Home  Government Affairs   Newsroom   Meetings   Publications	Shopping Cart   Site Map

Contact: Media Relations Officer.

AAMC Statement on HHS Clinical Research Recommendations

Jordan J. Cohen, M.D., President
Association of American Medical Colleges
May 26, 2000

---

The AAMC applauds the Administration's efforts to bolster the existing protections for human participants in clinical research. The Association believes fervently that the health and welfare of all research participants must be the highest priority. Acknowledgment of this fact and scrupulous attention to the enforcement of appropriate safeguards are necessary to preserve trust between participants in clinical research and all those conducting that research. Ultimately, research requiring the participation of human subjects is only possible if clinical research is built on a foundation of mutual respect and trust.

The AAMC supports the general intent of the Administration's efforts and looks forward to further clarification of the recommendations and to further details regarding the standards that will guide their implementation.

The recommendations dealing with education are particularly welcome. Indeed, they are in lockstep with the AAMC's long-standing efforts, which have been intensified over the past year, to familiarize the research community with existing federal oversight regulations. Since last spring, the AAMC has hosted a conference and several oversubscribed workshops to educate and inform academic researchers. In addition, the AAMC has called upon medical schools and teaching hospitals to revisit their institutional conflict-of-interest guidelines to ensure that they are responsive to the contemporary biomedical research environment, and that they are not just policies on paper but programs in action.

Finally, one area that is noticeably absent in the HHS recommendations is the consideration of an IRB accreditation mechanism akin to those that have proved effective in promoting and ensuring the quality of medical practice and research. The AAMC is working with a number of partners to develop such a mechanism that will help researchers and their institutions ensure a safe environment for clinical research. The Association believes this concept merits further discussion and support from all parties involved.