by Council on Governmental Affairs, Association of Public and Land-grant Universities, August 24, 2011

On August 23, the Department of Health and Human Services (HHS) issued thefinal rule on management of financial conflicts of interest of extramural research investigators, which includes NIH funded researchers. According to the NIH, the revised regulations institute a more rigorous approach and include changes to address investigator disclosure, institutional management of financial conflicts of interest, and federal oversight. In particular, the regulations:

• Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities as opposed to only those that they see as related to Public Health Service (PHS)-supported research.
• Lower the monetary threshold for disclosure of significant financial interests, generally from $10,000 to $5,000.
• Require institutions to report to the PHS awarding component more comprehensively on identified financial conflicts of interest and how they are being managed.
• Require institutions to make certain information concerning identified financial conflicts of interest held by senior/key personnel accessible to the public.
• Require investigators to be trained on the regulations and their institution’s financial conflict of interest policy at designated times.

Institutions and investigators will have one year to comply with the changes. For details please see the final rule for the exact language. The NIH Financial Conflict of Interest website also offers further information including a side-by-side comparison of the 1995 (current regulations) and new 2011 regulations.