All NIJ employees, contractors, and award recipients must be cognizant of the importance of protecting the rights and welfare of human subject research participants. All research conducted at NIJ or supported with NIJ funds must comply with all Federal, U.S. Department of Justice (DOJ), Office of Justice Programs, and NIJ regulations and policies concerning the protection of human subjects and the DOJ confidentiality requirements.
Why is it important for those of us involved in research to care about these requirements? Fulfilling our obligations under these regulations is important for several reasons other than just being in compliance with the regulations and processing the research award, including:
- Following these procedures provides research subjects protection from harm that might result from their participation in research.
- Complying with these procedures (e.g., IRB review, informed consent, confidentiality concerns) improves the overall quality of the research we conduct and the data used in the analysis.
- Consideration of the confidentiality and human subject issues and compliance with the rules will allow us to continue to conduct difficult research on important societal problems and to provide a scientifically informed basis for making important public policy decisions.
- The codes of conduct and ethical standards of our profession to which we adhere require the dutiful protection of human research subjects and confidentiality.
- Many of these concepts have longstanding associations with other fundamental aspects of our society (e.g., belief in individual rights, representative government), and fulfilling our obligations defines us as a society and a nation.
NIJ policy provides for the protection of the privacy and wellbeing of individuals who participate in NIJ research studies under two different, but philosophically related, sets of regulations:
Forms and Regulations
Forms:
- Protection of Human Subjects 'Common Rule' (pdf)
- NIJ-specific Instructions for Common Rule (pdf, 1 page), Updated 2021
- Model Privacy Certificate
Fillable version (pdf, 11 pages) - Model Employee Confidentiality Statement
- Sample Consent Form for Reporting (doc, 1 page)
Regulations:
- Protection of Human Subjects, 28 CFR 46
- Confidentiality of Identifiable Research and Statistical Information, 28 CFR 22
Other Sources:
- FAQ's on Informed Consent (HHS)
- FAQ's on Prisoner Research (HHS)
- Confidentiality of Identifiable Research and Statistical Information Regulations
- Protection of Human Subjects Regulations
- International Compilation of Human Subject (HHS)
Guidance regarding Human Subjects Protection documentation for NIJ/OJP-funded awards submitted after January 21, 2019
Provisions of the Revised Common Rule (45 CFR 46 of the July 19, 2018 edition of the e-Code of Federal Regulations) take effect for a number of executive branch agencies on January 21, 2019. Because the Department of Justice (DOJ) is not a signatory of the Revised Common Rule, the DOJ regulations regarding human subjects protection, 28 CFR Part 46, remain in effect for DOJ’s research awards; the provisions of the Revised Common Rule do not apply. IRB documentation from NIJ/OJP awardees must reflect 28 CFR Part 46 citations and can no longer be accepted using 45 CFR part 46 references after January 21, 2019.
Awardees are reminded to notify their IRBs of the need to use the DOJ human subjects protections regulation (28 CFR Part 46) when reviewing all NIJ/OJP -funded research awards.
Exemption categories listed in 45 CFR Part 46 Revised Common Rule cannot be accepted until such time the DOJ has signed on to the Revised Common Rule.
Questions may be referred to Cheryl Crawford Watson, Human Subjects Protection Officer, National Institute of Justice, Office of Justice Programs at [email protected]. The subject line of the email should include the award number and grant managers should be included on cc: line.