As a reminder, while operations at the University of North Carolina are closed, an emergency use of an investigational drug, biologic or device is permissible without prior IRB approval if the following criteria are met:
- A human subject in a life-threatening or severely debilitating situation exists necessitating the use of the investigational drug, biologic or device;
- No standard acceptable alternative treatment is available; and
- Because of the immediate need to use the investigational drug, biologic or device, there is not sufficient time to use existing procedures to obtain IRB approval.
Emergency uses must be reported to the IRB within 5 working days, both the form and the SOP (page 14) are attached if needed. The OHRE has designated several chairs that can consult about the process, if desired, and that can help initiate and receive submissions of mandatory reporting during this “Closure” time-period. To report an emergency use during this time-period please do the following:
- Complete the “Report of Emergency Use of a Test Article to the IRB”;
- Send to one of the following contacts during this time period:
The OHRE will resume reviewing submissions on January 2, 2019 when the University is no longer closed.
During this time period we will prioritize continuing reviews, however if a study does expire, please remember that federal regulations do not allow for research activities to continue, unless by not completing the research interventions subjects would be placed at increased risk. If this occurs please complete a protocol exception request at the earliest opportunity and either submit through IRBIS if available, or submit to one of the individuals above if not available.
The UNC OHRE will not be enforcing the 7 day reporting period for NSI’s until the University re-opens on January 2, 2019.
Cassandra Myers, CIP
Director, Office of Human Research Ethics
University of North Carolina at Chapel Hill