Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Practice Guideline
. 2021 Jan 22;39(4):633-640.
doi: 10.1016/j.vaccine.2020.10.075. Epub 2020 Oct 28.

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

Euzebiusz Jamrozik  1 , Katherine Littler  2 , Susan Bull  3 , Claudia Emerson  4 , Gagandeep Kang  5 , Melissa Kapulu  6 , Elena Rey  7 , Carla Saenz  8 , Seema Shah  9 , Peter G Smith  10 , Ross Upshur  11 , Charles Weijer  12 , Michael J Selgelid  13 ; WHO Working Group for Guidance on Human Challenge Studies in COVID-19
Affiliations
Practice Guideline

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

Euzebiusz Jamrozik et al. Vaccine. .

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.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [EJ has received consulting fees from WHO and funding from The Wellcome Trust for research on the ethics of human challenge studies. CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. MJS is he has received funding from The Wellcome Trust for previous research on the ethics of human challenge studies. No competing interests: SB,CE,GK,MK,KL,ER,CS,PGS, SS, RU].

References

    1. WHO Director-General. WHO Director-General’s opening remarks at the media briefing on COVID-19: 11 March 2020. Geneva: World Health Organization; 2020 (https://www.who.int/dg/speeches/detail/who-director-general-s-opening-re..., accessed 3 May 2020).
    1. COVID-19: potential impact on the world’s poorest people. Rome: World Food Programme; 2020.
    1. Gates B. Responding to Covid-19: a once-in-a-century pandemic? N Engl J Med. 2020;382:1677–1679. doi: 10.1056/NEJMp2003762. - DOI - PubMed
    1. Lipsitch M., Swerdlow D.L., Finelli L. Defining the epidemiology of Covid-19: studies needed. N Engl J Med. 2020;382:1194–1196. doi: 10.1056/NEJMp2002125. - DOI - PubMed
    1. Jamrozik E, Selgelid MJ. Human challenge studies in endemic settings: ethical and regulatory issues. SpringerBriefs in Ethics; 2020.

Publication types

MeSH terms