Examples
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.
Counter-examples
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).
Editorial commentary
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).
This entry defines the Common Rule itself. For a subpart-by-subpart map of the whole regulation — Subparts A through E, who each one protects, and how the Common Rule differs from FDA’s 21 CFR 50/56 — see 45 CFR 46 and the Common Rule: What Each Subpart Covers.
The 2018 revision organises exempt research into eight categories at §46.104(d) — spanning normal educational-practice research, benign behavioural interventions, secondary research use of already-collected identifiable information under specified conditions, and others — two of which (categories 7 and 8) require limited IRB privacy/confidentiality review rather than a purely administrative determination. Institutions conducting non-exempt federally supported human-subjects research must hold a Federalwide Assurance (FWA), a written institutional commitment filed with HHS’s Office for Human Research Protections (OHRP) to apply the Common Rule to the research it covers.
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
The regulatory line runs back to the National Research Act of 1974, which created the commission that produced the Belmont Report.
Also known as
45 CFR 46 · Federal Policy for the Protection of Human Subjects · Revised Common Rule
Machine-readable encodings
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