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## Roy Bercaw's Citizen's Bill - Massachusetts

Cambridge, MA writer and researcher, Roy Bercaw, wrote this bill, which was filed with the Massachusetts state legislature. It addresses the need for protection from criminal medical experimentation. Hearings are scheduled for May 13, 1999 before the Health Care Committee.

     1 Citation of Chapter
         This chapter shall be known and may be cited as the Protection
    of Human Subjects in Experimentation Act.
     2 Findings and Declarations
         Medical experimentation benefits mankind, however such
    experimentation on human subjects shall be undertaken with due
    respect to the preciousness of human life and the right of
    individuals to determine what is done to their own bodies.
         (a) The Nuremberg Code of Ethics in Medical Research was
    issued in 1943 after the Doctor's Trial of Nazi doctors for
    unethical use of human beings in medical experiments; subsequently,
    the Declaration of Helsinki established recommendations guiding
    doctors in experimentation involving human subjects. 55 years after
    the Nuremberg Code was written there are still no penalties for non
    compliance with federal laws on human experimentation.
         (b) Neither the Nuremberg Code nor the Declaration of Helsinki
    are codified under law and are, therefore, unenforceable. Persons
    are being irreparably harmed and the researchers are not being held
    accountable for their actions.
         (c) Medical experiments must be done in such a way as to
    protect the rights of the human subjects involved.
         (d) There is, and will continue to be a growing need for
    protection for citizens of the Commonwealth from unauthorized,
    needless, hazardous, or negligently performed medical experiments
    on human beings.
         This chapter provides minimum statutory protections for the
    citizens of the Commonwealth with regard to human experimentation
    and provides penalties for those who violate such provisions.
     3 Experimental subject's bill of rights; contents
         As used in the chapter, "experimental subject's bill of
    rights," means a list of the rights of a subject in a medical
    experiment, written in a language in which the subject is fluent.
    Except as otherwise provided in  7, this list shall include, but
    not be limited to the subject's right to:
         (a) Be informed of the nature and purpose of the experiment.
         (b) Be given an explanation of the procedures to be followed
    in the medical experiment, and any drug or device to be utilized.
         (c) Be given a description of any attendant discomforts and
    risks reasonably to be expected from the experiment.
         (d) Be given an explanation of any benefits to the subject
    reasonably to be expected from the experiment, if applicable.
         (e) Be given a disclosure of any appropriate alternative
    procedures, drugs or devices that might be advantageous to the
    subject, and their relative risks and benefits.
         (f) Be informed of the avenues of medical treatment, if any,
    available to the subject after the experiment if complications
    should arise.
         (g) Be given an opportunity to ask any questions concerning
    the experiment or the procedures involved.
         (h) Be instructed that consent to participate in the medical
    experiment may be withdrawn at any time and the subject may
    discontinue participation in the medical experiment without
    prejudice.
         (i) Be given a copy of the signed and dated written consent
    form as provided for by  4 or  9.
     4 Informed consent
         As used in this chapter, "informed consent" means the
    authorization given pursuant to  6 to have a medical experiment
    performed after each of the following conditions have been
    satisfied:
         (a) The subject is provided with a copy of the experimental
    subject's bill or rights, prior to consenting to participate in any
    medical experiment, containing all the information required by  3
    and such copy is signed and dated by the subject as specified in
    6.
         (b) No person who suffers from any mental disability shall be
    allowed to be used for any medical experiment under any conditions.
    Any violation of this section by any professional licensed by the
    Commonwealth will result in an automatic suspension of that license
    for life.
         (c) Any person who participates in a human experiment on a
    person with a mental disability shall be subject to criminal
    penalties consistent with the severity of harm done to the person
    with a mental disability as stated in other codes and statutes in
    effect at the time of the experiment.
         (d) A written consent form is signed and dated by the subject
    as specified in  6.
         (e) The subject as specified in  6, is informed both verbally
    and within the written consent form, in nontechnical terms and in
    a language in which the subject as specified in  6, is fluent, of
    the following facts of the proposed medical experiment which might
    influence the decision to undergo the experiment, including but not
    limited to:
         (1) An explanation of the procedures to be followed in the
    medical experiment and any drug or device to be utilized, including
    the purposes of such procedures, drugs or device. If a placebo is
    to be administered or dispensed to a portion of the subjects
    involved in a medical experiment, all subjects of such experiment
    which shall be informed of such fact, however, they need not be
    informed as to whether they will actually be administered or
    dispensed a placebo.
         (2) A description of any attendant discomfort and risks to the
    subject reasonably to be expected.
         (3) An explanation of any benefits to the subject reasonably
    to be expected, if applicable.
         (4) A disclosure of any appropriate alternative procedures,
    drugs or devices that might be advantageous to the subject, and
    their relative risks and benefits.
         (5) An estimate of the expected recovery time of the subject
    after the experiment.
         (6) An offer to answer any inquiries concerning the experiment
    or the procedures involved.
         (7) An instruction to the subject that he or she is free to
    withdraw his prior consent to the medical experiment and to
    discontinue participation in the medical experiment at any time,
    without prejudice to the subject.
         (8) The name, institutional affiliation, if any, and address
    of the person or persons actually performing and primarily
    responsible for the conduct of the experiment.
         (9) The name of the sponsor or the funding source, if any, or
    manufacturer if the experiment involves a drug or device, and the
    organization, if any, under whose general aegis the experiment is
    conducted.
         (10) The name, address, and phone number of an impartial third
    party, not associated with the experiment, to whom the subject may
    address complaints about the experiment.
         (f) Consent is voluntary and freely given by the human subject
    as specified by  6, without the intervention of any element of
    force, fraud, deceit, duress, coercion, or undue influence.
     5 Medical experiment
         As used in this chapter, "medical experiment" means:
         (a) The severance or penetration or damaging of tissues of a
    human subject or the use of a drug or device, as defined in  11
    or  10, electromagnetic radiation, pulsed microwaves, lasers,
    ultra sound, radar, thermal imaging, heat or cold, radio waves,
    sound or a biological substance or organism, in or upon a human
    subject in the practice or research of medicine in a manner not
    reasonably related to maintaining or improving the health of such
    subject or otherwise directly benefiting such subject.
         (b) This prohibition includes psychologists exercising extra
    legal control over human subjects using above-mentioned devices
    drugs and technology for non-invasive psychological conditioning
    and/or legal experimentation.
         (c) The investigational use of a drug or device.
         (d) Withholding medical treatment from a human subject for any
    purpose other than maintenance or improvement of the health of the
    subject.
     6 Informed consent
         (a) Except as otherwise provided in this section, no person
    shall be subjected to any medical experiment unless the informed
    consent of such person is obtained.
         (b) If a person is under a conservatorship as provided by any
    provision of any probate codes or statutes, or if he suffers from
    any mental disability or has ever suffered from a mental disabili-
    ty, or if he is developmentally disabled, he may not under any
    conditions or circumstances be used for any medical experiments.
         (d) Informed consent given by a person other than the human
    subject shall not be valid to fulfill the requirements of this
    chapter.
     7 Violations; damages; penalties; waiver of rights

         (a) Any person who is primarily responsible for conduct of a
    medical experiment and who negligently allows such experiment to be
    conducted without a subject's consent, as provided in this chapter,
    shall be liable to such subject in an unlimited amount of money
    damages as determined by a court.
         (b) Any person who is primarily responsible for the conduct of
    a medical experiment and who willfully fails to obtain the
    subject's informed consent, or obtains consent under deceptive acts
    as provided in this chapter, shall be liable to such subject in an
    unlimited amount of money damages and imprisonment as determined by
    a court.
         (c) In keeping with the tradition of the survivors of the Nazi
    Holocaust, there shall be no statute of limitations for bringing
    tort and criminal actions against violators of this chapter.
         (d) Any person who is primarily responsible for the conduct of
    a medical experiment and who willfully fails to obtain the
    subject's informed consent, or obtains consent under deceptive acts
    as provided in this chapter, and thereby exposes a subject to a
    known substantial risk of serious injury, either bodily harm or
    psychological harm shall be guilty of a felony punishable by
    imprisonment in state prison for a period not to exceed life
    imprisonment without parole, or a fine of one hundred million
    dollars ($100,000,000) or both.
         (e) Any representative or employee of a pharmaceutical
    company, who is directly responsible for contracting with another
    person for the conduct of a medical experiment, and who has
    knowledge of risks or hazards with respect to such experiment, and
    who willfully withholds information of such risks and hazards from
    such person contracting for the conduct of the medical experiment,
    and thereby exposes a subject to substantial risk of serious
    injury, either bodily harm or psychological harm, shall be guilty
    of a felony punishable by imprisonment in state prison for a period
    not to exceed life imprisonment without parole or a fine of one
    hundred million dollars ($100,000,000) or both.
         (f) Each and every medical experiment performed in violation
    of any provision of this chapter, is a separate and actionable
    offense.
         (g) Any attempted or purported waiver of the rights guaran-
    teed, or requirements prescribed by this chapter, whether by a
    subject or any other person, as specified in  6, is void.
         (h) Nothing in this section shall be construed to limit the
    right of an injured subject to recover damages under any other
    applicable law.
     8 Law governing
         The provisions of this chapter shall not supersede, but shall
    be in addition to any criminal statutes, constitutional provisions,
    and laws governing medical abuses in experimentation elsewhere in
    the Massachusetts General Laws and laws of the United States.
     9 Investigators within institutions holding a federal assurance;
    application of chapter.
         This chapter shall apply to any person who is conducting a
    medical experiment within the Commonwealth. That includes inves-
    tigators within an institution which holds an assurance with the
    Department of Health and Human Services pursuant to Part 46 of
    Title 45 of the Code of Federal Regulations. Informed consent in
    the method and manner required by state or federal regulations is
    required, whichever is more strict. Failure to comply with federal
    laws will expose the investigators to state criminal and tort
    liability as provided in this chapter. All provisions of this
    chapter apply to institutional research.
     10 Device
         "Device" means any instrument, apparatus, machine, contriv-
    ance, implant, in vitro reagent, or other similar or related
    article, including any component, part or accessory, that is any of
    the following:
         (a) Recognized in the official National Formulary or the
    United States Pharmacopoeia, or any supplement to them.
         (b) Intended for use in the diagnosis of disease or other
    condition, or in the cure, mitigation, treatment or prevention of
    disease in humans or any other animal.
         (c) Intended to affect the structure of any function of the
    body of humans or any other animal and that does not achieve any of
    its principal intended purposes through any chemical action within
    or on the body of humans or other animals and that is not dependent
    upon being metabolized for the achievement of any of its principal
    intended purposes.
         (d) Any beam or wave generated by a mechanical or electrical
    machine capable of inflicting pain, causing death, affecting the
    thought processes moods or emotions of a human being, or capable of
    disturbing the sleep of a human being or other animal. Firearms
    described in M.G.L. Chapter 140,  131 J, are included in this
    definition.
     11 Drug
         "Drug" means any of the following:
         (a) Any article recognized in an official compendium.
         (b) Any article used or intended for use in the diagnosis,
    cure, mitigation, treatment or prevention of disease in human
    beings or any other animal.
         (c) Any article other than food, that is used or intended to
    affect the structure or any function of the body of human beings or
    any other animal.
         (d) Any article used or intended for use as a component of any
    article designated in subdivision (a), (b), (c) of this section.
         The term "drug" does not include any device.
         Any food for which a claim, (as described in Sections
    403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(3)  (21
    U.S.C. Sec. 343(r)(3) or Sections 403(r)(1)(B) (21 U.S.C. Sec.
    343(r)(1)(B)) and 403(r)(1)(B)) and 403(r)(5)(D) (21 U.S.C. Sec.
    343(r)(5)(D)) of the federal act), is made in accordance with the
    requirements set forth in Section 403(r) (21 U.S.C. Sec. 343(r)) of
    the federal act, is not a drug under subdivision (b) solely because
    the label or labeling contains such a claim.
                                 - END -

         Proposed and submitted to the Massachsuetts General Court,
    House of Representatives on December 2, 1998, by
                                       Roy Bercaw
                                       Porter Square PO Box 400297
                                       Cambridge MA 02140 USA
                                       617-499-7965
                                       e-mail: roybercaw@hotmail.com

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