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Human Tissue ResearchA European perspective on the ethical and legal challenges$
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Christian Lenk, Nils Hoppe, Katharina Beier, and Claudia Wiesemann

Print publication date: 2011

Print ISBN-13: 9780199587551

Published to Oxford Scholarship Online: May 2011

DOI: 10.1093/acprof:oso/9780199587551.001.0001

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How to achieve ‘free movement of tissue’ in the EU research area 1

How to achieve ‘free movement of tissue’ in the EU research area 1

(p.127) Chapter 13 How to achieve ‘free movement of tissue’ in the EU research area1
Human Tissue Research

Jasper Bovenberg

Oxford University Press

In accordance with Garwood-Gowers' observation of governments' interests in human tissue research, this chapter explores the shipment of tissue samples and data between countries as it is promoted by the establishment of the European Research Area (ERA). Whilst biobank-related research brings new opportunities for Europe and the world, at the same time it raises the question of Europe's ability to sustain a competitive edge in knowledge and innovation. One factor affecting Europe's ability to sustain its edge in biomedical research are the legal and regulatory challenges to the shipment of biological samples across the borders of its member states. While sample shipment has become an industry of its own, the legality of sending a sample of human origin from, let's say, the Dutch pathology archives, to a (public) research institute in Sevilla, Spain, is fraught with uncertainty for EU scientists and their institutions. This chapter addresses the legal challenges of tissue transfer by taking into account the different concerns of stakeholders and donors, but also concerns couched at institutional or national levels. It suggests a way to overcome these concerns. In particular, it suggests meeting the donors' concerns by informed consent procedures and institutional concerns by a special sample transfer policy. In response to national concerns, export controls are recommended.

Keywords:   sample, shipment, contractual clauses, EU, free movement, research area, biomedical research, safeguards, material transfer policy

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