Informed Consent and Comprehensibility Issues

At a glance

Project leader : Dr. Felix Steiner
Co-project leader : Prof. Dr. Maureen Ehrensberger-Dow
Project team : Gianni De Nardi, Dr. Igor Matic, Romina Schaub-Torsello, Martin Schuler
Project budget : CHF 270'000
Project status : completed
Funding partner : Federal government (Bundesamt für Gesundheit BAG)
Project partner : Bundesamt für Gesundheit BAG
Contact person : Felix Steiner

Description

Research involving humans as subjects can be problematic from an ethical standpoint, because people’s welfare and personal sphere should be protected. For this reason, legislation regulates that potential participants must be informed about research procedures and any risks associated with them. The Swiss Federal Act on Research involving Human Beings (Human Research Act) stipulates that study participants must provide their informed consent on the basis of comprehensible oral and written information.

A team from the ZHAW School of Applied Linguistics is carrying out a project about issues surrounding informed consent on behalf of the Federal Office of Public Health (FOPH). In view of the revision of the Human Research Act, the FOPH is interested in knowing exactly what “comprehensible information” means for potential study participants from a linguistic perspective. In the first project phase, the ZHAW team consolidated the most important findings from the research literature and proposed a comprehensibility model for informed consent. A corpus of written patient information texts was analysed and comprehensibility issues identified by applying this model.

In the second phase of the project, the ZHAW team is focusing on three aspects of comprehensibility issues:

1. The influence of regulatory authorities on patient information with a view to deriving good-practice recommendations.

2. The comprehensibility of the consent form for biobanks (“general consent”)

3. The combination of oral and written modalities for obtaining informed consent with respect to various participant profiles.

An integral part of the evaluation of the HRA, the informed consent project deploys a wide range of methods from the discipline of applied linguistics to determine effective ways to present information in comprehensible form to potential research participants.

Publications

De Nardi, Gianni; Matic, Igor; Steiner, Felix,

2021.

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

In:

AILA World Congress, online, 15-20 August 2021.
Matic, Igor; De Nardi, Gianni; Steiner, Felix,

2021.

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

AILA Review.

34(1), pp. 37-56.

Available from: https://doi.org/10.1075/aila.20007.mat
De Nardi, Gianni; Matic, Igor; Steiner, Felix,

2021.

Laien-Fachwortgebrauch für die Aufklärung nutzen : das Projekt eines digitalen Varianten-Fachwörterbuchs.

Bulletin suisse de linguistique appliquée.

1(No spécial 2021), pp. 169-186.

Available from: https://doi.org/10.21256/zhaw-23895
De Nardi, Gianni; Matic, Igor; Steiner, Felix,

2020.

Digitaler Zugang zu laienverständlichem Fachwortschatz im Kontext der Humanforschung.

In:

Applied linguistics in the digital age : conference of the Swiss association for applied linguistics, Neuchâtel, 12-14 February 2020.
De Nardi, Gianni; Matic, Igor; Steiner, Felix,

2019.

Die Kombination von mündlicher und schriftlicher Informed-Consent-Aufklärung.

In:

Zweite transdisziplinäre Fachtagung "Beschwerden - Anamnese - Befund", Netzwerk Gesundheitskommunikation, Winterthur, 1.-2. September 2019.
De Nardi, Gianni; Ehrensberger-Dow, Maureen; Matic, Igor; Steiner, Felix,

2019.

Consenso informato in forma comprensibile : sintesi del progetto di ricerca «Comprensibilità – Requisito della legga sulla ricerca umana e la sua attuazione».

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18857
De Nardi, Gianni; Ehrensberger-Dow, Maureen; Matic, Igor; Steiner, Felix,

2019.

Consentement éclairé et compréhensibilité : résumé du projet de recherche «La compréhensibilité – und prérequis pour la Loie relative à la recherche sur l’être humain et pour sa mise en application».

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18856
De Nardi, Gianni; Ehrensberger-Dow, Maureen; Matic, Igor; Steiner, Felix,

2019.

Informed consent and comprehensibility issues : summary of the research project «Comprehensibility – A Requirement of the Human Research Act and its Implementation».

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18858
De Nardi, Gianni; Ehrensberger-Dow, Maureen; Matic, Igor; Steiner, Felix,

2019.

Informed Consent in verständlicher Form : Zusammenfassung des Forschungsprojekts «Verständlichkeit – Anforderung des Humanforschungsgesetzes und deren Umsetzung».

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18834
De Nardi, Gianni; Matic, Igor; Steiner, Felix,

2019.

Informed-Consent-Aufklärung aus Sicht der Forschenden.

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18833
Matic, Igor; Steiner, Felix; De Nardi, Gianni,

2018.

Verständlichkeit kontrollieren : Auffassungen der Schweizer Ethikkommissionen bei der Prüfung von Informed-Consent-Aufklärungsdokumenten [poster].

In:

13. Internationale Tagung zur Funktionalen Pragmatik, Winterthur, 4.-6. Oktober 2018.
De Nardi, Gianni; Matic, Igor; Steiner, Felix,

2018.

Verständlichkeit von schriftlicher Aufklärung zur Forschungsteilnahme : die Auffassungen und Strategien von Ethikkommissionen und Forschenden.

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18832
De Nardi, Gianni; Ehrensberger-Dow, Maureen; Matic, Igor; Steiner, Felix,

2018.

Verständlichkeitsstudie Generalkonsent : Aufklärung und Einwilligung zur Weiterverwendung von biologischem Material und gesundheitsbezogenen Personendaten für die Forschung.

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18831
Ehrensberger-Dow, Maureen; Matic, Igor; Steiner, Felix,

2016.

Informed Consent : Literaturbericht, Verständlichkeitsmodell und Evaluation der swissethics-Templates.

Winterthur:

ZHAW Zürcher Hochschule für Angewandte Wissenschaften.

Available from: https://doi.org/10.21256/zhaw-18830

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