Sponsored Programs & Research Compliance

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.

Does the Activity You Plan to Conduct Require 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 the activity you plan to conduct fits this definition.  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.

If you are a capstone student in the MPA program, you might find this resource helpful to determine if your study requires IRB approval or not.

After reviewing these materials, if you find that the activity you plan to conduct is not subject to IRB approval, best practice is to submit a brief notification to the IRB through IRBIS (see below) to obtain an official determination.  To do this, begin completing a new application and indicate in the screening questions which aspect is not applicable (research or human subjects).  There will be a few more brief questions to describe your study.  If planning to conduct a survey you must upload a copy so that the IRB can confirm it does not meet the definition of human subjects research.

IRBIS (IRB Information System)

Do you need to fill out an application to conduct human subjects research or to modify an existing study?  UNCW uses the IRB Information System ("IRBIS") as its online application system to process all IRB-related requests.

Go to 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

COVID-19 Update

UNCW business operations are currently functioning as usual, including the UNCW IRB.

Naturally, UNCW researchers are expected to comply with federal, state, local government, and university restrictions and instructions regarding COVID-19.   The safety of UNCW personnel and human subjects is paramount.

To best protect the safety of staff and human subjects who are participating in UNCW research, please review the methods used in any ongoing study you oversee and determine whether any of the in-person activities can be modified to online/remote activities to reduce risk of COVID-19 exposure to UNCW staff and human subjects. 

If the in-person activities cannot be modified to be online/remote, the IRB has created Directions and Guidelines for Conducting in-person Human Subject Research Activities that must be followed in order to secure approval.  Please also visit UNCW's Best for the Nest website for resources and guidelines for returning to campus.  Other pandemic-related resources for research are posted here.   Please contact IRB@uncw.edu if you have any questions about conducting face-to-face human subjects research while pandemic conditions remain.

You do not need to notify the IRB if you intend to temporarily halt a study.  However, if you plan to modify research activities at any time, please be reminded that any changes to the IRB-approved methods and procedures must be reviewed and approved by the IRB, and we will process those requests as quickly as possible to minimize your down time. Requests to modify approved human subjects research can be submitted through the IRBIS system.  (From the IRBIS home screen, if you look on the far left side of the screen for the Dashboard, and under the heading Create New Submission, you will see a link to the Modification form.)

Please direct any questions about how human subjects research activities may be impacted by COVID-19 to IRB@uncw.edu.

IRB Office Location

IRB staff continue to work remotely and all business operations are functional.  We are available to conduct virtual training presentations and assist with completing IRBIS applications.  Please contact us at IRB@uncw.edu for assistance.  Under normal conditions, the IRB Office will return to the Administrative Annex building at 622 MacMillan Ave. North (between the CIE building and Isaac Bear Early College).

 

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 exempt or expedited review, which are accepted on a continuous basis.

IRB Meeting Dates and Submission Deadlines

PROTOCOL SUBMISSION DEADLINE

FULL COMMITTEE MEETING

August 19, 2020

September 2, 2020

September 23, 2020

October 7, 2020

October 21, 2020

November 4, 2020

November 18, 2020

December 2, 2020

December 16, 2020

January 13, 2021

January 20, 2021

February 3, 2021

February 17, 2021

March 3, 2021

March 24, 2021

April 7, 2021

April 21, 2021

May 5, 2021

IRB meetings held during the 2020-2021 academic year will be conducted via Zoom until further notice.

IRB Consent Templates

All research studies approved by the UNCW IRB require an informed consent process that demonstrates that the researcher has adequately informed subjects of what researchers are asking them to do.  But not all studies require the use of the standard consent process, which is asking the research subject to physically sign a multiple page, written document that contains all elements of informed consent.

Studies that qualify for an exemption based upon certain regulatory categories can use an alternate consent process, such as providing a brief, one-page consent form, obtaining verbal consent from subjects just prior to research participation, or by providing a brief consent message at the top of a survey. The UNCW IRB has created several informed consent templates that can be customized to your particular research study. 

Alternative Consent Formats

The templates below may be appropriate when a study is low risk and uncomplicated, and subjects are adults.  The use of these alternate forms for non-exempt studies may require the submission of the Informed Consent Checklist (see below).

Standard Consent Template

If your research has a more complicated study design (follow-up participation, interventions that warrant a more detailed explanation, or involves deception), you will be required to use the standard consent template.

COVID-19 Addendum

IF during pandemic conditions you plan to conduct human subjects research that involves in-person activities, you must meet appropriate standards outlined in the Directions and Guidance for Restarting Human Subjects Research Paused due to COVID-19 and must incorporate the Informed Consent Addendum linked below:

Research With Children

If your research study seeks to conduct research with minors (under 18 years old), you will be required to provide a parental permission form and a child assent form.

If your study involves the use of younger children, you may want to consider using an alternate assent format.  Below are two examples of how you can obtain assent from younger children.

Informed Consent Checklist

IF you use an alternative consent format for a non-exempt study, 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 standard templates above or when a study qualifies for an exemption.)

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)  We strongly recommend that you use these instructions when enrolling in CITI Program online courses to avoid enrolling in the incorrect course, as there are numerous courses offered.

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.


Go to 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/.