Scaling Electronic Consent for Research Integrated into Clinical Routine Processes.

Area of Science:

• Health Informatics
• Clinical Research Management
• Digital Health

Background:

• Collecting informed consent for research within routine clinical processes presents significant challenges.
• Integrating digital consent solutions without increasing healthcare professional workload is a key objective.

Purpose of the Study:

• To describe the design, implementation, and real-world deployment of an electronic consenting application.
• To evaluate the feasibility and efficiency of embedding an electronic consent app into clinical routine processes.

Main Methods:

• Development and deployment of a secure electronic consent app utilizing REST endpoints for dynamic content and data submission.
• User interface optimization for diverse user groups, including older adults.
• Integration with existing clinical infrastructure for participant registration and pseudonymization.

Main Results:

• The system has successfully collected 7177 consents across 68 templates on 66 devices since 2021.
• Low support demand reported, with 369 users and 14 supported research projects.
• Automated derivation of usage permissions from structured consent data demonstrated.

Conclusions:

• Scaling electronic consent collection in clinical settings is achievable through comprehensive architectural integration.
• The developed system demonstrates a practical and efficient solution for managing electronic informed consent in research.
• Embedding digital consent tools within clinical workflows can be streamlined without adding significant burden.