HHS Finalizes Comprehensive Revisions to the Common Rule

On Jan. 19, 2017, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies promulgated a final rule (82 Fed. Reg. 7149) to update and strengthen the federal Policy for the Protection of Human Subjects (the Common Rule), the set of federal regulations governing the conduct of clinical research involving human subjects. The final rule, which includes extensive changes to the informed consent process and institutional review board (IRB) oversight, marks the first major reform to the Common Rule since its original issuance in 1991. The revisions to the Common Rule will have implications ...