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

Area of Science:

• Medical Informatics
• Health Data Management
• Patient Engagement in Research

Background:

• The German Medical Informatics Initiative (MII) supports research using routine clinical data.
• Broad consent frameworks are utilized to engage patients in research.
• Current systems lack transparency in patient consent and data use for research.

Purpose of the Study:

• To propose a data management process and reference infrastructure.
• To improve transparency for patients regarding their consent history and data use in research.
• To enable patients to track their involvement in research studies.

Main Methods:

• Analysis of the data provision process at University Hospital Dresden (UKD).
• Identification of roles and data flows for secondary data use under broad consent.
• Evaluation of existing MII tools for secure data access capabilities.

Main Results:

• Development of a structured data access process.
• Implementation of a reference infrastructure for patient-facing applications.
• Foundation laid for secure patient access to consent and study details.

Conclusions:

• Existing MII tools can be repurposed for patient-centric transparency in secondary data use.
• The developed infrastructure supports patient tracking of consent and data.
• Future work will focus on scalability, access control, and ethical considerations.