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The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

1979 (drafted 1976–1978) · Postwar Contemporary · Essays · English

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Abstract

Written: Drafted 1976–1978; published 18 April 1979
Setting: 1974–1979; Belmont Conference Center, Elkridge, Maryland, and Washington, D.C.
Author: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Country: United States
Language: English
Genre: Ethics report
Form: Summary, introduction and three parts (A–C)
Recommended: Grades 9–12 (Formal government prose; discusses abuses in past research.)

Background. A federal law of 1974 set up an advisory body after Americans learned that a government study had left poor Black men in Alabama with untreated syphilis for forty years, and that other studies had used prisoners and institutionalized children without real agreement.

Distinction. The document separates ordinary treatment, meant to help a particular patient, from investigation designed to yield general knowledge, which must undergo review. It notes that new or unusual treatments are not research merely because they are untried, though they should be studied formally as soon as possible.

Principles. It names three moral foundations: treating people as self-governing while shielding those less able to decide for themselves; doing good by weighing benefits against harms; and sharing burdens and benefits fairly.

History. Fairness is illustrated by past abuses, from Nazi camp experiments to the Alabama study, in which disadvantaged groups carried the risks.

Applications. Each foundation is turned into practice: consent that is informed, understood and voluntary; systematic assessment of risks and benefits; and fair procedures for choosing participants.

Influence. Although it issued no regulations itself, the document became the ethical basis for federal research rules and for the review boards that now examine studies across the country and abroad.

Key figures

The National Commission: Federal advisory body created in 1974
Kenneth John Ryan: Chair of the commission

Summary

The Belmont Report is a short statement of ethical principles for research involving human beings, issued by an American national commission and published on 18 April 1979. It takes its name from the Belmont Conference Center in Elkridge, Maryland, where the commission held intensive discussions in 1976. The commission was created by the National Research Act of 1974. Public trust in medical research had been shaken by revelations about the Tuskegee study, in which the U.S. Public Health Service had followed hundreds of poor Black men with syphilis in Alabama from 1932 to 1972 without treating them, even after penicillin became the standard cure. Other studies had used prisoners, institutionalized children and hospital patients without proper consent. The report has three parts. Part A distinguishes medical practice, which aims at the benefit of an individual patient, from research, which aims to produce general knowledge; research must be reviewed. Part B sets out three basic ethical principles. Respect for persons means treating individuals as autonomous agents and protecting those whose autonomy is diminished, such as children or the very ill. Beneficence means not only refraining from harm but maximizing possible benefits and minimizing possible harms. Justice concerns fairness in who bears the burdens of research and who receives its benefits; the report notes that the poor, the institutionalized and minorities have too often borne burdens while others benefited, citing the Nazi camps and Tuskegee. Part C applies the principles. Respect for persons requires informed consent, with attention to information, comprehension and voluntariness. Beneficence requires a systematic assessment of risks and benefits. Justice requires fair procedures for selecting subjects. The report did not itself make rules, but it became the ethical basis of the federal regulations, later known as the Common Rule, that govern research funded by the United States government, and it is studied by researchers and review boards around the world.

Plot or Argument

Summary and introduction
The commission explains its charge under the National Research Act and the need for broad principles beyond codes such as Nuremberg.
Part A: practice and research
Practice serves the individual patient; research seeks generalizable knowledge and must be reviewed.
Part B: basic ethical principles
Respect for persons, beneficence and justice.
Part C: applications
Informed consent, assessment of risks and benefits, and fair selection of subjects.

Lessons

Three principles
The report reduces a complex field to three principles that can guide judgment in many situations. Principles are not rules, but they shape how rules are made.
- What are the three principles, and what does each require?
- Why might principles be more useful than a long list of rules?
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Protecting the vulnerable
Respect for persons includes protecting those with diminished autonomy, such as children and prisoners. The report recognizes that consent alone is not always enough.
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- What makes a person vulnerable in research?
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Justice and history
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- How can a society share the burdens of research fairly?
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For the Christian reader
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- Which biblical teachings support the three principles?
- Are there moral questions in research that the report's principles cannot answer?
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Context

By the 1960s and 1970s medical research in the United States had grown enormously, funded by the federal government. Henry Beecher's 1966 article listed unethical published studies, and in 1972 newspapers revealed the Tuskegee syphilis study.

Composition

The National Research Act of 1974 created the commission. Its discussions at the Belmont Conference Center in February 1976 and later meetings produced the report, which was published for public comment in the Federal Register in April 1979.

Reception

The report became the ethical foundation of federal research regulations (45 CFR 46, adopted across agencies as the Common Rule in 1991) and of institutional review boards, and it is widely taught in research ethics courses.

Justice Law Virtue Ethics Science / Knowledge Race Slavery

Comparisons

The Nuremberg Code (Permissible Medical Experiments)
The Belmont Report builds on the Nuremberg Code but replaces its list of rules with three broad principles.
Hippocratic Writings
The Hippocratic duty to help and not harm is an ancestor of the principle of beneficence.
Buck v. Bell
Buck v. Bell shows how vulnerable people were treated before modern protections.
An Inquiry into the Causes and Effects of the Variolae Vaccinae (with Further Observations and A Continuation of Facts)
Jenner's experiment on a child can be judged by the Belmont principles.

Quotes

“Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.”

— National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Part B: Basic Ethical Principles.Quote card

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For Students

A reading companion for classical Christian high school students. See the student guide.

Reading Guide

Watch for

The difference between practice and research.
The two parts of respect for persons.
How justice is illustrated by history.
The three applications in Part C.

Key terms and names

Autonomy: A person's capacity to make his or her own decisions.
Beneficence: Doing good: maximizing possible benefits and minimizing possible harms.
Institutional review board: A committee that reviews proposed research to protect human subjects.
Vulnerable subjects: People, such as children or prisoners, whose ability to consent freely is limited.

Seminar Questions

Comprehension What are the three basic principles?
Comprehension How does the report distinguish practice from research?
Interpretation Why does the report mention the Tuskegee study under justice?
Interpretation How do the three applications follow from the principles?
Interpretation How does the Report distinguish research from ordinary medical practice, and why does the distinction matter?
Big Question When the principles conflict, which should come first?

Faith Connections

Micah 6:8 (Scripture)
"Do justly, and to love mercy": justice and beneficence together.
Matthew 7:12 (Scripture)
The Golden Rule as a test for how researchers treat subjects.
The Nuremberg Code (Great Conversation)
The earlier code that Belmont develops.

Logic and Rhetoric

Central argument: Research with human beings must be guided by respect for persons, beneficence and justice, which are applied through informed consent, risk-benefit assessment and fair selection of subjects.

Rhetorical device: principle and application. The report states three principles in Part B and then shows how each becomes a practice in Part C.

Debate: Resolved: that broad principles protect research subjects better than detailed rules.

Memory Work

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
Part B: Basic Ethical Principles. A concise statement of the three principles.

Writing Prompts

Essay: Explain how each Belmont principle answers a specific historical abuse.

Comparison with The Nuremberg Code (Permissible Medical Experiments): Compare the approach of the Nuremberg Code and the Belmont Report to protecting human subjects.

Medical Lens

The foundation of American research ethics regulation, with the principles of respect for persons, beneficence and justice.

Medical Ethics Physicians Doctors

Part B
The three principles.
Medical Ethics
Part C
Informed consent, risk-benefit assessment and selection of subjects.
Medical Ethics

Creative Prompts

Essay
Apply the three Belmont principles to a proposed study of a new medicine in children.
Classroom
Create a chart linking each principle to its application in Part C.
Dialogue
Write a review-board discussion of a risky study, with members appealing to each principle.