Human Subjects Research (IRB)

Site Menu:

• First Things First - Do You Need IRB Approval?
• IRB Submissions - - NEW Submission System "OSPREY"
• Notices and Updates - including COVID-19 information
• IRB Meeting Schedule and Submission Deadlines
• Consent Templates
• Training Requirements
• UNCW IRB Policy
• Standard Operating Procedures
• UNCW IRB Contact Information
• Link/QR code to Research Integrity Office Customer Satisfaction Survey
• UNCW Internal Audit Contact Information

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.

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 OSPREY (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.

NEW!! IRB Submission System "OSPREY"

As we’ve announced by email, we have now transitioned to our new IRB submission system! 

"OSPREY" (Online Sponsored Programs & Research Enterprise sYstem) will be a one-stop-shop for all your research administration needs, including proposal development, grant management, conflict of interest reporting and applications to conduct human subjects research (IRB).  Click here for more general information about OSPREY.

OSPREY LOGIN:  https://osprey.infoedglobal.com/

You may wish to bookmark this URL, since many users will need it not only for IRB submissions but also for grant administration and conflict of interest reporting.

Please note these important points:


Study data from IRBIS has not yet been converted to OSPREY.  We are working on this with technical staff, but have been told it may take some time.  If you need to submit a new action in OSPREY for an ongoing study, please contact the IRB at irb@uncw.edu for assistance.  Please note that most studies transferred from IRBIS to  OSPREY will include basic study information only.

OSPREY IRB Resources:

General Video Introduction to OSPREY and the new IRB Module!
To request a one-on-one clinic or a departmental tour, please email irb@uncw.edu.

Notices and Updates

The UNCW IRB is continuing to offer all services virtually.  We are available to conduct virtual training presentations and assist with completing IRBIS applications.  Please contact us at IRB@uncw.edu for assistance.

COVID-19 Updates:

At the current time, face-to-face research is permitted. Please visit UNCW's Best for the Nest website for resources and guidelines related to COVID-19. Naturally, UNCW researchers are expected to comply with federal, state, local government, and university restrictions and instructions regarding COVID-19, such as requirements on wearing face coverings indoors. The safety of UNCW personnel and human subjects is paramount. 

The informed consent addendum document, that discusses the health and safety guidelines during a pandemic, is no longer required to be provided to research subjects to sign.


Please contact IRB@uncw.edu if you have any questions about conducting face-to-face human subjects research while pandemic conditions remain.

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.  If your study does not require review by the full board, please submit requests for approval at least ten (10) days prior to the anticipated start date of the activity to allow adequate time for review, revision and approval.

IRB meetings held during the 2022-2023 academic year will be conducted via Zoom.

IRB Consent Templates

All non-exempt 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 requires an appropriate process to ensure understanding and typically requiring 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).

• Human Subjects Informed Consent Alternate Format - Bullet Statements Template
• Human Subjects Informed Consent Alternate Format - Example Letter Format

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.

• Human Subjects Informed Consent Form Template
• Here is an example of a completed consent form

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.

• Human Subjects Assent/Permission Form Template
• Human Subjects Permission Only Template

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.

• Human Subjects Assent Example for children ages 4-6
• Human Subjects Assent Example for children ages 7-11

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.)

COVID-19 Addendum

This addendum is not required at this time due to current CDC, state and university recommendations. However, we are keeping it posted for now in case pandemic conditions return.

• Human Subjects Informed Consent Addendum - Risk and Safety Precautions Due to COVID 19

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

• Contact the IRB at IRB@uncw.edu, 910-962-7774

IRB Officials

• IRB Chair: Dr. Kristin Bolton, 910-962-3372, boltonk@uncw.edu
• IRB Co-Chair:  Dr. Scott James, 910-962-7284, jamess@uncw.edu
• Institutional Official: Dr. Stuart Borrett, 910-962-7430, borretts@uncw.edu

Tell the IRB team in the Research Integrity Office how we're doing on this quick, 4-question survey, which you can also access by scanning this QR code!



Additionally, 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/.

Resources

Fall 2022 Update for Human Subjects Research under COVID-19 conditions
Face-to-face research is currently permitted. Please follow the Best for the Nest guidelines for the latest information on face covering and other requirements. It is the researchers' responsibility to monitor conditions as they may change.

*Please note - the resources below may reference our former submission system IRBIS.  We are working hard to update these resources.  All new requests for IRB review must be submitted in OSPREY.

Basic IRB Information FAQs
A handout with information about the purpose of the IRB.

Tips for Smooth Sailing through IRB Review
A handout with UNCW-specific tips for submitting an IRB application.

Research Decision Chart 
This may help you determine if you are conducting "research" as defined by IRB regulations.

QI/QA/Program Evaluation Decision Chart
If the activity you plan to conduct is not research, this chart may help you determine if it is Quality Improvement/Quality Assurance (QI/QA) or a program evaluation.

Human Subjects Decision Chart 
This may help you determine if your research involves the use of human subjects.

Information for Faculty Advisors
A handout with information for faculty members who are advising a student researcher who is conducting human subjects research.

FAQ for Human Subjects Researchers
A handout that answers questions frequently asked by researchers conducting humans subjects research.

What Level of IRB Review is Needed?
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, interviews, focus groups, etc.) are reviewed as exempt from further oversight. Studies involving vulnerable populations such as prisoners or persons with diminished capacity to consent, activities involving more then moderate exercise, or other higher risk activities will require review by the full IRB, are subject to the deadlines posted to the left, and must comply with an annual review requirement.  Other studies as determined by federal guidance may receive expedited review.

Code of Federal Regulations 
(45 CFR 46) Regulations governing the protection of human subjects in research.

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 10/22/23.

UNCW RIO FAQs

UNCW SPARC FAQs