Comprehensibility as an ethical dimension
The comprehensibility of the patient information and consent forms is a prerequisite for good, fair and correct information concerning participation in clinical trials and research projects. Unfortunately, not all such documents submitted to ethics committees fulfil this requirement to the desired and necessary extent. The research group of Prof. Felix Steiner at the ZHAW (Zürcher Hochschule für Angewandte Wissenschaften) has published numerous articles on the topic of comprehensibility of information documents in recent years. To facilitate implementation, an example-based guideline has now been developed in collaboration with Prof. Steiner and swissethics, which succinctly lists the essential aspects needed for a comprehensible information document: the information must be provided in a step-by-step, coherent and descriptive manner using simple words and layman-comprehensible sentences, as well as appropriate visualizations. The guide is currently available in German (link) and French (link). The Italian version will follow soon.