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Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
When working with certain governmental entities, there are additional steps and protections that PIs and IRBs must be aware of and execute, or risk complications with their funding.
DOJ Research applies to research conducted, supported or otherwise subject to regulation by the DOJ (or one of its agencies), which is usually carried out through the National Institute of Justice (NIJ). NOTE: the implementation of programmatic or operational initiatives made through pilot projects within the Bureau of Prisons (a DOJ agency) is not considered to be research. (see: 28 CFR 46.101(b)).
DOJ is one of the Common Rule agencies and has its own set of regulations found in 28 CFR Part 46. As described in this document, human subjects research (HSR) is any research that collects (1) Data through intervention or interaction with the individual, or (2) Identifiable private information from or about a living individual as part of a systematic investigation and designed to develop or contribute to generalizable knowledge (see: Office of Justice Programs’ Decision Tree for determining whether an activity constitutes research involving human participants).
Researchers are responsible for consulting with their NIJ Program Officer to confirm that all NIJ requirements are met prior to beginning research. Among those requirements are the following:
- A Privacy Certificate must be approved by the NIJ Human Subjects Protection Officer;
- All researchers and their staff are required to sign Employee Confidentiality Statements, which are maintained locally;
- Informed Consent : the informed consent document must include the following information:
- The name of the funding agency;
- A statement describing confidentiality of participant records
- The participant must 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 and the identity of the individual cannot be protected, the participant must be explicitly notified;
- Any information regarding when research intends to disclose information, such as if the participant reports immediate risk to the participant or others. The risks of this disclosure must be included in the consent document;
- Researchers are not required to report child abuse unless the participant signs another consent document to allow child abuse reporting.
Research Conducted with the Bureau of Prisons (BOP)
All research within the Bureau of Prisons must be done in accordance with 28 CFR 512. Some of the requirements for BOP research include:
- The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
- The project must minimize risk to participant; risks to participants must be reasonable in relation to anticipated benefits. The selection of participants within any one institution must be equitable.
- Incentives may not be offered to help persuade inmate participants to participate. However, soft drinks and snacks to be consumed at the test setting may be offered.
- Researchers must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
- Except as noted in the informed consent statement to the participant, researchers must not provide research information which identifies a participant to any person without that participant’s prior written consent to release the information.
- The researcher must have academic preparation or experience in the area of study of the proposed research.
- The research design must be compatible with both the operation of prison facilities and protection of human participants. Researchers must observe the rules of the institution or office in which the research is conducted.
- 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 investigator 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 investigator 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. (See: OPI: IPD, Number: 1070.07.)
- The submission of the research proposal must include the information outlined in 28 CFR 512.12, and must be submitted and will be processed and reviewed by the Bureau Research Review Board in accordance with 28 CFR 512.14.
Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research participants who are both:
- No longer in Bureau of Prisons custody.
- Participating in authorized research being conducted by Bureau employees or contractors.
For research conducted within BOP, additional required elements of informed consent include:
- Identification of the researchers
- Anticipated uses of the results of 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 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/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.
A waiver of documentation of informed consent can be approved if the researcher can demonstrate that the only link to the participant's identity is the signed statement of informed consent or that there is significantly more risk to the participant if the statement is signed. The signed statement shall be submitted to the chairperson of the appropriate local research review board.
Copyright Provisions As a precondition to the conduct of research under this subpart, researchers shall grant in writing to the Bureau a royalty-free, non-exclusive, and irrevocable license to reproduce, publish, translate, and otherwise use and authorize others to publish and use original materials developed as a result of research conducted under this subpart.
In the initial IRB application, researchers should provide links to the DOJ regulations on human subjects protection and privacy (see: Human Subject and Privacy Protection).
If IRB approval is required for a project, researchers must submit a copy of the IRB's approval as well as supporting documentation concerning the IRB's institutional affiliation, necessary assurances, etc., to the funding agency (usually NIJ) prior to the initiation of any research activities that are not exempt from the requirements of 28 CFR Part 46.
If research is being conducted with the consent of BOP, there are additional regulatory requirements in 28 CFR 215 that researchers must follow:
- All research proposals must be reviewed by the Bureau Research Review Board (BRRB). The BRRB monitors research projects at least yearly, for compliance with Bureau policies. It is the investigator’s responsibility to communicate and submit proposals to the BRRB.
- Implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered by the Bureau to be research.
- A non-employee of the Bureau is limited in access to information available under the Freedom of Information Act. He/she 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.
There are no additional funding requirements for DOJ studies. Refer to the UW department of Research and Sponsored Programs website for guidance: https://www.rsp.wisc.edu/
There are no additional training requiremetns for DOJ studies. Researchers and their study staff are expected to take human participants research training as required by the UW, and maintain this certification while participating on an DOJ trial. The UW uses the CITI program for this training. The NIH has a FAQ that discusses who on the researcher’s study team is required to have human participants training, and what programs satisfy this requirement.
There are additional reporting requirements for studies that are conducted and within the BOP.
- At least once a year, the investigator shall provide the Chief of the 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 investigator shall distribute one copy of the report to each of the following:
- The chairperson of the Bureau Research Review Board
- Regional director
- Warden of each institution that provided data or assistance.
Researchers must include an abstract in the report of finding.
- In any publication of results, researchers shall acknowledge the Bureau's participation in the research project.
- Prior to submitting for publication the results of a BOP study, researchers must provide two copies of the material (for informational purposes only) to the Chief, Ofice of Research and Evaluation.
- The Researcher shall expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau.
Many NIJ solicitations require applicants to include a data archiving plan as part of their funding application; researchers should keep this in mind when formulating their budgets. At the end of the award period, recipients of NIJ funding follow guidelines to submit data resulting from their projects to NIJ for archiving with the National Archive of Criminal Justice Data (NACJD), including copies of the informed consent document, data collection instruments, surveys, or other relevant research materials. Note: there are certain exemptions to this data reporting requirement, which will be detailed in your NIJ award letter.
- FAQ, Regarding the National Institute of Justice's Confidentiality and Human Subject Protection Requirements
NIJ Privacy Certificate
Sample NIJ Employee Confidentiality Statement
28 CFR Part 512, Subpart B - DOJ regulations for conducting research within the Bureau of Prisons
OPI: IPD, Number: 1070.07, Date: 5/12/99, Subject: Research – DOJ Program Statement about research in the Federal Bureau of Prisons
NIJ Data Submission Checklist and Secondary Data Analyst User's Guide
- Exemptions for data reporting to National Archive of Criminal Justice Data (NACJD) – data reporting is otherwise required for NIJ-funded research