General consent

SAMS » Ethics » Topics A–Z » General consent

In recent decades, medical research has led to major advances in prevention and care. For this research, patient samples and data are indispensable. The SAMS has been seeking for many years to ensure that an ethically sound framework exists for the use of sensitive information.

In 2006, the SAMS issued medical-ethical guidelines and recommendations on the subject of biobanks. These focused on the collection, storage and use of human biological material for education and research. The guidelines stated that consent obtained from the donors of biological material «can generally also cover the further use of samples and data for future research projects», but conditions were stipulated for such «general consent». In 2010, based on these guidelines, templates were published for general consent (information and consent) and for biobank regulations. These documents were prepared by a joint working group of the Biobank Suisse (BBS) foundation and the SAMS.

 

Since 2014, medical research in Switzerland has been comprehensively regulated by the Human Research Act (HRA). The SAMS «Biobanks» guidelines have therefore been withdrawn, although they remain available in the Archive. The HRA incorporates the concept of general consent, which is permissible under certain conditions. In order to establish a harmonised Swiss‑wide basis for this type of informed consent, the SAMS and the association of Swiss Ethics Committees on research involving humans (swissethics) published a Swiss general consent template in 2017. On the basis of experience with this template and in consultation with the SAMS, the Swiss University Medicine Association (unimedsuisse) published a revised version, prepared by a university hospital working group, in autumn 2018. While this joint template marks a significant milestone, it still falls short of the ideal of a harmonised Swiss-wide version.

 

The document is available in English, French, German and Italian on the unimedsuisse website.

 

Publications

The opportunities and challenges associated with the Swiss general consent template were discussed in detail in the 3/2016 issue of the SAMS Bulletin (available in PDF format in French / German).

 

Fundamental reflections on responsible data sharing can be found in the 4/2018 issue of the SAMS Bulletin (available in PDF format in French / German).

 

 

 

CONTACT

lic. iur. Michelle Salathé
Head Department Ethics