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Published January 22, 2021 | Version v1.0.0
Journal Article Open

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

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


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.


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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March 30, 2023
March 20, 2024