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Spotlight on HHS FCOI Regulation Changes

December 2011

In August, 2011, the U.S. Department of Health and Human Services (HHS) issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). An Institution applying for or receiving NIH funding from a grant, cooperative agreement, or contract must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e. August 24, 2012.

This regulation aims to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants, cooperative agreements, and contracts will be free from bias resulting from Investigator financial conflicts of interest.

Major changes to the previous  regulations from 1995 include:
• Lower financial disclosure thresholds ($5000 minimum threshold)
• New conflict of interest training (every 4 years for investigators receiving PHS funds)
• New public accessibility requirements
• Increased transparency for travel reimbursement

The Rockefeller University is in the process of creating implementation plans to comply with the revised regulations here on campus, so stay tuned for additional details in the coming months.

NIH Financial Conflict of Interest Information (FCOI)
NIH FCOI Webinar
Summary of Major Changes 

All SR-PD Spotlights

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