Current U.S. Regulations

(as of September 2022)

 In 1981, the Department of Health and Human Services (DHHS) issued the Code of Federal Regulations (CFR) Title 45, Part 46 on the protection of human subjects. The FDA issued CFR Title 21, Parts 50 (protection of human subjects), and 56 (Institutional Review Boards). The 45 CFR Part 46, Subpart A, was adopted in 1991 across multiple agencies and departments involved in research on human subjects. The Department of Veterans Affairs follows the same rule at 38 CFR Part 16.

The Common Rule (2018) requires research institutions to have procedures that assure compliance with the protection of human research subjects, including obtaining informed consent. The Common Rule details requirements for the function of Institutional Review Boards and demands additional protections for vulnerable groups such as pregnant women, minors, and incarcerated persons.

References:

Title 45 of the Code of Federal Regulations, Part 46 – Protection of Human Subjects (The Common Rule 2018). Available at: https://www.ecfr.gov/on/2018-07-19/title-45/subtitle-A/subchapter-A/part-46

HHS - OHRP. 45 CFR 46. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

Title 21 of the Code of Federal Regulations, Part 50. Protection of Human Subjects. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50

Title 21 of the Code of Federal Regulations, Part 56 - Institutional Review Boards. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56

Last updated: September 10, 2022 

Milestones in Medical Ethics