
More than 66,000 patients contribute their health data to the SMITH Consortium
The Medical Informatics Initiative’s broad patient consent enables large-scale, multi-site medical research
As of March 2025, a total of 66,228 patients at university hospitals in the SMITH Consortium have given consent for their health data to be used for research since 2018. This means that the number of consents has increased sixfold since July 2022. This success has been made possible by the continuous expansion of the technical infrastructure and the associated processes.
The Broad Consent of the Medical Informatics Initiative (MII) is the basis for the use of routine medical data. By signing the broad consent form, patients authorize the use of their data collected during routine medical care for research purposes. The research purpose is broadly defined because it is not clear at the time of consent what future questions the data will be used for. The unique feature of the broad consent is that it is standardized across the country, allowing for multi-site research regardless of state laws. It is valid for five years and can be revoked at any time.
Consent Working Group Optimizes Processes for Informed Consent
As legislation and requirements for informed consent are constantly changing, the Consent Working Group was established at the MII. The group looks at the current legal framework for the use of health data and develops processes for obtaining informed consent. The use of videos, for example, is intended to reduce the time needed to provide information, while an appealing visual design of consent documents aims to better inform patients. Due to the diverse use cases and partners of the MII, the pool of data that can be accessed for research is constantly growing. As a result, additional modules are being added to the consent process, for example to collect cardiovascular or mental health data.
Patients are comprehensively informed about the use of their data
To obtain consent, trained staff at participating MII hospitals approach patients and inform them about the use of their data. Shortly after admission, patients have the opportunity to learn about the MII and informed consent through flyers, posters, an educational film, and the patient website. In some cases, patients are provided with educational materials prior to their inpatient stay. Ensuring patient autonomy is key: patients can only give consent after they have been thoroughly informed. The project register in the German Portal for Medical Research Data (FDPG) also provides patients with an overview of the projects for which their data will be used.
Trust Centers Ensure Privacy-Compliant Processing of Health Data
As health data is particularly sensitive, it must be processed under strict conditions. To this end, independent trust centers were set up or trust services were established at the clinical SMITH sites located in Aachen, Bonn, Düsseldorf, Essen, Halle, Hamburg, Jena, and Leipzig. In these trust centers, patient data is processed in accordance with data protection regulations by replacing personally identifiable information with pseudonyms. In this way, researchers cannot draw any conclusions about the identity of the data providers. In case of revocation, only the trust center can re-establish the link between identity and research data and remove the corresponding data from the repertoire of the Data Integration Centers. For the electronic management of consents and revocations, the sites use the General Informed Consent Administration Service (gICs) of the University of Greifwald or, alternatively, technical procedures integrated into the clinical workstation.
Broad consent makes a decisive contribution to research Consent information is processed at participating sites’ Data Integration Centers so that it can be taken into account when researchers submit requests through the FDPG or for local research projects. This includes information on whether health data, health insurance data and/or biomaterial will be made available for research. By signing the Broad Consent, patients have the opportunity to make their own contribution to improving knowledge about their disease. Projects are currently underway in the areas of rare diseases, oncology and infectious diseases, among others.