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
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Data de Publicação: | 2023 |
Outros Autores: | , |
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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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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1797051501464518656 |