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.
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.
- UC Berkeley Conflict of Interest web site
- NIH OER Financial Conflict of Interest web page
- Federal Register (8/25/2011): Final Rule Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
- NIH Guide Notice (8/23/2011): Issuance of the Final Rule - Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
- Sally Rockey NIH blog post: Charting a Renewed Course for Managing Financial Conflicts of Interest
- NIH news (8/23/11): HHS Tightens Financial Conflict of Interest Rules for Researchers