Research, as defined by the U.S. Department of Health and Human Services' Office for Human Research Protections, means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The Research Decision Chart may help you determine if you are conducting "research" as defined by IRB regulations.

Human subject means 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.  The Human Subjects Decision Chart may help you determine if your research involves the use of human subjects.

Levels of IRB Review:

There are three types of IRB review depending on the level of risk involved in the project: exempt, expedited and full IRB review.  According to UNCW IRB policy, researchers may NOT make their own determination as to the appropriate type of review. Only the IRB Chair or designate, can determine which type of review is applicable.

IRB Training Requirements:

Any person involved in the design and/or conduct of a human subject research project must complete the approved online human subject protections training program offered by the University of Miami's Collaborative Institutional Training Initiative (CITI).  Instructions on how to register for online training and a link to the CITI website (PDF)

Federalwide Assurance:

A Federalwide Assurance is an agreement with the United States Department of Health and Human Services (DHHS) to conduct human subject research in accordance with certain principles. UNCW has agreed to follow these regulations for all research involving human subjects, regardless of the funding source FWA00001025, Expires 10/28/18.

IRB Forms:

If you are unable to retrieve any of these forms, they can be obtained by contacting the Research Compliance Manager, Leanne Prete 962-7774). Researchers must submit to the IRB a signed hard copy along with any supporting documentation (surveys, consent forms, etc.).

Code of Federal Regulations (45 CFR 46) Regulations governing the protection of human subjects in research


Human Subjects Research

Professor Julian Keith conduct research on memory In order to protect the rights of human subjects used in research, UNCW has its own federally mandated Institutional Review Board (IRB). Faculty members from a variety of scientific and non-scientific disciplines and a community representative serve on this committee to review and approve research projects involving human subjects. The Office of Research Services (ORS) is the administrative office that coordinates the activities of the IRB.

According to UNCW IRB policy, all research projects involving human subjects must be approved by the IRB. The research and human subjects decision charts (linked below in FAQ) can help researchers determine if their projects meet the federal definition of research with human subjects. Sponsored Programs will not accept funding for human subject research from an external agency without documentation of IRB approval.

IRB Meeting Schedule and Submission Deadlines

The IRB typically meets on a monthly basis to review protocols subject to full committee review. Following is the meeting schedule and submission deadlines. Researchers must submit their Human Subject Protocol forms by the submission deadline in order to receive IRB review on the desired meeting date. Researchers should plan accordingly to avoid delays.

Please note: minimal risk activities involving populations that are not considered vulnerable are generally not subject to full committee review. The IRB determines the appropriate form of review. The following submission deadlines do not apply to protocols qualifying for expedited review, which are accepted on a continuous basis.



December 17, 2014

January 14, 2015

January 21, 2015

February 4, 2015

February 18, 2015

March 4, 2015

March 18, 2015

April 1, 2015

April 22, 2015

May 6, 2015

IRB committee meetings will be held from 9:30am to 11:30am in Hoggard Hall, Room 116.

IRB Contact Information:

IRB Coordinator: Lee Prete, 910-962-7774, pretel@uncw.edu


IRB Officials:

IRB Chair: Candace Gauthier, 910-962-3558, gauthierc@uncw.edu

Institutional Official: Ron Vetter, 910-962-3224, vetterr@uncw.edu


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