The US Department of Health and Human Services (HHS) has issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing and ultimately avoiding investigators' financial conflicts of interest. Staff from the National Institutes of Health worked with others in HHS to revise the 1995 regulations to update and enhance the objectivity and integrity of the research process.
Major changes to the regulations include the definition of significant financial interest (SFI), the extent of investigator disclosure, the information reported to the Public Health Service (PHS) awarding component, the information made accessible to the public, and investigator training.
The revised regulations require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities. Institutions are required to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed. Further, the revised regulations require institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel; and lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000. It also requires investigators to complete training related to the regulations and their institution's financial conflict of interest policy.
Additional details about the major changes to the regulations can be found at: http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf.
The regulations will be implemented no later than 365 days after publication of the final rule in the Federal Register.
The 1995 regulations were revised after a review of public comments from the advance notice of proposed rulemaking and the notice of proposed rulemaking. The final rule amends the PHS regulations "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought" and "Responsible Prospective Contractors".
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