Finally the Final Rule: HHS Issues Long-Awaited Final Rule Revising Public Health Service Conflict Of Interest Requirements


On August 23, 2011, the U.S. Department of Health and Human Services (“HHS”) issued a final rule amending the Public Health Service (“PHS”) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors (42 C.F.R. Part 50). The rule, which regulates the disclosure of financial conflicts of interests by research institutions and investigators that seek or receive PHS funding, was initially adopted in 1995. The final rule reflects HHS’ efforts to strengthen transparency and oversight in the face of increasing numbers of, and complexity in, financial relationships between biomedical researchers and industry.

To access Ropes & Gray’s annotation of the chart prepared by HHS that compares the final rule to the 1995 regulations, please click here. The key revisions in the final rule are:

• Modifying the scope of reportable significant financial interests, including limiting the sources of income excluded from the definition of significant financial interests (e.g., certain income previously excluded when received from any public or nonprofit entity will now be excluded only if received from specified categories of public and nonprofit entities);

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