Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group

Creators: Jamrozik, Euzebiusz¹; Littler, Katherine²; Bull, Susan¹; Emerson, Claudia³; Kang, Gagandeep⁴; Kapulu, Melissa⁵; Rey, Elena⁶; Saenz, Carla⁷; Shah, Seema Kirti^{8, 9}; Smith, Peter G.¹⁰; Upshur, Ross¹¹; Weijer, Charles¹²; Selgelid, Michael J.¹³; WHO Working Group for Guidance on Human Challenge Studies in COVID-19

1. University of Oxford
2. World Health Organization
3. McMaster University
4. Christian Medical College
5. Kenya Medical Research Institute
6. Centro Internacional de Entrenamiento e Investigaciones Medicas
7. Pan American Health Organization
8. Northwestern University
9. Lurie Children's Hospital
10. London School of Hygiene & Tropical Medicine
11. Dalla Lana School of Public Health
12. Western University
13. Monash University

Abstract

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable. (C) 2020 The Authors. Published by Elsevier Ltd.

Other

original_citation: Jamrozik E, Littler K, Bull S, Emerson C, Kang G, Kapulu M, Rey E, Saenz C, Shah S, Smith PG, Upshur R, Weijer C, Selgelid MJ, Cha WHOWGGH. Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group. Vaccine. 2021;39(4):633-640.

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