Seen but not heard? Children in Clinical Trials

Cave, Emma

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.