PMID: 16506728Mar 2, 2006Paper

Towards the development of ethical practices in paediatric clinical trials: the special position of the terminally ill child

Journal of Law and Medicine
William J Keough

Abstract

This article examines the emotive and vexing issue of the involvement of terminally children in paediatric clinical trials. Particular emphasis is placed on the participation of such children in Phase I clinical studies, as such studies do not yield any benefit to the individual child. It provides an historical overview of medical research involving children and examines the moral arguments surrounding the participation of children in clinical trials. The article examines the conflict between doctor-as-researcher and doctor-as-treater as well as the problems presented by proxy consent providers. The role played by the human research ethics committee in this area is examined, as is the regulatory framework established by the National Health and Medical Research Council. The article argues that the participation of terminally ill children in Phase I clinical trials is not morally repugnant provided that there is a total commitment to the protection of the child participant's well-being during the dying process. It is argued that the moral justification for such position derives from the utilitarian notion that participation in such studies aims to benefit future generations of ill children.

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