45 CFR 46

The HHS regulations for the protection of human subjects in research at 45 CFR 46 include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects. The Common Rule, subpart A, was revised in recent years (the “2018 Requirements”). Subparts B, C, and D provide additional protections for certain populations in research. Subpart E provides requirements for institutional review board registration. Access the regulatory language using the links below.

In general, research initiated before January 21, 2019 continues to comply with the pre-2018 Common Rule unless the institution chose to transition it to the revised Common Rule.