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. 2022 May 13:9:837197.
doi: 10.3389/fmed.2022.837197. eCollection 2022.

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

Ki Young Huh  1 , Sang-Un Jeong  2 , Seol Ju Moon  2 , Min-Ji Kim  2 , Wooseok Yang  3 , Myeonggyu Jeong  3 , Ildae Song  4 , Yong-Geun Kwak  2   5 , SeungHwan Lee  1 , Min-Gul Kim  2   5   6
Affiliations

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

Ki Young Huh et al. Front Med (Lausanne). .

Abstract

The recent advent of the dynamic consent concept intensified the data integrity issue in clinical trials. Incorporating blockchain technology into a dynamic consent platform can be a feasible solution. Due to various clinical trial settings, a demand-driven development strategy is required. We developed a blockchain-based dynamic consent platform named METORY tailored for clinical trials. The platform consisted of three parts: web and mobile application user interface, study management platform, and blockchain platform. Hyperledger Fabric, an enterprise-grade private blockchain framework, was used to integrate blockchain into the study consent platform. We conducted user acceptance tests and applied feedback to the improvement of the platform. Identity and role-based access control was constructed by combining mobile-application-based certificate system and access control functionalities in Hyperledger fabric. Data were encrypted using SHA-256 prior to transmission to blockchain server and TLS protocol was used for in-transit encryption. File-system level encryption was separated implemented within the security measures from Amazon RDS. Users' experience in the clinical trial was acceptable in the ease and usefulness of the platform.

Keywords: blockchain; clinical trials; dynamic consent; mobile application; platform.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Schematic representation of the development process.
Figure 2
Figure 2
Data flow and architecture of the platform.
Figure 3
Figure 3
Summary of the preliminary survey on the functions of the platform.
Figure 4
Figure 4
Web interface of the study and consent management: a dashboard for the study management (A), and the signed consent form where hash values were attached (B).
Figure 5
Figure 5
Mobile application interface of the consent process: participation in a study (A), access to the informed consent form (B), electronic signature (C), and chat-ting module between the subject and the investigator (D).
Figure 6
Figure 6
Integration of consent information into the blockchain platform: generation of a transaction (A) and appendage of the blocks (B).
See this image and copyright information in PMC

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