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...

ver descrição completa

Detalhes bibliográficos
Autores: Lopez-Parra, M, Zamora-Carmona, F, Sianes-Gallen, M, Lopez-Gonzalez, E, Gil-Rey, D, Costa-Ventura, H, Borras-Sanchez, M, Rayo-Posadas, G, Arizu-Puigvert, M, Vives-Vilagut, R
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Recursos:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p1330
Acesso em linha:https://i3pt.portalinvestigacion.com/publicaciones/1330
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85131723412&doi=10.3390%2fhealthcare10061036&partnerID=40&md5=28858e613ffa0f9d539053c099ea709d
Access Level:acceso abierto
Palavra-chave:aged
informed consent form
nurses
randomized controlled trial
id ES_e1cb7a70c1e3daee0a2b4c0ce627faba
oai_identifier_str oai:i3pt.fundanetsuite.com:p1330
network_acronym_str ES
network_name_str España
repository_id_str
spelling Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled TrialLopez-Parra, MZamora-Carmona, FSianes-Gallen, MLopez-Gonzalez, EGil-Rey, DCosta-Ventura, HBorras-Sanchez, MRayo-Posadas, GArizu-Puigvert, MVives-Vilagut, Ragedinformed 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.MDPI2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/1330https://www.scopus.com/inward/record.uri?eid=2-s2.0-85131723412&doi=10.3390%2fhealthcare10061036&partnerID=40&md5=28858e613ffa0f9d539053c099ea709dHealthcareISSN: 22279032reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulíinstname:Institut d'Investigació i Innovació Parc Taulí (I3PT)Inglésinfo:eu-repo/semantics/openAccessoai:i3pt.fundanetsuite.com:p13302026-06-21T15:30:37Z
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: Lessons Learned from a Randomized Controlled Trial
spellingShingle Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
Lopez-Parra, M
aged
informed consent form
nurses
randomized controlled trial
title_short 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_sort Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
dc.creator.none.fl_str_mv Lopez-Parra, M
Zamora-Carmona, F
Sianes-Gallen, M
Lopez-Gonzalez, E
Gil-Rey, D
Costa-Ventura, H
Borras-Sanchez, M
Rayo-Posadas, G
Arizu-Puigvert, M
Vives-Vilagut, R
author Lopez-Parra, M
author_facet Lopez-Parra, M
Zamora-Carmona, F
Sianes-Gallen, M
Lopez-Gonzalez, E
Gil-Rey, D
Costa-Ventura, H
Borras-Sanchez, M
Rayo-Posadas, G
Arizu-Puigvert, M
Vives-Vilagut, R
author_role author
author2 Zamora-Carmona, F
Sianes-Gallen, M
Lopez-Gonzalez, E
Gil-Rey, D
Costa-Ventura, H
Borras-Sanchez, M
Rayo-Posadas, G
Arizu-Puigvert, M
Vives-Vilagut, R
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 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://i3pt.portalinvestigacion.com/publicaciones/1330
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85131723412&doi=10.3390%2fhealthcare10061036&partnerID=40&md5=28858e613ffa0f9d539053c099ea709d
url https://i3pt.portalinvestigacion.com/publicaciones/1330
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85131723412&doi=10.3390%2fhealthcare10061036&partnerID=40&md5=28858e613ffa0f9d539053c099ea709d
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv Healthcare
ISSN: 22279032
reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
instname:Institut d'Investigació i Innovació Parc Taulí (I3PT)
instname_str Institut d'Investigació i Innovació Parc Taulí (I3PT)
reponame_str r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869422325611364352
score 15.811543

Registos relacionados