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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

OMB Extends Review of the Common Rule

May 29, 2015—The White House Office of Management and Budget (OMB) Office of Information and Regulatory Affairs announced May 26 that it is extending the time for its review of the proposed rule to revise 45 CFR 46 (the Common Rule). The proposed rule would “revise current human subjects regulations in order to strengthen protections for research subjects while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” A review must be completed before the proposed rule can be released for further public comment.

An advance notice of proposed rulemaking (ANPRM) was issued by the Department of Health and Human Services (HHS) in July 2011 [see Washington Highlights, July 29, 2011], and set forth the department’s intent to strengthen the protections for human subjects while recognizing that the categories of research being conducted, the prevalence of multisite trials, and the types of data being collected have changed dramatically in the 20 years since the Common Rule was adopted. The AAMC submitted a response to the ANPRM in October 2011, supporting an overhaul of the regulations guiding human subjects research. Currently, there is no date listed for completion of the review.

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org