A research team with senior author Jean-Paul Ebejer from the Centre for Molecular Medicine and Biobanking at the University of Malta has created a blockchain solution for dynamic consent in biobanking called Dwarna. They published their solution in the European Journal of Human Genetics.
The researchers used the non-cryptocurrency based blockchain Hyperledger as a platform in their software, which also includes WordPress and PostgreSQL databases. Hyperledger is an open source collaborative platform created to advance cross-industry blockchain technologies. Hosted by The Linux Foundation, the global collaboration includes leaders in finance, banking, internet of things (IoT), supply chains, manufacturing and technology.
Dwarna was built using Hyperledger Composer, an extensive, open development toolset and framework that supports the existing Hyperledger Fabric blockchain. Hyperledger Fabric is a codebase combining work by Digital Asset, libconsensus from Blockstream and OpenBlockchain from IBM; and Hyperledger Sawtooth, developed at Intel’s incubation group. The Hyperledger Composer project is now in deprecated status, which means it is no longer actively maintained and Hyperledger Fabric v1.4+ is recommended instead.
Dynamic consent aims to give individuals an opportunity to be better informed about their consent choices and the ongoing research process in general, and to grant control over how their biospecimens and data are used. Dynamic consent allows research participants to access a record of their consent decisions. Participants can revisit previous decisions and alter their decision. In other words, if the participant signed a paper consent form at the start of the process, this is not the final word on their consent status. They can update or revoke their consent at any time. Dwarna provides this functionality.
Blockchain is essentially a fully up-to-date record of transactions between two peers (individuals or organizations) that due to its digital design is highly secure, making it apparently impossible for non-authenticated individuals to alter the ledger.
Dwarna is a perfect medium for maintaining consent as the participant can alter their status securely, and the researchers have a highly accurate timeline of consent, so there is no doubt as to the consent status of biobank samples. The always up-to-date consent status is also amenable to piping into LIMS systems so that samples can be immediately blacklisted if a research participant withdraws their consent. Dwarna’s entire implementation is available on GitHub under the GNU General Public License v3.0.
“Trust in the biobanking process is contingent on how the web portal stores its data. Dwarna’s data are notably separated in three different databases—consent data in the blockchain, user and study information in the off-chain PostgreSQL database, and login information in WordPress’ database. Dwarna adopts data minimization best practices and stores only the necessary consent-related information.” – The authors wrote
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