Common Rule (45 CFR 46)

The US federal policy for the protection of human subjects codified at 45 CFR Part 46 Subpart A and adopted by twenty federal departments and agencies, which applies to all non-exempt human-subjects research conducted or supported by those agencies.

ByCASRAI Editorial Board

· Last updated 21 May 2026

Worked examples

Is an instance

An NIH-funded multisite behavioural-intervention study relies on a single IRB of record as required by u00a746.114(b), with all participating institutions ceding review.

Is an instance

A study using leftover de-identified clinical specimens is determined to be exempt under u00a746.104(d)(4) and does not require continuing review.

Looks similar, but isn't

Not an instance

A wholly privately funded marketing study with no federal involvement is not regulated under the Common Rule (though institutional policy may still require IRB review).

Not an instance

Activities meeting the regulatory definition of public-health surveillance authorised by a public-health authority are excluded under u00a746.102(l)(2).

The Common Rule establishes mandatory minimum standards for IRB review, informed consent, and assurance of compliance for federally funded human-subjects research in the United States. The 2018 revised Common Rule introduced new exempt categories, eliminated continuing review for many minimal-risk studies, mandated single-IRB review for cooperative research, required a new concise summary at the beginning of consent forms, and introduced broad consent as an option for the storage and secondary research use of identifiable private information and biospecimens. Additional protections apply under Subparts B (pregnant women, fetuses, neonates), C (prisoners), and D (children).

References

Common Rule 45 CFR 46 (2018 revision), Subparts A-E
Federal Register notice 82 FR 7149 (19 January 2017) and 83 FR 28497 (19 June 2018) effective and general compliance date
OHRP Human Subject Regulations Decision Charts

Use in your systems

JATS XML <role> element

xml

<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="Common Rule (45 CFR 46)"
      vocab-term-identifier="https://casrai.org/dictionary/term/common-rule-45-cfr-46" />

Schema.org DefinedTerm (JSON-LD)

json

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