Code of Federal Regulations 45 CFR 46
45 CFR 46 is a federal policy, enforced by the Department of Health and Human Services (DHHS), for the protection of human subjects. This policy applies to any human subject research supported by any of the 17 agencies of the federal government that support human subject research. The policy also includes additional protections for vulnerable subjects such as pregnant women, human fetuses and neonates, prisoners and children. This policy is also known as the "Common Rule."

21 CFR 50 Protection of Human Subjects
21 CFR 50, enforced by the Food and Drug Administration (FDA), codifies the requirements for informed consent. This regulation is almost identical to the regulations set forth by the DHHS's "Common Rule."

21 CFR 56 Institutional Review Boards
21 CFR 56, enforced by the FDA, codifies the requirements for Institutional Review Boards (IRBs). This regulation is almost identical to the regulations set forth by the DHHS's "Common Rule".

Belmont Report
The Belmont Report was created as a result of the 40-year United States Public Health Service Syphilis Study at Tuskegee, whereby syphilis subjects were denied treatment for their disease. This legislation, which was passed in 1974, created regulations to protect human subjects and created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to examine ethical issues related to human subject research.

Nuremberg Code
The Nuremburg Code was created as a result of the atrocities committed against humans during World War II. It addressed the significance of obtaining informed consent, of ensuring that this consent was voluntary and of ensuring that any individual "who initiates, directs, or engages in the experiment" bears responsibility for the quality of consent.

Declaration of Helsinki
The significances of the Nuremberg Code were further articulated and expanded in the Declaration of Helsinki, which was originally set forth in 1964. The Declaration's significance was that it called for prior approval and ongoing monitoring of research by independent ethical review committees.