Introduction

This introduction presents an overview of the key concepts covered in the subsequent chapters of this book. The book provides reports on the implementation of Directive 95/46/EC on data protection that were prepared for the first workshop of the EC funded 5th Framework Programme concerted action project, 'Privacy in Medical Research and Law' (PRIVIREAL), which took place at the University of Sheffield. Protection of privacy of subjects in medical research depends as much on ethics review as on data protection law. PRIVIREAL brings together experts on relevant law and on ethics review of medical research from across all the European Union (EU) Member States and Norway, as well as the Newly Associated States (NAS), to evaluate the interaction between implementation of the Directive and research ethics review in protecting Directive rights of research subjects, with a view to making recommendations to the Commission about how to optimise protection provided by research ethics review.