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Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial

The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosth...

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Autores principales: López-Parra, Maria, Zamora-Carmona, Francesc, Sianes-Gallén, Mònica, López-González, Esmeralda, Gil-Rey, Dolors, Costa-Ventura, Helena, Borrás-Sánchez, Miriam, Rayo-Posadas, Gemma, Arizu-Puigvert, Marta, Vives-Vilagut, Roser
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9222813/
https://www.ncbi.nlm.nih.gov/pubmed/35742087
http://dx.doi.org/10.3390/healthcare10061036
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author López-Parra, Maria
Zamora-Carmona, Francesc
Sianes-Gallén, Mònica
López-González, Esmeralda
Gil-Rey, Dolors
Costa-Ventura, Helena
Borrás-Sánchez, Miriam
Rayo-Posadas, Gemma
Arizu-Puigvert, Marta
Vives-Vilagut, Roser
author_facet López-Parra, Maria
Zamora-Carmona, Francesc
Sianes-Gallén, Mònica
López-González, Esmeralda
Gil-Rey, Dolors
Costa-Ventura, Helena
Borrás-Sánchez, Miriam
Rayo-Posadas, Gemma
Arizu-Puigvert, Marta
Vives-Vilagut, Roser
author_sort López-Parra, Maria
collection PubMed
description The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects.
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spelling pubmed-92228132022-06-24 Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial López-Parra, Maria Zamora-Carmona, Francesc Sianes-Gallén, Mònica López-González, Esmeralda Gil-Rey, Dolors Costa-Ventura, Helena Borrás-Sánchez, Miriam Rayo-Posadas, Gemma Arizu-Puigvert, Marta Vives-Vilagut, Roser Healthcare (Basel) Article The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects. MDPI 2022-06-02 /pmc/articles/PMC9222813/ /pubmed/35742087 http://dx.doi.org/10.3390/healthcare10061036 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
López-Parra, Maria
Zamora-Carmona, Francesc
Sianes-Gallén, Mònica
López-González, Esmeralda
Gil-Rey, Dolors
Costa-Ventura, Helena
Borrás-Sánchez, Miriam
Rayo-Posadas, Gemma
Arizu-Puigvert, Marta
Vives-Vilagut, Roser
Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
title Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
title_full Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
title_fullStr Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
title_full_unstemmed Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
title_short Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
title_sort patient information and informed consent for research in the elderly: lessons learned from a randomized controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9222813/
https://www.ncbi.nlm.nih.gov/pubmed/35742087
http://dx.doi.org/10.3390/healthcare10061036
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