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CASRAI

Definition · Plain-language

Belmont Report

The Belmont Report is the 1979 statement of ethical principles that underpins the protection of human subjects in US research.

CASRAI research-methods explainer — Belmont Report

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Origin

The Belmont Report was issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created by the U.S. National Research Act of 1974. It responded to ethical failures in earlier research, most notably the Tuskegee syphilis study. The report distilled a small set of broad principles intended to guide ethical decisions across all human-subjects research, rather than a long list of rules.

The three principles

Respect for persons treats individuals as autonomous agents and protects those with diminished autonomy, grounding the requirement for informed consent. Beneficence obliges researchers to maximise possible benefits and minimise harms, grounding the assessment of risks and benefits. Justice concerns the fair distribution of the burdens and benefits of research, grounding equitable selection of subjects so that vulnerable groups are not exploited.

Its lasting influence

The Belmont principles became the ethical foundation of U.S. federal regulation. The Common Rule (45 CFR 46) operationalises them through Institutional Review Board review, informed-consent requirements, and special protections for vulnerable populations. Decades on, the report remains the reference framework taught in research-ethics training and cited when novel ethical questions arise that the regulations do not directly address.

Key facts

At a glance

  • Definition: foundational US human-subjects research-ethics report
  • Published: 1979
  • Author: National Commission (under the 1974 National Research Act)
  • Principles: respect for persons, beneficence, justice
  • Applications: informed consent; risk/benefit; fair subject selection
  • Legacy: ethical basis of the Common Rule and IRB review

Common misconceptions

What people often get wrong

Often heard: The Belmont Report is a law or regulation.

Actually: It is an ethics report, not a regulation. Its principles were later codified into federal regulation through the Common Rule (45 CFR 46).

Often heard: The Belmont Report has four principles.

Actually: It sets out three principles — respect for persons, beneficence and justice. The four-principle approach is a separate bioethics framework.

Often heard: It applies only to medical research.

Actually: Its principles apply to all research with human subjects, including behavioural and social-science research.

Referenced across the research world

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  • Harvard University logo
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  • ORCID logo
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