From Broad Consent to Patient Engagement: A Framework for Consent Management and Study Oversight.

Abstract

Introduction: The German Medical Informatics Initiative (MII) promotes the use of routine clinical data for research, supported by the broad consent framework to ensure patient engagement. This work proposes a data management process and reference infrastructure to improve transparency by enabling patients to track their consent history and data use in research.

Methods: We analyzed the data provision process at the University Hospital Dresden (UKD) to identify roles and data flows relevant to secondary data use under broad consent. Established MII tools in use at UKD were evaluated for their suitability in enabling secure data access.

Results: We developed a structured data access process and implemented a reference infrastructure that lays the groundwork for a potential patient-facing application providing secure access to consent and study details.

Conclusion: The reference infrastructure demonstrates how existing MII tools can be repurposed to offer patient-centric transparency in secondary data use. Future work will address scalability, access control, and ethical considerations, such as patient expectations and the clarity of information.