Title: The implementation of Directive 2001/20/EC into Belgian law and the specific provisions on pediatric research
Authors: Pinxten, Wim ×
Dierickx, Kris
Nys, Herman #
Issue Date: Jul-2008
Publisher: Kluwer Academic Publishers
Series Title: European Journal of Health Law vol:15 issue:2 pages:153-61
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.
ISSN: 0929-0273
VABB publication type: VABB-1
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Interfaculty Centre for Biomedial Ethics and Law
× corresponding author
# (joint) last author

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