45 CFR 46 Subpart C: Prisoners in Research

45 CFR 46 Subpart C (Additional Protections for Prisoners in Research)

The section of the Common Rule (45 CFR 46, §§46.301-46.306) that governs HHS-conducted or HHS-funded biomedical or behavioral research involving prisoners as subjects. A protocol falls under Subpart C whenever a subject meets the §46.303 definition of "prisoner" — involuntary confinement or detention in a penal institution, including pretrial detainees and individuals in alternative-to-incarceration facilities. The reviewing IRB must satisfy the §46.304 composition requirements (a non-prison-affiliated majority plus at least one prisoner or prisoner representative), make the additional findings required by §46.305, and may approve the research only if it fits one of the four categories permitted under §46.306.

ByCASRAI Editorial Board

· Last updated 3 Aug 2026

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Examples

Worked examples

Is an instance
A study administering an anonymous, minimal-risk survey about the psychological effects of incarceration to consenting jail inmates fits §46.306(a)(2)(i) — study of the causes, effects, and processes of incarceration itself — provided the reviewing IRB includes a prisoner representative and finds the risk no greater than minimal.
Is an instance
A clinical trial offering an investigational hepatitis treatment to incarcerated subjects, where the condition disproportionately affects the prison population, can proceed only under §46.306(a)(2)(iii) after the HHS Secretary consults appropriate experts and publishes notice in the Federal Register — a step none of the other three permitted categories require.

Counter-examples

Looks similar, but isn't

Not an instance
A study that enrolls only correctional staff or officers, with no confined individuals as subjects, does not trigger Subpart C — the subpart applies based on the confinement status of the actual subjects, not the research setting.
Not an instance
Research studying prison architecture or corrections policy using publicly available records or interviews with formerly incarcerated (now released) individuals does not trigger Subpart C, since the §46.303 definition of "prisoner" requires current involuntary confinement, not a prison-related topic.

Machine-readable encodings

Use in your systems

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Schema.org DefinedTerm (JSON-LD)

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