The Office of Human Research Ethics (OHRE) is responsible for ethical and regulatory oversight of research at the University of North Carolina at Chapel Hill that involves human subjects. OHRE supports and oversees the work of the Institutional Review Boards (IRBs).
current announcements (for older items, see News section)
- November 13, 2014: As of 1:15 PM, IRBIS access has been restored for investigators and department approvers/reviewers. However, until further notice, department approvers and reviewers must access individual submissions using the IRB Number or Reference ID lookups at the top of the IRBIS Home screen, rather than compile a list of waiting submissions at the Dashboard Routing Inbox. For the time being, Approvers/Reviewers should not click the Routing Inbox Dept Approval / Dept Review links.
- October 28, 2014: Effective November 1, 2014, submissions that remain in “draft” status (i.e., never submitted to the IRB) for more than six months will be automatically deleted on a monthly schedule. To prevent deletion, simply access the submission and click the Save button on any screen. Deletion of a “draft” post-approval submission (i.e., Modification, Renewal, or Closure) will not remove any previously approved submissions for that protocol.
- October 21, 2014: We continue to experience delays in processing time. Recent changes in our computer system (IRBIS) have impacted the time it takes to review and approve submissions. We appreciate your patience while we get through this transition. Click here for guidance on how to monitor the status of your submission.
- October 2, 2014: IMPORTANT INFORMATION ABOUT EVENT REPORTING:
1. Do not wait to submit a reportable event to the IRB until you have all the information about the event. Report the event promptly and follow-up with additional information as it becomes available.
2. A UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others) that is also a Serious Adverse Event must be reported ASAP, but no later than one (1) week from the time you become aware of the event.
3. All other UPIRSOs must be reported ASAP, but no later than two (2) weeks from the time you become aware of the event.
4. Protocol violations must be reported ASAP, but no later than one (1) week from the time you identify the issue.
5. Other events that are reportable to the IRB include subject complaints and breach of confidentiality.
For more information, please review UNC SOP 19.0 and 23.0 http://research.unc.edu/files/2014/05/2014-04-24-OHRE-Standard-Operating-Procedures-FINAL-CLEAN.pdf
The IRBs at the University of North Carolina at Chapel Hill are organized by area of expertise. The IRBs are:
- Biomedical IRB (Committees A through D) Reviews research involving School of Medicine, School of Pharmacy, UNC Hospitals, and research in other units that involves biomedical interventions. Expertise is focused on medical, surgical, physiological or pharmacological studies. Includes research with drugs, devices, counseling, or other interventions. Studies that require dental expertise are reviewed by Biomedical Committee B.
- Non-Biomedical IRB (Committee E) A combination of the former Behavioral and Public Health-Nursing IRBs. Reviews research in psychology, child development, education, anthropology, information and library science, social work, journalism, and many other disciplines under Academic Affairs, as well as studies from the School of Public Health, School of Nursing, nursing-related studies at UNC Hospitals, non-medical research from the Injury Prevention Research Center, Carolina Population Center, Health Promotion Disease Prevention, and Sheps Center. Expertise is focused on research in behavioral and social sciences, the humanities, epidemiology and other research in a public health or nursing context.
For questions or comments
- General questions: by email, email@example.com,
or by phone, 919-966-3113
- Technical questions about online submission:
call David Tegnell at IRBIS Help Desk, 919-966-3685
- Substantive (non-technical) questions about stipulations:
call OHRE office (919-966-3113) and ask to speak with reviewing coordinator
- Check the status of your review: at irbis.unc.edu
(also, see guidance)
- IRB training requirements:
by email, firstname.lastname@example.org