title: Informed consent for paediatric clinical trials in Europe.
abstract: Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data.
  
  
  
  National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material.
  
  
  
  Consent and assent requirements are heterogeneous across these countries. We compiled our findings in 'The Informed Consent and Assent Tool Kit', a table including 27 national consent and assent requirements listed by individual country.
  
  
  
  Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe.
authors.affiliation: Finnish Investigators Network for Pediatric Medicines, Clinical Research Institute Helsinki University Central Hospital Ltd, Helsinki, Finland.|Tampere Center for Child Health Research, 33014 University of Tampere, Tampere, Finland.
authors.forename: Pirkko
authors.initials: P
authors.lastname: Lepola
authors.affiliation: The Hospital for Sick Children Research Institute, Toronto, Canada.
authors.forename: Allison
authors.initials: A
authors.lastname: Needham
authors.affiliation: PRA Health Sciences, Reading, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Mendum
authors.affiliation: RegulinX, Surbiton, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Sallabank
authors.affiliation: Department of Child, Adolescent and Developmental Neurology, University Children's Hospital/University Medical Centre Ljubljana, Ljubljana, Slovenia.
authors.forename: David
authors.initials: D
authors.lastname: Neubauer
authors.affiliation: Department of Pharmacology and Toxicology, Radboud University, Nijmegen, The Netherlands.
authors.forename: Saskia
authors.initials: S
authors.lastname: de Wildt
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D005060:Europe; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence
keywords: Ethics; clinical trials; informed consent of minors; paediatrics; regulations and guidelines