1PURPOSE
1.1This document describes the requirements and procedures for research involving prisoners.
2POLICY
2.1Regulations about research with prisoners. Different federal funding agencies have different regulations concerning the involvement of prisoners in research. It is UW policy to comply with all applicable regulations, as follows:
2.1.1Research involving any of the federal agencies that signed the regulations at 45 CFR 46 SubpartC.The HHS regulations (45 CFR 46 Subpart C) apply to all research involving prisoners that is supported by:
2.1.1.1Health and Human Services (HHS)
2.1.1.2Department of Defense (DOD)
2.1.1.3Department of Homeland Security
2.1.1.4Central Intelligence Agency
2.1.1.5Department of Energy
2.1.2Research involving the Department of Defense.In addition to the Subpart C requirements, DOD-supported research cannot involve prisoners of war.
2.1.3U.S. Department of Justice and Bureau of Prisons. These agencies have their own requirements that differ significantly from the HHS Subpart C regulations. The UW applies Subpart C to research involving these agencies only as described in Section 2.1.5.
2.1.4Food and Drug Administration (FDA).The FDA does not have any regulations specific to prisoner research.
2.1.5All other research: The UW applies its Flexibility Policy by choosing to comply with all of the requirements of the Subpart C regulations for all research, except for the following:
2.1.5.1Certification and authorization
2.1.5.2HHS Secretarial Consultation
2.1.5.3Requirement to categorize, and restrict, prisoner research within five federally-described categories of research
2.1.5.4Prohibition against granting exempt status. However, the UW restricts exempt status to certain types of prisoner research (seeGUIDANCE: Exempt Research).
2.1.5.5Management of incidental prisoners (see Section 8).
2.2Emergency exception to informed consent. The waiver of informed consent allowed for certain types of more-than-minimal risk emergency research is not permitted for federally funded research involving prisoners, by federal regulation. However, continued involvement of prisoners who are inadvertently enrolled in such research is allowed, if the prisoners provide informed consent for their continued participation (reference 11.7).
2.3Level of IRB review.
2.3.1Initial review may be performed by the expedited process instead of the full convened IRB when:
2.3.1.1The research involves no interaction or intervention with prisoners; and
2.3.1.2The research meets the standard criteria for expedited review and the definition of minimal risk as defined for prisoners.
2.3.1.3The reviewer is encouraged to obtain consultation from a prisoner advocate, as needed.
2.3.2Continuing review must be performed using the same process as the initial review, unless the research qualifies for expedited review.
2.3.3Modificationsto studies initially reviewed by a full convened IRB are reviewed as follows:
2.3.3.1More than a minor change (as defined in the SOP Expedited Review): the full convened IRB must conduct the review and a prisoner advocate must participate in the review.
2.3.3.2Minor change: may be reviewed by the expedited process. The reviewer is encouraged to obtain consultation from a prisoner advocate, as needed.
2.4Research involving prisoners cannot begin until all of the applicable requirements and procedures described in this document have been completed.
2.5These regulations, requirements, and procedures apply to:
2.5.1Individuals who are prisoners at the time of enrollment in the research, and
2.5.2Individuals who become prisoners after they are enrolled in the research.
2.6Researchers are responsible for identifying and ensuring compliance with the laws and regulations of the applicable prison jurisdiction(s). The IRB application should specify the prison jurisdictions involved.
3DEFINITIONS
3.1Prisoner: Any individual involuntarily confined or detained in a penal institution. The term includes 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.
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.
Examples of the application of this definition:
Substance abuse treatment. Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners. Individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.
Psychiatric institutionalization.Individuals with a psychiatric illness who have been committed involuntarily to an institution as an alternative to criminal prosecution or incarceration are prisoners.Individuals who have been voluntarily institutionalized or who have been civilly committed to non-penal institutions for treatment because their illness makes them a danger to themselves or others are not prisoners.
Parole.Parolees who are detained in a treatment center as a condition of parole are prisoners. Persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners.
Probation; monitoring devices. Probationers and individuals wearing monitoring devices are generally not considered to be prisoners. However, situations of this kind frequently require an analysis of the particular circumstances. Consult with HSD management, who may consult with OHRP.
3.2“Incidental” prisoner subjects. Subjects may become incarcerated after they have already enrolled in a study. For example, a longitudinal study of non-incarcerated youth at high risk for drug and alcohol abuse is likely to eventually have subjects who become incarcerated during the course of the study.See Section 8 (below).
3.3Minimal risk definition for prisoner research: 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.OHRP interprets the term “healthy persons” as referring to healthy persons who are not prisoners. Note that this definition of minimal risk differs from the definition of minimal risk for other research.
3.4Prisoner advocate:An IRB member who has a close working knowledge, understanding and appreciation of prison conditions from the perspective of prisoners. The prisoner advocate may be a former prisoner or anyone else who meets the requirements stated here (examples: public defense attorney; prison chaplain; volunteer counselor; member of a community-based prisoner advocacy group).The prisoner advocate cannot be an employee of a correctional system.
3.5Certification: The process by which an IRB communicates to the federal Office of Human Research Protections (OHRP) that the IRB has reviewed and approved a study involving prisoners in compliance with applicable federal regulations governing prisoner research. See Section 7 (below).
4RESPONSIBILITIES
4.1Specific responsibilities of the IRB, researchers, and IRB staff are described throughout this document.
5PROCEDURES: Researcher Requirements
5.1Researchers conducting non-exempt researchmust provide the UW IRB with a completed Supplement for Vulnerable Populations as part of the paper application packet. The application materials should specify the prisonjurisdictions involved. Researchers submitting in Zipline do not need to use this supplement; the required questions are embedded in the IRB Protocol form.
5.2Researchers are responsible for identifying and ensuring compliance with the laws and regulations of the applicable jurisdiction(s) and of the penal institutions.
6PROCEDURES: IRB Review
6.1Pre-review by HSD staff. In addition to standard pre-review activities, the appropriate IRB administrator also:
6.1.1Identifies all applicable regulations about research with prisoners.
6.1.2Provides the IRB with information about the applicable regulations and their requirements.
6.1.3If required by applicable regulations: identifies the most appropriate federally-defined category of prisoner research and recommends it to the IRB for their consideration and determination.
6.2Special composition of the IRB. When a full convened IRB reviews research involving prisoners, the following requirements must be met(even when prisoners are not the focus of the study):
6.2.1A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved.
6.2.2At least one voting member of the IRB must be a prisoner advocate (see Definitions, Section 3) with appropriate background and experience to serve in that capacity, unless the research is occurring at multiple sites and another site has already conducted IRB review with a prisoner advocate.
6.2.2.1When a research project is reviewed by more than one IRB, only one of the IRBs needs to satisfy this requirement. It is UW policy that to assume that the UW IRB will need to satisfy this requirement unless documentation of prisoner advocate review at another institution is provided to the UW IRB.
6.2.3The prisoner advocate must receive all review materials (same as the primary reviewer).
6.2.4The prisoner advocate must participate in any review by the convened IRB of research involving prisoners. Participation may be in person, by phone, video-conference, or other medium. If the prisoner advocate cannot participate, the review cannot proceed.
6.2.5The prisoner advocate must present his/her review to the IRB (orally or in writing) at the meeting when the prisoner research is reviewed.
6.3IRB member rosters and prisoner advocates.The resume or vitae of the prisoner/prisoner advocate member should clearly establish the member’s qualifications for the role of prisoner advocate.
6.3.1Prisoner advocates are listed on the IRB membership roster as voting members but with the stipulation in the “Comments” section that the advocate will only count towards quorum when s/he is in attendance and reviewing studies that are governed by Subpart C.
6.3.2HSD staff are responsible for tracking quorum requirements and changes throughout an IRB meeting (see SOP IRB Meeting Conduct), including the potential impact when a prisoner advocate joins an ongoing meeting.
6.4Level of IRB review. Prisoner research may qualify for expedited review, as described above in Section 2.3.
6.5Required IRB findings. The IRB may approve the research involving prisoners only if it makes the determinations described in the WORKSHEET: Prisoners,except for research involving the National Institute of Justice, Department of Justice, or the federal Bureau of Prisons.
6.5.1Research involving the National Institute of Justice, Department of Justice or the federal Bureau of Prisons. There are numerous additional responsibilities for the IRB and the researcher. The WORKSHEET:Department of Justice is used for guidance and documents the actions and determinations of the IRB in the CHECKLIST: Master.
6.6Waiver of consent.The standard procedures and requirements for waiving or altering consent apply to prisoner research. However, even if informed consent is waived or altered, the HHS prisoner regulations still require that the prisoner subjects be clearly informed in advance that participation in the research will have no effect on their parole, if such notification is relevant.
6.6.1The exception to the informed consent requirement that is allowed for certain types of more-than-minimal risk emergency research are not allowed for research involving prisoners that is subject to the Subpart C regulations, except as described below in Section 9.
7PROCEDURES: Certification
7.1Prisoner research supported by any federal agency that adopted the HHS Subpart C regulations must meet two additional requirements.
7.1.1Certification. The UW must certify to the Secretary of the U.S. Department of Health and Human Services through the Office of Human Research Protections (OHRP) that one of its IRBs has reviewed and approved the research in compliance with the applicable regulations; and
7.1.2Authorization. The Secretary (through OHRP) must determine that the proposed research falls within the categories of permissible prisoner research and that the IRB review has met the special requirements for prisoner research. The research cannot begin until the UW IRB has received OHRP’s authorization letter.
7.2Certification materials.After the IRB review has been completed, HSD staff that support the IRB prepare the packet of certification materials required by OHRP:
7.2.1The IRB-approved protocol.
7.2.2Any relevant grant application or proposal that was submitted to funding agencies (e.g., NIH) within the federal Department of Health and Human Services.
7.2.3The complete IRB application.
7.2.4Any other information requested or required by the IRB, and considered during the IRB review.
7.2.5A draft letterwith the following information:
7.2.5.1Statement that the IRB has reviewed the research under regulations 45 CFR 46, Subpart C and has made the seven findings required under 45 CFR 46.305(a).
7.2.5.2Which categories of permissible prisoner research applies to the study.
7.2.5.3Name and address of the UW and HSD.
7.2.5.4UW OHRP assurance number (i.e., FWA number).
7.2.5.5Name and IRB registration number of the IRB that performed the review.
7.2.5.6Name of the federal funding agency, and relevant grant number.
7.2.5.7The date(s) of the IRB meeting(s) in which the protocol was considered, including a brief chronology that encompasses:
7.2.5.7.1Date of initial IRB review.
7.2.5.7.2Date of review of prisoner involvement.
7.3Letter completion and submission. A member of the HSD management team reviews, edits, and signs the certification letter.
7.3.1Copies of the completed letter are made for the IRB file and for the researcher.
7.3.2The letter and packet are sent to OHRP, with receipt acknowledgment requested.
7.4Authorization by OHRP. OHRP determines whether the proposed research involves one of the permissible categories of prisoner research, and if so which one. Following its review of the certification packet, OHRP sends HSD a letter with its determination and decision.
7.4.1OHRP has the authority to re-categorize the study from the category identified by the UW IRB to what OHRP determines to be a more appropriate category.
7.4.2A copy of the OHRP determination letter is provided to the researcher, indicating that prisoner involvement can proceed. The original OHRP letter is placed in the IRB file.
7.5Modifications. Modifications to the approved and certified study do not require re-certification with OHRP unless there is a fundamental change in the research that alters the applicability of the approved prisoner research category.
7.6Multi-site studies. Some prisoner studies may be “multi-site” studies, meaning that multiple institutions are engaged in the same research study involving prisoners. Each engaged institution must certify to OHRP, 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.
7.6.1This is in contrast to the requirement for involvement for a prisoner advocate. Only one of the sites needs to meet the requirement for involvement of a prisoner advocate.
8PROCEDURES: “Incidental” prisoners
8.1“Incidental” prisoner subjects. Subjects may become incarcerated after they have already enrolled in a study. For example, a longitudinal study of un-incarcerated youth at high risk for drug and alcohol abuse is likely to eventually have subjects who become incarcerated during the course of the study.
8.2Anticipation of incidental prisoner subjects.If this is likely, researchers should point out this possibility to the IRB in the IRB application. When reviewing the study, the IRB uses its discretion to decide whether to review the research for prisoner involvement (including certification and OHRP authorization, if required), in anticipation of the possibility that some subjects may become prisoners. In making this decision, the IRB considers:
8.2.1The probability that study subjects will become prisoners;
8.2.2The importance of continuing the study while subjects are incarcerated (i.e., can study procedures wait until after the subject has been released from incarceration);
8.2.3Any negative impact on future incarcerated subjects if prisoner review has not already occurred, due to the delay required for additional IRB review and for the certification process; and
8.2.4Whether there is sufficient information available to make the required prisoner-related findings.
8.3Incidental prisoner subjects in a study not already approved for prisoners.
8.3.1Reporting to the IRB.Ifthe researcher would like study activities or data collection to continue while the subject is incarcerated the researcher reports the situation to the IRB within 3 business days, by submitting aPAPER REPORT: RNIfor paper applications, or submitting a Report of New Information (RNI) with associated modification for studies in Zipline (seeINSTRUCTIONS: Submit RNI (Researcher Version) and INSTRUCTIONS: Create Study Modification).
8.3.1.1If study activities/data collection will cease while the subject is incarcerated or the subject is safely withdrawn from the study the event does not require reporting.
8.3.1.1.1For Department of Defense funded EFIC (Exception From Informed Consent) studies only: All incidental incarceration of a research subject must be reported to HSD (using the process described in section 8.3.1), even if study activities and data collection will not occur during the incarceration.
8.3.2Continuation or termination of research procedures.All research interactions and interventions with, and obtaining identifiable private information about, the incarcerated subject must cease except as noted here.
8.3.2.1For research involving federal agencies that apply Subpart C regulations:
8.3.2.1.1Terminate the participant’s enrollment, OR review the research under Subpart C if it is feasible for the participant to remain in the study, OR postpone study procedures until the subject is no longer incarcerated.
8.3.2.1.2Before terminating enrollment, the IRB should consider the risks associated with terminating participation in the study.
8.3.2.1.3If the participant cannot be terminated for health or safety reasons:
8.3.2.1.3.1Keep the participant enrolled in the study and review the research under Subpart C. If some of the requirements of Subpart C cannot be met, but it is in the best interests of the participant to remain the study, keep the participant enrolled and inform OHRP of the decision along with the justification, OR
8.3.2.1.3.2Remove the participant from the study and keep the participant in the study intervention under an alternate mechanism such as compassionate use, off label use, etc.
8.3.2.2For research involving the Department of Justice or Bureau of Prisons: follow their regulations and guidance.
8.3.2.3For all other research: decide whether it is in the best interests of the participant to remain in the study or to terminate enrollment, and whether it is feasible for the participant to remain in the study.
8.3.2.3.1If it is in the best interests of the participant to remain in the study, keep the participant in the study and review the research at the next meeting of the convened IRB.
8.3.2.4If the subject will be incarcerated temporarily, it is possible that the incarceration will have no effect on the study – for example, it may be possible to delay doing a scheduled follow-up interview until after the subject has been released from incarceration. If this is the case, then the subject may remain enrolled without the IRB conducting a prisoner research review.