Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution's financial interests in human subjects research.

The AAMC Task Force on Financial Conflicts of Interest in Clinical Research issued this report, the second of two, in October 2002. (The first report is also published in this issue of Academic Medicine.) This report offers a unique perspective on the new phenomenon of "institutional" conflicts of interest. The task force acknowledges the diverse obligations of academic institutions that conduct research and also invest in-and accept the philanthropy of-commercial research sponsors. The task force emphasizes the importance of disclosing institutional financial interests as an integral part of the research process, critical to allaying public concerns, and to strengthening the trust relationship between research subjects, the public and the scientific community. The task force found that the safety and welfare of research subjects and the objectivity of the research could be-or could appear to be-compromised whenever an institution holds a significant financial interest that may be affected by the outcome of the research. Thus, the task force recommends separating the functional and administrative responsibilities related to human subjects research from those related to investment managing and technology licensing, and encourages the establishment of institutional conflicts-of-interest committees. As in the first report, the task force recommends that institutions should develop policies establishing a rebuttable presumption against the conduct of research at or under the auspices of an institution where potential conflicts in human subjects research are identified. This presumption against engaging in the research is to be balanced against compelling circumstances in favor of the conduct of the proposed research activity.