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Prisoners

Prisoners are identified as a vulnerable population because they may be limited in their ability to make a truly voluntary and un-coerced decision regarding research participation. A prisoner is any individual who is involuntarily confined or detained in a penal institution. This includes individuals who are:

  1. serving criminal or civil sentences in prison or jail,
  2. detained while awaiting arraignment, trial, or sentencing,
  3. confined in facilities as an alternative to prosecution or incarceration such as court-ordered residential substance abuse treatment, and
  4. involuntarily committed to an institution as an alternative to jail.

Individuals on probation, parolees, or those wearing a monitoring device are generally excluded from the definition of prisoner unless there is a condition of confinement that restricts their freedom of movement.

This webpage includes information on the following:

Considerations for Prisoners as Research Participants

Additional safeguards to protect the rights and welfare of prisoner participants are outlined in 45 CFR 46 Subpart C.  These additional protections apply when the research intends to enroll prisoners in the study, and when an enrolled participant becomes incarcerated during study participation and research activities will continue during their incarceration.

When prisoners are to be included as research participants, the IRB application should address the intent to include this population and explain how risks will be minimized, consent will be obtained, and privacy and confidentiality concerns will be addressed as they relate to the participant’s status as a prisoner. Additionally, recruitment of prisoners for participation in research must be conducted independently of prison staff to prevent undue influence.  The consent form should also include a statement that:

  • The prisoner participant’s legal standing, including their sentence or any term of probation or parole, will not be impacted by their decision to take part in the study or to refuse to participate in the study.  
  • No data collected in the study will be shared with the Department of Corrections. 

Permitted Categories of Research Involving Prisoners

Federal regulations (45 CFR 46 Subpart C (§46.306)) include four permissible categories for research involving prisoners. This includes research on the causes of criminal behavior, conditions affecting prisoners as a class such as infectious diseases, or practices intended to improve the prisoner participant’s health or well-being.

CategoryRequirementExamples

§46.306(a)(2)(i)

 

 

  1. Study of the possible causes, effects, and processes of incarceration or criminal behavior;
  2. Research must involve no more than minimal risk; and
  3. Research presents no more than inconvenience to the participants.
  • A study of the relationship between substance use, mental illness, and criminal activity
  • A study on the impact of parental incarceration on youth in juvenile detention centers

 

§46.306(a)(2)(ii)

 

  1. Study of prisons as institutions or of prisoners as incarcerated individuals;
  2. Research must involve no more than minimal risk; and 
  3. Research presents no more than inconvenience to the participants.
  • An observational study assessing ambient noise, temperature, and air quality in distinct cell blocks.
  • A study evaluating the nutritional quality and dietary standards of prison food.

 

§46.306(a)(2)(iii)

 

  1. Research on conditions particularly affecting prisoners as a class;
  2. May involve more than minimal risk;
  3. Does not require direct benefit; and
  4. Requires HHS Secretary level approval and notice published in the Federal Register.
  • Testing vaccines or treatments for hepatitis which is much more prevalent in prisons than elsewhere
  • A study evaluating social and psychological conditions prevalent among incarcerated populations such as alcoholism, drug addiction and sexual assaults

 

§46.306(a)(2)(iv)

 

  1. Research on practices intended to improve the health or well-being of the prisoner participant.
  2. For studies including a control group which may not benefit from the research, HHS Secretary level approval and notice publication in the Federal Register required.
  • Testing a new, experimental medication for hepatitis C that is otherwise unavailable in the standard prison clinic
  • A study of a new cognitive behavioral therapy program designed to reduce severe depression symptoms in incarcerated individuals

Federal regulations also allow prisoners to be included in some epidemiological research when the following criteria are met:

  • The sole purpose of the research is to describe disease prevalence/incidence or risk factor associations for a disease;
  • The research poses no more than minimal risk and no more than inconvenience; and
  • Prisoners are not the specific target population or particular focus of the research.

For epidemiological and federally funded research involving prisoners, approval from the Office for Human Research Protections (OHRP) must first be obtained before the research can commence. The IRB will facilitate OHRP’s review.

Additional IRB Requirements

The IRB must find that the prisoner research complies with the following seven additional requirements as specified in the federal regulations (45 CFR 46 Subpart C (§46.305)).  The IRB application should address how requirements 2-7 have been met.

  1. The study satisfies the criteria for permissible research.
  2. Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.
  3. The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.
  4. Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project unless justification is provided for following some other procedures.
  5. The information is presented in language which is understandable to the subject population.
  6. Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole. AND
  7. Follow-up examination or care of participants after the end of their participation is provided, when needed, and adequate provisions have been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.

Research involving prisoners typically requires review by the convened IRB with a prisoner representative present when the research is reviewed. Additional time for IRB review may be required based on the availability of the prisoner representative. 

FAQs

The regulatory definition of minimal risk for prisoners differs from how it is defined for other populations. The federal regulations (45 CFR 46 Subpart B (§46.303)) define minimal risk in prisoner research as the probability and magnitude of physical or psychological harm normally encountered in the daily lives or routine examinations of healthy persons who are not incarcerated.

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. See the Exempt Research webpage for additional information.

If a participant becomes incarcerated and the IRB approved protocol was not previously approved for prisoner participants, a prompt report should be submitted to the IRB explaining when the researchers learned of the participant’s status as a prisoner and if any study activities have been conducted during the participant’s incarceration. Additionally, a modification to the IRB application will be required to include prisoner participants if study participation will continue during the participant’s incarceration. All identifiable data collection and research interactions, except those required for the participant’s continued safety and welfare, should stop until the modification to add prisoner participants to the research has been approved by the IRB and HHS federal approval received, if required.

In addition to federal and state requirements, a waiver from the Chief Research and Development Officer (CRADO) is required for VA investigators to conduct research involving prisoners while on official duty or at VA facilities. The CRADO waiver request will need to include the rationale for conducting the research involving prisoners and additional protections that will be taken to ensure prisoners are able to make voluntary and un-coerced decisions about participation in the research.

California (Section 3502) prohibits all biomedical research on prisoners with the exception of participation in investigational new drug (IND) research when the following conditions are met:

  • Any physician who provides medical care to prisoners may provide a patient who is a prisoner with a drug or treatment through a treatment protocol or treatment IND; and
  • The physician determines that access to that drug is in the best medical interest of the patient; and
  • The prisoner participant has provided informed consent.

Additionally, research involving California state prisoners or facilities requires approval from the California Department of Corrections and Rehabilitation (CDCR) and the Committee for the Protection of Human Subjects (CPHS). When there is participant compensation, a predefined plan for compensation is set by the warden.

Research involving prisoners or facilities in county or municipal detention centers, such as San Mateo County Correctional Facilities, may have additional local requirements. 

Resources

Page updated July, 2026