Code of Federal Regulations (CFR) Title 45 Part 46

Title 45 Part 46 of the Code of Federal Regulations (CFR) outlines federal regulations designed to protect human research participants. It sets standards for the ethical conduct of research involving people, including how studies are reviewed and approved, ensuring informed consent, and safeguarding participant rights and welfare. These rules apply mainly to research funded or regulated by the Department of Health and Human Services (HHS) and help ensure that research is conducted ethically, transparently, and responsibly.