Compliance

The �鶹��ý Institutional Review Board

The New �鶹��ý City University Institutional Review Board (IRB) is an administrative body that protects the rights and welfare of human research subjects. The Board was created in accordance with rules maintained by the U.S Department of Health and Human Services (DHHS), specifically the Code of Federal Regulations, . The actions of the �鶹��ý IRB also follow all applicable federal, state, and local laws and regulations as well as �鶹��ý policies governing the protection of human research participants.

The IRB assures that research pursued with the cooperation of human participants is conducted ethically and in full compliance with mandatory directives. As required by federal policy, the �鶹��ý IRB is directed by a Chair and is comprised of members with multidisciplinary expertise and backgrounds. The IRB employs a group deliberation process to assess proposed research protocols and related materials.

All research involving human participants must be reviewed and approved by the �鶹��ý IRB before such research is initiated. Studies that qualify as human subjects research include those in which data, samples, or specimens are collected from human participants in the course of investigation, and those which utilize data, samples, or specimens gathered from human participants at some prior time, either by the active researchers or by another party.

The policy applies to any:

research, whether new, ongoing, or proposed, regardless of funding status and source, whether conducted at �鶹��ý or elsewhere, by anyone affiliated with �鶹��ý, including faculty, staff, and students
person performing research under the auspices of another organization at �鶹��ý
investigator(s) from outside the �鶹��ý community intending to perform research on members of the �鶹��ý community or on its campus, with the additional requirement that he/she must designate an �鶹��ý faculty or staff member to serve as principal or co-principal investigator.

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Application Process and Timeline

The IRB Application Process

The �鶹��ý IRB reviews all projects that meet the definition of research and involve human subjects prior to any data collection to determine the appropriate level of review.

There are three types of review:

Exempt Review for projects involving data from databases, the internet, and/or other publicly-available sources
Expedited Review for low-risk studies
Full Review for research that is high-risk and/or involves subjects in protected categories (physically/mentally challenged individuals, minors (0-17), pregnant women, prisoners).

Step 1: Determine if a project requires IRB review.
If you are unsure, please submit an outline of the proposed study to Kelly Resch, IRB administrator, at kresch@njcu.edu. Once in receipt of a satisfactory outline, a determination about whether or not the project requires IRB review will be made. The typical timeline for determining that a project is exempt is five-to-ten working days.

Projects Requiring Expedited or Full Review

Step 1: CITI (Collaborative Institutional Training Initiative) certification in human subjects research is a federally-mandated requirement of IRB review and proof of such must be provided as part of the IRB application. As CITI certification is required for all who will be involved in the research, ensure that everyone named in the application has current CITI certification or becomes certified by completing CITI training.

Complete CITI training and certification at .
First, simply register through �鶹��ý’s membership by creating a username and password; begin typing New �鶹��ý City University and it will pop up as an option. Once registered, go to the human subjects section, click on “Add a course,” and then select what is appropriate. Unless a project involves laboratory experiments, completion of the CITI course in social and behavioral research is usually appropriate.

Step 2: Download the IRB application at /doc/njcu-irb-application-mw.
Review the IRB application and especially its first two pages, the IRB Checklist, which provides information about all of the documents that will need to be submitted as part of the application.

Step 3: Email any questions to Kelly Resch at kresch@njcu.edu.

Step 4: Complete the application, gather all required documents, and submit everything as one word document to kresch@njcu.edu.

Step 5: All applications are reviewed before submission to the �鶹��ý IRB. Satisfactory applications are acknowledged and forwarded to the �鶹��ý IRB. Any incomplete applications or any about which there are questions or issues requiring clarification are returned to the researcher(s). Once satisfactorily revised, IRB applications are forwarded to the �鶹��ý IRB and the applicant(s) is/are notified of this action.

IRB Review
IRB applications are reviewed on a rolling basis. Expedited reviews normally take 4-8 working weeks; full reviews typically take 6-12 weeks. Please note that IRB members are given ten working days to review an application and that they provide feedback and have questions on almost all applications. Although these time frames allow for revision(s) and subsequent review(s), they also assume reasonable response times from applicants. (These timelines do not apply during semester breaks and busy times of the academic year when there is very limited reviewer availability.)

Approved Research
Once an IRB application is approved, an approval letter is sent to the applicant(s) and the study can begin.

Research That Is Not Approved
In the event that an application is not approved pending receipt of additional information, clarifications, or modifications, the reasons for the denial are provided in writing. The applicant may continue to submit modified applications and/or respond to the IRB in writing; a response in writing will be reviewed by the IRB chair as soon as possible.

Following IRB Approval

Continuing a Study
IRB approval is granted for one year. Should any research seem likely to exceed the 12-month approval period, researchers should contact Kelly Resch at kresch@njcu.edu at least six weeks prior to the approved end date regarding what is required to continue the study.

Research Changes
If there are any changes to an IRB-approved study during the one-year approval period, those modifications must be submitted and/or approved by the �鶹��ý IRB. In the event of such changes, please email an outline of the proposed changes along with the IRB approval letter to Kelly Resch at kresch@njcu.edu.

Research Problems
All unanticipated problems involving risks to human subjects must be reported to the �鶹��ý IRB as soon as possible.

Is IRB Review Necessary? (not required for submission with the IRB application package)
The IRB Application
Sample Consent Forms

Questions:

Kelly Resch, IRB Administrator, at kresch@njcu.edu
Dr. Meriem Bendaoud, �鶹��ý IRB Chair, at mbendaoud@njcu.edu.