Section XIV:

Research Involving Prisoners

WPP #: XIV-1

Title 1:

Prisoners as Research Participants (Special Protections)

Effective Date:

09-24-14

Revision History:

06-20-00; 09-25-00; 05-23-03; 06-07-04; 12-06-04; 06-21-06; 05-20-14

Policy Statement

If an investigator indicates that prisoners will participate in the research, or that participants may reasonably be expected to be incarcerated at some time point during the study, the VCU IRB will follow the requirements found at 45 CFR 46, Subpart C.

Principal investigators must plan for the inclusion of prisoners in research prior to enrolling prisoners as subjects. Additionally, principal investigators must report the involvement of a research subject who is or has become a prisoner to the IRB within 5 business days of being alerted to the subject's status as a prisoner.

Description and Procedures

  1. Applicability and Purpose

    The VCU IRB applies Subpart C (Special Protections for Prisoners) to research involving prisoners, including situations where a human subject becomes a prisoner after the research has commenced.

    "Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and un-coerced decision whether or not to participate as subjects in research, it is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in activities to which this subpart is applicable." [45 CFR 46.302].

    In accordance with the above regulatory language, concerns regarding coercion apply whether the research involves individuals who are prisoners at the time of enrollment in the research or who become prisoners after they become enrolled in the research. In the latter situation, it is unlikely that review of the research and the consent document contemplated the constraints imposed by incarceration.” – OHRP Guidance May 23, 2003

  2. Definition of Prisoner:

    "Prisoner" is defined by HHS regulations at 45 CFR part 46.303(c) as "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." – OHRP Guidance May 23, 2003

    Note: It is the VCU IRB's understanding and practice that individuals who, in most cases, have certain freedoms (such as returning to their residence in the evening) are not considered research participants for whom Subpart C applies. However, it is recognized that individuals subject to probationary supervision are in an extremely vulnerable situation and at great risk for recidivism. For this reason, the IRB may choose to apply some of the added considerations at Subpart C to such individuals in an effort to afford maximal protection in the research setting.

  3. Process for Review and Approval:

    There are three separate pathways which cause a research project to be identified as prisoner research, thus subject to the additional requirements of 45 CFR 46 Subpart C. These pathways are as follows:

    • Initial Review Submission: A research project is presented to the IRB describing the inclusion or involvement of (targeted or by chance) research subjects that are prisoners.
    • Amended Submission: A research project is ongoing, with IRB approval, and one or more of the research subjects happens to become incarcerated or otherwise meet the definition of ‘prisoner’.
    • Amended Submission (No Justification): A research project is ongoing, with IRB approval, and the principal investigator identifies a potential need to include prisoners in future recruitment efforts.

    Each one of these pathways involves similar requirements for the IRB, and some differing requirements/options. These are briefly described in the next two sections of this WPP.

  4. Initial Review Submission (Prospective Review for Prisoners)

    When a research project is presented to the IRB describing the inclusion or involvement of research subjects that are prisoners the following process occurs:

    • The principal investigator must specify that prisoners are to be enrolled in the initial IRB submission, and include additional information necessary to review the research for the inclusion of prisoners.
    • The primary and/or secondary reviewer must be a prisoner advocate (prisoner representative) in accordance with the requirements detailed in this WPP.
    • The review type requested must be appropriate given the research and the requirements detailed in this WPP.
    • The IRB must find that the research falls into one of the four (4) approved categories for prisoner research as detailed in this WPP.
    • The IRB must document all findings of the IRB panel, including appropriate responses to the 7 additional findings required of the IRB (in cases of prisoner research) as detailed in this WPP.
    • For research that is funded by the DHHS (or otherwise federally funded, with required reporting to the DHHS): Full documentation of the IRB findings (in the minutes) must be sent to the DHHS following the certification process as detailed in this WPP. Upon certification by the DHHS that the research fits into the prisoner category and that the IRB findings have been documented, the DHHS will issue a certification letter for the IRB. Upon receipt of the certification letter, the IRB will issue an approval.
  5. Modification Submission

    When a research project is presented to the IRB with a modification describing the inclusion or involvement of research subjects that are prisoners, the following process occurs:

    • As applicable: Immediately upon learning (from whatever source) that a research subject has become incarcerated or otherwise meets the definition of ‘prisoner,’ the principal investigator must cease all research data collection, unless he/she has determined (in his/her professional opinion) that the research is in the best interest of the subject. In the case that the determination has been made in favor of continuing the research, the principal investigator must justify the continuation to the IRB, as detailed in this WPP. [NOTE: The VCU IRB requires prompt notification of the prisoner status (within no more than 5 working days). The justification process should be concurrent with the submission of a modification to the IRB, including updates to the submission to specify that prisoners are enrolled.. This justification process only applies to amendments to continue currently enrolled subjects who become prisoners. However, the remaining steps also apply to amendments to allow for future involvement/recruitment of prisoners.]
    • The principal investigator must submit an amendment to the VCU IRB within 10 business days (of having knowledge of the incarceration). This amendment will provide additional information necessary to review the research for the inclusion of prisoners.
    • The primary and/or secondary review must be a prisoner advocate (prisoner representative) in accordance with the requirements detailed in this WPP
    • The review type requested must be appropriate given the research and the requirements detailed in this WPP.
    • The IRB must find that the research falls into one of the four (4) approved categories for prisoner research as detailed in this WPP.
    • The IRB must document all findings of the IRB panel, including appropriate responses to the 7 additional findings required of the IRB (in cases of prisoner research) as detailed in section J of this WPP.
    • For research that is funded by the DHHS (or otherwise federally funded, with required reporting to the DHHS): Full documentation of the IRB findings (in the minutes) must be sent to the DHHS following the certification process as detailed in this WPP.
    • Upon certification by the DHHS that the research fits into the prisoner category and that the IRB findings have been documented, the DHHS will issue a certification letter for the IRB. Upon receipt of the certification letter, the IRB will issue an approval.
  6. Types of Review by the VCU IRB and Special Considerations
    • Types of Review
      • Exempt – NOT PERMITTED [45 CFR46.301(a)
      • Expedited – Expedited review by the VCU IRB will only be permitted for prisoner research that involves (1) research previously approved by the IRB, where a currently enrolled research participant has become incarcerated (or otherwise meets the definition of ‘prisoner’) and the currently enrolled research participant plans to continue in the research; (2) a retrospective review of prisoner records; (3) minor modifications to previously approved prisoner research; (4) any other prisoner research which would otherwise qualify for exemption (i.e. data registry) provided the research qualifies for review by the expedited procedure by meeting all applicability criteria (minimal risk, not classified, etc.), and by all research procedures falling into one allowable categories of research; or (5) continuing review of research approved to involve prisoners where no participants have been enrolled and no additional risks have been identified - Expedited Category 8b. NOTE: In all cases, the prisoner advocate must participate in the review process and all required findings must be fully and completely addressed and documented.
      • Full – Standard review for all prisoner research.
    • Special Considerations
      • Minors: If a legal minor (less than 18 years of age) were to be detained in a juvenile detention facility, Subpart D (Children) would apply IN ADDITION to Subpart C (Prisoners). Accordingly, regulations pertinent to pregnant women, neonates, and fetuses (Subpart B) are also applicable for research targeting pregnant women who are also incarcerated.
    • Documentation of IRB Findings: All determinations of the Panel, including 7 additional determinations under 45 CFR 46.305, category of permissible research, and determination of minimal risk will be documented in the minutes of the meeting during which the research was reviewed. All determinations will be supported through documented protocol specific findings.
  7. Prisoner Representative:

    The VCU IRB will involve prisoner representatives in the review of all research involving prisoners in addition to reviewers based upon area of scientific expertise, as follows:

    The VCU IRB must have present at its meeting a designated prisoner advocate in order to review projects involving the use of prisoners in research.

    “In addition to satisfying the requirements of 45 CFR 46.116 and 46.117, when an IRB reviews a protocol involving prisoners as subjects that is conducted or supported by HHS, the composition of the IRB must satisfy the following requirements of HHS regulations at 45 CFR 46.304(a) and (b):

    • 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.
    • At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one IRB, only one IRB need satisfy this requirement."

    "In the absence of choosing someone who is a prisoner or has been a prisoner, the IRB should choose a prisoner representative who has a close working knowledge, understanding and appreciation of prison conditions from the perspective of the prisoner."

    "In addition, the IRB must notify OHRP of any change in the IRB roster occasioned by the addition of a prisoner or a prisoner representative, as required by HHS regulations at 45 CFR 46.103(b)(3). IRBs should be alert to the impact of roster changes on quorum requirements under HHS regulations at 45 CFR 46.108(b)."

    "If a protocol involving prisoners as subjects is to be reviewed by more than one IRB, only one IRB must satisfy the requirement that at least one member of the IRB be a prisoner or a prisoner representative."

    "For research involving prisoners as subjects, the IRB must meet the special composition requirements of 45 CFR 46.304 for all types of review of the protocol, including initial review, continuing review, review of protocol amendments, and review of reports of unanticipated problems involving risks to subjects." - OHRP Guidance May 23, 2003

  8. Justification For Continuation of Currently Enrolled Prisoner-Subjects:

    In the case of research that is ongoing at the time a currently enrolled subject becomes incarcerated, the research with that incarcerated subject must cease (during the time of incarceration) unless the principal investigator has justified that it is in the best interest of the research subject to continue and the IRB Chairperson or convened IRB has determined that the justification is sufficient. The VCU IRB requires prompt notification of the IRB (within no more than 5 working days).

    Research may continue ONLY in the case where the Principal Investigator has determined (in his or her clinical judgment) that continuation in the research is in the best interest of the now prisoner-subject. This justification must be submitted to the IRB.

  9. Categories of Allowable Prisoner Research:

    The following categories exist for research allowable to include prisoner subjects. The principal investigator must identify the category that he/she is requesting as part of his/her submission to the VCU IRB. The VCU IRB will identify/verify the category as part of its seven (7) additional findings as detailed in this WPP. All human subject research involving prisoners at VCU, must fit into one of these categories in order to be considered for approval.

    The permissible categories are [45 CFR 46.306(a)(2)(A-D)]:

    (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 and no more than inconvenience to the subjects;”

    Because the definition of minimal risk for prisoner research differs from the definition of minimal risk used elsewhere in the regulations, the ‘prisoner research definition of minimal risk is provided below:

    Definition of Minimal Risk in Prisoner Research Subpart 45 CFR 46.303(d)


    “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


    (B) study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than 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 (through OHRP) 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 (through OHRP) 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.”

    (5th/E Category) - Epidemiological Research Waiver - An additional category of permissible research was added with publication of a waiver in the June 20, 2003 Federal Register as follows: Epidemiological Research - defined as ‘public health research that focuses on a particular condition or disease in order to (i) describe its prevalence or incidence by identifying all cases, including prisoner cases, or (ii) study potential risk factor associations, where the human subjects may include prisoners in the study population but not exclusively as a target group [Fed. Reg. June 20, 2003], provided that the study presents no more than minimal risk and no more than inconvenience to the subjects (see definition of minimal risk unique to prisoners, above)

  10. Seven (7) Additional Findings:

    The following seven (7) additional findings are required to be made and documented by the IRB as part of the review process when prisoners are requested to be included (or continued) as research subjects. If research is sponsored by DHHS the IRB may be asked to carry out additional requirements, as requested [45 CFR 46.305(b)]. These seven findings are identified at 45 CFR 46.305(a)(1-7:

    (1) the research under review represents one of the categories of research permissible under 45 CFR 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 IRB 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 IRB 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.”

  11. Certification for DHHS-Sponsored Research:

    For research conducted or supported by the U.S. Department of Health and Human Services to involve prisoners, two actions must occur [45 CFR 46.305(c)]. [NOTE: the certification process only applies to DHHS-sponsored research, unless the principal investigator identifies another certification process as required by a sponsor.]:

    (1) CERTIFICATION: “the institution engaged in the research must certify to the Secretary (through OHRP) that the IRB designated under its assurance of compliance has reviewed and approved the research under 45 CFR 46.305; and

    (2) APPROVAL: “the Secretary (through OHRP) must determine that the proposed research falls within the categories of research permissible under 45 CFR 46.306(a)(2).

    The Institutional Official, on behalf of the IRB, will send all certifications to OHRP and await review and approval of the certification prior to issuing IRB approval to include prisoners in the research. In this case, investigators will be informed of the status, pending certification. The correspondence to OHRP will specifically name the research protocol and any relevant HHS grant application or proposal. A copy of the research proposal will be sent with the correspondence, in accordance with OHRP guidance (OHRP “’research proposal’ includes the IRB-approved protocol, any relevant HHS grant application or proposal, any IRB application information required by the IRB, and any other information requested or required by the IRB to be considered during initial IRB review”). Prisoner certification letters must address all areas required by the OHRP guidance on Certification Letters.

References

45 CFR 46, Subpart C
OHRP Guidance May 23, 2003
OHRP guidance on Certification Letters