40 Years of Research Ethics: The Drafting of the Belmont Report

by Meryn Robinson, education and membership services,  and Avery Avrakotos, education and policy manager

Since its founding in 1974, PRIM&R’s highest priority has been to provide those charged with ensuring research protections, as well as those involved in the design and implementation of research protocols, with the education, practical tools, and cutting-edge strategies needed for their work protecting subjects. As we celebrate our 40th anniversary, we are reflecting upon four decades of connecting and protecting and recounting some of the events that have shaped the field’s rich history in our 40 Years of Research Ethics series.

Few tenets of research ethics are as ubiquitous as the principles in The Belmont Report: respect, beneficence, and justice. The Belmont Report, which summarizes these principles and their application to human subjects research, provided a moral framework that serves as the basis for the federal regulations governing the conduct of research on human subjects.

Partly in response to public outcry following an exposé on the US Public Health Service Syphilis Study at Tuskegee, the 93rd United States Congress enacted the National Research Act of 1974. The National Research Act created the first national bioethics commission, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with identifying “the ethical principles which should underlie the conduct of biomedical and behavioral research with human subjects and develop guidelines that should be followed in such research.” Members of the commission held a closed retreat at the Belmont Conference Center, a facility owned by the Smithsonian Institution in Elkridge, MD, February 13–16, 1976. With the assistance of advisors and a collection of scholarly essays on the role of and nature of moral principles for research, the commissioners produced the first draft of what would eventually come to be known as The Belmont Report, or, more formally, Ethical Principles and Guidelines for the Protection of Human Subjects of Research.

The report discusses the boundaries between research and practice, outlines the three now famous principles of respect for persons, beneficence, and justice, and applies these principles to the conduct of research with human subjects. PRIM&R Board Member, Robert J. Levine, MD, served as a special consultant to the National Commission during the drafting of The Belmont Report. In an interview for People & Perspectives, PRIM&R’s new oral history project, Dr. Levine reflected on his career and the development of this seminal work.

Some thirty eight years later, The Belmont Report remains one of the most influential guiding documents for the conduct of research with human subjects in the United States and around the world.