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 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; they participate in interviews; 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, 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 procedures by which data are gathered and manipulations to the subject or subject's environment are made for research purposes.
Interaction includes communication or interpersonal contact between the researcher and the subject of the study.
Private information covers observation or recording of behavior when an individual can expect that this behavior is not being observed, and information provided by an individual about themselves for a specific purpose which the individual can expect will not be made public (e.g., personal data provided in response to questionnaires, or for medical records). Private information must be identifiable to an individual or readily associated by the investigator or linked with the data to qualify as 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 “Brief Description of Project” section, you will need to state "No data identifiable to a private person will be collected," following the insertion of your project description. You will also need to 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. Completing the Privacy Certificate and
Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form prior to submitting the application can help improve the overall quality of your application. 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)(1-6) or that the study has been or will be reviewed and approved by an Institutional Review Board (IRB) with a current valid 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. Failure to provide this information 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: Find an IRB in your area and apply to have your project approved. Alternatively, 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
- 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)(1-6) 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 your institution does not have a FWA and you believe your project is exempt from the human subject requirements as described in 28 CFR 46.101(b)(1-6), you may apply to NIJ by providing written documentation that includes the exemption reason and details explaining how it applies to your project. This information will be reviewed by the NIJ Human Subject Protection Officer and the Office of Justice Programs, Office of General Counsel to make the final determination on the study’s exemption status. (See Exemption Request Information.)
- 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?
- 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 along with the FWA number and the reviewed and approved documentation.
- 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 (NIH) or HHS. Grantees must provide an approved Privacy Certificate. Under the DOJ confidentiality statute (42 USC 3789g), 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 consents 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 privacy regulations (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.
- Q: What do the subjects in my research need to know?
- A. Subjects need to be informed that identifiable data collected with DOJ 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.
See additional requirements.
- 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. See an example of a separate consent form for reporting (doc, 1 page). Please contact your grant manager and/or the NIJ Human Subjects Protection Officer if you have any further questions regarding this issue.
- Q: What is the relationship between the Common Rule and the Federal Regulation for the Protection of Human Subjects?
- A: The "Common Rule" is the term used by eighteen federal agencies who have adopted the same regulations governing human subjects of research. Each agency’s regulations are printed in the Code of Federal Regulations (CFR) with different preface numbers but the same section (§) numbers. The text of the regulation in each case is identical.
NIJ's regulation is listed as 28 CFR Part 46 §101…124, while HHS' regulation, consisting of the identical text, is 45 CFR Part 46 §101…124.
Some agencies have adopted additional regulations ("Subparts", see below) dealing with special populations. The Common Rule is also referred to as "Subpart A" of the HHS regulations of human research 45 CFR 46, to distinguish it from the other subparts listed below. Institutions provide an assurance that they will comply with the regulations regarding human subjects research. It is commonly filed with the federal agency that sponsors their research. However, most universities have assurances from HHS. Under the Common Rule, each agency (e.g., NIJ) agrees to accept an assurance issued by HHS as a commitment that the institution will follow the regulations.
- Q: What are the Subparts of the regulations?
A: Subpart A, known as the Common Rule, relates to human subjects research in general.
The other Subparts (B, C and D of the HHS version) relate to special research populations and have been adopted by some agencies. (See
Subpart B relates to research on fetuses, neonates, and pregnant women.
Subpart C relates to research with prisoners, and in general stipulates that the IRB include a prisoner or prisoner representative (among other requirements).
Subpart D relates to research with children, and in general mandates that adequate provisions be made for soliciting the assent of children and permission of their parents or guardians.
DOJ has chosen not to adopt Subparts B, C and D. Only Subpart A regulations are necessarily relevant for DOJ, and consequently NIJ-funded projects. The Common Rule indicates that vulnerable populations include subjects, such as children, prisoners, pregnant women or handicapped or mentally disabled persons.
Institutions that follow Subparts B, C and D for HHS-sponsored research may continue to do so for NIJ-funded projects.
Many institutions have signed FederalWide Assurances with HHS in which they may have agreed to apply the subparts to all research. In many cases, problems are caused, not by the regulations themselves, but by overly restrictive interpretations by IRBs. For example, Subpart C's mandate of an IRB member who is "a prisoner, or prisoner's representative with appropriate background and experience ..." can be met by a suitable member of the sociology or criminal justice faculty. The regulations do not require a formal affiliation with a prisoner association. Subpart D's mandate of informed consent is subject to "the extent that consent is required by §46.116 of Subpart A..." and does not automatically and invariably require written consent forms. As § 46.116.d. specifies, informed consent can be modified or waived for a project which:
- could not reasonably be carried out without the waiver or alteration,
- is of no more than minimal risk,
- the waiver or alteration will not adversely affect the rights and welfare of the subjects,
- the subjects will be provided with additional pertinent information after participation, as appropriate.
These conditions cover some research supported by NIJ.
Date Modified: October 13, 2011