Rapid Review of Therapy Protocols for Public Health Emergencies

• Published in: Ethics & human research Vol. 46; no. 2; pp. 16 - 21
• Main Authors: Gordon, Bruce G., Lowe, Abigail E., Kratochvil, Christopher J.
• Format: Journal Article
• Language: English
• Published: United States 01-03-2024
• Subjects: COVID-19; Ebola; Emergencies; Ethical Review; human subjects research; Humans; institutional review board (IRB); local rapid‐response institutional review board; Pandemics; Public Health; public health emergency; single IRB (sIRB); local rapid-response institutional review board; institutional review board (IRB); public health emergency; human subjects research; Ebola; single IRB (sIRB)
• ISSN: 2578-2355; 2578-2363
• DOI: 10.1002/eahr.500203

ABSTRACT
How 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.