A prisoner is defined by the U.S. Department of Health and Human Services 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.
While individuals under probation or parole are in an extremely vulnerable situation, they are not considered to be prisoners.
The regulations allow for four categories of research with prisoners as subjects that are allowable:
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.
Study of prisons 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.
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).
Research on practices, both innovative and accepted, which have the intent and reasonability of improving the health or well-being of the subject.
When investigators plan on using prisoners as subjects, they must include a justification for the use of prisoners as well as an explanation of how the research falls into one of these allowable categories.
When a protocol 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 nonprisoner 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 protocol.
Note: For Health and Human Services-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 conducting research with prisoners, initial protocols, 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 protocol.
When a previously enrolled subject becomes a prisoner, all research interactions and interventions with (and the obtaining of identifiable private information about) the now-incarcerated subject must cease, and the principal investigator must notify the IRB.
If the investigator would like to continue the subject's involvement in the research, the protocol must be reviewed by the IRB in accordance with subpart C of the Code of Federal Regulations (by the full committee with a prisoner representative present) before research with the subject may continue.
Alternatively, the investigator may discontinue the subject's involvement with the research.
Note: In special circumstances in which the principal investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, an IRB chairperson or designee may determine that the subject may continue to participate in the research until the requirements of subpart C are satisfied.
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All research involving prisoners must be reviewed by the full committee in accordance with subpart C of the Federal Regulations, including all modification and continuation requests.