85. Department of Justice Regulations for Human Research Protection
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. University and Affiliate investigators conducting research subject to the additional NIJ requirements must complete and submit the NIJ research form. The IRB member assigned to the review will use the NIJ review worksheet to confirm the additional requirements were sufficiently addressed.
DoJ regulations include additional requirements for research involving the Bureau of Prisons (§512). Currently none of the prison facilities in Nevada are under the jurisdiction of the Bureau of Prisons. University or Affiliate investigators wishing to conduct research in facilities overseen by the Bureau of Prisons are advised to contact the RIO to discuss the planned research. At that time, the University IRB will develop the necessary policies to allow such research to occur.
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 RIO 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.