Human Subject Protection

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.

If you or a student you advise plan to conduct an activity that is not systematic (like a classroom project for practice) or is not designed to add to the body of knowledge on a topic (such as an evaluation of a specific program like a QI/QA project) it might not require IRB review.

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. 

If you or a student you advise plan to collect information from individuals but the information you plan to collect does not pertain to them personally, the individuals might be considered key informants rather than human subjects, such as surveys or interviews that are directed to subject matter experts, and the researcher is not interested in the individual's personal credentials , behaviors or motivations, etc.  If you or a student you advise plans to obtain existing data about individuals, and the data set is anonymous or already de-identified before you receive it, the individuals might not be considered human subjects.

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 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.

Please email irb@uncw.edu if you would like access to relevant decision charts.  You may also find it helpful to review decision charts provided by the U.S. Office of Human Research Protections (OHRP).

OSPREY (Online Sponsored Programs & Research Enterprise sYstem) is 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).

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.

If you need assistance completing an application, you may request a one-on-one IRB clinic by appointment only.  

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

All non-exempt research studies approved by the UNCW IRB require an informed consent process that demonstrates the researcher has adequately informed participants about what they are asked to do. However, not all studies require the use of the standard consent process, which requires the research subject to physically sign a multiple-page, written document containing all the elements of informed consent.

Studies that qualify for an exemption based on specific regulatory categories can use an alternative consent process, such as providing a brief, one-page consent form, obtaining verbal consent from participants immediately before they participate in the research, or displaying a brief consent message at the top of the survey. The UNCW IRB has created several informed consent templates that can be customized to your particular research study.

** The following templates are available on the UNCW SharePoint site and may require a UNCW login credential. ** 

Click here for the following informed consent templates for research on adult subjects.

Alternative Consent -

These templates may be suitable when a study is low-risk, uncomplicated, and involves adults as participants. However, using these alternate forms for non-exempt studies requires submitting the Informed Consent Checklist on the SharePoint site.

• Human Subjects Informed Consent Alternate Format - Bullet Statements Template
• Human Subjects Informed Consent Alternate Format - Example Letter Format
• IRB Exempt_Survey_Consent_Statement - For exempt studies using surveys
• IRB_Focus Groups_Consent Script Template 
• IRB_Verbal Consent Script_Interviews_Template

Standard Consent Template - 

You must use the standard consent template if your research has a more complicated study design (e.g., follow-up participation, interventions that warrant a more detailed explanation, or deception).

• Human Subjects Informed Consent Template

Extended Reality (VR) Consent Template -

• Human Subjects Informed Consent Template for XR Studies

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 remember to include all of the elements of informed consent 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.)

Research With Minors -

Click here for assent and permission templates for research with minors.

If your research study seeks to conduct research with minors (under 18 years old), you must 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 younger children, you may want to consider using an alternate assent format. Generally, only parental permission is required for children under the age of 4.

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

Any person involved in the design and 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).

Please follow the instructions below to register for the correct course. Numerous courses are offered, and it is easy to get confused, so close attention to details is necessary.

Go to the CITI website.

To Register –

1. Click, Select your Organization Affiliation
2. Type “Wilm” into the search field
3. Select the University of North Carolina Wilmington
4. Click the box next to I AGREE to the terms …
5. Click the box to affirm your affiliation with UNCW
6. Click Create a CITI Program account.
7. Enter your information on the Personal Information page. Your UNCW email must be your preferred one, and there is a place to add a secondary one.
8. Continue to Step 3 –

To Add a Course – Read through CITI Course Enrollment Procedure

Scroll down to CITI Course Enrollment Questions.

Question 1 provides options for the Full, Basic Human Subject Research course. If you have not yet completed the course (or cannot produce documentation that you completed it), choose either: Biomedical Research Investigators OR Social & Behavioral Research Investigators.

** We cannot accept a certificate for a refresher course unless you have the certificate of completion for the Full, Basic Course. **

Once you’ve selected the course, scroll to the bottom and select either Complete Registration for new users or Complete Update for returning users.

This should take you back to your course list, where you can confirm that the correct course was added.

If you have trouble using the CITI website, please use a current version of one of the following browsers: Chrome, Firefox, MS Edge, or Safari.