On January 2nd, the National Institute of Justice (NIJ) updated their guidance regarding Human Subjects Protections to remind organizations that:

“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.” [emphasis added]

The guidance goes on to remind organizations that this means that the exemption categories listed in the Revised Common Rule cannot be applied to DOJ/NIJ/OJP research until such time as DOJ signs on to the revised rule.

Organizations who conduct research subject to DOJ regulations will need to maintain procedures to ensure compliance with 28 CFR Part 46.  Procedures and materials used for research subject to the pre-2018 Common Rule should be able to be adapted for use for such research.  IRB offices will need to be cognizant of the need to cite 28 CFR Part 46 on IRB letters, minutes, etc.  As a reminder, DOJ research is also subject to DOJ regulations on the Confidentiality of Identifiable Research and Statistical Information at 28 CFR Part 22.  Research conducted within the Federal Bureau of Prisons is subject to the requirements described at 28 CFR Part 512.