The U.S. Department of Health and Human Services recently published its final rule governing financial conflicts of interest involving investigators conducting Public Health Service (PHS)-supported research. Although similar to the financial conflict of interest regulations promulgated in 1995 that it amends, the 2011 FCOI Regulation contains several modifications that will have a meaningful impact on the conflict of interest compliance programs at grantee organizations.

On August 25, 2011, the U.S. Department of Health and Human Services (HHS) published its final rule governing financial conflicts of interest involving investigators conducting Public Health Service (PHS)-supported research (the 2011 FCOI Regulation), “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors.” 76 Fed. Reg. 53,256 (Aug. 25, 2011) (to be codified at 42 C.F.R. pts. 50 & 94). Although there are significant similarities between the 2011 FCOI Regulation and the financial conflict of interest regulations promulgated in 1995 (the 1995 FCOI Regulation) that it amends, the 2011 FCOI Regulation contains several modifications that will have a meaningful impact on the conflict of interest compliance programs at grantee organizations. These changes constitute the first major revision to the 1995 FCOI Regulation, and are the result of more than two years’ work since the Advance Notice of Proposed Rulemaking was announced by National Institutes of Health (NIH) on May 8, 2009.