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

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.

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

“…Data were encrypted during transfer between investigators and participants. Subjects were identified by a mobile authentication system integrated in the electronic consent system 19 . Subjects were instructed for the study procedures by the delegated investigators via the teleconference system.…”

“…Subjects were identified by a mobile authentication system integrated in the electronic consent system. 19 Subjects were instructed for the study procedures by the delegated investigators via the teleconference system. After subjects agreed to participate in the study, subjects electronically signed the informed consent form, and the signed copy was recorded onto the blockchain platform.…”

“…12 In a previous study, we developed a blockchain-based electronic consent application named METORY and evaluated the application in a DCT scenario. 15,19 We integrated an electronic diary module into METORY to manage DCT procedures in a single application. The application can keep logs for the study procedures, and investigators can analyze the adherence to study procedures with the log.…”

“…In a previous study, we developed a blockchain‐based electronic consent application named METORY and evaluated the application in a DCT scenario 15,19 . We integrated an electronic diary module into METORY to manage DCT procedures in a single application.…”

Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review

“…The decentralized nature of blockchain ensures that these records cannot be altered by a single party, safeguarding the integrity of the participant’s documented consent independent of any 1 system or device. Moreover, blockchain offers means for mathematical and privacy-preserving verification of (consent) records and associated user identities, with no dependence on trusted intermediaries for reliable recordkeeping [ 10 ]. Such can be used for decentralized authentication and authorization, bolstering individual autonomy.…”