O processo de consentimento na pesquisa clínica: da elaboração à obtenção

Detalhes bibliográficos
Autor(a) principal: Silva, Luci Meire Pereira da [UNIFESP]
Data de Publicação: 2005
Outros Autores: Oliveira, Filipe de [UNIFESP], Muccioli, Cristina [UNIFESP]
Tipo de documento: Artigo
Idioma: por
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: http://dx.doi.org/10.1590/S0004-27492005000500026
http://repositorio.unifesp.br/handle/11600/2731
Resumo: The consent form is a document recommended for international declarations, resolutions and specific laws currently used in research on health. The practice or the accomplishment of the informed consent in the exercise of the medicine and the research in human beings is pertains to the last decades and characterizes the perfectioning of biomedical ethics, constitutes a legal and ethical requirement in clinical research involving human beings. The main challenge of the consent process is to guarantee the adequate understanding of the individual, however the social, cultural and intellectual aspects as well as the relationship between physician and patient, sometimes, can affect this process. The purpose of this paper is to present important criteria in the consent process that need to be highlighted in accordance with specific tenets and resolutions, such as Resolution 196/96 of the National Council of Health.
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spelling O processo de consentimento na pesquisa clínica: da elaboração à obtençãoThe process of consent in clinical trials: from elaboration to accomplishmentBiomedical researchConsent formsInformed consentBioethicsClinical TrialsPesquisa biomédicaTermos de consentimentoConsentimentoBioéticaEnsaios clínicosThe consent form is a document recommended for international declarations, resolutions and specific laws currently used in research on health. The practice or the accomplishment of the informed consent in the exercise of the medicine and the research in human beings is pertains to the last decades and characterizes the perfectioning of biomedical ethics, constitutes a legal and ethical requirement in clinical research involving human beings. The main challenge of the consent process is to guarantee the adequate understanding of the individual, however the social, cultural and intellectual aspects as well as the relationship between physician and patient, sometimes, can affect this process. The purpose of this paper is to present important criteria in the consent process that need to be highlighted in accordance with specific tenets and resolutions, such as Resolution 196/96 of the National Council of Health.O termo de consentimento é um documento recomendado por declarações internacionais, códigos de ética, resoluções e leis específicas para ser utilizado no cotidiano de pesquisas em saúde. A prática ou a obtenção do consentimento informado no exercício da medicina e da pesquisa em seres humanos é própria das últimas décadas e caracteriza o aperfeiçoamento da ética biomédica, constitui um requerimento legal e ético na pesquisa clínica envolvendo seres humanos. O principal desafio do processo de consentimento é garantir a compreensão adequada do indivíduo, entretanto os aspectos sociais, culturais e intelectuais dos indivíduos, ou mesmo a relação existente entre médico e paciente, às vezes, podem comprometer esse processo. O objetivo desse trabalho é apresentar critérios importantes no processo de consentimento que merecem ser destacados e abordados de acordo com normas e resoluções específicas.Universidade Federal de São Paulo (UNIFESP) Departamento de OftalmologiaUNIFESP, Depto. de OftalmologiaSciELOConselho Brasileiro de OftalmologiaUniversidade Federal de São Paulo (UNIFESP)Silva, Luci Meire Pereira da [UNIFESP]Oliveira, Filipe de [UNIFESP]Muccioli, Cristina [UNIFESP]2015-06-14T13:31:46Z2015-06-14T13:31:46Z2005-10-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion704-707application/pdfhttp://dx.doi.org/10.1590/S0004-27492005000500026Arquivos Brasileiros de Oftalmologia. Conselho Brasileiro de Oftalmologia, v. 68, n. 5, p. 704-707, 2005.10.1590/S0004-27492005000500026S0004-27492005000500026.pdf0004-2749S0004-27492005000500026http://repositorio.unifesp.br/handle/11600/2731porArquivos Brasileiros de Oftalmologiainfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2024-07-28T09:17:38Zoai:repositorio.unifesp.br/:11600/2731Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-07-28T09:17:38Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv O processo de consentimento na pesquisa clínica: da elaboração à obtenção
The process of consent in clinical trials: from elaboration to accomplishment
title O processo de consentimento na pesquisa clínica: da elaboração à obtenção
spellingShingle O processo de consentimento na pesquisa clínica: da elaboração à obtenção
Silva, Luci Meire Pereira da [UNIFESP]
Biomedical research
Consent forms
Informed consent
Bioethics
Clinical Trials
Pesquisa biomédica
Termos de consentimento
Consentimento
Bioética
Ensaios clínicos
title_short O processo de consentimento na pesquisa clínica: da elaboração à obtenção
title_full O processo de consentimento na pesquisa clínica: da elaboração à obtenção
title_fullStr O processo de consentimento na pesquisa clínica: da elaboração à obtenção
title_full_unstemmed O processo de consentimento na pesquisa clínica: da elaboração à obtenção
title_sort O processo de consentimento na pesquisa clínica: da elaboração à obtenção
author Silva, Luci Meire Pereira da [UNIFESP]
author_facet Silva, Luci Meire Pereira da [UNIFESP]
Oliveira, Filipe de [UNIFESP]
Muccioli, Cristina [UNIFESP]
author_role author
author2 Oliveira, Filipe de [UNIFESP]
Muccioli, Cristina [UNIFESP]
author2_role author
author
dc.contributor.none.fl_str_mv Universidade Federal de São Paulo (UNIFESP)
dc.contributor.author.fl_str_mv Silva, Luci Meire Pereira da [UNIFESP]
Oliveira, Filipe de [UNIFESP]
Muccioli, Cristina [UNIFESP]
dc.subject.por.fl_str_mv Biomedical research
Consent forms
Informed consent
Bioethics
Clinical Trials
Pesquisa biomédica
Termos de consentimento
Consentimento
Bioética
Ensaios clínicos
topic Biomedical research
Consent forms
Informed consent
Bioethics
Clinical Trials
Pesquisa biomédica
Termos de consentimento
Consentimento
Bioética
Ensaios clínicos
description The consent form is a document recommended for international declarations, resolutions and specific laws currently used in research on health. The practice or the accomplishment of the informed consent in the exercise of the medicine and the research in human beings is pertains to the last decades and characterizes the perfectioning of biomedical ethics, constitutes a legal and ethical requirement in clinical research involving human beings. The main challenge of the consent process is to guarantee the adequate understanding of the individual, however the social, cultural and intellectual aspects as well as the relationship between physician and patient, sometimes, can affect this process. The purpose of this paper is to present important criteria in the consent process that need to be highlighted in accordance with specific tenets and resolutions, such as Resolution 196/96 of the National Council of Health.
publishDate 2005
dc.date.none.fl_str_mv 2005-10-01
2015-06-14T13:31:46Z
2015-06-14T13:31:46Z
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1590/S0004-27492005000500026
Arquivos Brasileiros de Oftalmologia. Conselho Brasileiro de Oftalmologia, v. 68, n. 5, p. 704-707, 2005.
10.1590/S0004-27492005000500026
S0004-27492005000500026.pdf
0004-2749
S0004-27492005000500026
http://repositorio.unifesp.br/handle/11600/2731
url http://dx.doi.org/10.1590/S0004-27492005000500026
http://repositorio.unifesp.br/handle/11600/2731
identifier_str_mv Arquivos Brasileiros de Oftalmologia. Conselho Brasileiro de Oftalmologia, v. 68, n. 5, p. 704-707, 2005.
10.1590/S0004-27492005000500026
S0004-27492005000500026.pdf
0004-2749
S0004-27492005000500026
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv Arquivos Brasileiros de Oftalmologia
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 704-707
application/pdf
dc.publisher.none.fl_str_mv Conselho Brasileiro de Oftalmologia
publisher.none.fl_str_mv Conselho Brasileiro de Oftalmologia
dc.source.none.fl_str_mv reponame:Repositório Institucional da UNIFESP
instname:Universidade Federal de São Paulo (UNIFESP)
instacron:UNIFESP
instname_str Universidade Federal de São Paulo (UNIFESP)
instacron_str UNIFESP
institution UNIFESP
reponame_str Repositório Institucional da UNIFESP
collection Repositório Institucional da UNIFESP
repository.name.fl_str_mv Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)
repository.mail.fl_str_mv biblioteca.csp@unifesp.br
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