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HRPP during Closure

December 23, 2022

Members of the Drexel Research Community,
The Office of Research & Innovation, Human Research Protections Program, is sharing the following as a reminder during our closure for winter break:
While operations at Drexel University are closed, an emergency use of an investigational drug, biologic or device is permissible without prior IRB approval if the following criteria are met:

  1. A human subject in a life-threatening or severely debilitating situation exists necessitating the use of the investigational drug, biologic or device;
  2. No standard acceptable alternative treatment is available; and
  3. 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.

To report an emergency use during this time-period, please visit the HRPP website for instructions under “Researchers” click on “How To Submit” then scroll down to the “EMERGENCY USE, COMPASSIONATE USE AND HUMANITARIAN USE DEVICE” section to access the worksheets and templates.

Please email, and copy, John Roberts, HRPP Executive Director, to consult about the process, or to discuss mandatory reporting during this “closure” time-period. 

The Drexel HRPP will resume reviewing submissions on January 3, 2023, when the University reopens.

Continuing Reviews

During this time, 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. 

NSI-Safety Information​

The Drexel HRPP will not be enforcing the 7-day reporting period for NSIs until the University re-opens on January 3, 2023.

Thank you,
Drexel HRPP Team