Open consent, biobanking and data protection law

Can open consent be ‘informed’ under the forthcoming data protection regulation

Dados Bibliográficos

ID8248683
AutoresDara Hallinan (0000-0002-1160-821X, Fraunhofer Society, autor correspondente), Michaël Friedewald (0000-0001-8295-9634, Fraunhofer Society)
Ano2015
Volume11
Fascículo1
Data de publicação2015-12-01
Peer ReviewedSim
Open AccessSim
TipoARTICLE
PeriódicoLife Sciences Society and Policy (JOURNAL)
Identificadores do periódicoISSN: 2195-7819 • E-ISSN: 2195-7819
EditoraSpringer Science and Business Media LLC (PUBLISHER)
DOI10.1186/s40504-014-0020-9
PMID26085311
PMCIDPMC4480798
OpenAlexW2111260511
IdiomaEN
Citações recebidas18
Referências citadas18

This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly

Biobank · Bioinformatics · Biology · Business · Data Protection Act 1998 · Geography · Informed consent · Internet privacy · Political science · World Wide Web · Computer Science · Ethics in Clinical Research · Law · Medicine · Patient Dignity and Privacy · Privacy-Preserving Technologies in Data