August 25, 2011

NIH Revises Financial Conflict of Interest Regulations

The Department of Health and Human Services has issued a final rule, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” that revises the regulations on disclosing and reporting conflicts of interest. The final rule amends the PHS regulations issued in 1995 “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” and “Responsible Prospective Contractors.”

The new regulations maintain the general framework of the 1995 regulations, but make some significant changes.

In particular, the new regulations:
  • Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
  • Lower the monetary threshold at which significant financial interests 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 how they are being managed.
  • Require institutions to make certain information accessible to the public concerning identified financial conflicts of interest held by senior/key personnel.
  • Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.
Institutions applying for or receiving National Institutes of Health or other PHS funding from a grant, cooperative agreement, or contract that is covered by the final rule must be in full compliance with all of the revised regulatory requirements by August 24, 2012. In the interim, or until the institutional financial conflict of interest policy is revised and published, institutions should continue to comply with the 1995 regulations.

The UC Office of the President and the UC campuses will be working on revising UC policy for disclosure of financial interests, and UC Berkeley policy and procedures will be changed accordingly and available on the UC Berkeley Conflict of Interest web site.