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IRB and the Office of Human Research Ethics

Announcements

OHRE/IRB Unsecure Communication Update – 10/26/2020

As of 10/26/2020 the “Transmission of Sensitive Information” standard has been updated. Although the standard is broader than communication with research subjects, it is inclusive of them as well and this revision will allow for an exception to the current process to permit texting or email with an individual through an exception process that involves obtaining the individual’s consent for certain types of messages.

The Office for Human Research Ethics (OHRE) has been working on this update for research participant communication in collaboration with Information Technology Services (ITS), ITS Policy Office, Privacy Office, Office of Clinical Trials (OCT), and IT-School of Medicine (SOM)

Updates have been made to IRBIS, consent templates, and a FAQ has been completed.

Resources

Please click here for information regarding OHRE’s Coronavirus Update –  June 10, 2020.

Resumption of Human Subject Research- Q & A Zoom Session from June 1, 2020: Slides available here and Audio Recording of the presentation here.

Please click here to learn more about UNC’s implementation of the Revised Common Rule which went into effect on January 21, 2019.
The UNC Office of Human Research Ethics/Institutional Review Board (OHRE/IRB) needs you! Please click here to learn more about the UNC IRB Membership Drive.

Upcoming Events

There are no upcoming events at this time.

Introduction to Human Research Subject Protection at UNC

Last year, over one million people took part in research studies at UNC-Chapel Hill. Who are these participants, who is studying them and why? Read more…

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).

IRB Boards A through F review research in a wide variety of areas:

  • Biomedical Research: 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 or oncology expertise are reviewed by Biomedical Boards B or D.
  • Behavioral and Public Health-Nursing Research: such as 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.
  • As well as expertise in reviewing 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.