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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

DOI

10.1016/j.vaccine.2020.10.075

Type

Journal article

Journal

Vaccine

Publication Date

22/01/2021

Volume

39

Pages

633 - 640

Keywords

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