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Title: Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials
Authors: Pinxten, Wim ×
Dierickx, Kris
Nys, Herman #
Issue Date: Oct-2009
Publisher: Springer-Verlag
Series Title: European Journal of Pediatrics vol:168 issue:10 pages:1225-1234
Abstract: The involvement of minors in clinical research is
inevitable to catch up with the lack of drugs labeled for
pediatric use. To encourage the responsible conduct of
pediatric clinical trials in the EU, an extensive legal
framework has been developed over the past decade in
which the practical, ethical, legal, social, and commercial
issues in pediatric research are addressed. In this article, the
European legal framework surrounding pediatric clinical
trials is analyzed from the perspective of the major ethical
concerns in pediatric research. The four principles of
biomedical ethics will be used as a conceptual framework
(1) to map the ethical issues addressed in the European
legal framework, (2) to study how these issues are
commonly handled in competent adults, (3) to detect
workability problems of these paradigmatic approaches in
the specific setting of pediatric research, and (4) to illustrate
the strong urge to differentiate, specify, or adjust these
paradigmatic approaches to guarantee their successful
operation in pediatric research. In addition, a concise
comparative analysis of the European regulation will be
made. To conclude our analysis, we integrate our findings
in the existing ethical discussions on issues specific to
pediatric clinical research.
ISSN: 0340-6199
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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