On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). The final rule introduces significant changes to the current regulations and is intended to strengthen the protection of human subjects while reducing administrative burden for investigators and IRBs.
In September of 2015, a Notice of Proposed Rulemaking was released by HHS and during the public comment period, representatives from Penn State’s Human Research Protections Program provided feedback on the proposed revisions. Many of the revisions deemed controversial by the research community were not included in the final rule published on January 19.
Most of the provisions in the final rule will go into effect on January 19, 2018.
Read a summary of the changes here:
To access the full version in the federal register: