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.
Highlights
Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source
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
COVID-19 would probably claim millions of lives and place extreme strain on health care systems worldwide. While control measures such as physical distancing can help to reduce the spread of COVID-19, these measures come at enormous social and economic costs that may be disproportionately borne by underprivileged groups
Summary
The pandemic of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, poses an extraordinary threat to global public health, socioeconomic stability, food security and other social goods [1,2]. Such studies can be valuable for testing vaccines [5,6] They can be substantially faster to conduct than vaccine field trials, in part because far fewer participants need to be exposed to experimental vaccines in order to provide (preliminary) estimates of efficacy and safety. Challenge studies are used to study processes of infection and immunity from their inception [5] They could be used to (a) validate tests for immunity to SARS-CoV-2, (b) identify correlates of immune protection, and (c) investigate the risks of transmission posed by infected individuals [4,10]. This document aims to provide guidance to scientists, research ethics committees, funders, policy-makers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining key criteria that would need to be satisfied in order for such studies to be ethically acceptable
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