HRPP policies & procedures manual

1101: Department of Justice supported research

1. Purpose

The purpose of this policy is to define IRB procedures as they apply to human subjects research that is funded by the Department of Justice (DOJ). Research supported by the DOJ requires compliance with additional federal regulations, directives and instructions.

2. Specific policy

2.1 Bureau of Prisons

For research conducted within the Bureau of Prisons, the University, IRB, researchers and 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 subjects. 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 in addition to the IRB.

A research project conducted within the Bureau of Prisons must have an adequate research design and contribute to the advancement of knowledge about corrections.

Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.

Research participation

Selection of subjects within any one organization must be equitable.

Incentives may not be offered to help persuade inmate subjects 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 subjects who are:

  • No longer in Bureau of Prisons custody and
  • Participating in authorized research being conducted by Bureau employees or contractors.
Investigator’s responsibilities
  • A non-employee of the Bureau may receive records that are 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.
  • Except as noted in the consent statement to the subject, the researchers must not provide research information that 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 with the written consent of the individual to whom the data pertain.
  • 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 may not be stored in, or introduced into, 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 subjects, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the project.
  • The researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
  • At least once a year, the researcher shall provide the chief, Office of Research and Evaluation, with a report on the progress of the research.
  • 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, along with the report of findings:
    • The chairperson of the Bureau Research Review Board
    • The regional ORA director
    • The warden of each institution that provided data or assistance
  • In any publication of results, the researcher shall acknowledge the Bureau’s participation in the research project.
  • The researcher shall expressly disclaim approval or endorsement of the published materials as an expression of the policies or views of the Bureau.
  • Prior to submitting for publication the results of a research project conducted under this subpart, the researcher shall provide two copies of the material, for informational purposes only, to the chief, Office of Research and Evaluation, Central Office, Bureau of Prisons.
  • The principal investigator must design the research in a manner that minimizes risk to subjects.
  • For research conducted within the Bureau of Prisons, the researcher must have academic preparation or experience in the area of study of the proposed research.
  • For research conducted within the Bureau of Prisons, when submitting a research proposal, the applicant shall provide the following information:
  • A summary statement, which includes:
    • Names and current affiliations of the researcher.
      • Title of the study
      • Purpose of the study
      • Location of the study
      • Methods to be employed
      • Anticipated results
      • Duration of the study
      • Number of subjects (staff or inmates) required and amount of time required from each
      • Indication of risk or discomfort involved as a result of participation and a discussion of the likelihoods that the risks and discomforts will actually occur
    • A comprehensive statement, which includes:
      • Review of related literature
      • Detailed description of the research method
      • Significance of anticipated results and their contribution to the advancement of knowledge
      • Specific resources required from the Bureau of Prisons
      • Description of steps taken to minimize any risks
    • A description of physical or administrative procedures to be followed to:
      • Ensure the security of any individually identifiable data that are being collected for the study.
      • Destroy research records or remove individual identifiers form those records when the research has been completed.
    • A description of any anticipated effects of the research study on organizational programs and operations
    • Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules
    • A statement regarding assurances and certification required by 28 CFR 46, if applicable

    2.2 Disclosure

    For research conducted within the Bureau of Prisons, required elements of the disclosure include:

    • Identification of the researchers
    • Anticipated uses of the results of the research
    • A statement that participation is completely voluntary and that the subject may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or 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 subject indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the subject 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 subject’s release or parole eligibility

    3. National Institute of Justice (NIJ) funded research

    For research funded by the National Institute of Justice (NIJ):

    • All projects are required to have a privacy certificate approved by the NIJ human subjects protection officer.
    • All researchers and research staff are required to sign employee confidentiality statements, which are maintained by the responsible researcher.
    • All projects are required to have a privacy certificate approved by the NIJ human subjects protection officer.
    • The confidentiality statement on the consent document must state that confidentiality can only be broken if the subject reports immediate harm to subjects or others.

    For National Institute of Justice-funded research, a copy of data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, or their relevant research materials.

    4. Applicable regulations and guidelines

    28 CFR 512

    5. Forms


    6. Procedures employed to implement this policy & assignment of responsibility

    ORA director, chairpersons of IRBs, IRB members, IRB coordinator, and institutional officialEnsure compliance with federal regulations, policy and procedures to guarantee the protection of human subjects participating in research.

    Report to the vice president for research any inappropriate attempts to influence the IRB process.
    Institutional official and ORA director Evaluate on an ongoing basis the HRPP program for adherence and compliance with federal, state, and local policy and regulations.