Definition · Plain-language
Common Rule
The Common Rule is the baseline U.S. federal regulation protecting people who take part in research, requiring IRB review and informed consent.
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What it requires
The Common Rule sets the baseline protections for research involving human subjects conducted or supported by the federal agencies that adopt it. Core requirements include prospective review and approval by an Institutional Review Board, legally effective informed consent, and additional safeguards for vulnerable populations such as children and prisoners (addressed in further subparts). It defines what counts as “research” and “human subject” and which activities are exempt.
Why “Common”
The rule is called “common” because it is a single, shared policy adopted in identical form by many federal departments and agencies — the Department of Health and Human Services, the National Science Foundation and others. This harmonisation means an institution can apply one consistent set of human-subjects protections regardless of which agency funds a given study, rather than reconciling agency-specific rules.
The 2018 revisions
A significant revision of the Common Rule took general effect in 2018. It introduced new categories of exempt research, required key information to be presented up front in consent forms to aid comprehension, and made other changes intended to reduce burden for low-risk research while strengthening transparency. The revised rule reshaped how IRBs assess exemptions and structure consent, while keeping the Belmont principles at its core.
Key facts
At a glance
- Definition: US federal policy protecting human research subjects
- Citation: 45 CFR 46, Subpart A
- Requires: IRB review and informed consent
- Scope: adopted by many federal agencies (hence “Common”)
- Revision: major update took effect in 2018
- Basis: operationalises the Belmont Report principles
Common misconceptions
What people often get wrong
Often heard: The Common Rule and the Belmont Report are the same thing.
Actually: The Belmont Report is the ethics framework; the Common Rule is the federal regulation that implements those principles in law.
Often heard: The Common Rule covers all research everywhere.
Actually: It governs human-subjects research conducted or supported by adopting federal agencies; FDA-regulated and privately funded work may follow related but distinct rules.
Often heard: The Common Rule has not changed since the 1990s.
Actually: A substantial revision generally took effect in 2018, adding new exemptions and consent requirements.
Going deeper
