The Belmont Report

Over four days in February 1976, members of a federal commission met at the Smithsonian Institution's Belmont Conference Center. The National Research Act, signed on 12 July 1974, had created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and told it to identify the basic ethical principles for research on people, to mark the line between research and accepted medical practice, and to address risk and benefit, the choice of subjects, and informed consent. Its 11 members were chaired by Kenneth John Ryan, chief of staff at the Boston Hospital for Women.

Stephen Toulmin, a consulting philosopher, wrote the first draft after the Belmont meeting. Tom Beauchamp, a staff philosopher, revised parts of it, and the commission approved the wording in June 1978. The commission submitted the report to the President in September 1978. The Department of Health, Education, and Welfare printed it in the Federal Register on 18 April 1979 for public comment. Unlike most of the commission's reports, it made no specific recommendations for administrative action; the commission asked that it be adopted in its entirety as department policy.

The text defined research as activity designed to test a hypothesis and contribute to generalizable knowledge, and said anything containing an element of research should be reviewed. Respect for persons meant treating individuals as autonomous agents and protecting those with diminished autonomy. Beneficence came down to two rules: do not harm, and maximize possible benefits while minimizing possible harms. Justice concerned who receives the benefits of research and who bears its burdens. As examples of injustice the report named poor ward patients of the 19th and early 20th centuries, prisoners in Nazi concentration camps and the rural Black men of the Tuskegee syphilis study. Each principle had an application: informed consent (information, comprehension and voluntariness), assessment of risks and benefits, and fair selection of subjects.

The report was not a regulation. The Department of Health and Human Services revised its human-subjects rules in January 1981, and in June 1991 federal departments and agencies adopted a shared version, the Common Rule, which requires institutional review board approval and informed consent for research they conduct or support. Nagai and colleagues argue that the report did not change the basic sections of the 1981 regulations. The 2017 revision of the Common Rule describes the report's three principles as underlying the rule and requires agency decisions on what the rule covers, and any waivers, to be consistent with them.