Vulnerable Subjects - Prisoners

Prisoners are considered a vulnerable research population because the very fact of incarceration may make it difficult for them to give truly voluntary informed consent.

• Prisoner is defined to include 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,
• individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and
• individuals detained pending arraignment, trial, or sentencing.

Persons receiving care in a medical treatment setting who are also "prisoners" as defined above, can be considered for enrollment in research only as permitted for other prisoners as subjects.

When a previously enrolled research subject becomes a prisoner, the Principal Investigator must notify the IRB immediately. The IRB should then promptly review the protocol in accordance with the requirements of 45CFR46 subpart C if the Principal Investigator wishes to have the prisoner subject continue to participate in the research.

Categories of Research in Which Prisoners May Participate

To protect this study population, federal regulations stipulate that the only studies that may use prisoners are the following:

• Studies of the possible causes, effects, and processes of incarceration and criminal behavior, if those studies present no more than minimal risk or inconvenience to the subjects.
• Studies of prisons as institutions, or of prisoners as incarcerated persons, if those studies present no more than minimal risk or inconvenience to the subjects.
• Research on conditions affecting prisoners as a class (e.g., research on hepatitis, drug addiction, sexual assaults, and other conditions more prevalent in a prison population than elsewhere), but only after the secretary of the Department of Health and Human Services has consulted with experts in medicine, ethics, and penology and published a notice approving the proposed research in the Federal Register.
• Research on practices that are intended, and reasonably likely, to enhance the well-being of the subjects; however, if some of the prisoners will be assigned to control groups which will not benefit from the research, then the study must first be approved by the secretary of the Department of Health and Human Services, after consultation with appropriate experts as described above.

The Secretary of DHHS waived the applicability of 45 CFR 46.305(a)(l) and 46.306(a)(2) for certain research conducted or supported by DHHS that involves epidemiologic studies that meet the following criteria:

• In which the sole purposes are to describe the prevalence or incidence of a disease by identifying all cases, or to study potential risk factor associations for a disease, and
• Where the institution responsible for the conduct of the research certifies to the Office for Human Research Protections, DHHS, acting on behalf of the Secretary, that the IRB approved the research and fulfilled its duties under 45 CFR 46.305(a)(2)-(7) and determined and documented that the research presents no more than minimal risk and no more than inconvenience to the prisoner-subjects, and prisoners are not a particular focus of the research.

Additional Duties of the IRB

When the IRB reviews research that will involve prisoners they are required to first confirm that the proposed study fits within the permissible categories of research described above. Then, it must determine:

• 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 (usually demonstrated by enrolling non-prisoner subjects from the community, as well).
• 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 subjects, adequate provision is made for such care, taking into account the varying length of prisoners' sentences.

Finally, an IRB that reviews research involving prisoners is required to have at least one member who is either a prisoner, or a prisoner representative; and a majority of the IRB members cannot be in any way associated with the prison(s) involved. (This requirement may be waived if two or more IRBs are involved in reviewing the same protocol, and at least one of the IRBs meets this condition.)