Research Involving Prisoners

This includes:

• Individuals serving criminal or civil sentences in prison or jail
• Individuals detained while awaiting arraignment, trial, or sentencing
• Individuals confined in facilities as an alternative to prosecution or incarceration
• Individuals involuntarily committed to an institution as an alternative to jail

Examples:

• A person in court-ordered residential substance abuse treatment is a prisoner.
• A person receiving court-ordered treatment while living at home is not.
• A parolee detained in a treatment center is a prisoner.
• A person on probation in the community is generally not a prisoner.

If you are unsure whether Subpart C applies, contact IRBO.

Subpart C applies when:

• You intend to enroll prisoners in your study, or
• A currently enrolled participant becomes incarcerated and you wish to continue research activities during incarceration.

Even if only a small number of participants may become prisoners, your protocol must address this possibility.

You must also comply with applicable state, local, Tribal, and Department of Corrections (DOC) requirements. Each state has a Department of Corrections (DOC) with specific regulations/rules. This federal website provides information about corrections departments by state: State departments of corrections | USAGov.

Under federal regulations (45 CFR 46.306), prisoners may be included only in specific categories of research.

Category 1

Study of causes, effects, or processes of incarceration or criminal behavior

• Must involve no more than minimal risk and no more than inconvenience.

Category 2

Study of prisons as institutions or prisoners as incarcerated persons

• Must involve no more than minimal risk and no more than inconvenience.

Category 3

Research on conditions particularly affecting prisoners as a group

• May involve more than minimal risk
• Does not require direct benefit
• Requires additional federal-level review and Federal Register notice
• Examples: hepatitis research, vaccine trials, research on substance use

Category 4

Research on practices intended to improve health or well-being of prisoners

• May require federal-level review if control groups may not benefit

2003 Epidemiologic Waiver

Certain epidemiologic studies may be allowed if:

• The sole purpose is to describe disease prevalence/incidence or risk factors
• The research poses no more than minimal risk and no more than inconvenience
• Prisoners are not the focus of the research

The IRB must certify compliance to OHRP.

Under the 2018 Common Rule:

• Research involving prisoners generally cannot be deemed exempt.
• Exempt research may include prisoners only if they are incidentally included in a broader population and not the focus of the research.

Under the pre-2018 Common Rule, exempt research cannot include prisoners.

Prisoners cannot be enrolled in emergency research approved under 45 CFR 46.101(i).

If you plan to enroll prisoners (or anticipate the possibility), your protocol must:

• Clearly state your intent to include prisoners
• Identify the regulatory category that applies
• Describe additional safeguards
• Explain how risks are minimized
• Address privacy and confidentiality in the correctional setting
• Broadly detail the ways in which data collection would or would not change based on the person(s) being incarcerated.
• Describe how participant selection will be fair
• Explain how follow-up will occur, including after release
• Describe how you will obtain consent
  • Even in the case where you simply want to ask questions as a scheduled visitor at the facility and will not collect samples this will be tricky. This interaction will not be like a typical visit. It is likely that you must have full institutional permission to interact with the incarcerated person for the purposes of conducting research. For example, if conducting informed consent or conducting a survey, both of these activities would go well beyond what a typical visitor could do.

If prisoners are not your target population but may be incidentally enrolled, include a subsection addressing how you will handle this situation.

Before submission:

• Contact the relevant correctional facility or DOC.
• Determine what activities are allowed.
• Obtain required institutional permissions.
• Submit documentation of permission with your IRB application.

Important considerations:

• You may not be able to collect data inside the facility without permission.
• Mail correspondence may be read by DOC officials, which means the privacy of the incarcerated person cannot be guaranteed.
• Transporting prisoners for research is usually not permitted.
• The study team cannot transport prisoners.

Your protocol must explain how research activities will occur within these limitations.

You must create a consent form specifically for incarcerated participants.

The consent form must include the following language about parole:

• “Your legal standing, including your sentence or any term of probation or parole will not be impacted by your decision to take part in this study or to refuse to volunteer for this study.”  
• “No data collected will be shared with the Department of Corrections.” 

The consent form must also describe:

• Any special follow-up procedures
• Any limits to privacy
• How participants can contact the study team

If you request a waiver or alteration of consent under 45 CFR 46.116(e)-(f), the protocol must justify it. Even if consent is waived, prisoners must be informed that participation will not affect parole.

If a participant becomes incarcerated and your protocol was not previously approved for prisoner participation:

1. Submit a Reportable New Information (RNI) in the NIH eIRB system immediately.
2. Stop all research interactions and identifiable data collection.
3. Submit a modification requesting approval for continued participation.
4. Wait for IRB approval and written authorization from OHRP.

No research activities may continue until approval is received, except those necessary for the participant’s safety and welfare (with IRB Chair permission).

If the IRB disapproves continued participation, the participant must be withdrawn. For additional information, refer to OHRP Guidance–Prisoner Involvement in Research (May 23, 2003)

If no research activities occur during incarceration, and the participant resumes participation after release, Subpart C review may not be required—but you must still notify IRBO.

When reviewing research involving prisoners:

• The IRB must include a prisoner representative.
• A majority of IRB members cannot be associated with the prison.
• The IRB must document seven specific regulatory findings under 45 CFR 46.305.

If approved, NIH must submit certification materials to OHRP.

The research cannot begin until OHRP issues authorization.

Research involving prisoners is complex and requires early planning.

Contact IRBO before submission if:

• You are unsure whether Subpart C applies
• You anticipate enrolling even one prisoner
• A participant becomes incarcerated
• You are considering an epidemiologic waiver

OHRP Subpart C — Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 

OHRP Guidance – Prisoner Involvement in Research (May 23, 2003) 

OHRP Prisoner Research FAQs 

68 Fed. Reg. 36929 (Jun. 20, 2003) - Waiver of the Applicability of Certain Provisions of Department of Health and Human Services Regulations for Protection of Human Research Subjects for Department of Health and Human Services Conducted or Supported Epidemiologic Research Involving Prisoners as Subjects