Institutional Review Board (IRB)

UNC faculty, staff and students who wish to conduct research that includes human research subjects must receive approval of the University's Institutional Review Board (IRB) prior to any data collection.

For research and research-related activity involving human subjects, UNC is guided by university policy, the ethical principles set forth in the Belmont Report and by federal regulations found in Title 45, Part 46 of the Code of Federal Regulations.

Please refer below to the Procedures for Research Involving Human Participants at UNC and the complete IRB Package when preparing IRB protocols for committee review.

UNC faculty members who serve on the IRB are skilled researchers – representing diverse departments, perspectives and research methodologies – who review the proposed work within the context of human subject protections and ethical research practices.

IRB Procedures

Designed to assist faculty, staff, and students who conduct research with human participants (subjects) at UNC, this document describes the role of the Institutional Review Board (IRB), the policies that govern research with human subjects, and the procedures UNC researchers must follow.

Novice researchers and those new to UNC should read the entire document. Experienced UNC researchers may use it as a reference document when preparing an IRB application.

Procedures for Research Involving Human Participants at UNC (pdf)

Additional Procedures for Classroom Research (Omnibus)

UNC Human Subjects Federal Wide Assurance Number

IRB Application Forms

Complete IRB Application Package (pdf)

Includes the Cover Page, Narrative Instructions, and all Consent Forms, or you may access these separate sections below:

IRB Application Cover Page (pdf)
The cover page with original signatures is required with all IRB applications.
Writing an IRB Application at UNC (pdf)
A description of what is required in the narrative portion of an IRB application.
Examples of Consent Forms (may be used as templates)
- Standard Consent Form when Signature is Required (Word)
- Consent Form when Signature is Not Required (Word)
- Parental Consent Form when Signature is Required (Word)
- Assent Form for Minor when Signature is Required (Word)

Protocol for Research Involving Human Body Specimens (pdf)

Change of Protocol Form (pdf)

The Change of Protocol Form is required to obtain IRB approval when changes are made to a protocol that was previously approved through an expedited or full board review.

Continuation Review Form – Contact Sherry May at 351-1910

IRB approval is required to continue the research beyond the end date of a previously approved protocol.

Classroom Research (Omnibus)

Students conducting research for course credit in a normally scheduled course (i.e., not for directed studies, thesis, dissertation credits) may have their IRB application reviewed by the course instructor if the instructor has Omnibus IRB Approval for his/her course.

Omnibus IRB Approval for a Scheduled Course covers exempt-status research projects being conducted by students registered for the scheduled course. It is the instructor’s responsibility to obtain this IRB approval prior to the conduct of any research. If students wish to engage in research that falls under expedited or full board review, then the student, with the instructor acting as the research advisor, must submit an application to the IRB in accordance with the guidelines outlined in this document.

The instructor may serve as first reviewer of the expedited application, and an IRB Co-Chair will be the final reviewer.

Requirements for Omnibus IRB Approval for a Scheduled Course

Instructors supervising course-related, student research must be familiar with IRB policies and issues in order to ensure that research participants are treated ethically (e.g., risks are low, informed consent policy is followed, confidentiality is maintained). Instructors must complete on-line training prior to supervising such projects and document the training as part of the Omnibus IRB application process. Instructors must submit an exempt-status IRB application for the course in which students will be conducting research. Types of research projects should be mentioned within the narrative of the IRB application.

Instructors should include a copy of the course syllabus in the IRB application.
Instructors should have students submit an exempt-status IRB application as part of the course requirements. The instructor will review these for IRB-related concerns. Instructors must keep a record of all exempt-status applications completed by students under their guidance. Instructors should send the list with students’ names and project titles to the Office of Sponsored Programs at the end of the semester.

This omnibus approval must be renewed every four years.