Institutional Review Board (IRB)
NEW! Common Rule Revisions and Updates can be found on this page.
The use of human subjects in research at UNC is regulated by University Regulations 3-8-104, enacted by the Board of Trustees to ensure that all research involving human subjects carried out under the auspices of UNC conforms to ethical standards.
3-8-104 Human Subjects. It is the policy of the University that all research and research-related activities, in which humans are used as subjects, shall be subject to review under current Public Health Service regulations by an Institutional Review Board (IRB). The involvement of humans subjects in research covered by this policy shall be prohibited until the IRB has reviewed and approved the research protocol.
All research projects conducted under the auspices of the university (e.g. by faculty, students, or staff) involving human subjects must be reviewed and approved by the university's Institutional Review Board (IRB). Faculty, students and staff planning human research must submit requests for IRB approval prior to any data collection.
UNC Regulations and procedures regarding the use of human subjects are guided by the ethical principles set forth in the Belmont Report. The university and the IRB adhere to the federal regulations found at CFR Title 45, Part 46. The role of the IRB is to support UNC researchers in conforming to the ethical standards for the protection of human subjects, researchers, and the university. The IRB is committed to carrying out this charge in a manner that will support and assist researchers.
REVISED COMMON RULE!
The Federal Policy for the Protection of Human Subjects, known as the Common Rule has undergone substantive revisions. The effective date for the revised Common Rule is JANUARY 21 2019. Please refer to this document for important changes and revisions.
Visit our FAQ page.
- NEW! Procedures for Research Involving Human Participants at UNC (pdf)
- Definitions Comparison Chart (pdf)
- Exempt Comparison Chart (pdf)
- The IRB Submission Process-Using IRBNET
- IRB.net for UNC users
UNC has implemented the IRBNet system to streamline the IRB application and review process. IRBNet provides a paperless, electronic method for submission, tracking and review of applications for IRB approval. Researchers can create, edit, and submit their applications for IRB approval, and IRB members can review and take action on applications at any time from any computer with Internet access.
- Writing an IRB application narrative (pdf)
- Submitting a new project in IRBNET (pdf)
- Revising an existing project in IRBNET (pdf)
- Submitting a continuation review request in IRBNET (pdf)
- Protocol for research involving human body specimens (pdf)
- Requirements for course-based research (Omnibus) (pdf)
- IRB Frequently Asked Questions
- UNC Human Subjects Federal Wide Assurance: FWA00000784
- View Additional IRB Resources
- Federal policies and guidelines on the use of human subjects
- Training in the use of human subjects
- "Ethically Impossible" STD Research in Guatemala 1946-1948
The revelation that in the 1940s the U.S. Public Health Service supported research in Guatemala that intentionally exposed thousands of Guatemalans to sexually transmitted diseases without their consent resulted in an investigation by the Presidential Commission for the Study of Bioethical Issues. The findings of that investigation are available in this Commission report and related study guide.
- A Study Guide to "Ethically Impossible"
"Designed for higher education, this study guide allows students to assess for themselves the PHS debates about the scientific validity and political sensitivity of the research.
- UNC Service for Recruitment of Research Participants
Researchers needing to recruit research participants may advertise their studies on the Office of Research website after obtaining an IRB approval.
NOTE: if you have questions regarding recruitment of research participants, please contact Nicole Morse.
- UNC Data Security Plan for Research Involving Human Subjects
As part of the IRB application, researchers need to identify any data that are stored electronically and that if disclosed, would cause material or legal harm to research participants. Researchers who are collecting, handling, or storing such data must define their security level, as specified in the UNC Data Security Plan, and submit an application to UNC Information Management and Technology (IM&T).
NOTE: If you have question regarding data security, please contact Forrest Swick, Information Technology Security.