Regulatory policies in paediatric research: how harmonised are the ethical principles?

Abstract

Trials involving children generate considerable practical problems of a mainly ethical nature. While there is wide-ranging agreement on the basic ethical requisites for these trials, substantial--and even profound--differences remain between national and international regulatory policies. For the European Union Directive 2001/20/EC is the basic reference for national regulations regarding clinical trials. Article 4 of this Directive deals with trials on minors. The present article compares the regulations of this Article with four other documents regulating paediatric trials in Europe, the US and Japan. This comparison points to different approaches relating particularly to: risk acceptability, risk/benefit assessments, informed consent, assent of minors.