Sweeping Changes under Consideration for “Common Rule” Human Subjects Protection Requirements


On July 22, 2011, the U.S. Department of Health and Human Services (“HHS”) announced an Advance Notice of Proposed Rulemaking (“ANPRM”) describing comprehensive potential revisions to the Common Rule. The Common Rule, which represents a common set of requirements for human subjects protection in research funded by fifteen federal agencies, was adopted in 1991. The ANPRM reflects HHS’s intent to revise the regulatory requirements to address the evolution in the conduct of research over the last two decades. According to HHS, the volume of research conducted, the sites where research occurs, and the types of research conducted have all expanded. The technology used in research, including genomics, has also affected the conduct of research. The revisions under consideration are intended to enhance human subjects protection while simultaneously making the oversight of research less burdensome and inefficient.

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