45 CFR 46.303(c.)
Who is a Prisoner?
Prisoner means 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.
The regulations governing research involving human subjects have regulations specific to research that will involve prisoners as study subjects. These are enumerated in Subpart C of 45 CFR part 46 and in IRB SOP 503: Research Involving Prisoners.
To ensure that the research conforms to all of the requirements, the IRB uses a Subpart C Checklist
When Study Subjects become Prisoners after Enrolling in a Clinical Research Study
When research plan does not intend to enroll prisoners, subjects may still becomes incarcerated. Incarceration of a subject must be reported to the IRB as soon as practicable in order to determine whether or not they may continue to participate in the study and if so, whether or not the IRB must re-review the research to apply Subpart C protections.
Federally Funded Research
When the research is federally funded, the regulations require that the IRB apply all of the protections of Subpart C . The research will require review at meeting attended by a prisoner representative and the IRB must determine if the research meets all of the requirements for approval under Subpart C.
What Activities Must Cease?
All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must be suspended immediately (except as noted below).
Upon receipt of the investigator's report that a previously enrolled research subject has become a prisoner, if the investigator wishes to have the prisoner subject continue to participate in the research, the IRB must promptly re-review the proposal in accordance with the requirements of Subpart C, and the institution(s) engaged in the research involving the prisoner subject must send a certification to OHRP and wait for a letter of authorization in reply. Otherwise, the prisoner subject must stop participating in the research, except as noted below.
Exception to the Requirement to Cease All Research Activities
OHRP allows one important exception to the requirement that all research interactions or interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease until the regulatory requirements for research involving prisoners are met.
In special circumstances in which the investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, the subject may continue to participate in the research until the requirements of Subpart C are satisfied.
The investigator must promptly notify the IRB of this occurrence, so that the IRB can re-review the study.
Note that in these circumstances, some of the regulatory criteria may not be applicable; for example, the criterion regarding the selection of subjects within the prison may not be applicable, if the subject was recruited outside of an incarcerated context.
The IRB will document these findings accordingly and the PI will be informed of the outcome of this review.
Research that is not Federally Funded
When the research is not federally funded, IRB SOP 503: Research Involving Prisoners permits subjects who enrolled in a research study prior to incarceration to continue participation, whenever it is practicable.
Epidemiologic Studies Involving Prisoners
For epidemiologic studies involving prisoners the IRB must find that 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.
- 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.
More information about Prisoners in Research
- Prisoner Research - FAQs on OHRP's website (19 FAQs)
- OHRP Guidance on the Involvement of Prisoners in Research (2003)