Overview of Human Subjects Protection
To ensure that human subjects are adequately protected from unreasonable risks and properly informed of the potential harms and benefits from their participation in research, NIJ and recipients of its funds are required to comply with Department of Justice regulations at 28 CFR Part 46 (Protection of Human Subjects). These regulations, often referred to as the "Common Rule," generally require that projects using federal monies for research involving human subjects are reviewed and approved by an Institutional Review Board (IRB) prior to the expenditure of federal funds for that research.
If IRB approval is required for a project, applicants must submit a copy of the IRB's approval as well as supporting documentation concerning the IRB's institutional affiliation, necessary assurances, etc., to NIJ prior to the initiation of any research activities that are not exempt from the requirements of 28 CFR Part 46.
Researchers must provide subjects with sufficient information, in an understandable format, so that they can make a voluntary decision whether or not to participate in the study. The informed consent process is fundamental in ensuring respect for persons and should serve to educate the subject about the research, the benefits and risks, and the voluntary nature of their participation.
When to Submit
You are strongly encouraged to submit human subjects protection documentation at the same time you submit your grant application.
IRB review and submission may occur after an award is received but no funds will be released for research activities involving the human subjects component of the study until NIJ's human subjects protection officer receives the required documentation and the special conditions placed on the award to protect human subjects are removed. Failure to provide this information in a timely manner may cause significant delay in the start-up of a funded research award.
How to Submit
Human Subjects Protection Form
You are strongly encouraged to use the form Protection of Human Subjects Assurance Identification/IRB Certification/Declarations of Exemption (Common Rule) [pdf].
Following are some specific instructions for applicants of NIJ funding:
Box 1: Check Request Type: Original (New Award) or Continuation (Do not check Exemption here)
Box 2: Check Type of Award Mechanism: Grant, Contract, Cooperative Agreement, Fellowship, or Other
Box 3: Insert National Institute of Justice as Name of Federal Department or Agency
Box 4: Insert Title of Application
Box 5: Insert Principal Investigator Name
Box 6: For Assurance Status of this Project, five options for response are provided:
- Option 1) Assurance on file with HHS and IRB has approved. (Please note that the Federalwide Assurance (FWA) number, its expiration date, and the IRB registration number should be provided here. The Certification of IRB review and approval citing 28 CFR Part 46 must also be provided.)
- Option 2) Assurance on file with another Federal agency or department and IRB has approved. (NOTE: The FWA number, expiration date, and IRB registration number must be provided here. The Certification of IRB review and approval must also be provided.)
- Option 3) No Assurance has been filed. The institution declares that it will provide and Assurance and Certification of IRB review and approval upon request.
All applicants should check the third option unless the applicant has already submitted this research application to and received approval or exemption from an IRB with an Assurance on file.
- Option 4) Exemption Status: Pre-2018 Common Rule - Use this option ONLY if one of the exemptions listed in the DOJ Human Subjects Protection regulation 28 CFR Part 46 §101(b)1-4 applies. Your IRB approval of exemption memo must be provided, citing 28 CFR Part 46 and the specific exemption category.
- Option 5) Exemption Status: This option does not apply to NIJ/OJP-funded awards since DOJ did not sign on to the 2018 Common Rule.
Box 7: For Certification of IRB Review, if an Assurance is on file (that is, if Option 1 or 2 was selected in Box 6), complete the applicable response in Box 7 if IRB review and determination has occurred. If IRB review has not occurred, check the last option indicating IRB review is forthcoming.
Box 8: Comments: If the project does not involve human subjects, place the following statement in this box: “This project will not involve human subjects.” If the project does not involve human subjects and this statement is placed in Box 8, then there should be no other items checked in Boxes 6 & 7.
Boxes 10-16: Complete as indicated. The signing official must be a representative of the applicant institution, i.e., Director, Office of Sponsored Research or Chair, IRB, not the Principal Investigator. The form must be dated. Electronic signatures and dates are acceptable
Submitting Information Via a Signed Letter
You also may submit a letter, on institutional letterhead, signed by the IRB chairman that:
- Includes the FWA number.
- Includes the IRB review determination citing the Department of Justice human subjects protection regulation 28 CFR Part 46.
- Addresses the relevant items from the form.
- Includes as an attachment the IRB-reviewed and approved or exempted protocol
The regulations define certain categories of research that are exempt from IRB review, either because of the nature of the research itself or the manner in which the research is carried out. [See 28 CFR § 46.101(b).]
If the research is determined to be exempt from the regulations by an IRB, applicants must submit supporting documentation concerning the IRB's approval of the exemption. If the project does not involve human subjects, applicants must provide appropriate documentation to support the lack of human subject involvement. Applicants should review 28 CFR Part 46 to determine their individual project requirements.
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.
[note 1] This includes funding through grants, subgrants, contracts, subcontracts, cooperative agreements, and interagency agreements.
Reviewed and updated