Document Detail


Diversified harmony: Supranational and domestic regulation of pediatric clinical trials in the European Union.
MedLine Citation:
PMID:  21658637     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Over the past decades, considerable legislative effort has been made to facilitate and encourage clinical research in the European Union (EU). Hereby, specific attention has been paid to the urgent need to conduct research in minors. In this article, we will analyze the regulation that currently governs pediatric clinical research conduct at the supranational level of the EU and at the level of individual EU member states. Our analysis will focus on the way in which the national and supranational legal frameworks address five ethical issues that are specific to pediatric clinical research: (a) informed consent, (b) the necessity to conduct research in minor subjects, (c) the interests of the subject concerned, (d) the risks and burdens involved, and (e) the pediatric expertise of protocol review committees. We conclude by discussing the harmonization and diversification of the legal requirements that govern pediatric clinical research in the EU.
Authors:
Wim Pinxten; Kris Dierickx; Herman Nys
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society     Volume:  10 Suppl 2     ISSN:  1873-5010     ISO Abbreviation:  J. Cyst. Fibros.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-06-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101128966     Medline TA:  J Cyst Fibros     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  S183-98     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
Affiliation:
Centre for Biomédical Ethics and Law, K. U. Leuven, BE-3000 Leuven, Belgium.
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