http://content.nejm.org/cgi/content/short/343/22/1616

Conflict-of-Interest Policies for Investigators in Clinical Trials

Bernard Lo, M.D., Leslie E. Wolf, J.D., M.P.H., and Abiona Berkeley, J.D.

ABSTRACT

Background There is substantial concern that financial conflicts of interest on the part of investigators conducting clinical trials may compromise the well-being of research subjects.

Methods We analyzed policies governing conflicts of interest at the 10 medical schools in the United States that receive the largest amount of research funding from the National Institutes of Health. These institutions are Baylor College of Medicine, Columbia University College of Physicians and Surgeons, Harvard Medical School, Johns Hopkins University School of Medicine, the University of Pennsylvania School of Medicine, the University of California at Los Angeles School of Medicine, the University of California at San Francisco School of Medicine, the University of Washington School of Medicine, Washington University School of Medicine at St. Louis, and Yale University School of Medicine.

Results All 10 universities required that faculty members disclose financial interests to university officials. Only four required disclosure by all members of the research staff. Five universities required disclosure of all financial interests, even though federal regulations specify a threshold for disclosure. Six universities required disclosure to the institutional review board as well as to a committee on conflicts of interest or a university official. Four universities had stricter requirements for investigators conducting clinical trials than required by federal regulations. One university prohibited investigators from having stock, stock options, consulting agreements, or decision-making positions involving a company that sponsored the research. A second university prohibited researchers from trading stock or stock options in a company that sponsored the research or sold the product or device under study. Two universities ordinarily did not allow faculty members to participate in clinical research if they had what federal regulations refer to as a "significant" financial interest in the company owning the product or device being studied, but exceptions were allowed.

Conclusions Policies governing conflicts of interest at leading medical schools in the United States vary widely. We suggest that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research. Of the 10 medical schools we studied, only 1 had a policy that was close to this standard.

Source Information

From the Program in Medical Ethics (B.L., L.E.W.), the Center for AIDS Prevention Studies (B.L., L.E.W.), the Division of General Internal Medicine (B.L., L.E.W.), and the Office of Student Affairs (A.B.), University of California at San Francisco, San Francisco.

Address reprint requests to Dr. Lo at bernie@medicine.ucsf.edu.

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