HHS Proposes Overhaul of Human Subject Protections for Domestic Clinical Trials


In an advance notice of proposed rulemaking published in the July 26, 2011, Federal Register, the U.S. Department of Health and Human Services issued a request for comments on amendments to 45 C.F.R. Part 46, Subpart A (the Common Rule) to improve protections of human subjects in research and to revise the research process to reduce burdens, delays and ambiguities for investigators. The broad scope of the areas of possible revision underscores the importance of stakeholders to review, and provide comments regarding, the questions and concerns raised by the agency in this advance notice of proposed rulemaking.

On July 26, 2011, the Office of the Secretary of the U.S. Department of Health and Human Services (HHS), in coordination with the Office of Science and Technology Policy (OSTP), published an advance notice of proposed rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” 76 Fed. Reg. 44,512 (July 26, 2011). The stated purpose of the ANPRM is to solicit comments in order to identify ways to “better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay and ambiguity for investigators.” 76 Fed. Reg. 44,512. The ANPRM would amend 45 C.F.R. Part 46, Subpart A (referred to as the Common Rule). Comments are due by September 26, 2011.

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