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Title: Legal Nature of Custodianship of Human Biological Material Stored in Biobanks
Authors: Verlinden, Michiel
Ectors, Nadine
Nys, Herman
Huys, Isabelle #
Issue Date: Oct-2012
Series Title: Biopreservation and Biobanking vol:10 issue:5 pages:A39-A39
Conference: ESBB & Spanish National Biobank Network Joint Conference location:Granada date:7-9 November 2012
Abstract: A comparative analysis of 90 access arrangements revealed several definitions of ‘custodianship’; the following common elements were found: (a) responsibility to safeguard (i) confidentiality, integrity and security of the collection and (ii) the interests of donors; (b) right to control use, access, transfer and/or disposal of HBM and associated data. These responsibilities and rights are determined by the purpose for which a biobank is set up and the terms stipulated in the consent form, unlike in the case of ‘ownership’, which is in principle unconditional. Access arrangements furthermore often do not clearly stipulate which person or institute holds custodianship.
The project investigates to which extent the nature of custodianship of HBM can be determined on the basis of existing legislation and whether it differs from custodianship of data as defined in data protection legislation. It furthermore looks into the relationship between custodianship and (intellectual) property rights/ownership rights and/or possession of HBM.
ISSN: 1947-5535
Publication status: published
KU Leuven publication type: IMa
Appears in Collections:Interfaculty Centre for Biomedial Ethics and Law
Translational Cell & Tissue Research
Research Centre for Pharmaceutical Care and Pharmaco-economics (-)
# (joint) last author

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