Analysing and optimising Informed Consent in cooperation with practitioners

Researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project (Informed Consent). In Switzerland, this is regulated by the Human Research Act (HRA) and supervised by cantonal ethics committees. Information and consent represent a complex procedure, and the participant concerned "must receive comprehensible oral and written information" (HRA, Art. 16).

Using a mixed methods approach, we examine comprehensibility on various linguistic levels and identifiy obstacles to comprehension in the Informed Consent process. In order to integrate research-based and practice-based knowledge, we cooperated with different groups of practitioners (ethics committees, researchers, and participants):

• Analysis of research literature on Informed Consent, development of a linguistic model and corpus analysis of information documents;
• Usability testing of information documents to identify obstacles to comprehension;
• Focus groups with ethics committees to identify their views on comprehension, and to understand their reviewing process;
• Interviews with researchers in order to identify their views on comprehension, and to understand their information processes.

Based on the results, the follow-up project aims to optimise the Informed Consent process on various levels. Here, too, we are working with different groups of practitioners:

• Revision of template: addition of agenda items to information documents to combine and interlink oral and written information;
• Interactive glossary based on quantitative data;
• Workshop with ethics committees to optimise supervisory processes.

The projects shows how the expertise of applied linguistics in cooperation with practitioners can deliver an important impact in both academic analysis and optimisation of professional procedures. Ultimately, this contributes to researchers/theory and practitioners/application.