Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Assent - differences in Europe and potential for harmonization

Julia Vogel (Abschlußjahr: 2016)

Summary
Language: English
Both globally and in the EU, thought has been given to the need and conditions for the 'assent' of a paediatric patient to participate in a clinical trial. Worldwide, EU-wide and nationally, there are laws and guidelines published by organisations and working-groups, which completely or partially address the subject 'clinical trials in children' involving requirements and recommendations for the 'Informed Consent'/'assent process'.
There is a disparity of opinions concerning basic aspects as the appropriate age to give 'assent' or an independent 'Informant Consent', the number of required signatures of the parents/legal representatives, the type of patient information and the method of the process.
To find out to what extent the 'assent-procedure' for participation in a paediatric clinical trial is standardised or harmonised and how big the need for optimisation is, a survey was conducted in four member states of the EU as a core part of this Master’s Thesis.
Pages: 58, Annexes: pages : 20