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 Research Integrity Office (RIO) 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. UNCW 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.  If after reviewing this chart you find your activity does not meet the IRB definition of "research," you may want to review the Quality Improvement/Quality Assurance (QI-QA)/Program Evaluation Decision Chart for more guidance.

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

UNCW uses the IRB Information System ("IRBIS") as its online application system to process all IRB-related requests.  Please use IRBIS to create a new study, modify a study, submit a modification, or submit a closure form.

Please Note: IRBIS is hosted by the UNC System Office. 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

IRB Office has Moved

The IRB Office has moved to the new Administrative Annex building!  Our email addresses, phone numbers and campus mail box (#5973) remain the same, but our physical location is 622 MacMillan Ave. North (between the CIE building and Isaac Bear Early College).

Changes to the Common Rule

Please be aware that the regulations that guide IRB administration, known as the Common Rule (HHS 45 CFR 46), changed on January 21, 2019.  Below is a link to a brief summary about how the changes will likely impact UNCW researchers and the UNCW IRB transition plan. Please see the Informed Consent section below for revised templates that conform to the revised Rule. If you have questions about the new rule, please email the UNCW IRB office at IRB@uncw.edu.

Revised Common Rule - UNCW Impacts and Transition Plan

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.

IRB Meeting Dates and Submission Deadlines

PROTOCOL SUBMISSION DEADLINE

FULL COMMITTEE MEETING

August 21, 2019

September 4, 2019

September 18, 2019

October 2, 2019

October 23, 2019

November 6, 2019

November 20, 2019

December 4, 2019

December 18, 2019

January 15, 2020

January 22, 2020

February 5, 2020

February 19, 2020

March 4, 2020

March 18, 2020

April 1, 2020

April 22, 2020

May 6, 2020

2019-2020 IRB committee meetings are held in Morton Hall, Room 202 from 9:30 - 11:30 a.m.

IRB Consent Templates

Research Integrity staff 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. The following templates conform to the Revised Common Rule, effective 1/21/19.  All templates are in a downloadable/executable PC based format.

Here is a summary of the changes regarding informed consent that are included in the Revised Common Rule, which is effective 1/21/19.

Consent/Assent/Permission Templates

Here is an example consent form written using the new Informed Consent Template that includes the new requirements in the Revised Common Rule effective 1/21/19.

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.  Also, when these 1-page forms are used the "key information" requirement in the Revised Common Rule is not 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 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.

UNCW IRB Policy

Standard Operating Procedures

SOP 1.1 Not Human Subjects Research (NHSR) Activities
SOP 4.1 Member Selection, Resignation, Removal Procedures
SOP 5.1 Exemption Determinations
SOP 5.2 Expedited Review Procedures
SOP 5.3 Full Board Review Procedures
SOP 6.1 Training Requirements
SOP 6.2 Online Research Procedures
SOP 6.3 Anonymous Surveys and Questionnaires
SOP 6.4 Research Involving Other Institutions
SOP 6.5 International Research
SOP 6.6 Deception
SOP 6.7 Adverse Event, Unanticipated Problem Reporting Procedures
SOP 6.8 Informed Consent Procedures
SOP 9.1 Conflict of Interest Evaluation Procedures
SOP 10.1 Research Audit Procedures
SOP 11.1 Findings of Noncompliance

IRB Contact Information

IRB Officials


Please be aware that the Office of Internal Audit at UNCW maintains an anonymous reporting tool to facilitate reporting of allegations of fraud, waste, abuse, or mismanagement of funds. Concerns about ethical practices may also be reported anonymously to the State Auditor’s Fraud and Abuse Hotline by calling 1-800-730-8477 or filing a complaint online at http://www.ncauditor.net/HotTips/.