Implementing informed consent in federated medical research: a blueprint designed to safeguard data subject rights in Germany

Background The establishment of the complementary infrastructures Medical Informatics Initiative (MII) and the Network of University Medicine (NUM) has significantly advanced the medical research landscape in Germany. While the MII is focused on the standardization and integration of university clinics routine data, NUM established a central infrastructure for clinical studies and data sharing, both focusing on the cross-institutional integration of health data as basis for strengthening medical research. Within the project NUM Routine Data Platform (NUM-RDP), a federated record linkage approach was implemented across 34 affiliated German university hospitals. Accordingly, a federated Trusted Third Party (fTTP) performed pseudonymisation and privacy-preserving record linkage across all participating sites. This work aims to extend the established fTTP approach to managing consent and withdrawal while bearing in mind the current legal frameworks and research initiatives for the use of health data. Methods A concept for an extended fTTP, termed ‘fTTP Consent,’ is proposed to bridge communication gaps between different sites, facilities and components. This allows for a central coordination for the implementation of patients' consent decisions regarding the storage, transfer and scientific use of their health data in a uniform manner. Results Two practical use cases for an ´fTTP Consent´ have been identified and conceptualized. Firstly, the cross-site improvement of workflows and automated processes to ensure that consent data is correct in formal, legal, semantic and syntactic terms. Secondly, the cross-site improvement of automated notification processes for new or updated consent data including respective withdrawal- and objection-processes. Conclusions The ‘fTTP Consent’ is designed to reduce communicatory and personnel efforts. It should ensure the correct and up-to-date realisation of data subject rights using the NUM-RDP as an example. The designed concept could help to overcome challenges in different consent-scenarios (opt-in, opt-out). Furthermore, it could streamline communication and data linkage processes between institutions and countries in future research projects.