U.S. Representative | PRESS RELEASE
Diana DeGette | 1600 Downing St., Suite 550 Denver, Colorado 80218
First Congressional District of Colorado | 1530 Longworth House Office Building Washington, D.C. 20515-0601

FOR IMMEDIATE RELEASE | March 22, 2002
DeGette, Greenwood Introduce Bill to Protect Volunteers in Medical Research "HUMAN RESEARCH PROTECTIONS ACT OF 2002" INTRODUCED TODAY
WASHINGTON, D.C. - U.S. Reps. Diana DeGette (D-CO) and Jim Greenwood (R-PA) introduced legislation today to provide critical patient protections for participants in medical research projects. Reps. DeGette and Greenwood introduced the legislation at a press conference on Capitol Hill.

"With the proliferation of human subject research, it is critical that the federal government live up to its responsibility to protect those people who volunteer for research," said DeGette. "We need to make sure that research is helping people, not hurting them." She added that the bill is not intended to halt or hinder research, but to ensure its safety and effectiveness.

"Medical research, the advancement of science, and the development of new therapies are some of the most important activities that the federal government supports and regulates," Greenwood stated. "Human participation in clinical trials is the lynchpin for introducing these wonderful new therapies into society. Without volunteers, we will not be able to test these new products, to truly determine their safety and efficacy or take existing therapies and see if they work in new and miraculous ways. Our legislation provides the necessary protections for these volunteers."

Key elements of the bill are a requirement that all research involving human subjects, regardless of its funding source, be approved by an Institutional Review Board and the establishment of a research subject's legal right of informed consent.

The Human Research Subject Protections Act of 2002 is a response to the growing demand for human trials for medical research and the lack of governmental regulations. Recent failures in the protection of human research subjects have weakened public confidence in medical research. A recent TIME magazine cover story exposed the patchwork regulatory system and cases in which participants have been harmed. The National Bioethics Advisory Commission and the HHS Office of Inspector General have strongly supported the need for comprehensive reforms and stronger oversight of human research subject protections.

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