Recent outbreaks of Ebola and Zika virus have revealed the threats posed by emerging infectious diseases (EIDs). Although interventions are urgently needed, research during an outbreak can raise logistical and ethical challenges. Human challenge studies, where researchers deliberately expose healthy volunteers to disease, are powerful tools to prepare for future EID outbreaks and accelerate product development. However, some human challenge studies have been controversial, and systematic ethical analysis is limited. The overall objective of this project is to bring together a diverse group of experts and stakeholders to develop a new, comprehensive, and practical ethical framework for the use of human challenge studies for EIDs. This project has two aims: (1) To determine under what conditions human challenge studies on EIDs can be ethically justified, and (2) to identify additional safeguards to protect and respect participants and communities and foster public trust.
A new ethical and regulatory approach for the use of human challenge studies with emerging infectious diseases
Seattle Children's Hospital | Ann & Robert H. Lurie Childrens Hospital of Chicago
Annette Rid et al., Judging the social value of controlled human infection studies, Bioethics, Aug 2020.Read more
Sean C. Murphy et al., Reexamining the categorical exclusion of pediatric participants from controlled human infection trials, Bioethics, Jul 2020.Read more
Seema K. Shah et al., Ethics of controlled human infection to study COVID-19, Science, May 2020.Read more