qUICK LINKS

DOES YOUR STUDY REQUIRE IRB REVIEW?

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.

 

WHAT LEVEL OF IRB REVIEW IS NEEDED?

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.  While only the IRB Chair or designate can determine which type of review is applicable, in general, low risk studies (like anonymous surveys) are reviewed as exempt from further oversight. Studies involving vulnerable populations, disclosure of illegal activities, or other higher risk activities will require review by the full IRB and are subject to the deadlines posted to the left. All other studies generally receive expedited review, requiring annual renewal.

 

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 the correct CITI course (PDF).

If you experience difficulty using the CITI website, please check to see if you are using a current version (issued within last 3-4 years) of one of the following browsers: Chrome, Firefox, Internet Explorer, or Safari.

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).

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 Sponsored Programs and Research Compliance (SPARC) 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 can help researchers determine if their projects meet the federal definition of research with human subjects (see Quick Links column on the right side of this page for links to these charts). SPARC will not accept funding for human subject research from an external agency without documentation of IRB approval.

NEW: Effective July 1, 2015, all new protocols must be submitted through the online IRB system, "IRBIS." IRBIS can be accessed at this link: https://uncw.myresearchonline.org/irb/index.cfm.

Please review this notice for other important information regarding IRB procedural changes for 2015-2016!

Please Note: If you receive a login error message when you try to log in to IRBIS ("Login Failed"), try using a different browser or try deleting your browsing history (In Internet Explorer, go to Tools, then Delete Browsing History).

UPDATE: Come to one of our INTRO TO IRBIS trainings!

When and Where:

Wednesday, August 26, 2015 from 9:00am - 10:00am, Hoggard 116
Tuesday, September 1, 2015 from 10:00am - 11:00am, Hoggard 116
Monday, September 14, 2015 from 3:00pm - 4:00pm, Hoggard 116
Monday, October 26, 2015 from 10:00am - 11:30am, McNeil 1051

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 19, 2015

September 2, 2015

September 23, 2015

October 7, 2015

October 21, 2015

November 4, 2015

November 18, 2015

December 2, 2015

December 16, 2015

January 13, 2016

IRB committee meetings are generally held from 9:30am to 11:30am in Hoggard Hall. The September 2 meeting will be in Hoggard Hall, Room 125. All other meetings will be 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

 


UNC Wilmington | 601 S. College Road, Wilmington NC 28403 | 910.962.3000 | About this Site | Copyright Notice | Feedback | Page maintained by:  M. McKeown [ mckeownm AT uncw DOT edu ]