Clinical Investigations Using Human Subjects (issued by NIH):
This was the first federal protection in the U.S. issued for the protection of human subjects in research and experiments.
To ensure the protection and safeguarding of human subjects, this review focused on a risk-benefit analysis to ensure that the benefit gained from participation outweighed the risks and incorporated an informed consent procedure (Gostin, Vanchieri, and Pope 74).
In 1974, these NIH were applied to the entire Department of Health, Education, and Welfare and eventually became codified as, “Title 45, Part 46 of the Code of Federal Regulations,” in 1981.