COGR: NIH Release Conflict of Interest (8/30/2011)

The National Institutes of Health (NIH) reported on August 23, 2011 the release of the final financial conflicts of interest (FCOI) regulations – formally entitled Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors ((42 CFR Part 50 and 45 CFR Part 94). The final regulations are scheduled to appear in the Federal Register on Thursday, August 25.  A copy of the final regulations, a side-by-side comparison of the current 1995 regulations and the changes, the NIH Guide notice (which includes the side-by-side) as well as other information is available on the NIH website at: http://grants.nih.gov/grants/policy/coi/ .  Institutions will be required to implement the new regulation within 365 days of its publication in the Federal Register.  In the interim (between release and the implementation date), institutions will be required to follow the current 1995 regulations. 
 
Briefly, some notable changes:

·         The proposed required website posting of identified financial conflicts of interest has been modified.  Public accessibility is required either through a website or in a written response to a requestor within five business days of a request. 
·         The de minimis threshold is set at $5,000 for disclosures by investigators to their institutions of remuneration for services or equity interest in a publicly traded company with a $0 de minimis for disclosure of equity in a non-publicly traded company.
·         Disclosures of significant financial interests by the investigator to the institution are related to an investigator’s institutional responsibilities which are to be defined in the institution’s policy. 
·         An initial training is required before engaging in PHS funded research with training repeated at least every four years.

NIH is expected to post a Frequently Asked Questions (FAQ) to its website shortly.  If you have questions, you may consider posing those questions to NIH at FCOICompliance@mail.nih.gov

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