title: Diversified harmony: supranational and domestic regulation of pediatric clinical trials in the European Union.
abstract: Over the past decades, considerable legislative effort has been made to facilitate and encourage clinical research in the European Union (EU). Hereby, specific attention has been paid to the urgent need to conduct research in minors. In this article, we will analyze the regulation that currently governs pediatric clinical research conduct at the supranational level of the EU and at the level of individual EU member states. Our analysis will focus on the way in which the national and supranational legal frameworks address five ethical issues that are specific to pediatric clinical research: (a) informed consent, (b) the necessity to conduct research in minor subjects, (c) the interests of the subject concerned, (d) the risks and burdens involved, and (e) the pediatric expertise of protocol review committees. We conclude by discussing the harmonization and diversification of the legal requirements that govern pediatric clinical research in the EU.
authors.affiliation: Centre for Biomédical Ethics and Law, K U Leuven, 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: D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards* / Q000639:trends; D003299:Cooperative Behavior; D005060:Europe; D005062:European Union; D006801:Humans; D007878:Legislation as Topic / Q000639:trends*; D010372:Pediatrics / Q000592:standards*