The Implementation of Directive 2001/20/EC into Belgian Law and the Specific Provisions on Pediatric Research

in European Journal of Health Law
Authors: Herman Nys 1 , Kris Dierickx 2 and Wim Pinxten 3
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1 1Centre for Biomedical Ethics and Law-KULeuven, Kapucijnenvoer 35, B-3000 Leuven Belgium
2 2Centre for Biomedical Ethics and Law-KULeuven, Kapucijnenvoer 35, B-3000 Leuven Belgium
3 3Centre for Biomedical Ethics and Law-KULeuven, Kapucijnenvoer 35, B-3000 Leuven Belgium;, Email: wim.pinxten@med.kuleuven.be
Online Publication Date:
01 Jan 2008
Volume/Issue:
Volume 15: Issue 2
Article Type:
Research Article
DOI:
https://doi.org/10.1163/157180908X322996
Keywords:
CONSENT; LEH; MINORS; ETHIC COMMITTEE; PEDIATRIC RESEARCH; EUROPEAN DIRECTIVE
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Abstract

The European Clinical Trial Directive (2001/20/EC) was implemented into the Belgian legal system by the Law of 7 May 2004 concerning experiments on the human person (LEH). Apart from implementing the European Directive, this law also broadens the scope of the Directive from interventional clinical trials to all medical experiments involving human persons. This article offers an overview of the requirements for involving minors in medical experiments that are captured in the LEH, illustrates the process of protocol review by an ethics committee, and discusses the dissimilarities between the LEH and the European Directive.

The Implementation of Directive 2001/20/EC into Belgian Law and the Specific Provisions on Pediatric Research

in European Journal of Health Law
E-ISSN:
1571-8093
Print ISSN:
0929-0273
Publisher:
Brill | Nijhoff
Cover European Journal of Health Law

Sections

Information

Page Count:
153–161
Subjects:
Health Law, Human Rights and Humanitarian Law
Copyright:
© 2008 Koninklijke Brill NV, Leiden, The Netherlands 2008

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