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Revised Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is effective July 19, 2018.

Research initiated before January 21, 2019 is required to comply with the pre-2018 Requirements (i.e., the version of the Common Rule initially promulgated in 1991, and amended in 2005). The exception to this general rule is that on and after July 19, 2018, an institution may voluntarily elect for a study (or set of studies) to comply instead with the revised Common Rule. This election must be documented by the institution or an IRB. During the delay period, these studies that have transitioned to the revised Common Rule must comply with the pre-2018 Requirements, but with three burden-reducing provisions of the revised Common Rule applying in lieu of or in addition to their corresponding provision in the pre-2018 Requirements. Studies that transition to comply with the revised Common Rule must comply with the entirety of the 2018 Requirements on and after January 21, 2019.

Delay of Revisions to the Common Rule

  • Delay of Revisions to the Common Rule Interim Final Rule published on January 22, 2018 in the  Federal Register (PDF 186 KB)
  • Delay of Revisions to the Common Rule Interim Final Rule Announcement
  • Additional Delay of Revisions to the Common Rule Notice of Proposed Rulemaking published on April 20, 2018 in the Federal Register (PDF 225 KB)
  • Additional Delay of Revisions to the Common Rule Notice of Proposed Rulemaking Announcement
  • Additional Delay of Revisions to the Common Rule Final Rule published  on June 19, 2018 in the Federal Register (PDF 224 KB)
  • Additional Delay of Revisions to the Common Rule Final Rule Announcement 

Related Information

  • The Common Rule, Updated
    By Jerry Menikoff, Julie Kaneshiro, and Ivor Pritchard
    New England Journal of Medicine, January 19, 2017 (Vol. 376 No. 3)
    View this article online (Requires NEJM subscription or article purchase)
     

Background Information

Content created by Office for Human Research Protections
Content last reviewed on January 19, 2017