HHS has regulations on individual investigator financial interests in federally funded or regulated research. The universities generally acknowledged a need for better coordination, and several of the universities told us they were taking steps to develop these linkages. As part of our study, we asked the five universities to provide some basic data on investigators’ financial conflicts of interest in clinical research involving human research subjects. Although Not Required, Universities Had Policies and Procedures That Addressed Aspects of Institutional Financial Conflicts of Interest

While there are no federal regulations or guidelines on institutional financial conflicts of interest or how to manage them, the universities we visited had policies and procedures that addressed aspects of these issues, such as the management of investment funds, technology transfer activities, use of licensing income, and the acceptance of equity in start-up companies. Current Regulations and Oversight Have Limitations for Promoting Research Integrity and Human Subjects Protection

In our review, we identified limitations with the HHS regulations and oversight of financial conflicts of interest in biomedical research that have implications for promoting the integrity of research and protecting human research subjects. However, this guidance does not provide detailed advice on managing institutional financial conflicts of interest. HHS’ Draft Interim Guidance on Financial Conflicts of Interest Is Promising but Limited With Regard to Institutional Conflicts

In December 2000 HHS developed draft guidance entitled “Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing With Issues of Financial Interests and Human Subject Protection: Draft Interim Guidance.” This guidance drew on information obtained at a conference HHS held in August 2000 on financial conflicts of interest in clinical research and comments it received.
Why GAO Did This Study

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.

What GAO Found

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.