Under the Swiss Human Research Act (HRA), patients who agree to the further use of their data and samples for potential research projects need to give their written informed consent (referred to as general consent, or GC).
In order to establish a harmonised, nationwide basis for this type of informed consent, the Swiss Academy of Medical Sciences (SAMS) and the Swiss Association of Research Ethics Committees (swissethics) established a task force (supported by the SCTO) and published a general consent template for Switzerland in 2017. Based on experience with this template and in consultation with the SAMS, unimedsuisse (a Swiss association of university medicine) published a revised version in autumn 2018, which was prepared by a university hospital working group.
The third issue of our Regulatory Affairs Platform’s online journal RA Watch featured a deep dive article on general consent.