The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe
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The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe

By Katharina Beier
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Book Description

Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project (“Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis”) to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project’s results.

Table of Contents
  • Tiss_eu_book .pdf
    • Titelei
    • Contents
    • Introduction
    • First International Status Conference of the Tiss.EU Project, Göttingen
      • Ethical and Legal Aspects of Research with Human Tissue in Europe (Katharina Beier)
    • First International Workshop in Hannover
      • Rights and Entitlements in Human Tissue and Cells (Katharina Beier)
    • Second International Workshop in Budapest
      • Anonymisation and Pseudonymisation as Means of Privacy Protection (Petra Bárd, Judit Sándor)
    • Third International Workshop in Paris
      • Biobanks for Research Purposes (Christine Noiville, Florence Bellivier, Virginie Commin)
    • Second International Status Conference of the Tiss.EU Project, Göttingen
      • Privacy, Confidentiality and Personality Rights in Biobanking and Genetic Research with Human Tissue (Katharina Beier)
    • Fourth International Workshop of the Tiss.EU Project, Padua
      • Procurement, Storage and Transfer of Tissues and Cells for Non-Clinical Purposes in a Legal and Ethical Perspective (Alessandra Bernardi, Luciana Caenazzo, Renzo Pegoraro)
    • Fifth International Workshop of the Tiss.EU Project, Leiden
      • Rights and Entitlements in Human Tissue andCells: the BENELUX Countries (Jasper A. Bovenberg)
    • Sixth International Workshop of the Tiss.EU Project, Stockholm
      • Anonymisation and Pseudonymisation as a Meansof Privacy Protection (Claudio Tamburrini)
    • Seventh International Workshop of the Tiss.EU Project, Dublin
      • The Transfer, Storage and Procurement of HumanCells and Tissues (Elizabeth Yuko, Bert Gordijn)
    • Eighth International Workshop of the Tiss.EU Project, Birmingham
      • Biobanking: Ethics, Governance, and Regulation (Sean Cordell)
    • Ninth International Workshop of the Tiss.EU Project, Vilnius
      • Procurement, Storage and Transfer of Tissues and Cells for Non-Clinical Research Purposes (Vilius Dranseika, Eugenijus Gefenas)
    • Final International Status Conference of the Tiss.EU Project, Göttingen
      • The Future of Biobanking in Europe: Searching for Answers to the Ethical and Legal Challenges of Human Tissue Research (Katharina Beier, Silvia Schnorrer)
    • Conclusions
    • Contributors
    • Backpage
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