The law was passed following a series of congressional hearings on human-subjects research, directed by Senator Edward Kennedy.

The National Research Act gained traction as a response to the infamous Tuskegee syphilis study.

[2] The National Research Act issued Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects (45 CFR 46).

The Act also formalized a regulated IRB process through local institutional review boards, also overseen by the Office of Human Research Protections.

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