IRB and the Office of Human Research Ethics

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Announcements

  • September 16, 2016: As previously announced, beginning September 19, 2016 any new study submitted for IRB review may be required to have scientific review completed and documented. All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must undergo scientific review. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol. To facilitate this process, a new Scientific Review section has been added to the Initial IRB application.  Read more…
  • September 2, 2016: All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must be submitted for review to the UNC Scientific Review Committee. Beginning Monday, September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented prior to the review. Click here for additional information.
  • August 12, 2016: The IRB guidance titled “How to Request a Reliance Agreement” has been updated August 12, 2016, as follows:  Page 4 and 5 – Previously the IRB has only required a CV or resume for investigators; this requirement has been extended to all external collaborators regardless of role.
  • July 21, 2016: The IRB has posted an updated Statement of Compliance.
  • June 28, 2016: The IRB may experience delays in processing time.  Recent changes in staffing 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.
  • For older items, see News section

Organizational Structure

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). 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.

IRB Safety Committee: This committee handles submissions that are atypical or otherwise outside the norm, as well as Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) and other compliance issues, Humanitarian Use Devices (HUDs), emergency research on single patients under a single subject treatment IND.  It meets monthly but can be convened rapidly should circumstances require.

Contact

CB# 7097
720 Martin Luther King, Jr. Blvd.
Bldg# 385, Second Floor
Chapel Hill, NC 27599-7097

Ph: 919-966-3113
Fax: 919-966-7879
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