Frequently Asked Questions Regarding the National Institute of Justice's Confidentiality and Human Subject Protection Requirements
- Q: How do I know if my research involves human subjects?
- A: 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."
- Q: What if my research does not involve human subjects and I will not be collecting any data identifiable to a private person?
- A: 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 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.
- Q: Must I submit the Privacy Certificate and the Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form with my grant application?
- A: No. However, you are strongly encouraged to do so. 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.
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 or will be reviewed and approved by an IRB with a current valid Federalwide assurance must also be submitted.
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. 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.
- Q: If I receive an award with special funds withholding conditions for human subjects' protection and privacy, how are these special conditions removed so funds are released for research activities?
- A: 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 and accessed electronically in the Grant Management System (GMS). NIJ grant monitors will be available to review these conditions immediately after the award is made.
- Q: What should I do if my institution does not have a U.S. Department of Health and Human Services' (HHS) approved human subjects review program as indicated by a current Federalwide Assurance (FWA) number?
- A: 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.
- Q: Should I inform my IRB of the DOJ regulations on human subjects protection and privacy?
- A: Yes. It is suggested that NIJ-funded researchers provide links to the DOJ regulations in their IRB applications. These regulations can be found on NIJ.gov at http://www.nij.gov//funding/humansubjects/welcome.htm. 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.
- Q: How do I claim an exemption from the human subjects protection requirements?
- A: 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.
- Q: Must I submit the form provided on NIJ's Human Subjects Protection Web page titled "A Protection of Human Subjects Assurance Identification/IRB Certification/Declarations of Exemption" to prove that my institution has a FWA or that the study has been determined to be exempt?
- A. 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.
- Q. If I am applying for an NIJ Fellowship, must I comply with the privacy certificate and the human subjects protection requirements?
- A: Yes, all research sponsored or conducted by NIJ must meet these requirements.
- Q. Does NIJ issue or accept certificates of confidentiality in place of a privacy certificate?
- 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.
- Q. Does NIJ have an IRB?
- 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) and the informed consent documentation in compliance with the DOJ regulations at 28 CFR 46.116. 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.
- Q: What do the subjects in my research need to know in regard to informed consent?
- 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.
- Q: How do State mandatory reporting laws affect identifiable data collected under the DOJ privacy regulations?
- A: 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.
- Q: On January 21, 2019, the Revised Common Rule went into effect, the purpose of which was to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. I noticed that the Department of Justice (DOJ) did not sign on, so what regulations apply to my NIJ-funded research?
- A. 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.
Date Modified: June 6, 2019