIDS: a tale of two worlds. Science 1998 Jun 19;280(5371):1844-5.

> Pitisuttithum P, Migasena S, Laothai A, Suntharasamai P, Kumpong C, Vanichseni S. Risk behaviours and comprehension among intravenous drug users volunteered for HIV vaccine trial. J Med Assoc Thai 1997 Jan;80(1):47-50.

> Porter JP, Glass MJ, Koff WC. Ethical considerations in AIDS vaccine testing. IRB Rev Hum Subj Res 1989 May-Jun;11(3):1-4.

> Public Health Service (US). Consultation on international collaborative human immunodeficiency virus (HIV) research. Law Med Health Care 1991 Fall-Winter;19(3-4):259-63.

> Robb ML, Khambaroong C, Nelson KE. Studies in Thailand of the vertical transmission of HIV [letter]. N Engl J Med 1998 Mar 19;338(12):843-4. Comment on: N Engl J Med 1998 Mar 19;338(12):834-5.

> Schoepf BG. Ethical, methodological and political issues of AIDS research in Central Africa. Soc Sci Med 1991;33(7):749-63. Comment in: Soc Sci Med 1992 Mar;34(5):589-90.

> Semba RD. Ethics of HIV trials [letter]. Lancet 1997 Nov 22;350(9090):1547.

> Sharpe G. The ethics and legality of HIV seroprevalence studies. Health Law Can 1990;11(4):102-18.

> Shorr AF. AIDS and the FDA: an ethical case for limiting patient access to new medical therapies. IRB Rev Hum Subj Res 1992 Jul-Aug;14(4):1-5.

> Sieber JE, Sorensen JL. Conducting social and behavioral AIDS research in drug treatment clinics. IRB Rev Hum Subj Res 1992 Sep-Oct;14(5):1-5.

> Simberkoff MS, Hartigan PM, Hamilton JD. Ethical dilemma in continuing a zidovudine-placebo trial in symptomatic human immunodeficiency virus infection. Trans Assoc Am Physicians 1991;104:92-6.

> Simonds RJ, Rogers MF, Dondero TJ. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):836-7; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> Smith PG, Hayes RJ, Mulder DW. Epidemiological and public health considerations in the design of HIV vaccine trials. AIDS 1991;5 Suppl 2:S105-11.

> Snow W. International Conference on Advances in AIDS Vaccine Development. AIDS Res Hum Retroviruses 1992 Aug;8(8):1433-4.

> Stein RE. Vaccine liability and participant compensation incentives in HIV vaccine trials. AIDS Res Hum Retroviruses 1994;10 Suppl 2:S297-300.

> Stolley PD. The hazards of misguided compassion [editorial]. Ann Intern Med 1993 May 15;118(10):822-3.

> Stone VE, Mauch MY, Steger K, Janas SF, Craven DE. Race, gender, drug use, and participation in AIDS clinical trials. Lessons from a municipal hospital cohort. J Gen Intern Med 1997 Mar;12(3):150-7. Comment in: J Gen Intern Med 1997 Mar;12(3):198-9.

> Swanson JM, Chenitz C, Zalar M, Stoll P. A critical review of human immunodeficiency virus infection- and acquired immunodeficiency syndrome-related research: the knowledge, attitudes, and practice of nurses. J Prof Nurs 1990 Nov-Dec;6(6):341-55.

> Tacket CO, Edelman R. Ethical issues involving volunteers in AIDS vaccine trials [letter]. J Infect Dis 1990 Feb;161(2):356. Comment on: J Infect Dis 1989 Aug;160(2):205-8.

> Tafesse E, Murphy TF. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World [letter]. N Engl J Med 1998 Mar 19;338(12):838; discussion 840-1. Comment on: N Engl J Med 1997 Sep 18;337(12):853-6.

> Temoshok LR. Behavioral research contributions to planning and conducting HIV vaccine efficacy studies. AIDS Res Hum Retroviruses 1994;10 Suppl 2:S277-80.

> Thomas SB, Quinn SC. The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV education and AIDS risk education programs in the black community. Am J Public Health 1991 Nov;81(11):1498-505. Comment in: Am J Public Health 1991 Nov;81(11):1393-4.

> Thomasma DC, McElhinney TK. Ethical concerns about AIDS. Pharos 1990 Spring;53(2):7-11.

> Turner CF, Sheon AR. Behavioral studies relevant to vaccine trial preparation: an introduction. AIDS Res Hum Retroviruses 1994;10 Suppl 2:S273-6.

> Twomey JG Jr. Investigating pediatric HIV research ethics in the field. West J Nurs Res 1994 Aug;16(4):404-13.

> UNAIDS to weigh vaccine ethics [news]. Science 1997 Sep 19;277(5333):1751.

> Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997 Oct 2;337(14):1003-5.

> Vaughn W. Ethics of HIV trials [letter]. Lancet 1997 Nov 22;350(9090):1547. Comment on: Lancet 1997 Sep 27;350(9082):897. Comment in: Lancet 1998 Jan 17;351(9097):220.

> Wadman M. US dispute over live AIDS vaccine trials [news]. Nature 1997 Oct 2;389(6650):426.

> Weber J. Trials and tribulations: ethical dilemmas in HIV therapy [editorial]. Curr Opin Immunol 1997 Oct;9(5):625-7.

> Wehrwein P, Morris K. HIV-1-vaccine-trial go-ahead reawakens ethics debate [news]. Lancet 1998 Jun 13;351(9118):1789.

> Wongchoosri S, Wera-arpachai M, Gulgolgarn V, Ketsararat W, Sittisombut N, Tovanabutra S. Studies in Thailand of the vertical transmission of HIV [letter]. N Engl J Med 1998 Mar 19;338(12):844. Comment on: N Engl J Med 1998 Mar 19;338(12):834-5.

> Zion D. Can communities protect autonomy? Ethical dilemmas in HIV preventative drug trials. Camb Q Healthc Ethics 1995 Fall;4(4):516-23.

> Zion D. Ethical considerations of clinical trials to prevent vertical transmission of HIV in developing countries. Nat Med 1998 Jan;4(1):11-2.

> Wadman M. Controversy flares over AIDS prevention trials in third world [news]. Nature 1997 Oct 30;389(6654):894.

> Zion D. The ethics of AIDS vaccine trials [letter]. Science 1998 May 29;280(5368):1329-30; discussion 1331-2. Comment on: Science 1998 Jan 9;279(5348):186-8.

> Return to table of contents

> ## AIDS/HIV research - Books

> Adverse reactions to HIV vaccines: medical, ethical, and legal issues. Washington: Congress of the United States, Office of Technology Assessment; 1995. 197 p. (HIV-related issues. Background paper; 11).

> AIDS Action Foundation, Working Group. HIV prevention vaccines: social, ethical, and political considerations for domestic efficacy trials. Washington: The Foundation; 1994 Jul. 54 p.

> Dixon JE, editor. Catastrophic rights: experimental drugs & AIDS. Vancouver: New Star Book; 1990. 131 p.

> Epstein S. Impure science: AIDS, activism, and the politics of knowledge. Berkeley: University of California Press; 1996. 466 p.

> Fuenzalida-Puelma H, Linares Parada AM, LaVertu DS. Ethics and law in the study of AIDS. Washington: Pan American Health Organization; 1992. 273 p.

> Gostin LO, Lazzarini Z. Human rights and public health in the AIDS pandemic. New York: Oxford University Press; 1997. 212 p.

> Grady C. The search for an AIDS vaccine: ethical issues in the development and testing of a preventive HIV vaccine. Bloomington: Indiana University Press; c1995. 193 p. (Medical ethics series).

> Grady C. Ethical issues in the development and testing of a preventive HIV vaccine. Ann Arbor (MI): University Microfilms International; 1993. 471 p.

> Gray JN, Lyons PM, Melton GB. Ethical and legal issues in AIDS research. Baltimore: Johns Hopkins University Press; 1995. 199 p.

> Kerns TA. Ethical issues in HIV vaccine trials. New York: St. Martin's Press; 1997. 249 p.

> Kerns TA. Jenner on trial: an ethical examination of vaccine research in the age of smallpox and the age of AIDS. Lanham (MD): University Press of America; c1997. 98 p.

> Kwitny J. Acceptable risks. New York: Poseidon Press; 1992. 466 p.

> Loue S. Legal and ethical aspects of HIV-related research. New York: Plenum Press; c1995. 218 p. (The language of science).

> Nichols EK. Expanding access to investigational therapies for HIV infection and AIDS: conference summary; 1990 Mar 12-13. Washington: National Academy Press; 1991. 73 p.

> Nussbaum B. Good intentions: how big business and the medical establishment are corrupting the fight against AIDS. New York: Atlantic Monthly Press; 1990. 352 p.

> Putney SD, Bolognesi D. AIDS vaccine research and clinical trials. New York: M. Dekker; c1990. 480 p.

> The ethical conduct of AIDS vaccine trials: report of the Working Party on Ethical Aspects of AIDS Vaccine Trials. London: Medical Research Council; 1991. 40 p. (MRC ethics series).

> Twomey JG. Clinical research ethics and pediatric HIV infection. Ann Arbor (MI): University Microfilms International; 1993. 236 p.

> Women and HIV Disease: Falling Through the Cracks: Hearing (1991 Jun 6). Washington: U.S. Government Printing Office; 1992. 247 p.

> Return to table of contents

> ## Cancer research - Journal Articles

> Anderson SJ, Costantino JP, Brown AM, Bryant JL, Cronin WM, Dignam JJ, Jones JM, Rockette HE, Wieand S. Breast cancer trials on trial: a case of conflicting ethical interests [letter]. Cancer 1995 Oct 1;76(7):1294-5. Comment on: Cancer 1995 May 15;75(10):2403-6.

> Blumberg BS. Ethics and cancer therapy. Biomed Pharmacother 1993;47(9):393-5.

> Cassidy J, Macfarlane DK. The role of the nurse in clinical cancer research. Cancer Nurs 1991 Jun;14(3):124-31.

> Cheson BD. Cancer clinical trials. Clinical trials programs. Semin Oncol Nurs 1991 Nov;7(4):235-42.

> Clinical trials: what cancer patients need to know. The British Association of Cancer United Patients (BACUP). Nurs Stand 1997 Sep 24;12(1):32-3.

> Cockburn J, Redman S, Kricker A. Should women take part in clinical trials in breast cancer? Issues and some solutions. J Clin Oncol 1998 Jan;16(1):354-62.

> Cox K, Avis M. Ethical and practical problems of early anti-cancer drug trials: a review of the literature. Eur J Cancer Care (Engl) 1996 Jun;5(2):90-5.

> Cox K, Avis M. Psychosocial aspects of participation in early anticancer drug trials. Report of a pilot study. Cancer Nurs 1996 Jun;19(3):177-86.

> Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, Siegler M. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 1995 May;13(5):1062-72. Published erratum appears in J Clin Oncol 1995 Sep;13(9):2476. Comment in: J Clin Oncol 1995 May;13(5):1049-51; J Clin Oncol 1995 Sep;13(9):2472.

> Drury M. Developing new drugs for cancer [letter]. BMJ 1991 Nov 16;303(6812):1270. Comment on: BMJ 1991 Oct 26;303(6809):1005-6.

> Eardley A, Cribb A, Pendleton L. Ethical issues in psychosocial research among patients with cancer. Eur J Cancer 1991;27(2):166-9.

> Eastman P. Ready, set, go...stop: lessons learned from cancer prevention trials [news]. J Natl Cancer Inst 1998 Apr 1;90(7):494-6.

> Faulder C. Better safe than sorry [the Tamoxifen Prevention Trial]. Bull Med Ethics 1992 Feb;75:29-33.

> Harding M. Chemotherapy in non-small cell lung cancer. It may not be ethical to ask patients to participate in future trials [letter]. BMJ 1996 Jan 27;312(7025):249. Comment on: BMJ 1995 Oct 7;311(7010):889-90.

> Henderson MM. Ethical issues: changing attitudes and practices. Cancer Detect Prev 1994;18(4):323-7.

> Horton R. ICRF: from mayhem to meltdown. Lancet 1997 Oct 11;350(9084):1043-4.

> Jensen AB, Madsen B, Andersen P, Rose C. Information for cancer patients entering a clinical trial--an evaluation of an information strategy. Eur J Cancer 1993;29A(16):2235-8.

> Joslin CA. The patient's view of breast cancer trials [letter]. Lancet 1992 Feb 1;339(8788):314. Comment on: Lancet 1992 Jan 4;339(8784):44-5.

> Kardinal CG. Ethical issues in cancer clinical trials. J La State Med Soc 1994 Aug;146(8):359-61.

> Kaufman D. Cancer therapy and the randomized clinical trial: good medicine? CA Cancer J Clin 1994 Mar-Apr;44(2):109-14.

> Lacombe D. Ethical issues in cancer clinical trials: a European perspective. Eur J Cancer 1997 Feb;33(2):184-5.

> Lambird PA, Oneson RH. College of American Pathologists Foundation Conference VII: Ethical guidelines for biomedical technology development and application--the breast cancer paradigm: recommendations and summary. Arch Pathol Lab Med 1994 Nov;118(11):1093-5.

> Mariani L. Experimental and nonexperimental studies: methodological, ethical, and practical implications in the context of hepatobiliary tumors. J Surg Oncol Suppl 1993;3:181-5.

> Markman M. Ethical difficulties with randomized clinical trials involving cancer patients: examples from the field of gynecologic oncology. J Clin Ethics 1992 Fall;3(3):193-5.

> Markman M. Ethical issues in clinical trials in oncology. Cleve Clin J Med 1997 May;64(5):275-7.

> Markman M. The objective clinical scientist versus the advocate: a complex ethical and political dilemma facing cancer investigators and the public. Cancer Invest 1995;13(3):324-6.

> McKenna RJ Sr, Laszlo J, Durant J, Hermann JF, Huguley C, Leventhal B, Roach E, Siegler M. Breakout I. Ethical considerations. Cancer 1990 May 15;65(10 Suppl):2407-8.

> Much JK. Ethical issues and paclitaxel (TAXOL) administration. Semin Oncol Nurs 1993 Nov;9(4 Suppl2):16-20.

> Mueller CB. Breast cancer trials on trial. A case of conflicting ethical interests. Cancer 1995 May 15;75(10):2403-6. Comments in: Cancer 1995 May 15;75(10):2407-9; discussion 2410-1; Cancer 1995 Oct 1;76(7):1294-5.

> Mueller CB. The lumpectomy fraud. Poisson, the National Surgical Adjuvant Breast Project, and a crisis of ethics. Arch Surg 1994 Oct;129(10):1001-3.

> Narasimhan P, Kalra J. Ethical questions on the testicular seminoma study [letter]. J Clin Oncol 1996 Feb;14(2):684. Comment on: J Clin Oncol 1995 Sep;13(9):2255-62.

> Nayfield SG. Ethical and scientific considerations for chemoprevention research in cohorts at genetic risk for breast cancer. J Cell Biochem Suppl 1996;25:123-30.

> Nyren O. Chemoprevention trials in cancer research--ethical considerations. Acta Oncol 1998;37(3):235-9. Comment in: Acta Oncol 1998 ;37(3):225.

> Penson RT, Doyal L, Slevin ML. Ethical issues in cancer treatment. Br J Urol 1995 Nov;76 Suppl 2:37-40.

> Pfeffer MR. Ethics and the oncologist. Med Law 1993;12(3-5):235-40.

> Prestifilippo J, Antman K, Berkman BJ, Kaufman D, Lantos J, Lawrence W Jr, Levine RJ, McKenna RJ Sr. The ethical treatment of cancer. What is right for the patient? Cancer 1993 Nov 1;72(9 Suppl):2816-9.

> Read C. Adjuvant treatment with tamoxifen. Local research ethics committees should review their approval of prevention trial [letter]. BMJ 1996 Apr 20;312(7037):1036. Comment on: BMJ 1996 Feb 17;312(7028):389-90.

> Report of group A of the American Cancer Society Research Workshop on Cancer and Nutrition: panel on human studies. Cancer Res 1993 May 15;53(10 Suppl):2449s-2451s.

> Slevin M, Mossman J, Bowling A, Leonard R, Steward W, Harper P, McIllmurray M, Thatcher N. Volunteers or victims: patients' views of randomised cancer clinical trials. Br J Cancer 1995 Jun;71(6):1270-4.

> Sutherland HJ, da Cunha R, Lockwood GA, Till JE. What attitudes and beliefs underlie patients' decisions about participating in chemotherapy trials? Med Decis Making 1998 Jan-Mar;18(1):61-9.

> Tabak N. Decision making in consenting to experimental cancer therapy. Cancer Nurs 1995 Apr;18(2):89-96.

> Tabak N. Doctors' policy on explaining the implementation of novel experimental treatment to cancer patients. Med Law 1994;13(3-4):331-55.

> Young FE. Ethical and financial considerations in third-party support of investigational cancer therapies. Cancer 1993 Nov 1;72(9 Suppl):2854-8.

> Return to table of contents

> ## Cancer research - Books

> Cancer Patient Access to Unapproved Treatments: Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce. 104th Cong. 2nd Sess. (1996 Feb 29) [microfiche]. Washington: U.S. Government Printing Office; 1996. 71 p.

> Oldham RK. Bioethics: opportunities, risks, and ethics -- the privatization of cancer research. Franklin (TN): Media America; 1992. 416 p.

> Williams CJ, editor. Introducing new treatments for cancer: practical, ethical, and legal problems. New York: Wiley; 1992. 492 p.

> Return to table of contents

> ## Emergency medicine, acute care and critical care research - Journal Articles

> American College of Emergency Physicians. Ethics manual. Ann Emerg Med 1991 Oct;20(10):1153-62.

> Ault A. FDA may pull the plug on consent waiver [news]. Lancet 1997 Oct 11;350(9084):1084.

> Barsan WG. Emergency medicine. JAMA 1991 Jun 19;265(23):3115-8.

> Biros MH. Development of the multiorganizational document regarding emergency research consent [editorial]. Acad Emerg Med 1996 Feb;3(2):101-5.

> Biros MH. Institutional review board approval: when and why? [editorial]. Acad Emerg Med 1998 Feb;5(2):91-2.

> Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 1995 Apr 26;273(16):1283-7. Comment in: JAMA 1995 Apr 26;273(16):1299-300; JAMA 1995 Apr 26;273(16):1300-2; JAMA 1995 Oct 18;274(15):1196.

> Biros MH, Runge JW, Lewis RJ, Doherty C. Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances. Acad Emerg Med 1998 Apr;5(4):359-68.

> Bradley K, Osborn HH, Tang M. College research associates: a program to increase emergency medicine clinical research productivity. Ann Emerg Med 1996 Sep;28(3):328-33.

> Brody BA, Katz J, Dula A. In case of emergency: no need for consent. Hastings Cent Rep 1997 Jan-Feb;27(1):7; discussion 7-12.

> Cline D, Henneman P, Van Ligten P, Spivey W, Olson J, Levitt A, Dire D, Zink B, Lowe R, Seaberg D, et al. A model research curriculum for emergency medicine. Ann Emerg Med 1992 Feb;21(2):184-92.

> Cobaugh DJ, Spillane LL, Schneider SM. Research subject enroller program: a key to successful emergency medicine research. Acad Emerg Med 1997 Mar;4(3):231-3.

> Dresser R, Whitehouse P. Emergency research and research involving subjects with cognitive impairment: ethical connections and contrasts [editorial]. J Am Geriatr Soc 1997 Apr;45(4):521-3. Comment on: J Am Geriatr Soc 1997 Apr;45(4):474-81.

> Emergency Nurses Association. Code of Ethics for Emergency Nurses With Interpretive Statements. J Emerg Nurs 1990 Nov-Dec;16(6):22A-24A.

> Ethical emergencies [editorial]. Lancet 1992 Feb 15;339(8790):399.

> FDA proposes easing research consent requirements in life-threatening situations [news]. Am J Health Syst Pharm 1995 Nov 1;52(21):2379.

> Firshein J. Informed consent rule in USA will require more money [news]. Lancet 1997 Jan 11;349(9045):111.

> Food and Drug Administration (US). Protection of human subjects; informed consent and waiver of informed consent requirements in certain emergency research; final rules. Fed Regist 1996 Oct 2;61(192):51498-531

> Fost N. Waived consent for emergency research. Am J Law Med 1998;24(2-3):163-83

> Fraker LD, Orsay EM, Sloan EP, Bunney EB, Holden JA, Hart RG. A novel curriculum for teaching research methodology. J Emerg Med 1996 Jul-Aug;14(4):503-8.

> Fresco C, Maggioni AP, Franzosi MG, Tognoni G. Ethical committees and noninformed consent [letter]. J Am Coll Cardiol 1994 Oct;24(4):1178. Comment on: J Am Coll Cardiol 1994 Jan;23(1):27-34.

> Hallstrom Al. The case for randomization without consent in emergency care. IRB Rev Hum Subj Res 1990 Jul-Aug;12(4):5.

> Hoekstra J. Randomized trials and common sense [editorial]. Ann Emerg Med 1997 Jan;29(1):164-6. Comment on: Ann Emerg Med 1997 Jan;29(1):1-12; Ann Emerg Med 1997 Jan;29(1):13-87.

> Isaacman DJ, Reynolds EA. Effect of a research nurse on patient enrollment in a clinical study. Pediatr Emerg Care 1996 Oct;12(5):340-2.

> Iserson KV. Research and barbaric medicine. Am J Emerg Med 1998 Mar;16(2):208.

> Iserson KV, Lindsey D. Research on critically ill and injured patients: rules, reality, and ethics. J Emerg Med 1995 Jul-Aug;13(4):563-7.

> Iserson KV, Mahowald MB. Acute care research: is it ethical? Crit Care Med 1992 Jul;20(7):1032-7.

> Karlawish JH, Hall JB. The controversy over emergency research. A review of the issues and suggestions for a resolution. Am J Respir Crit Care Med 1996 Feb;153(2):499-506. Comment in: Am J Respir Crit Care Med 1996 Feb;153(2):507-8.

> Karlawish JH, Sachs GA. Research on the cognitively impaired: lessons and warnings from the emergency research debate. J Am Geriatr Soc 1997 Apr;45(4):474-81. Comment in: J Am Geriatr Soc 1997 Apr;45(4):521-3.

> Kiernan V. Emergency trials 'by popular consent.' [news]. New Sci 1995 Nov 4;148(2002):6.

> Kim DT, Spivey WH. A retrospective analysis of institutional review board and informed consent practices in EMS research. Ann Emerg Med 1994 Jan;23(1):70-4. Comment in: Ann Emerg Med 1994 Oct;24(4):759-60.

> Konigova R. Ethical problems in burn injury in the past decade. Acta Chir Plast 1992;34(3):178-81.

> Lackner FX. Research in critically ill patients. Acta Anaesthesiol Scand Suppl 1997;111:160-2.

> Lamiell JM, Grabenstein JD, Vander Hamm DG. Review of the 1995 Food and Drug Administration/National Institutes of Health Public Forum on informed consent in clinical research conducted in emergency circumstances. Mil Med 1995 Dec;160(12):599-603.

> Levine RJ. Research in emergency situations. The role of deferred consent [editorial]. JAMA 1995 Apr 26;273(16):1300-2. Comment on: JAMA 1995 Apr 26;273(16):1261-8; JAMA 1995 Apr 26;273(16):1283-7.

> Levine RJ, Abramson NS, Safar P. Deferred consent. Control Clin Trials 1991 Aug;12(4):546-52. Comment on: Control Clin Trials 1991 Aug;12(4):525-45.

> Mader TJ, Playe SJ. Emergency medicine research consent form readability assessment. Ann Emerg Med 1997 Apr;29(4):534-9.

> Manning JE. Research in emergency medicine. N C Med J 1997 Jul-Aug;58(4):296-9.

> Mariner WK. Research in emergency care without consent: new proposed FDA rules. Lancet 1995 Dec 9;346(8989):1505-6.

> Marwick C. Assessment of exception to informed consent [news]. JAMA 1997 Nov 5;278(17):1392-3.

> Marwick C. FDA gets feedback on informed consent waiver [news]. JAMA 1996 Feb 7;275(5):347.

> Marwick C. Informed consent waiver for emergency research [news]. JAMA 1995 Oct 18;274(15):1184-5.

> Marwick C. Research in emergency circumstances [news]. JAMA 1995 Mar 1;273(9):687-8.

> McCarthy CR. Ethical considerations of new guidelines for emergency research [editorial]. Am J Respir Crit Care Med 1996 Feb;153(2):507-8. Comment on: Am J Respir Crit Care Med 1996 Feb;153(2):499-506.

> McCarthy CR. To be or not to be: waiving informed consent in emergency research. Kennedy Inst Ethics J 1995 Jun;5(2):155-62.

> McCarthy CR. Update on waiving informed consent in emergency research [letter]. Kennedy Inst Ethics J 1995 Dec;5(4):385-6.

> Menasche A, Levine RJ. FDA revises informed consent regulations for emergency research [article and comment on proposed rule]. IRB Rev Hum Subj Res 1995;17(5-6):19-22.

> Merz JF, Caplan AL. Informed consent for emergency research [letter]. JAMA 1995 Oct 18;274(15):1196. Comment on: JAMA 1995 Apr 26;273(16):1283-7.

> Miller BL. The ethics of cardiac arrest research. Ann Emerg Med 1993 Jan;22(1):118-24.

> Miller BL. Informed consent to research on emergency care [editorial]. Ann Emerg Med 1991 Nov;20(11):1267-9. Comment on: Ann Emerg Med 1991 Nov;20(11):1251-65.

> Morgan A. Informed consent: finding a path toward prudent policy. Pacing Clin Electrophysiol 1997 Mar;20(3 Pt 1):730-1.

> Morley C. Informed consent in medical research. Consent is not always practical in emergency treatments [letter]. BMJ 1997 May 17;314(7092):1480. Comment on: BMJ 1997 Apr 12;314(7087):1059-60.

> Nightingale SL. From the Food and Drug Administration: proposal for emergency use research. JAMA 1995 Nov 22;274(20):1578.

> Olson CM. The letter or the spirit. Consent for research in CPR [editorial]. JAMA 1994 May 11;271(18):1445-7. Comment on: JM1994 May 11;271(18):1405-11. Comment in: JM1994 Nov 16;272(19):1477-8.

> Olson CM, Jobe KA. Reporting approval by research ethics committees and subjects' consent in human resuscitation research. Resuscitation 1996 Jun;31(3):255-63.

> Olson JE, Hamilton GC, Angelos MG, Singer JI, Eilers ME, Gaddis M. Objectives to direct the training of emergency medicine residents on off-service rotations: research. J Emerg Med 1992 Sep-Oct;10(5):631-6.

> Orlowski JP. The impact of DNR orders on CPR research: educational and ethical implications. Clin Res 1993 Dec;41(4):595-600.

> Panacek EA, Lewis RJ. Guidelines for clinical investigator involvement in industry-sponsored clinical trials. SAEM Research Committee. Acad Emerg Med 1995 Jan;2(1):43-5.

> Paris PM. Relationship between academia and industry: ethical considerations. Ann Emerg Med 1996 Apr;27(4):416-7.

> Passamani E. Clinical trials--are they ethical? N Engl J Med 1991 May 30;324(22):1589-92. Comment in: N Engl J Med 1991 Nov 21;325(21):1513-5.

> Pinder M, Tshukutsoane S, Scribante J, Piccolo R, Lipman J. Critical care research and pre-emptive informed consent: a practical approach used in Chris Hani Baragwanath ICU. Intensive Care Med 1998 Apr;24(4):353-7.

> Prentice E. An even safer safety net. Hastings Cent Rep 1997 May-Jun;27(3):46.

> Prentice ED, Antonson DL, Leibrock LG, Kelso TK, et al. IRB review of a Phase II randommized clinical trial involving incompetent patients suffering from severe closed head injury. IRB Rev Hum Subj Res 1993 Sep-Oct;15(5):1-7.

> Public Health Service (US). Action related to emergency research activity. Fed Regist 1995 Jul 26;60(143):38353-4.

> Runge JW. Informed consent: an unresolved issue [letter]. Ann Emerg Med 1990 Jul;19(7):841. Comment on: Ann Emerg Med 1989 Jul;18(7):766-71.

> Rydman RJ, Zalenski RJ, Fagan JK. An evaluation of research training in a large residency program. Acad Emerg Med 1994 Sep-Oct;1(5):448-53.

> Sanders AB, Keim SM, Sklar D, Adams J, Society for Academic Emergency Medicine. Emergency physicians and the biomedical industry. Annals of Emergency Medicine 1992 May 1992;21(5):556-558.

> Schou J. Ban prehospital randomized studies [letter]. Eur J Emerg Med 1997 Sep;4(3):174-5. Comment in: Eur J Emerg Med 1997 Sep;4(3):123-4.

> Sklar DP. Ethical issues associated with pain research in emergency medicine. Ann Emerg Med 1996 Apr;27(4):418-20.

> Smithline HA, Gerstle ML. Waiver of informed consent: a survey of emergency medicine patients. Am J Emerg Med 1998 Jan;16(1):90-1.

> Somberg JC. Research in emergency care without consent: new proposed FDA rules [letter]. Lancet 1996 Feb 17;347(8999):475-6.

> Spivey WH, Abramson NS, Iserson KV, MacKay CR, Cohen MP. Informed consent for biomedical research in acute care medicine. Ann Emerg Med 1991 Nov;20(11):1251-65. Comment in: Ann Emerg Med 1991 Nov;20(11):1267-9.

> Waiver of informed consent requirements in certain emergency research. Fed Regist 1996 Oct 2;61(192):53531-3.

> Watts DD. Informed consent in emergency research: what every emergency nurse should know. J Emerg Nurs 1997 Feb;23(1):70-4.

> Whitley TW, Spivey WH, Abramson NS, Angelos MG, Barsan WG, Bradley K, Brown CG, Cordel WH, Dart RC, Krause GS, et al. A basic resource guide for emergency medicine research. Ann Emerg Med 1990 Nov;19(11):1306-9.

> Wichman A. Ethics of proxy consent for research involving patients with adult respiratory distress syndrome [letter]. JAMA 1996 Sep 25;276(12):949-50. Comment on: JAMA 1996 Feb 7;275(5):383-9; JAMA 1996 Feb 7;275(5):404-5.

> Wichman A, Sandler AL. Research involving critically ill subjects in emergency circumstances: new regulations, new challenges. Neurology 1997 May;48(5):1151-5.

> Wolfgang L. Waivers proposed for emergency studies [news]. Science 1995 Oct 6;270(5233):25-6.

> Yarborough M. What good are we doing? The role of clinical research in enhancing critical care medicine. J Crit Care 1993 Dec;8(4):228-36.

> Return to table of contents

> ## Drug and medical device research and development - Journal Articles

> Abernethy DR, Azarnoff DL. Pharmacokinetic investigations in elderly patients. Clinical and ethical considerations. Clin Pharmacokinet 1990 Aug;19(2):89-93.

> American College of Clinical Pharmacy Research Affairs Committee. Ethical issues related to clinical pharmacy research. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):523-30.

> Annas GJ. FDA's compassion for desperate drug companies. Hastings Cent Rep 1990 Jan-Feb;20(1):35-7.

> Browne TR. Clinical trials performed for the new drug approval process in the United States: standard methods and alternative methods. Epilepsy Res Suppl 1993;10:31-44.

> Canadian Medical Association. Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association Journal 1994 Jan 15 1994;150(2):256A-256C.

> Carroll P, Maher VF. Legal issues in experimental investigations of medications. Adv Clin Care 1990 May-Jun;5(3):6.

> Dollow S. Safety of patients participating in drug trials. Glaxo's reply [letter]. BMJ 1998 Sep 19;317(7161):818.

> Ebihara A, Takahashi K, Ikemoto F, Yamamoto K. Clinical pharmacology and clinical trials in Japan. J Mol Med 1996 Aug;74(8):479-86.

> Edgar H, Rothman DJ. New rules for new drugs: the challenge of AIDS to the regulatory process. Milbank Q 1990;68 Suppl 1:111-42.

> Ethical issues related to clinical pharmacy research. American College of Clinical Pharmacy. Pharmacotherapy 1993 Sep-Oct;13(5):523-30.

> Fisher LD. The use of one-sided tests in drug trials: an FDA advisory committee member's perspective. J Biopharm Stat 1991;1(1):151-6.

> French JA. Obstacles encountered in designing antiepileptic drug trials. Epilepsy Res Suppl 1993;10:81-9.

> Gram L, Schmidt D. Innovative designs of controlled clinical trials in epilepsy. Epilepsia 1993;34 Suppl 7:S1-6.

> Graves NM. The role of the pharmacist in investigational AED trials. Epilepsy Res Suppl 1993;10:201-9.

> Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs, American Academy of Pediatrics. Pediatrics 1995 Feb;95(2):286-94.

> Haynes WG, Webb DJ. Ethics of volunteer research: the role of new EC guidelines. Br J Clin Pharmacol 1991 Dec;32(6):671-6.

> Hillman AL, Eisenberg JM, Pauly MV. Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. N Engl J Med 1991 May 9;324(19):1362-5.

> Hilton A, Dubbleman R. Oncology nursing: research protocols for drug regimens. Nurs Stand 1990 Jul 11-17;4(42):26-7.

> Holdsworth MT. Ethical issues regarding study designs used in serotonin-antagonist drug development [editorial]. Ann Pharmacother 1996 Oct;30(10):1182-4.

> Hubscher O. Ethics of drug trials in developing countries. World Health Forum 1993;14(1):25-7.

> Idanpaan-Heikkila JE. WHO guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products: Responsibilities of the Investigator. Ann Med 1994 Apr;26(2):89-94.

> Investigational device exemptions, 21 C.F.R. Sect. 812 (1998 revised).

> Investigational new drug application, 21 C.F.R. Sect. 312 (1998 revised).

> Kastrissios H, Blaschke TF. Medication compliance as a feature in drug development. Annu Rev Pharmacol Toxicol 1997;37:451-75.

> Katz R. The domestic drug regulatory process: why time is of the essence. Epilepsy Res Suppl 1993;10:91-106.

> Kellett JM. Drug trial ethics [letter]. J Med Ethics 1994 Dec;20(4):270.

> Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, et al. Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute. J Cell Biochem Suppl 1994;20:55-62.

> Kelloff GJ, Johnson JR, Crowell JA, Boone CW, DeGeorge JJ, Steele VE, Mehta MU, Temeck JW, Schmidt WJ , Burke G, et al. Guidance for development of chemopreventive agents. J Cell Biochem Suppl 1994;20:25-31.

> Kessler DA. FDA's revitalization of medical device review and regulation. Biomed Instrum Technol 1994 May-Jun;28(3):220-6.

> Kolff WJ. Delays by recalcitrant FDA, reluctant NIH, and fearful industry: the cost in human life, happiness, money, and loss of opportunity for American industry [editorial]. Artif Organs 1993 Sep;17(9):753-7.

> La Puma J, Stocking CB, Rhoades WD, Darling CM, Ferner RE, Neuberger J, VandenBurg M, Dews I, Tobias JS. Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients. BMJ 1995 Jun 24;310(6995):1660-3. Published erratum appears in BMJ 1995 Aug 5;311(7001):373.

> Lee PP, Yang JC. The nonapproved use of medications. Ophthalmology 1991 Jul;98(7):1071-4.

> Leppik IE. Sources of variability in clinical trials of new drugs for epilepsy. Epilepsy Res Suppl 1993;10:157-66.

> Levine RJ. FDA's new rule on treatment use and sale of investigational new drugs. IRB Rev Hum Subj Res 1987 Jul-Aug;9(4):1-4.

> Lexchin J. Drug makers and drug regulators: too close for comfort. A study of the Canadian situation. Soc Sci Med 1990;31(11):1257-63.

> Lupton ML. Artificial wombs: medical miracle, legal nightmare. Med Law 1997;16(3):621-33.

> Maloney DM. Despite clinical hold, subjects have right to keep getting experimental drug: Dahl vs HEM Pharmaceuticals Corporation (Part III). Hum Res Rep 1996 Feb;11(2):4-5.

> Maloney DM. International research agreement leads to new U.S. guidelines [news]. Hum Res Rep 1995 Apr;10(4):1-2.

> Manuel SM, Piascik P. How FDA approves biotechnology drugs. Am Pharm 1995 May;NS35(5):14-5.

> Mbuyi-Muamba JM. Drug trials in developing countries: the need for ethics. World Health Forum 1993;14(1):28-9.

> McBride G. Phase one trials can exploit terminally ill patients [news]. BMJ 1994 Mar 12;308(6930):679-80.

> Menache S, Menache A. Between animal experiments and informed consent. Med Law 1996;15(3):413-5.

> Miller J, Kinsella D, Klein A, Rusted I. Ethical aspects of pharmaceutically-based clinical investigation: report on a national workshop. NCBHR Commun 1990 Oct-Nov;1(1):7-10.

> Mitchell P. Drug industry lobbies against European research-data directive [news]. Lancet 1997 May 10;349(9062):1378.

> MRC to go ahead with controversial tamoxifen trial [news]. Bull Med Ethics 1991 Oct;72:3-5.

> Netley G. Calls for strengthened drug-trial guidelines in Japan [news]. Lancet 1997 Feb 22;349(9051):552.

> O'Malley K. Ethical dilemmas in drug evaluation. Ir J Med Sci 1990 Aug;159(8):244.

> Phillips M. Serious intercurrent disease in healthy volunteers in clinical pharmacological research [letter]. Lancet 1992 Mar 28;339(8796):813. Comment on: Lancet 1992 Feb 22;339(8791):504. Comment in: Lancet 1992 Apr 25;339(8800):1058.

> Proudfoot A. Let ethics committees authorise new drugs for treatment [letter]. Med J Aust 1991 Sep 16;155(6):421. Comment on: Med J Aust 1991 Aug 5;155(3):204.

> Reneman RS. New developments in clinical testing of medical devices for Europe 1992. Eur J Cardiothorac Surg 1992;6 Suppl 1:S102-6.

> Rockhold FW, Enas GG. Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. Stat Med 1993 Mar;12(5-6):471-9.

> Roizen R. Why I oppose drug company payment of physician/investigators on a per patient/subject basis. IRB Rev Hum Subj Res 1988 Jan-Feb;10(1):9-10.

> Scheifele DW. Clinical trials and tribulations: a personal view of interacting with pharmaceutical manufacturers. Clin Invest Med 1997 Jun;20(3):188-92.

> Scott JW. How did the male become the normative standard for clinical drug trials? Food Drug Law J 1993;48(2):187-93.

> Shamoo AE. Policies and quality assurance in the pharmaceutical industry. Account Res 1990;1(4):273-84.

> Shapiro MF. Data audit by a regulatory agency: its effect and implication for others. Account Res 1992;2(3):219-29.

> Shenfield GM, Hirshorn JE. Good clinical practice in the investigation of pharmaceutical products. Med J Aust 1991 May 6;154(9):631-6.

> Sherertz RJ, Streed SA. Medical devices. Significant risk vs nonsignificant risk. JAMA 1994 Sep 28;272(12):955-6. Comment in: JAMA 1994 Sep 28;272(12):968-9; JAMA 1995 Jun 28;273(24):1906; discussion 1906-7.

> Shirk MB, Hale KN. Obtaining drugs from foreign markets. Am J Hosp Pharm 1992 Nov;49(11):2731-9.

> Toon S. Relevance of pharmacokinetic studies in volunteers. Clin Pharmacokinet 1993 Oct;25(4):259-62.

> Treiman DM. Ethical considerations. Epilepsy Res Suppl 1993;10:137-48.

> Treiman DM. Study population selection. Epilepsy Res Suppl 1993;10:125-35.

> Tueting P. Investigational drugs and research. Psychiatr Med 1991;9(2):333-47.

> Wadman M. $100 payout after drug data withheld [news]. Nature 1997 Aug 21;388(6644):703.

> Walker MC, Sander JW. New antiepileptic drug trials in developing countries: are they necessary? Seizure 1996 Sep;5(3):165-9.

> Walsh D, Drumm B. Legislation and drug trials. Arch Dis Child 1997 Apr;76(4):296-7.

> Warrington SJ. Ethics of evaluation of new drugs in human volunteers. Ann Acad Med Singapore 1991 Jan;20(1):101-5.

> Warrington SJ, Ankier SI. The physicians' role in the clinical development of new medicines. Postgrad Med J 1990 Jan;66(771):34-9.

> Wells F. Informed consent to postmarketing research. British rules outlaw disguised promotion of drugs [letter]. BMJ 1995 Sep 9;311(7006):692.

> Wells FO. Ethical issues in the pharmaceutical industry. Br J Urol 1995 Nov;76 Suppl 2:41-7.

> Wilks MF, Woollen BH. Human volunteer studies with non-pharmaceutical chemicals: metabolism and pharmacokinetic studies. Hum Exp Toxicol 1994 Jun;13(6):383-92. Comment in: Hum Exp Toxicol 1994 Jun;13(6):381-2.

> Return to table of contents

> ## Drug and medical device research and development - Books

> Association of British Pharmaceutical Industry, Working Party on Non-patient Volunteer Studies. Guidelines for medical experiments in non-patient human volunteers. London: Association of the British Pharmaceutical Industry; 1988. 15 p.

> Bennett PN. Good clinical practice and ethics in European drug research. Symposium on Good Clinical Practice and Ethics in European Drug Research; 1993 Mar 18-19, Brussels. Bath: Bath University Press; 1994. 159 p.

> Bennett PN, editor. Ethical responsibilities in European drug research. England: University of Bath Press; 1990. 84 p.

> Brody BA. Ethical issues in drug testing, approval, and pricing: the clot dissolving drugs. New York: Oxford University Press; 1995. 268 p.

> Champey Y, Levine RJ, Lietman PS, editors. Development of new medicines--ethical questions: proceedings of a symposium; 1988 Dec 2; Paris. New York: Royal Society of Medicine Services; 1988. 96 p. (International congress and symposium series; 148). Sponsored by Fondation Rhone-Poulenc Sante.

> Ethical aspects of pharmaceutically-based clinical investigation: proceedings of a workshop, 1990 May 30-31, Ottawa. Ottawa: National Council on Bioethics in Human Research; 1990. 16 p.

> European and Nordic regulations and guidelines for good clinical practice. Austin (TX): Pharmaco Dynamics Research, Inc. Regulatory Affairs Dept.; c1990. 134 p.

> Good clinical trial practice: Nordic guidelines. 1st ed. Uppsala (Sweden): Nordic Council on Medicines; 1989 Dec. 38 p.

> Guidelines on good clinical research practice. London: Association of the British Pharmaceutical Industry; 1988 Mar. 22 p.

> Maynard DE. International good clinical practice: the GCP compliance handbook. Buffalo (IL): Interpharm Press; c1996. 495 p.

> Parnham MJ. Ethical issues in drug research: through a glass darkly. Amsterdam: IOS Press; 1996. 155 p.

> Problems in Securing Informed Consent of Subjects in Experimental Trials of Unapproved Drugs and Devices: Hearing (1994 May 23). Washington: U.S. Government Printing Office; 1994. 270 p.

> Rosenbaum D, Dresser M. Clinical research coordinator handbook: GCP tools and techniques. Buffalo Grove (IL): Interpharm Press; c1997. 299 p. (Practical clinical trials series; vol. 1).

> Rosenbaum D, Smith F. Clinical research monitor handbook: GCP tools and techniques. Buffalo Grove (IL): Interpharm Press; c1998. 463 p. (Practical clinical trials series).

> Rosenbaum D, Smith F. Physician investigator handbook: GCP tools and techniques. Buffalo Grove (IL): Interpharm Press; c1997. 418 p. (Practical clinical trials series).

> Wells FO. Medicines: good practice guidelines. Belfast: Queen's University of Belfast; c1990. 196 p.

> Return to table of contents

> ## Institutional review boards and ethics committees - Journal Articles

> Abbott K, Blair F, Duncan S. Participatory research. Can Nurse 1993 Jan;89(1):25-7.

> Abeliovich D, Quint A, Weinberg N, Verchezon G, Lerer I, Ekstein J, Rubinstein E. Cystic fibrosis heterozygote screening in the Orthodox Community of Ashkenazi Jews: the Dor Yesharim approach and heterozygote frequency. Eur J Hum Genet 1996;4(6):338-41.

> Adams J. Institutional review boards: the public safety net. J Pediatr Oncol Nurs 1995 Apr;12(2):93-5.

> Ahmed AH, Nicholson KG. Delays and diversity in the practice of local research ethics committees. J Med Ethics 1996 Oct;22(5):263-6.

> Alberti KG. Local research ethics committees [editorial]. BMJ 1995 Sep 9;311(7006):639-40. Published erratum appears in BMJ 1995 Oct 7;311(7010):892. Comment on: BMJ 1995 Sep 9;311(7006):659-60; BMJ 1995 Sep 9;311(7006):660-1; BMJ 1995 Sep 9;311(7006):661. Comment in: BMJ 1995 Dec 9;311(7019):1571; BMJ 1995 Dec 9;311(7019):1572; BMJ 1996 Jan 6;312(7022):54-5

> Alderete E. The formulation of a health research agenda by and for indigenous peoples: contesting the Western scientific paradigm. J Altern Complement Med 1996 Fall;2(3):377-85.

> Aldrich N, Darling CM. Hospital ethics committees as community educators: a model for institutions. HEC Forum 1995 Jul;7(4):252-63.

> Aldridge HD, Walport MJ. Ethical issues in clinical research: the role of the research ethics committee. Br J Urol 1995 Nov;76 Suppl 2:23-8.

> Amdur RJ, Bankert E. Continuing IRB review when research activity is limited to routine follow-up evaluations. IRB Rev Hum Subj Res 1997 Jan-Feb;19(1):7-10.

> Amdur RJ, Biddle C. Institutional review board approval and publication of human research results. JAMA 1997 Mar 19;277(11):909-14. Comments in: JAMA 1997 Mar 19;277(11):922-3; JAMA 1997 Aug 13;278(6):477.

> Annas GJ. Ethics committees: from ethical comfort to ethical cover. Hastings Cent Rep 1991 May-Jun;21(3):18-21.

> Areen J. The greatest rewards and the heaviest penalties. Hum Gene Ther 1992 Jun;3(3):277-8.

> Ayer S. Submitting a research proposal for ethical approval. Prof Nurse 1994 Sep;9(12):805-6.

> Bai K. Characteristics of ethics committees of Japanese medical schools. Med Law 1992;11(5-6):337-43.

> Baldwin J. How to gain ethical committee approval. Mod Midwife 1994 Nov;4(11):27-9.

> Bandeira R. Hospital ethics committees in Portugal. HEC Forum 1990;3(6):347-8.

> Banner RO, DeCambra H, Enos R, Gotay C, Hammond OW, Hedlung N, Issell BF, Matsunaga DS, Tsark JA. A breast and cervical cancer project in a native Hawaiian community: Wai'anae cancer research project. Prev Med 1995 Sep;24(5):447-53.

> Barton A. Local research ethics committees. Monitoring body is needed for audit [letter]. BMJ 1997 Nov 29;315(7120):1465.

> Beech BA, Robinson J. Local research ethics committees: hindrance or help? [letter]. Br J Obstet Gynaecol 1995 Oct;102(10):842. Comment on: Br J Obstet Gynaecol 1995 Jan;102(1):1-2.

> Benster R, Pollock AM. Guidelines for local research ethics committees: distinguishing between patient and population research in the Multicentre Research Project. Public Health 1993 Jan;107(1):3-7.

> Beran RG. Should there be an accredited ethics committee system for centralised review of multicentre clinical research? Med J Aust 1998 Feb 16;168(4):174-6. Comment in: Med J Aust 1998 May 18;168(10):528.

> Bergkamp L. American IRBs and Dutch research ethics committees: how they compare. IRB Rev Hum Subj Res 1988 Sep-Oct;10(5):1-6.

> Berry J. Local Research Ethics Committees can audit ethical standards in research. J Med Ethics 1997 Dec;23(6):379-81.

> Berry TJ, Ades TE, Peckham CS. Too many ethical committees [letter]. BMJ 1990 Dec 1;301(6763):1274.

> Black M, Leese B, Gosden T. Local research ethics committees. Differences in application process cause problems [letter]. BMJ 1995 Dec 9;311(7019):1572. Comment on: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Sep 9;311(7006):659-60; BMJ 1995 Sep 9;311(7006):660-1; BMJ 1995 Sep 9;311(7006):661.

> Blunt J. Research ethics committees must ensure registration of research and accessibility of results [letter]. BMJ 1998 Jan 24;316(7127):312. Comment on: BMJ 1997 Sep 13;315(7109):683.

> Blunt J, Savulescu J, Watson AJ. Meeting the challenges facing research ethics committees: some practical suggestions. BMJ 1998 Jan 3;316(7124):58-61.

> Bonkovsky FO. The development of the Bioethics Program of the National Institutes of Health Warren G. Magnuson Clinical Center. HEC Forum 1995 Jan;7(1):33-6.

> Boston P, Jordan S, MacNamara E, Kozolanka K, Bobbish-Rondeau E, Iserhoff H, Mianscum S , Mianscum-Trapper R, Mistacheesick I, Petawabano B, Sheshamush-Masty M, Wapachee R, Weapenicappo J. Using participatory action research to understand the meanings aboriginal Canadians attribute to the rising incidence of diabetes. Chronic Dis Can 1997;18(1):5-12.

> Brennan TA. Researcher as witness [editorial]. J Clin Ethics 1992 Winter;3(4):308-9.

> Brower V. Vulnerable groups at risk from commercial ethical review boards [news]. Nat Med 1997 Jul;3(7):705.

> Browne A, Sweeney VP, Norman M. Ethics committee education: report on a Canadian project. HEC Forum 1996 Oct;8(5):290-300.

> Brudermuller G, Seelmann K. How to discuss ethics in institutional review boards? Methods Find Exp Clin Pharmacol 1992 Nov;14(9):737-42.

> Bruening WH, Brock MJ, Schellhause ER. Educating the ethics committee. J Nurs Staff Dev 1997 Sep-Oct;13(5):255-9.

> Burnett L, Proos AL, Chesher D, Howell VM, Longo L, Tedeschi V, Yang VA, Siafakas N, Turner G. The Tay-Sachs disease prevention program in Australia: Sydney pilot study. Med J Aust 1995 Sep 18;163(6):298-300.

> Butler D. Bioethics panels may be threat to public debate on research [news]. Nature 1996 Jan 25;379(6563):289.

> Butler D. CNRS returns fire on ethics review panel [news]. Nature 1997 Jul 10;388(6638):110.

> Butler D. European biotech industry plans ethics panel [news]. Nature 1997 Jul 3;388(6637):6.

> Byk C. International Association for Law, Ethics and Science (the Milazzo group) convenes colloquium on The law of 20 December 1988 on biomedical research: committees for the protection of persons or ethical committees? (Paris, 21 Nov 1991) [news]. Int Dig Health Legis 1992;43(2):393-7.

> Cadwell K, White E. Global participatory action research (GLOPAR) [letter]. J Hum Lact 1995 Dec;11(4):262.

> Cartwright A, Madden AP, Rushton A, Murray GH, Drury M. Research ethics committees [letters]. BMJ 1990 Mar 3;300(6724):607-8.

> Cassidy VR, Oddi LF. Nurses on hospital IRBs: a critical voice in protecting human subjects. Nursingconnections 1993 Spring;6(1):31-8.

> Cattorini P, Mordacci R. Ethics committees in Italy. HEC Forum 1992;4(3):219-26.

> Chalmers D, Pettit P. Towards a consensual culture in the ethical review of research. Australian Health Ethics Committee. Med J Aust 1998 Jan 19;168(2):79-82.

> Charo RA. Principles and pragmatism. Kennedy Inst Ethics J 1996 Sep;6(3):319-22. Comment on: Kennedy Inst Ethics J 1996 Sep;6(3);289-311.

> Chen AM, Wismer BA, Lew R, Kang SH, Min K, Moskowitz JM, Tager IB. Health is strength: a research collaboration involving Korean Americans in Alameda County. Am J Prev Med 1997 Nov-Dec;13(6 Suppl):93-100.

> Chesapeake Research Review, Inc. Ellicott City MD. On being an IRB. IRB Rev Hum Subj Res 1995 Sep-Dec;17(5-6):12-6.

> Chesler MA. Participatory action research with self-help groups: an alternative paradigm for inquiry and action. Am J Community Psychol 1991 Oct;19(5):757-68.

> Cho MK, Billings P. Conflict of interest and institutional review boards. J Investig Med 1997 Apr;45(4):154-9.

> Christakis NA. Should IRBs monitor research more strictly? IRB Rev Hum Subj Res 1988 Mar-Apr;10(2):8-10.

> Clein P. Local research ethics committees in the UK. Palliat Med 1997 Jan;11(1):55-6.

> Coggan C, Disley B, Patterson P. Community based intervention on adolescent risk taking: using research for community action. Inj Prev 1998 Mar;4(1):58-61.

> Cohen M. Should there be an accredited ethics committee system for centralised review of multicentre clinical research? [letter]. Med J Aust 1998 May 18;168(10):528. Comment on: Med J Aust 1998 Feb 16;168(4):174-6.

> Cohen M, Palafox PA. The legal liability of the institutional review board. Clin Rev Allergy 1994 Summer;12(2):211-8.

> Colen BD. Proceedings of the Workshop on Inherited Breast Cancer in Jewish Women: Ethical, Legal, and Social Implications. LawMed News 1996 Summer;2(1):1-4.

> Cookson JB. Auditing a research ethics committee. J R Coll Physicians Lond 1992 Apr;26(2):181-3.

> Corcega TF. Participatory research: getting the community involved in health development. Int Nurs Rev 1992 Nov-Dec;39(6):185-8.

> Cornwall A, Jewkes R. What is participatory research? Soc Sci Med 1995 Dec;41(12):1667-76.

> Coughlin SS. Invited commentary: on the role of ethics committees in epidemiology professional societies. Am J Epidemiol 1997 Aug 1;146(3):209-13.

> Creutzfeldt W. Function and duties of an ethics committee at a university faculty of medicine: 13 years of personal experience. Forensic Sci Int 1994 Dec 16;69(3):307-14.

> Danis M. Should ethics committees study themselves? [editorial]. J Clin Ethics 1994 Summer;5(2):159-62. Comment on: J Clin Ethics 1994 Summer;5(2):121-5.

> Danis M, Grady C. Institutional review board review and consent for research: what's behind the statistics? [editorial]. Crit Care Med 1998 Sep;26(9):1488-9. Comment on: Crit Care Med 1998 Sep;26(9):1596-602.

> Danks DM. Ethics committees [letter]. Lancet 1991 Feb 9;3337(8737):369.

> Darvall L. Increased review responsibilities for Australian institutional ethics committees. IRB Rev Hum Subj Res 1995;17(1):9.

> Degnin FD. Max Weber on ethics case consultation: a methodological critique of the conference on evaluation of ethics consultation. J Clin Ethics 1997 Summer;8(2):181-92.

> DeRenzo EG, Bonkovsky FO. Bioethics consultants to the National Institutes of Health's intramural IRB system: the continuing evolution. IRB Rev Hum Subj Res 1993;15(3):9-10.

> DeRenzo EG, Wichman A. A pilot project: bioethics consultants as non-voting members of IRBs at the National Institutes of Health. IRB Rev Hum Subj Res 1990;12(6):6-8.

> Deutsch E. The functions of ethical committees. Int J Bioethics 1990 Sep;1(3):177-82.

> Diamond AL, Laurence DR. Better research ethics committees: comments on guidance from the Department of Health and the European Community. J R Coll Physicians Lond 1993 Apr;27(2):141-6.

> Dickersin K, Min YI , Meinert CL. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA 1992 Jan 15;267(3):374-8. Comment in: JAMA 1991 Jan 15;267(3):411-2.

> Dickinson JA. Getting help for research: the RACGP research committees. Aust Fam Physician 1991 Nov;20(11):1659-62.

> Dockerty JD, Elwood M. The difficulties and costs of ethical assessment of a national research project. N Z Med J 1992 Aug 12;105(939):311-3. Comment in: N Z Med J 1992 Sep 23;105(942):388.

> Domen RE. A survey of ethics committees in national medical organizations in the United States. HEC Forum 1995 Nov;7(6):333-8.

> Dorff EN. Jewish theological and moral reflections on genetic screening: the case of BRCA1. Health Matrix 1997 Winter;7(1):65-96.

> Douglas A. New role for ethics committees. N Z Med J 1993 Dec 8;106(969):528-9.

> Douglass AJ, Jarvis A, Bloore S. Monitoring of health research by ethics committees. N Z Med J 1998 Mar 13;111(1061):79-81.

> Doyal L. Towards a standard application form for LRECs. Bull Med Ethics 1994 Sep;101:15-28.

> Drevdahl D. Coming to voice: the power of emancipatory community interventions. ANS Adv Nurs Sci 1995 Dec;18(2):13-24.

> Drury M. Ethical appraisal for multi-centre medical research. J Med Ethics 1990 Sep;16(3):148-9.

> Drury M. Ethics and multicentre research projects [letter]. BMJ 1992 Jun 27;304(6843):1696. Comment on: BMJ 1992 May 2;304(6835):1129-30; BMJ 1992 May 30;304(6839):1446.

> Dudley H. Local research ethics committees. Attitude of their members is the critical factor [letter]. BMJ 1995 Dec 9;311(7019):1571. Comment on: BMJ 1995 Sep 9;311(7006):639-40.

> Edgar H, Rothman DJ. The institutional review board and beyond: future challenges to the ethics of human experimentation. Milbank Q 1995;73(4):489-506.

> Eichler HG. Hazards of misguided ethics committees. Lancet 1995 Oct 28;346(8983):1115-6. Comments in: Lancet 1995 Dec 16;346(8990):1632; Lancet 1996 Jan 6;347(8993):62-3.

> Ellis SJ. Ethics review and clinical trials [letter]. Lancet 1998 Apr 4;351(9108):1066. Comment on: Lancet 1998 Jan 24;351(9098):225.

> Enquselassie F, Nokes J, Cutts F. Ethics committees. Communities' confidentiality should be maintained and community consent sought [letter]. BMJ 1996 Jan 6;312(7022):54-5. Comment on: BMJ 1995 Sep 9;311(7006):639-40.

> Ethics committee approval for German clinical trials [news]. Lancet 1995 Mar 4;345(8949):577.

> Ethics committees and health services research [letter]. J Public Health Med 1991 Aug;13(3):230-1. Comment on: J Public Health Med 1990;12(3-4):190-6.

> Federal agency can still appoint special ethics advisory boards [news]. Hum Res Rep 1994 Jul;9(7):6.

> Feldman MK. Mode of inquiry. Minn Med 1996 Jun;79(6):18-23.

> Fetters MD. Nemawashi essential for conducting research in Japan. Soc Sci Med 1995 Aug;41(3):375-81.

> Finkenbine R, Gramelspacher G. Physicians' attitudes toward hospital ethics committees. Indiana Med 1991 Nov;84(11):804-7.

> Fleetwood J, Unger SS. Institutional ethics committees and the shield of immunity. Ann Intern Med 1994 Feb 15;120(4):320-5. Published erratum appears in Ann Intern Med 1994 Jul 15;121(2):154. Comments in: Ann Intern Med 1994 Feb 15;120(4):335-8; Ann Intern Med 1994 Sep 1;121(5):386; discussion 387; Ann Intern Med 1994 Sep 1;121(5):386-7; Ann Intern Med 1994 Nov 1;121(9).

> Fletcher JC. The bioethics movement and hospital ethics committees. Md Law Rev 1990;50(3):859-94.

> Fletcher JC, Hoffmann DE. Ethics committees: time to experiment with standards. Ann Intern Med 1994 Feb 15;120(4):335-8. Comment on: Ann Intern Med 1994 Feb 15;120(4):320-5. Comments in: Ann Intern Med 1994 Sep 1;121(5):386; discussion 387; Ann Intern Med 1994 Sep 1;121(5):386-7.

> Food and Drug Administration (US). Information sheets: guidance for Institutional Review Boards and clinical investigators. 1998 update [monograph on the Internet]. Rockville (MD): The Administration; 1998 Sep [cited 1999 May 10]. [12 web p.]. Available from: http://www.fda.gov/oc/oha/IRB/toc.html.

> Food and Drug Administration (US). Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. Fed Regist 1998 Nov 9;63(216);60353-6.

> Foster C, Holley S. Ethical review of multi-centre research: a survey of multi-centre researchers in the South Thames region. J R Coll Physicians Lond 1998 May-Jun;32(3):242-5.

> Foster CG, Marshall T, Moodie P. The annual reports of Local Research Ethics Committees. J Med Ethics 1995 Aug;21(4):214-9.

> Foster MW, Bernsten D, Carter TH. A model agreement for genetic research in socially identifiable populations. Am J Hum Genet 1998 Sep;63(3):696-702.

> Foster MW, Eisenbraun AJ, Carter TH. Communal discourse as a supplement to informed consent for genetic research. Nat Genet 1997 Nov;17(3):277-9.

> Freedman B. Multicenter trials and subject eligibility: should local IRBs play a role? IRB Rev Hum Subj Res 1994;16(1-2):1-6.

> Furler J. Ethics committees: is the tail wagging the dog? [letter]. Med J Aust 1993 Jan 18;158(2):140; discussion 142. Comment on: Med J Aust 1992 Nov 2;157(9):636-7.

> Furler J, Burnell RH, Jamrozik K. Ethics committees: is the tail wagging the dog? [letters and response]. Med J Aust 1993 Jan 18;158(2):140-1.

> Gallagher EM, Scott VJ. The STEPS Project: participatory action research to reduce falls in public places among seniors and persons with disabilities. Can J Public Health 1997 Mar-Apr;88(2):129-33.

> Garfield P. Cross district comparison of applications to research ethics committees. BMJ 1995 Sep 9;311(7006):660-1. Comments in: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Dec 9;311(7019):1571; BMJ 1995 Dec 9;311(7019):1572; BMJ 1996 Jan 6;312(7022):54.

> Gelder MG. A national committee for the ethics of research. J Med Ethics 1990 Sep;16(3):146-7.

> Geller G, Bernhardt BA, Helzlsouer K, Holtzman NA, Stefanek M, Wilcox PM. Informed consent and BRCA1 testing [letter]. Nat Genet 1995 Dec;11(4):364.

> Gershon D. Cracks in the RAC [news]. Nature 1991 Oct 17;353(6345):591.

> Gibson RS, Yeudall F, Drost N, Mtitimuni B, Cullinan T. Dietary interventions to prevent zinc deficiency. Am J Clin Nutr 1998 Aug;68(2 Suppl):484S-487S.

> Ginzler M, Davies J, McPherson K, Black N. Ethics committees and health services research. J Public Health Med 1990;12(3-4):190-6.

> Glasa J, Holoman J, Klepanec J, Soltes L. Ethics committees and achievement of good clinical practice. Therapie 1996 Jul-Aug;51(4):369-72.

> Godwin PGR, Kimbel KH. Ethics committees [letters]. Lancet 1995 Apr 22;345(8956):1051.

> Goodman NW, MacGowan A. Are research ethics committees behaving unethically? If committees were sued who would be liable? [letter]. BMJ 1997 Mar 1;314(7081):676-7. Comment on: BMJ 1996 Nov 30;313(7069):1390-3. Comment in: BMJ 1997 Jul 5;315(7099):60-1.

> Gordon B, Prentice E. Continuing review of research involving human subjects: Approach to the problem and remaining areas of concern. IRB Rev Hum Subj Res 1997 Mar-Apr;19(2):8-11.

> Graf HP, Cole D. Ethics-committee authorization in Germany. J Med Ethics 1995 Aug;21(4):229-33.

> Grams GD, Herbert C, Heffernan C, Calam B, Wilson MA, Grzybowski S, Brown D. Haida perspectives on living with non-insulin-dependent diabetes. CMAJ 1996 Dec 1;155(11):1563-8.

> Gray S, Frankel S. The trouble with ethics committees [letter]. J R Coll Physicians Lond 1994 Sep-Oct;28(5):484. Comment on: J R Coll Physicians Lond 1994 Mar-Apr;28(2):102-4.

> Green LW, O'Neill M, Westphal M, Morisky D. The challenges of participatory action research for health promotion [editorial]. Promot Educ 1996 Dec;3(4):3-5.

> Griener GG, Storch JL. The educational needs of ethics committees. Camb Q Healthc Ethics 1994 Summer;3(3):467-77. Comment in: Camb Q Healthc Ethics 1994 Summer;3(3):478-82.

> Grisso T, Baldwin E, Blanck PD, Rotheram-Borus MJ, Schooler NR, Thompson T. Standards in research: APA's mechanism for monitoring the challenges. Am Psychol 1991 Jul;46(7):758-66.

> Haddad AM. Annotated bibliography: nursing ethics committees. HEC Forum 1997 Mar;9(1):93-105.

> Haderka J. Ethics committees in Czechoslovakia. Bull Med Ethics 1991 Jun;69:18-19.

> Hagey RS. The use and abuse of participatory action research [editorial]. Chronic Dis Can 1997;18(1):1-4.

> Hall D. The research imperative and bureaucratic control: the case of clinical research. Soc Sci Med 1991;32(3):333-42.

> Hamet P, Petrasovits A. How to translate science into community action. J Hum Hypertens 1996 Feb;10 Suppl 1:S89-92.

> Harries UJ, Fentem PH, Tuxworth W, Hoinville GW. Local research ethics committees. Widely differing responses to a national survey protocol. J R Coll Physicians Lond 1994 Mar-Apr;28(2):150-4. Comments in: J R Coll Physicians Lond 1994 Mar-Apr;28(2):102-4; J R Coll Physicians Lond 1994 Jul-Aug;28(4):382.

> Harris EA. Ethical committees in practice [letter]. N Z Med J 1990 Jun 13;103(891):279.

> Harris J. The ethics of national ethics committees. J R Coll Physicians Lond 1994 Jul-Aug;28(4):323-4.

> Hayes GJ. Ethics committees: group process concerns and the need for research. Camb Q Healthc Ethics 1995 Winter;4(1):83-91.

> Hayes GJ, Hayes SC, Dykstra T. A survey of university institutional review boards: characteristics, policies, and procedures. IRB Rev Hum Subj Res 1995;17(3):1-6.

> Hayry M. Ethics committees, principles and consequences. J Med Ethics 1998 Apr;24(2):81-5.

> Hecker R. Participatory action research as a strategy for empowering aboriginal health workers. Aust N Z J Public Health 1997 Dec;21(7):784-8.

> Heitman E. A proactive role for the ethics committee or ethics consultant: meeting the JCAOH standards on patient rights. Trends Health Care Law Ethics 1993 Fall;8(4):11-6.

> Henderson DJ. Consciousness raising in participatory research: method and methodology for emancipatory nursing inquiry. ANS Adv Nurs Sci 1995 Mar;17(3):58-69.

> Herbert CP. Community-based research as a tool for empowerment: the Haida Gwaii Diabetes Project example. Can J Public Health 1996 Mar-Apr;87(2):109-12.

> Herman SS. A noninstitutional review board comes of age. IRB Rev Hum Subj Res 1989 Mar-Apr;11(2):1-6.

> Hilgartner S. Research fraud, misconduct, and the IRB. IRB Rev Hum Subj Res 1990 Jan-Feb;12(1):1-4.

> Hoffmann DE. Evaluating ethics committees: a view from the outside. Milbank Q 1993;71(4):677-701.

> Holley S, Foster C. Ethical review of multi-centre research: a survey of local research ethics committees in the south Thames region. J R Coll Physicians Lond 1998 May-Jun;32(3):238-41.

> Holm S. How many lay members can you have in your IRB? -- An overview of the Danish system. IRB Rev Hum Subj Res 1992 Nov-Dec;14(6):8-9, 11.

> Horner JS. Criteria for decision making in local research (ethics) committees. Public Health 1993 Nov;107(6):403-11.

> Horwitz R. Ethical review of multi-centre research. Bull Med Ethics 1994 Oct;102:13-5.

> Hotopf M. Why do research ethics committees disagree? [letter]. J R Coll Physicians Lond 1995 Nov-Dec;29(6):550. Comment on: J R Coll Physicians Lond 1995 Jul-Aug;29(4):315-8.

> Hotopf M, Wessely S, Noah N. Are ethical committees reliable? J R Soc Med 1995 Jan;88(1):31-3. Comments in: J R Soc Med 1995 Jun;88(6):363; J R Soc Med 1995 Jul;88(7):423; J R Soc Med 1995 Oct;88(10):603.

> Hunt G. Local research ethics committees and nursing: a critical look. Br J Nurs 1992 Jul 23-Aug 13;1(7):349-51.

> Idanpaan-Heikkila J. WHO views on responsibilities of research ethics boards and Good Clinical Practice (GCP). NCBHR Commun 1993 Nov-Dec;4(2):7-10.

> Institutional review boards, 21 C.F.R. Sect. 56 (1998 revised).

> Jamrozik K. Ethics committees: is the tail wagging the dog? Med J Aust 1992 Nov 2;157(9):636-7. Comments in: Med J Aust 1993 Jan 18;158(2):140; discussion 142; Med J Aust 1993 Jan 18;158(2):140-2; Med J Aust 1993 Feb 1;158(3):216.

> Jayaraman KS. India may set up genetics advisory panel [news]. Nature 1997 Jun 26;387(6636):836.

> Jean A, Pare S, Parizeau MH. Hospital ethics committees in Quebec: an overview. HEC Forum 1990;3(6):339-46.

> Jenkins GC. Local research ethics committees. Problems of students must not be ignored [letter]. BMJ 1995 Dec 9;311(7019):1571. Comment on: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Sep 9;311(7006):659-60; BMJ 1995 Sep 9;311(7006):660-1; BMJ 1995 Sep 9;311(7006):661.

> Jones JS, White LJ, Pool LC, Dougherty JM. Structure and practice of institutional review boards in the United States. Acad Emerg Med 1996 Aug;3(8):804-9.

> Juengst ET. Groups as gatekeepers to genomic research: conceptually confusing, morally hazardous, and practically useless. Kennedy Inst Ethics J 1998 June;8(2):183-200.

> Kallgren CA, Tauber RT. Undergraduate research and the institutional review board: a mismatch or happy marriage? Teach Psychol 1996 Feb;23(1):20-5.

> Kaur B, Taylor J. Ethics committees. Separate criteria should be drawn up for questionnaire based epidemiological studies [letter]. BMJ 1996 Jan 6;312(7022):54. Comment on: BMJ 1995 Sep 9;311(7006):659-60; BMJ 1995 Sep 9;311(7006):660-1; BMJ 1995 Sep 9;311(7006):661.

> Kellett J. Ethics committees [letter]. Lancet 1996 Jun 1;347(9014):1559. Comment on: Lancet 1996 Mar 23;347(9004):833-4.

> Kellett JM. Ethics committees [letter]. Lancet 1996 Feb 3;347(8997):331. Comment in: Lancet 1996 Mar 23;347(9004):833-4.

> Kelly SE, Marshall PA, Sanders LM, Raffin TA, Koenig BA. Understanding the practice of ethics consultation: results of an ethnographic multi-site study. J Clin Ethics 1997 Summer;8(2):136-49.

> Kent G. The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs. J Med Ethics 1997 Jun;23(3):186-90.

> Kimbel KH. Ethics committees [letter]. Lancet 1995 Apr 22;345(8956):1051. Comment on: Lancet 1995 Mar 11;345(8950):653.

> Kimbel KH. Regulation of ethics committees in Germany [news]. Lancet 1994 Aug 6;344(8919):398.

> King PA. Credibility, persuasiveness, and effectiveness [commentary]. Kennedy Inst Ethics J 1996 Sep;6(3):313-7. Comment on: Kennedy Inst Ethics J 1996 Sep;6(3):289-311.

> Kirkpatrick SM. Participatory nursing research. A promising methodology in Third World countries. West J Nurs Res 1990 Jun;12(3):282-92.

> Kirkwood M, Simmons D, Weblemoe T, Voyle J, Richards D. Perceptions of diabetes among rural Maori elders and spokespersons. N Z Med J 1997 Nov 14;110(1055):415-7.

> Kloot MHH van der. Different profiles for the institutional ethics committee in the Netherlands. HEC Forum 1994 May;6(3):139-56.

> Kloot MHH van der. Institutional ethics committees in the Netherlands. HEC Forum 1992;4(3):209-17.

> Kluge EH. The roles and functions of hospital-based ethics committees. CMAJ 1996 Apr 1;154(7):1094-5.

> Labonte R, Robertson A. Delivering the goods, showing our stuff: the case for a constructivist paradigm for health promotion research and practice. Health Educ Q 1996 Nov;23(4):431-47.

> Laurell AC, Noriega M, Martinez S, Villegas J. Participatory research on workers' health. Soc Sci Med 1992 Mar;34(6):603-13.

> Lehrman S. Jewish leaders seek genetic guidelines...[news]. Nature 1997 Sep 25;389(6649):322.

> Less JR, Alpert S, Nightingale SL. Institutional review boards and medical devices [editorial]. JAMA 1994 Sep 28;272(12):968-9. Comment on: JAMA 1994 Sep 28;272(12):955-6.

> Liberati A. Consumer participation in research and health care [editorial]. BMJ 1997 Aug 30;315(7107):499. Comment in: BMJ 1998 Jan 10;316(7125):148.

> Liddle BJ, Brazelton EW. Psychology faculty satisfaction and compliance with IRB procedures. IRB Rev Hum Subj Res 1996;18(6):4-6.

> Lind SE. The institutional review board: an evolving ethics committee. J Clin Ethics 1992 Winter;3(4):278-82.

> Lindsey E, Stajduhar K. From rhetoric to action: establishing community participation in AIDS-related research. Can J Nurs Res 1998 Spring;30(1):137-52.

> Lock S. Monitoring research ethical committees [editorial]. BMJ 1990 Jan 13;300(6717):61-2.

> Loewy EH. An inquiry into ethics committees' understanding: how does one educate the educators? Camb Q Healthc Ethics 1993 Fall;2(4):551-5.

> Lovell SL. Understanding the institutional review board. Nurse Anesth 1992 Jun;3(2):75-81.

> Lusky R. Educating healthcare ethics committees (EHEC 1992-1996): the evaluation results. HEC Forum 1996 Oct;8(5):247-89.

> Macara AW. Ethical review of multi-centre trials. J Med Ethics 1990 Sep;16(3):150-2.

> Macaulay AC, Delormier T, McComber AM, Cross EJ, Potvin LP, Paradis G, Kirby RL, Saad-Haddad C, Desrosiers S. Participatory research with native community of Kahnawake creates innovative Code of Research Ethics. Can J Public Health 1998 Mar-Apr;89(2):105-8.

> Macaulay AC, Paradis G, Potvin L, Cross EJ, Saad-Haddad C, McComber A, Desrosiers S, Kirby R, Montour LT , Lamping DL, Leduc N, Rivard M. The Kahnawake Schools Diabetes Prevention Project: intervention, evaluation, and baseline results of a diabetes primary prevention program with a native community in Canada. Prev Med 1997 Nov-Dec;26(6):779-90.

> Macilwain C. Tribal groups attack ethics of genome diversity project [news]. Nature 1996 Sep 19;383(6597):208.

> Mackay CR. New study of the IRB system. Kennedy Inst Ethics J 1992 Sep;2(3):283-84.

> Macklin R. Disagreement, consensus, and moral integrity. Kennedy Inst Ethics J 1996 Sep;6(3):289-311.

> Macleod C. Research as intervention within community mental health. Curationis 1997 Jul;20(2):53-6.

> Madder H, Myles P, McRae R. Ethics review and clinical trials [letter]. Lancet 1998 Apr 4;351(9108):1065-6. Comment on: Lancet 1998 Jan 24;351(9098):248-51.

> Madjar I, Higgins I. Of ethics committees, protocols, and behaving ethically in the field: a case study of research with elderly residents in a nursing home. Nurs Inq 1996 Sep;3(3):130-7.

> Maloney DM. Institutional review board approval required by rule [news]. Hum Res Rep 1996 Aug;11(8):3.

> Maloney DM. Institutional review board becomes enmeshed in lawsuit [news]. Hum Res Rep 1994 Nov;9(11):4.

> Maloney DM. Institutional review boards now given explicit responsibility in new federal rule [news]. Hum Res Rep 1995 Feb;10(2):1-2.

> Marshall E. Review boards: a system 'in jeopardy'? [news]. Science 1998 Jun 19;280(5371):1830-1.

> Martin DK, Meslin EM, Kohut N, Singer PA. The incommensurability of research risks and benefits: practical help for research ethics committees. IRB Rev Hum Subj Res 1995;17(2):8-10.

> Marwick C. NIH 'Research Risks Office' reprimands hospital institutional review board [news]. JAMA 1990 May 9;263(18):2420.

> Matsunaga DS, Enos R, Gotay CC, Banner RO, DeCambra H, Hammond OW, Hedlund N, Ilaban EK, Issell BF, Tsark JA. Participatory research in a Native Hawaiian community. The Wai'anae Cancer Research Project. Cancer 1996 Oct 1;78(7 Suppl):1582-6.

> Mayhew PA. Research and quality management studies: ethical considerations. Medsurg Nurs 1994 Apr;3(2):149-50, 148.

> McClintock T, Friendship C, Kaur B, Taylor J, Enquselassie F, Nokes J, Cutts F. Ethics committees [and epidemiological research] [letters]. BMJ 1996 Jan 6;312(7022):54-5.

> McKinnell I. Local research ethics committees [letter]. J R Coll Physicians Lond 1998 May-Jun;32(3):274-5.

> McLean SA. Research ethics committees: principles and proposals. Health Bull (Edinb) 1995 Sep;53(5):243-8.

> McNeill PM, Berglund CA, Webster IW. Do Australian researchers accept committee review and conduct ethical research? Soc Sci Med 1992 Aug;35(3):317-22.

> McNeill PM, Berglund CA, Webster IW. How much influence do various members have within research ethics committees? Camb Q Healthc Ethics 1994 Fall;3(4):522-32.

> McNeill PM, Berglund CA, Webster IW. Reviewing the reviewers: a survey of institutional ethics committees in Australia. Med J Aust 1990 Mar 19;152(6):289-96.

> Meade TW. The trouble with ethics committees [editorial]. J R Coll Physicians Lond 1994 Mar-Apr;28(2):102-4. Comment on: J R Coll Physicians Lond 1994 Mar-Apr;28(2):150-4. Comments in: J R Coll Physicians Lond 1994 May-Jun;28(3):274; J R Coll Physicians Lond 1994 Jul-Aug;28(4):382; J R Coll Physicians Lond 1994 Sep-Oct;28(5):484.

> Meslin EM. Protecting human subjects from harm through improved risk judgments. IRB Rev Hum Subj Res 1990 Jan-Feb;12(1):7-10.

> Meslin EM, Lavery JV, Sutherland HJ, Till JE. Judging the ethical merit of clinical trials: what criteria do research ethics board members use? IRB Rev Hum Subj Res 1994 Jul-Aug;16(4):6-10.

> Micetich KC. Reflections of an IRB chair. Camb Q Healthc Ethics 1994 Fall;3(4):506-9.

> Mitchell SC, Steingrub J. The changing clinical trials scene: the role of the IRB. IRB Rev Hum Subj Res 1988 Jul-Aug;10(4):1-5.

> Mitchell T, Fletcher I. Stating the case for nursing research ethics committees: a discussion paper. Nurse Educ Today 1998 Feb;18(2):133-7.

> Montgomery J. Improving review of multi-centre trials [report and comment]. Bull Med Ethics 1994 Feb;95:19-22.

> Moodie P. The role of local research ethics committees [editorial]. BMJ 1992 May 2;304(6835):1129-30. Comments in: BMJ 1992 May 30;304(6839):1446; BMJ 1992 Jun 27;304(6843):1696.

> Moodie PC, Marshall T. Guidelines for local research ethics committees. BMJ 1992 May 16;304(6837):1293-5. Comment in: BMJ 1992 Jun 27;304(6843):1696.

> Moran J. Local research ethics committees. Report of the 2nd National Conference. J R Coll Physicians Lond 1992 Oct;26(4):423-31.

> Munhall PL. Institutional review of qualitative research proposals: a task of no small consequence. NLN Publ 1993 Aug;(19-2535):409-23.

> National Council on Bioethics in Human Research (Canada). Ethics of clinical trials for research ethics boards: proceedings of a national workshop [summaries of workshop position papers; synthesis reports; and NCBHR draft discussion paper]. NCBHR Commun 1991 Nov-Dec;2(2):4-23.

> National Council on Bioethics in Human Research (Canada) Working Group on Evaluation. Protecting and promoting the human research subject: a review of the function of research ethics boards in Canadian faculties of medicine. NCBHR Commun 1995 Winter;6(1):3-32.

> Nelson NJ. Ashkenazi community is not unwilling to participate in genetic research [news]. J Natl Cancer Inst 1998 Jun 17;90(12):884-5.

> Nelson WA, Wlody GSr. The evolving role of ethics advisory committees in VHA. HEC Forum 1997 Jun;9(2):129-46.

> Neuberger J, Madhok R, McEwan RT. Too many ethical committees [letters]. BMJ 1991 Jan 19;302(6769):180.

> Neuhauser D. More tales from institutional review boards [comment]. Health Matrix 1994 Spring;4(1):153-8.

> New Australian health ethics committee [news]. Issues Reprod Genet Eng J Int Feminist Anal. 1992;5(2):171.

> Nicholson RH. Seeking harmony in discord. Hastings Cent Rep 1998 Jan-Feb;28(1):7.

> Nkozo-Mtembu LL. Participatory research in psychiatric nursing. Curationis 1996 Sep;19(3):57-9.

> Nyborg WL. Determining risk to subjects: exposure to ultrasound. IRB Rev Hum Subj Res 1987 May-Jun;9(3):1-5.

> Oddens BJ, De Wied D. Local research ethics committees. Committees should devise special forms for the social sciences [letter]. BMJ 1995 Dec 9;311(7019):1572. Comment on: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Sep 9;311(7006):659-60; BMJ 1995 Sep 9;311(7006):660-1; BMJ 1995 Sep 9;311(7006):661.

> Oliver S. The progress of lay involvement in the NHS Research and Development Programme. J Eval Clin Pract 1996 Nov;2(4):273-80.

> Ortega R, Dal Re R. Clinical trials committees: how long is the protocol review and approval process in Spain? A prospective study. IRB Rev Hum Subj Res 1995 Jul-Aug;17(4):6-9.

> Palca J. Institutional review boards. A net too thin. Hastings Cent Rep 1996 May-Jun;26(3):4.

> Palca J. Society's choices. Hastings Cent Rep 1995 May-Jun;25(3):7.

> Pargiter R, Bloch S. The ethics committee of a psychiatric college: its procedures and themes. Aust N Z J Psychiatry 1997 Feb;31(1):76-82. Comment in: Aust N Z J Psychiatry 1997 Feb;31(1):83-4.

> Penn ZJ, Steer PJ. Local research ethics committees: hindrance or help? [editorial]. Br J Obstet Gynaecol 1995 Jan;102(1):1-2. Comments in: Br J Obstet Gynaecol 1995 Aug;102(8):671-2; Br J Obstet Gynaecol 1995 Oct;102(10):842.

> Phillips DF. Institutional review boards under stress: will they explode or change? [news]. JAMA 1996 Nov 27;276(20):1623-6. Published erratum appears in JAMA 1997 Feb 12;277(6):460.

> Pierce E. Are research ethics committees behaving unethically? Committees are now being expected to do everything [letter]. BMJ 1997 Mar 1;314(7081):676. Comment on: BMJ 1996 Nov 30;313(7069):1390-3. Comments in: BMJ 1997 Jul 5;315(7099):60; BMJ 1997 Jul 5;315(7099):60-1.

> Piercy FP, Thomas V. Participatory evaluation research: an introduction for family therapists. J Marital Fam Ther 1998 Apr;24(2):165-76.

> Popp AJ, Moore DL. Institutional review board evaluation of neuroscience protocols involving human subjects. Surg Neurol 1994 Feb;41(2):162-7.

> Porter JP. How unaffiliated/nonscientist members of institutional review boards see their roles. IRB Rev Hum Subj Res 1987 Nov-Dec;9(6):1-6.

> Post SG. The IRB, ethics, and the objective study of religion in health. IRB Rev Hum Subj Res 1995;17(5-6):8-11.

> Powell DE. Local research ethics committees: hindrance or help? [letter]. Br J Obstet Gynaecol 1995 Aug;102(8):671-2. Comment on: Br J Obstet Gynaecol 1995 Jan;102(1):1-2.

> Prentice ED, Antonson DL. A protocol review guide to reduce IRB inconsistency. IRB Rev Hum Subj Res 1987 Jan-Feb;9(1):9-11.

> Rains JW, Ray DW. Participatory action research for community health promotion. Public Health Nurs 1995 Aug;12(4):256-61.

> Rawlins R. Local research ethics committees. Research discovers the right thing to do; audit ensures that it is done right [letter]. BMJ 1997 Nov 29;315(7120):1464.

> Redshaw ME, Harris A, Baum JD. Research ethics committee audit: differences between committees. J Med Ethics 1996 Apr;22(2):78-82.

> Regan FA, Hewitt PE. Reliability of ethics committees [letter]. J R Soc Med 1995 Jul;88(7):423. Comment on: J R Soc Med 1995 Jan;88(1):31-3.

> Reiser SJ, Knudson P. Protecting research subjects after consent: the case for the research intermediary. IRB Rev Hum Subj Res 1993 Mar-Apr;15(2):10-11.

> Research ethics committees [letter]. BMJ 1990 Feb 10;300(6721):395-6. Published erratum appears in BMJ 1990 Feb 17;300(6722):470. Comment on: BMJ 1990 Jan 13;300(6717):61-2.

> Richardson M. Participatory research methods: people with learning difficulties. Br J Nurs 1997 Oct 23-Nov 12;6(19):1114-21.

> Riis P. What a national research ethics committee does. Bull Med Ethics 1992 Dec;84:13-6.

> Robbins G. Ethics committees [letter]. Lancet 1995 Mar 11;345(8950):653. Comment on: Lancet 1995 Jan 21;345(8943):143-8. Comment in: Lancet 1995 Apr 22;345(8956):1051.

> Robinson A. Transformative 'cultural shifts' in nursing: participatory action research and the 'project of possibility'. Nurs Inq 1995 Jun;2(2):65-74.

> Robinson K. The layman's role in a research ethics committee. J R Coll Physicians Lond 1991 Jan;25(1):43.

> Roseman KD. Man-child in a promised land: a layman serves on the human subjects committee. IRB Rev Hum Subj Res 1987 Mar-Apr;9(2):8-10.

> Rosnow RL, Rotheram-Borus MJ, Ceci SJ, Blanck PD, Koocher GP. The institutional review board as a mirror of scientific and ethical standards. Am Psychol 1993 Jul;48(7):821-6.

> Rothenberg KH. Breast cancer, the genetic quick fix, and the Jewish community: ethical, legal, and social challenges. Health Matrix 1997 Winter;7(1):97-124.

> Saito T. Ethics committees in Japanese medical schools. HEC Forum 1992;4(4):281-7.

> Sanchez J, Costa A, Fresquet A, Abadias M, Bartlett A. HIV screening in 'healthy' volunteers and Ethics Committees [letter]. Br J Clin Pharmacol 1994 May;37(5):469. Comment in: Br J Clin Pharmacol 1995 Feb;39(2):213-4.

> Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996 Nov 30;313(7069):1390-3. Comments in: BMJ 1997 Mar 1;314(7081);676; BMJ 1997 Mar 1;314(7081):676-7; BMJ 1997 Jul 5;315(7099):60-1.

> Savulescu J, Chalmers I, Blunt J. Does setting good practice standards for research ethics committees increase their legal liability? [letter]. BMJ 1997 Jun 21;314(7097):1833.

> Schell LM, Tarbell AM. A partnership study of PCBs and the health of Mohawk youth: lessons from our past and guidelines for our future. Environ Health Perspect 1998 Jun;106 Suppl 3:833-40.

> Schreier BA, Stadler HA. Perspectives of research participants, psychologist investigators, and institutional review boards. Percept Mot Skills 1992 Jun;74(3 Pt 2):1067-72.

> Scott G, Goode K. Reporting the outcome of ethics review. Bull Med Ethics 1995 Aug;110:16-8.

> Scott K, Receveur O. Ethics for working with communities of Indigenous Peoples. Can J Physiol Pharmacol 1995 Jun;73(6):751-3.

> Scott PV, Pinnock CA. Local research ethics committees BMA's advice about approval of clinical audit studies is confusing [letter]. BMJ 1997 Jul 5;315(7099):60. Comment on: BMJ 1997 Mar 1;314(7081):676.

> Scott PV, Pinnock CA, Stone Peter G, Blogg CE. Local research ethics committees [letters]. BMJ 1997 Jul 5;315(7099):60-1. Comment on: BMJ 1997 Mar 1;314(7081):676.

> Seeley JA, Kengeya-Kayondo JF, Mulder DW. Community-based HIV/AIDS research--whither community participation? Unsolved problems in a research programme in rural Uganda. Soc Sci Med 1992 May;34(10):1089-95.

> Seng JS. Praxis as a conceptual framework for participatory research in nursing. ANS Adv Nurs Sci 1998 Jun;20(4):37-48.

> Setton GC, Garvican L, Wilson R. Informed consent. Ethical principles may need to be adapted when research subject is not an individual subject [letter]. BMJ 1997 Jul 26;315(7102):251.

> Sherman M, Van Vleet JD. The history of institutional review boards. Regul Aff J 1991 Winter;3:615-27.

> Sieber JE. On studying the powerful (or fearing to do so): a vital role for IRBs. IRB Rev Hum Subj Res 1989 Sep-Oct;11(5):1-6.

> Sieber JE, Baluyot RM. A survey of IRB concerns about social and behavioral research. IRB Rev Hum Subj Res 1992;14(2):9-10.

> Skolnick BE. Ethical and institutional review board issues. Adv Neurol 1998;76:253-62.

> Skolnick BE. Role of the institutional review board in clinical trials. Epilepsy Res Suppl 1993;10:193-200.

> Sleight P. Data-monitoring committees in clinical trials [letter]. Lancet 1993 May 8;341(8854):1219-20.

> Smith MA, Jalaludin B, Leeder SR, Smith WT. Isn't one institutional ethics committee's approval enough? [letter]. Med J Aust 1994 May 16;160(10):662. Comment in: Med J Aust 1994 Sep 19;161(6):398-9.

> Smith MA, Jalaludin B, Leeder SR, Smith WT. Isn't one institutional ethics committee's approval enough? [letter]. Med J Aust 1994 May 19;161(6):398-9. Comment in: Med J Aust 1994 May 16;160(10) :662.

> Smith ML. The future of healthcare ethics committees. Trends Health Care Law Ethics 1994 Spring;9(2):7-10.

> Smith ML, Day J, Collins R, Erenberg G. A survey on awareness and effectiveness of bioethics resources. HEC Forum 1992;4(3):187-97.

> Smith SE, Pyrch T, Lizardi AO. Participatory action-research for health. World Health Forum 1993;14(3):319-24.

> Smith T, Moore EJ, Tunstall-Pedoe H. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview. BMJ 1997 May 31;314(7094):1588-90.

> Solbakk JH. Ethics review committees [in biomedical research] in the Nordic countries: history, organization, and assignments. HEC Forum 1990;3(4):215-20.

> Soltis-Jarrett V. The facilitator in participatory action research: les raisons d'etre. ANS Adv Nurs Sci 1997 Dec;20(2):45-54.

> Sonneborn K, Collier J. Ethics committees. Wandsworth District Research Ethics Committee [letter]. Lancet 1996 Mar 23;347(9004):833-4. Comment on: Lancet 1996 Feb 3;347(8997):331. Comment in: Lancet 1996 Jun 1;347(9014):1559.

> Sonneborn K, Vallance P. The complementary roles of local and national ethics committees [letter]. J R Coll Physicians Lond 1994 Jul-Aug;28(4):382. Comment on: J R Coll Physicians Lond 1994 Mar-Apr;28(2):102-4; J R Coll Physicians Lond 1994 Mar-Apr;28(2):150-4.

> Sperber AD, Henkin Y, Shany S. Methodological issues in conducting a community-based clinical drug trial. Fam Pract Res J 1993 Dec;13(4):311-21.

> Spicker SF, Ross JW, Lusky RA. Educating heathcare ethics committees: a national dissemination project [grant proposal]. HEC Forum 1993 Jan;5(1):52-72.

> Spiers HR. Community consultation and AIDS clinical trials: I. IRB Rev Hum Subj Res 1991 May-Jun;13(3):7-10.

> Spiers HR. Community consultation and AIDS clinical trials: II. IRB Rev Hum Subj Res 1991 Jul-Aug;13(4):1-6.

> Spiers HR. Community consultation and AIDS clinical trials: III. IRB Rev Hum Subj Res 1991 Sep-Oct;13(5):3-7.

> Stacey TE. Ethical review of research in the NHS: the need for change [editorial]. J R Coll Physicians Lond 1998 May-Jun;32(3):190-2.

> Stanciu S, Trifan A, Scripcaru G. Social obligations in medical research: medical aspects. Rev Med Chir Soc Med Nat Iasi 1993 Jan-Mar;97(1):488, 490.

> Stone PG, Blogg CF. Local research ethics committees. National research ethics committee is needed [letter]. BMJ 1997 Jul 5;315(7099):60-1. Comment on: BMJ 1996 Nov 30;313(7069):1390-3; BMJ 1997 Mar 1;314(7081):676; BMJ 1997 Mar 1;314(7081);676-7.

> Sugarman J. Should hospital ethics committees do research? J Clin Ethics 1994 Summer;5(2):121-5. Comment in: J Clin Ethics 1994 Summer;5(2):159-62.

> Talbot D, Reynolds DJ. Local research ethics committees. Oxford committee was concerned that trial might be unethical [letter]. BMJ 1997 Nov 29;315(7120):1464.

> Tandy MK. Independent commercial IRBs [letter]. IRB Rev Hum Subj Res 1996 May-Jun;18(3):10.

> Tappin DM, Cockburn F. Ethics and ethics committees: HIV serosurveillance in Scotland. J Med Ethics 1992 Mar;18(1):43-6.

> Tealdi JC, Mainetti JA. Hospital ethics committees. Bull Pan Am Health Organ 1990;24(4):410-8.

> Thevoz JM. Research and hospital ethics committees in Switzerland. HEC Forum 1992;4(1):41-7.

> Thomasma DC. Education of ethics committees. Bioethics Forum 1994 Fall;10(4):12-8.

> Thomasma DC. Models of the doctor-patient relationship and the ethics committee: Part One. Camb Q Healthc Ethics 1992 Winter;1(1):11-31.

> Thompson JL. Exploring gender and culture with Khmer refugee women: reflections on participatory feminist research. ANS Adv Nurs Sci 1991 Mar;13(3):30-48.

> Tinstman C. Understanding the role of the institutional review board. Gastroenterol Nurs 1995 Jul-Aug;18(4):153-4.

> Toellner R. Experiences with committees dealing with the issues of ethics. Forensic Sci Int 1994 Dec 16;69(3):329-36.

> Tomlinson J. Are research ethics committees behaving unethically? Committee would not consider application before payment of 100 pounds [letter]. BMJ 1997 Mar 1;314(7081):676. Comment on: BMJ 1996 Nov 30;313(7069):1390-3. Comment in: BMJ 1997 Jul 5;315(7099):60-1.

> Travers KD. Reducing inequities through participatory research and community empowerment. Health Educ Behav 1997 Jun;24(3):344-56.

> Travers KD. The social organization of nutritional inequities. Soc Sci Med 1996 Aug;43(4):543-53.

> Tripp JH, Dunstan G. Why do research ethics committees disagree? J R Coll Physicians Lond 1995 Sep-Oct;29(5):410-1.

> Tuffs A. Central ethics committee formed in Germany [news]. Lancet 1995 Aug 12;346(8972):433.

> Tunstall-Pedoe H. Local research ethics committees. Local committees have strengths too [letter]. BMJ 1995 Dec 9;311(7019):1570-1.

> Tunstall-Pedoe H, Watling MIL, Dewhurst JK, Jenkins GC, Dudley H, Oddens BJ, De Wied D, Black Mary, Leese B, Gosden T. Local research ethics committees [letters]. BMJ 1995 Dec 9;311(7019):1570-2.

> Valdiserri RO, Tama GM, Ho M. The role of community advisory committees in clinical trials of anti-HIV agents. IRB Rev Hum Subj Res 1988 Jul-Aug;10(4):5-7.

> Veatch RM, Moreno JD. Consensus in panels and committees: conceptual and ethical issues -- introduction. J Med Philos 1991 Aug;16(4):371-3.

> Wadman M. Ethics of private panels comes under scrutiny [news]. Nature 1997 May 29;387(6632):445.

> Wadman M. 'Group debate' urged for gene studies [news]. Nature 1998 Jan 22;391(6665):314. Comment in: Nature 1998 Mar 5;392(6671):14; Nature 1998 Apr 16;392(6677):646.

> Wadman M. Jewish leaders meet NIH chiefs on genetic stigmatization fears [news]. Nature 1998 Apr 30;392(6679):851.

> Waggoner WC. Institutional review boards. Clin Dermatol 1991 Oct-Dec;9(4):429-34.

> Wald N, Peckham C. Independent ethical review of studies involving personal medical records [letter]. J R Coll Physicians Lond 1995 Sep-Oct;29(5):446.

> Walshe JM. Ethical committees? [letter]. Lancet 1990 Dec 8;336(8728):1448-9. Comment on: Lancet 1990 Nov 10;336 (8724):194-5. Comment in: Lancet 1990 Dec 22-29; 336 (8730):1587.

> Walters L. Data monitoring committees: the moral case for maximum feasible independence. Stat Med 1993 Mar;12(5-6):575-80.

> Warnock M. Ethics committees. Baillieres Clin Obstet Gynaecol 1991 Sep;5(3):761-77.

> Warren R, Allan J. Getting through ethics committees: partnerships between researchers and clinicians working with mentally ill clients. Aust N Z J Ment Health Nurs 1997 Mar;6(1):37-43.

> Watling MI, Dewhurst JK. Local research ethics committees. Central ethics committee might have to face hostile locals [letter]. BMJ 1995 Dec 9;311(7019):1571. Comment on: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Sep 9;311(7006):659-60.

> Watling MIL, Dewhurst JK. Current experience of central versus local ethics approval in multicentre studies. J R Coll Physicians Lond 1993 Oct;27(4):399-402.

> Weeramanthri T, Currie BJ. Isn't one institutional ethics committee's approval enough? [letter]. Med J Aust 1994 Sep 19;161(6):398-9. Comment on: Med J Aust 1994 May 16;160(10):662.

> Weinstein BD, McCurdy DB. Point and counterpoint: should expertise in bioethics be required for serving on a HEC? HEC Forum 1993 Nov;5(6):368-73.

> Wells F. Ethics and journal publishing: taking the debate forward. A committee for scientific dishonesty--the way forward? [letter]. Addiction 1995 Oct;90(10):1316-7. Comment in: Addiction 1996 Jul;91(7):1063-4.

> Westphal MF, da Silva NN, Maciel MG. Participatory research as social mobilization for health. Promot Educ 1996 Dec;3(4):21-4.

> While AE. Ethics committees: impediments to research or guardians of ethical standards? BMJ 1995 Sep 9;311(7006):661. Published erratum appears in BMJ 1995 Sep 23;311(7008):792. Comments in: BMJ 1995 Sep 9;311(7006):639-40; BMJ 1995 Dec 9;311(7019):1571; BMJ 1995 Dec 9;311(7019):1572; BMJ 1996 Jan 6;312(7022):54.

> While AE. Research ethics committees at work: the experience of one multi-location study. J Med Ethics 1996 Dec;22(6):352-5.

> Wiesing U. Ethics committees in Germany. HEC Forum 1990;3(4):221-6.

> Williams AM. Neuroscience nursing research: human subjects considerations. J Neurosci Nurs 1991 Apr;23(2):133-5.

> Willms D, Bhatia R, Lowe J, Niemi F, Stewart D, Westmoreland-Traore J. Five conversations: reflections of stakeholders on the impact of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S44-8, S49-53.

> Willms D, Singer SM, Adrien A, Godin G, Maticka-Tyndale E, Cappon P. Participatory aspects in the qualitative research design of phase II of the ethnocultural communities facing AIDS study. Can J Public Health 1996 May-Jun;87 Suppl 1:S15-25, S16-27.

> Wise J. Royal College calls for central research ethics committee [news]. BMJ 1996 Aug 3;313(7052):251.

> Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. BMJ 1996 Nov 16;313(7067):1245-8.

> Wismer BA, Moskowitz JM, Chen AM, Kang SH, Novotny TE, Min K, Lew R, Tager IB. Rates and independent correlates of Pap smear testing among Korean-American women. Am J Public Health 1998 Apr;88(4):656-60.

> Wojtynek JE, Hutchinson RA, Thornton JP, O'Brien P. Institutional review boards and quality assurance activities [letter]. Am J Hosp Pharm 1991 Jan;48(1):72, 75.

> Yealy DM, Paris PM, Vukmir RB. Prehospital IRBs and consent [letter]. Ann Emerg Med 1994 Oct;24(4):759-60. Comment on: Ann Emerg Med 1994 Jan;23(1):70-4.

> Return to table of contents

> ## Institutional review boards and ethics committees - Books

> Christensen JO. Medical ethics committees: a selective bibliography of recent references. Monticello (IL): Vance Bibliographies; 1991. 23 p. (Public administration series, bibliography; P 3099).

> Department of Health and Human Services (US), Office of Inspector General. Institutional review boards: their role in reviewing approved research [monograph on the Internet]. Boston: Office of Evaluations and Inspections, Boston Regional Office; June 1998. 190 p. Available from: http://www.dhhs.gov/progorg/oei.

> Forming a moral community: a resource for healthcare ethics committees. Berkeley (CA): Bioethics Consultation Group Inc.; 1992. 161 p.

> Foster CG. Manual for research ethics committees. London: King's College, Centre of Medical Law and Ethics; 1992. 1 vol.

> Foster CG. Manual for research ethics committees. 2nd ed. London: King's College, Centre of Medical Law and Ethics; 1993. 1 vol. Looseleaf.

> Fry-Revere S, editor. The accountability of bioethics committees and consultants. Frederick (MD): University Publishing Group; c1992. 141 p.

> Guidelines on the practice of ethics committees in medical research involving human subjects: a report of the Royal College of Physicians. 2nd ed. London: Royal College of Physicians of London; 1990. 43 p.

> Institutional review boards, a system in jeopardy. Hearing Before the Subcomm. on Human Resources Comm. on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, second session. (1998 Jun 11). Washington: U.S. Government Printing Office; 1999.

> Kiger AF, compiler. Institutional ethics committees: January 1975 through December 1988 : 434 citations. Bethesda (MD): National Library of Medicine, Reference Section; 1988. 18 p. (Current bibliographies in medicine; 88-16).

> Local research ethics committees. London: U.K. Department of Health; 1991 Aug 19. 26 p.

> Melley CD. A philosophical investigation of health-care ethics committees, ethics consultation and the role of the philosopher in the health-care setting. Saarbrucken (Germany): Christopher Daniel Melley; 1991. 195 p.

> Meslin EM. Protecting human subjects from harm in medical research: A proposal for improving risk judgements by institutional review boards. Ann Arbor (MI): University Microfilms International; 1989. 336 p.

> Neuberger J, editor. Ethics and health care: the role of research ethics committees in the United Kingdom. London: King's Fund Institute; c1992. 48 p. (Research report (King's Fund Institute); 13).

> Penslar RL. Protecting human research subjects: institutional review board guidebook [loose-leaf]. Rev., updated and expanded 2nd ed. Bethesda (MD): National Institutes of Health, Office of Protection from Research Risks; 1993. 1 vol.

> Ross JW. Health care ethics committees: the next generation. Chicago: American Hospital Pub; c1993. 188 p.

> Spicker SF, editor. Health care ethics committee experience: selected readings from HEC Forum. Malabar (FL): Krieger Pub; 1998.

> The clinical trial notification scheme: draft guidelines for institutional ethics committees. Canberra: Australian Government Publishing Service; 1992. 14 p.

> Toward a Canadian Advisory Council on Biomedical Ethics: study paper. Ottawa: Law Reform Commission; 1990. 119 p.

> Whither IRB's in the 1990s?: new directions and new decisions, October 12-13, 1989. Boston: Public Responsibility in Medicine and Research; c1989. 138 p.

> Return to table of contents

> ## Bioethics education - Journal Articles

> Aldridge D. Of ethics and education: strategies for curriculum development [editorial]. J R Soc Med 1992 Oct;85(10):594-7.

> Ales KL, Charlson ME, Williams-Russo P, Allegrante JP. Using faculty consensus to develop and implement a medical ethics course. Acad Med 1992 Jun;67(6):406-8.

> Andre J. Learning to see: moral growth during medical training. J Med Ethics 1992 Sep;18(3):148-52.

> Andrews MD. Ethical and legal dilemmas in medicine: an introduction for medical students. J Okla State Med Assoc 1991 May;84(5):222-4.

> Arda B, Ors Y. Teaching medical ethics with an ethics to teach. Bull Med Ethics 1996 Mar;116:19-22.

> Asai A, Kishino M, Fukui T, Masano T. Postgraduate education in medical ethics in Japan. Med Educ 1998 Jan;32(1):100-4.

> Babapulle CJ. Teaching of medical ethics in Sri Lanka. Med Educ 1992 May;26(3):185-9.

> Barclay ML, Elkins TE. A computer conference format for teaching medical ethics. Acad Med 1991 Oct;66(10):592-4.

> Baylis F, Downie J. Ethics education for Canadian medical students. Acad Med 1991 Jul;66(7):413-4.

> Bebeau MJ, Thoma SJ. The impact of a dental ethics curriculum on moral reasoning. J Dent Educ 1994 Sep;58(9):684-92.

> Benatar SR. Teaching medical ethics. QJM 1994 Dec;87(12):759-67.

> Bickel J. Medical students' professional ethics: defining the problems and developing resources. Acad Med 1991 Dec;66(12):726-9.

> Bickel J. Proceedings of the AAMC Conference on Students' and Residents' Ethical and Professional Development October 27-28, 1995. Introduction. Acad Med 1996 Jun;71(6):622-3.

> Blasszauer B. Teaching medical ethics [letter]. J Med Ethics 1995 Apr;21(2):118. Comment on: J Med Ethics 1994 Dec;20(4):239-43.

> Blechner BB, Hager CL, Williams NR. The Jay Healey technique: teaching law and ethics to medical and dental students. Am J Law Med 1994;20(4):439-55.

> Branch WT, Pels RT. Add professors and stir [letter]. Hastings Cent Rep 1995 Jan-Feb;25(1):49.

> Bryant JH. Educating tomorrow's doctors. World Health Forum 1993;14(3):217-30; discussion 231-52.

> Bryson-Brockmann W, Roll D. Single-case experimental designs in medical education: an innovative research method. Acad Med 1996 Jan;71(1):78-85.

> Bulger RE, Reiser SJ. Studying science in the context of ethics. Acad Med 1993 Sep;68(9 Suppl):S5-9.

> Burack JH. Response to Further exploration of the relationship between medical education and moral development by Donnie J Self, DeWitt C Baldwin, Jr, and Frederic D Wolinsky (CQ Vol 5, No 3). Deriving ought from p: methodological and theoretical pitfalls in quantitative ethics [letter]. Camb Q Healthc Ethics 1997 Spring;6(2):226-32. Comment on: Camb Q Healthc Ethics 1996 Summer;5(3):444-9.

> Burling SJ, Lumley JS, McCarthy LS, Mytton JA, Nolan JA, Sissou P, Williams DG, Wright LJ. Review of the teaching of medical ethics in London medical schools. J Med Ethics 1990 Dec;16(4):206-9.

> Cain JM, Elkins T, Bernard PF. The status of ethics education in obstetrics and gynecology. Obstet Gynecol 1994 Feb;83(2):315-20.

> Calman K. The profession of medicine. BMJ 1994 Oct 29;309(6962):1140-3. Comments in: BMJ 1994 Oct 29;309(6962):1099-100; BMJ 1994 Dec 17;309(6969):1657; BMJ 1994 Dec 17;309(6969):1657-8; BMJ 1994 Dec 17;309(6969):1658; BMJ 1994 Dec 17;309(6969):1658-9.

> Campbell AV. Ethics after Cartwright. N Z Med J 1991 Feb 13;104(905):36-7. Comments in: N Z Med J 1991 Apr 10;104(909):146-7; N Z Med J 1991 Jun 12;104(913):235.

> Caplan RM. CME ethics, continued. Iowa Med 1990 Mar;80(3):135.

> Carse AL. The 'voice of care': implications for bioethical education. J Med Philos 1991 Feb;16(1):5-28.

> Chamberlain JE, Nisker JA. Residents' attitudes to training in ethics in Canadian obstetrics and gynecology programs. Obstet Gynecol 1995 May;85(5 Pt 1):783-6.

> Charon R, Banks JT, Connelly JE, Hawkins AH, Hunter KM, Jones AH, Montello M, Poirer S. Literature and medicine: contributions to clinical practice. Ann Intern Med 1995 Apr 15;122(8):599-606. Comments in: Ann Intern Med 1995 Apr 15;122(8):618-9; Ann Thorac Surg 1995 Dec 15;123(12):965; discussion 966; Ann Thorac Surg 1995 Dec 15;123(12):965-6.

> Charon R, Fox RC. Critiques and remedies: medical students call for change in ethics teaching. JAMA 1995 Sep 6;274(9):767, 771.

> Churchill LR. AIDS and 'dirt': reflections on the ethics of ritual cleanliness. Theor Med 1990 Sep;11(3):185-92. Comment in: Theor Med 1991 Jun;12(2):151-6.

> Classe JG. Ethics redux [editorial]. J Am Optom Assoc 1996 Sep;67(9):509-11.

> Cohen JJ. An awesome responsibility for medical educators. Acad Med 1996 Jan;71(1):56.

> Coles R. The moral education of medical students. Acad Med 1998 Jan;73(1):55-7.

> Coughlin SS. Model curricula in public health ethics. Am J Prev Med 1996 Jul-Aug;12(4):247-51.

> Coughlin SS, Etheredge GD. On the need for ethics curricula in epidemiology. Epidemiology 1995 Sep;6(5):566-7.

> Coutts MC. Teaching ethics in the health care setting, part I: survey of the literature [bibliography]. Kennedy Inst Ethics J 1991 Jun;1(2):171-85.

> Coutts MC. Teaching ethics in the health care setting, part II: sample syllabus. Kennedy Inst Ethics J 1991 Sep;1(3):263-73.

> Coverdale JH. The status of ethics education in Australasian psychiatry. Aust N Z J Psychiatry 1996 Dec;30(6):813-8.

> Currie C, Green J, Davies S, Morgan C. Cost effectiveness of medical ethics training [letter]. J Med Ethics 1997 Oct;23(5):328.

> Derse AR. Ethics emergent [editorial]. Ann Emerg Med 1990 Feb;19(2):210-2.

> Desjardins J, Kenny NP, Lynch A, Crelinsten GL, Grunberg F, Watts J, Ruedy J. Teaching of biomedical ethics in postgraduate training programs. Ann R Coll Physicians Surg Can 1992 Aug;25(5):308-12.

> Dibbern DA Jr, Wold E. Workshop-based learning: a model for teaching ethics. JAMA 1995 Sep 6;274(9):770-1.

> Diekema DS, Shugerman RP. An ethics curriculum for the pediatric residency program. Confronting barriers to implementation. Arch Pediatr Adolesc Med 1997 Jun;151(6):609-14.

> Dorsch JL. BIOETHICSLINE use by medical students: curriculum-integrated instruction and collection development implications. Bull Med Libr Assoc 1997 Apr;85(2):147-53.

> Douglas-Steele D, Hundert EM. Accounting for context: future directions in bioethics theory and research. Theor Med 1996 Jun;17(2):101-19.

> Downing MT, Way DP, Caniano DA. Results of a national survey on ethics education in general surgery residency programs. Am J Surg 1997 Sep;174(3):364-8.

> Doyal L, Gillon R. Medical ethics and law as a core subject in medical education. A core curriculum offers flexibility in how it is taught-but not that it is taught [editorial]. BMJ 1998 May 30;316(7145):1623-4.

> Dressel R, Christ G, Reiter-Theil S. Training ethics teachers in Germany. Bull Med Ethics 1995 Jun;109:13-5.

> Elliott D. Case studies for teaching research ethics. Prof Ethics 1995 Spring-Summer;4(3-4):179-98.

> Erde EL. The inadequacy of role models for educating medical students in ethics with some reflections on virtue theory. Theor Med 1997 Mar-Jun;18(1-2):31-45.

> Finocchio LJ, Bailiff PJ, Grant RW, O'Neil EH. Professional competencies in the changing health care system: physicians' views on the importance and adequacy of formal training in medical school. Acad Med 1995 Nov;70(11):1023-8.

> Forrow L, Wolf ML. Ideals in action: the U.S. Schweitzer Fellows Programs. Acad Med 1998 Jun;73(6):658-61.

> Fox E, Arnold RM, Brody B. Medical ethics education: past, present, and future. Acad Med 1995 Sep;70(9):761-9.

> Frank RR, Becker MJ. Ethics/human values curricula in US medical schools: results of a recent survey. Health Care Anal 1994 Feb;2(1):80.

> Friedman PJ. Research ethics: a teaching agenda for academic medicine. Acad Med 1990 Jan;65(1):32-3.

> Fulford KW, Yates A, Hope T. Ethics and the GMC core curriculum: a survey of resources in UK medical schools. J Med Ethics 1997 Apr;23(2):82-7.

> Gauthier CC. Teaching the virtues: justifications and recommendations. Camb Q Healthc Ethics 1997 Summer;6(3):339-46.

> Gilbert J, Jeffrey D. How much ethics is needed to make a good doctor? [letters]. Lancet 1993 Feb 20;341(8843):498-9.

> Gillon R. Thinking about a medical school core curriculum for medical ethics and law [editorial]. J Med Ethics 1996 Dec;22(6):323-4. Comment on: J Med Ethics 1996 Dec;22(6):325-6.

> Goals of medicine. Setting new priorities. Hastings Cent Rep 1996 Nov-Dec;26(6):S1-27.

> Goldbort RC. How dare you sport thus with life?: Frankensteinian fictions as case studies in scientific ethics. J Med Humanit 1995 Summer;16(2):79-91.

> Green B, Miller PD, Routh CP. Teaching ethics in psychiatry: a one-day workshop for clinical students. J Med Ethics 1995 Aug;21(4):234-8.

> Green MJ, Mitchell G, Stocking CB, Cassel CK, Siegler M. Do actions reported by physicians in training conflict with consensus guidelines on ethics? Arch Intern Med 1996 Feb 12;156(3):298-304.

> Greene D. The use of service learning in client environments to enhance ethical reasoning in students. Am J Occup Ther 1997 Nov-Dec;51(10):844-52.

> Grundstein-Amado R. Values education: a new direction for medical education. J Med Ethics 1995 Jun;21(3):174-8.

> Hanson MJ. Do as I do [bioethics education]. Hastings Cent Rep 1992 Sep-Oct;22(5):3.

> Hart CW. From innocence to experience: teaching medical ethics to medical students. J Relig Health 1995 Spring;34(1):55-60.

> Healey MA. Lies students tell [letter]. CMAJ 1997 May 1;156(9):1266; discussion 1267. Comment on: CMAJ 1997 Jan 15;156(2):219-22.

> Hensel WA, Rasco TL. Storytelling as a method for teaching values and attitudes. Acad Med 1992 Aug;67(8):500-4.

> Holm S, Nielsen GH, Norup M, Vegner A, Guldmann F, Andreasen PH. Changes in moral reasoning and the teaching of medical ethics. Med Educ 1995 Nov;29(6):420-3.

> Homenko DF, Kohn M, Rickel T, Wilkinson ML. Student identification of ethical issues in a primary care setting. Med Educ 1997 Jan;31(1):41-4.

> Hope T. Ethics and law for medical students: the core curriculum [editorial]. J Med Ethics 1998 Jun;24(3):147-8.

> Hope T. Teaching medical ethics: healthy variety, but are we learning from each other? Bull Med Ethics 1991 Aug;70:22-3.

> Hughes J. Ultimate justification: Wittgenstein and medical ethics. J Med Ethics 1995 Feb;21(1):25-30.

> Hundert EM, Douglas-Steele D, Bickel J. Context in medical education: the informal ethics curriculum. Med Educ 1996 Sep;30(5):353-64.

> Hundert EM, Hafferty F, Christakis D. Characteristics of the informal curriculum and trainees' ethical choices. Acad Med 1996 Jun;71(6):624-42.

> Jones AH. Literature and medicine: narrative ethics. Lancet 1997 Apr 26;349(9060):1243-6.

> Kane GC, Leone FT, Rowane J, Fish JE. Nationwide perspective on the use of a formal ethics curriculum during critical care fellowship training [letter]. Acad Med 1998 Jan;73(1):103.

> Kent H. Medical, health-science students bring different perspectives to interdisciplinary ethics course. CMAJ 1997 May 1;156(9):1317-8.

> Kinsella D, Lockyer J, Brownell K. Ethics training for residents [abstract]. Acad Med 1994 May;69(5):432.

> Knight JA. Moral growth in medical students. Theor Med 1995 Sep;16(3):265-80; discussion 281-9.

> Komesaroff PA. Review essay: the nature of medicine and the teaching of medical ethics. Bioethics 1990 Jan;4 (1):66-77.

> Kopelman LM. Philosophy and medical education. Acad Med 1995 Sep;70(9):795-805.

> Krulwich TA, Friedman PJ. Integrity in the education of researchers. Acad Med 1993 Sep;68(9 Suppl):S14-S18.

> Kuczewski M, Wicclair MR, Arnold RM, Pinkus RL, Aumann GM. Make my case: ethics teaching and case presentations. J Clin Ethics 1994 Winter;5(4):310-5. Comment in: J Clin Ethics 1994 Winter;5(4):347-8.

> Layman E. Ethics education: curricular considerations for the allied health disciplines. J Allied Health 1996 Spring;25(2):149-60.

> Levine RJ. Some reflections on postgraduate medical ethics education. Ethics Behav 1997;7(1):15-26.

> Loudon I. The Hippocratic oath [letter]. BMJ 1994 Aug 6;309(6951):414.

> Lynch A, Gourdeau R. Medical ethics 101 [editorial]. Ann R Coll Physicians Surg Can 1990 Jan;23(1):13-5.

> Macrina FL, Munro CL. The case study approach to teaching scientific integrity in nursing and the biomedical sciences. J Prof Nurs 1995 Jan-Feb;11(1):40-4.

> Macrina FL, Munro CL. Graduate teaching in principles of scientific integrity [and] Resource materials on scientific integrity issues. Acad Med 1993 Dec;68(12):879-86.

> Makoul G, Curry RH. Patient, physician & society: Northwestern University Medical School. Acad Med 1998 Jan;73(1):14-24.

> McGee G. Phronesis in clinical ethics. Theor Med 1996 Dec;17(4):317-28.

> Methodologies of teaching. The Ethics Committee of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg 1996 Sep;115(3):258-61.

> Michels R. Ethics education or moral persuasion? [commentary on H.S. Moffic, J. Coverdale, and T. Bayer, Ethics education for psychiatry]. J Clin Ethics 1991 Fall;2(3):166.

> Miner RD. Academy helps budding colleagues through ethics program. Ann Dent 1997 Oct:2, 5, 8

> Morton KR, Lamberton HH, Testerman JK, Worthley JS, Loo LK. Why does moral reasoning plateau during medical school? [letter]. Acad Med 1996 Jan;71(1):5-6.

> Napper SA, Hale PN. Teaching of ethics in biomedical engineering. IEEE Eng Med Biol Mag 1993 Dec;12(4):100-5.

> Nicholas B, Gillett G. Doctors' stories, patients' stories: a narrative approach to teaching medical ethics. J Med Ethics 1997 Oct;23(5):295-9.

> Nolan PW, Smith J. Ethical awareness among first year medical, dental and nursing students. Int J Nurs Stud 1995 Oct;32(5):506-17.

> O'Toole J. The story of ethics: narrative as a means for ethical understanding and action. JAMA 1995 May 3;273(17):1387, 1390.

> Ors Y. Teaching medical ethics in the subjunctive mood. Bull Med Ethics 1993 Nov;93:31-6.

> Parker M. Autonomy, problem-based learning, and the teaching of medical ethics. J Med Ethics 1995 Oct;21(5):305-10.

> Parker MH, Price DA, Harris PG. Teaching of medical ethics: implications for an integrated curriculum. Med Educ 1997 May;31(3):181-7.

> Pearlman RA. The value of an oath of professional conduct: process, content, or both? [commentary on H.S. Moffic, et al., The Hippocratic Oath and clinical ethics]. J Clin Ethics 1990 Winter;1(4):292-3.

> Pellegrino ED. The Hippocratic Oath and clinical ethics [commentary on H.S. Moffic, et al., The Hippocratic Oath and clinical ethics]. J Clin Ethics 1990 Winter;1(4):290-1.

> Poker AM. Making optimal use of information technology [letter]. Acad Med 1997 Jun;72(6):471-2. Comment on: Acad Med 1997 Jan;72(1):36-41.

> Pruitt R, Young EWD, Ross JW, Gross ML, Schwartz R. Facing fallibility and feelings: can medical ethics education play a role? Mak Rounds Health Faith Ethics 1996 Feb 12;1(11):4-8.

> Quinn CA. A conceptual approach to the identification of essential ethics content for the undergraduate nursing curriculum. J Adv Nurs 1990 Jun ;15(6):726-31.

> Ralston HJ 3rd, Beattie DS, Berns KI, Goode LD, Kelley WN, Lennarz WJ, Marton LJ, Prange AJ Jr, Shipp AC. Capturing the promise of science in medical schools. Acad Med 1996 Dec;71(12):1314-23.

> Reiser SJ, Heitman E. Creating a course on ethics in the biological sciences. Acad Med 1993 Dec;68(12):876-9.

> Roberts A, Fincher RM. Teaching third-year medical students how to handle ethical dilemmas. J Med Assoc Ga 1997 Nov;86(4):327-9.

> Rosnow RL. Teaching research ethics through role-play and discussion. Teach Psychol 1990 Oct;17(3):179-81.

> Rossignol AM, Goodmonson S. Are ethical topics in epidemiology included in the graduate epidemiology curricula? Am J Epidemiol 1995 Dec 15;142(12):1265-8.

> Ruckdeschel JC, Albrecht TL, Blanchard C, Hemmick RM. Communication, accrual to clinical trials, and the physician-patient relationship: implications for training programs. J Cancer Educ 1996 Summer;11(2):73-9.

> Sanders M. The forgotten curriculum: an argument for medical ethics education. JAMA 1995 Sep 6;274(9):768-9.

> Schatz IJ. Empathy and medical education. Hawaii Med J 1995 Apr;54(4):495-7.

> Schubert-Lehnhardt V. Teaching medical ethics in Germany. Bull Med Ethics 1992 Feb;75:13-5.

> Seedhouse D. Against medical ethics: a response to Cassell. J Med Ethics 1998 Feb;24(1):13-7.

> Self DJ, Baldwin DC Jr, Wolinsky FD. Further exploration of the relationship between medical education and moral development. Camb Q Healthc Ethics 1996 Summer;5(3):444-9. Comment in: Camb Q Healthc Ethics 1997 Spring;6(2):226-32.

> Self DJ, Davenport E. Measurement of moral development in medicine. Camb Q Healthc Ethics 1996 Spring;5(2):269-77.

> Self DJ, Gopalakrishnan G, Kiser WR, Olivarez M. The relationship of empathy to moral reasoning in first-year medical students. Camb Q Healthc Ethics 1995 Fall;4(4):448-53.

> Self DJ, Olivarez M. Retention of moral reasoning skills over the four years of medical education. Teach Learn Med 1996;8(4):195-9.

> Self DJ, Olivarez M, Baldwin DC Jr. Clarifying the relationship of medical education and moral development. Acad Med 1998 May;73(5):517-20.

> Self DJ, Olivarez M, Baldwin DCJr. The amount of small-group case-study discussion needed to improve moral reasoning skills of medical students. Acad Med 1998 May;73(5):521-3.

> Self DJ, Skeel JD, Jecker NS. A comparison of the moral reasoning of physicians and clinical medical ethicists. Acad Med 1993 Nov;68(11):852-5.

> Self DJ, Skeel JD, Jecker NS. The influence of philosophical versus theological education on the moral development of clinical medical ethicists. Acad Med 1993 Nov;68(11):848-52.

> Shotton L. The ethics of teaching nursing ethics. Health Care Anal 1997 Sep;5(3):259-63.

> Sidorov JJ. Education in medical ethics [article and discussion]. Gastroenterol Jpn 1993 Jul;28(Suppl 6):3-10.

> Silverman DR. Narrowing the gap between rhetoric and the reality of medical ethics. Acad Med 1996 Mar;71(3):227-37.

> Singer PA. Bioethics for clinicians [editorial]. CMAJ 1996 Jul 15;155(2):189-90. Comment on: CMAJ 1996 Jul 15;155(2):177-80.

> Singer PA, Robb A, Cohen R, Norman G, Turnbull J. Performance-based assessment of clinical ethics using an objective structured clinical examination. Acad Med 1996 May;71(5):495-8.

> Sofaer B. Enhancing humanistic skills: an experiential approach to learning about ethical issues in health care. J Med Ethics 1995 Feb;21(1):31-4.

> Sonis J, Gorenflo DW, Jha P, Williams C. Teaching of human rights in US medical schools. JAMA 1996 Nov 27;276(20):1676-8. Comment in: JAMA 1996 Nov 27;276(20):1679-81.

> Spafford MM, Strong G. Design elements of professional ethics courses. Optom Vis Sci 1995 Oct;72(10):741-52.

> St Onge J. Medical education must make room for student-specific ethical dilemmas. CMAJ 1997 Apr 15;156(8):1175-7.

> Strohmetz DB, Skleder AA. The use of role-play in teaching research ethics: a validation study. Teach Psychol 1992 Apr;19(2):106-8.

> Strong C, Miller BE, Photopulos GJ, Smiley LM. An approach to teaching ethical, legal, and psychosocial aspects of gynecologic oncology in a residency program. Obstet Gynecol 1997 Jan;89(1):142-4.

> Sukol RB. Teaching ethical thinking and behavior to medical students. JAMA 1995 May 3;273(17):1388-9.

> Sulmasy DP, Dwyer M, Marx E. Knowledge, confidence, and attitudes regarding medical ethics: how do faculty and housestaff compare? Acad Med 1995 Nov;70(11):1038-40.

> Sulmasy DP, Geller G, Levine DM, Faden R. Medical house officers' knowledge, attitudes, and confidence regarding medical ethics. Arch Intern Med 1990 Dec;150(12):2509-13.

> Sulmasy DP, Marx ES. Ethics education for medical house officers: long-term improvements in knowledge and confidence. J Med Ethics 1997 Apr;23(2):88-92.

> Swazey JP, Bird SJ. Teaching and learning research ethics. Prof Ethics 1995 Spring-Summer;4(3-4):155-78.

> Swenson SL, Rothstein JA. Navigating the wards: teaching medical students to use their moral compasses. Acad Med 1996 Jun;71(6):591-4.

> Taubes G. IIT: serving up ethics for lunch. Science 1995 Jun 23;268(5218):1716.

> Taubes G. Indiana: wrong answers--but no right ones. Science 1995 Jun 23;268(5218):1707. Published erratum appears in Science 1995 Sep 22;269(5231):1657.

> Taubes G. Pittsburgh: interwoven with the fabric of learning. Science 1995 Jun 23;268(5218):1709.

> Teaching ethics: right to refuse? [letter]. Hastings Cent Rep 1991 May-Jun;21(3):39-40.

> Teaching medical ethics and law within medical education: a model for the UK core curriculum. J Med Ethics 1998 Jun;24(3):188-92.

> Tealdi JC. Teaching bioethics as a new paradigm for health professionals. Bioethics 1993 Apr;7(2-3):188-99.

> ten Have H. Teaching ethics within the medical curriculum. Health Care Anal 1994 May;2(2):173-7.

> Thompson JN. Moral imperatives for academic medicine. Acad Med 1997 Dec;72(12):1037-42.

> Thornton BC, Callahan D, Nelson JL. Bioethics education. Expanding the circle of participants. Hastings Cent Rep 1993 Jan-Feb;23(1):25-9.

> Thornton H. Learning about randomised controlled trials. Bull Med Ethics 1993 Apr;87:21-3.

> Tokuda Y. Teaching ethics in Japan [letter]. Lancet 1995 Jun 17;345(8964):1574. Comment on: Lancet 1995 Apr 15;345(8955):980; Lancet 1995 Apr 15;345(8955):980-1; Lancet 1995 Jun 3;345(8962):1446; Lancet 1995 Jun 3;345(8962):1446-7.

> Triana JE. Humanistic and social education for physicians: the experience of the Colombian School of Medicine. J Med Philos 1996 Dec;21(6):651-7.

> Tysinger JW, Klonis LK, Sadler JZ, Wagner JM. Teaching ethics using small-group, problem-based learning. J Med Ethics 1997 Oct;23(5):315-8.

> Valiathan MS. Training doctors for tomorrow. Indian Pediatr 1996 Jun;33(6):481-92.

> Veatch RM. Should we study the Hippocratic Oath? [commentary on H.S. Moffic, et al., The Hippocratic Oath and clinical ethics]. J Clin Ethics 1990 Winter;1(4):291-2.

> Waz WR, Henkind J. The adequacy of medical ethics education in a pediatrics training program. Acad Med 1995 Nov;70(11):1041-3.

> Weatherall DJ. Teaching ethics to medical students [editorial]. J Med Ethics 1995 Jun;21(3):133-4.

> Weiner R. Ethics rounds. Fla Nurse 1995 Jan;43(1):2, 16.

> Weisberg M, Duffin J. Evoking the moral imagination: using stories to teach ethics and professionalism to nursing, medical, and law students. J Med Humanit 1995 Winter;16(4):247-63.

> White BD, Zaner RM. Clinical ethics training for staff physicians: designing and evaluating a model program. J Clin Ethics 1993 Fall;4(3):229-35. Comment in: J Clin Ethics 1993 Fall;4(3):273-5.

> White R. Lead by example [letter]. Br J Anaesth 1997 May;78(5):628-9.

> Wichman A, Foa R. Ethics education in neurology residency programs: results of a survey. Neurology 1996 May;46(5):1481-3.

> Williamson B. Medical ethics, teaching and the new genetics [editorial]. J Med Ethics 1996 Dec;22(6):325-6. Comment in: J Med Ethics 1996 Dec;22(6):323-4.

> Williamson C, Wilkie P. Teaching medical students in general practice: respecting patients' rights [editorial]. BMJ 1997 Nov 1;315(7116):1108-9. Comment on: BMJ 1997 Nov 1;315(7116):1142.

> Wurzbach ME. Teaching nursing ethics on interactive television: fostering interactivity. J Nurs Educ 1993 Jan;32(1):37-9.

> Return to table of contents

> ## Bioethics education - Books

> Baylis F, Downie J, et al. Undergraduate medical ethics education: a survey of Canadian medical schools. Canada: Westminster Institute for Ethics and Human Values; 1990. 142 p.

> Grafius LC. Ethics for everyone: a practical guide to interdisciplinary biomedical ethics education. Chicago: American Hospital Pub; c1995. 223 p.

> Nelson HL. Stories and their limits: narrative approaches to bioethics. New York: Routledge; 1997. 284 p. (Reflective bioethics).

> Thornton BC, Callahan D. Bioethics education: expanding the circle of participants. Briarcliff Manor (NY): The Hastings Center; 1993. 35 p.

> Return to table of contents

> ## Case studies - Journal Articles

> Casebook in psychiatric ethics. Introduction. Rep Group Adv Psychiatry 1990;(129):1-9.

> Cassidy VR. Literary works as case studies for teaching human experimentation ethics. J Nurs Educ 1996 Mar;35(3):142-4.

> Coope CM. Does teaching by cases mislead us about morality? J Med Ethics 1996 Feb;22(1):46-52. Comment in: J Med Ethics 1996 Feb;22(1):3-4.

> Durbin PT, Engel JD, Blacklow RS, Wellenbach BL. Sensitizing residents to moral issues by case discussions. Acad Med 1991 Oct;66(10):588.

> Gillon R. Case studies and medical education [editorial]. J Med Ethics 1996 Feb;22(1):3-4. Comment on: J Med Ethics 1996 Feb;22(1):46-52.

> Jonsen AR. Case analysis in clinical ethics. J Clin Ethics 1990 Spring;1(1):63-5.

> Tannsjo T. The morality of clinical research--a case study. J Med Philos 1994 Feb;19(1):7-21.

> Return to table of contents

> ## Case studies - Books

> Ackerman TF, Strong C. A casebook of medical ethics. New York: Oxford University Press; 1989. 240 p.

> Coughlin SS, Soskolne CL, Goodman KW. Case studies in public health ethics. Washington: American Public Health Association; 1997. 180 p.

> Crigger BJ, editor. Cases in bioethics: selections from the Hastings Center report. 2nd ed. New York: St. Martin's Press; c1993. 297 p.

> Forman EN, Ladd RE, editors. Ethical dilemmas in pediatrics: a case study approach. New York: Springer-Verlag; c1991. 142 p.

> Group for the Advancement of Psychiatry, Committee on Medical Education. A casebook in psychiatric ethics. New York: Brunner Mazel; 1990. 113 p. (Report; 129).

> Horn P. Clinical ethics casebook. Belmont (CA): Wadsworth Pub. Co.; 1998.

> Korenman SG, Shipp AC. Teaching the responsible conduct of research through a case study approach: a handbook for instructors. Washington: Association of American Medical Colleges; c1994. 226 p.

> Levine C, editor. Cases in bioethics: selections from the Hastings Center report. New York: St. Martin's Press; 1989. 291 p.

> Penslar RL. Research ethics: cases and materials. Bloomington: Indiana University Press; 1995.

> Thomas JE, Waluchow WJ, editors. Well and good: case studies in biomedical ethics. Rev. ed. Peterborough (Ont): Broadview Press; c1990. 218 p.

> Return to table of contents

> ## Audiovisual materials for teaching the ethics of research involving human participants

> Atomic guinea pigs. Sacrifice zone [videorecording]. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 40 min., sound, color with black and white, 1/2 in.

> Addressing the dil[e]mmas of medical ethics [audiocassette]. Blake, Mary Beth. Teach'em, Inc. producer. Chicago: Foundation of the American College of Healthcare Executives; 1987. 1 sound cassette: 1 7/8 ips.

> An approach to ethical dilemmas: case studies & policies [audiocassette]. Cohen, Elliott G. Teach'em, Inc., producer. Chicago: Foundation of the American College of Healthcare Executives; 1987. 2 sound cassettes: 1 7/8 ips.

> Balancing society's mandates: I.R.B. review criteria [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health; 1986. 1 videocassette: 38 min., sound, color, 3/4 in. Available also from National Institutes of Health, Office of Extramural Research under title Protecting Human Subjects. Three Instructional Films. Evolving Concern. Balancing Society's Mandates. The Belmont Report; 1/2 in.

> The Belmont report: basic ethical principles and their applications [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health; 1986. 1 videocassette: 34 min., sound, color with black and white, 3/4 in. Available also from National Institutes of Health, Office of Extramural Research under title Protecting Human Subjects. Three Instructional Films. Evolving Concern. Balancing Society's Mandates. The Belmont Report; 1/2 in.

> Bioethics for health professionals [computer program]. Version 1.0. Rorden, Judith Waring. Orlando (FL): Computerized Educational Systems; 1996. 1 computer disk: 3 1/2 in. Accompanied by 1 manual. System requirements: Any IBM PC/XT/AT/PS-2 or compatible; 512 RAM; DOS 3.0 or greater; col. monitor preferred; optional record keeping requires an IBM or compatible 80 column dot matrix printer.

> Bioethics vs. clinical ethics: practical applications in hospital administration [audiocassette]. LaPuma, John. Chicago: Foundation of the American College of Healthcare Executives; 1989. 1 sound cassette: 1 7/8 ips.

> The birth of bioethics [videorecording]. Jonsen, Albert R; Scribner, Belding H. University of Washington, School of Medicine, Dept. of Medical History and Ethics, producer. Seattle: University of Washington, Health Sciences Center for Educational Resources; 1993. 14 videocassettes: 14 hr., 40 min., 49 sec., sound, color, with black and white, 1/2 in. Conference held Sept. 23-24, 1993 in Seattle, Wash.

> Confidentiality and privacy [videorecording]. Reeter, Alan K. Medfilms, Inc., producer. Tucson (AZ): Medfilms; 1997. 1 videocassette: 10 min., sound, color with black and white, 1/2 in. Accompanied by 1 guide, 9 p.

> Confidentiality, ethical and legal considerations [videorecording]. Blenkhorn Phyllis; Calfee Barbara E; Rolince Pat. Cleveland: Fairview Audio-Visuals; 1989. 1 videocassette: 18 min., sound, color, 3/4 in. Issued also as a 1/2 in. videocassette.

> Conflicts in caring: medical, ethical, and legal perspectives in bioethical decision-making [videorecording]. Bradley, Lou; Glaser, Jack. Sight & Sound, Inc., producer. Kansas City: Sheed & Ward; 1988. 1 videocassette: 30 min., sound, color, 1/2 in.

> The deadly deception [videorecording]. Films for the Humanities; WGBH (Television station: Boston, Mass.), producers. Boston: WGBH Educational Foundation; 1993. 1 videocassette: 60 min., sound, color, 1/2 in.

> Doctors, nurses, and informed consent [videorecording]. Blenkhorn, Phyllis; Irwin, John R. Cleveland: Fairview Audio-Visuals; 1988. 1 videocassette:18 min., sound, color, 3/4 in. Issued also as a 1/2 in. videocassette.

> Ethics committees: necessary invention of modern health care [videorecording]. Glaser, Jack. Mount Carmel Mercy Hospital, Audiovisual Services, producer. Kansas City (MO): Sheed & Ward; 1988. 1 videocassette: 23 min., sound, color, 1/2 in.

> The ethics of cloning [videorecording]. Films for the Humanities. New River Media, producer. Princeton (NJ): Films for the Humanities & Sciences; 1997. 1 videocassette: 29 min., sound, color, 1/2 in.

> Evolving concern: protection for human subjects [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health; 1986. 1 videocassette: 23 min., sound, black and white with color, 3/4 in. Available also from National Institutes of Health, Office of Extramural Research under title Protecting Human Subjects. Three Instructional Films. Evolving Concern. Balancing Society's Mandates. The Belmont Report; 1/2 in.

> Fetal surgery and tissue implant: right or wrong? [videorecording]// . Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 58 min., sound, color, 1/2 in.

> Gene research: promises and dilemmas [videorecording]. Rose, Steven P. R. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 33 min., sound, color, 1/2 in.

> The human experiment [videorecording]. Columbia University Seminars on Media & Society. WNET (Television station: New York, N.Y.), producer. New York: Trustees of Columbia University in the City of New York; 1989. 1 videocassette: 60 min., sound, color, 1/2 in. Issued also as a 3/4 in. videocassette.

> Informed consent: what every physician should know [videorecording]. Webb, M. Sharon. Rob Cooper Creative Production Services, producer. United States: SEAK, Inc.; 1995. 1 videocassette: 55 min., sound, color, 1/2 in.

> Integrity in scientific research: five video vignettes [videorecording]. Amram Nowak Associates, producer. Washington: American Association for the Advancement of Science; 1996. 5 videocassettes: 43 min., sound, color, 1/2 in. Accompanied by: 1 guide, 50 p. Produced for the American Association for the Advancement of Science in cooperation with the Medical College of Georgia, Division of Health Communication.

> The JCAHO patient rights standards: implications for assessing patients' competence [videorecording]. Hixon, Thomas J. University of Arizona, National Center for Neurogenic Communication Disorders, producer. Tucson (AZ): Arizona Board of Regents; 1992. 1 videocassette: sound, color, 1/2 in. Accompanied by 1 guide, 6 leaves. (Telerounds; 5).

> The man-made man [videorecording]. Sheen, Martin; narrator. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1998. 1 videocassette: 60 min., sound, color, 1/2 in.

> The man who believes in body transplants [videorecording]. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1997. 1 videocassette: 30 min., sound, color, 1/2 in.

> On 'doubling' in Nazi doctors: the psychological uncovering of evil [audiocassette]. Lifton, Robert Jay. American Psychoanalytic Association, producer. Chicago: Teach'em; 1987? 1 sound cassette: analog. Recorded at the American Psychoanalytic Association's Fall Meeting, held at the Waldorf Astoria in New York City, Dec. 16-20, 1987.

> Practical considerations [videorecording]. Wivel, Nelson. Bethesda (MD): BioConferences International Inc.; 1993. 1 videocassette: sound, color, 1/2 in. Recorded at BioEast '93, held in Washington, D.C.

> Protecting human subjects. Three instructional films. Evolving concern. Balancing society's mandates. The Belmont Report [videorecording]. National Institutes of Health (US); Food and Drug Administration (US). National Library of Medicine, producer. Bethesda (MD): National Institutes of Health, Office of Extramural Research; 1986. 1/2 in.

> Protection of human research subjects. Computer-based training for researchers [computer program on the Internet]. Bethesda (MD): National Institutes of Health, Office of Human Subjects Research; [cited 1999 Feb 23]. Available from: http://helix.nih.gov:8001/ohsr/newcbt/. Program may be downloaded or used online. System Requirements for Downloading: Macintosh PowerPC running System 7.5.1 or higher; Macintosh 68k PC running System 7.1.2 or higher; Windows PC running Microsoft Windows 95/98/NT/3.1 or higher. This training course is an educational requirement for all National Institutes of Health employees who conduct research.

> The science of cloning [videorecording]. Films for the Humanities, producer. Princeton (NJ): Films for the Humanities & Sciences; 1997. 1 videocassette: 25 min., sound, color, 1/2 in.

> We all have our reasons: community perceptions of HIV vaccine research [videorecording]. Kanter, Ron. Video/Film Associates, producer. Philadelphia: University of Pennsylvania, School of Medicine, Dept. of Psychiatry; 1997? 1 videocassette: 25 min., sound, color, 1/2 in. Accompanied by: 1 guide, 21 p.

> Return to table of contents

> ## Bioethics journals

> Bioethics. Oxford: Blackwell Publishers Ltd. 1987- .

> Bulletin of Medical Ethics. London: Royal Society of Medicine Press Ltd. No. 53, 1989- .

> Cambridge Quarterly of Healthcare Ethics. New York: Cambridge University Press. 1992- .

> Ethics and Behavior. Mahwah (NJ): Lawrence Erlbaum Associates, Inc. 1991- .

> Hastings Center Report. Garrison (NY): The Hastings Center. 1971- .

> Human Research Report: Protecting Researchers and Research Subjects. Omaha (NE): Deem-Corporation. 1986- .

> IRB: A Review of Human Subjects Research. Garrison (NY): The Hastings Center. 1979- .

> Journal of Clinical Ethics. Frederick (MD): The Journal of Clinical Ethics, Inc. 1990- .

> Journal of Law, Medicine & Ethics. Boston (MA): American Society of Law, Medicine & Ethics. 1973- .

> Journal of Medical Ethics. London: BMJ Publishing Group. 1975- .

> Journal of Medicine and Philosophy. Lisse (Netherlands): Swets & Zeitlinger. 1976- .

> Kennedy Institute of Ethics Journal. Baltimore (MD): Johns Hopkins University Press. 1991- .

> Nursing Ethics: An International Journal for Health Care Professionals. London: Arnold. 1994- .

> Science and Engineering Ethics. Guildford, Surrey (UK): Opragen Publications. 1995- .

> Theoretical Medicine and Bioethics: Philosophy of Medical Research and Practice. Dordrecht (Netherlands): Kluwer Academic Publishers. 1977- .

> Return to table of contents

> ## Bioethics databases

> BIOETHICSLINE [database on the Internet]. Washington: Georgetown University, Kennedy Institute of Ethics, National Reference Center for Bioethics Literature; 1974- . Updated bimonthly. Available free from: National Library of Medicine, http://www.nlm.nih.gov; National Reference Center for Bioethics Literature, http://bioethics.georgetown.edu/bioline.htm. Index of bioethics literature.

> CINAHL (Cumulative Index to Nursing and Allied Health Literature) [database on the Internet]. Glendale (CA): Cinahl Information Systems. 1982- . Updated monthly. Available from: Cinahl Information Systems, http://www.cinahl.com/; Aries Systems Corp., North Andover, MA; Data-Star, Philadelphia, PA; EBSCO Publishing, Peabody, MA; Healthgate Data Corp., Malden, MA; OCLC First Search, Dublin, OH; Ovid Technologies, New York; SilverPlatter Information, Norwood, MA; PaperChase, Boston, MA; Synthesys Technologies, Austin, TX. Index of nursing and allied health literature.

> HISTLINE [database on the Internet]. Bethesda (MD): National Library of Medicine; 1964- . Updated monthly. Available free from: National Library of Medicine, http://www.nlm.nih.gov. Index of history of medicine literature.

> LEXIS [databases on the Internet]. Dayton (OH): Mead Data Central. Available from: http://www.lexis-nexis.com/lncc/. Source of numerous legal databases.

> LOCATORplus [library catalog on the Internet]. Bethesda (MD): National Library of Medicine. Updated daily. Available free from: National Library of Medicine, http://www.nlm.nih.gov. National Library of Medicine catalog of books, journals, and audiovisuals.

> MEDLINE [database on the Internet]. Bethesda (MD): National Library of Medicine; 1960- . Updated weekly. Available from: National Library of Medicine (free), http://www.nlm.nih.gov; Ovid Technologies, New York; Knight-Ridder, Detroit, MI; CompuServe, Columbus, OH; PaperChase, Boston, MA; LEXIS-NEXIS, Dayton, OH. Index of nearly 4000 medical journals.

> WESTLAW [databases on the Internet]. St. Paul (MN): West Group. Available from: http://www.westgroup.com/. Source of numerous legal databases.

> Return to table of contents

> ## Source materials - U.S. federal government laws, regulations, and guides concerning the protection of human subjects - Journal Articles

> Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines. J Law Med Ethics 1996 Spring;24(1):18-35.

> Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 1995 Apr 26;273(16):1283-7. Comment in: JAMA 1995 Apr 26;273(16):1299-300; JAMA 1995 Apr 26;273(16):1300-2; JAMA 1995 Oct 18;274(15):1196.

> Biros MH, Runge JW, Lewis RJ, Doherty C. Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances. Acad Emerg Med 1998 Apr;5(4):359-68.

> Centers for Disease Control and Prevention (US), Agency for Toxic Substances and Disease Registry. Policy on the inclusion of women and racial and ethnic minorities in externally awarded research; notice. Fed Regist 1995 Sep 15;60(179):47947-51.

> de Jong J, Reatig N. SAMHSA philosophy and statement of ethical principles. Ethic Behav 1998;8(4):339-43.

> Food and Drug Administration (US). Addendum to the Points to Consider in Human Somatic Cell and Gene Therapy (1991). Hum Gene Ther 1996 Jun 10;7(9):1181-90.

> Food and Drug Administration (US). Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice. Fed Regist 1993 Jul 22;58(139):39406-16.

> Food and Drug Administration (US). Information sheets: guidance for Institutional Review Boards and clinical investigators. 1998 update [monograph on the Internet]. Rockville (MD): The Administration; 1998 Sep [cited 1999 May 10]. [12 web p.]. Available from: http://www.fda.gov/oc/oha/IRB/toc.html.

> Food and Drug Administration (US). Informed consent for human drugs and biologics; determination that informed consent is not feasible; interim rule and opportunity for public comment. Fed Regist 1990 Dec 21;55(246):52814-7.

> Food and Drug Administration (US). Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. Fed Regist 1998 Nov 9;63(216);60353-6.

> Food and Drug Administration (US). Protection of human subjects; informed consent and waiver of informed consent requirements in certain emergency research; final rules. Fed Regist 1996 Oct 2;61(192):51498-531

> Food and Drug Administration (US). Protection of human subjects; informed consent; proposed rule. Fed Regist 1995 Sep 21;60(183):49086-103.

> Institutional review boards, 21 C.F.R. Sect. 56 (1998 revised).

> Investigational device exemptions, 21 C.F.R. Sect. 812 (1998 revised).

> Investigational new drug application, 21 C.F.R. Sect. 312 (1998 revised).

> National Human Genome Research Institute (US). The use of human subjects in large-scale DNA sequencing [monograph on the Internet]. [Bethesda (MD)]: The Institute. [date unknown; cited 1998 Sep 28]. NHGRI-DOE guidance on human subjects issues in large-scale DNA sequencing: August 17, 1996; [7 p.]. Available from: http://www.nhgri.nih.gov/Grant_info/Funding/Statements/RFA/human_subjects.html.

> National Institutes of Health. Recombinant DNA research; actions under guidelines; notice. Fed Regist 1990 Sep 12;55(177):37565-7.

> National Institutes of Health. Recombinant DNA research; actions under guidelines; notice -- E. Points to consider for protocols for the transfer of recombinant DNA into the genome of human subjects. Fed Regist 1990 Mar 1;55(41):7443-7.

> National Institutes of Health. Recombinant DNA research: notice of intent to propose amendments to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) regarding enhanced mechanisms for NIH oversight of recombinant DNA activities. Fed Regist 1996 Jul 8;61(131):35774-7.

> National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines; notice. Fed Regist 1996 Nov 22;61(227):59726-42.

> National Institutes of Health. Recombinant DNA research: proposed actions under the guidelines; notice. Fed Regist 1997 Feb 14;62(31):7108-23.

> Office of Science and Technology Policy (US). Federal policy for the protection of human subjects; final rule. Fed Regist 1991 Jun 18;56(117):28003-23.

> Protection of human subjects, 21 C.F.R. Sect. 50 (1998 revised).

> Public Health Service (US). Action related to emergency research activity. Fed Regist 1995 Jul 26;60(143):38353-4.

> Public Health Service (US). Draft Public Health Service guideline on infectious disease. Issues in xenotransplantation (August 1996); notice. Fed Regist 1996 Sep 23;61(185):49919-32.

> Waiver of informed consent requirements in certain emergency research. Fed Regist 1996 Oct 2;61(192):53531-3.

> Wilson DJ. NIH guidelines for research involving recombinant DNA molecules. Accountability Res 1993;3(2-3):177-85.

> Return to table of contents

> ## Source materials - U.S. federal government laws, regulations, and guides concerning the protection of human subjects - Books

> The Belmont report: ethical principles and guidelines for the protections of human subjects. Bethesda (MD): U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; l979. 8 p. Reprinted in numerous books and Internet web sites.

> Department of Energy (US), Office of Energy Research. Protecting human research subjects at the Department of Energy: human subjects handbook [loose-leaf]. Washington: Department of Energy, Assistant Secretary for Environment, Safety, and Health, Office of Energy Research, Office of Health and Environmental Research; 1992-. 1 vol.

> DOE human subjects research handbook: protecting human research subjects [microform]. 2nd ed. Washington: Department of Energy, Office of Health and Environmental Research; 1996. Rev. ed. of: Protecting human research subjects at the Department of Energy. 1992.

> English A. State minor consent statutes: a summary. Cincinnati: Children's Hospital Medical Center, Division of Adolescent Medicine, National Center for Youth Law for the Center for Continuing Education in Adolescent Health; 1995. 197 p.

> Guidelines for the conduct of research at the National Institutes of Health. Bethesda (MD): National Institutes of Health; 1990 Mar 21. 15 p.

> Guidelines for the conduct of research involving human subjects at the National Institutes of Health. Bethesda (MD): National Institutes of Health; 1995 Apr. 21 p.

> Outreach notebook for the NIH guidelines on inclusion of women and minorities as subjects in clinical research. Bethesda (MD): National Institutes of Health, 1994. 37 p.

> Penslar RL. Protecting human research subjects: institutional review board guidebook [loose-leaf]. Rev., updated and expanded 2nd ed. Bethesda (MD): National Institutes of Health, Office of Protection from Research Risks; 1993. 1 vol.

> Washington M, editor. Fetal research: a survey of state law. Washington: Library of Congress; 1988. 15 p. (CRS report for Congress; 88-198 A).

> Return to table of contents

> ## Source materials - guidelines for the protection of human subjects published by U.S. non-government organizations - Journal Articles

> American Academy of Pediatrics. Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995 Feb;95(2):286-94.

> American College of Clinical Pharmacy Research Affairs Committee. Subcommittee. Ethical issues related to clinical pharmacy research. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):523-30.

> American College of Clinical Pharmacy Task Force on Women's Health and Research Issues. Women as research subjects. [ACCP white paper]. Pharmacotherapy 1993 Sep-Oct;13(5):534-42.

> American College of Emergency Physicians. Ethics manual. Ann Emerg Med 1991 Oct;20(10):1153-62.

> American College of Obstetricians and Gynecologists. Committee on Ethics. Preembryo research: history, scientific background, and ethical considerations. ACOG Committee Opinion 136, Apr 1994. Int J Gynaecol Obstet 1994 Jun;45(3):291-301.

> American Hospital Association. A patient's bill of rights [monograph on the Internet]. Chicago: The Association; c1992 [cited 1998 Sep 28]. [141 lines]. Available from: http://www.aha.org/resource/pbillofrights.html.

> American Medical Association. Board of Trustees. Frozen pre-embryos [report]. JAMA 1990 May 9;263(18):2484-7.

> American Medical Association, Council on Scientific Affairs and Council on Ethical and Judicial Affairs. Medical applications of fetal tissue transplantation. JAMA 1990 Jan 26;263(4):565-70.

> American Public Health Association. Protecting confidential data in disease registries. [Policy statement 9515]. Am J Public Health 1996 Mar;86(3):443-4.

> American Society of Human Genetics. ASHG report: statement on informed consent for genetic research. Am J Hum Genet 1996 Aug;59(2):471-4.

> Beauchamp TL, Cook RR, Fayerweather WE, Raabe GK, Thar WE, Cowles SR, Spivey GH. Ethical guidelines for epidemiologists. J Clin Epidemiol 1990;44(1 Suppl):S151-S69.

> Bernat JL, Beresford HR, American Academy of Neurology. The American Academy of Neurology Code of Professional Conduct. Neurology 1993 Jun;43(6):1257-60.

> College on Problems of Drug Dependence. College on Problems of Drug Dependence policy on administering drugs with abuse potential in human research. IRB Rev Hum Subj Res 1996 Sep-Oct;18(5):5-7.

> Emergency Nurses Association. Code of Ethics for Emergency Nurses With Interpretive Statements. J Emerg Nurs 1990 Nov-Dec;16(6):22A-4A.

> Ethics manual. Fourth edition. American College of Physicians. Ann Intern Med 1998 Apr 1;128(7):576-94

> Gidding SS, Camp D, Flanagan MH, Kowalski JA, Lingl LL, Silverman BL, Langman CB. A policy regarding research in healthy children. J Pediatr 1993 Dec;123(6):852-5.

> International Committee of Medical Journal Editors. Protection of patients' rights to privacy [guidelines]. BMJ 1995 Nov 11;311(7015):1272.

> National Council for Hospice and Specialist Palliative Care Services (Great Britain). Guidelines on research in palliative care [official statement]. Bull Med Ethics 1995 Aug;(110):19-20.

> Nuremberg Military Tribunal. The Nuremberg code [reprint]. JAMA 1996 Nov 27;276(20):1691.

> Return to table of contents

> ## Source materials - guidelines for the protection of human subjects published by U.S. non-government organizations - Books

> Addendum to the 1995 edition of the Principles of medical ethics: with annotations especially applicable to psychiatry. Washington: American Psychiatric Association; 1995. 11 p.

> American College of Physicians, Ad Hoc Committee on Medical Ethics. American College of Physicians ethics manual. 2nd ed. Philadelphia: The College; 1989. Reprinted from Annals of Internal Medicine 1989; 111:245-52; 327-35.

> American Medical Association, Council on Ethical and Judicial Affairs. Code of medical ethics, current opinions. Current opinions: including the principles of medical ethics, fundamental elements of the patient-physician relationship and rules of the Council on Ethical and Judicial Affairs. Chicago: American Medical Association; 1992.

> American Medical Association, Council on Ethical and Judicial Affairs. Code of medical ethics. Reports of the Council on Ethical and Judicial Affairs of the American Medical Association. Chicago: The Association; 1992-.

> American Medical Association, Council on Ethical and Judicial Affairs. Reports. Chicago: The Association; 1990. 1 vol. Loose-leaf binder; revised Jan 1990.

> American Medical Association, Council on Ethical and Judicial Affairs, Southern Illinois University at Carbondale, School of Medicine, Southern Illinois University at Carbondale, School of Law. Code of medical ethics, current opinions with annotations. Current opinions with annotations: including the principles of medical ethics, fundamental elements of the patient-physician relationship and rules of the Council on Ethical and Judicial Affairs. Chicago: American Medical Association; 1994.

> American Nurses' Association. Code for nurses: with interpretative statements. Kansas City (MO): The Association; 1985. 16 p.

> Annas GJ. The rights of patients: the basic ACLU guide to patient rights. Carbondale (IL): Southern Illinois University Press; 1989.

> Bird LP, Barlow J, editors. Codes of medical ethics, oaths, and prayers: an anthology. Richardson (TX): Christian Medical & Dental Society; 1989. 103 p.

> Canter MB. Ethics for psychologists: a commentary on the APA ethics code. Washington: American Psychological Association; c1994. 254 p.

> Code of medical ethics: current opinions with annotations. 1996-1997 edition. Chicago: American Medical Association, Council on Ethical and Judicial Affairs; 1996. 191 p.

> College of American Pathologists. Minutes of the Board of Governors meeting; 1995 Aug 2. [Northfield (IL)]: The College; [1995]. Statement on the utilization of stored tissues.

> CPRI Work Group on Confidentiality, Privacy, and Security. Sample confidentiality statements and agreements for organizations using computer-based patient record systems. Schaumburg (IL): Computer-Based Patient Record Institute; c1996. 29 p.

> Developing a code of ethics in research: a guide for scientific societies. Washington: Association of American Medical Colleges; c1997. 42 p.

> Institute of Medicine, Board on Health Sciences Policy. Inclusion of women in clinical trials: policies for population subgroups. Washington: National Academy Press; 1993. 11 p.

> International Chiropractors Association. Policy handbook & code of ethics. 2nd ed. Arlington (VA): International Chiropractors Association; 1991. 52 p.

> Kitchens LW. Ethics manual: approved by the American College of Physicians. 4th ed. Philadelphia: American College of Physicians; c1998.

> Maynard EP. Ethics manual: approved by the American College of Physicians. 3rd ed. Philadelphia: American College of Physicians; c1993. 68 p.

> Opinions of the Ethics Committee on the principles of medical ethics: with annotations especially applicable to psychiatry. Washington: American Psychiatric Association; 1995. 63 p.

> Opinions of the Ethics Committee on the principles of medical ethics: with annotations especially applicable to psychiatry. 1989 ed. Washington: American Psychiatric Association; 1989. 40 p.

> Pincus HA, Lieberman JA, Ferris S. Ethics in psychiatric research: a resource manual on human subjects research. 1st ed. Washington: American Psychiatric Association; c1998.

> Rowland HF, Rowland AB. Hospital consents manual. Gaithersburg (MD): Aspen Publishers; 1992.

> Silva MC. Ethical guidelines in the conduct, dissemination, and implementation of nursing research. Washington: American Nurses Pub.; 1995. 56 p.

> The ethical ophthalmologist: a primer. San Francisco: American Academy of Ophthalmology; 1993. 246 p. Loose-leaf.

> The principles of medical ethics with annotations especially applicable to psychiatry. 1989 ed. Washington: American Psychiatric Association; 1989. 17 p.

> Return to table of contents

> ## Source materials - Guidelines for the protection of human subjects published by non-U.S. government and other organizations - Journal Articles

> Annotated bibliography and appendices: international codes of ethics. Bulletin Pan Am Health Org 1990;24(4):582-629.

> Boer GJ. Ethical guidelines for the use of human embryonic or fetal tissue for experimental and clinical neurotransplantation and research. Network of European CNS Transplantation and Restoration (NECTAR). J Neurol 1994 Dec;242(1):1-13.

> British Psychological Society. Ethical research in psychology: revised ethical principles for conducting research with human participants. Bull Med Ethics 1991 May ;68:8-11.

> Canada Federal Centre for AIDS Working Group on Anonymous Unlinked HIV Seroprevalence Research. Revised guidelines on ethical and legal considerations in anonymous unlinked HIV seroprevalence research. Can Med Assoc J 1992 May 15;146(10):1743-4.

> Canadian Medical Association. Code of Ethics of the Canadian Medical Association (approved by General Council, August 1996). Can Med Assoc J 1996 Oct 15;155(8):1176A-1176B. Comment in: Can Med Assoc J 1996 Oct 15;155(8):1063-5.

> Canadian Medical Association. Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association Journal 1994 Jan 15 1994;150(2):256A-256C.

> Council for International Organizations of Medical Sciences. International guidelines for ethical review of epidemiological studies. Law Med Health Care 1991 Fall-Winter;19(3-4):247-58.

> Council of Europe Committee of Ministers. European guidance on medical research [official statements]. Bull Med Ethics 1990 Mar;56:8-10.

> Dommel FW, Alexander D. The Convention on Human Rights and Biomedicine of the Council of Europe. Kennedy Inst Ethics J 1997 Sep;7(3):259-76.

> European Association of Tissue Banks. New rules proposed for tissue banks. Official statement. Bull Med Ethics 1994 May;98(10-1)

> European Parliament. Cloning animals and human beings. [Resolution of 12 March 1997]. Bull Med Ethics 1997 May;128:10-1.

> Gene Therapy Advisory Committee (Great Britain). Guidance on making proposals to conduct gene therapy research on human subjects. Gene Ther 1994 Nov;1(6):343-63.

> Hall J, Hamerton J, Hoar D, Korneluk R, Ray P, Rosenblatt D, Wood S, Canadian College of Medical Geneticists. Policy statement concerning DNA banking and molecular genetic diagnosis. Clin Invest Med 1991 Aug;14(4):363-5.

> International guidelines for ethical review of epidemiological studies. Law Med Health Care 1991 Fall-Winter;19(3-4):247-58.

> International Workshop on Legal Aspects of the Human Genome Project (Bilbao 24-26 May 1993) adopts Bilbao Declaration. Int Dig Health Legis 1994;45(2):234-7.

> Rosenberg SA. TNF/TIL Human Gene Therapy Clinical Protocol: memo to the RAC, July 6, 1990; original protocol, April 23, 1990; addendum to protocol, May 24, 1990; and response to Points to Consider, July 9, 1990. Hum Gene Ther 1990 Winter;1(4):441-80.

> Royal Australasian College of Surgeons. Code of ethics. Arch Surg 1996 Aug;131(8):900-1.

> Royal College of Physicians. Research involving patients: summary and recommendations of a report of the Royal College of Physicians. J R Coll Physicians Lond 1990 Jan ;24(1):10-4.

> Teehan M, Canadian Psychiatric Association. Guidelines for Phase IV clinical trials. Can J Psychiatry 1994 Dec;39(10):629-30.

> World Medical Association is reanimated [news]. Bull Med Ethics 1994 Sep;101:3-5.

> Return to table of contents

> ## Source materials - Guidelines for the protection of human subjects published by non-U.S. government and other organizations - Books

> Animal tissue into humans: a report by the Advisory Group on the Ethics of Xenotransplantation, 1996. London: Her Majesty's Stationery Office; 1997. 258 p.

> Animal-to-human transplants: the ethics of xenotransplantation. London: Nuffield Council on Bioethics; 1996 Mar. 147 p.

> Association of British Pharmaceutical Industry, Working Party on Non-patient Volunteer Studies. Guidelines for medical experiments in non-patient human volunteers. London: Association of the British Pharmaceutical Industry; 1988. 15 p.

> Bankowski Z, Levine RJ. Ethics and research on human subjects: international guidelines: proceedings of the 26th Council for International Organization of Medical Sciences Conference; 1992 Feb 5-7; Geneva, Switzerland. Switzerland: CIOMS; 1993. 63 p.

> Baylis F, Downie J, compilers. Codes of ethics: ethics codes, standards, and guidelines for professionals working in a health care setting in Canada. Toronto: Hospital for Sick Children, Dept. of Bioethics; 1992. 148 p.

> British Medical Association. Philosophy & practice of medical ethics. London: British Medical Association; 1988. 139 p. Rev. ed. of: The handbook of medical ethics. British Medical Association. c1984.

> British Medical Association, Professional and Scientific Division. Rights and responsibilities of doctors. London: British Medical Association; 1988. 135 p.

> Code of ethics. Wellington: New Zealand Medical Association; 1992 Dec. 8 p.

> Code of practice: consultation document. London: Human Fertilisation and Embryology Authority; 1991. 37 p.

> Committee to Review the Guidance on the Research Use of Fetuses and Fetal Material (Great Britain). Review of the guidance on the research use of fetuses and fetal material. London: Her Majesty's Stationery Office; 1989 Jul. 30 p.

> Confidentiality, use, and disclosure of personal health information. London: Great Britain, Department of Health; 1994 Aug 10. 23 p. Draft guidance.

> Council of Europe, Parliamentary Assembly. Recommendation 1100 (1989): On the use of human embryos and foetuses in scientific research. Strasbourg: The Council; 1989. 10 p.

> Donated ovarian tissue in embryo research and assisted conception: public consultation document. London: The Human Fertilisation and Embryology Authority; 1994. 12 p. Reprinted in Hum Reprod 1994 May;9(5):931-5.

> Donated ovarian tissue in embryo research and assisted conception: report. London: The Human Fertilisation and Embryology Authority; 1994 Jul. 13 p.

> European and Nordic regulations and guidelines for good clinical practice. Austin (TX): Pharmaco Dynamics Research, Inc. Regulatory Affairs Dept.; c1990. 134 p.

> Foster CG. Manual for research ethics committees. London: King's College, Centre of Medical Law and Ethics; 1992. 1 vol.

> Foster CG. Manual for research ethics committees. 2nd ed. London: King's College, Centre of Medical Law and Ethics; 1993. 1 vol. Looseleaf.

> Good clinical trial practice: Nordic guidelines. 1st ed. Uppsala (Sweden): Nordic Council on Medicines; 1989 Dec. 38 p.

> Guidelines for research on somatic cell gene therapy in humans. Ottawa: Minister of Supply and Services; 1990. 44 p.

> Guidelines for the ethical conduct of medical research involving children. London: British Paediatric Association, Ethics Advisory Committee; 1992 Aug. 18 p.

> Guidelines on ethics for medical research. Rev. ed. Tygerberg: South African Medical Research Council; 1993. 119 p.

> Guidelines on good clinical research practice. London: Association of the British Pharmaceutical Industry; 1988 Mar. 22 p.

> Guidelines on the practice of ethics committees in medical research involving human subjects: a report of the Royal College of Physicians. 2nd ed. London: Royal College of Physicians of London; 1990. 43 p.

> Human Fertilisation and Embryology Authority (Great Britain). Statutory storage period for embryos. London: Department of Health; 1995 Jul. 13 p. Report by the Human Fertilisation and Embryology Authority to the Health Ministers of the United Kingdom.

> International ethical guidelines for biomedical research involving human subjects. Geneva: World Health Organization, Council for International Organizations of Medical Sciences. 1993. 63 p.

> Local research ethics committees. London: U.K. Department of Health; 1991 Aug 19. 26 p.

> Manual for centres. London: The Human Fertilisation and Embryology Authority; 1991 Jun. 1 vol. Looseleaf.

> Maynard DE. International good clinical practice: the GCP compliance handbook. Buffalo (IL): Interpharm Press; c1996. 495 p.

> Mentally incapacitated adults and decision-making: medical treatment and research. London: Her Majesty's Stationery Office; 1993. 139 p.

> Morgan D, Lee RG. Blackstone's guide to the Human Fertilisation and Embryology Act 1990: abortion and embryo research -- the new law. London: Blackstone Press; 1991. 261 p.

> National Health and Medical Research Council (Australia). NHMRC Statement on Human Experimentation and Supplementary Notes, 1992. Canberra: Australian Government Publishing Service; 1992 Nov. 23 p.

> NH & MRC Medical Research Ethics Committee (Australia). Guidelines for the use of genetic registers in medical research. Canberra: Australian Government Pub Service; c1991. 18 p.

> Proposed international guidelines on ethical issues in medical genetics and genetic services: report of a WHO meeting on ethical issues in medical genetics, 1997 Dec 15-16, Geneva. Geneva: World Health Organization, Human Genetics Programme; c1998. 15 p.

> Report of the Committee on the Ethics of Gene Therapy. London: Her Majesty's Stationery Office; 1992 Jan. 41 p.

> Research involving human subjects. Copenhagen: Ministry of Health; 1989. 111 p.

> Research involving patients: a report of the Royal College of Physicians. London: Royal College of Physicians of London; c1990. 48 p. (Medical ethics publications).

> Responsibility in investigations on human participants and material and on personal information. London: Medical Research Council; 1992 Nov. 15 p.

> Rosenbaum D, Dresser M. Clinical research coordinator handbook: GCP tools and techniques. Buffalo Grove (IL): Interpharm Press; c1997. 299 p. (Practical clinical trials series; vol. 1).

> Rosenbaum D, Smith F. Clinical research monitor handbook: GCP tools and techniques. Buffalo Grove (IL): Interpharm Press; c1998. 463 p. (Practical clinical trials series).

> Rosenbaum D, Smith F. Physician investigator handbook: GCP tools and techniques. Buffalo Grove (IL): Interpharm Press; c1997. 418 p. (Practical clinical trials series).

> Statement of WHO Expert Advisory Group on Ethical Issues in Medical Genetics, 1997 Dec 15-16, Geneva. Geneva: World Health Organization, Human Genetics Programme, Division of Noncommunicable Diseases; c1998. 7 p.

> Swedish act concerning use of gene technology on human beings and experiments with fertilised ova. Stockholm: Ministry of Health and Social Affairs; 1991. 17 p.

> The Canadian Medical Association code of ethics. Ottawa: The Association; 1990 Apr. 6 p.

> The clinical trial notification scheme: draft guidelines for institutional ethics committees. Canberra: Australian Government Publishing Service; 1992. 14 p.

> The ethical conduct of AIDS vaccine trials: report of the Working Party on Ethical Aspects of AIDS Vaccine Trials. London: Medical Research Council; 1991. 40 p. (MRC ethics series).

> The ethical conduct of research on children. London: Medical Research Council, Working Party on Research on Children; 1991 Dec. 21 p.

> The ethical conduct of research on the mentally incapacitated. London: Medical Research Council, Working Party on Research on the Mentally Incapacitated; 1991 Dec. 23 p.

> Wells FO. Medicines: good practice guidelines. Belfast: Queen's University of Belfast; c1990. 196 p.

> World Health Organization, Fiftieth World Health Assembly. Cloning in human reproduction. Geneva: World Health Organization; 1997 May 14. 10 p.

> http://www.nlm.nih.gov/ US National Library of Medicine Gateway. Library Services Catalog, Databases, Historical Materials, MeSH, Publications, Training, Grants, Network of Libraries. Research AOL
> U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894 National Institutes of Health, Department of Health & Human Services Copyright, Privacy, Accessibility

> > All logos and trademarks in this site are property of their respective owner.
> > FAIR USE NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, and for the general purpose of criticism, comment, news reporting, teaching, research and / or educational purposes only. We believe this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. If you wish to use this material for purposes other than provided by law. You must obtain permission from the copyright owner. For more information go to: http://fairuse.stanford.edu/Copyright_and_Fair_Use_Overview/chapter9/index.html,