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Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study

Aim: In the absence of an effective treatment, informed participation in dementia research can hardly be underestimated. However, although informed consent is key in biomedical research, it may become a barrier to participation. Whether informed consent may cause confusion and contribute to unfair p...

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Autores principales: Falvo, Ilaria, Fiordelli, Maddalena, Amati, Rebecca, Ibnidris, Aliaa, Albanese, Emiliano, Fadda, Marta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8058191/
https://www.ncbi.nlm.nih.gov/pubmed/33897504
http://dx.doi.org/10.3389/fpsyt.2021.656822
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author Falvo, Ilaria
Fiordelli, Maddalena
Amati, Rebecca
Ibnidris, Aliaa
Albanese, Emiliano
Fadda, Marta
author_facet Falvo, Ilaria
Fiordelli, Maddalena
Amati, Rebecca
Ibnidris, Aliaa
Albanese, Emiliano
Fadda, Marta
author_sort Falvo, Ilaria
collection PubMed
description Aim: In the absence of an effective treatment, informed participation in dementia research can hardly be underestimated. However, although informed consent is key in biomedical research, it may become a barrier to participation. Whether informed consent may cause confusion and contribute to unfair participant selection in dementia research is not known. In preparation of a future epidemiological study on the prevalence and impact of dementia in Switzerland, we aimed to conduct a qualitative study to explore participants' comprehension of the purpose of informed consent form and process shortly after participation in the pilot and validation study that preceded the large scale survey. Methods: We conducted a qualitative study with 22 participants of the validation phase of an epidemiological study on the prevalence and impact of dementia in Switzerland to capture their understanding of both the nature and the content of the informed consent form and process. Participants were older adults (65 years or more) eligible for a dementia epidemiological study and their informant (a person who could provide information on their health and cognition). None of the participants reported to be suffering from dementia at the time of the interview. Results: We found that participants held inaccurate and potentially trust-threatening beliefs regarding the scope of the informed consent. Participants identified contradictory contextual, formal and content needs that are difficult to be fulfilled, and misperceived the clinical and research settings in terms of informed consent procedures. Conclusions: Participants and their proxies should be informed about both the scope of the informed consent process, and the content of the informed consent document in a focused, age-appropriate manner, while dispelling confusion about the purpose of research.
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spelling pubmed-80581912021-04-22 Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study Falvo, Ilaria Fiordelli, Maddalena Amati, Rebecca Ibnidris, Aliaa Albanese, Emiliano Fadda, Marta Front Psychiatry Psychiatry Aim: In the absence of an effective treatment, informed participation in dementia research can hardly be underestimated. However, although informed consent is key in biomedical research, it may become a barrier to participation. Whether informed consent may cause confusion and contribute to unfair participant selection in dementia research is not known. In preparation of a future epidemiological study on the prevalence and impact of dementia in Switzerland, we aimed to conduct a qualitative study to explore participants' comprehension of the purpose of informed consent form and process shortly after participation in the pilot and validation study that preceded the large scale survey. Methods: We conducted a qualitative study with 22 participants of the validation phase of an epidemiological study on the prevalence and impact of dementia in Switzerland to capture their understanding of both the nature and the content of the informed consent form and process. Participants were older adults (65 years or more) eligible for a dementia epidemiological study and their informant (a person who could provide information on their health and cognition). None of the participants reported to be suffering from dementia at the time of the interview. Results: We found that participants held inaccurate and potentially trust-threatening beliefs regarding the scope of the informed consent. Participants identified contradictory contextual, formal and content needs that are difficult to be fulfilled, and misperceived the clinical and research settings in terms of informed consent procedures. Conclusions: Participants and their proxies should be informed about both the scope of the informed consent process, and the content of the informed consent document in a focused, age-appropriate manner, while dispelling confusion about the purpose of research. Frontiers Media S.A. 2021-04-07 /pmc/articles/PMC8058191/ /pubmed/33897504 http://dx.doi.org/10.3389/fpsyt.2021.656822 Text en Copyright © 2021 Falvo, Fiordelli, Amati, Ibnidris, Albanese and Fadda. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Psychiatry
Falvo, Ilaria
Fiordelli, Maddalena
Amati, Rebecca
Ibnidris, Aliaa
Albanese, Emiliano
Fadda, Marta
Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study
title Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study
title_full Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study
title_fullStr Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study
title_full_unstemmed Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study
title_short Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study
title_sort participants' comprehension of the informed consent in an epidemiological study on dementia prevalence: a qualitative study
topic Psychiatry
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8058191/
https://www.ncbi.nlm.nih.gov/pubmed/33897504
http://dx.doi.org/10.3389/fpsyt.2021.656822
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