U.S. Department of Health and Human Services issues final rule on investigator financial conflicts of interest in Public Health Service funded research

On August 25, 2011 the Department of Health and Human Services (HHS) published a final rule amending its long-standing regulations on financial conflicts of interest in Public Health Service (PHS) funded research. 76 Fed. Reg. 53,256 (August 25, 2011). The new rule, titled "Promoting Objectivity in Research," adopts the majority of changes proposed in the HHS Notice of Proposed Rulemaking (NPRM), issued on May 21, 2010. 75 Fed. Reg. 28,688 (May 21, 2010). For the majority of institutions that conduct PHS-funded research, including research under National Institutes of Health (NIH) grants and contracts, the new rule will require revision of institutional policy and disclosure forms. Institutions will likely face increased administrative burden associated with the rule's enhanced reporting obligations, public accessibility requirements, new training components, and enhanced subrecipient-monitoring responsibilities. To help institutions take needed steps to comply with the revised regulations, HHS is developing guidance materials, that will be accessible on NIH's Financial Conflicts of Interest website.

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