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Seen but not heard? Children in Clinical Trials

Cave, Emma

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Abstract

The Medicines for Human Use (Clinical Trials) Regulations put into effect the European Union Clinical Trials Directive 2001, which aims to facilitate and harmonise standards in research across Europe. The Regulations apply only to ‘clinical trials of investigational medicinal products’ (CTIMPs). The author discusses the consent requirements which restrict the ability of competent minors to consent or assent. Additionally, concerns are raised regarding the risk benefit ratio applied in paediatric clinical trials. The Regulations may prove overly restrictive of research which is not of direct benefit to the research participants, to the detriment of child health generally.

Citation

Cave, E. (2010). Seen but not heard? Children in Clinical Trials. Medical Law Review, 18(1), 1-27. https://doi.org/10.1093/medlaw/fwp024

Journal Article Type Article
Publication Date Feb 1, 2010
Deposit Date Jul 18, 2013
Publicly Available Date Feb 25, 2014
Journal Medical Law Review
Print ISSN 0967-0742
Electronic ISSN 1464-3790
Publisher Oxford University Press
Peer Reviewed Peer Reviewed
Volume 18
Issue 1
Pages 1-27
DOI https://doi.org/10.1093/medlaw/fwp024
Keywords Clinical trials, Gillick, Consent, Medical research, Children.

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