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.
Editorial commentary
Frequently Asked Questions
Does Subpart C apply to someone who has been released from prison or is now on parole?
No. The §46.303 definition of “prisoner” requires current involuntary confinement or detention. Once a person is released — including onto parole — research involving that individual no longer triggers Subpart C, even if the research topic concerns their time in prison.
Does Subpart C cover people in a court-ordered alternative-to-incarceration program, such as a mandated drug treatment facility?
Yes. The §46.303 definition of “prisoner” extends beyond individuals held in a conventional penal institution to include pretrial detainees and people confined to alternative-to-incarceration facilities under court order. If subjects meet that definition, the study falls under Subpart C regardless of the facility type.
What must an IRB have in place before it can review research involving prisoners?
Beyond its standard composition, the reviewing IRB must satisfy the §46.304 requirements: a majority of members with no affiliation to the prison(s) involved, plus at least one prisoner or prisoner representative among its members. The IRB must also make the additional findings required by §46.305 before approving the study.
What kinds of research involving prisoners are allowed under Subpart C?
Research on prisoners may be approved only if it fits one of four categories permitted under §46.306. These include studies of the causes, effects, and processes of incarceration itself, and — under stricter conditions requiring HHS Secretary consultation and Federal Register notice — research on conditions that disproportionately affect the prison population.
Does Subpart C apply to a study that only enrolls correctional officers or prison staff?
No. Subpart C applies based on the confinement status of the actual research subjects, not the setting where the research takes place. A study enrolling only staff, with no confined individuals as subjects, does not trigger Subpart C’s additional requirements.
When were these additional protections for prisoners added to the Common Rule?
Subpart C was added in 1978, following concerns about abuses in prison-based research, to establish the additional IRB composition and review requirements described above.
Machine-readable encodings
Use in your systems
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