Clinical trials (CTs) are essential for the advancement of medical research, paving the way for the development and adoption of new treatments, and contributing to the evolution of healthcare. An essential factor for the success of a CT is the appropriate management of its participants and their personal data. According to the current regulations, collecting and using personal data from participants must comply with rigorous standards. Therefore, healthcare institutes need to obtain freely given, specific, informed, and unambiguous consent before being able to collect the data. Some of the major limitations of the current technological solutions are the lack of control over the granularity of consent grants, as well as the difficulty of handling dynamic changes of consent over time. In this paper, we present SCoDES, an approach for trusted and decentralized management of dynamic consent in clinical trials, based on blockchain technology (BCT). The usage of blockchain provides a set of features that allow maintaining consent information with trust guarantees while avoiding the need for a dedicated or centralized third trusted party. We provide a full implementation of SCoDES, made available as a self-contained infrastructure, with the possibility to interact with external services, and using hyperledger as a blockchain framework.
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A blockchain is permissioned if the identities of the users and rights to participate in the consensus (writing to the ledger and/or validating the transactions) are controlled by a membership service.
An EDC is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.
Hyperledger is an open-source collaborative effort created to advance cross-industry blockchain technologies. It is a global collaboration, hosted by The Linux Foundation, including leaders in finance, banking, Internet of Things, supply chains, manufacturing and Technology (IBM 2019).
A consensus algorithm defines the mechanisms ruling agreement among several peers about the correctness and security of a given transaction.
Business network refers to a blockchain application developed with hyperledger composer.
Every operation that needs to communicate with the blockchain network needs to be authenticated. To avoid redundancy, this step is omitted in the next descriptions.
For the purposes of the study, a custom definition of the trial has been used.
REDCap-Tools is a non-official organization that provides several interfaces and project using REDCap, helping developers to exploit REDCap’s advanced functions to their full potential (Burns et al. 2019).
Data coming from different platforms concerning the same user.
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The authors want to acknowledge the SCoDES project supporting this study.
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Albanese, G., Calbimonte, JP., Schumacher, M. et al. Dynamic consent management for clinical trials via private blockchain technology. J Ambient Intell Human Comput 11, 4909–4926 (2020). https://doi.org/10.1007/s12652-020-01761-1