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Research, Innovation & Impact

Research involving prisoners

Federal regulations have additional requirements to protect prisoners involved in human subjects research under 45 CFR 46 Subpart C. See below for answers to key questions.

Definition

Prisoners are defined as any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals:

  • Sentenced to such an institution under a criminal or civil statute.
  • Detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution.
  • Detained pending arraignment, trial or sentencing.

Examples

Examples provided by the Office for Human Research Protections (OHRP) include:

  • Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners; however, individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.
  • Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration are prisoners; however, individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness, or who have been civilly committed to nonpenal institutions for treatment because their illness makes them a danger to themselves or others, are not prisoners.
  • Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners.
  • Probationers and individuals wearing monitoring devices are generally not considered to be prisoners; however, situations of this kind frequently require an analysis of the particular circumstances of the planned subject population. Institutions may consult with OHRP when questions arise about research involving these populations.

Categories of prisoner research (45 CFR 46.306)

The study must fall under one of the four categories below.

  • Category I: Studies of possible causes, effects and processes of incarceration and of criminal behavior that involve no more than minimal risk and no more than inconvenience to the subjects.
  • Category II: Studies of prisons as institutional structures or of prisoners as incarcerated persons that involve no more than minimal risk and no more than inconvenience to the subjects.
  • Category III: Studies on conditions particularly affecting prisoners as a class. Studies may proceed only after the HHS Secretary has consulted with appropriate experts, including experts in penology, medicine and ethics, and published notice in the Federal Register of his intent to approve such research. Examples:
    • Vaccine trial and other research on hepatitis, which is much more prevalent in prisons than elsewhere.
    • Research on social and psychological problems, such as alcoholism, drug addiction and sexual assaults.
  • Category IV: Research on practices, both innovative and accepted, that have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups that may not benefit from the research, the study may proceed only after the HHS Secretary has consulted with appropriate experts, including experts in penology, medicine and ethics, and published notice, in the Federal Register of the intent to approve such research. 

For all categories of research not HHS supported or conducted, OHRP Subpart C certification is not required.

Note on categories III and IV: When the research is not HHS-supported or conducted, MU will consult with appropriate experts in penology, medicine, and ethics. The IRB will not submit the research to the HHS Secretary when it is not HHS supported or ondcuted. See our Additional Protections for Vulnerable Populations, International and non-English-Speaking Participants SOP for additional guidance.

Criteria for approval of prisoner research (45 CFR 46.305)

  1. The research falls under one of the four categories listed in the "what human subjects research can be conducted with prisoners" section.
  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. Unless the principal investigator provides to the Board justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.
  5. The information is presented in language that 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.
  7. Where the Board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
     

For epidemiologic studies, the following must be true:

  1. The sole purpose is one of the following:
     
    • To describe the prevalence or incidence of a disease by identifying all cases.
    • To study potential risk factor associations for a disease.
  2. The research presents no more than minimal risk and no more than inconvenience to the prisoner subjects.
  3. Prisoners are not a particular focus of the research.

Prisoners can only be involved if the research is aimed at a broader subject population that only incidentally includes prisoners. For example, it is acceptable to post a public survey link that prisoners might access and complete on their own, as long as they are not the intended focus of the study.

Yes, under one of the two options below involving minimal risk:

  • Research involving interaction with prisoners may be expedited if the IRB determines the research involves no greater than minimal risk for the prison population being studied.
  • Research that doesn’t involve interaction with prisoners (e.g., existing data or record review) may be expedited if the IRB determines the research involves no greater than minimal risk for the prison population being studied. 

Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives or in the routine medical, dental or psychological examination of healthy persons. The wording of the Subpart C definition differs from the Subpart A definition (which is generally applied to all research involving human subjects). The Subpart C definition:

  • Refers to “physical or psychological harm” as opposed to “harm or discomfort.”
  • Compares the probability and magnitude of harm in the research to the probability and magnitude of those harms normally encountered in daily life, or in “routine medical, dental or psychological examinations,” as opposed to “routine physical or psychological examinations or tests.”
  • Identifies “healthy persons” as the comparison group against which the risks of the research should be measured, rather than leaving the comparison group unspecified. “Healthy persons” refers to individuals who are not prisoners.

Generally, it is no different than studies without prisoners. 

  • Expedited studies can be submitted at any time, as there are no deadlines for expedited review.
  • Studies requiring full board review must be submitted by the 25th of each month.
  • Typically, for studies not involving prisoners, the turnaround time for complete submissions is 10-14 days.
  • Because prisoner research requires review by an IRB-appointed prisoner representative, it may take a little longer.
  • If the study is federally funded, the MU IRB must certify (send documentation) to the Office of Human Research Protections (OHRP) stating MU IRB reviewed the research and determined that all criteria for approval specified by federal regulations are met. Research may begin only after OHRP authorizes the research by notifying MU they agree with the determinations of the MU IRB. This can take additional time. Please consult with the IRB early if you anticipate submitting a study involving prisoners.

The IRB recognizes that research involving prisoners raises the issue of whether the subject’s situation prohibits the exercise of free choice to participate in research and whether the prisoner’s confidentiality will be adequately maintained. 

Researchers must ensure consent is voluntary, informed and documented while also protecting prisoners’ rights and welfare. This includes addressing potential coercion, ensuring confidentiality and providing adequate information about the research and its potential impact on the prisoner. 

Please see our Informed Consent and Assent Process FAQs for the types of consent and when they apply. 

Written informed consent (or the electronic equivalent) must be obtained unless the study is minimal risk and meets the requirements for a waiver of documentation of consent (no signature required).

Consent may be waived or altered so long as the IRB reviews the research and makes the appropriate findings regarding the waiver or alteration of informed consent requirements. However, even if informed consent is waived or altered, subjects must be clearly informed in advance that participation in the research will have no effect on their parole, if such notification is relevant. See 45 CFR 46.305(a)(6).

However, prisoners cannot be involved in planned emergency research where the requirement for informed consent has been waived by the Secretary under the authority of 45 CFR 46.101(i).

Many penal institutions and authorities have different restrictions regarding compensation. Please check with the appropriate officials prior to developing your plan for compensating incarcerated subjects and carefully consider how compensation may influence a prisoner’s willingness to participate. Institutional privileges cannot be granted for participating in the research. 

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. In addition, parole boards may not take into account a prisoner’s participation in the research in making decisions regarding parole and each prisoner is informed in advance that their participation will have no effect on his or her parole.

First, confirm the participant meets the federal definition of a prisoner (see first section on this page).

If the participant is a prisoner, you must either: 

  • Terminate enrollment (considering the risks associated with terminating) and consult the IRB.
  • Submit an amendment form to either:
     
    • Include prisoners (if it’s feasible for the participant to remain in the study).
    • Add the individual as a new participant in the study.

The Federal Bureau of Prisons has adopted extensive regulations for researchers seeking to use federal prisoners as research subjects. 

Among other things, these regulations prohibit use of prisoners within federal facilities for “medical experimentation, cosmetic research or pharmaceutical testing” 28 C.F.R. 512.11(a)(3). 

In addition, strict limitations are imposed on incentives to prisoner participants, and researchers may not promise confidentiality to subjects who reveal a future intent to engage in criminal behavior.