Informed Consent and Comprehensibility Issues Research involving humans as subjects can be problematic from an ethical standpoint, because people’s welfare and personal sphere should be protected. For this reason, legislation regulates that potential participants must be informed about research procedures and any risks associated with them. The Swiss Federal Act on Research involving Human Beings (Human Research Act) stipulates that study participants must provide their informed consent on the basis of comprehensible oral and written information. A team from the ZHAW School of Applied Linguistics is carrying out a project about issues surrounding informed consent on behalf of the Federal Office of Public Health (FOPH). In view of the revision of the Human Research Act, the FOPH is interested in knowing exactly what “comprehensible information” means for potential study participants from a linguistic perspective. In the first project phase, the ZHAW team consolidated the most important findings from the research literature and proposed a comprehensibility model for informed consent. A corpus of written patient information texts was analysed and comprehensibility issues identified by applying this model. In the second phase of the project, the ZHAW team is focusing on three aspects of comprehensibility issues:
1. The influence of regulatory authorities on patient information with a view to deriving good-practice recommendations.
2. The comprehensibility of the consent form for biobanks (“general consent”)
3. The combination of oral and written modalities for obtaining informed consent with respect to various participant profiles. An integral part of the evaluation of the HRA, the informed consent project deploys a wide range of methods from the discipline of applied linguistics to determine effective ways to present information in comprehensible form to potential research participants.