June 01, 2010

NIH Seeks Comments on Proposed Changes to Financial Conflict of Interest Regulations

The Department of Health and Human Services issued a Notice of Proposed Rulemaking in the May 21 Federal Register requesting public comment on the proposed changes to the Public Health Service (PHS) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors. The National Institutes of Health is accepting comments on behalf of the PHS; comments must be received by July 20, 2010.

NIH Director Francis Collins stated in a May 20 press briefing that this “will be a substantial change in the way in which NIH seeks to oversee potential financial conflicts of interest.”

Briefly, the proposed rules would change the threshold for a “significant financial interest” to $5,000 from the current $10,000, and would require institutions to determine if a conflict of interest is significant, report to the NIH or other PHS agency details on how conflicts of interest are being managed, and publish information concerning identified financial conflicts of interests on publicly accessible web sites. See the 26-page Federal Register Notice and other resources for complete information.

July 21 Update

The Department of Health and Human Services has extended the comment period for 30 days to August 19, 2010, to clarify certain elements of the proposed rule for which HHS is seeking additional comment.