An overview of Belgian legislation applicable to biobank research and its interplay with data protection rules

This contribution aims to present in a clear and concise manner the intricate legal framework for biobank research in Belgium. In Part 1, we describe the Belgian biobank infrastructure, with a focus on the concept of biobank. In Part 2, we provide an overview of the applicable legal framework, namely the Act of 19 December 2008 on Human Body Material (HBM), and its amendments. Attention is given to an essential piece of self-regulation, namely the Compendium on biobanks issued by the Federal Agency on Medicine Products and Health (FAMPH). Furthermore, we delineate the interplay with relevant d... Mehr ...

Verfasser: Lalova, Teodora
Negrouk, Anastassia
Dollé, Laurent
Bekaert, Sofie
Debucquoy, Annelies
Derèze, Jean-Jacques
Valcke, Peggy
Kindt, Els J.
Huys, Isabelle
Dokumenttyp: bookChapter
Erscheinungsdatum: 2021
Verlag/Hrsg.: Springer
Schlagwörter: Law and Political Science / Medicine and Health Sciences
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-28879276
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://biblio.ugent.be/publication/8746771

This contribution aims to present in a clear and concise manner the intricate legal framework for biobank research in Belgium. In Part 1, we describe the Belgian biobank infrastructure, with a focus on the concept of biobank. In Part 2, we provide an overview of the applicable legal framework, namely the Act of 19 December 2008 on Human Body Material (HBM), and its amendments. Attention is given to an essential piece of self-regulation, namely the Compendium on biobanks issued by the Federal Agency on Medicine Products and Health (FAMPH). Furthermore, we delineate the interplay with relevant data protection rules. Part 3 is dedicated to the main research oversight bodies in the field of biobanking. In Part 4, we provides several examples of the ‘law in context’. In particular, we discuss issues pertaining to presumed consent, processing of personal data associated with HBM, and information provided to the donor of HBM. Finally, Part 5 and 6 addresses the impact of the EU General Data Protection Regulation (GDPR), suggests lines for further research, and outline the future possibilities for biobanking in Belgium.