United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2001-11-26 monographic deposited born digital GA 1.13:GAO-02-89 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-02-89 P0b002ee1803822db f:d0289 DGPO 2010-08-12 2011-03-24 GAOREPORTS-GAO-02-89 machine generated eng fdlp REPORT GAOREPORTS-GAO-02-89 GAO-02-89 Biomedical research Colleges and universities Conflict of interests Federal regulations Safety Other Written Product A02485 Recent allegations that conflicts of interest may have affected biomedical research and led to harming human research subjects have heightened concerns about the financial relationships between individual research investigators or their research institutions and private industry. These financial partnerships have yielded significant achievements, notably treatments for diseases and conditions such as acquired immunodeficiency syndrome (AIDS) and strokes. Their benefits notwithstanding, some collaborations have raised concerns that research investigators or institutions with significant financial interests in the research may focus attention on the financial rewards, compromising their integrity and the safety of human subjects. In such situations, the significant financial interest presents a conflict of interest. GAO reviewed five universities which have developed broad policies and procedures regarding individual investigators' financial conflicts of interest. All five had difficulty providing basic data on investigators' financial conflicts of interest in clinical research involving human subjects. The universities acknowledged a need for better coordination of information about investigators' financial relationships, and several of the universities were developing mechanisms to do so. Policies and procedures at the five universities addressed aspects of institutional financial conflicts of interest, such as technology transfer activities and financial relationships with small start-up companies that market university-developed products. However, Department of Health and Human Services (HHS) regulations and its oversight of financial conflicts of interest in biomedical research have limitations for promoting the integrity of research and protecting human subjects. Recently, HHS has taken steps to improve its oversight and monitoring. Further, HHS has drafted guidance on financial conflicts of interest. However, this guidance does not provide detailed advice on managing institutional financial conflicts of interest. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-02-89/html/GAOREPORTS-GAO-02-89.htm GAO-02-89 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-02-89 Other Written Product GAO-02-89; Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest; Biomedical research Colleges and universities Conflict of interests Federal regulations Safety Public Law 96-517