FOR IMMEDIATE RELEASE
June 8, 2000

Contact: Josh Freed
(202) 225-4431

“HUMAN RESEARCH PROTECTION ACT OF 2000” UNVEILED TODAY

WASHINGTON, DC — Rep. Diana DeGette (D-CO) introduced bipartisan legislation today to provide critical patient protections for citizens involved in medical research projects. Rep. DeGette introduced the legislation at a Capitol Hill press conference with the bill’s co-authors, Rep. Henry Waxman (D-CA) and Rep. John Mica (R-FL).

“This legislation is the first comprehensive reexamination of the regulations that govern human medical research in more than 19 years and it is long over due,” said Rep. DeGette. “As medical research facilities around the nation embark on improving their human subject protections, it is critical that the federal government live up to its responsibility to ensure patient protections.”

Endorsing the new legislation at the press conference were: Dr. Jonathan Moreno, a leading bioethicist, panelist for the Advisory Committee on Human Radiation Experiments, and author of Undue Risk: Secret State Experiments on Humans; Dr. Kay Perrin, a leading advocate for human research protections stemming from her experience in uncovering abuses at the University of South Florida in the early 1990’s; and, Dr. Jordan J. Cohen, President of the Association of American Medical Colleges and a national expert on medical research.

The bill addresses current problems in medical research by increasing funding for the Office for Protection of Human Subjects and establishing standards for research institutions around the country. The legislation has four main objectives: 1) Expanding human subject protections to all Americans; 2) Improving the education and training of investigators and Institutional Review Board (IRB) members in human subject protections; 3) Improving the informed consent process; and, 4) Expanding resources to IRBs to thoroughly and appropriately review all human subject research.

Representative DeGette’s attention was drawn to this issue last year when the Food and Drug Administration shut down medical research programs at the University of Colorado Health Sciences Center. The Health Sciences Center, which is one of our nation’s crown jewels in medical research, had not adequately addressed the situation that its Institutional Review Board was overwhelmed by a rapid increase in public and private research projects. The university has since taken many steps to ensure patient protections in all of its research programs.

Nationally, recent failures in the protection of human research subjects, including in gene therapy experiments, have weakened public confidence in medical research. The National Bioethics Advisory Commission and the Advisory Committee on Human Radiation Experiments have strongly supported the need for comprehensive reforms and stronger oversight of human research subject protections. Despite their recommendations and the explosive growth in medical research, the Human Research Subject Protections Act of 2000 is the first effort at comprehensive reform in almost 20 years.
 
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