Comprehensibility as an ethical dimension
The new template for the patient information for clinical trials is based on linguistic criteria for comprehensibility and at the same time meets the regulatory and legal requirements. It was developed and elaborated by swissethics (working group with consultation of all ethics committees) in collaboration with Prof. Dr. Felix Steiner and his team (previously at the ‘Zurich University of Applied Sciences’, ZHAW). Prof. Steiner was mandated by the FOPH to carry out a systematic analysis of information documents to assess their comprehensibility. As of now, the use of the new template is obligatory for clinical trials submitted to the ethics committees. In a transitional period until 31.03.2023, the old template is also still accepted.