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. 2024 Mar-Apr;46(2):16-21.
doi: 10.1002/eahr.500203.

Rapid Review of Therapy Protocols for Public Health Emergencies

Affiliations

Rapid Review of Therapy Protocols for Public Health Emergencies

Bruce G Gordon et al. Ethics Hum Res. 2024 Mar-Apr.

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.

Keywords: Ebola; human subjects research; institutional review board (IRB); local rapid-response institutional review board; public health emergency; single IRB (sIRB).

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References

    1. Keusch, G. T., and K. P. W. J. MacAdam, “Clinical Trials during Epidemics,” Lancet 389 (2017): doi:10.1016/S0140-6736(17)31602-1;
    1. Stellmach, D., et al., “Anthropology in Public Health Emergencies: What Is Anthropology Good For?,” BMJ Global Health 3 (2018): doi:10.1136/bmjgh-2017-000534.
    1. Lurie, N., et al., “Research as a Part of Public Health Emergency Response,” New England Journal of Medicine 368 (2013): doi:10.1056/NEJMsb1209510;
    1. Brett-Major, D. M., et al., “Advanced Preparation Makes Research in Emergencies and Isolation Care Possible: The Case of Novel Coronavirus Disease (COVID-19),” American Journal of Tropical Medicine and Hygiene 102, no. 5 (2020): doi:10.4269/ajtmh.20-0205.
    1. Meyer, M. N., et al., “An Ethics Framework for Consolidating and Prioritizing COVID-19 Clinical Trials,” Clinical Trials 18, no. 2 (2021): doi:10.1177/1740774520988669.

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