Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica

Detalhes bibliográficos
Autor(a) principal: Garcia do Nascimento de Castro, Talita
Data de Publicação: 2023
Outros Autores: Mapelli, Lina Domênica, de Oliveira Gozzo, Thais
Tipo de documento: Artigo
Idioma: por
Título da fonte: Journal Health NPEPS
Texto Completo: https://periodicos.unemat.br/index.php/jhnpeps/article/view/10760
Resumo: Objective: to evaluate the consent process of clinical research participants. Method: descriptive study with prospective collection. Results: 70 participants, 83% were women; average age of 46.7 years; 55.7% were white; 45.75% had a partner; 38.6% had little education; 49.3% were economically active. Participant, research and Free and Informed Consent Term, 74.3% reported not having knowledge about the type of research they were involved in; risks or discomfort were received by 51.4%; 62.3% were informed about the benefits; 62.7% were unaware of indemnities. Regarding the form and content of the document, 86.8% reported that it was easy to read; 62.2% found the document long; 71.1% reported that the words were easy to understand. Conclusion: there is a need to encourage national studies that evaluate the perceptions of research participants regarding their rights, as well as the construction of instruments that enable this verification in the Brazilian population.
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spelling Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínicaAutonomia PessoalBioéticaConsentimento Livre e EsclarecidoConfidencialidadeÉtica em PesquisaObjective: to evaluate the consent process of clinical research participants. Method: descriptive study with prospective collection. Results: 70 participants, 83% were women; average age of 46.7 years; 55.7% were white; 45.75% had a partner; 38.6% had little education; 49.3% were economically active. Participant, research and Free and Informed Consent Term, 74.3% reported not having knowledge about the type of research they were involved in; risks or discomfort were received by 51.4%; 62.3% were informed about the benefits; 62.7% were unaware of indemnities. Regarding the form and content of the document, 86.8% reported that it was easy to read; 62.2% found the document long; 71.1% reported that the words were easy to understand. Conclusion: there is a need to encourage national studies that evaluate the perceptions of research participants regarding their rights, as well as the construction of instruments that enable this verification in the Brazilian population. Objetivo: evaluación del proceso de consentimiento de los participantes en investigaciones clínicas. Método: estudio descriptivo con recopilación prospectiva. Resultados: 70 participantes, 83% eran mujeres; edad media de 46,7 años; 55,7% eran de raza blanca; 45,75% tenían pareja; 38,6% tenían pocos estudios; 49,3% eran económicamente activos. Participante, investigación y Plazo de Consentimiento Libre e Informado, el 74,3% declaró no tener conocimiento del tipo de investigación en la que participaba; los riesgos o molestias fueron recibidos por el 51,4%; el 62,3% fue informado sobre los beneficios; el 62,7% desconocía las indemnizaciones. En cuanto a la forma y el contenido del documento, el 86,8% afirmó que era fácil de leer; el 62,2% consideró que el documento era largo; el 71,1% afirmó que las palabras eran fáciles de entender. Conclusión: es necesario incentivar estudios nacionales que evalúen las percepciones de los participantes en investigaciones sobre sus derechos, así como la construcción de instrumentos que permitan esa verificación en la población brasileña.Objetivo: avaliar o processo de consentimento dos participantes de pesquisa clínica. Método: estudo exploratório, retrospectivo e quantitativo, desenvolvido em hospital de referência nacional em oncologia entre maio de 2016 e janeiro de 2017. Foi elaborado formulário e submetido a teste piloto. Utilizou-se o índice de legibilidade de Flesch-Kincaid (ILFK) na avaliação dos Termos de Consentimento Livre e Esclarecido (TCLE). Realizou-se análise descritiva e univariada. Resultados: o cálculo do ILFK revelou que 100% dos TCLEs apresentaram leitura muito difícil. A idade do participante foi estatisticamente significante nas questões sobre ajuda na leitura do TCLE antes da assinatura (p=0,02), dificuldade de leitura do TCLE (p=0,04) e se assinou o TCLE antes de iniciar a participação (p=0,02). A escolaridade apresentou significância quanto à questão sobre indenizações (p=0,02), e o sexo, quanto à questão de ajuda de familiar para a leitura do TCLE (p=0,01). Conclusão: percebeu-se a necessidade em estabelecer padrões que proporcionem tomada de decisão consciente e própria do participante, considerando a escolaridade, necessidades pessoais, crenças e costumes.Editora UNEMAT2023-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://periodicos.unemat.br/index.php/jhnpeps/article/view/10760Journal Health NPEPS; Vol. 8 No. 1 (2023): Janeiro-JunhoJournal Health NPEPS; Vol. 8 Núm. 1 (2023): Janeiro-JunhoJournal Health NPEPS; v. 8 n. 1 (2023): Janeiro-Junho2526-1010reponame:Journal Health NPEPSinstname:Universidade do Estado de Mato Grosso (UNEMAT)instacron:UNEMATporhttps://periodicos.unemat.br/index.php/jhnpeps/article/view/10760/7665Garcia do Nascimento de Castro, TalitaMapelli, Lina Domênicade Oliveira Gozzo, Thaisinfo:eu-repo/semantics/openAccess2023-09-08T12:20:52Zoai:ojs.pkp.sfu.ca:article/10760Revistahttp://periodicos.unemat.br/index.php/jhnpepsPUBhttps://periodicos.unemat.br/index.php/jhnpeps/oainpeps@unemat.br2526-10102526-1010opendoar:2023-09-08T12:20:52Journal Health NPEPS - Universidade do Estado de Mato Grosso (UNEMAT)false
dc.title.none.fl_str_mv Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
title Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
spellingShingle Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
Garcia do Nascimento de Castro, Talita
Autonomia Pessoal
Bioética
Consentimento Livre e Esclarecido
Confidencialidade
Ética em Pesquisa
title_short Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
title_full Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
title_fullStr Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
title_full_unstemmed Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
title_sort Consentimento livre e esclarecido em participantes de pesquisa clínica/ Free and informed consent in clinical research participants/ Consentimiento libre e informado en participantes de linvestigación clínica
author Garcia do Nascimento de Castro, Talita
author_facet Garcia do Nascimento de Castro, Talita
Mapelli, Lina Domênica
de Oliveira Gozzo, Thais
author_role author
author2 Mapelli, Lina Domênica
de Oliveira Gozzo, Thais
author2_role author
author
dc.contributor.author.fl_str_mv Garcia do Nascimento de Castro, Talita
Mapelli, Lina Domênica
de Oliveira Gozzo, Thais
dc.subject.por.fl_str_mv Autonomia Pessoal
Bioética
Consentimento Livre e Esclarecido
Confidencialidade
Ética em Pesquisa
topic Autonomia Pessoal
Bioética
Consentimento Livre e Esclarecido
Confidencialidade
Ética em Pesquisa
description Objective: to evaluate the consent process of clinical research participants. Method: descriptive study with prospective collection. Results: 70 participants, 83% were women; average age of 46.7 years; 55.7% were white; 45.75% had a partner; 38.6% had little education; 49.3% were economically active. Participant, research and Free and Informed Consent Term, 74.3% reported not having knowledge about the type of research they were involved in; risks or discomfort were received by 51.4%; 62.3% were informed about the benefits; 62.7% were unaware of indemnities. Regarding the form and content of the document, 86.8% reported that it was easy to read; 62.2% found the document long; 71.1% reported that the words were easy to understand. Conclusion: there is a need to encourage national studies that evaluate the perceptions of research participants regarding their rights, as well as the construction of instruments that enable this verification in the Brazilian population.
publishDate 2023
dc.date.none.fl_str_mv 2023-06-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://periodicos.unemat.br/index.php/jhnpeps/article/view/10760
url https://periodicos.unemat.br/index.php/jhnpeps/article/view/10760
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://periodicos.unemat.br/index.php/jhnpeps/article/view/10760/7665
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Editora UNEMAT
publisher.none.fl_str_mv Editora UNEMAT
dc.source.none.fl_str_mv Journal Health NPEPS; Vol. 8 No. 1 (2023): Janeiro-Junho
Journal Health NPEPS; Vol. 8 Núm. 1 (2023): Janeiro-Junho
Journal Health NPEPS; v. 8 n. 1 (2023): Janeiro-Junho
2526-1010
reponame:Journal Health NPEPS
instname:Universidade do Estado de Mato Grosso (UNEMAT)
instacron:UNEMAT
instname_str Universidade do Estado de Mato Grosso (UNEMAT)
instacron_str UNEMAT
institution UNEMAT
reponame_str Journal Health NPEPS
collection Journal Health NPEPS
repository.name.fl_str_mv Journal Health NPEPS - Universidade do Estado de Mato Grosso (UNEMAT)
repository.mail.fl_str_mv npeps@unemat.br
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