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  • Washington Highlights

    OMB Extends Review of the Common Rule

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    Stephen Heinig, Director, Science Policy

    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, 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.