Title: Regulating trust in pediatric clinical trials
Authors: Pinxten, Wim ×
Nys, Herman
Dierickx, Kris #
Issue Date: Jul-2008
Series Title: Medicine, health care, and philosophy vol:11 issue:4 pages:439-444
Abstract: The participation of minors in clinical trials is essential to provide safe and effective medical care to children. Because few drugs have been tested in children, pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In this article, we analyze how the enrollment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents. After a brief description of the problems associated with involving minors in clinical research, we consider how existing "relationships of trust" can be used as a place where the concerns of research subjects can be more fully discussed and addressed. Building on the tacit recognition of trust found in The European Clinical Trials Directive we make policy recommendations that allow for clearer, more ethically informed guidelines for enrolling minors in clinical research.
ISSN: 1386-7423
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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