Broad Consent – comparison of approaches in the DACH region

DACH Symposium for Clinical Trials

As part of the DACH Symposium for Clinical Trials 2024 in Berlin, a session was dedicated to the topic of Broad Consent. Experts from Germany (D), Austria (A), and Switzerland (CH) shared insights into the legal and organizational frameworks in their respective countries. Johannes Drepper (TMF e.V.), Helmuth Haslacher (BBMRI.at, Medical University of Vienna, MedUni Wien Biobank), and Annette Magnin (Cantonal Ethics Commission Zurich) highlighted similarities and differences in their approaches.

Broad Consent & DACH region

Broad consent refers to the agreement by research study participants or patients to allow the use of their biological samples and data for future research projects whose specific details are not known at the time of consent. This type of consent is crucial for biobanks as it provides the flexibility to use samples and data for biomedical research under predefined ethical and legal conditions. Study participants/patients having signed a consent retain the right to withdraw their participation from a biobank at any time without giving reasons.

Legally, broad consent is based, among other frameworks, on the General Data Protection Regulation (GDPR) and corresponding national legislation. Initiatives in Germany (https://www.medizininformatik-initiative.de/de/mustertext-zur-patienteneinwilligung) and Switzerland (https://www.unimedsuisse.ch/de/projekte/generalkonsent) have already established harmonized documents for this consent process. In Austria, broad consents are issued at individual sites based on the Research Organization Act (Forschungsorganisationsgesetz, FOG). The potential for a national harmonization is currently being discussed by working groups within the Austrian biobank consortium BBMRI.at. For legal questions regarding Broad Consent, the Legal Helpdesk of BBMRI.at offers support and guidance (https://bbmri.at/home/legal-issues/).