Prisoners Involved as Participants in Review- PRO133   

Procedure
 

Investigator Responsibilities

• Completes FOR200 IRB Application eForm to indicate prisoners will be a target population for research activities. (Note: If the participant population has an increased potential to become prisoners, and the investigator will be interacting, intervening, or collecting identifiable private information during the incarceration, the investigator may choose, at the time of initial review, to have the proposal reviewed in accordance with Subpart C.)
• Provides information addressing:
  • Obtaining informed consent, protecting subject confidentiality, and preventing coercion and undue influence;
  • Any possible advantages accruing to the prisoner through participation in the research, when compared to the general living conditions; medical, dental or psychological care; quality of food; amenities and opportunity for earnings in the prison;
  • Why the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
  • Selection of participants; and
  • Plans for ensuring follow-up examination or care of participants after the end of their participation, if necessary.
• Indicates in the consent process and documents that each prisoner is clearly informed before enrollment that participation in the research will have no effect on their parole or appeals process and outlines any additional protections afforded to this population.
• Obtains and provides to the IRB documentation of approval from the detention or correctional facility involved.
• Provides Bureau of Prison’s (BOP) central IRB (BRRB) review and approval if participants are in a federal prison facility.
• Provides additional information and documentation required under the regulations at 28 CFR 512 (see GUI341) for research being conducted within the BOP.
• Provides additional information and documentation required under the regulations at 28 CFR 46 (see GUI341) for research being sponsored by the DOJ/NIJ.
• Provides any additional documents or materials required for certification to the Secretary (through OHRP) for federally funded research involving prisoners.

For research not previously approved by the IRB and OHRP in accordance with 45 CFR 46 Subpart C for prisoners when a participant becomes a prisoner:

• Immediately notifies the IRB with a problem report submission of the event.
• Ceases all research interactions and interventions with, and obtaining identifiable private information about, the now incarcerated prisoner-participant until the requirements of Subpart C have been satisfied with respect to the relevant research activities unless approved by the IRB Chair to continue because it is in the best interest of the participant to remain in the research study while incarcerated.
• Asserts to the IRB Chair, when applicable, that it is in the best interests of the participant to remain in the research study while incarcerated and requests permission to continue participant in the research.
• Applies for approval of protocol in accordance with 45 CFR Part 46 Subpart C for prisoners.

OIRB Responsibilities

Reviewing Staff:

• Conducts an administrative review at the time of initial and continuing review, review of modifications, or unanticipated problems taking into consideration the requirements under 45 CFR Part 46 Subpart C, and 28 CFR 512 Subpart B, if applicable. Note: Research subject to subpart C cannot be exempt under 45 CFR 46.104, except for research aimed at involving a broader subject population that only incidentally includes prisoners.
• Contacts Investigator and/or study coordinator with questions or needed clarification/documentation regarding the prisoner population.
• Verifies with administrative staff that a prisoner/prisoner representative is scheduled for attendance at the convened meeting for initial and continuing review or review of modifications that affect or may affect the prisoner population.
• Assures the IRB discusses and makes separate and distinct findings on the following:
  • Whether the protocol meets the criteria for a permissible category of research in 45 CFR 46.306(a)(2)
    • If the protocol does not meet a category in 45 CFR 46.306(a)(2), does research involve epidemiologic (observational) research to which a waiver of 45 CFR 46.305(a)(1) and 45 CFR 46.306(a)(2) applies (see Attachment A to POL033 UAB Policy on Additional Safeguards for Prisoners Involved in Research)
  • Whether the protocol meets the requirements for each subparagraph at 45 CFR 46.305(a)(2)–(7) using GUI317 the prisoner checklist
• Assures the IRB reviews the plan for informed consent process and any protocol specific findings justifying the waiver of consent process; or waiver of documentation of consent
• Documents discussion and determinations of the IRB for the minutes.
• Drafts a letter, for HHS funded studies, certifying to the Secretary (through OHRP) that the IRB designated under its assurance:
  • Was duly constituted under 45 CFR 46.304
  • Made the seven findings required under 45 CFR 46.305(a), including the finding that the proposed research represents one of the permissible categories of research under 45 CFR 46.306(a)(2), or the waiver provisions for epidemiologic research
• Includes the following additional materials/information with the certification letter to OHRP:
  • The IRB-approved protocol application (which includes the protocol and any IRB submission materials including the informed consent documents);
  • Any relevant HHS grant application or proposal;
  • UAB’s OHRP Assurance Number;
  • IRB Number for Designated IRB;
  • Site(s) where research involving prisoners will be conducted;
  • If prisoner research site is “engaged in research,” provide OHRP Assurance Number;
  • HHS Grant Award Number;
  • HHS Funding Agency Name and Grants/Program Officer Name and Telephone Number;
  • Title of HHS Grant;
  • Title of Protocol (if the same as the title of the grant, indicate as such);
  • Version date of the informed consent document to be used with prisoners;
  • Date(s) of IRB meeting(s) in which the protocol was considered and provide a chronology of:
    • Date of initial IRB review, and/or
    • Date of Subpart C reviews including:
      • Type of IRB review (initial review, continuing review, review of modification, unanticipated problems),and
      • Special IRB review for prisoner issues;
  • Principal Investigator; and
  • Reason for IRB review (choose the applicable reasons):
    • Non-prison study (not previously reviewed and certified under Subpart C) in which a participant has become incarcerated (or otherwise fits the definition of prisoner in 45 CFR 46.303(c)) and the PI wishes to continue the individual’s participation in the study
    • Non-prison study with at-risk population (e.g., probationers, substance abusers)
    • Non-prison study, majority of study population are non-prisoners, but the investigator seeks to enroll some prisoners (as defined in 45 CFR 46.303(c))
    • Minimal risk HHS-conducted or -supported epidemiologic research, majority of study population are non-prisoners but PI seeks to enroll some prisoners (prisoners are not the focus of the study) and the sole purpose of the study is either:
      • To describe the prevalence or incidence of a disease by identifying all cases, or
      • To study potential risk factor associations for a disease
    • Initial Subpart C review of study designed to be conducted in a prison or using prisoners as defined in 45 CFR 46.303(c), the PI seeks to enroll already incarcerated participants
• Includes the following optional information (suggested by OHRP, but not necessary) in the prisoner certification letter, as applicable:
  • Justification for the use of prisoners in the study. If applicable, delineate the protocol to be conducted in the prison from the overall project described in the grant application;
  • Study objectives or study aims;
  • Brief summary of study procedures;
  • Customary treatment or services at the prison (or alternative to incarceration) research site(s) for the condition being studied;
  • Description of how risks specific to a prison (or alternative to incarceration) setting are minimized;
  • Whether the prison site(s) are “engaged in research” and whether they have obtained an assurance with OHRP;
  • Whether a Certificate of Confidentiality was obtained by the PI for the study;
  • Description of recruitment procedures in the specific prison (or alternative to incarceration) setting; and/or
  • Description of how the informed consent document was modified for use with a prison population or specific prisoner and whether the subsequently incarcerated participant will be reconsented.
• Electronically sends all prisoner research certification letters to subpartc@hht.gov, addressed to:

OHRP Prisoner Research Coordinator

Office for Human Research Protections (OHRP)

Department of Health and Human Services

The Tower Building

1101 Wootton Parkway, Suite 200

Rockville, MD 20852

• Notifies the investigator the prisoner certification letter has been forwarded to OHRP and that no prisoner participants can be enrolled or involved until the IRB/institution receives a letter from OHRP, acting on behalf of the Secretary of HHS, stating it has determined that the proposed research falls within the categories of research permissible under 45 CFR 46.306(a)(2) or qualifies under a waiver for epidemiologic research and the research has been approved.
• Issues IRB approval after all the criteria in Subpart C are satisfied and, if HHS funded, the research has been approved by OHRP.

Administrative Staff:

• Enters protocol information in the electronic system indicating the protocol involves prisoners and whether the study is HHS funded.
• Schedules prisoner representative for the convened IRB meeting at the time of initial and continuing review or when modifications or unanticipated problems are on the agenda.
• Assists Review Staff in preparing the letter of determination to the investigator.
• Documents discussion and required determinations of the IRB in the minutes including:
  • Prisoner representative is present during the discussion and determinations;
  • Prisoner representative votes on action items;
  • The permissible category of research in 45 CFR 46.306(a)(2) or qualification for waiver in epidemiologic research, if applicable; and
  • Additional findings required under HHS regulations at 45 CFR 46.305(a)(2)-(7) (see GUI317 prisoner checklist); protocol-specific findings justifying waiver of either the consent process or documentation of consent.
• Assures CV or resume of prisoner representative serving on the IRB is on file in the OIRB.
• Mails approval and date-stamped informed consent documents, if applicable (for HHS-funded research only after verifying whether HHS approval has been obtained).

IRB Responsibilities

Primary Reviewer(s):

• Reviews and presents the protocol at the time of initial or continuing review to the convened IRB documenting the additional protections for prisoners.

The IRB may not review or make determinations at the time of initial and continuing review or review of modifications to the research or unanticipated problems regarding studies involving prisoners unless there is a member in attendance who is a prisoner or a prisoner representative with a close working knowledge, understanding, and appreciation of prison conditions from the perspective of the prisoner.

For Initial Submissions, the IRB:

• Reviews the proposed research, plan for the informed consent process, and any accompanying documents to determine whether the study meets criteria 45 CFR 46.111 and 21 CFR 56.111, if applicable, for approval (see policies and procedures for POL022, PRO122 initial; PRO147 continuing; and PRO148 modification review by the convened IRB)
• Discusses and makes separate and distinct findings on the following:
  • Whether the protocol meets the criteria for a permissible category of research in 45 CFR 46.306(a)(2)
    • If the protocol does not meet a category in 45 CFR 46.306(a)(2), does research involve epidemiologic (observational) research to which a waiver of 45 CFR 46.305(a)(1) and 45 CFR 46.306(a)(2) apply (see Attachment A to POL033)
  • Whether the protocol meets the requirements for each subparagraph at 45 CFR 46.305(a)(2)–(7) using the prisoner checklist

For previously IRB-approved research but the IRB has not previously reviewed the study for prisoner populations and a participant becomes a prisoner after the research commences, the IRB Chair may determine that the participant may continue to participate in the research until the requirements of Subpart C are satisfied in special circumstances in which the PI asserts that it is in the best interest of the participant to remain in the research study while incarcerated.

For previously reviewed research, the IRB:

• Re-reviews the research including the provisions of Subpart C and takes one of the following actions:
  • Determines IRB review and approval for prisoners is not required because the research interactions and interventions or obtaining identifiable private information will not occur while the participant is a prisoner
  • Allows withdrawal of the participant(s) from the study when withdrawal will not affect the best interests of the participant or the research cannot be performed
  • Approves the research for prisoners under 45 CFR Subpart C or waiver for epidemiologic research if all the requirements are met and study is not funded by HHS
  • Ratifies previous approval of research for non-prisoner participants but defers protocol for prisoner-participants because research does not meet the requirements of 45 CFR 46.305 or waiver for epidemiologic research, and
    • Notifies investigator that all interactions and interventions with, and obtaining identifiable private information about, the prisoner-participant must cease because the requirements of Subpart C have not been satisfied with respect to the relevant protocol, with one exception. In special circumstances in which the Principal Investigator asserts that it is in the best interest of the participant to remain in the research study while incarcerated, the IRB Chair may determine that the participant may continue to participate in the research until the requirements of Subpart C are satisfied.
  • Ratifies previous approval of research for non-prisoner participants, approves federally funded research under requirements of 45 CFR 46 Subpart C or waiver for epidemiologic research, and certifies approval to OHRP, and
    • Notifies investigator that all interactions and interventions with, and obtaining identifiable private information about, the prisoner-participant must cease until the requirements of Subpart C have been satisfied with respect to the relevant protocol, with one exception. In special circumstances in which the Principal Investigator asserts that it is in the best interest of the participant to remain in the research study while incarcerated, the IRB Chair may determine that the participant may continue to participate in the research until the requirements of Subpart C are satisfied.
    • Notifies investigator that research activities may not be commenced without OHRP’s approval unless the IRB Chair has determined an exception applies.