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Code of Federal Regulations:

Research, as defined by the 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 will help you to determine if you are may help you determine if you are conducting "research" as defined by IRB regulations.

Human Subjects Research:

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 Chair, Candace Gauthier 962-3558). Researchers must submit to the IRB Chair a signed hard copy along with any supporting documentation (surveys, consent forms, etc.).

 

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.

PROTOCOL SUBMISSION DEADLINE

FULL COMMITTEE MEETING

August 20, 2014

September 3, 2014

September 17, 2014

October 1, 2014

October 22, 2014

November 5, 2014

November 19, 2014

December 3, 2014

December 17, 2014

January 14, 2015

IRB Contact Information:

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

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

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

 


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