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  • Washington Highlights

    Office for Human Research Protections Hosts Public Meeting on Revised Common Rule

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    Daria Grayer, Director, Regulation and Policy

    The Department of Health and Human Services’ (HHS) Secretary’s Advisory Committee on Human Research Protections (SACHRP) July 10-11 held a public meeting to discuss the recent revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”) that institutions, researchers, and Institutional Review Boards (IRBs) must implement before the January 21, 2019 compliance date. The regulations are scheduled to go into effect July 19, 2018.

    SACHRP discussed several topics related to the revised regulations, such as recommendations for the revised expedited review list and appropriate compensation for research subject participation and dedicated significant time to the committee’s draft commentary on the new requirements for informed consent, which were described by Stephen Rosenfeld, MD, SACHRP chair, as “one of the most important products of the final rule.” This further underscores the statement by Jerry Menikoff, MD, PhD, HHS Director of the Office for Human Research Protections (OHRP), in the agency’s press release announcing the Common Rule revisions, “[w]e are very hopeful that these changes [to informed consent] and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants.” On September 7, OHRP will host its first workshop on the revised Common Rule, “Meeting New Challenges in Informed Consent in Clinical Research.”

    The committee also discussed implementation of the transition provisions and the three “burden reducing” provisions regulated entities may voluntarily adopt on July 19, approximately six months before the January 21, 2019 compliance date [see Washington Highlights, June 22]. SACHRP intended to discuss draft guidance on implementing these optional burden reducing provisions but removed this discussion from the agenda since the guidance was not cleared for public release by federal officials and it is still uncertain when such guidance will be issued.

    The AAMC will continue to monitor developments related to the revised Common Rule and post updates on the association's Common Rule webpage, which currently includes an opportunity to provide feedback on the kind of resources and tools that would be most helpful during the implementation process.