Modernizing Informed Consent for Ubiquitous Personal Health Information Collection: A Blockchain Dynamic Informed Consent Platform for Public Health Research

Abstract

Public health research is increasingly dependent on ubiquitous collections of personal health information (PHI) and personal data drawn from wearable sensors, electronic records, and connected devices. Traditional informed-consent processes, often paper-based and one-time agreements, cannot meet the demands of real-time data flows, cross-institutional sharing, and evolving regulatory requirements. This thesis proposes and tests a novel approach to dynamic informed consent, grounded in data governance theory and implemented through tamper-evident ledger technologies. First, it develops an Inter-Organizational Data Governance (IODG) framework tailored for public health research. Using the Governance Analytical Framework, the thesis maps actors, social norms, and transaction types, and allocates decision rights and accountability to researchers, data custodians, regulators, and data subjects. The framework emphasizes personal data sovereignty and prescribes a phased implementation, with validation, endorsement, and machine-readable policies to make PHI sharing lawful, transparent, and auditable. Second, the thesis translates this framework into the Consentio platform (“I consent”, in Latin), a web-based dynamic consent platform. Governance clauses are decomposed into formal requirements and encoded as use cases, class and state diagrams; propositional logic invariants enforce legal states; Angular route guards and validators prevent unauthorized actions; and a permissioned ledger records immutable, cryptographically verifiable receipts for approvals, consent, and data-sharing events. Third, a mixed-methods user evaluation assesses the platform. Ten participants (five researchers and five data subjects) reported high usability (global PSSUQ mean = 1.82 on a 1–7 scale), moderate to high digital skills and strong satisfaction, yielding a favorable Net Promoter Score. A reflexive thematic analysis of interviews and open-ended feedback revealed eight themes: participants valued granular control and centralized dashboards but sought clearer explanations of revocation limits and ledger security; progressive disclosure balanced efficiency and comprehension; and researchers desired customization, improved notifications, and audit-ready reporting. The findings suggest that coupling principled governance, formal system design and ledger-backed auditability can modernize informed consent management for data-intensive public health research, enhancing trust, autonomy and regulatory compliance. Future work should extend the framework to more diverse populations, refine interface elements for error recovery and ledger explanation, and evaluate scalability and interoperability across varied research domains.