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Ethical and Legal Requirements of Transnational Genetic Research

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Table of Contents

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

About the Author

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.


... a very helpful and thorough review of the ethical literature ...there is no doubt that the authors have addresses a set of questions that are pressing for the facilitation of transnational genetic research; their reflections on both the ethical and the legal issues take us deep into the difficulties of getting the regulatory environment right ...this is a particularly timely and valuable contribution to the literature. Roger Brownsword Law, Innovation and Technology July 2011 The book ... is remarkable in that it presents a complete technical and legal framework to enable researchers to build a European research infrastructure that promises further scientific advancement in the therapy or prevention of diseases. Readers will enjoy a detailed analysis of informed consent from an ethical and legal perspective, and furthermore an excellent compendium of legal analysis concerning genetic data protection in Europe. Policy-makers, professionals, and researchers who search for a complete and elaborated critical and legal framework for genetic research in (European) transnational constellations will certainly benefit from this volume. Hans Christian Wilms European Journal of International Law Volume 22, 2011

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