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Archive for July 8th, 2016

National Academies Call for Commission to Examine Human Subject Research Regulations

NASEM LogoThe National Academies of Sciences, Engineering and Medicine (NASEM) recently released a report recommending “that Congress authorize and the president appoint an independent national commission to examine and update the ethical, legal, and institutional frameworks governing research involving human subjects.”  The report also urges the executive branch to “withdraw the Notice of Proposed Rulemaking for the Common Rule (formally known as the Federal Policy for Protection of Human Subjects)” because the “regulatory structure protecting human research subjects should not be revised until the national commission has issued its recommendations and the research community, patient groups, and the public have had a chance to consider and react to them.”  On 9/8/15, sixteen federal agencies announced proposed rulemaking on the Common Rule, initially asking for public comment up to 12/7/15 (80 Fed. Reg. 53933; see 9/11/15 C|M|Law Library blog post).  The public comment deadline was extended to 1/6/16, and there have been thousands of comments on the massive proposed rule.  The NASEM report, Optimizing the Nation’s Investment in Academic Research:  A New Regulatory Framework for the 21st Century (2016), was authored by members of the NASEM Policy and Global Affairs Committee on Science, Technology, and Law and Committee on Federal Research Regulations and Reporting Requirements.  It is available here to read online and free PDF download.  For more information, see the 6/29/16 NASEM news release.