In the U.S., a series of highly publicized abuses in research led to the enactment of the 1974 National Research Act that created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the National Commission was to identify the basic ethical principles for the conduct of research and develop guidelines to implement the principles. In 1978, the Commission published a document known as the Belmont Report, which describes three fundamental ethical principles: respect for persons, beneficence, and justice.

Based on the Belmont Report and other work of the National Commission, the Department of Health and Human Services revised and expanded its regulations for the protection of human subjects.