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HHS: Research Financial Conflicts of Interest Final Rules

Federal Register, August 25, 2011, Page 53256-53293


Department of Health and Human Services


This final rule implements changes to the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors. Since the promulgation of
the regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research Institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, led to changes that expand and add transparency to Investigators’ disclosure of Significant Financial Interests (SFIs), enhance regulatory compliance and effective institutional oversight and management of Investigators’ financial
conflicts of interests, as well as increase the Department of Health and Human Services’ (HHS) compliance oversight.

Full copy of Federal Register notice 2011-21633


Effective Date: This final rule is effective as of September 26, 2011

Further Information

Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852–7669, telephone 301–496–4607, fax 301–402–0169, e-mail, concerning questions about the rulemaking process; and Dr. Sally Rockey, NIH Deputy Director for Extramural Research, concerning substantive questions about the rule, e-mail