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: The NIJ confidentiality and human subjects protection requirements are intended to protect research study participants from risks associated with a breach of confidentiality or any physical harm resulting from their participation in the study. In general, if your research study is collecting or analyzing information obtained from an individual person whose responses are the object of the study, you are conducting human subjects research. In addition, if your research study is collecting personally identifiable private information about an individual, you are conducting human subjects research. Some examples common to NIJ- funded research include: studies with individuals who complete questionnaires or participate in interviews, whose behavior is observed, or whose subjective perceptions of their activities are studied; when data about individuals will be used for research purposes; and when biomedical or clinical studies involve humans. In certain circumstances, studies involving the use of human tissues may also qualify as human subjects research.
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 procedures by which data are gathered and manipulations of the subject or subject’s environment for research purposes. Interaction includes communication or interpersonal contact between the researcher and the study subject. Private information covers observation or recording of behavior when someone can expect that this behavior is not being observed, and information provided by an individual about themselves for a specific purpose which the person can expect will not be made public (e.g., personal data provided in response to questionnaires, medical records). Private information must be identified to an individual or readily ascertained by the investigator or associated with the data in order for the information to constitute research involving human subjects.
Several categories of human subjects research are exempt from the requirement of 28 CFR 46.101(b)(1-6). Please see the discussion under Exemption Request Information .
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 must still complete the privacy certificate and form titled Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption and include them with your grant application. On the privacy certificate, in the section Brief Description of Project, indicate “No data identifiable to a private person will be collected.” In subsequent boxes, insert “Not applicable since this study is not collecting any individually identifiable data.” Do not leave form sections blank and do not insert “N/A” or “not applicable” without providing a reason. On the form titled Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption, in box 8, indicate “This project will not involve human subjects.” Both forms must have the appropriate signatures and dates affixed.
Q: Must I submit the privacy certificate and the human subjects protection documentation at the time that I submit my grant application?
A: No, however you are strongly encouraged to do so. Completing the privacy certificate and human subjects protection documentation prior to submitting the application can help improve the overall quality of the application. Before funds can be expended from an award, a proper privacy certificate must be submitted with the signatures of the principal and co-principal investigators, and an authorized institutional representative. If the study is exempt from the human subjects protection requirements under 28 CFR 46.101(b)(1-6), or if the study has been or will be reviewed and approved by an Institutional Review Board (IRB), documentation with a current valid assurance must also be submitted. The IRB review and submission of the privacy certificate may occur after the award, but federal regulations prohibit federal funds from being used on human subjects related research until the research is IRB-approved or determined to be exempt by an IRB; therefore, 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 listed above 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.
Q: If I receive an award with special funds withholding conditions for human subjects protection and privacy, how are the special conditions removed so that funds are released for research activities?
A: Special withholding conditions for human subjects protection and privacy 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 Institutional Review Board (IRB) approval alone. The special withholding conditions must be removed for research involving human subjects and/or the collection of identifiable data to commence.
It is incumbent upon the grantee (both the office of sponsored research/office of grants & contracts AND the researcher) to abide by the standard and special conditions that attach to NIJ awards. Such conditions are contained in all award packages and can be accessed electronically in the Grant Management System. NIJ grant monitors are readily available to go over these conditions soon 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-approved human subjects review program as indicated by a current Federalwide Assurance number?
A: Find an Institutional Review Board locally and apply for a review of your project protocol. The following URL from the Office for Human Research Protections lists a registry of domestic IRBs: http://ohrp.cit.nih.gov/search/asearch.asp#ASUR.
Q: How do I claim an exemption from the human subjects protection requirements?
A: If you believe your project is exempt from the human subject requirements as described in 28 CFR 46.101(b)(1-6), and if your institution has a current Federalwide Assurance (FWA), your institution’s Institutional Review Board must review your exemption request.
If you believe your project is exempt from the human subject requirements as described in 28 CFR 46.101(b)(1-6), and your institution does not have an FWA, then you may apply to NIJ by providing written documentation describing which exemption applies and the rationale as to why you believe it applies. This information will be reviewed by the NIJ human subjects protection officer and the Office of Justice Programs, Office of General Counsel, to make the final determination on whether or not the study is exempt. (See Exemption Request Information )
Q: Must I use 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 submit documentation that my institution has a U.S. Department of Health and Human Services approved Federalwide Assurance (FWA) that has been reviewed and approved by the Institutional Review Board (IRB) or that the study has been determined to be exempt?
A: No, but you are strongly encouraged to do so. A letter, on institution letterhead, signed by the IRB chairman containing the FWA number and the IRB review determination will be acceptable so long as the relevant items from the form are addressed in the letter, and the IRB-reviewed/approved or exempted protocol is attached. IRB approvals and/or exemptions must be submitted on institutional letterhead, and be signed and dated.
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 nor accept certificates of confidentiality issued by the National Institutes of Health or the U.S. Department of Health and Human Services. Grantees must provide an assurance that they will protect identifiable information collected under NIJ/DOJ funding by submitting a properly completed privacy certificate (PC). Once the PC is approved by NIJ’s human subjects protection officer, the identifiable data collected is then immune from legal process under the DOJ confidentiality statute (42 USC 3789g). Neither the PC nor the informed consent documentation should contain language about certificates of confidentiality. The PC and consents should accurately describe that the identifiable data collected is immune from process because the researcher submitted a PC, it was approved by NIJ and is thus covered by DOJ statute.
Q. Does NIJ have an Institutional Review Board (IRB)?
A. No. NIJ does not have an IRB. NIJ has a human subjects protection officer who reviews IRB approvals from awardees to ensure that they (the IRB) have reviewed the study protocol in compliance with the DOJ human subjects protection regulations (28 CFR Part 46) and the informed consent documentation is 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. How do state mandatory reporting laws affect identifiable data collected under the DOJ privacy regulations?
A. There are two exceptions to the confidentiality of identifiable data collected under DOJ privacy regulations, and they are harm to self and/or others. Therefore, the following language is acceptable for inclusion in informed consent documentation:
“What is discussed during our interview will be kept confidential with two exceptions: We are compelled by law to inform an appropriate other person if we hear and believe that you are in danger of hurting yourself or someone else, or if there is reasonable suspicion that a child, elder or dependent adult will be abused or a crime committed.”
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 further questions on this topic.