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Purpose and Applicability

This page provides guidance for HSD staff about the additional regulatory requirements for research conducted with support from any program in the Department of Justice (DOJ), including the National Institute of Justice (NIJ) and Bureau of Prisons (BOP).

Guidance

DOJ regulations apply to research that is:

• Funded by DOJ (most often, from National Institutes of Justice).
• Conducted with any involvement of DOJ, including sites, institutions, personnel.
• Supported by any resources of DOJ (for example, the Bureau of Justice Statistics).

DOJ defines human subjects research according to the original Common Rule (28 CFR 46.102(d)).

Procedure

As required by DOJ, the IRB applies 28 CFR Part 46 to all research funded by any DOJ agency; it is the pre-2018 Common Rule.

The IRB applies the DOJ research regulations and consent requirements as listed in the WORKSHEET Department of Justice. When the research includes prisoners, per HSD policy, the use of a prisoner advocate and the prisoner Criteria for Approval are applied as described in the WORKSHEET Prisoners.

Privacy Certificate.

• 28 CFR 22 is the confidentiality/privacy regulation which only applies to research funded by any Office of Justice (OJP) Programs (a division of the DOJ) agencies.
• 28 CFR Part 22 is not a DOJ requirement, rather it applies only to OJP-funded research.
• A Privacy Certificate is required for all OJP-funded research supported by the OJP agencies. A template for the Privacy Certificate is located on the NIJ website, and submission instructions, are located on the NIJ website.
• If a study is initially funded by HHS or CDC and has an automatic Certificate of Confidentiality (CoC) and then obtains DOJ funding which requires a Privacy Certificate, the protections of the Privacy Certificate supersede the CoC. All consent materials should describe the Privacy Certificate protections rather than those of the CoC.
• If the need for a Privacy Certificate is identified, the reviewer:
  1. Informs the Team Operations Lead (TOL) so they can help coordinate the review and obtain the IRB Chair signature.
  2. If the researcher has not already submitted the Privacy Certificate application with their IRB materials, the reviewer informs the researcher that they must apply to the National Institute of Justice for a Certificate and that the application must be submitted with their IRB materials.
  3. The reviewer informs the researcher that the IRB must approve the study and the IRB Chair must sign the Privacy Certificate before the research can begin. NIJ has designated the IRB Chair as the Institutional Official.
  4. Once the Privacy Certificate application has been received, the reviewer ensures that the confidentiality and privacy protections described in the Certificate application are consistent with protections described in the IRB application.
  5. When the IRB approves the study, the TOL/SRA arranges for the IRB Chair signature and ensures that a copy of the completed Certificate application is uploaded to the Zipline application. If the researcher receives a confirmation that the Privacy Certificate has been granted, that should also be uploaded to Zipline.

Related Materials

WORKSHEET Department of Justice
WORKSHEET Prisoners

Regulatory References

• 28 CFR 22 Office of Justice Programs agencies, Confidentiality of Identifiable Research Information
• 28 CFR 46 Department of Justice, Human Subjects Protections
• 28 CFR 512 U.S. Bureau of Prisons, Department of Justice – Research
• National Institute of Justice website http://www.nij.gov/funding/humansubjects/

Version Information

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Keywords: CoC and privacy certificate; Federal agencies; Prisoners