Dynamic consent management for clinical trials via private blockchain technology

Abstract

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.

Blockchain and IoMT against Physical Abuse: Bullying in Schools as a Case Study

“…Similarly, ref. [43] developed SCoDES, a Hyperledger blockchain framework based on PoC to improve the procedures for managing patient consent, with confidentiality, to share their health data with clinicians. The collected data from the sensors is shared between medical platforms using appropriate software (e.g., React, REpresentational State Transfer (REST) Server, and Research Electronic Data Capture (REDCap)).…”

A Permissioned Blockchain Network for Security and Sharing of De-identified Tuberculosis Research Data in Brazil

“…23 Moreover, a consent management application for clinical trials has simplified data sharing for scientific research. 24 Yet, a method for managing digital rights to promote reuse of research data, leveraging smart contracts, was developed. 25 In Brazil, the São Paulo State Research Support Foundation (FAPESP) has been promoting discussions on the challenges and opportunities in the management of research data to promote solid guidance policies as an integral part of best practices.…”

“…In turn, ABE solutions deliver a strong method to provide confidentiality (over encryption) and access control for applications, based on user attributes. Existing blockchain solutions built to deal with research data usually focus on the management of patient consents, 24 data rights, 25 and access control. 23 Indeed, those are strong methods that can be used to protect data.…”

Ensuring protocol compliance and data transparency in clinical trials using Blockchain smart contracts

“…The study conducted in [28] implements a blockchain-based solution that enables patients and stakeholders to manage consent information in a manner that is transparent, immutable, traceable, and secure. Another study [29] has introduced a framework, which helps to deal with the dynamic nature of consent management. The authors in [30] proposed a blockchain-based framework that aims to enforce Institutional Review Board (IRB) regulations (i.e., subject recruitment, informed consent management, secondary data sharing, monitoring risks, and generating automated assessments for continuous review) on data collection.…”