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Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group Open Access (recommended)

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.

Descriptions

Resource type(s)
Article
Keyword
Bioethics
Ethics
Research ethics
Clinical trials
Coronavirus
COVID-19
Human challenge studies
Controlled human infection
Rights
Attribution 4.0 International

Creator
Jamrozik, Euzebiusz
Littler, Katherine
Bull, Susan
Emerson, Claudia
Kang, Gagandeep
Kapulu, Melissa
Rey, Elena
Saenz, Carla
Shah, Seema Kirti
Smith, Peter G.
Upshur, Ross
Weijer, Charles
Selgelid, Michael J.
WHO Working Group for Guidance on Human Challenge Studies in COVID-19
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.
Related URL
Publisher
ELSEVIER SCI LTD
Date Created
2021-01-22
Original Identifier
(PMID) 33341309
Grants and funding
Medical Research CouncilUK Research & Innovation (UKRI)Medical Research Council UK (MRC)European Commission [MR/R010161/1] Funding Source: Medline; Wellcome TrustWellcome TrustEuropean Commission Funding Source: Medline; World Health OrganizationWorld Health Organization [001] Funding Source: Medline
DOI
10.1016/j.vaccine.2020.10.075

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