Latest changes to the ICF template for clinical trials


Following comments from various stakeholders and after careful evaluation, swissethics is publishing a new and revised version of the ICF template for clinical trials. The focus continues to be on the comprehensibility of the text for laypersons through a clear and simple choice of words, good structuring and visualization of the text.

With the entry into force of the revised Federal Act on Data Protection (FADP), the rights of participants in clinical trials or research projects have been strengthened. These rights are now included in the template. A gradation between coding and anonymization, the so-called risk of re-identification, has also been introduced. Further explanations have been added in the speech bubbles to help researchers create a document that is easy for participants to understand.