On August 23, 2011, the Department of Health and Human Services (HHS) issued a Final Rule updating conflict of interest standards for institutions and investigators seeking or receiving Public Health Service (PHS) funding via federal grant, cooperative agreement, or contract.  The Final Rule modifies and supplements regulations first implemented in 1995, titled “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought” and “Responsible Prospective Contractors,” codified at 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94, respectively.

The National Institutes of Health (NIH) issued a press release detailing some of the major changes to the regulations, which include: revising the definition of significant financial interest (SFI), expanding mandatory investigator disclosure, increasing the amount of information reported to the PHS Awarding Component, making accessible to the public certain conflict of interest information, and mandating certain investigator training.  For example, the new regulations:

  • Require investigators to disclose to their institutions all SFIs related to their institutional responsibilities, in addition to their research responsibilities.
  • Lower the monetary threshold at which SFIs require disclosure, generally from $10,000 to $5,000.
  • Require institutions to report to the PHS Awarding Component additional information on identified financial conflicts of interest and the manner in which they are being managed.
  • Require institutions to make certain information concerning identified SFIs accessible to the public via website or by written response within five business days of a request.
  • Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.

Notably, the Final Rule modified a provision featured in the Proposed Rule (75 Fed. Reg. 28668, May 21, 2010), which would have required all institutions to post investigators’ SFIs on a publicly accessible website.  The Final Rule allows institutions to forgo online publication and requires only that institutions respond to certain individual requests for SFI information within five business days.

Any institution applying for or receiving PHS funding must be compliant with the new regulations no later than August 24, 2012 or immediately upon making its institutional Financial Conflict of Interest policy publicly available, as required by the new regulations.  Until then, institutions and investigators must continue to remain compliant with the 1995 regulations.

The Final Rule can be found here.  The NIH press release regarding the updated conflict of interest rules may be read here.  U.S. Senator Charles Grassley released a statement on August 23, 2011 responding to the publication of the Final Rule; Senator Grassley’s press release is available here.