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GDPR Requirements for Biobanking Activities Across Europe

Edited by: Valentina Colcelli, Roberto Cippitani, Christoph Brochhausen-Delius, Rainer Arnold

ISBN13: 9783031429439
Published: December 2023
Publisher: Springer International
Country of Publication: Switzerland
Format: Hardback
Price: £199.99



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The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality.

Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.

Subjects:
Data Protection, Medical Law and Bioethics
Contents:
Introduction
Medical Research and Data Protection in Europe. The Emergence of General Legal Principles

Part I. Syllabus of the Burning Questions
Anonymisation (Part I)
Anonymisation: The Trap for Biobanking (Part II)
Applying National Law in Cross-Border Research Activity
Archived Tissue
Blockchain and Dynamic Consent
Brexit Effects
Broad Consent
Cloud
Consent Requirements
Consent and Assent by Children
Consent and Technology
Consent from Children and Vulnerable People
Consent Withdrawal
Covid-19
Dynamic Consent
Ethics Committees
Ethic and Biobanks
Ethical Principles and Legal Provisions
EU Legislation and Health Data Protection
Forensic Databases (Part I)
Forensic Databases (Part II)
Future Research
Genetic Data
Granularity
Imaging Biobank
Industry Perspective
Joint Controller Agreement
Legitimate Interests
Ownership of Human Biological Material
Paediatric Biobanks (General Overview)
Public Interest
Rare Diseases and Data Protection (Part I)
Rare Diseases and Legal, Ethical, Technical and Societal Needs (Part II)
Rare Paediatric Diseases
Residual Material
Retention Time: Conservation of Personal Data (Part I)
Retention Time: Conservation of Tissues (Part II)
Retrospective Research
Scientific Research and the Biomedical Sector. Requirements and Methods for Planning and Managing a “Data Protection by Design” Project
Secondary Use (Part I)
Secondary Use and Dual Use of Biomaterial Samples (Part II)
Transfer of the Personal Data for Research Purposes Towards Non-EU Countries
Users

Part II. Biobanking Legal and Ethical Requirements Across Europe: National Reports (in Alphabetic Order)
Towards Regulation for the European Health Data Research: A Comparative Analysis
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom

Part III. Conclusion
Conclusion