MSU HRPP Manual Section 2-2-C-i

2-2-C-i, Bureau of Prisons

The U.S. Department of Justice provides additional requirements when research is conducted within the Bureau of Prisons (Bureau). The Bureau encompasses the federal prisons; these requirements do not apply to state prison systems under the jurisdiction of the States.This policy addresses the applicability of the Bureau requirements to human subject research reviewed by the Michigan State University (MSU) Institutional Review Boards (IRB).

General provisions for the protection of human subjects in research are codified in 28 CFR 46 and are applicable to research conducted in the Bureau. The provisions of 28 CFR 512 Subpart B specify additional requirements for researchers who conduct research within the Bureau. In addition, each Bureau facility may have unique requirements. Individuals engaged in human subject research subject to 28 CFR 512 are responsible for complying with the requirements as applicable.

Applicability
Even if the research is determined to be exempt under 28 CFR 46 (or 45 CFR 46), the requirements in 28 CFR 512 are applicable. For example, the consent requirements under 28 CFR 512 must be followed, even if the project is determined to be exempt under 28 CFR 46 (or 45 CFR 46). No research is exempt from 28 CFR 512.

The requirements in 28 CFR 512 apply regardless of funding source and are applicable to research involving inmates or Bureau staff.

For purposes of 28 CFR 512 Subpart B, implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.

MSU IRB and Bureau Review and Approval
In addition to MSU IRB review and approval, proposed research must also be reviewed and approved by the Bureau (e.g., 28 CFR 512.13, 28 CFR 512.14). A copy of the research proposal submitted to the Bureau for review, the informed consent statement, and the approval letter from the Bureau Director or the Assistant Director (if approval authority is delegated) should be submitted with the MSU IRB application. Situations in which the Bureau approval cannot be obtained until after MSU IRB approval is obtained will be handled on a case by case basis. At the time of MSU IRB renewal, the progress reports required by the Bureau (28 CFR 512.19) should be submitted to the MSU IRB. However, if the progress reports indicate noncompliance or unanticipated problems involving risks to subjects or others, they should be reported to the IRB in accordance with the Human Research Protection Program (HRPP) Manual 4-8 “Reporting.” See HRPP Manual 9-1 “Unanticipated Problems Involving Risks to Subjects or Others” and 9-2 “Noncompliance” for guidance. The MSU IRB must also be promptly notified if the Bureau Director suspends or terminates the research study. See HRPP Manual 4-8 “Reporting” for policies and procedures on reporting.

Informed Consent
A written informed consent statement must be provided to each subject (staff or inmate) before the research begins. The criteria in 28 CFR 512.16 are in addition to the requirements in 28 CFR 46.116 and must be included for research determined exempt under 28 CFR 46 (or 45 CFR 46). However, the informed consent requirements may be incorporated into a consent document that contains elements of consent required by 28 CFR 46.116.

The written informed consent statement must contain the following:

  1. Identification of the principal investigator(s)

  2. Objectives of the research study

  3. Procedures to be followed in the conduct of the 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 discomforts and risk, including a description of anticipated discomfort and risk

  8. A statement that participation is completely voluntary and that the subject may withdraw consent and end participation in the study at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable)

  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 someone else, or if the subject is an inmate, indicates an intent to leave the facility without authorization.

  10. A statement that participation in the research study will have no effect on the inmate subject’s release date or parole eligibility

  11. An offer to answer questions about the research study

  12. Appropriate additional information as needed to describe adequately the nature and risks of the research.

For researchers who are non-employees, the subject’s signature is required on the statement. The signed document is then submitted to the chairperson of the local research review board appointed by the warden (this may not be the IRB). However, if the researcher can demonstrate that the only link to the subject’s identity is the signed statement of informed consent or that there is significantly more risk to the subject if the statement is signed, the signature requirement may be waived. There are different requirements for researchers who are employees of the Bureau. See 28 CFR 512.

Bureau Requirements for Research Studies and Researchers
The following requirements will be assessed by the Bureau during their review. MSU researchers should be aware of these requirements and incorporate them into their study as appropriate.

Research conducted in the Bureau must meet the following criteria:

  1. In all research studies the rights, health, and human dignity of individuals involved must be respected.

  2. The study must have an adequate research design and contribute to the advancement of knowledge about corrections.

  3. The study must not involve medical experimentation, cosmetic research, or pharmaceutical testing.

  4. The study must:

    1. Minimize the risks to subjects

    2. Risks to subjects must be reasonable in relation to anticipated benefits

    3. Selection of subjects within any one institution must be equitable

    4. When applicable, informed consent must be sought and documented (see Informed Consent Section below)

  5. Incentives may not be offered to help persuade inmate subjects to participate.

    1. However, soft drinks and snacks to be consumed at the test setting may be offered.

    2. Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research subjects who are both:

      i. No longer in the Bureau custody; and

      ii. Participating in authorized research being conducted by Bureau employees or contractors

  6. Researcher must have academic preparation or experience in the area of study of the proposed research.

  7. Researcher must assume responsibility for actions of any person engaged to participate in the research study as an associate, assistant, or subcontractor to the researcher.

  8. Except as noted in the informed consent statement to the subject, the researcher must not provide research information which identifies a subject to any person without that 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.

  9. The researcher must adhere to applicable provisions of the Privacy Act of 1974 and regulations pursuant to this Act.

  10. The research design must be compatible with both the operation of prison facilities and protection of human subjects. The researcher must observe the rules of the institution or office in which the research is conducted.

  11. Any research who is a non-employee of the Bureau must sign a statement in which the researcher agrees to adhere to the provisions of this sub-part.

  12. Except for computerized data records maintained at an official Department of Justice site, records which contain nondisclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system.

  13. If the researcher is conducting a study of special interest to the Office of Research and Evaluation (ORE), the researcher may be asked to provide ORE with the computerized research data, not identifiable to individual subjects, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the study.

  14. The researcher must submit planned methodological changes in a research study to the IRB for approval, and may be required to revise study procedures in accordance with the new methodology.

Under limited circumstances (requests from federal agencies, the Congress, the Federal judiciary, or State or local governments to collect information about areas for which they are responsible and requests by private organizations for organizational rather than personal information from Bureau staff), exceptions to the requirements described above may be approved by the ORE.

Additional Requirements
There are additional requirements under 28 CFR 512 that are not described within this section that are applicable (e.g. publication, copyright). Individuals engaged in human subject research subject to 28 CFR 512 are responsible for complying with all requirements. See 28 CFR 512 for requirements.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 12-11-2015.

Related HRPP Manual Sections

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