AAMC Task Force Issues Report on Institutional Conflicts of Interest in Research
Washington D.C., September 23, 2002—The Association of American Medical Colleges (AAMC) has released the second report of its Task Force on Financial Conflicts of Interest in Clinical Research. The report, "Protecting Subjects, Preserving Trust, Promoting Progress II," proposes a framework for the oversight of financial conflicts of interest at institutions that conduct human subjects research.
Building upon the Task Force's first report, which focused on an individual's financial interests in his or her own research, this second report addresses a research-conducting institution's conflicts of interest, such as a financial relationship with a commercial research sponsor or an indirect financial interest in the outcome of the research project itself.
The report also addresses the financial interests of institutional officials with research oversight responsibilities. "A dean of research, for example, or a department chair, or laboratory director, who might have a financial interest in research being conducted by someone over whom they have direct authority," said David Korn, M.D., senior vice president in the AAMC Division of Biomedical and Health Sciences Research. "The Task Force has highlighted several examples of institutional financial interests in research that should be of especial concern and receive strict scrutiny."
The Task Force's key recommendation is that institutions separate their financial and research management functions as cleanly as possible. According to the report, the welfare of human subjects and the objectivity of the research could be - or reasonably appear to be - compromised whenever an institution holds a significant financial interest that might be affected by the research outcome. The report further recommends that, under some circumstances, human subjects research not be conducted at a conflicted institution, unless compelling circumstances warrant.
The report issues guidelines for establishing "institutional conflict of interest committees" to formally review financial relationships, and to assess the nature and determine the management of any conflict of interest. These committees should include one or more external (or "public") representatives, as well as individuals who have sufficient seniority, expertise, and independence to evaluate the competing interests at stake and make credible recommendations to the institution.
In its report, the Task Force also addresses the responsibility of Institutional Review Board (IRB) members to report financial interests. IRB members, like other institutional officials, should disclose any potential conflicts of interest regarding human subjects research.
"Both of these reports are a major step forward in protecting the safety and retaining the confidence of those who volunteer to participate in clinical research. By offering institutions ethical guidelines that will enhance scrutiny but not inhibit the research process, we can better sustain the public's trust in the research enterprise," said Jordan J. Cohen, M.D., AAMC president.
"The evaluation of financial interests in contemporary human subjects research is often complicated and highly situational, requiring detailed, case by case analysis. We anticipate that the implementation of these guidelines will be a challenging task for research institutions, and one that will take time to complete," said Dr. Korn. "Although we believe that the adoption of these policies and recommendations will contribute greatly to the integrity of the research process, as well as to public confidence, the process will take time. It certainly won't happen overnight."
Chaired by William Danforth, M.D., chancellor emeritus of Washington University at St. Louis, the AAMC Task Force on Financial Conflicts of Interest in Clinical Research is made up of 28 members, representing the academic medical community, clinical investigators, patient representatives, industry, ethicists, law, and the media. The task force's first report, on conflicts of interest for individual researchers, was released in December 2001.
"Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research," is available at www.aamc.org/research/coi
The Association of American Medical Colleges is a not-for-profit association representing all 144 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and nearly 90 academic and scientific societies. Through these institutions and organizations, the AAMC represents 148,000 faculty members, 83,000 medical students, and 115,000 resident physicians. Additional information about the AAMC and U.S. medical schools and teaching hospitals is available at www.aamc.org/newsroom.
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