Exempt human subjects research

Human subjects research that an institution's IRB or another authorized reviewer — never the investigator personally — has formally determined falls within one of the eight categories listed at 45 CFR 46.104(d) of the U.S. Common Rule, and has accordingly been relieved from the initial full-board or expedited review pathway and from ongoing continuing review. 'Exempt' describes the outcome of a review decision, not an absence of review: a study is not exempt merely because an investigator judges it low-risk, anonymous, or otherwise harmless. It becomes exempt only once someone with institutional authority has checked the protocol against the specific regulatory category and recorded that determination, typically through the IRB office rather than a convened committee meeting. Four of the eight categories — (d)(2), (d)(3), (d)(7), and (d)(8) — additionally require a 'limited IRB review' of privacy, confidentiality, or broad-consent safeguards before the exemption applies, so even exempt research can pass through IRB scrutiny once; it is only relieved of the continuing, ongoing review that non-exempt research remains subject to.

ByCASRAI Editorial Board

· Last updated 16 Jul 2026

Examples

Worked examples

Is an instance
An investigator fields a fully anonymous online survey of adult attitudes toward a public-policy question, collecting no names, IP addresses, or other identifiers. The IRB office reviews the protocol against 46.104(d)(2), issues a written exempt determination, and the investigator begins recruitment only after that determination is on file — not on the basis of the investigator's own read of the regulation.
Is an instance
A researcher plans a secondary analysis of a federal survey dataset that was already de-identified and publicly available before the analysis began. The IRB determines the study exempt under 46.104(d)(4) because the data source itself — not the investigator's judgment about risk — satisfies the category, and documents that determination before analysis starts.

Counter-examples

Looks similar, but isn't

Not an instance
A graduate student decides independently that a set of low-stakes home-visit interviews 'obviously' qualifies as minimal-risk and begins recruiting without ever submitting the protocol for review. This is not exempt research — it is undetermined research with no exemption on record. OHRP guidance and most institutional policies do not let investigators self-certify exemption, precisely because of this conflict of interest.
Not an instance
A study proposes to retain identifiable biospecimens for future secondary use under the broad-consent exemption at 46.104(d)(7)/(d)(8), but the limited IRB review of the consent documentation and confidentiality safeguards that categories 7 and 8 require hasn't yet occurred. Until that limited review happens, the study does not qualify for the exemption and remains subject to standard IRB review.

Also known as

Exempt research · 45 CFR 46.104 exemption · Exemption determination (human subjects)

Machine-readable encodings

Use in your systems

JATS XML <role> element

xml

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Schema.org DefinedTerm (JSON-LD)

json

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