Department of Justice

POLICY

For research that is funded or supported by the Department of Justice, the IRB and Principal Investigators will comply with the Department of Justice regulations at 28 CFR 46 (Protection of Human Subjects).

UTHealth Houston IRB will review submissions supported by the Department of Justice (DOJ) or conducted within the federal Bureau of Prisons with respect to the following additional requirements. Research funded through the National Institute of Justice (NIJ) must comply with the provisions of 28 CFR Part 46, related to human subject protections, and also 28 CFR Part 22, related to privacy and confidentiality of research data. Specific requirements for such research are outlined below.

PI Responsibilities for National Institute of Justice (NIJ) funded research:

1. All projects are required to have a privacy certificate approved by the NIJ Human Subjects Protection Officer. The NIJ Privacy Certificate (PC) guidelines and format provide instructions and a useful tool for documenting that researchers understand their obligations and how they will fulfill their obligations under the confidentiality regulations found in 28 CFR Part 22. (https://nij.ojp.gov/funding/privacy-certificate-guidance )
2. All researchers and research staff are required to sign employee confidentiality statements, which are maintained by the responsible researcher. A model employee confidentiality statement can be found at https://nij.ojp.gov/funding/model-employee-confidentiality-statement.
3. Consent documents must disclose funding agency name. Consent forms must include the following language: “The research team will take reasonable steps to protect the confidentiality of your information. The consent document will explain the extent to which your information will be kept confidential and any circumstances under which confidentiality may be legally limited.”
4. All research staff involved in DoJ supported research will be trained in human subjects protections and confidentiality requirements, as required by federal regulations and institutional policies and DoJ specific requirements.
5. A copy of all 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 other relevant research materials.
6. 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.
7. 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.
8. In any publication of results, the researcher shall acknowledge the Bureau's participation in the research project.
9. The researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
10. 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.

For research conducting within the Bureau of Prisons –

1. Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.
2. The University, IRB, and researchers and research staff must follow the requirements of 28 CFR 512, including:
   1. The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
   2. The research design must be compatible with both the operation of prison facilities and protection of human participants. The researcher must observe the rules of the institution or office in which the research is conducted.
   3. The project must have an adequate research design and contribute to the advancement of knowledge about corrections.
   4. 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.
   5. All research proposals will be reviewed by the Bureau Research Review Board.
3. 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.
4. Except as noted in the consent statement to the participant, the researcher must not provide research information that identifies a participant to any person without that participant’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 pertain.
5. Except for computerized data records maintained at an official DoJ 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.
6. 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.
7. The researcher must have academic preparation or experience in the area of study of the proposed research and when submitting a research proposal, the applicant shall provide the following information:
   1. A summary statement, which includes:
      1. Names and current affiliations of the 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 amount of time required from each.
      9. Indication of risk or discomfort involved as a result of participation
   2. 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.
   3. 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
   4. Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules.
   5. A statement regarding assurances and certification required by 28 CFR 46, if applicable.

8. For research conducted within the Bureau of Prisons required elements of disclosure include:
   • The identity of the researcher
   • Anticipated uses of the results of the research.
   • The extent to which confidentiality of records identifying the participant will be maintained. For studies sponsored by NIJ, the participant should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the participants need to be explicitly notified. If the researcher intends to disclose any information, the participant needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The participant must be informed of any risks that might result from this disclosure and must explicitly provide written consent prior to participating in the research.
   • 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 (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 participant indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the participant 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 participant's release date or parole eligibility.

REFERENCES

1. 28 CFR 46 Protection of Human Subjects
2. Model Employee Confidentiality Statement
3. Model Privacy Certificate
4. NIJ-specific Instructions for Common Rule, Updated 2025

If you find errors in this document, contact [email protected]

 

Document Number:	101-C24
Document Name:	Department of Justice
Reviewed by:	Associate Vice President, Research Compliance
Revision History:	1 Jun 2026