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.
The effective date of the revised Common Rule is July 19, 2018. Research begun before that date will be regulated under the pre-2018 Common Rule unless the institutional review board overseeing the research decides to apply the revised Common Rule. Research begun after July 19, 2018 will be regulated under the revised Common Rule.
- Read the Final Rule published on January 19, 2017 in the Federal Register (Preamble and regulatory text) (PDF - 794 KB)
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)
The Common Rule, UpdatedBy Jerry Menikoff, Julie Kaneshiro, and Ivor PritchardNew England Journal of Medicine, January 19, 2017 (Vol. 376 No. 3)View this article online (Requires NEJM subscription or article purchase)
Content last reviewed on January 19, 2017