CONSENT: A Software Architecture for Dynamic and Secure Consent Management

Current research in consent management techniques focuses on isolated aspects of data security, privacy, or auditability, but important issues like (i) dynamically integrating regulatory updates into form generation, (ii) support in content generation with verifiable audit trails, and (iii) tools that make compliance reasoning transparent for non-legal users are not yet addressed. This paper introduces CONSENT, an architecture that integrates AI-based consent reasoning using Large Language Models (LLMs) for automated consent-form drafting and compliance evaluation, alongside blockchain technology for secure and auditable storage. The architecture builds on prior work to address the aforementioned issues by introducing three supporting mechanisms: (a) Specialized AI models coordinated through expert routing which coordinate subtasks such as automation in form generation and regulatory compliance, (b) Retrieval-Augmented Generation (RAG) that supports the integration of regulatory updates into forms, and (c) Explainable AI (XAI) for the reasoning behind form content and compliance assessments. CONSENT architecture is evaluated through 250 test cases and a pilot case study for clinical trial consent management involving 20 engineers and attorneys, who evaluated the prototype on form quality (i.e., coherence, conciseness, factuality, fluency, and relevance) as well as time and effort efficiency. Results show that CONSENT substantially reduces the manual effort in consent-form creation while providing transparent, audit-ready compliance assessments, highlighting its potential for dynamic, user-centric consent management.