Good Clinical Practice (GCP)
Full course · Clinical Research Foundations
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See how ethical principles became modern regulations and oversight systems
The Belmont Report, published in 1979, was a landmark document. But it was just that: a document. It articulated what ethical research should look like, but it could not compel anyone to follow its guidance. For the principles to protect real people in real studies, they needed to become law.
This happened through a regulation known as the Common Rule.
The Common Rule, formally codified at 45 CFR 46, took the Belmont principles and translated them into specific, enforceable requirements. First issued by the Department of Health and Human Services in 1981, then adopted by 15 federal agencies in 1991 — at which point it became known as the 'Common Rule', this regulation applies to all research involving human subjects that receives federal funding or is conducted at institutions that have agreed to follow federal standards.
The transformation was straightforward but profound:
Respect for Persons became detailed requirements for informed consent: what information must be provided, how voluntariness must be ensured, what additional protections apply to vulnerable populations.
Beneficence became requirements for risk-benefit assessment: how risks must be minimized, how they must be reasonable in relation to anticipated benefits, how ongoing monitoring must occur.
Justice became requirements for equitable subject selection: how the burdens and benefits of research must be fairly distributed, how selection cannot be based on convenience or vulnerability alone.
The regulation did something else equally important: it created a mandatory system of independent oversight. Research could no longer proceed based solely on a researcher's own judgment about ethics. Every study involving human subjects would require review and approval by an independent committee before a single participant could be enrolled.
From Belmont to Modern Regulatory Framework
1979
Belmont Report
1981
45 CFR 46 Issued
1991
Common Rule Adopted
1996
ICH GCP Finalized
2018
Revised Common Rule
2025
ICH E6(R3)
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