swissethics publishes a new template of the patient information for the “Re-Consent”
In clinical trials, sometimes fundamental conditions change in the course of the study, for example when new safety data are available or it is clear that the participants are exposed to a (new) risk. In this case, an amendment is submitted to the ethics committee and the participants must be informed accordingly and give their consent in writing (so-called "re-consent").
For the first time, swissethics is publishing a template for re-consent in the form of a short form, which ensures that participants are informed about the main changes in a concise and comprehensible manner. The templates and the guidance documents are published in German, French and Italian.