Proposed Changes to Regulations that Govern Federally-supported Research Involving Human Subjects

The NCRR Federal Register contains an Advanced Notice of Proposed Rule Making seeking public comments on sweeping proposed changes to the regulations that govern federally-supported research involving human subjects (known as the Common Rule). The revisions (see table) are intended to strengthen the protections for human subjects while recognizing that the categories of research being conducted, the prevalence of multisite trials, and the types of data being collected have changed dramatically in the 20 years since the Common Rule was simultaneously adopted by various federal agencies and departments.