Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

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 publication




Journal article



Publication Date





633 - 640


Bioethics, Clinical trials, Controlled human infection, Coronavirus, Covid-19, Ethics, Human challenge studies, Research ethics, Antiviral Agents, Biomedical Research, COVID-19, COVID-19 Vaccines, Ethics Committees, Research, Healthy Volunteers, Human Experimentation, Humans, Informed Consent, Patient Selection, SARS-CoV-2, Vaccination, World Health Organization