Volume 34, Issue 1
  • ISSN 1461-0213
  • E-ISSN: 1570-5595
Buy:$35.00 + Taxes



Medical researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project (). 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 (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 metrics loading...

Loading full text...

Full text loading...


  1. Appelbaum, P. S.
    (2010) Understanding “understanding”: An important step toward improving informed consent to research. AJOB Primary Research, 1(2), 1–3. doi:  10.1080/21507716.2010.499322
    https://doi.org/10.1080/21507716.2010.499322 [Google Scholar]
  2. Bernstein, J. H.
    (2015) Transdisciplinarity: A review of its origins, development, and current issues. Journal of Research Practice, 11(1), Article R1. Retrieved fromjrp.icaap.org/index.php/jrp/article/view/510/412
    [Google Scholar]
  3. Busch, A.
    (2015) 20. Medizindiskurse: Mediale Räume der Experten-Laien-Kommunikation. InA. Busch & T. Spranz-Fogasy (Eds.), Handbuch Sprache in der Medizin (pp.369–388). De Gruyter. doi:  10.1515/9783110296174‑021
    https://doi.org/10.1515/9783110296174-021 [Google Scholar]
  4. Busch, A., & Spranz-Fogasy, T.
    (2015) Sprache in der Medizin. InE. Felder & A. Gardt (Eds.), Handbuch Sprache und Wissen (pp.335–357). De Gruyter. doi:  10.1515/9783110295979.335
    https://doi.org/10.1515/9783110295979.335 [Google Scholar]
  5. De Nardi, G., Matic, I., & Steiner, F.
    (2018) Verständlichkeit von schriftlicher Aufklärung zur Forschungsteilnahme: Die Auffassungen und Strategien von Ethikkommissionen und Forschenden. ZHAW Zürcher Hochschule für Angewandte Wissenschaften. doi:  10.21256/zhaw‑18832
    https://doi.org/10.21256/zhaw-18832 [Google Scholar]
  6. (2019) Informed-Consent-Aufklärung aus Sicht der Forschenden. ZHAW Zürcher Hochschule für Angewandte Wissenschaften. doi: 10.21256/zhaw‑18833
    https://doi.org/10.21256/zhaw-18833 [Google Scholar]
  7. Deppermann, A.
    (2008) Gespräche analysieren: Eine Einführung (4. Aufl.). VS Springer. doi:  10.1007/978‑3‑531‑91973‑7
    https://doi.org/10.1007/978-3-531-91973-7 [Google Scholar]
  8. Ehrensberger-Dow, M., Matic, I., & Steiner, F.
    (2016) Informed Consent: Literaturbericht, Verständlichkeitsmodell und Evaluation der swissethics-Templates. ZHAW Zürcher Hochschule für Angewandte Wissenschaften. doi: 10.21256/zhaw‑18830
    https://doi.org/10.21256/zhaw-18830 [Google Scholar]
  9. Enfield, K. B., & Truwit, J. D.
    (2008) The purpose, composition, and function of an institutional review board: Balancing priorities. Respiratory Care, 53(10), 1330–1336.
    [Google Scholar]
  10. Gefenas, E.
    (2012) Informed consent. InR. Chadwick (Ed.), Encyclopedia of applied ethics (pp.721–730). Elsevier. 10.1016/B978‑0‑12‑373932‑2.00149‑6
    https://doi.org/10.1016/B978-0-12-373932-2.00149-6 [Google Scholar]
  11. Göpferich, S.
    (2019) InN. Janich (Ed.). Textlinguistik: 15 Einführungen und eine Diskussion (2., aktualisierte und erweiterte Auflage). Narr Francke Attempto.
    [Google Scholar]
  12. Groß, A., & Harren, I.
    (2016) Einleitung: Wissen in institutioneller Interaktion. InA. Groß, & I. Harren (Eds.), Wissen in institutioneller Interaktion (pp.7–25). Peter Lang. doi:  10.3726/978‑3‑653‑04973‑2
    https://doi.org/10.3726/978-3-653-04973-2 [Google Scholar]
  13. Heritage, J., & Clayman, S.
    (2010) Talk in action: Interactions, identities and institutions. Wiley-Blackwell. 10.1002/9781444318135
    https://doi.org/10.1002/9781444318135 [Google Scholar]
  14. Ilić, N., Auchlin, A., Hadengue, A., Wenger, A., & Hurst, S. A.
    (2013) Informed consent forms in oncology research: Linguistic tools identify recurrent pitfalls. AJOB Primary Research, 4(4), 39–54. doi:  10.1080/21507716.2013.788101
    https://doi.org/10.1080/21507716.2013.788101 [Google Scholar]
  15. Kruse, J.
    (2015) Qualitative Interviewforschung. Ein integrativer Ansatz. Beltz Juventa.
    [Google Scholar]
  16. Lentz, J., Kennett, M., Perlmutter, J., & Forrest, A.
    (2016) Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemporary Clinical Trials, 49, 65–69. doi:  10.1016/j.cct.2016.06.005
    https://doi.org/10.1016/j.cct.2016.06.005 [Google Scholar]
  17. Lidz, C. W.
    (2006) The therapeutic misconception and our models of competency and informed consent. Behavioral Sciences & the Law, 24(4), 535–546. doi:  10.1002/bsl.700
    https://doi.org/10.1002/bsl.700 [Google Scholar]
  18. Linell, P., & Luckmann, T.
    (1991) Asymmetries in dialogue: Some conceptual preliminaries. InI. Marková & K. Foppa (Eds.), The dynamics of dialogue (pp.1–20). Harvester Wheatsheaf.
    [Google Scholar]
  19. Matic, I., Steiner, F., & De Nardi, G.
    (2020) Experten-Laien-Kommunikation in der mündlich-schriftlichen Aufklärung zu Humanforschungsprojekten. Sprache im Beruf, 3(2), 223–245. doi:  10.25162/sprib‑2020‑0012
    https://doi.org/10.25162/sprib-2020-0012 [Google Scholar]
  20. Miller, J., & Glassner, B.
    (2016) The `inside’ and the `outside’: Finding realities in interviews. InD. Silverman (Ed.), Qualitative Research (4th ed., pp.51–66). Sage.
    [Google Scholar]
  21. Paris, A., Deygas, B., Cornu, C., Thalamas, C., Maison, P., Duale, C., Kane, M., Hodaj, E., & Cracowski, J.-L.
    (2015) Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: A study in real settings. British Journal of Clinical Pharmacology, 80(5), 1010–1020. doi:  10.1111/bcp.12716
    https://doi.org/10.1111/bcp.12716 [Google Scholar]
  22. Perrin, D.
    (2018) On, for, and with practitioners: A transdisciplinary approach to text production in real-life settings. AILA Review, 31, 53–80. doi:  10.1075/aila.00013.per
    https://doi.org/10.1075/aila.00013.per [Google Scholar]
  23. Pietrzykowski, T., & Smilowska, K.
    (2021) The reality of informed consent: Empirical studies on patient comprehension – Systematic review. Trials, 22(1), 57. doi:  10.1186/s13063‑020‑04969‑w
    https://doi.org/10.1186/s13063-020-04969-w [Google Scholar]
  24. Pilegaard, M.
    (2016) The ethics of informed consent. An applied linguistics perspective. InP. Ordóñez-López & N. Edo-Marzá (Eds.), Medical discourse in professional, academic and popular settings (pp.79–102). Multilingual Matters. 10.21832/9781783096268‑006
    https://doi.org/10.21832/9781783096268-006 [Google Scholar]
  25. Pilegaard, M., & Berg Ravn, H.
    (2014) Informed consent: Towards improved lay-friendliness of patient information sheets. Communication and Medicine, 10(3), 201–211. doi:  10.1558/cam.v10i3.201
    https://doi.org/10.1558/cam.v10i3.201 [Google Scholar]
  26. Realpe, A., Adams, A., Wall, P., Griffin, D., & Donovan, J. L.
    (2016) A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented. Journal of Clinical Epidemiology, 76, 166–174. doi:  10.1016/j.jclinepi.2016.02.002
    https://doi.org/10.1016/j.jclinepi.2016.02.002 [Google Scholar]
  27. Saldaña, J.
    (2009) The coding manual for qualitative researchers. Sage.
    [Google Scholar]
  28. Sand, K., Kaasa, S., & Loge, J. H.
    (2010) The understanding of informed consent information – Definitions and measurements in empirical studies. AJOB Primary Research, 1(2), 4–24. doi:  10.1080/21507711003771405
    https://doi.org/10.1080/21507711003771405 [Google Scholar]
  29. Santel, F., Bah, I., Kim, K., Lin, J.-A., McCracken, J., & Teme, A.
    (2019) Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA’s Center for Devices and Radiological Health. Contemporary Clinical Trials, 85, 105831. doi:  10.1016/j.cct.2019.105831
    https://doi.org/10.1016/j.cct.2019.105831 [Google Scholar]
  30. Schatz, T., Haberstroh, J., Bindel, K., Oswald, F., Pantel, J., Paulitsch, M., Konopik, N., & Knopf, M.
    (2017) Improving comprehension in written medical informed consent procedures. GeroPsych, 30(3), 97–108. doi:  10.1024/1662‑9647/a000169
    https://doi.org/10.1024/1662-9647/a000169 [Google Scholar]
  31. Schulz, M.
    (2012) Quick and easy!? Fokusgruppen in der angewandten Sozialwissenschaft. InM. Schulz, B. Mack, & O. Renn (Eds.), Fokusgruppen in der empirischen Sozialwissenschaft. Von der Konzeption bis zur Auswertung (pp.9–22). VS Springer. 10.1007/978‑3‑531‑19397‑7_1
    https://doi.org/10.1007/978-3-531-19397-7_1 [Google Scholar]
  32. Shafiq, N., & Malhotra, S.
    (2011) Ethics in clinical research: Need for assessing comprehension of informed consent form?Contemporary Clinical Trials, 32(2), 169–172. doi:  10.1016/j.cct.2010.12.002
    https://doi.org/10.1016/j.cct.2010.12.002 [Google Scholar]
  33. Stark, L. J. M.
    (2012) Behind closed doors IRBs and the making of ethical research. University of Chicago Press.
    [Google Scholar]
  34. Stead, M., Eadie, D., Gordon, D., & Angus, K.
    (2005) ‘‘Hello, hello – it’s English I speak!’’: a qualitative ex-ploration of patients’ understanding of the science of clinical trials. J Med Ethics, 31, 664–669. doi:  10.1136/jme.2004.011064
    https://doi.org/10.1136/jme.2004.011064 [Google Scholar]
  35. Tam, N., Huy, N., Thoa, L., Long, N., Trang, N., Hirayama, K., & Karbwang, J.
    (2015) Participants’ understanding of informed consent in clinical trials over three decades: Systematic review and meta-analysis. Bulletin of the World Health Organization, 93(3), 186–198. doi:  10.2471/BLT.14.141390
    https://doi.org/10.2471/BLT.14.141390 [Google Scholar]
  36. Vogele, D., Schöffski, O., Efinger, K., Schmidt, S. A., Beer, M., & Kildal, D.
    (2020) Aufklärungserfolg, Zufriedenheit und Verbesserungsmöglichkeiten bei Computertomographie-Aufklärungen. Der Radiologe, 60(11), 1077–1084. 10.1007/s00117‑020‑00727‑w
    https://doi.org/10.1007/s00117-020-00727-w [Google Scholar]
  37. Wade, J., Donovan, J. L., Athene Lane, J., Neal, D. E., & Hamdy, F. C.
    (2009) It’s not just what you say, it’s also how you say it: Opening the ‘black box’ of informed consent appointments in randomised controlled trials. Social Science & Medicine, 68(11), 2018–2028. doi:  10.1016/j.socscimed.2009.02.023
    https://doi.org/10.1016/j.socscimed.2009.02.023 [Google Scholar]
  38. Young, R.
    (2009) Informed consent and patient autonomy. InH. Kuhse & P. Singer (Eds.), A companion to bioethics (pp.530–540). Blackwell. doi:  10.1002/9781444307818.ch44
    https://doi.org/10.1002/9781444307818.ch44 [Google Scholar]

Data & Media loading...

This is a required field
Please enter a valid email address
Approval was successful
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error