Human Subject Protection

Not all research projects qualify as research requiring IRB oversight. To determine whether IRB review is necessary, each question below must be answered ‘Yes ’:

Does it meet the definition of research as defined by the federal regulations?

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Does it include human subjects as defined by the federal regulations?

A living individual about whom an investigator obtains information or biospecimens through intervention or interaction, or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

If the answer to both questions is “yes,” then the project is human subjects research and falls under IRB oversight. According to UNCW IRB policy, all research projects involving human subjects must be reviewed by the IRB. Researchers will use OSPREY to complete the application. Please email our office for instructions on completing this type of application in OSPREY.

If your project does not meet these definitions, such as program evaluations not intended to apply beyond the program, case studies, quality improvement initiatives, and key informant interviews, then IRB review is not required. These studies are called not human subject research (NHSR). It is best practice to submit a brief notification to the IRB through OSPREY to obtain an official determination. Please email our office for instructions on completing this type of application in OSPREY.

OSPREY (Online Sponsored Programs & Research Enterprise sYstem) is the site for all your research administration needs, including proposal development, grant management, conflict of interest reporting, IRB, and IACUC applications.

RIO has created instructions for researchers when completing the various applications in OSPREY. Please email our office to request the ones you need. If you need targeted help, please reach out, we are happy to help!

Exempt research, as defined by OHRP, refers to human subjects research that falls under specific categories outlined in federal regulations and is determined to involve no more than minimal risk. 

While exempt research doesn't require the same level of ongoing oversight as other types of research, it still needs to be reviewed and determined as exempt by the IRB. Submit an IRB application in OSPREY. 

Exempt Categories (broad overview):

Exempt 1: Normal educational practices in established or commonly acceptable educational settings.

Exempt 2: Research involving the use of educational tests, survey procedures, interview/focus groups, or observation of public behavior. (This category cannot be used with children.)

Exempt 3: Research involving benign behavioral interventions in conjunction with the collection of information from the participants.

Exempt 4: Secondary research uses identifiable private information or identifiable biospecimens

Exempt 5: Federal demonstration projects.

Exempt 6: Taste and Food quality evaluation and consumer acceptance studies.

 UNCW does not use Exempt Category 7 or 8.                                                                                                       

Federal regulations allow certain types of research applications to be reviewed by a single reviewer instead of a full committee. The term for this type of review is expedited (hence, “expedited” because a single review is typically speedier than a full board review).

To be eligible for an expedited review, the proposed study must be:

• No more than minimal risk, AND
• Identification of the participants or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation or be stigmatizing, OR reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal, AND
• Involves procedures in one or more of the following categories (detailed information can be found here):

Expedited 1. Clinical studies of drugs and/or medical devices when certain conditions are met.

Expedited 2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.

Expedited 3. Prospective collection of biological specimens for research purposes by noninvasive means.

Expedited 4. Collection of data through noninvasive procedures routinely employed in clinical practice.

Expedited 5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

Expedited 6. Collection of data from voice, video, digital, or image recordings made for research purposes.

Expedited 7. Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Expedited 8. Continued review of studies initially reviewed by convened IRB.

Expedited 9. Continuing review of research initially reviewed by the convened IRB which are minimal risk.

All non-exempt research must include an informed consent process that demonstrates participants have been properly informed about what their participation involves. As a researcher, you're responsible for informing participants about the study’s purpose, procedures, risks, and benefits, and obtaining their consent before involving them. While the consent document is essential, participants must also have the chance to ask questions and speak with a knowledgeable team member. This discussion is a key part of the "informed consent process."

Below you will find informed consent templates for a variety of research studies. UNCW currently does not support electronic consent on non-exempt research.

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

Click here for informed consent templates working with adults.

Full Board Studies, or more complicated expedited studies

• IRB_Informed Consent_Full Board_Template

If you’ve requested a waiver for any part of your informed consent, you must complete the checklist below to demonstrate that all federally required elements are included, and upload it to Section F of the OSPREY application:

• IRB_Informed Consent_Checklist

Other Informed Consent Templates - These templates may be suitable when a study is minimal-risk, uncomplicated, and involves adults as participants.

• IRB_Informed Consent Letter
• IRB_Informed Consent_Bullet Points
• IRB_Informed Consent_XR Studies

The templates below can ONLY be used for exempt studies, where obtaining a signature is not required.

• IRB_Consent Script_Focus Groups
• IRB_Verbal Consent Script_Interviews
• IRB_Survey_Consent Statement

Research With Children - If your research involves minors (under 18 years old), you must obtain parental permission and the minor's assent. The term permission is used instead of informed consent when referring to the agreement of a child's parent or guardian, while assent refers to the child’s affirmative agreement to participate in the research. Mere failure to object is not assent. Children can decline to participate even if the parents provide permission.

Since children under the age of 5 are usually not capable of providing meaningful assent due to limited cognitive and verbal skills, we recommend requesting a waiver of consent for this age group (completed in the OSPREY application). Even when assent is waived, researchers should explain the procedure in age-appropriate language (e.g., “We’re going to look at pictures together”) before working with the child.

For children over the age of 5, you may use a combined permission and assent form that is written for both the parent and the child. The form should be understandable to the child, and both the parent and the child must sign it to indicate their agreement to participate.

Use your discretion whether to use the combined form or only the parent permission form.  If you obtain ONLY parent permission, then you must ask for assent from the minor before working with them.

Click here for permission and assent templates. The age range is a suggestion, and researchers should use the one best suited to their study population.

• IRB_Permission and Assent Combined
• IRB Permission Only
• IRB Assent Ages 5-8
• IRB Assent Ages 9-12
• IRB Assent Ages 12-17

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.