Research with Minors in Greece and the EU Directive on Clinical Trials

Abstract

This article describes the legal rules for research with minors in Greece in relation to the EU Directive on clinical trials and the Greek Code of Medical Ethics.

Ethical key issues and fundamental rights in paediatric research

“…With reference to acceptable risk and burden for children involved in clinical research, Greece, Ireland, Italy, and Belgium would seem to follow the more liberal Directive (requiring "minimising" risk and burden, also if there is only group benefit). The Netherlands, France and Finland seem to follow the stricter Additional Protocol on Biomedical research [22], that requires minimal risk and burden if there is only group benefit [33,[46][47][48][49][50].…”