Analysing and optimising Informed Consent in cooperation with ethics committees and medical researchers
IgorMatic,GianniDe Nardi & FelixSteiner
ZHAW Zurich University of Applied Sciences
Abstract
Medical researchers are ethically and legally required to inform participants and get written permission before
enrolling them into a human research project (Informed Consent). Accordingly, information and consent represent a
complex procedure, and the participant concerned “must receive comprehensible oral and written information” (Swiss legislation:
Human Research Act (HRA) Art. 16). A triangle of stakeholders is involved in the procedure: ethics committees that review and
approve research projects and Informed Consent (IC) documents, medical researchers who produce the documents and
discuss enrolment with patients, and patients who have to be informed comprehensibly. From a linguistic point of view, the
question arises as to which perceptions of comprehensibility form the basis of the IC process and how shared language can be
established considering the complex relationship between these stakeholders. This contribution presents findings from two
perspectives (ethics committees and researchers) while considering the needs of all three stakeholders. Firstly, the
conceptualisation of comprehensibility among three ethic committees is presented, and steps toward harmonisation are outlined.
Secondly, limitations of how researchers conduct oral IC information are analysed, and the measures that were implemented to
improve patient information are discussed. A transdisciplinary approach is key in establishing these solutions because they do not
stem from linguistic analysis alone but have been developed in close collaboration with members of ethics committees and medical
researchers. Thus, the project 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.
Informed Consent (IC) is a central requirement for medical research with people: anyone who agrees to
participate in health-related research must have understood the purpose, risks and course of the study in question. The linguistic
bases for this understanding are the written documents and verbal interaction that should ultimately enable patients to make an
informed decision. Accordingly, the communicative prerequisite for this is a dialogue between experts (researchers) and laypersons
(patients), which, on the one hand, implies a sufficient transfer of knowledge and, on the other hand, aims to promote mutual
understanding. In addition, the IC process is overseen by ethics committees (ECs), which protect patients’ rights by reviewing
research proposals and determining whether they fulfil ethical standards (Enfield & Truwit,
2008). Therefore, the communicative triangle of ECs, researchers and patients, represents a form of multistakeholder
discourse.
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