Biomedical Research

HHS Direction Needed to Address Financial Conflicts of Interest Gao ID: GAO-02-89 November 26, 2001

Financial relationships between individual investigators or their research institutions and private industry have yielded significant results, including treatments for such diseases as AIDS and strokes. However, some collaborations have raised concerns that the focus on financial reward might compromise the integrity of the research and the safety of human research subjects. GAO reviewed five universities with broad policies and procedures on financial conflicts of interest. All five had difficulty providing basic data on individual investigators' financial conflicts of interest in clinical research involving human subjects. The universities acknowledged a need for better coordination of information on investigators' financial relationships, and several universities were developing ways to do so. Policies and procedures at the five universities addressed financial conflicts of interest affecting institutions, including technology transfer activities and financial relationships with small start-up companies that market products developed by the universities. The Department of Health and Human Services has had limited success in promoting the integrity of biomedical research and protecting human subjects. HHS has taken steps to improve its oversight and monitoring and has drafted guidance on financial conflicts of interest, but this guidance does not provide detailed advice on how to manage institutional conflicts of interest.

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