Cave, Emma (2010) 'Seen but not heard? Children in clinical trials.', Medical law review., 18 (1). pp. 1-27.
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.
| Item Type: | Article |
|---|---|
| Keywords: | Clinical trials, Gillick, Consent, Medical research, Children. |
| Full text: | (AM) Accepted Manuscript Download PDF (371Kb) |
| Status: | Peer-reviewed |
| Publisher Web site: | http://dx.doi.org/10.1093/medlaw/fwp024 |
| Publisher statement: | This is a pre-copyedited, author-produced PDF of an article accepted for publication in Medical Law Review following peer review. The definitive publisher-authenticated version Cave, Emma (2010) 'Seen but not heard? Children in clinical trials.', Medical law review., 18 (1). pp. 1-27 is available online at: http://medlaw.oxfordjournals.org/content/18/1/1.full.pdf+html?sid=52f00ff4-3880-45a6-99d3-5b928db8beb0 |
| Date accepted: | No date available |
| Date deposited: | 25 February 2014 |
| Date of first online publication: | February 2010 |
| Date first made open access: | No date available |
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