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NIH updates COI Regs

NIH strengthens existing regulations on managing
financial conflicts of interest, affecting all investigators
seeking public health service funding

The U.S. Department of Health and Human Services (HHS) has issued a final rule that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).

The changes focus on Investigators’ disclosure requirements of significant financial interests (SFIs), Institutions’ reporting and management of identified financial conflicts of interest (FCOI), and public disclosure of information regarding Investigator FCOI.    The changes include clarification of how the regulations apply in circumstances in which an Investigator or a PHS-funded research project transfers from one Institution to another.   They also mandate each investigator to undertake COI training at their institution.

To learn about the specific changes, you may

All institutions applying for PHS funding must be in full compliance no later than August 24, 2012.  Additional information regarding the implementation of these new regulations by ETSU, including availability of training and revised procedures for reporting significant financial interest, will be communicated in early 2012. 

For more information:

Questions?  E-mail ORSPA at .

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