ByChristina Schüttler

Milestone accomplished: Go-ahead for Broad Consent

The Federal and State Data Protection Board has officially and unanimously accepted the version of the model text for broad consent and the associated documents provided by the NSG. This decision now enables medical research to obtain broad cnsent for the use of pseudonymised clinical data throughout Germany on the basis of the EU Basic Data Protection Regulation. This is an indispensable prerequisite, particularly with regard to future research projects whose issues have not yet been identified when patient consent is obtained.

In the next step, the model text will be coordinated in the university hospitals with the respective local ethics commissions so that it can be implemented promptly.

Further information can be found in the press release of the TMF and the press release of the Data Protection Board. The resolution is published online on the website of the Data Protection Board.