Frequently Asked Questions Regarding Confidentiality and Human Subject Protection Requirements

Research that involves collecting or analyzing information obtained from an individual person whose responses about themselves are the object of the study is considered human subject research. Some examples of human subject research, common to NIJ-funded research, include when participants complete questionnaires about themselves; they participate in interviews designed to collect information about themselves; their behavior is observed; and their opinions of their activities are studied. The use of identifiable data about individuals and studies that involve human tissues and DNA for research purposes may also qualify.

The regulations at 28 CFR 46.102 (d) define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Human subject is defined in section 46.102(f) as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information."

Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).  Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”

You are required to complete the Privacy Certificate and Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form and include them with your grant application. When completing the Privacy Certificate, following the insertion of your project description you will need to state "No data identifiable to a private person will be collected." You may also insert "Not applicable since this study is not collecting any individually identifiable data" in the subsequent boxes. Do not leave form sections blank or insert Not Applicable without providing a reason. In the final disposition of data section, a statement acknowledging the requirement to archive de-identified study data consistent with the data archiving plan should be inserted.

In Box 8 of the Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form insert "This project will not involve human subjects."

Both forms must have the appropriate signatures and date.

If your project does not involve human subjects or the collection of identifiable data and these forms are completed correctly and attached to the grant application to be funded, funds can be made available at the time the award is made.  If the forms are not included, the award is likely to have funds withheld until the forms are received.

If your project does involve human subjects or the collection of identifiable data, you may submit the Protection of  Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form with the 3rd box in Item 6 selected that states IRB review will be obtained if requested.

The IRB review and submission of the Privacy Certificate may occur after the grant has been awarded, but no funds will be released for research activities involving the human subject component of the study until NIJ's Human Subjects Protection Officer receives the required documentation listed above and the special conditions placed on the award to protect human subjects are removed. Before funds can be disbursed, a proper Privacy Certificate must be submitted with the signatures of the principal and co-principal investigators and an authorized institutional representative. Documentation that the study is exempt from the human subject protection requirements under 28 CFR 46.101(b)(1-4) by an Institutional Review Board (IRB) or that the study has been reviewed and approved by an IRB with a current valid Federalwide assurance must also be submitted. Funds can be released for activities unrelated to the direct involvement of human subjects.   Failure to provide IRB and privacy documentation in a timely fashion may cause significant delay in the start-up of a funded research award.

They are removed when NIJ's Human Subjects Protection Officer has received the required documentation and approved a grant adjustment notice lifting the conditions. Grantees should contact their NIJ grant manager for assistance. It should be noted that the researcher cannot and should not begin human subjects research or the collection of identifiable data based on their institution's IRB approval alone. The special withholding conditions must be removed for research involving human subjects and/or the collection of identifiable data to begin.

It is important that the grantee (both the office of sponsored research/office of grants and contracts and the researcher) abides by the standard and special conditions that are required by NIJ. The standard and special conditions can be found in all award packages. NIJ grant monitors will be available to review these conditions immediately after the award is made.

You can search for commercial IRBs that review research on the Web. While NIJ does not endorse or recommend the use of any particular commercial IRBs, NIJ does accept the findings of commercial IRBs that review studies for compliance with the DOJ human subjects protection and confidentiality regulations.

Yes. It is suggested that NIJ-funded researchers provide links to the DOJ regulations in their IRB applications. Review these regulations on our website.  Awardees should be aware that the DOJ regulations for human subjects protection at 28 CFR Part 46 are different from the Revised Common Rule, that went into effect 1/21/19.  NIJ can only accept IRB determinations based on 28 CFR Part 46.

If you believe your project is exempt from the human subjects protection requirements as described in 28 CFR 46.101(b) (1-4) and if your institution has a current FWA, you must apply to your own institution’s IRB or a commercial IRB for an exemption.  If you are granted an exemption from IRB review, you must still comply with the notification requirements in 28 CFR Part 22.27.  NIJ must review and approve all consent-related documentation under 28 CFR Part 22 even if your research has received an exemption under 28 CFR Part 46.

No. However, you are strongly encouraged to do so. A letter submitted on institution letterhead that addresses the relevant items from the form signed by the IRB chairperson and including the FWA number will also be acceptable. Studies deemed exempt by an IRB require an IRB exemption letter.

: Yes, all research sponsored or conducted by NIJ must meet these requirements.

A: No. NIJ does not issue or accept Certificates of Confidentiality issued by National Institutes of Health or HHS. Grantees must submit a Privacy Certificate, which is reviewed and approved by the funding agency. Under the DOJ confidentiality statute (34 USC 10231(a)), this makes the identifiable data collected immune from any legal action. Neither the Privacy Certificate nor the informed consent documentation should contain language about Certificates of Confidentiality. The Privacy Certificate and consent forms should accurately describe that the identifiable data collected is immune from legal process because the researcher submitted a Privacy Certificate; it was approved by NIJ and is, therefore, covered by DOJ statute.

A: No. NIJ has a Human Subjects Protection Officer who reviews IRB approvals from awardees to ensure that the IRB has reviewed the study protocol in compliance with the DOJ human subjects protection regulations (28 CFR Part 46), the informed consent documentation in compliance with the DOJ regulations at 28 CFR 46.116 and the notification requirements in the DOJ confidentiality regulation (28 CFR Part 22). The NIJ Human Subjects Protection Officer will accept the findings of the awardee’s IRB provided the findings comply with the DOJ regulations cited above.

A: Researchers need to follow the general requirements for informed consent found at 28 CFR 46.116.  For instance, subjects need to be informed that study participation is voluntary and that identifiable data collected with NIJ funds can only be used for research and statistical purposes, and no other purpose without the subject’s consent. They should also be informed that the study is funded by NIJ. If the award has a data archiving special condition, the subjects should also be told that the de-identified study data will be archived at the National Archive of Criminal Justice Data (NACJD).  Other notification requirements can be found in 28 CFR Part 22.27.

Current or past abuse is not reportable, unless a separate consent to allow reporting is obtained from the research subject; this is in addition to a consent to participate in the research study. Please contact your grant manager and/or the NIJ Human Subjects Protection Officer if you have any further questions regarding this issue.

DOJ anticipates completing the process of amending the Department’s own regulation 28 CFR Part 46 at some time in the future in order to be consistent with the changes made for other agencies in the Revised Common Rule. However, until such time DOJ signs on, IRBs reviewing NIJ- or OJP-funded research must use and cite 28 CFR Part 46. Of particular note, in the Revised Common Rule there are changes made to the exemption categories, which will not apply and cannot be accepted for NIJ- or OJP-funded research. Please contact your grant manager and/or the NIJ Human Subjects Protection Officer if you have any further questions regarding this issue.

No, this form is signed by an authorizing official of the applicant organization. IRB review, if required, occurs after an award is made.

There are commercial IRBs whose review services can be purchased, and included in the study budget.. NIJ does not endorse any particular commercial IRB. There may be local universities that might agree to partner for IRB review, if the applicant organization has a relationship with the university. All IRBs reviewing DOJ-funded research must be informed that the DOJ human subjects protection regulation at 28 CFR Part 46 (pre-2018 Common Rule) should be used to review the IRB application.

No, the only exemptions in 46.101(b) are 1-4 that can be used to exempt DOJ-funded research if the study meets any of the listed criteria. B5 and B6 exemptions are not applicable to DOJ-funded research. B5 for public service benefit/service programs refers to programs that provide a monetary benefit to recipients, such as Food Stamps (SNAP Food Benefits) Welfare or Temporary Assistance for Needy Families (TANF) Medicaid and Children's Health Insurance Program (CHIP).

An application is not required to contain complete IRB approved documentation, rather the human subjects form required with applications Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule) in box 6 can indicate that IRB review is forthcoming. Once an award is made, no work may begin until NIJ has approved the submitted IRB documentation and has released funds.

If an application is awarded, it is the responsibility of the awardee to submit human subjects protection and privacy documentation. If the sub-awardee is conducting research on behalf of the awardee, then the sub-awardee can submit the documentation provided the awardee has a reliance agreement with the sub. If both are conducting research, they can agree, again using a reliance agreement, to use a single IRB. If they cannot agree or wish to have both the awardee’s IRB and the sub’s IRB review the study, then both IRBs will need to provide consistent but separate IRB documentation. The human subjects regulation that applies to NIJ-funded awards is 28 CFR Part 46 (pre-2018 Common Rule), which should be used by IRBs to review NIJ-funded protocols and cited in IRB determination letters.