WHO guidance on the ethical conduct of controlled human infection studies
Overview
Alleviating the impact of infectious diseases on human health remains a key global health priority. In controlled human infection studies (CHIS), healthy volunteers are intentionally exposed to pathogens in a controlled environment, in order to promote understanding of the pathogenesis, transmission, prevention and treatment of infectious diseases in humans. Such studies may be conducted to gain insights into how pathogens infect human hosts and cause disease, to better understand immune responses to infection, or to evaluate the efficacy of vaccines and drugs designed to prevent and treat infectious diseases. CHIS have a long history and have made important contributions to the treatment and prevention of many infectious diseases of global health importance. Although recognition of the potential value of CHIS is leading to such studies increasingly being conducted in a wider range of contexts, they remain a relatively unfamiliar research method. This guidance has been developed in response to requests to the World Health Organization (WHO) for guidance on ethical questions associated with CHIS, especially in the context of growing interest in conducting CHIS in endemic settings.
This document aims to provide guidance to scientists, research ethics committees, funders, policy-makers, and regulators in deliberations regarding the design, conduct and governance of controlled human infection studies.
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