With the advancement of molecular technologies, genetic research has made enormous progress over the last decade. To facilitate genetic research, the collection, integration and exploitation of data are prerequisite. Genetic data, however, providing information not only about the person herself but also about her family, parentage and ethnic decent, are regarded as both the most valuable and vulnerable data, worthy of protection by all and any means. On the other hand, clinical research makes it necessary to disclose and exchange genetic data. In order to resolve this dilemma ethical and legal requirements must be observed. To this end, this book provides for an in-depth overview of the respective requirements. In its legal part focus is laid on the European Data Protection Directive 95/46/EC and its impact on Trans-European Research Projects and other genetic research networks.
Nikolaus Forgo is professor of law at the University of Hannover and a specialist in the field of data protection and data security. Regine Kollek is professor for technology assessment in the field of biotechnology at the University of Hamburg, and author of numerous relevant publications. Dr Marian Arning, Dr Tina Kruegel and Dr Imme Petersen are research fellows at the Universities of Hannover and Hamburg.
List of abbreviations 1. Introduction 1.1. From clinical to clinico-genomic research: New ethical and legal challenges 1.2. The ACGT project: Developing an ICT infrastructure 1.3. Aim and structure of the book 2. Ethical requirements 2.1. Introduction 2.2. Informed consent 2.3. The right to know, the duty to inform, and the quality of feedback 2.4. Summary of consolidated ethical requirements 2.5. Outlook: Ethical challenges in the european context 3. Legal requirements 3.1. Introduction 3.2. Theoretical analysis 3.3 Data protection within a trans-european research project - using the example of ACGT 3.4. Data protection framework within genetic research networks 4. Legal conclusion 5. References 6. Appendix 1- legal terminology 7. Appendix 2 - relevant regulation