Conflict-of-interest policies for investigators in clinical trials.

Background: There is substantial concern that financial conflicts of intere st on the part of investigators conducting clinical trials may compromise t he well-being of research subjects. Methods: We analyzed policies governing conflicts of interest at the 10 med ical schools in the United States that receive the largest amount of resear ch funding from the National Institutes of Health. These institutions are B aylor College of Medicine, Columbia University College of Physicians and Su rgeons, Harvard Medical School, Johns Hopkins University School of Medicine , the University of Pennsylvania School of Medicine, the University of Cali fornia at Los Angeles School of Medicine, the University of California at S an Francisco School of Medicine, the University of Washington School of Med icine, Washington University School of Medicine at St. Louis, and Yale Univ ersity School of Medicine. Results: All 10 universities required that faculty members disclose financi al 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 f or disclosure. Six universities required disclosure to the institutional re view board as well as to a committee on conflicts of interest or a universi ty official. Four universities had stricter requirements for investigators conducting clinical trials than required by federal regulations. One univer sity 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 stoc k or stock options in a company that sponsored the research or sold the pro duct or device under study. Two universities ordinarily did not allow facul ty members to participate in clinical research if they had what federal reg ulations refer to as a ``significant'' financial interest in the company ow ning the product or device being studied, but exceptions were allowed. Conclusions: Policies governing conflicts of interest at leading medical sc hools in the United States vary widely. We suggest that university-based in vestigators and research staff be prohibited from holding stock, stock opti ons, or decision-making positions in a company that may reasonably appear t o 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. (N Engl J Med 2000;343:1616-20.) (C) 2000, Massachusetts Medical Society.