Scaling Electronic Consent for Research Integrated into Clinical Routine Processes

Collecting electronic consent for research within clinical routine processes remains challenging. How can an electronic consent app for research be designed and embedded into clinical routine processes so that it is simple to operate and does not add additional workload? This article describes the implementation and real-world deployment of an electronic consenting app by the Charité/BIH Trusted Third Party that has been in production use over multiple years. The app consumes REST endpoints for dynamic template rendering, participant search, and dual-signature submission, with a user interface optimized for older adults. Since 2021, the system has been used to collect 7177 consents across 68 templates on 66 devices used by 369 users, with low support demand and has supported 14 projects that derived usage permissions automatically from structured consent information. Our results indicate that scaling electronic consent is feasible when embedded in a comprehensive architecture that combines participant registration, pseudonymization and consent management.