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 January 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 January 19, 2018, will be regulated under the revised Common Rule.

• Read the Final Rule published in the Federal Register (Preamble and regulatory text) (PDF – 794 KB)
• Read the regulatory text of the revised Common Rule

Delay of Revisions to the Common Rule

• Delay of Revisions Federal Register Notice (PDF 186 KB)
• Delay of Revisions to the Common Rule Announcement