图书简介
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
Introduction.- Medical research and data protection in Europe. The emergence of general legal principles.- Part I Syllabus of the burning questions.- Anonymisation (Part I) ‘What is the state-of-the-art of anonymisation in data-driven health research and its role in the “European Health Data Space Regulation”?’.- Anonymisation - The trap for biobanking (Part II) ‘Why the anonymisation could be a trap for the biobanking activity? Can there really be anonymisation in the research biobanks?’.- Applying national law in cross-border research activity ‘Which national law should be applied in cross-border research activity in the local implementation of GDPR?’.- Archived tissue ‘What is the potential use for research under GDPR for archived tissue specimens obtained in a diagnostic or therapeutic pattern?’.- Blockchain and dynamic consent ‘Can the blockchain realise proper support for dynamic consent?’.- Brexit effects ‘What are the “Brexit effects” on the exchange of data and biological samples with the UK?’.- Broad consent ‘Do patients have to be informed about the concrete research projects for which their data and biosamples are to be used? Is so-called broad consent adequate?’.- Cloud ‘How is it possible to exchange research and personal data using the cloud without being a danger to patients?’.- Consent requirements ‘What are the terms and conditions of informed consent?’.- Consent and assent by children ‘Management of assent and consent by children. What should be done when they reach the appropriate age: Obligations and recommendations?’.- Consent
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