HHS Issues Final Rule Amending Regulations Regarding Investigator Financial Conflicts of Interest Related to Research Funded by PHS


Major Changes Regarding Investigator Disclosures, Obligations of Institutions, and Public Access to Information

The Department of Health and Human Services (HHS) issued a Final Rule on August 25 that amends the 1995 regulations “Responsibility of applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R. Part 50, Subpart F) and “Responsible Prospective Contractors” (45 C.F.R. Part 94). These regulations address financial interests of investigators that relate to research funded by the Public Health Service (PHS). Despite complaints from research institutions regarding the increased administrative burdens created by the proposed amendments, HHS adopted most of the amendments as proposed in the Notice of Proposed Rulemaking. The Final Rule includes major changes to the definition of an investigator’s significant financial interests, including the monetary threshold, the scope of investigator disclosures to their institution, the responsibilities of institutions, and public disclosure of investigator financial conflicts of interest. Although HHS invited comment on addition regulatory provisions to address institutional conflicts of interest, the agency concluded that additional study was needed prior to formulation of such provisions. The Final Rule takes effect on September 24, 2011 and institutions must be in compliance by August 24, 2012.

For the first time, investigators must disclose all significant financial interests (SFI) related to their instititutional responsibilities, and the institution, not the investigator, must make the determination whether the SFI relates to the PHS funded research. Consistent with the current regulations, institutions will then determine if the SFI constitutes a financial conflict of interest (FCOI). The Final Rule also imposes new obligations on institutions regarding investigator training, management of FCOI, and reporting to the PHS awarding component. Institutions must also ensure that information regarding certain FCOI of senior/key research personnel is accessible to the public

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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