Rapid Review of Therapy Protocols for Public Health Emergencies

Author:

Gordon Bruce G.1,Lowe Abigail E.2,Kratochvil Christopher J.3

Affiliation:

1. Assistant vice‐chancellor for regulatory affairs, and executive chairman of the IRBs at the University of Nebraska Medical Center

2. Assistant professor at the College of Allied Health Professions and a scholar at the Global Center for Health Security at the University of Nebraska Medical Center

3. Senior advisor and Distinguished Chair at the Global Center for Health Security, and vice chancellor of external relations at the University of Nebraska Medical Center

Abstract

ABSTRACTHow research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid‐response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid‐Response IRB's subsequent transition to a multisite single IRB model during the current Covid‐19 pandemic. The rapid‐response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process.

Funder

DHHS Office of the Secretary

Publisher

Wiley

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