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Common Rule Resources and Updates

Latest Updates

July 20, 2018 - The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) announced the availability of three draft guidance documents on the revised Common Rule relating to the three burden-reducing provisions that regulated entities are permitted to adopt during the delay period (see below). On July 25 OHRP published the draft guidance in the Federal Register. Comments due August 24, 2018. Federal Register notice can be found here. Draft guidance documents are as follows:

HHS Q&As on the Revised Common Rule can be found here.

July 19, 2018 - As of July 19, 2018, regulated entities have the option to implement three "burden reducing provisions" of the revised Common Rule during the delay period (July 19, 2018 through January 21, 2019). Studies that decide to implement any of the three provisions during the delay period, must comply with with all of the revised Common Rule's requirements on January 21, 2019 for the full duration of that study. A decision about whether to adopt any of the burden reducing provisions may depend on the nature and progress of the study. The three burden reducing provisions include:

1. Revised definition of "research" which deems certain activities not to be research;

2. Allowance for no annual continuing review of certain categories of research; and

3. Elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

June 19, 2018 - HHS issued a final rule delaying for an additional six months (until January 21, 2019) the general compliance date for the revised Common Rule while allowing the voluntary adoption of three "burden-reducing provisions" of the revised rule during the delay period. On May 16, the AAMC, Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR) submitted a letter to HHS in response the request for comments on the April 19 Notice of Proposed Rulemaking (NPRM).

March 19, 2018 - the AAMC, AAU, APLU responded to HHS' request for comments on January 22, 2018 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.

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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 and Presentations

  • Presentation to the AAMC Compliance Officers' Forum - "The Revised Common Rule: Where Are We Now? What Happens Next?" (June 20, 2018, slides )
  • Understanding the IFR to Delay the Effective and Compliance Date (January 23, 2018, slides  recording)
  • Overview of the Final Rule (January 25, 2017, slides with recording / slides only 
  • Previous Education on the NPRM (AAMC Webinars)

External Resources

News and Publications

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.