Special Requirements and Guidance for Investigators
WPP #: XVII-18
Additional Requirements for Human Subject Protection in Research Funded by the Department of Justice (DoJ) including the National Institute of Justice
All non-exempt research involving human participants supported through a funding award from the Department of Justice (DoJ), including the National Institute of Justice, must comply with additional requirements established by the DoJ in order to be approved by the IRB. These requirements do not apply to use of identifiable information that is designated under existing statutes as public or to information gained regarding future criminal conduct.
Research or statistical project means any program, project, or component thereof which is supported I whole or in part with funds appropriated under the Omnibus Crime Control and Safe Streets Act of 1968 and whose purpose is to develop, measure, evaluate, or otherwise advance the state of knowledge in a particular area. The term does not include “intelligence” or other information-gathering activities in which information pertaining to specific individuals is obtained for purposes directly related to enforcement of the criminal laws.
Private, identifiable information means information is either 1) labeled by name or other personal identifier, or 2) can, by virtue of sample size or other factors, be reasonably interpreted as referring to a particular private person
Procedures and Guidance
DoJ supported research must comply with the following regulatory requirements:
- 28 CFR 46 – Protection of Human Subjects
- 28 CFR 22 – Confidentiality of Identifiable Research and Statistical Information
- 42 U.S.C. 3789g – Confidentiality of Information
Department of Justice policy provides for protection of privacy and well-being of individuals who are participants in DOJ research studies. The regulations:
- Protect the privacy of individuals by limiting the use of private, identifiable information for research or statistical purposes.
- Protect private information provided by individuals from use in any judicial, legal, or administrative process without the individual’s prior consent.
- Improve the scientific quality of DOJ/NIJ research programs by minimizing the subject’s concerns over the use of the data.
- Clarify for researchers the limitations on the use of privately identifiable information for only research or statistical purposes.
- Ensure that our understanding and knowledge of the broad criminal justice system will continue to advance by providing individual privacy protections.
- Additional Regulatory Requirements for Department of Justice Funded Research
The DoJ applies the Common Rule, as codified in 28 CFR 46to all non-exempt research. Requirements outlined in the Common Rule are detailed elsewhere in the VCU IRB WPPs. Additional requirements beyond what is identified elsewhere in the WPPs are outlined below:
- Privacy Certificate [28 CFR 22; 42 USC 3789g]
Applicants for DOJ funding must submit a Privacy Certificate as a condition of approval of a grant application or contract proposal regardless of whether the project involves the collection of identifiable data. Privacy Certificate Resources:
The Privacy Certificate must be submitted with the IRB application. The IRB will conduct a congruence review to ensure the IRB submission and the Privacy Certificate indicate the same confidentiality protections.
All NIJ (National Institute of Justice)-funded research projects are required to have a privacy certificate approved by the NIJ Human Subjects Protection Officer.
For NIJ-funded research, all researchers and research staff are required to sign employee confidentiality statements, which are maintained by the responsible researcher.
- Informed Consent – Additional Requirements [28 CFR 46.116]
When funded by the DOJ, the informed consent must disclose all of the following:
- The particular types of information that will be collected
- Private, identifiable information will only be used for research and statistical purposes. Any intended disclosures for research purposes must be explicitly identified in the informed consent document including what will be disclosed, under what circumstances, and to whom.
- The confidentiality statement in the informed consent document should disclose that confidentiality may be broken if the subject indicates future criminal intent.
- Participation in the research and provision of private identifiable information is voluntary and may be terminated at any time.
- Project findings and reports prepared for dissemination will not contain information which can reasonably be expected to be identifiable
- If applicable, where findings in a project cannot, by virtue of sample size or uniqueness of subject, be expected to totally conceal subject identity, this must be included in the informed consent.
- If funded by the National Institute of Justice:
- Statement that the study is funded by the National Institute of Justice (NIJ)
- A copy of all data must be de-identified and submitted to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys or other relevant research materials
- Reporting of Child Abuse
The Department of Justice regulations prohibit any disclosure of identifiable information, except where the researcher learns of intent to commit future criminal conduct. Virginia Code requires that all employees of institutions of higher education report actual or suspected child abuse to appropriate state agencies. When research is supported by the Department of Justice, in order to report child abuse, the researcher must obtain a separate consent to allow child abuse reporting. The National Institute of Justice provides a template consent for this purpose. The IRB should ensure that the research informed consent language does not conflict with this DOJ policy.
- Archiving of National Institute of Justice Data
Projects funded by the National Institute of Justice are required to submit de-identified data to the National Archive of Criminal Justice Data, including copies of the informed consent document, data collection instruments, surveys, and other relevant research materials. Plans for submitting data should be described in the Data Archiving Plan and approved by the NIJ grant manager. For more information, see NIJ funding information.
- Research Conducted Within the Federal Bureau of Prisons
For research conducted within the Bureau of Prisons, 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. Please refer to WPP XVII-19 for additional requirements for research conducted within the Federal Bureau of Prisons.
- Privacy Certificate [28 CFR 22; 42 USC 3789g]