On September 8, 2015, the U.S. Department of Health and Human Services and fifteen other federal departments and agencies announced proposed revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). The Notice of Proposed Rulemaking is the most significant attempt to overhaul the federal regulations governing the conduct of clinical research involving human subjects since the Common Rule was promulgated in 1991. Comments are due on January 6, 2016.