The challenge:

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Detailed consent provided by a patient or clinical study participant plays a decisive role in determining how personal health data can be used for future research. For the consistent use of data for medical research across Germany, it is critical to ensure essential elements of patient information and consent forms are standardised. Not all future research goals are known at the time the data are captured. It is therefore necessary to describe potential future use of data for research and healthcare in very general terms when a patient/participant declares consent (broad consent). German legislation governing data protection and hospital activities varies from state to state in terms of what research can be conducted using patient-care data without explicit consent. Similarly, there is no consensus among state oversight agencies with regard to how broad consent should be worded.

Achievements to date:

All participating university hospitals have agreed on a strictly consent-based approach: while in hospital, the patient is asked to consent to future use of clinical data on the basis of clearly expressed information. They have agreed on a standardised template text for both patient information and consent. This includes identical consent options for patients, enabling data to be used consistently across sites and consortia at a later date. The expertise of recognized actors and organizations throughout Germany, such as the Biobanks Working Group of the Medical Ethics Committee and the Data Protection Working Group of the TMF, has been incorporated into the development and coordination of the template text. The Conference of Independent Data Protection Commissioners of the Federal Government and the German federal states gave their approval to the template text on 15 April 2020. Established dialogue procedures between the relevant working groups and the TMF - Technology and Methods Platform for Networked Medical Research e.V. as an association of scientific experts were used for coordination with the data protection authorities of the federal states.

Current documents:

 Download: Template text (English)
       version 1.6d (10/11/2020) [PDF | 445 kb]

 Download: Template text (German)
       version 1.6d (16/04/2020) [PDF | 445 kb]

Download: Template text (Turkish)
       version 1.6d (21/01/2021) [PDF | 445 kb]

Download: Guide to the Use of Nationally Harmonised Patient Information and Consent Documents for the Secondary Use of Patient Data (English)
     version 0.9d (10/11/2020) [PDF | 354 kb]

Download: Handreichung zur Anwendung der national harmonisierten Patienteninformations- und Einwilligungsdokumente zur Sekundärnutzung von Patientendaten (German)
      version 0.9d (16/04/2020) [PDF | 354 kb]

Other versions of the consent form:

Download: Template text with additional module for NUM-CODEX (German)
       version 1.6f (03/08/2021) [PDF | 379 kb]

Explanatory film for patients:

Extern gehostetes Video URL

More information:

Download: Begründung für eine krankheitsübergreifende Zweckbestimmung in den Einwilligungserklärungen der Medizininformatik-Initiative" (German)
      (21/09/2018) [PDF | 324 kb]

Download: Stellungnahme der AG Consent der Medizininformatik-Initiative zur Eigentumsübertragung bei Biomaterial und Drittlandsübermittlungen (German)
      (26/08/2019) [PDF | 378 kb]

Download: Stellungnahme der AG Consent der Medizininformatik-Initiative zu
patientenindividueller Datennutzungstransparenz und Dynamic Consent (German)

      (28/03/2019) [PDF | 345 kb]