Jessica L. O'Hara
The US Department of Health and Human Services (HHS) issued an amendment Wednesday, July 21, 2010, to its May 21 notice of proposed rulemaking regarding financial conflicts of interest (FCOI). The regulations put forth in May proposed significant changes in how institutions and investigators funded by the National Institutes of Health (NIH) and other Public Health Service (PHS) agencies disclose, report, and manage FCOI, including requiring institutions to provide the awarding agency significant additional information on identified FCOI and how they are being managed as well as lowering the monetary threshold at which interests require disclosure from $10,000 to $5,000. The previous July 20 deadline for comments on the proposal has been extended to August 19.
According to the amendment, since the release of the notice, HHS has received questions concerning the authorities that exist under the current regulations and the proposed revisions that permit the HHS Public Health Service (PHS) to enforce compliance by institutions and investigators. The amendment seeks additional comment on:
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“How the regulations apply in circumstances in which an investigator or a PHS-funded research project transfers from one institution to another, or in which a new institution, and investigators at the new institution, become involved in an ongoing PHS-funded research project (e.g., where the new institution becomes a subgrantee on the project)."
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“Whether the proposed changes to the regulations’ references to the enforcement authorities available to the PHS, including those discussed above, should be further revised and clarified in the regulations."
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“Whether regulations should include one or more descriptions of specific measures that the Department, including a PHS awarding component, may initiate as a result of particular types of identified FCOI or non-compliance under the regulations.”
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“Whether the regulations should further clarify that, as part of the institution’s FCOI determination process, institutional officials must consider whether an investigator’s [significant financial interest] was previously determined to be a FCOI and subject to a management plan with regard to other PHS-funded research project(s).”
The notice was released in light of concerns raised by Senator Charles Grassley (R-IA), Ranking Member of the Senate Committee on Finance, who has drawn much attention to FCOI in recent years.
Comments may be provided to HHS online via the Federal eRulemaking Portal or through written submission. Additional instructions for submitting comments are available in the notice.