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).
- July 15, 2014: CITI Good Clinical Practice (GCP) training (link to CITI site) is now required of all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects and a drug, device or biologic is included in the study. Deadline for completion is October 1, 2014. A refresher course will be required every two years.
The GCP training requirement is in addition to the OHRE requirement for Human Research Ethics Training (CITI Human Subjects Research Protection modules).
If you have further questions regarding the required GCP training, please contact the Office of Clinical Trials at email@example.com or call 919-843-2698.
- June 12, 2014: A new version of the IRB SOPs (dated 4/24/2014) is posted here and includes the following changes:
- SOP 3.2-Revised to reflect current practices regarding inter-institutional agreements (specifically, reliance on central IRBs).
- SOP 19-Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) reporting revised to require reporting of events that meet all three criteria (previously events that meet criteria 1 & 2 (related and unexpected) were reportable to the IRB)
- SOP 22-Revised to clarify that all events meeting the criteria for an UPIRSOs or cases of alleged serious or continuing non-compliance, will be reviewed by the convened IRB for a final determination.
- SOP 29-Revised HIPAA section to add information regarding “compound authorizations”
- SOP 37- New SOP: Sponsor-initiated holds, suspension and termination of IRB approval (Sections of SOPs 14.3 and 18.1 deleted to eliminate duplication.)
- Revised appendices: F, I, J, K, Q, R, U & Y
- May 8, 2014: Two changes to the routing of IRB correspondence, effective immediately:
1) Co-Investigators will now be copied on all IRB-related correspondence automatically, in addition to Principal Investigators and Faculty Advisors. Other members of the research team (e.g., Study Coordinators, Regulatory Associates) can still be added to the copy list, optionally, as currently done.
2) Department heads will be copied on determinations that a project is “Not Human Subjects Research” (NHSR). While these activities do not require IRB approval, they may still raise concerns and/or warrant departmental oversight.
- January 28, 2014: Recent changes in our computer system (IRBIS) have led to a delay in processing time. This is impacting the time it takes to review and approve submissions. We appreciate your patience while we get through this transition.
- January 21, 2014: For the past two weeks, there has been intense media coverage of research conducted by a UNC employee on literacy rates among student-athletes. These reports contained numerous errors and misrepresentations with regard to the IRB status of this research. CLICK HERE for a statement prepared by the Office of Human Research Ethics, which oversees the IRBs, to respond to media inquiries and address inaccuracies in prior reports.
- October 30, 2013: Effective October 15, 2013, UNC will rely on the approval and oversight of the central/independent IRB already involved with an industry-sponsored, multicenter trial, provided certain criteria are met. Please CLICK HERE for a guidance document providing an overview of the process for requesting reliance on a central or independent IRB.
Informational sessions were offered to provide background, introduce the new policy and demonstrate the abbreviated application used for this scenario. Please CLICK HERE for the slides used in these sessions.
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.