Public Health Ethics 9 (1):92-103 (2016)

Michael Selgelid
Monash University
Charles Weijer
University of Western Ontario
Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by research involving purposefully infecting healthy volunteers. In this article, we present two separate challenge studies and highlight the ethical issues of human challenge studies as seen through a well-constructed framework. Beyond the same stringent ethical standards seen in other areas of medical research, we conclude that human challenge studies should also include: independent expert reviews, including systematic reviews; a publicly available rationale for the research; implementation of measures to protect the public from spread of infection beyond the research setting; and a new system for compensation for harm. We hope these additions may encourage safer and more ethical research practice and help to safeguard public confidence in this vital research alternative in years to come
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DOI 10.1093/phe/phv026
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References found in this work BETA

.Julian Savulescu - 2007 - Oxford University Press.
Payment for Research Participation: A Coercive Offer?A. Wertheimer & F. G. Miller - 2008 - Journal of Medical Ethics 34 (5):389-392.
Limits on Risks for Healthy Volunteers in Biomedical Research.David B. Resnik - 2012 - Theoretical Medicine and Bioethics 33 (2):137-149.

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Citations of this work BETA

Good Reasons to Vaccinate: Mandatory or Payment for Risk?Julian Savulescu - 2021 - Journal of Medical Ethics 47 (2):78-85.

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