On August 25, 2011, the Department of Health and Human Services 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 amends financial conflict of interest regulations that were issued in 1995. 

The new ruling, which went into effect on August 24, 2012, involves investigator disclosures of financial conflict of interest for all research funded by the Public Health Service (PHS) —including NIH grants and cooperative agreements. 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 concerning senior/key personnel.
• Require investigators to complete training related to the regulations and their institution's financial conflict of interest policy.

In order to fully comply with the new regulations, GBMC created a new "Policy on Financial Conflicts of Interest in Public Health Service Funded Research" and "Financial Conflict of Interest Disclosure Statement for Projects Funded by the Public Health Service (PHS) including NIH" form. 

All investigators must complete the above-mentioned financial conflict of interest disclosure form and required training before submitting a funding proposal to any PHS agency or non-PHS agency using the PHS financial conflict of interest regulations. Disclosure statements must then be updated annually and within 30 days of a change in financial status. Investigators must undergo re-training every four years. 

For additional information, please contact the IRB Office staff.