title: The implementation of Directive 2001/20/EC into Belgian law and the specific provisions on pediatric research.
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.
authors.affiliation: Centre for Biomedical Ethics and Law-KULeuven, Kapucijnenvoer 35, B-3000 Leuven, Belgium. wim.pinxten@med.kuleuven.be
authors.forename: Wim
authors.initials: W
authors.lastname: Pinxten
authors.forename: Kris
authors.initials: K
authors.lastname: Dierickx
authors.forename: Herman
authors.initials: H
authors.lastname: Nys
mesh_terms: D000293:Adolescent; D001530:Belgium; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D002648:Child; D002669:Child Welfare; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent; D033242:Minors / Q000331:legislation & jurisprudence*; D011640:Public Policy