Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-19

Title 19:

Additional Requirements for Research Conducted Within the Federal Bureau of Prisons

Effective Date:

7-29-14

Revision History:

5-27-14

Policy Statement

All research involving human participants conducted within the Bureau of Prison system must comply with additional requirements established by the Bureau of Prisons in order to be approved by the IRB. These requirements apply to all research including exempt, expedited, and full board research except implementation of Bureau programmatic or operational initiatives made through pilot projects, which are not considered research activities. When applicable, this policy should be utilized in combination with WPP XIV-1: Prisoners as Research Subjects and WPP XVII-18 Research Funded by the Department of Justice.

Procedures and Guidance

Research conducted within the Bureau of Prisons is regulated by the following regulations:

  1. Additional Regulatory Requirements for Research Conducted in the Bureau of Prisons [28 CFR 512]

    When conducting research within Bureau of Prison facilities, involving either inmates or employees as research subjects, the following regulatory requirements must be met, in addition to the basic requirements identified in 28 CFR 46 – Protection of Human Subjects [The Common Rule] or elsewhere in the VCU IRB Written Policies and Procedures.

    1. When research will be conducted within a Bureau of Prison facility, off site agreements must be in place indicating research will also be reviewed and monitored by the Bureau Research Review Board (BRBB).
    2. The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
    3. The project must have an adequate research design and contribute to the advancement of knowledge about corrections.
    4. The researcher must have academic preparation or experience in the area of study of the proposed research.
    5. The selection of subjects within any one institution must be equitable.
    6. The researcher must observe the rules of the institution or office in which the research is conducted.
    7. 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.
    8. Incentives may not be offered to help persuade inmate subjects to participate. However, soft drinks and snacks may 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 subjects who are both:
      • No longer in Bureau of Prisons custody, and
      • Participating in authorized research being conducted by Bureau employees or contractors.

      Monetary rewards would be considered nominal if they do not exceed twice the minimum wage for each hour of the subject’s expected participation in the research activity.

    9. Except as noted in the informed consent, the research may not provide research information which identifies a subject to any person without the subject’s prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertains.
    10. Except for computerized data records maintained at an official Department of Justice site, records that contain non-disclosable information directly traceable to a specific person will not be stored in, or introduced into, an electronic retrieval system. The IRB application should specify that no directly identifiable records will be maintained electronically. Coded information would not be directly identifiable.
    11. 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 a statistical research or reporting record is provided to the agency.
    12. 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.
    13. Content of Research Proposal [28 CFR 512.12]

      When submitting a research proposal, the researcher shall provide the following information in a summary statement, which includes the following:

      1. Names and current affiliations of researchers
      2. Title of the study
      3. Purpose of the study
      4. Location of the study
      5. Methods to be employed
      6. Anticipated results
      7. Duration of the study
      8. Number of participants (staff or inmates) required and the amount of time required from each
      9. Indication of risk or discomfort involved as a result of participation
      10. A comprehensive statement, which includes:
        1. Review of related literature
        2. Detailed description of the research method
        3. Significance of anticipated results and their contribution to the advancement of knowledge
        4. Specific resources required from the Bureau of Prisons
        5. Description of all possible risks, discomforts and benefits to individual participants or a class of participants, and a discussion of the likelihood that the risks and discomforts will actually occur
        6. Description of steps taken to minimize any risks
      11. Description of physical or administrative procedures to be followed to:
        1. Ensure the security of any individually identifiable data that are being collected for the study
        2. Destroy research records or remove individual identifiers from those records when the research has been completed
        3. Description of any anticipated effects of the research study on organizational programs and operations
        4. Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires and interview schedules
      12. A statement regarding assurances and certification required by 28 CFR 46, if applicable
    14. Informed Consent Requirements [28 CFR 512.16]
      1. Before commencing a research project involving prison staff or inmates as participants, the researcher must obtain signed, written informed consent from each participant prior to beginning research activity. A copy of the consent document must be given to each participant. The consent must contain the following information:
        1. Identification of the principal investigator(s)
        2. Objectives of the research project
        3. Procedures to be followed in the conduct of research
        4. Purpose of each procedure
        5. Anticipated uses of the results of the research
        6. A statement of benefits reasonably to be expected
        7. A declaration concerning discomfort and risk, including a description of anticipated discomfort and risk
        8. 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
        9. 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 subject indicates an intent to commit future criminal conduct or harm himself/herself, or, if the subject is an inmate, indicates an intent to leave the facility without authorization
        10. A statement that participation in the research project will have no effect on the inmate participant’s release date or parole eligibility
        11. An offer to answer questions about the research project
        12. Appropriate additional information as needed to describe adequately the nature and risks of the research
      2. Waiving Documentation of Consent – The IRB may waive the requirement for signed informed consent if the researcher can demonstrate either of the following:
        1. The only link to the subject’s identity is the signed statement of informed consent, or
        2. There is significantly more risk to the subject if the statement is signed.
      3. Storage of Original Informed Consent Documents – The original of any signed consent form should be placed in the specific research project’s file at the institution where the research is conducted. The VCU principal investigator should maintain a copy in his/her research records AND provide a copy of the signed form to the VCU IRB. The VCU IRB should maintain a copy in the research record.
    15. Bureau of Prisons Research Oversight [28 CFR 512.17]

      All research conducted within the Bureau of Prisons is subject to oversight by the Bureau Research Review Board (BRRB), in addition to local VCU IRB oversight. This includes the following:

      1. All research must also be approved by the BRRB prior to beginning.
      2. The BRRB will monitor all research projects for compliance with Bureau policies at least once per year. The VCU IRB shall assist in this review by providing information, as requested.
      3. The VCU IRB will report to the BRRB any violations of research policy to the appropriate Warden and regional director, the Chairperson of the BRRB, and the Director , Bureau of Prisons.
    16. Publication of Research Results
      1. When publishing research results, the researcher must acknowledge the Bureau’s participation in the research project.
      2. The researcher must expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
      3. Prior to submitting for publication, the researcher must provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.
      4. At least 12 working days before any report of findings is to be released, the researcher shall distribute one copy of the report to each of the following: the chairperson of the Bureau Research Review Board, the regional director, and the warden of each institution that provided data or assistance. The researcher shall include an abstract in the report of findings.

References

See body of WPP
WPP XIV-1: Prisoners as Research Subjects
WPP XVII-18: Department of Justice Funded Research