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

Teodora Lalova, Anastassia Negrouk, Laurent Dollé, Sofie Bekaert (UGent) , Annelies Debucquoy, Jean-Jacques Derèze, Peggy Valcke, Els J. Kindt and Isabelle Huys
(2021) GDPR and biobanking : individual rights, public interest and research regulation across Europe. In Law, Governance and Technology Series 43. p.187-213
Author
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Abstract
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.

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MLA
Lalova, Teodora, et al. “An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules.” GDPR and Biobanking : Individual Rights, Public Interest and Research Regulation across Europe, edited by Santa Slokenberga et al., vol. 43, Springer, 2021, pp. 187–213, doi:10.1007/978-3-030-49388-2_10.
APA
Lalova, T., Negrouk, A., Dollé, L., Bekaert, S., Debucquoy, A., Derèze, J.-J., … Huys, I. (2021). An overview of Belgian legislation applicable to biobank research and its interplay with data protection rules. In S. Slokenberga, O. Tzortzatou, & J. Reichel (Eds.), GDPR and biobanking : individual rights, public interest and research regulation across Europe (Vol. 43, pp. 187–213). https://doi.org/10.1007/978-3-030-49388-2_10
Chicago author-date
Lalova, Teodora, Anastassia Negrouk, Laurent Dollé, Sofie Bekaert, Annelies Debucquoy, Jean-Jacques Derèze, Peggy Valcke, Els J. Kindt, and Isabelle Huys. 2021. “An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules.” In GDPR and Biobanking : Individual Rights, Public Interest and Research Regulation across Europe, edited by Santa Slokenberga, Olga Tzortzatou, and Jane Reichel, 43:187–213. Cham: Springer. https://doi.org/10.1007/978-3-030-49388-2_10.
Chicago author-date (all authors)
Lalova, Teodora, Anastassia Negrouk, Laurent Dollé, Sofie Bekaert, Annelies Debucquoy, Jean-Jacques Derèze, Peggy Valcke, Els J. Kindt, and Isabelle Huys. 2021. “An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules.” In GDPR and Biobanking : Individual Rights, Public Interest and Research Regulation across Europe, ed by. Santa Slokenberga, Olga Tzortzatou, and Jane Reichel, 43:187–213. Cham: Springer. doi:10.1007/978-3-030-49388-2_10.
Vancouver
1.
Lalova T, Negrouk A, Dollé L, Bekaert S, Debucquoy A, Derèze J-J, et al. An overview of Belgian legislation applicable to biobank research and its interplay with data protection rules. In: Slokenberga S, Tzortzatou O, Reichel J, editors. GDPR and biobanking : individual rights, public interest and research regulation across Europe. Cham: Springer; 2021. p. 187–213.
IEEE
[1]
T. Lalova et al., “An overview of Belgian legislation applicable to biobank research and its interplay with data protection rules,” in GDPR and biobanking : individual rights, public interest and research regulation across Europe, vol. 43, S. Slokenberga, O. Tzortzatou, and J. Reichel, Eds. Cham: Springer, 2021, pp. 187–213.
@incollection{8746771,
  abstract     = {{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.}},
  author       = {{Lalova, Teodora and Negrouk, Anastassia and Dollé, Laurent and Bekaert, Sofie and Debucquoy, Annelies and Derèze, Jean-Jacques and Valcke, Peggy and Kindt, Els J. and Huys, Isabelle}},
  booktitle    = {{GDPR and biobanking : individual rights, public interest and research regulation across Europe}},
  editor       = {{Slokenberga, Santa and Tzortzatou, Olga and Reichel, Jane}},
  isbn         = {{9783030493875}},
  issn         = {{2352-1902}},
  language     = {{eng}},
  pages        = {{187--213}},
  publisher    = {{Springer}},
  series       = {{Law, Governance and Technology Series}},
  title        = {{An overview of Belgian legislation applicable to biobank research and its interplay with data protection rules}},
  url          = {{http://doi.org/10.1007/978-3-030-49388-2_10}},
  volume       = {{43}},
  year         = {{2021}},
}
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