In exchange and cooperation with data protection experts and representatives of the pharmaceutical industry, swissethics publishes a recommendation on the application (or non-application) and an addendum template to the patient information on the European General Data Protection Regulation (GDPR) within the framework of research in Switzerland. The document is available in German, French and Italian.

In recent months, a swissethics working group has drawn up proposals to show where the ethics commissions believe the Human Research Act (HRA) and the ordinances need to be revised. The final summary report, written in German, can be accessed under the following link. This document is aimed at all stakeholders who are involved in research involving human beings and at the legislator. The proposals are to be considered as a basis for the further dialogue.

Starting June 11, 2018, all notifications of safety events (SE/SAEs, SUSARs, DSUR/ASR, urgent safety notifications, other safety notifications) must be done exclusively through the new Safety Form. This also includes the submission of documents that contain information which reveals treatment assignment in a double-blind study. The submission of safety reports by email or through the main application form will no longer be accepted.

Please read the corresponding FAQ on how to use the new Safety Form before submitting any safety document. Failure to comply with the instructions may result in inspection findings.

The safety form is available under “submit an application / forms available”.

On 25.5.2018 the European Data Protection Regulation (GDPR) comes into force. swissethics has therefore updated the legal disclaimer (available in German and French).