45 CFR Part 46 Subpart A

The National Research Act (Pub. L. 93-348) created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This Commission identified a set of ethical principles, and later practical guidelines, for US Government-funded research involving human beings. Ultimately the Department of Health and Human Services wrote and adopted a set of regulations requiring recipients of USG funding to create their own institutional bureaucracies for overseeing research that involves human subjects. These regulations, embodied in Title 45 Part 46 subpart A of the Code of Federal Regulations, exist for one purpose: to safeguard the welfare of human research subjects.

Although CFR 45 Part 46 applies only to work funded by HHS, regulations with the same language were adopted in 1991 by 14 other grant-giving USG agencies, including the Department of Defense (DoD), the National Aeronautics and Space Administration (NASA), and the National Science Foundation (NSF). For this reason 45 CFR part 46 subpart A is referred to as ``the Common Rule for the protection of human subjects''[#!common-rule!#].