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. 2020 May;28(5):609-626.
doi: 10.1038/s41431-019-0560-9. Epub 2019 Dec 16.

Dwarna: a blockchain solution for dynamic consent in biobanking

Nicholas Mamo  1 , Gillian M Martin  1   2   3 , Maria Desira  1 , Bridget Ellul  4 , Jean-Paul Ebejer  5
Affiliations

Dwarna: a blockchain solution for dynamic consent in biobanking

Nicholas Mamo et al. Eur J Hum Genet. 2020 May.

Abstract

Dynamic consent aims to empower research partners and facilitate active participation in the research process. Used within the context of biobanking, it gives individuals access to information and control to determine how and where their biospecimens and data should be used. We present Dwarna-a web portal for 'dynamic consent' that acts as a hub connecting the different stakeholders of the Malta Biobank: biobank managers, researchers, research partners, and the general public. The portal stores research partners' consent in a blockchain to create an immutable audit trail of research partners' consent changes. Dwarna's structure also presents a solution to the European Union's General Data Protection Regulation's right to erasure-a right that is seemingly incompatible with the blockchain model. Dwarna's transparent structure increases trustworthiness in the biobanking process by giving research partners more control over which research studies they participate in, by facilitating the withdrawal of consent and by making it possible to request that the biospecimen and associated data are destroyed.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1. The typical blockchain structure.
Figure adapted from Nakamoto [42].
Fig. 2
Fig. 2. The block structure.
a The calculation of the Merkle Root with pruned elements made transparent and b the block header after removing unnecessary data. Figure adapted from Nakamoto [42].
Fig. 3
Fig. 3. Dwarna’s data linkage.
A simplified model of the research partners’ data linkage in Dwarna.
Fig. 4
Fig. 4. Dwarna’s ERD.
An ERD that shows how Dwarna stores its data. Data about research partners, researchers, biobank managers, and studies are stored in the PostgreSQL database. Consent changes are stored in the blockchain.
Fig. 5
Fig. 5. The authentication and consenting workflow.
Research partners first authenticate themselves with Hyperledger Composer. Dwarna then issues identities for them if need be, saving the business network card in the off-chain database for later reuse. Research partners can then consent to research studies.
See this image and copyright information in PMC

Comment in

References

    1. Holub P, Kohlmayer F, Prasser F, Mayrhofer MT, Schlünder I, Martin GM, et al. Enhancing reuse of data and biological material in medical research: from FAIR to FAIR-health. Biopreserv Biobank. 2018;16:97–105. doi: 10.1089/bio.2017.0110. - DOI - PMC - PubMed
    1. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet. 2015;23:141–6. doi: 10.1038/ejhg.2014.71. - DOI - PMC - PubMed
    1. World Medical Association. WMA Declaration of Helsinki—ethical principles for medical research involving human subjects. In: 64th WMA General Assembly. 2013. - PubMed
    1. World Health Organization. Council for International Organizations of Medical Sciences. Commentary on Guideline 9. International ethical guidelines for health-related research involving humans. World Health Organization; 2016.
    1. European Union. Article 1—charter of fundamental rights of the European Union. OJ C 202. European Union; 2016. p. 389–405.

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