MSU HRPP Manual Section 2-2-C-ii

2-2-C-ii, National Institute of Justice Funded Research

All research conducted at NIJ or supported with NIJ funds (NIJ employees, contractors, award recipients) must comply with all U.S. Department of Justice (DOJ), Office of Justice Programs, and NIJ regulations and policies concerning the protection of human subjects and the DOJ confidentiality requirements.

In addition to the Basic DOJ policy for Protection of Human Subjects (28 CFR 46), additional requirements provide statutory protection to private information under the authority of 42 U.S.C. § 3789g and under DOJ regulations for the Confidentiality of Identifiable Research and Statistical Information found in 28 CFR Part 22.

Procedure for Review
Researchers who are applying for NIJ funding and require the signed Privacy Certificate and the Human Subjects Protection Form (described below) should submit the “NIJ Form Request” to the MSU HRPP office. The form with appropriate attachments should be submitted to the HRPP at least 10 business days before the protocol submission deadline to allow time for review and modifications, if needed. Individuals within the HRPP office are designated as institutional representatives who review and sign the Privacy Certificate and the Human Subjects Protection Form.

Privacy Certificate
Applicants for NIJ funding are required to submit a Privacy Certificate as a condition of approval of a grant application or contract proposal regardless of whether the project involves the collection of identifiable data. In cases where no personally identifiable information will be collected, the Privacy Certificate should contain a statement to this effect and a brief project description. The Privacy Certificate must be approved by the NIJ Human Subjects Protection Officer.

The Privacy Certificate assures that the applicant understands their responsibilities to protect the confidentiality of research and statistical information and has developed specific procedures to ensure that this information is only used or revealed in accordance with the requirements of 42 USC §3789g and 28 CFR Part 22. A Model Privacy Certificate with instructions can be found at http://www.nij.gov/funding/humansubjects/documents/NIJ_pccr_fillable.pdf

The Privacy Certificate requires the grantee limit access to data to those employees having a need for such data and that such employees shall be advised of and agree in writing to comply with the regulations in 28 CFR 22 and the grantee certifies that all project personnel, including subcontractors, have been advised of and have agreed, in writing, to comply with all procedures to protect privacy and the confidentiality of personally identifiable data. The Principal Investigator is responsible for obtaining agreements in writing that meet the requirements provided in the Privacy Certificate and for maintaining such forms. A Model Employee Confidentiality Statement can be found at http://www.nij.gov/funding/humansubjects/pages/employee-confidentiality.aspx

Human Subjects Protection Form
The NIJ strongly encourages the use of the form “Protection of Human Subjects Assurance Identification / IRB Certification / Declaration of Exemption.”

The NIJ strongly encourages researchers to submit human subjects protection documentation at the same time the grant application is submitted.

Timing
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.

Consent Form
For studies sponsored by NIJ the subject should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the subjects need to be explicitly notified. If the investigator intends to disclose any information, the subject needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The subject must be informed of any potential risks which may result from this disclosure and must explicitly provide prior written consent. The confidentiality statement on the consent form must state that confidentiality can only be broken if the subject reports immediate harm to subjects or others.

When identifiable data is collected under the DOJ privacy regulations, current or past abuse is not reportable, unless a separate consent to allow reporting is obtained from the research subject, in addition to a consent to participate in the research study. Additional information can be obtained from the grant manager and/or the NIJ Human Subjects Protection Officer if researchers have any further questions regarding this issue.

Notification must be provided in accordance with 22 CFR 22.27.

National Archive of Criminal Justice Data
Many recipients of NIJ research funding must submit data resulting from their grant projects to NIJ for archiving with the National Archive of Criminal Justice Data (NACJD) as a condition of the grant award. Data deposits include the Data Submission Checklist,  data Archiving Plan (updated for project completion), IRB approval, informed consent and privacy certificate, Data (de-identified), Documentation, Syntax, Bibliographies, and inventory of files. http://www.nij.gov/funding/data-resources-program/Pages/submitting.aspx

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 12-11-2015.

Related HRPP Manual Sections

None

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 2-2-C-ii, National Institute of Justice Funded Research.