On 15 April, a national standard text for patient consent was approved during the conference of independent German federal and state data protection supervisory authorities (Datenschutzkonferenz, DSK). All university hospitals involved in the Medical Informatics Initiative (MII) of the German Federal Ministry of Education and Research (BMBF) had previously agreed on the standard text. Approval of the standard consent documents means broad consent can now be obtained for the use of pseudonymised samples and clinical data across Germany in line with the European General Data Protection Regulation (GDPR). This is an important condition for diverse research projects aiming to optimise patient care and precision medicine through to the development of AI-based tools to support decision-making.
Various stakeholders from all across Germany, such as the biobanks working group of the Permanent Working Party of Research Ethics Committees in Germany (AK-EK), contributed their expertise to development and coordination of the text.
Concrete application of the text at the university hospitals will be coordinated with the local ethics committees in the near future and the standard text introduced promptly.
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