Washington D.C.-The Association of American Medical Colleges (AAMC) today released the first report of its Task Force on Financial Conflicts of Interest in Clinical Research-"Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Interests in Research." The guidelines propose that institutions adopt high standards for the reporting, review, and disclosure of researchers' financial interests in federally funded and privately sponsored human subjects research.

"The committee members on our task force, who represented a wide variety of constituencies, wrestled with developing practical guidelines for those engaged in research involving human beings," said William Danforth, M.D., task force chair, and chancellor emeritus of Washington University. "I am confident that our recommendations will offer institutions a blueprint for protecting the interests of patients and their families while allowing important research to proceed."

The key focus of report is the recommendation that academic institutions presume that a "financially interested individual"-defined in the report as any researcher holding a significant financial interest in human subject research-may not conduct the research in question. The researcher may rebut this presumption only by demonstrating to a reviewing body that he or she has compelling reasons for doing so. Consequently, the report recognizes that each case of potential financial conflict of interest in research must be closely examined on its merits. To help achieve this goal, the task force recommends that academic institutions appoint a standing Conflicts of Interest committee responsible for:

• Reviewing requests made by financially interested individuals to conduct the research in question

• Documenting its subsequent findings in a summary report of its recommendations

• Sharing those findings with the appropriate Institutional Review Board and other responsible institution officials, and

• Specifying the monitoring procedures under which a financially interested individual will be permitted to conduct human subjects research.

The guidelines underscore the necessity, whenever they are present, of disclosing financial interests in human subjects research to participants, in publications, and in presentations of the research findings.

David Korn, M.D., senior vice president of AAMC's Division of Biomedical Health Sciences Research, emphasized that the new guidelines respect institutional autonomy and flexibility. "This report permits an institution to adopt even more stringent policies, and it in no way is meant to inhibit or impede productive relationships between academic medical research and the private sector," he said. "We do not wish to stifle the entrepreneurial spirit that spurs medical innovation; rather, we are attempting to create research relationships that are principled and will withstand public scrutiny."

In the coming year, the AAMC Task Force on Conflicts of Interest in Clinical Research will work to develop guidelines to monitor institutional financial interest in human subjects research.

"Protecting Subjects, Preserving Trust and Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Research" can be downloaded at www.aamc.org/coitf

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The Association of American Medical Colleges is a not-for-profit association representing all 129 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 68 Department of Veterans Affairs medical centers; and 94 academic and scientific societies. Through these institutions and organizations, the AAMC represents 109,000 faculty members, 67,000 medical students, and 104,000 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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