Sponsored Programs & Research Compliance

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Human Subjects Research (IRB)

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. SPARC will not accept funding for human subject research from an external agency without documentation of IRB approval.

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.

IRBIS

Please use IRBIS to create a new study, modify a study, submit a modification, or submit a closure form.

Please Note: The IRB Information System (IRBIS) is hosted by UNC-General Administration. If you experience operating difficulties, TAC will not be able to assist you. Please contact the IRB@uncw.edu for assistance. Also, 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 our browsing history (In Internet Explorer, go to Tools, then Delete Browsing History).

IRBIS Instructions

Notices and Updates

Changes to the Common Rule

Please be aware that the regulations that guide IRB administration, known as the Common Rule (HHS 45 CFR 46), are currently scheduled to change on January 19, 2018. However, a one-year delay has been proposed. We will keep you updated on developments. A brief summary of the changes to the Common Rule can be found here. More information, resources, and updated templates will follow. If you have questions about the new rule, please email the UNCW IRB office at IRB@uncw.edu.

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 23, 2017

September 6, 2017

September 20, 2017

 October 4, 2017

October 18, 2017

November 1, 2017

November 22, 2017

December 6, 2017

December 20, 2017

January 17, 2018

January 24, 2018

February 7, 2018

February 21, 2018

March 7, 2018

March 21, 2018

 April 4, 2018

April 18, 2018

May 2, 2018

Fall 2017 and Spring 2018 IRB committee meetings are held from 9:30 - 11:30 a.m. in Cameron School of Business, Room 104, except for the December meeting which will be held in Trask Coliseum, Room 115/117.

IRB Consent Templates

Research Compliance will make every attempt to ensure that the templates available here are in compliance with sponsor guidelines. However, the Principal Investigator has ultimate responsibility for compliance. All templates are in a downloadable/executable PC based format.

Consent/Assent/Permission Templates

Other consent formats are allowed. However, when you use a format other than one of the templates above, you must also complete and submit the Informed Consent Checklist to demonstrate that you remembered to include all of the elements of informed consent that are required by federal regulations:

Human Subjects Informed Consent Checklist
(NOTE: This additional form is NOT required when using one of the approved templates above.)

Alternative Consent Formats

These formats may be more appropriate than the Q&A template above when a study is low risk and uncomplicated, and subjects are adults. If these formats are used, researchers must also complete and submit the Informed Consent Checklist posted above to demonstrate that all required elements of consent were included.

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 Collaborative Institutional Training Initiative (CITI).

Any researcher who will work with sensitive data or protected health information must complete an additional course on data privacy and security. Courses on FERPA and Good Clinical Practice for Social & Behavioral Research are also available for those interested.

Click here for Instructions on how to register for the correct CITI courses (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.

IRB Contact Information

IRB Officials