Part 3: Legal Requirements
The Federal Common Rule
The heart of U.S. federal policy on protecting human subjects in research comes from the Department of Health and Human Services (DHHS) and is codified as title 45, part 46 of the Code of Federal Regulations (45 CFR 46) .
In 1991, many federal agencies adopted Subpart A, the general provisions of 45 CFR 46, as the federal Common Rule. The Common Rule agencies are listed in the Code of Federal Regulations.