The Belmont Report of 1979

Ethical Principles and Guidelines for Protecting Research Subjects

Oct 10, 2009

Despite ethical questions raised by the Nuremberg Code and other guidelines, human experimentation abuses continued. In 1974, public policy focused on clinical research.

In 1966, Henry K. Beecher raised ethical concerns about how human experimentation abuses had continued since the Nuremberg Code of 1947. Further exposés emerged in 1970 with experiments related to XYY syndrome, and in 1972 with the Tuskegee Study of Untreated Syphilis. Although no one event can be said to have promoted the public outcry for reform, it was clear that changes in how clinical research was conducted had to come.

The National Research Act Leads to a New Commission

On July 12, 1974, the National Research Act was enacted. This public law created The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, within the U.S. Department of Health, Education, and Welfare (HEW). For the first time, public policy focused on how research should be conducted on human subjects.

The Commission was established not only to set forth the basic ethical principles underlying biomedical research on human subjects, but also the guidelines necessary to ensure those principles would be observed. Specifically, the Commission was empowered to look at four separate areas:

The National Commission Begins Deliberations at the Belmont Conference Center

For four days in 1976, discussions began at the Belmont Conference Center in Elkridge, Maryland The original meetings were then supplemented by monthly sessions over a period of several years.

On April 18, 1979, the Commission published its findings as the Belmont Report, which is formally known as Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Not surprisingly, the Belmont Report harkens back to the Nuremberg Trials and the abuses committed by National Socialist (Nazi) researchers during World War II. Unlike the Nuremberg Code, however, the Belmont Report focused more on generalities in the hope that investigators could draw their own conclusions about how to conduct themselves.

The Belmont Report Emphasizes Three Principles

The Belmont Report and Informed Consent

In the area of informed consent, the Commission adopted a typical Beecher attitude — namely, that the importance of consent was unquestioned, but doubts persisted as to whether true consent could ever be attained. As the Commission stated, “controversy prevails over the nature and possibility of . . . informed consent.”

Of the three elements, the Commission struggled most with what information an investigator was required to divulge to a research subject. The standard observed in ordinary medical practice was believed inadequate, as “research takes place precisely when a common understanding does not exist.” Furthermore, the standard used in medical malpractice actions (i.e., ascertaining what a ‘reasonable person’ would need to know in order to consent) also was rejected on the grounds that a research volunteer may wish to know more than someone seeking therapeutic treatment. By compromise, the Commission recommended that a new standard for a “reasonable volunteer” be proposed, where enough information would be available to enable the volunteer to determine whether or not to “participate in the furthering of knowledge.”

Although understanding of the information presented was deemed important, the assessment of the level of comprehension was left to the investigator and not to the research subject. Once again, the balance of power in the physician-patient relationship shifted back toward the investigator, as in the Declaration of Helsinki.

Finally, the voluntariness of consent was acknowledged as the first principle set forth in the Nuremberg Code. The Commission, however, was reluctant to draw a line separating justifiable persuasion of a research subject from active coercion — thus acknowledging the influence of both, while satisfying neither.

Impact of the Belmont Report

The Belmont Report is perhaps more famous for what it did not do than what it accomplished. The Commission identified basic ethical principles in research and suggested vague guidelines for investigators to follow, but it did not tell researchers how they were to meet those objectives.

Curiously, the Commission asked that its findings be adopted in their entirety by HEW, even though Commission members emphasized the lack of specific recommendations for change. In this sense, the Commission followed the advice of ethicists such as Beecher, who believed that rules governing human experimentation were ineffective and that protection lay with basic ethical principles carried out by responsible investigators.

The Belmont Report was the beginning of public policy deliberation. Over the next few years, those policies would turn into law.

Jacobs F, Zonnenberg A. 2004. Tangible and Intangible Costs of “Protecting Human Subjects”: The Impact of the National Research Act of 1974 on University Research Activities. Education Policy Analysis Archives. 12(65):1–12.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education, and Welfare. DHEW Publication No. (OS) 78-0013. Washington, D.C.: U.S. Government Printing Office.

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