Human Subject Protection

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. You'll 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.   

Exempt studies do not require researchers to obtain signatures on informed consents, but it does require consent. You can find templates on our website.

Please email our office if you have any questions. These decision charts may help in determining if your study qualifies for an exemption and which category it best fits.                                                                                             

Federal regulations allow certain types of research applications to be reviewed by a single IRB member instead of the 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). 

For research studies to meet the expedited review process, they must pose minimal risk to the research participant. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

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.

FERPA: Guidelines for Using Student Work for Research

The Family Educational Rights and Privacy Act (FERPA) is a federal law regarding the privacy of student records and the obligations of the institution, primarily in the areas of release of the records and the access provided to these records. Educational institutions that receive funds administered by the U.S. Secretary of Education are bound by FERPA requirements. Institutions that fail to comply with FERPA may have funds administered by the Secretary of Education withheld.

FERPA takes precedence over OHRP regulations.

Important Definitions:

1. Coursework - Any student work that is graded, evaluated, or maintained by the institution as part of the academic process.
2. Directory Information – Information on students that can be found in the UNCW directory. If it is not listed in the directory, it is FERPA-protected information.
3. Student - an individual who is or has been in attendance at UNCW for degree-seeking courses, non-credit courses, life-long learning courses, and/or certificate courses. It does not include persons who have been admitted but did not attend the university. If the student is under 18, you must obtain parent permission and student assent.
4. Deidentified Data - Data that has been stripped of all personally identifiable information as defined by FERPA.
5. Identifiable Information - Any information that can be used to directly or indirectly identify a student.
6. Legitimate educational interest - a school official who is performing an authorized task or an activity that he or she is undertaking in the name of the university for which access to an educational record is necessary or appropriate to fulfill his or her professional responsibilities for the university.
7. School official -
   1. An employee, agent, or officer of the university or The University of North Carolina’s System Office in an administrative, supervisory, academic or research, or support staff position and acting in his or her official capacity, including a student assisting another school official in performing his or her tasks;
   2. A person serving on university committees, boards, and/or councils, including an individual serving on a disciplinary or grievance committee;
   3. Another educational institution that requests records for a particular student who seeks or intends to enroll or where the student is already enrolled provided the disclosure is for purposes related to the student’s enrollment or transfer; and
   4. A person or company with whom the university has contracted (e.g. internship and clinical facilities, attorney, auditor, or collection agent) but limited to only the specific student information needed to fulfill the contract. The contracting entity is bound to follow FERPA regulations for control, maintenance, use and re-disclosure of the information provided to it.
8. Education Records – records that are maintained by UNCW in any media (e.g., paper, electronic, digital image, film, video, audio tape) which contain information directly related to a student and are personally identifiable to a student. Education records do not include - 

1. 1. Personal records of university employees that are in the sole possession of the maker (i.e., notes of conversations) are used only as a personal memory aid, and are not accessible or revealed to any individual except a temporary substitute;
   2. Records of the UNCW police department used for law enforcement purposes;
   3. Student medical and counseling records maintained and used only in connection with provision of medical treatment or counseling of the student and are made available only to the individuals providing the treatment;
   4. Employment records unrelated to the student’s status as a student (these records are covered under the N.C. Personnel Records Act);
   5. Records created or received after an individual is no longer a student in attendance and that are not directly related to the individual’s attendance as a student (i.e., alumni records); or
   6. Grades on peer-graded papers before they are collected and recorded by a faculty member.

Researcher Responsibilities: Researchers are responsible for complying with FERPA when accessing student education records for research purposes, including to identify and recruit potential research participants or conducting a secondary analysis of the records.

FERPA-protected records may be used for research purposes under one of three conditions:

1. The student provides written permission (consent)- When a researcher wishes to access or use identifiable education records solely for research purposes, consent is required. Researchers must obtain participant signatures even for exempt studies, due to stricter FERPA requirements. The IRB cannot waive consent. Signed consents must be retained permanently. Consent must include:
   1. Description of the records to be disclosed
   2. Purpose of the disclosure
   3. Party or class of parties that will use the data
   4. Signature of the student and date (currently, UNCW does not allow e-consent).

2. There is a legitimate educational interest - At UNCW, the University Registrar determines whether a research project qualifies as having a legitimate educational interest. Ask yourself: Do I need this information to fulfill my official responsibilities for the institution? Faculty don’t automatically get access to all student information; they may only access what’s needed to support their students’ education.
3. The researcher receives de-identified data - The researcher receives records that do not include personally identifiable information. Faculty researchers cannot de-identify their own students' records for research purposes.

If you think you may want to use current coursework for research, be proactive and obtain consent from students during the semester (the consent must include the required elements listed above).

When working with student data from past classes, you must contact the University Registrar for review before submitting an application to the IRB. Please explain the justification for meeting one of the three criteria in Section C of the OSPREY application and upload the email correspondence to Section F of the OSPREY application.

Refer to 04.150 Student Records and Family Educational Rights and Privacy Act (FERPA) Policy for more information on FERPA.