Innovation in patient care and breakthroughs in medical research would be unthinkable without the data of our patients and test subjects. As TUM Medicine and Biobank, we treat this particularly sensitive data (Art. 9 GDPR) with the utmost care in order to maintain the trust placed in us.

The potential of personal health data for future research approaches depends significantly on the explicit consent of those affected. Therefore, it is critical to make essential aspects of patient information and consent uniform to provide the basis for uniform use of data across the country. Because not all medical questions that will be answered with these data in the future are known at the time of consent, it is necessary to formulate the purpose of data use within medical research and care in a broad way ("broad consent"). Regarding the conditions under which consent-free research based on patient data from hospital care is allowed, there are different regulations in the state data protection and state hospital laws. The wording of "broad consent" is also interpreted differently by state regulators.

All University Medicine sites have developed a procedure in a joint initiative that is completely based on patient consent. Under this procedure, patients are provided with detailed information during their hospital stay. Subsequently, they are asked for their consent to further use of their clinical data. A key aspect of this process is the model text that all sites have agreed upon for the information material and consent form. This model text ensures equal options for all patients and enables consistent reuse of data across all sites and within all consortia.

This model text was not created single-handedly. Rather, the expertise of various experts at the federal level was incorporated into its development, including the Biobanks Working Group of the Working Group of Medical Ethics Committees and the Data Protection Working Group of the TMF.

This collaborative approach has borne fruit: on April 15, 2020, the Conference of Independent Data Protection Commissioners of the Federal Government and the Länder gave their approval to the model text. In addition, established dialog procedures were used to coordinate with the data protection authorities of the federal states. These procedures were carried out in collaboration with the respective working groups and the TMF, an association of scientific experts. This is a significant step for the consistency and quality of data use in the field of health research.

On September 14, 2022, the board of directors of the Klinikum rechts der Isar (AöR) decided to use the MII's "Broad Consent" (version 1.6d) facility-wide at the TUM Medicine site.

For us, it is a special obligation to ensure the safety and trust of our patients!