All research involving prisoners must be reviewed by the full committee, including all modification and continuation requests. 

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45 CFR 46 Subpart C

Research with Prisoners

A prisoner is defined by HHS as any individual involuntarily confined or detained in a penal institution or facility, including individuals sentenced under criminal or civil statute or commitment proceedings which provide alternatives to incarceration, and individuals detained pending arraignment, trial, or sentencing. 

Note: While individuals under probation or parole are in an extremely vulnerable situation, they are not considered to be prisoners.

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Allowable Categories of Research

The regulations allow for four categories of research with prisoners as subjects that are allowable:

  1. Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.

  2. Study of prisoners as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.

  3. Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisoners than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults).

  4. Research on practices, both innovative and accepted, which have the intent and reasonability of improving the health or well-being of the subject. 

Additional Review Considerations

When an application is determined to fall into one of the allowable categories listed above, the IRB must consider in its deliberations:

  • Any advantages that prisoners will realize as a result of participation in the research, when compared to general living conditions within the prison, are not so great as to impair the prisoner’s ability to weigh the risks and benefits of participation and freely choose
  • The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers
  • Procedures for selecting subjects within the prison are fair, and free from arbitrary manipulation by prison authorities or other prisoners
  • Control subjects will be selected randomly from among the group of eligible volunteers, unless the principal investigator justifies a different procedure
  • The information presented during recruitment and consent procedures is in a language, and level of complexity, understandable to the subject population
  • The IRB is assured that the parole board will not take research participation into account in making decisions about parole, and each prisoner is informed in advance that participation will have no effect on the possibility of parole 
  • If medical follow-up is necessary to protect the health and welfare of the subject, adequate provision is made for such care, taking into account the varying length of prisoners’ sentences

The above considerations should be taken into account when completing the application. 

Note: For HHS-funded research involving prisoners, the IRB must certify to the Secretary (through OHRP) that it has reviewed the research and all additional considerations outlined above have been met. For research falling under categories 3 and 4, the Secretary will consult with experts, including experts in penology medicine and ethics, and publish a notice in the Federal Register of his intent to approve the research. 

When Participants Become Prisoners After Enrollment in Research

If a research participant is incarcerated after his/her enrollment in the research, the principal investigator must submit a Modification Request to the IRB to add the category of prisoners as a participant population. All research involving the subject must cease until the IRB approves the modification unless it is deemed to be in the participant’s best interest to continue his/her participation. IRB approval must still be sought immediately, however. 

Review Classification

When conducting research with prisoners, initial applications, modification requests, or continuation requests may not be reviewed under expedited review, but must be reviewed by the full committee. In addition, at least one member of the review board must be a prisoner or prisoner representative with the appropriate background, experience, knowledge, understanding, and appreciation for the conditions of the prison from the prisoner’s perspective, and no other board member may have any association with the prison(s) involved other than to review the application.