A Review on Impact of General Data Protection Regulation on ClinicalStudies and Informed Consent

Abstract

To harmonise personal data protection laws throughout the Europe, the Data Protection Directive 95/46/EC has been repealed by the new European General Data Protection Regulation (GDPR) Reg. (EU) 2016/679. GDPR will allow the data protection of the considerable number of citizens of the European Union. In this way, the Regulation will effect also on clinical investigations, and specifically, on the information process to provide consent. This paper goes to elucidating the main changes derived by the GDPR and to giving practical information on how to deal with informed consent and assent documents in concurrence with the regulation. Special spotlights on paediatric research and secondary use have been provided.