Prisoner Research

Overview

The purpose of this guidance is to assist investigators in understanding and complying with the additional regulatory requirements that apply to research involving prisoners.

Prisoners are considered a vulnerable population under 45 CFR 46 Subpart C, research involving prisoners requires additional safeguards to ensure that participation is voluntary, free from coercion or undue influence, and that privacy and confidentiality are protected.

Note that studies targeting a prisoner population will need to be reviewed by the full board. In addition, a prisoner advocate is required to review and be present at the IRB meeting. Prisoner studies sometimes require more time and effort than non-prisoner populations; please plan accordingly.

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Required When Conducting Research on Prisoners

Research involving prisoners may only be conducted when:

The IRB has reviewed and approved the study under the prisoner-specific requirements.
The institution has certified the approval from Department of Health and Human Services (DHHS).

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When Research on Prisoners Is Permissible

Minimal risk studies on incarceration or criminal behavior.
Minimal risk studies on prisons or prisoners as a population.
Research on issues that specifically affect prisoners.
Requires additional federal-level review and public notice.
Research intended to improve prisoners’ health or well-being.

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When Research on Prisoners Is Not Permissible

The institution has not certified the study to DHHS.
The study involves more than minimal risk.
Required additional federal review and public notice have not been completed (when applicable).
The research is conducted or supported by DHHS but does not comply with Subpart C, which requires additional protections for prisoners, including IRB approval with a prisoner representative, limited permissible research categories, and safeguards to ensure voluntary participation and minimize coercion.

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IRB Application Expectations

When submitting a study involving prisoners, investigators should clearly describe the following:

Section: Research Procedures

Q: Describe every interaction between the research personnel and the research subjects in clear, step-by-step detail in chronological order. The IRB must be able to fully understand what participants will experience, what researchers will do, and how data will be collected from beginning to end.

Include all procedures, even those that may seem routine or minor. The IRB must be able to evaluate participant protections based on a complete picture of the researcher–participant relationship.

Describe all research procedures involving prisoners or incarcerated individuals in sufficient detail for the IRB to evaluate the study's ethical and regulatory requirements.

Your description should include:

What research activities participants will complete and the estimated time required.
Where research activities will take place.
Who will conduct each research procedure.
Whether prison records, institutional information, or other information maintained by the correctional facility will be accessed.
Any interactions with correctional facility personnel that are necessary to conduct the research.

If prison staff, correctional officers, healthcare personnel, counselors, case managers, educators, or other institutional personnel will assist with the research, describe:

Their role in the study.
Whether they will identify, recruit, schedule, escort, monitor, consent, or otherwise interact with potential participants.
Whether they will have access to research data.
How their involvement will be structured to minimize the possibility of coercion, undue influence, or perceived pressure to participate.

The IRB must understand all operational support provided by the correctional facility to determine whether adequate protections are in place for prisoner participants.

Section: Subject Enrollment

Q: List the specific criteria that make someone eligible for this study. Identify the population you intend to study. Your study should include those who are able to participate and those who represent the population where your study is relevant.

When describing inclusion criteria, investigators should identify the specific characteristics that make an individual eligible for participation, such as:

Prisoner status (e.g., currently incarcerated individuals in a jail, prison, detention center, or correctional facility).
Age or age range.
Sex or gender, if relevant to the study.
Health status or medical condition.
Educational background.
Geographic location or correctional facility type.
Length of incarceration, custody level, or other characteristics relevant to the research objectives.
Justification for the use of the prisoner population.

Investigators should also identify exclusion criteria, including characteristics that would make participation inappropriate or unsafe. Examples may include:

Individuals unable to provide legally effective informed consent.
Individuals whose participation could create excessive risk to their safety or well-being.
Prisoners who do not meet the study's eligibility requirements.
Individuals whose participation is prohibited by correctional facility policies or applicable regulations.

Section: Vulnerable Population

You must identify prisoners as a vulnerable population in the IRB application and ensure that the study meets all requirements for research involving prisoners under 45 CFR 46 Subpart C.

Section: Compensation

When including compensation in research involving prisoners, extra care must be taken to ensure that it does not create coercion or undue influence, given the restricted environment and limited access to resources.

Q: Indicate the type of compensation and the maximum value a subject may receive during the course of participation

Compensation should align with what is normally permitted within the correctional facility.
Ensure that the type of compensation and maximum value does not create coercion or undue influence.

Q: Describe procedures to distribute compensation. Include distribution schedule, when it will be done, and how it will be done.

Explain how compensation will be distributed (e.g., electronic payment, gift card, check, or cash).
Identify who will distribute the compensation.
Describe any procedures used to document receipt of compensation.
Indicate when compensation will be distributed (e.g., upon completion of the study, after each study visit or activity, at predetermined milestones, or according to another specified schedule).

Section: Benefits of Participation

The IRB evaluates whether the potential benefits of a study justify the risks to research subjects, and investigators should describe only those benefits that may reasonably be expected to result from participation in the research. Clearly explaining these benefits helps determine whether they outweigh the risks.

Q: Please list the potential benefits of the study to society.

Example benefits:

Contribute to a better understanding of incarcerated populations and the social, behavioral, health, or systemic factors that affect them.
Inform evidence-based policies and correctional practices.
Support the development of improved rehabilitation, health, and reentry programs.
Contribute to knowledge that may improve outcomes for justice-involved individuals.
Promote safer and more equitable community and justice systems.

Section: Risks

Investigators should evaluate the probability, magnitude, duration, and reversibility of these risks based on the study design, content, and research subjects' population.

A. Physical

Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research.

Possible harm during in-person procedures if the study includes wearing devices or medical procedures (e.g., blood draws, movement within the facility).

Q: Provides the measures you will use to minimize risks and to monitor subjects for safety.