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Article published In: Developing shared languages: The fundamentals of mutual learning and problem solving in transdisciplinary collaboration
Edited by Marlies Whitehouse, Henrik Rahm and Séverine Wozniak
[AILA Review 34:1] 2021
► pp. 37–56

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Analysing and optimising Informed Consent in cooperation with ethics committees and medical researchers

 | ZHAW Zurich University of Applied Sciences
 | ZHAW Zurich University of Applied Sciences
 | ZHAW Zurich University of Applied Sciences
Published online: 9 September 2021
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https://doi.org/10.1075/aila.20007.mat
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.
Article outline
  • 1.Introduction
  • 2.Comprehensibility and Informed Consent: An introduction to the problem from a linguistic perspective
  • 3.Method: Transdisciplinary action research and semi-structured interviews with practitioners
  • 4.Results 1: The perspective of ECs
    • 4.1Review process
    • 4.2Comprehensibility criteria
  • 5.Results 2: The perspective of researchers
    • 5.1Thematic structure
    • 5.2Interactive organisation
  • 6.Practical solutions: Optimising comprehensibility in the Informed Consent process
    • 6.1Developing and implementing comprehensibility criteria for ECs and researchers
    • 6.2Combining oral and written information
  • 7.Conclusion
  • References
References (38)
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2025. Content and Readability of Informed Consent Documents Approved by Research Ethics Committees of Health Institutions in South-East Nigeria. Journal of Empirical Research on Human Research Ethics 20:3 ► pp. 97 ff. DOI logo
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2024. Improving Clinical Communication: a qualitative study on the Informed Consent. Revista de Lingüística y Lenguas Aplicadas 19 ► pp. 71 ff. DOI logo

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