ClinConNet: A Blockchain-based Dynamic Consent Management Platform for Clinical Research

TL;DR

ClinConNet tackles the problem of clinician-centric and siloed consent management by proposing a participant-centric platform that combines Self-Sovereign Identity (SSI), dynamic consent, and a consortium blockchain to securely manage consent proofs. The approach enables dynamic, revocable consent via smart contracts, with unlinkability between participants, projects, and organizations and adherence to the Right to Be Forgotten (RTBF). The authors implement a proof-of-concept using Hyperledger Fabric, an SSI wallet, and a web portal, achieving end-to-end consent establishment times around $170$–$200$ ms and write/read throughputs reaching approximately $250$–$320$ TPS, while keeping cryptographic operations under a few milliseconds. This work demonstrates the feasibility of real-time, private, and auditable dynamic consent in clinical research, with strong regulatory alignment and potential applicability to European initiatives like the European Health Data Space and European Digital Identity Wallet.

Abstract

Consent is an ethical cornerstone of clinical research and healthcare in general. Although the ethical principles of consent - providing information, ensuring comprehension, and ensuring voluntariness - are well-defined, the technological infrastructure remains outdated. Clinicians are responsible for obtaining informed consent from research subjects or patients, and for managing it before, during, and after clinical trials or care, which is a burden for them. The voluntary nature of participating in clinical research or undergoing medical treatment implies the need for a participant-centric consent management system. However, this is not reflected in most established systems. Not only do most healthcare information systems not follow a user-centric model, but they also create data silos, which significantly reduce the mobility of patient data between different healthcare institutions and impact personalized medicine. Furthermore, consent management tools are outdated. We propose ClinConNet (Clinical Consent Network), a platform that connects researchers and participants based on clinical research projects. ClinConNet is powered by a dynamic consent model based on blockchain and take advantage of dynamic consent interfaces, as well as blockchain and Self-Sovereign Identity systems. ClinConNet is user-centric and provides important privacy features for patients, such as unlinkability, confidentiality, and ownership of identity data. It is also compatible with the right to be forgotten, as defined in many personal data protection regulations, such as the GDPR. We provide a detailed privacy and security analysis in an adversarial model, as well as a Proof of Concept implementation with detailed performance measures that demonstrate the feasibility of our blockchain-based consent management system with a median end-to-end consent establishment time of under 200ms and a throughput of 250TPS.

Figures (8)

• Figure 1: Overview of ClinConNet system model.
• Figure 2: One-to-many relationships between actors, identifiers, consents and projects.
• Figure 3: Sequence diagram - Participant onboarding and login on ClinConNet.
• Figure 4: Sequence diagram - Establishing a mutually authenticated connection between the wallets of a participant and a research organization.
• Figure 5: Data flows and artifacts - the end-to-end process of formulating consent.