Based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978), the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects 45 CFR part 46 in the late 1970’s and early 1980’s. In 1978, the Commission’s report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” was published. It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report.
The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations. The Belmont Report identifies three fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice. Those principles remain the basis for the HHS human subject protection regulations.
In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.”
Today, the Belmont Report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subject research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.