September 2020

The United States Department of Justice (DOJ) is a signatory agency to the Common Rule for the conduct of human subjects research. In addition to the Common Rule requirements, the DOJ has its own regulations which govern the conduct of human research which it funds. It is the obligation of researchers at JHM to be aware of these requirements and present applications to the JHM IRBs that comply with them when implicated. When submitting eIRB applications with DOJ funding, researchers should list the applicable DOJ entity (either the National Institute of Justice or the Bureau of Prisoners) in section 9 (Support Information). Researchers may consult with a member of the OHSR Compliance Team with any questions. Members of the Compliance Team will assist the reviewing IRBs in conducting their reviews under these requirements, which are summarized below.

Research Funded by the National Institute of Justice (NIJ)

• All projects are required to have a privacy certificate approved by the NIJ human participants protection officer.
• All researchers and research staff are required to sign employee confidentiality statements, which are maintained by the responsible researcher. (These documents often additionally require the signature of a JHM institutional official. If so, they should be uploaded in eIRB section 20 (Supplemental Study Documents) Q. 1.)
• Under a privacy certificate, researchers and research staff do not have to report child abuse unless the participant signs another consent document to allow child abuse reporting.
• The informed consent documents must disclose or include:
  • The name(s) of the funding agency(ies);
  • The extent to which confidentiality of records identifying the participant will be maintained;
  • 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 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(s), data collection instruments, surveys, or other relevant research materials.

Research Funded by/Conducted Within the Bureau of Prisons (BOP)*

(* Please note that the BOP does not deem Implementation of Bureau programmatic or operational initiatives made through pilot projects to be research.)

• 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 participants. 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 BOP must sign a statement in which the researcher agrees to adhere to the requirements of 28 CFR 512.
• All research proposals will be reviewed by the Bureau Research Review Board.
• The project must have an adequate research design and contribute to the advancement of knowledge about corrections.
• The selection of participants within any one organization 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.
• 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 BOP custody.
  (ii) Participating in authorized research being conducted by BOP employees or contractors
• A non-employee of the BOP 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.
• Except as noted in the informed consent documents provided 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.
• Except for computerized data records maintained at an official U.S. 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.
• 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 informed consent documents must disclose or include:
  • The identity 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 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.
• 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 participate in the research project as an associate, assistant, or subcontractor to the researcher.
• When submitting a research protocol, the applicant must provide a summary statement, which includes:
  (A) Names and current affiliations of the researchers.
  (B) Title of the study.
  (C) Purpose of the study.
  (D) Location of the study.
  (E) Methods to be employed.
  (F) Anticipated results.
  (G) Duration of the study.
  (H) Number of participants (staff or inmates) required and amount of time required from each.
  (I) Indication of risk or discomfort involved as a result of participation.
• The applicant must also provide a comprehensive statement, which includes:
  (A) Review of related literature.
  (B) Detailed description of the research method.
  (C) Significance of anticipated results and their contribution to the advancement of knowledge.
  (D) Specific resources required from the BOP.
  (E) 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.
  (F) Description of steps taken to minimize any risks.
  (G) Description of physical or administrative procedures to be followed to:
  (i) Ensure the security of any individually identifiable data that are being collected for the study.
  (ii) Destroy research records or remove individual identifiers from those records when the research has been completed.
  (iii) Description of any anticipated effects of the research study on organizational programs and operations.
  (H) Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules.
  (I) A statement regarding assurances and certification required by federal regulations, if applicable.
• At least once a year, the researcher must provide the Chief, ORE, 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 must 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 must include an abstract in the report of findings.
• In any publication of results, the researcher must acknowledge the BOP's participation in the research project.
• The researcher must expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the BOP.
• Prior to submitting for publication the results of a research project, the researcher must provide two copies of the material, for informational purposes only, to the Chief, ORE, Central Office, BOP