FAIRsharing record for: Federal Policy for the Protection of Human Research Subjects

This FAIRsharing record describes: The U.S. Department of Health & Human Services (HHS) regulations for the protection of human subjects in research at 45 CFR 46, provided by the Office for Human Research Protections, includes five subparts: Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration. The Common Rule, subpart A, was revised in recent years. Access the regulatory language for all of the subparts using the links below. This collection guidance is provided by the Office for Human Research Protections (OHRP) as an annotated version of the Common Rule that highlights changes between the pre-2018 and 2018 versions of the Common Rule.