HRPP Manual Section 6-8-B
Special Categories of Research Subjects: Prisoners
Because prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is important to provide additional safeguards for the protection of prisoners (45 CFR 46.302). The Institutional Review Board (IRB) follows the requirements of 45 CFR 46 subpart C or equivalent protections as allowed by law.
Definition of Prisoners
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.” (45 CFR 46.303(c)). Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial.
Additional Requirements For IRB Composition and Review When Prisoners are Subjects
When research will involve prisoners as defined in the regulations, applications for initial review and renewal may not undergo an expedited review procedure; applications must be taken to the convened IRB for review and discussion. A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the IRB. The IRB member prisoner representative, who has appropriate background and experience to serve in that capacity, must be present (in-person or through web conferencing or teleconferencing) if the IRB reviews prisoner research at a convened IRB meeting. In addition, the IRB chair should assign the IRB member prisoner representative as the primary reviewer. Proposed minor changes that would otherwise qualify for expedited review may undergo an expedited review procedure. See the Human Research Protection Program (HRPP) Manual 8-6 “Revisions to an Approved Research Study” and 8-2 “Expedited Review Procedure.” The IRB member(s) reviewing the proposed minor change under the expedited procedure must include a prisoner representative.
Subject Becomes a Prisoner During Course of Research Study
If a human subject involved in ongoing research becomes a prisoner during the course of the study, and the relevant research was not reviewed and approved by the IRB in accordance with the requirements for research involving prisoners under subpart C of 45 CFR part 46, the investigator must promptly notify the IRB. 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.
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 findings required by 45 CFR 46.305(a) may not be applicable; for example, the finding required under 45 CFR 46.305(a)(4) regarding the selection of subjects within the prison may not be applicable, if the subject was recruited outside of an incarcerated context. The IRB should document findings of non-applicability accordingly. For U.S. Health and Human Services (HHS) conducted or supported research, certification must be obtained in accordance with 45 CFR 46.305(c).
Subject is Incarcerated Temporarily
If a subject is incarcerated temporarily while enrolled in a study and the temporary incarceration has no effect on the study, the subject may remain enrolled in the study if research activities, including the collection of identifiable information from the prisoner-subject, are paused during the subject’s incarceration.
If a subject is incarcerated temporarily while enrolled in a study and the temporary incarceration has an effect on the study (e.g., may affect the prisoner-subject’s health or safety), the process described above for circumstances when a human subject involved in ongoing research becomes a prisoner during the course of the research study would be followed.
Likely that Some Subjects are Likely to Be or Become Prisoners
If investigators anticipate that some of the subjects in a planned research study population are likely to be prisoners or become prisoners during the course of the study (for example, subjects in substance abuse treatment studies) the IRB may review the research prospectively for prisoner involvement in accordance with the requirements of subpart C of 45 CFR part 46. When an IRB reviews a research proposal in which the subjects are not prisoners, but in anticipation of the likelihood that some of the subjects will become prisoners during the course of the research, some of the seven findings required by 45 CFR 46.305(a) may not be applicable. As examples, if subjects are not recruited from within a prison, the finding under 45 CFR 46.305(a)(4) would not be applicable; and, if there is no particular parole board involved yet, the finding under 45 CFR 46.305(a)(6) would not be applicable. The IRB should document these findings accordingly. For HHS conducted or supported research, MSU must certify the research to the U.S. Office for Human Research Protections (OHRP) and the IRB must wait for OHRP to authorize the research study prior to initiating any interaction or intervention with, or obtaining identifiable private information about, prisoners.
The IRB should use their discretion in deciding whether to apply the additional requirements of subpart C to research in anticipation of some subjects being or becoming prisoners. In some cases, the involvement of subjects who may be prisoners or become prisoners can be anticipated in ways that make the additional protections of subpart C meaningful. In other cases there may be insufficient information available at that time to make the seven findings required by 45 CFR 46.305(a) (for example, the IRB may not know the specific penal institutions where subjects will be prisoners and therefore will lack important information about the local research context), and the IRB may have to wait until more specific information becomes available. In these instances, the IRB would need to conduct the subpart C review after research subject(s) have become incarcerated.
Categories
The following are the only categories (from 45 CFR 46.306(a)(2)) in which it is permissible to use prisoners as research subjects. The IRB must find that the proposed research falls into one of the permissible categories of research unless the Secretarial waiver described below is applicable.
“(A) study of the possible causes, effects and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk or inconvenience to the subjects;
(B) study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk or inconvenience to the subjects;
(C) research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the 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; or
(D) research on practices, both innovative and accepted, which 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 which may not benefit from the research, the study may proceed only after the 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.”
In addition, there is a HHS Secretarial waiver for certain epidemiological research conducted or supported by HHS. The requirements under subpart C (additional findings, certification) still apply to this category of research. The final action on the waiver was published in the Federal Register, Vol. 68, No. 119 (June 23, 2003) and is provided below.
“Waiv[es] the applicability of 45 CFR 46.305(a)(1) and 45 CFR 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
-
(i) To describe the prevalence or incidence of a disease by identifying all cases; or
-
(ii) 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
-
(i) The research presents no more than minimal risk and no more than inconvenience to the prisoner-subjects, and
-
(ii) Prisoners are not a particular focus of the research.”
-
The definition of “minimal risk” for research involving prisoners is different from the definition in 45 CFR 46 Subpart A. For research involving prisoners, "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.” (45 CFR 46.303(d))
Additional Criteria for Approval
In order to approve research involving prisoners the IRB must determine that the following criteria (from 45 CFR 46.305) are met.
“(1) the research under review represents one of the categories of research permissible under §46.306 (a)(2);
(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 which 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; and
(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.”
Certification
For HHS conducted or supported research, MSU must certify and receive approval from the HHS Secretary before the research may be conducted at the institution. The institution must certify to the Secretary that the IRB has approved the research under 45 CFR 46.305 and the Secretary must determine that the proposed research involves solely the types of research described in 45 CFR 46.306 (unless the Secretarial waiver is applicable).
“The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that the duties of the Board under this section have been fulfilled.” 45 CFR 46.305(c)
However, if the study is a collaborative research study involving prisoners, each institution must certify to OHRP in accordance with the requirements of HHS regulations at 45 CFR 46.305(c) and 46.306(a)(1), unless (a) an institution relied upon the review of an IRB operated by another institution engaged in the research; and (b) that IRB or the other institution certified to OHRP on behalf of both institutions.
Documentation
Review and approval research involving prisoners follows the procedures as required by the level of review. See HRPP Manual 8-2 “Expedited Review Procedure” and/or 8-3 “Full Board Review Procedure” for policies and procedures on review and documentation required for research involving prisoners.
Additional Considerations
For research studies subject to the requirements of the U.S. Department of Defense, see HRPP Manual 2-2-A “U.S. Department of Defense.”
For research studies subject to the requirements of the U.S. Department of Justice, see HRPP Manual 2-2-C “U.S. Department of Justice."
Approved By: Vice President of Research and Graduate Studies, 3-3-2005, Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 1-6-2010. Revision 3 approved by VP Research & Graduate Studies on 7-22-2011. Revision 4 approved by VP Research & Graduate Studies on 12-9-2015. Revision 5 approved by Assistant VP Regulatory Affairs on 11-27-2021. Revision 6 approved by Associate VP Research Regulatory Support on 7-23-2022.