Research Ethics Committees, Data Protection and Medical Research in European Countries

The Data Protection and Medical Research in Europe: PRIVIREAL series represents the results of this EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project. This volume relates to the second stage of this project and is concerned with the setting up and role of research ethics committees. It assesses their legal responsibilities, especially with regard to data protection matters and contains reports from more than 20 European countries on these issues. Focusing on the theoretical role and practical operation of research ethics committees and the impact of relevant international and national instruments, this volume will be an essential resource for all those concerned with data protection issues in medical research.

Autorentext

D. Beyleveld is Professor of Law, Sheffield Institute of Biotechnological Law and Ethics, Department of Law, University of Sheffield, UK, D. Townend is at the Maastricht University, The Netherlands and J. Wright is at the Sheffield Institute of Biotechnological Law and Ethics, Department of Law, University of Sheffield, UK.

Inhalt

Contents: Introduction, Deryck Beyleveld, David Townend and Jessica Wright; Research ethics committees in Austria, Peter Rehak; Belgian ethics committees and the protection of personal data, Guy Lebeer and Geneviève De Boeck; Research ethics committees in Bulgaria, Sylvia Tomova; Research ethics committees in the Czech Republic, Lukáš Prudil and Josef Kure; Research ethics committees in Denmark, Mary Rosenzweig and Lisbeth Knudsen; Research ethics in Estonia, Toomas Veidebaum; The general legal responsibility of research ethics committees in Finland, Lasse A. Lehtonen and Ritva Halila; The role of ethics committees in relation to French biomedical research: protection of the person and personal data, Brigitte Feuillet; Research ethics committees in Germany, Matthias Kettner; Research ethics committees in Greece, Tina Garanis-Papadatos and Dimitris Boukis; Research ethics committees in Hungary, Judit Sándor; Research ethics committees in Ireland, Deirdre Madden and Maeve McDonagh; Research ethics committees in Italy's legal system, Roberto Lattanzi; Research ethics committees in Latvia, Laima Rudze; Research ethics committees in Lithuania, Asta Cekanauskaite and Eugenijus Gefenas; Research ethics committees in Malta, Pierre Mallia; Medical research on human subjects and RECs in the Netherlands, Jessica Wright and Bert Gordijn; The Norwegian model for ethical review of medical research, Vigdis Kvalheim; Research ethics committees and personal data protection in Poland, Patrycja Bong-Polec and Pawel Luków; The constitution and operation of health ethics committees in Portugal: rights of patients to personal data protection, Helena Moniz, Sónia Fidalgo, Rafael Vale e Reis and Rosalvo Almeida; Bioethical review in Romania, Octavian Doaga; Research ethics committees in Slovakia, Jozef Glasa and Jane Miller; Research ethics committees in Slovenia, Joze Trontelj; Research ethics committees in Spain, Carlos Maria Romeo-Casabona and Pilar Nicolás; The Swedish system fo