New Project (Initial IRB Review)
All research with human subjects* as defined in 45 CFR 46 that is conducted at Fairleigh Dickinson University or by FDU students or personnel employed by the University must be submitted to the Institutional Review Board (IRB) for review.
This research includes, but is not limited to, the following:
- Dissertations, master’s theses, independent study projects, undergraduate honors projects;
- Proposals that involve the collection or review of data off campus (It is important to note that approval from IRBs at other institutions does not exempt researchers from the requirement that their projects receive approval from the FDU IRB);
- Any internal or external grant proposal;
- Studies involving the collection of archival data where no consent was obtained at the time of data collection
* Research with human subjects at FDU is consistent with the definition under 45 CFR 46 that is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge where a living individual is involved 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.
(1) Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
(2) Interaction includes communication or interpersonal contact between investigator and subject.
(3) 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).
Contact us especially if you are not sure if you are conducting human subjects research. We will be able to provide guidance to you and assist by making this determination.
IRB Administration Contact Information
Kim R. Diccianni, CIP, Human Research Compliance Manager
Metropolitan Campus, Becton Hall, Grants and Sponsored Projects, Room 200
1000 River Road, Mail Stop: T-BE2-02
Teaneck, New Jersey 07666