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Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group
Euzebiusz Jamrozik1, Katherine Littler2, Susan Bull3
1The Ethox Centre & Wellcome Centre for Ethics and the Humanities, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK; Monash Bioethics Centre, Monash University, Clayton, Victoria, Australia; Royal Melbourne Hospital Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.
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.
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