An Issue of Trust: Addressing Conflicts of Interest in Research

Reports of widespread conflicts of interests have raised questions about the integrity of biomedical research. Investigators' financial conflicts of interest have been alleged to compromise participant safety in clinical trials. Similarly, reports that senior NIH scientists may have extensive and unreported consulting relationships with for-profit companies have raised concerns that these commercial ties influence NIH policies. These allegations may undermine public trust in and support research. Government responses have included Congressional hearings and an NIH conference on conflicts of interests. In addition, stricter guidelines about conflicts of interest by investigators and NIH scientists have been recommended.

Although the focus has been on financial conflicts of interest, a broader view of conflicts of interests in research is needed. Non-financial conflicts of interest may compromise the independence and integrity of research oversight bodies, such as institutional review boards and data safety monitoring boards. However, little is known about how these research oversight bodies address conflicts of interests among their membership.

Dr. Wolf will describe the results of her study of IRB conflicts of interest policies. This empirical study involves a content analysis of IRB conflicts of interest policies for the 121 U.S. medical schools that receive NIH research funding. Findings identify gaps in who is covered by these policies, how conflicts of interests are defined, and what actions are required when a conflict exist. Preliminary data from a content analysis of DSMB conflicts of interest policies support these findings. The findings suggests ways for better addressing these conflicts of interest in research.

Leslie E. Wolf, J.D., M.P.H., is an Assistant Professor in the Program in Medical Ethics and the Center for AIDS Prevention Studies at the University of California, San Francisco. She is a graduate of Stanford University, Harvard Law School, and the Johns Hopkins School of Public Health.