Publication type: Article in scientific journal
Type of review: Peer review (publication)
Title: Analysing and optimising Informed Consent in cooperation with ethics committees and medical researchers
Authors: Matic, Igor
De Nardi, Gianni
Steiner, Felix
et. al: No
DOI: 10.1075/aila.20007.mat
Published in: AILA Review
Volume(Issue): 34
Issue: 1
Page(s): 37
Pages to: 56
Issue Date: 2021
Publisher / Ed. Institution: John Benjamins
ISSN: 1461-0213
1570-5595
Language: English
Subjects: Comprehensibility; Shared language; Informed consent; Oral and written information; Transdisciplinary action research; Verständlichkeit; Fachkommunikation; Wissenstransfer; Gesundheitskommunikation; Health communication
Subject (DDC): 400: Language, linguistics
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.
URI: https://digitalcollection.zhaw.ch/handle/11475/23880
Fulltext version: Published version
License (according to publishing contract): Licence according to publishing contract
Departement: Applied Linguistics
Organisational Unit: Institute of Language Competence (ILC)
Published as part of the ZHAW project: Informed Consent in verständlicher Form
Aufklärung in verständlicher Form in der Humanforschung
Appears in collections:Publikationen Angewandte Linguistik

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