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AAMC Endorses Bill to Protect Patients In Clinical Research

Jordan J. Cohen, M.D., President
Association of American Medical Colleges
June 8, 2000

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The AAMC endorses the legislation introduced today by Reps. Diana DeGette (D-Colo.), Henry Waxman (D-Calif.), John Mica (R-Fla.) and their colleagues designed to significantly enhance the protections provided to patients involved in clinical research. "The Human Research Subject Protections Act of 2000" includes a number of provisions long advocated by the AAMC as important steps toward ensuring the safety and welfare of all patients.

In particular, the AAMC supports the application of the Common Rule and vulnerable-population protections to all human research subjects independent of setting and funding source and agrees that the HHS Secretary should have the authority to modify these safeguards when necessary.

The AAMC also agrees with the legislation's requirement to educate investigators and institutional review board (IRB) members about human research subject protections. This provision dovetails nicely with the Association's ongoing efforts to educate and inform the research community about existing federal oversight regulations for clinical research.

Finally, the AAMC is very pleased that the bill calls for the accreditation of all IRBs by a nonprofit private entity effective two years after the enactment of the legislation. For the past several months, the AAMC, along with several other organizations, has been assessing the feasibility of creating such a mechanism. We look forward to working with the Congress and HHS to see that this concept becomes a reality.

The legislation introduced today, coupled with the HHS recommendations announced recently and the ongoing efforts on the part of the academic medical community, underscore the need to be diligent in ensuring human subjects protections. At a time of unparalleled promise in clinical research, we must redouble our efforts to create a safe environment for all individuals willing to advance the scientific process through their voluntary participation.