The challenge of human challenge research models: A Canadian perspective

Abstract

Research in which healthy volunteers are exposed to pathogens or other aetiologic agents that may cause disease remains controversial. Proponents suggest such work is key to understanding pathways of infection and the efficacy of vaccines and treatments. Yet, this research creates ethical and legal issues surrounding consent, participant vulnerability and the potential for harm. Moreover, public trust in research could be compromised if avoidable, serious harm occurs, making challenge research risky. Among Canadian research ethics guidelines, overarching messages are that participant interests cannot be subservient to those of research and that risks must be proportional to likely benefits. Moreover, common law fiduciary obligations to clinical research participants and the deterrent effect of potential tortious or criminal negligence act to reinforce the idea that challenge protocols should be a strategy of last resort. Researchers could benefit from clear guidance directly addressing the unique issues with challenge research.