85. Department of Justice Regulations for Human Research Protection
Updated Oct. 4, 2019
The Department of Justice (DoJ), which includes the National Institute of Justice (NIJ) and the Federal Bureau of Prisons and other agencies, complies with the Common Rule as codified at 28 CFR 46.
Additional confidentiality requirements at §22 apply to the collection of identifiable research and statistical data for projects funded (either directly or under a State plan) by the NIJ and other DoJ agencies as identified in §22.20, item (a), and to interagency agreements, grants, contracts, or subgrants awarded under the Crime Control Act, the Juvenile Justice Act, and the Victims of Crime Act. For the purposes of this policy, “NIJ” will be referenced but Investigators and the IRB will identify projects funded by other DoJ agencies or mechanisms to which the additional requirements apply.
Additional requirements at §512 apply to research that is conducted or supported by, or involves facilities overseen by the Bureau of Prisons.
University and Affiliate investigators conducting research subject to DoJ requirements must complete and submit the “Department of Justice Research” form available in IRBNet. For research involving the Bureau of Prisons, investigators must answer the “Bureau of Prisons Research” questions on that form. The IRB member assigned to the review will use the “Department of Justice Research Review Worksheet” to confirm the additional DoJ requirements were sufficiently addressed. For research involving the Bureau of Prisons, the IRB member will also use the “Bureau of Prisons Research Review Worksheet” to confirm those requirements are met as well.
Additional NIJ Requirements for Revealing or Disclosing Identifiable Information
In accordance with §22.22, research and statistical information relating to a private person may only be revealed (or disclosed) on a need-to-know basis to
- the recipient of a grant, contract, interagency agreement, subgrant, or subcontract subject to these regulations;
- any person, including subcontractors, employed by the recipient in connection with implementation of the grant, contract, or agreement;
- any individuals as required by federal regulations or applicable state law; and
- persons or organizations for research or statistical purposes if the DoJ requirements to transfer information are met.
Additional NIJ Requirements for Privacy Certificates
PIs conducting NIJ-funded research must comply with the regulations at §22.23 regarding requirements for Privacy Certificate for NIJ-funded research. The Privacy Certificate is a condition of approval for a grant applications or contract proposals in which a research or statistical project component involves the collection of information identifiable to a private person (see the online Policy Manual Definitions). Privacy Certificates must approved by the NIJ human subjects protection officer. See the NIJ Privacy Certification Guidance website for more information and a template. The fully executed Privacy Certificate must submitted to the IRB for acknowledgement before participant enrollment may commence.
Under the requirements for Privacy Certificates, all Principal Investigators (PIs) and researchers with access to data must be advised in writing of the confidentiality requirements and must agree in writing to abide by the requirements. The signed investigator agreements must be maintained by the PI and made available to the IRB upon request.
NIJ Requirement for Information Transfer Agreements
Under NIJ requirements at §22.24, PIs may only receive or transfer research information identifiable to a private person under an Information Transfer or Data Use Agreement. Additionally, University and Affiliate investigators must obtain IRB approval prior to the transfer of identifiable data, whether involved in the transfer as a recipient or a provider.
The person obtaining the Privacy Certificate (i.e., Grantee) is responsible for information transfers and must maintain a data transfer log. The Grantee and data recipient or provider must agree to the following regarding the transfer the Information:
- The Information will be used only for research and statistical purposes.
- The Information will not be revealed for any purpose except for information that has already been included in research findings (and/or databases) and is revealed on a need-to-know basis for research or statistical purposes, when the transfer is approved by the person providing the information under an Agreement, or under other authority.
- Use or dissemination of the Information other than as described in the Agreement constitutes a violation of the NIJ regulations and must be reported to the IRB.
- The recipient will ensure that adequate administrative and physical precautions are taken to secure the Information.
- Access to the Information will be limited to employees or subcontractors requiring such access to perform the activity for which the Information was obtained. Persons with access to the Information will be advised of and agree to comply with the NIJ regulations.
- Investigators will design project plans to preserve anonymity of private persons to whom the Information relates, including where appropriate, name-stripping and/or coding of data.
- Project findings and reports prepared for dissemination will not contain information which can reasonably be expected to be identifiable to a private person.
- Unless otherwise agreed upon, the recipient will return information identifiable to a private person that obtained in accordance with the Agreement upon completion of the project for which the Information was obtained. The recipient will not retain any copies of the Information.
The Grantee must provide NIJ with copies of all transfer agreements before they are executed, and the name and title of the persons with the authority to transfer the data.
NIJ Requirements for Final Disposition of Identifiable Materials
Under NIJ requirements at §22.25, upon completion of a research or statistical project, the PI must handle the information identifiable to an individual as described in the Privacy Certification. Generally by
- physically destroying of all copies of the materials or the identifiable portions after the required three-year recipient retention period or as soon as authorized by law; or
- removing identifiers from the data and destroying or separately maintaining the name-code index in a secure location. IRB approval is required until the name code index is destroyed.
Additional NIJ Requirements for Transfer of Information.
To comply with §22.26, requests to transfer of information identifiable to an individual must be submitted to the person submitting the Privacy Certificate and unless the request is from a DoJ agency.. Transfer requests must
- describe the general objectives of the project for which information is requested;
- specifically justify the need for the inclusion of identifiable information;
- confirm with justification that conduct of the project will not, either directly or indirectly, cause legal, economic, physical, or social harm to individuals whose identification is revealed in the transfer of information.
The IRB (or RI for exemptions) will not approve NIJ-funded research involving transfer of identifiable information if these requirements are not met.
Additional NIJ Requirements for Participant Notification (Informed Consent)
PIs must comply with the NIJ requirements §22.27 for notifying any person from whom information identifiable to a private person is to be obtained. The information may be provided either orally or in writing unless written consent is required.
Participants must be
- provided the name of the agency funding the research;
- told that their identifiable information will be kept confidential and will only be used for research and statistical purposes;
- told that complying with the request for the information is entirely voluntary and they may rescind their agreement at any time;
Participants must be explicitly notified if/when due to sample size or uniqueness of a participant, the findings cannot be expected to totally conceal an individual’s identity.
Researchers planning to disclose information from NIJ-funded research must obtain written consent from each prospective participant prior the individual’s participation in the research. The consent form must specify what information will be disclosed, the circumstances of the disclosure, and to whom the disclosure will be made; and must describe the risks that might result from the disclosure.
If information will be obtained through field observation of individual activity or performance and in the judgment of the researcher participant notification is impractical or may seriously impede the progress of the research, participant notification may not be required. The PI must explain why participants will not be informed about the research and for non-exempt research the PI must obtain IRB approval for a waiver of informed consent.
Additional NIJ Requirements Involving the National Archive of Criminal Justice Data
For NIJ-funded research, PIs must send copy of the de-identified data to the National Archive of Criminal Justice Data including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials.
PIs must include a copy of the archiving plan with the project submission for IRB approval and must reference the data archiving in consent materials.
Use of Identifiable Data from NIJ-funded Research for Judicial, Legislative or Administrative Purposes
Research or statistical information identifiable to a private person obtained from NIJ-funded research is immune from the legal process (e.g., mandatory reporting requirements). The individual to whom the data pertains must provide written consent for the explicit use of such information as evidence or for any judicial, legislative or administrative purpose or proceeding. Consent for such uses must be obtained at the time the information is sought and must limit, where appropriate, the scope of the information subject to the consent.
Additional DoJ Requirements for Research Involving the Bureau of Prisons
DoJ regulations at §512 specify additional requirements for research involving the Bureau of Prisons, as follows:
- In all research projects the rights, health, and human dignity of individuals involved must be respected.
- The project must have an adequate research design and contribute to the advancement of knowledge about corrections.
- The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
- The project must minimize risk to participants; risks to participants must be reasonable in relation to anticipated benefits. The selection of participants within any one institution must be equitable. When applicable, informed consent must be sought and documented.
- 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 participants who are both:
(i) No longer in Bureau of Prisons custody, and
(ii) Participating in authorized research being conducted by Bureau employees or contractors.
- The researcher must have academic preparation or experience in the area of study of the proposed research.
- 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.
- 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 pertains.
- The researcher must adhere to applicable provisions of the Privacy Act of 1974 and regulations pursuant to this Act.
- 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 part 512 subpart B.
- 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.
- 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.
- The researcher must submit planned methodological changes in a research project to the IRB for approval, and may be required to revise study procedures in accordance with the new
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 are reviewed by ORE to determine which provisions of this subpart may be waived without jeopardizing the safety of human subjects. ORE documents in writing the waiver of any specific provision along with the justification.
Informed Consent Requirements for Research Involving the Bureau of Prisons
Before commencing a research project requiring participation by staff or inmates, the researcher must give each participant a written informed consent statement containing the following information:
- Identification of the principal investigator(s).
- Objectives of the research project.
- Procedures to be followed in the conduct of research.
- Purpose of each procedure.
- Anticipated uses of the results of the research.
- A statement of benefits reasonably to be expected.
- A declaration concerning discomfort and risk, including a description of anticipated discomfort and risk.
- 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 an intent to commit future criminal conduct or harm himself/herself or someone else, or, if the participant is an inmate, indicates an 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.
- An offer to answer questions about the research project.
- Appropriate additional information as needed to describe adequately the nature and risks of the research.
Researchers who are not employees of the Bureau must obtain the participant’s signed consent prior to initiating the research activity. Written documentation of consent may be waived 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 participant if the statement is signed. Researchers who are employees of the Bureau must follow the requirements at §512.16(b) and §512.16(c).
Bureau Research Review Board (BRRB) Requirements
The Bureau of Prisons’ central institutional review, called the Bureau Research Review Board
(BRRB), reviews each project covered by 28 CFR 46 annually. The requirements for the composition of the BRRB are specified at §512.13. The requirements for the content of research proposals are listed at §512.12. The requirements for the submission of research proposals and the processing of proposals by the BRRB are specified at §512.14.
The BRRB monitors all research projects for compliance with Bureau policies. The Director, Bureau of Prisons, may suspend or terminate a research project if it is believed that the project violates research policy or that its continuation may prove detrimental to the inmate population, the staff, or the
orderly operation of the institution. The researcher must prepare reports of progress on the research at least once a year and submit at least one rep
IRB Submission Requirements for Research Involving the Bureau of Prisons
The researcher will complete the required IRBNet forms (including cover sheet, application form, and Department of Justice Research form), and ensure the following information is clearly stated:
- Names and current affiliations of the researchers.
- Title of the study.
- Purpose of the study.
- Location of the study.
- Review of related literature.
- Detailed description of the research method.
- Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules.
- A statement regarding assurances and certification required by federal regulations, if applicable.
- Anticipated results.
- Significance of anticipated results and their contribution to the advancement of knowledge.
- Description of any anticipated effects of the research study on organizational programs and operations.
- Duration of the study.
- Number of participants (staff or inmates) required and amount of time required from each.
- Specific resources required from the Bureau of Prisons.
- Indication of risk or discomfort involved as a result of participation.
- 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.
- Description of steps taken to minimize any risks.
- 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 from those records when the research has been completed.