Key criteria for the ethical acceptability of COVID-19 human challenge studies

Overview

The widespread use of safe and efficacious vaccines for COVID-19 could save many lives, prevent disease, and permit the safe relaxation of other public health measures. There is thus an urgent ethical imperative for well-designed and carefully conducted research aiming to develop such vaccines and increase relevant scientific knowledge regarding SARS-CoV-2. Controlled human infection studies, also known as human challenge studies, have been proposed as one means of testing the many vaccine candidates for SARS-CoV-2. In response to the need for ethical guidance to inform policy and decisions regarding the potential development of such research programs, WHO has developed key criteria that COVID-19 challenge study programs would need to meet to ensure that such research is conducted to the highest ethical standards.

This document aims to provide guidance to scientists, research ethics committees, funders, policy-makers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining key criteria that would need to be satisfied in order for such studies to be ethically acceptable.