National Research Act

The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines for human subject research and to oversee and regulate the use of human experimentation in medicine. The National Research Act gained traction as a response to the infamous Tuskegee syphilis study.

Provisions

The National Research Act issued Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects (45 CFR 46). The National Research Act is overseen by the Office of Human Research Protections. The Act also formalized a regulated IRB process through local institutional review boards, also overseen by the Office of Human Research Protections.