Cookies

We use cookies to ensure that we give you the best experience on our website. By continuing to browse this repository, you give consent for essential cookies to be used. You can read more about our Privacy and Cookie Policy.


Durham Research Online
You are in:

Seen but not heard? Children in clinical trials.

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

Save or Share this output

Export:
Export
Look up in GoogleScholar