A national survey of policies on disclosure of conflicts of interest in biomedical research

Background: Conflicts of interest pose a threat to the integrity of scienti fic research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other res earch institutions report the existence of conflicts of interest to the fun ding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. Methods: We surveyed all medical schools (127) and other research instituti ons (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 jo urnals in basic science and clinical medicine; and 17 federal agencies in o rder to analyze their policies on conflicts of interest. Results: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent) -- 5 medical schools and 10 other researc h institutions -- reported that they had no policy on conflicts of interest . Among the institutions that had policies, there was marked variation in t he definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual inc ome or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had polic ies requiring disclosure to funding agencies, only 7 percent had such polic ies regarding journals, and only 1 percent had policies requiring the discl osure of information to the relevant institutional review boards or to rese arch subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. Conclusions: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation , combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the curr ent standards may not be adequate to maintain a high level of scientific in tegrity. (N Engl J Med 2000;343:1621-6.) (C) 2000, Massachusetts Medical So ciety.