Patient Information and Informed Consent for Research in the Elderly

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: López-Parra, Maria|||0000-0003-3147-9870, Zamora-Carmona, Francisco|||0000-0002-4428-3378, Sianes Gallén, Mònica|||0000-0002-7496-5353, López-González, Esmeralda, Gil-Rey, Dolors, Costa Ventura, Helena, Borrás-Sánchez, Miriam, Rayo-Posadas, Gemma|||0000-0003-3217-8332, Arizu-Puigvert, Marta, Vives, Roser|||0000-0002-4369-778X
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:259883
Acceso en línea:https://ddd.uab.cat/record/259883
https://dx.doi.org/urn:doi:10.3390/healthcare10061036
Access Level:acceso abierto
Palabra clave:Aged
Informed consent form
Nurses
Randomized controlled trial
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spelling Patient Information and Informed Consent for Research in the Elderlylessons Learned from a Randomized Controlled TrialLópez-Parra, Maria|||0000-0003-3147-9870Zamora-Carmona, Francisco|||0000-0002-4428-3378Sianes Gallén, Mònica|||0000-0002-7496-5353López-González, EsmeraldaGil-Rey, DolorsCosta Ventura, HelenaBorrás-Sánchez, MiriamRayo-Posadas, Gemma|||0000-0003-3217-8332Arizu-Puigvert, MartaVives, Roser|||0000-0002-4369-778XAgedInformed consent formNursesRandomized controlled trialThe 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. 22022-01-0120222022-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/259883https://dx.doi.org/urn:doi:10.3390/healthcare10061036reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2598832026-06-06T12:50:31Z
dc.title.none.fl_str_mv 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
spellingShingle Patient Information and Informed Consent for Research in the Elderly
López-Parra, Maria|||0000-0003-3147-9870
Aged
Informed consent form
Nurses
Randomized controlled trial
title_short Patient Information and Informed Consent for Research in the Elderly
title_full Patient Information and Informed Consent for Research in the Elderly
title_fullStr Patient Information and Informed Consent for Research in the Elderly
title_full_unstemmed Patient Information and Informed Consent for Research in the Elderly
title_sort Patient Information and Informed Consent for Research in the Elderly
dc.creator.none.fl_str_mv López-Parra, Maria|||0000-0003-3147-9870
Zamora-Carmona, Francisco|||0000-0002-4428-3378
Sianes Gallén, Mònica|||0000-0002-7496-5353
López-González, Esmeralda
Gil-Rey, Dolors
Costa Ventura, Helena
Borrás-Sánchez, Miriam
Rayo-Posadas, Gemma|||0000-0003-3217-8332
Arizu-Puigvert, Marta
Vives, Roser|||0000-0002-4369-778X
author López-Parra, Maria|||0000-0003-3147-9870
author_facet López-Parra, Maria|||0000-0003-3147-9870
Zamora-Carmona, Francisco|||0000-0002-4428-3378
Sianes Gallén, Mònica|||0000-0002-7496-5353
López-González, Esmeralda
Gil-Rey, Dolors
Costa Ventura, Helena
Borrás-Sánchez, Miriam
Rayo-Posadas, Gemma|||0000-0003-3217-8332
Arizu-Puigvert, Marta
Vives, Roser|||0000-0002-4369-778X
author_role author
author2 Zamora-Carmona, Francisco|||0000-0002-4428-3378
Sianes Gallén, Mònica|||0000-0002-7496-5353
López-González, Esmeralda
Gil-Rey, Dolors
Costa Ventura, Helena
Borrás-Sánchez, Miriam
Rayo-Posadas, Gemma|||0000-0003-3217-8332
Arizu-Puigvert, Marta
Vives, Roser|||0000-0002-4369-778X
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Aged
Informed consent form
Nurses
Randomized controlled trial
topic Aged
Informed consent form
Nurses
Randomized controlled trial
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.
publishDate 2022
dc.date.none.fl_str_mv 2
2022-01-01
2022
2022-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/259883
https://dx.doi.org/urn:doi:10.3390/healthcare10061036
url https://ddd.uab.cat/record/259883
https://dx.doi.org/urn:doi:10.3390/healthcare10061036
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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