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

Euzebiusz Jamrozik; Katherine Littler; Susan Bull; Claudia Emerson; Gagandeep Kang; Melissa Kapulu; Elena Rey; Carla Saenz; Seema Shah; Peter G. Smith; Ross Upshur; Charles Weijer; Michael J. Selgelid; for the WHO Working Group for Guidance on Human Challenge Studies in COVID-19

doi:10.1016/j.vaccine.2020.10.075

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

Euzebiusz Jamrozik
, Katherine Littler
, Susan Bull
, Claudia Emerson
, Gagandeep Kang
, Melissa Kapulu
, Elena Rey
, Carla Saenz
, Seema Shah
, Peter G. Smith
, Ross Upshur
, Charles Weijer
, Michael J. Selgelid
, for the WHO Working Group for Guidance on Human Challenge Studies in COVID-19

Monash Bioethics Centre

Research output: Contribution to journal › Comment / Debate › Other › peer-review

60 Citations (Scopus)

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.

Original language	English
Pages (from-to)	633-640
Number of pages	8
Journal	Vaccine
Volume	39
Issue number	4
DOIs	https://doi.org/10.1016/j.vaccine.2020.10.075
Publication status	Published - 22 Jan 2021

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Bioethics
Clinical trials
Controlled human infection
Coronavirus
Covid-19
Ethics
Human challenge studies
Research ethics

Access to Document

10.1016/j.vaccine.2020.10.075

Cite this

Jamrozik, E., Littler, K., Bull, S., Emerson, C., Kang, G., Kapulu, M., Rey, E., Saenz, C., Shah, S., Smith, P. G., Upshur, R., Weijer, C., Selgelid, M. J., & for the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 (2021). Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group. Vaccine, 39(4), 633-640. https://doi.org/10.1016/j.vaccine.2020.10.075

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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.",

keywords = "Bioethics, Clinical trials, Controlled human infection, Coronavirus, Covid-19, Ethics, Human challenge studies, Research ethics",

author = "Euzebiusz Jamrozik and Katherine Littler and Susan Bull and Claudia Emerson and Gagandeep Kang and Melissa Kapulu and Elena Rey and Carla Saenz and Seema Shah and Smith, \{Peter G.\} and Ross Upshur and Charles Weijer and Selgelid, \{Michael J.\} and \{for the WHO Working Group for Guidance on Human Challenge Studies in COVID-19\}",

year = "2021",

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day = "22",

doi = "10.1016/j.vaccine.2020.10.075",

language = "English",

volume = "39",

pages = "633--640",

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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 & for the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 2021, 'Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group', Vaccine, vol. 39, no. 4, pp. 633-640. https://doi.org/10.1016/j.vaccine.2020.10.075

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T2 - Report of a WHO Working Group

AU - Jamrozik, Euzebiusz

AU - Littler, Katherine

AU - Bull, Susan

AU - Emerson, Claudia

AU - Kang, Gagandeep

AU - Kapulu, Melissa

AU - Rey, Elena

AU - Saenz, Carla

AU - Shah, Seema

AU - Smith, Peter G.

AU - Upshur, Ross

AU - Weijer, Charles

AU - Selgelid, Michael J.

AU - for the WHO Working Group for Guidance on Human Challenge Studies in COVID-19

PY - 2021/1/22

Y1 - 2021/1/22

N2 - 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.

AB - 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.

KW - Bioethics

KW - Clinical trials

KW - Controlled human infection

KW - Coronavirus

KW - Covid-19

KW - Ethics

KW - Human challenge studies

KW - Research ethics

UR - https://www.scopus.com/pages/publications/85099271872

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DO - 10.1016/j.vaccine.2020.10.075

M3 - Comment / Debate

C2 - 33341309

AN - SCOPUS:85099271872

SN - 0264-410X

VL - 39

SP - 633

EP - 640

JO - Vaccine

JF - Vaccine

IS - 4

ER -

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

Abstract

UN SDGs

Keywords

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