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Common Rule Resources and Updates

Latest Updates

  • May 16, 2018, The Association of American Medical Colleges, Association of American Universities, Association of Public and Land-grant Universities, and Council on Governmental Relations submitted a letter to the Department of Health and Human Services’ (HHS) in response to a request for comments on the April 20, 2018 Notice of Proposed Rulemaking (NPRM).

  • April 19, 2018, HHS and 16 other federal departments and agencies issued an NPRM to delay the general compliance date of the revised Common Rule for an additional six months, from July 19, 2018 to January 21, 2019, to “provide additional time to regulated entities for the preparations necessary to implement the 2018 requirements.” This NPRM follows the January 22, 2018 publication of an Interim Final Rule (IFR) delaying the revised Common Rule’s January 19, 2019 initial effective and compliance date until July 19, 2018.

  • March 19, 2018, the AAMC, Association of American Universities (AAU), and Association of Public & Land Grant Universities (APLU) responded  to HHS' request for comments on the IFR to further delay revisions to the Common Rule.

  • January 22, 2018, HHS and 15 other federal departments and agencies published in the Federal Register an IFR to delay the effective and general compliance date of the revisions to the Common Rule until July 19, 2018. The revised final rule was originally scheduled to go into effect on January 19, 2018. This IFR is separate from the Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year which was submitted to the Office of Management and Budget (OMB) on October 7, 2017. OMB concluded its review of the proposed rule on April 16, 2018.

  • January 23, 3:30-4 p.m. ET, the AAMC held a call to provide an update on what this delay means, opportunities for comment, and next steps for implementation (slides ) (recording).

Opportunity for Feedback

The AAMC would appreciate your feedback on the kind of resources, tools, and discussions that would be most helpful to you during the implementation process. Please click here to participate in a brief online survey.

Background

On January 19, 2017, HHS and 15 other federal departments and agencies released the final revisions to the Federal Regulations for the Protection of Human Subjects, also known as the Common Rule. The regulations, which have been in place since 1991, govern federally supported research involving human subjects. Among the changes to the regulations, the most significant include the mandate that a single Institutional Review Board (IRB) review and approve all multi-site research and the extension of the Common Rule to all clinical trials conducted at a U.S. institution that receives federal funding regardless of the funding source. The rule also requires new approaches to the informed consent process such as the publication of informed consent documents.

AAMC Resources

AAMC Webinars

  • AAMC Webinar on the Final Rule [Archive]

    A call for AAMC-member institutions was held on January 25, 2017, providing an overview of the major changes in the final rule and an update on how the new administration and Congress may affect its implementation (slides with recording) (slides only ).

  • AAMC Webinar on the Notice of Proposed Rulemaking [Archive]

    A series of webinars on specific changes proposed in the NPRM. Log into your AAMC account to access the presentations below.

    NPRM Overview – September 18, 2015 Slides Recording
    Informed Consent – October 13, 2015 Slides Recording
    The Categorization and IRB Review of Research – October 14, 2015 Slides Recording
    Research with Biospecimens – October 21, 2015 Slides Recording
    The Single IRB Mandate – October 22, 2015 Slides Recording

For questions, please contact Daria Grayer at dgrayer@aamc.org or (202) 741-5474.

External Resources

Other Resources

For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or (202) 478-9926. You may follow Heather on Twitter at twitter.com/HeatherHPierce.