1. Purpose
This SOP outlines additional protections that researchers and the WVU IRBs must provide
to prisoners involved in human subject research. The requirements described below
apply to research involving prisoners and individuals who later become prisoners
during their research participation.
2. Overview
Federal regulations require additional protections for prisoners involved in research.
These requirements include that research involving prisoners (except for emergency
use) may not be exempt from IRB review (i.e., Exempt or Flex review mechanisms
at WVU), the IRB reviewing prisoner research must include a prisoner representative,
and the proposed research must fall into one of the permissible categories described
in the recommendations.
3. General Information
3.1. Prisoners may be convicted felons or untried individuals who are
detained pending judicial action. The following are examples of individuals who
are considered prisoners under these regulations:
- Individuals who are detained in a residential facility for court-ordered substance
abuse treatment as a form of sentencing or as an alternative to incarceration
- Individuals with psychiatric illnesses who have been committed involuntarily
to an institution as an alternative to a criminal prosecution or incarceration
- Parolees who are detained in a treatment center as a condition of parole.
3.2. The following are examples of individuals who are not considered
prisoners under these regulations:
- Individuals who are receiving non-residential, court-ordered substance abuse
treatment and are residing in the community
- Individuals who have been voluntarily admitted to an institution for treatment
of a psychiatric illness or who have been civilly committed to non-penal institutions
for treatment because their illness makes them a danger to themselves or others
- Persons living in the community and sentenced to community-supervised monitoring,
including parolees
- Probationers and individuals wearing monitoring devices are generally not considered
to be prisoners; however, the specific circumstances of the planned participant
population should be carefully considered
3.3. Researchers are “engaged” in research involving prisoners when (for
purposes of the research) they obtain data through intervention or interaction,
or obtain identifiable private information about the prisoners. The following are
examples of activities that constitute engagement in research involving prisoners:
3.4. In addition to the “standard” regulatory requirements for IRB composition
(see SOP 006: IRB Meeting Conduct), when reviewing research involving prisoners
the following requirements also apply:
- At least one member of the IRB must be a prisoner, or a prisoner representative
with appropriate background and experience to serve in this capacity
- The prisoner representative should have a close working knowledge and understanding
of prison conditions from the prisoner’s perspective
- The prisoner representative should have the ability to express views independent
of the prison administration
- If the research is reviewed by more than one IRB, only one IRB must satisfy
this requirement
- A majority of IRB members (other than the prisoner representative) has no association
with the prison(s) involved.
Note: The IRB must meet these composition requirements for all types of review
by the convened IRB, including initial review, continuing review, and review
of amendments.
3.5. Expedited review of research involving prisoners must include a prisoner
representative who meets the requirements to perform expedited review, as described
in SOP 018: Expedited Review.
3.6. The DHHS exemption categories do not apply to research involving
prisoners except when the exempt research examines a broader population that only
incidentally involves prisoners.
Note: this exception for incidental prisoner inclusion will be made by the WVU
IRB on a case-by-case basis.
3.7. Prisoners may be involved in the emergency use of an investigational
drug, biologic, or unapproved medical device. (See SOP 53: Emergency Use of an
Investigational Drug, Biologic, or Device.)
4. Permissable Categories of Research Involving Prisoners
4.1. The following categories of research may involve prisoners:
- Research on the possible causes, effects, and processes of incarceration and
criminal behavior, provided that the study presents no more than minimal risk
for prisoners and no more than an inconvenience to the participants.
- Research on prisons as institutional structures or of prisoners as incarcerated
persons provided that the study presents no more than minimal risk for prisoners
and no more than an inconvenience to participants.
- Research on conditions particularly affecting prisoners as a class (e.g., vaccine
trials and other research on hepatitis, which is more prevalent in prisons
than elsewhere, and research on social and psychological problems such as alcoholism,
drug addiction, and sexual assault).
Note: Research in this category conducted or sponsored by DHHS may proceed
only after the Secretary (DHHS) has consulted with appropriate experts, including
experts in penology, medicine, and ethics, and published notice in the Federal
Register of their intent to approve the research.
- Research on practices, both innovative and accepted, which have the intent and
reasonable probability of improving the health or wellbeing of the participant. Note: For research conducted or sponsored by DHHS that require the assignment (in a manner consistent with protocols approved by the IRB) of prisoners to control groups that may not benefit from the research, the research may proceed only after the Secretary (DHHS) has consulted with appropriate experts, including experts in penology, medicine, and ethics and published notice in the Federal Register of their intent to approve the research.
4.2. Epidemiologic studies (e.g., related to chronic diseases, injuries,
and environmental health) that do not meet the criteria above can also involve
prisoners under all of the following conditions:
- The research presents no more than minimal risk for prisoners (e.g., interviews,
collection of biological specimens, etc.) and no more than inconvenience to
the prisoner-participants.
- Prisoners are not a particular focus of the research.
- The sole purpose of the research is
either 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.
5. Required IRB Findings for Research Invovling Prisoners
To approve research involving prisoners, along with determining that the regulatory
criteria for approval are satisfied for non-prisoner participants (see SOP 007:
IRB Approval Criteria), the IRB must make all of the following specific findings:
- The research represents one of the permissible categories (as noted above)
- Any possible advantages to the prisoner as a result of their 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 their ability to weigh the risks of the research
against such advantages in the “limited-choice” prison environment is impaired
- The risks involved in the research are commensurate with risks that would be
accepted by non-prisoner participants
- Procedures for the selection of participants within the prison are fair to all
prisoners and free from arbitrary intervention by prison authorities or prisoners
- Unless the researcher provides the IRB with written justification for following
some other procedures, control participants must be selected randomly from
the group of available prisoners that meet the characteristics needed for
that particular research
- The information is presented in language that is understandable to the participant
population
- 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 their parole
- Where the IRB finds there may be a need for follow-up exams or care of participants
at the end of their participation, adequate provision has been made for this
examination of care, taking into account the varying lengths of individual
prisoners’ sentences, and for informing participants of this fact.
6. Documentation and Certification
6.1. Protocol-specific findings related to the additional protections
required for research involving prisoners will be documented in the IRB meeting
minutes (or IRB records/electronic system for expedited review).
6.2. For prisoner research conducted or supported by DHHS, certification
that the IRB reviewed the research and made the findings required by the regulations
must be provided to the Secretary (DHHS) through the Office for Human Research
Protections (OHRP). Upon IRB approval, WVU OHRP staff will forward the certification
request to DHHS OHRP following the updated guidance on How to Prepare a Prisoner Certification Letter to OHRP.
6.3. Following its review of the prisoner certification request, if DHHS
OHRP determines that the study involves one of the permissible categories of research,
WVU will be notified by a letter authorizing the involvement of prisoners in the
proposed research. The research may proceed only after receipt of the DHHS OHRP
authorization letter. If multiple institutions are engaged in the same prisoner
research, each institution must request certification from DHHS OHRP unless an
institution relied on the review of another IRB.
6.4. Studies for which DHHS OHRP previously authorized prisoner involvement
do not require “recertification” if amended unless the change to the research alters
the applicability of the approved category of permissible prisoner research.
7. When a Participant Becomes a Prisoner
7.1. When an enrolled participant becomes a prisoner in a study that was
not reviewed and approved by the IRB in accordance with the requirements for research
involving prisoners (listed above):
- The PI must notify the IRB as described by SOP 031: Research Related Event Reporting.
- All research activities with the now prisoner-participant must cease until the
IRB can re-review the study (as applicable) to ensure that the requirements
listed above have been satisfied.
- If the participant is enrolled in a study that does not fall into one of the
categories of permitted research, the participant cannot continue in the
study.
- In special circumstances in which the researcher asserts that it is in the
best interests of the participant to remain in the study while incarcerated,
the IRB Chair may determine that the participant may continue to participate
until the re-review requirements are completed.
7.2. Upon receipt of notification that a previously enrolled research
participant has become a prisoner and the researcher requests that the research
is approved for prisoner participants, the IRB will promptly re-review the research
in accordance with the review requirements. In these circumstances, some of the
required findings may not be applicable (e.g., regarding the selection of participants
within the prison if the participant was recruited outside of an incarcerated context).
Any “non-applicable” findings should be documented along with the required specific
findings.
7.3. If a researcher anticipates that some of the participants in a proposed
study population are likely to be prisoners or become prisoners during the course
of the study, the IRB may review the research prospectively for prisoner involvement.
In this case, some of the required specific findings may not apply. The IRB should
use discretion in deciding whether sufficient information is available at the time
of review to make the required findings or to wait until more specific information
is available (e.g., the specific institution where participants will be prisoners
may be needed to evaluate the local research context).
8. Documentation
8.1. The IRB considers each of the specific findings related to additional
protections required for research involving prisoners. WVU OHRP staff document
discussions of controverted issues at convened meetings in the meeting minutes.
8.2. Specific findings are either documented by WVU OHRP staff in the
meeting minutes (i.e., for protocols reviewed by the convened board) or by expedited
reviewers in determinations in accord with applicable SOPs. The IRB does not reapply
categories during subsequent reviews unless changes to the protocol warrant such
review.
9. When Following Department of Justice (DOJ) Requirements:
9.1. For National Institute of Justice (NIJ) funded research:
- All projects are required to have a privacy certificate approved by the NIJ Human Subjects Protection Officer. (See also: Section 9.2)
- All researchers and research staff are required to sign employee confidentiality statements, which are maintained by the responsible researcher.
- The consent document must disclose the name(s) of the funding agency(ies).
9.2. For research conducted within the Bureau of Prisons:
- Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered research.
- WVU, the IRBs, and researchers/research staff must follow the requirements of 28 CFR 512, including:
- The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
- The research design must be compatible with both the operation of prison facilities and protection of human participants. The researcher must observe the rules of the institution or office in which the research is conducted.
- Any researcher who is a non-employee of the Bureau must sign a statement in which the researcher agrees to adhere to the provisions of 28 CFR 512.
- All research proposals will be reviewed by the Bureau Research Review Board.
- The selection of participants within any one organization must be equitable.
- Incentives may not be offered to help persuade inmate participants to participate. However, soft drinks and snacks to be consumed at the test setting may be offered.
- Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research participants who are both:
- No longer in Bureau of Prisons custody, AND
- Participating in authorized research being conducted by Bureau employees or contractors.
- A non-employee of the Bureau may receive records in a form not individually identifiable when advance adequate written assurance that the record will be used solely as statistical research or reporting record is provided to the agency.
- Except as noted in the consent statement to the participant, the researcher must not provide research information that identifies a participant to any person without that participant's prior written consent to release information. For example, research information identifiable to a participant individual cannot be admitted as evidence or used for any purpose in any action, suite, or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertains.
- Except for some computerized data records maintained at the official DoJ site, records that contain non-disclosable information directly traceable to a specific person may not be stored in, or introduced to, an electronic retrieval system.
- If the researcher is conducting a study of special interest to the Office of Research and Evaluation (ORE) but the study is not a joint project involving ORE, the researcher may be asked to provide ORE with the computerized research data, not identifiable to individual participants, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the project.
- Required elements of disclosure include:
- The identity of the researchers.
- Anticipated uses of the results of the research.
- The extent to which confidentiality of records identifying the participant will be maintained. For studies sponsored by NIJ, the participant should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the participants need to be explicitly notified. If the researcher intends to disclose any information, the participant needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The participant must be informed of any risks that might result from this disclosure and must explicitly provide written consent prior to participating in the research. (See also: Section 9.1)
- A statement that participation is completely voluntary and that the participant may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment by activity by staff as soon as practicable).
- A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a researcher may not guarantee confidentiality when the participant indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the participant is an inmate, indicates intent to leave the facility without authorization.
- A statement that participation in the research project will have no effect on the inmate participant's release date or parole eligibility.
10. References
WVU Policies:
SOP 006: IRB Meeting Conduct
SOP 007: IRB Approval Criteria
SOP 018: Expedited Review
SOP 031: Research Related Event Reporting
SOP 053: Emergency Use of an Investigational Drug, Biologic, or Device
Federal Regulations:
45 CFR 46 Subpart C
45 CFR 46.303
45 CFR 46.305
45 CFR 46.306
AAHRPP:
Standard II-4
