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GDPR Requirements for Biobanking Activities Across Europe

GDPR Requirements for Biobanking Activities Across Europe

  • 作者:
  • 出版商: Springer International
  • ISBN: 9783031429439
  • 出版时间 December 2023
  • 规格: Hardback
  • 适应领域: Switzerland ? 免责申明:
    Countri(es) stated herein are used as reference only
¥2,499.46
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  • 描述 
  • 大纲 
  • 详细

    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.

  • 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

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