Bioethical perspective of justice in clinical trials

Detalhes bibliográficos
Autor(a) principal: Silva, Cecilia Ferreira
Data de Publicação: 2016
Outros Autores: Ventura, Miriam, Castro, Claudia Garcia Serpa Osorio de
Tipo de documento: Artigo
Idioma: por
eng
spa
Título da fonte: Revista Bioética (online)
Texto Completo: https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119
Resumo: Brazil has a welcoming setting for clinical trials, with national regulations and a well-developed and institutionalized monitoring system. Resolution 466/2012 of the Conselho Nacional de Saúde (Brazilian National Health Council) adopted the principle of justice as a fundamental requirement for ethics in research. The aim of the present study was to investigate the bioethical meanings attributed to this principle in clinical trials with drugs in the country. The study was conducted through a thorough literature review, which was performed in twophases: understanding trial regulations and systematically researching the issue. Discussions regarding the principle of justice vary greatly when addressing the different stages of trials. The authors’ perceptions were organized into three categories, which are interchangeable to a certain degree. Empirical studies and discussions must be conducted in relation to the application of this principle during the ethical analysis of clinical trials, while also addressing the adequacy and effectiveness of this principle in reducing social injustices in the health sector.
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spelling Bioethical perspective of justice in clinical trialsPerspectivas bioéticas sobre la justicia en los ensayos clínicosPerspectivas bioéticas sobre justiça nos ensaios clínicosBiomedical researchpharmaceutical preparationssocial justiceethicsresearch.Investigación biomédica. Preparaciones farmacéuticas. Justicia social. Ética en Investigación.Pesquisa biomédica. Preparações farmacêuticas. Justiça social. Ética em pesquisa.Brazil has a welcoming setting for clinical trials, with national regulations and a well-developed and institutionalized monitoring system. Resolution 466/2012 of the Conselho Nacional de Saúde (Brazilian National Health Council) adopted the principle of justice as a fundamental requirement for ethics in research. The aim of the present study was to investigate the bioethical meanings attributed to this principle in clinical trials with drugs in the country. The study was conducted through a thorough literature review, which was performed in twophases: understanding trial regulations and systematically researching the issue. Discussions regarding the principle of justice vary greatly when addressing the different stages of trials. The authors’ perceptions were organized into three categories, which are interchangeable to a certain degree. Empirical studies and discussions must be conducted in relation to the application of this principle during the ethical analysis of clinical trials, while also addressing the adequacy and effectiveness of this principle in reducing social injustices in the health sector.Brasil es un campo próspero para ensayos clínicos, posee una reglamentación nacional y un sistema de seguimiento bien desarrollado e institucionalizado. La Resolución del Conselho Nacional de Saúde (CNS) (Consejo Nacional de Salud) 466/2012 incorpora el principio de la justicia como fundamental para garantizar la eticidad de las investigaciones. Este estudio tuvo como objetivo investigar los sentidos bioéticos atribuidos a este principio en la realización de ensayos clínicos con medicamentos en el país. Se trata de una revisión narrativa de la literatura, realizada en dos etapas: alcance o ámbito de las regulaciones en investigación y búsqueda sistemática sobre el tema. Hay una fragmentación en la discusión del principio de justicia en las diferentes etapas de los ensayos. Las percepciones de los autores fueron organizadas en tres categorías que, no obstante,tienen cierto grado de intercambiabilidad. Se debe profundizar en estudios empíricos y discusiones sobre la aplicación de este principio en el análisis ético de los ensayos clínicos y sobre la adecuación y efectividad con el fin de reducir las injusticias en la salud.O Brasil é campo próspero para ensaios clínicos, possui regulamentação nacional e sistema de monitoramento bem desenvolvido e institucionalizado. A Resolução do Conselho Nacional de Saúde CNS 466/2012 incorpora o princípio da justiça como fundamental para garantir a eticidade das pesquisas. Este estudo tevecomo objetivo investigar os sentidos bioéticos atribuídos a esse princípio na condução dos ensaios clínicos com medicamentos no país. Trata-se de revisão narrativa da literatura, realizada em duas etapas: compreensãodas regulamentações em pesquisa e busca sistemática sobre o tema. Há fragmentação da discussão sobre o princípio da justiça, abordando-se diferentes etapas dos ensaios. As percepções dos autores foram organizadas em três categorias que possuem certo grau de intercambialidade. Devem ser realizados estudos empíricos e discussões sobre a aplicação desse princípio na análise ética dos ensaios clínicos e sobre sua adequação e efetividade com vistas à redução das injustiças em saúde.CFM2016-07-20info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionAvaliado por ParesRevisão narrativa da literatura sobre ética em pesquisa e análise da regulamentação ética vigenteapplication/pdfapplication/pdfapplication/pdfhttps://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119Revista Bioética; Vol. 24 No. 2 (2016): Rev. bioét. (Impr.). 2016; 24 (2)Revista Bioética; Vol. 24 Núm. 2 (2016): Rev. bioét. (Impr.). 2016; 24 (2)Revista Bioética; v. 24 n. 2 (2016): Rev. bioét. (Impr.). 2016; 24 (2)1983-80341983-8042reponame:Revista Bioética (online)instname:Conselho Federal de Medicina (CFM)instacron:CFMporengspahttps://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119/1499https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119/1500https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119/1501Copyright (c) 2016 Revista Bioéticainfo:eu-repo/semantics/openAccessSilva, Cecilia FerreiraVentura, MiriamCastro, Claudia Garcia Serpa Osorio de2016-08-09T17:32:31Zoai:ojs.emnuvens.com.br:article/1119Revistahttps://revistabioetica.cfm.org.br/revista_bioeticaPUBhttps://revistabioetica.cfm.org.br/revista_bioetica/oaibioetica@portalmedico.org.br||revistabioetica@gmail.com1983-80421983-8034opendoar:2016-08-09T17:32:31Revista Bioética (online) - Conselho Federal de Medicina (CFM)false
dc.title.none.fl_str_mv Bioethical perspective of justice in clinical trials
Perspectivas bioéticas sobre la justicia en los ensayos clínicos
Perspectivas bioéticas sobre justiça nos ensaios clínicos
title Bioethical perspective of justice in clinical trials
spellingShingle Bioethical perspective of justice in clinical trials
Silva, Cecilia Ferreira
Biomedical research
pharmaceutical preparations
social justice
ethics
research.
Investigación biomédica. Preparaciones farmacéuticas. Justicia social. Ética en Investigación.
Pesquisa biomédica. Preparações farmacêuticas. Justiça social. Ética em pesquisa.
title_short Bioethical perspective of justice in clinical trials
title_full Bioethical perspective of justice in clinical trials
title_fullStr Bioethical perspective of justice in clinical trials
title_full_unstemmed Bioethical perspective of justice in clinical trials
title_sort Bioethical perspective of justice in clinical trials
author Silva, Cecilia Ferreira
author_facet Silva, Cecilia Ferreira
Ventura, Miriam
Castro, Claudia Garcia Serpa Osorio de
author_role author
author2 Ventura, Miriam
Castro, Claudia Garcia Serpa Osorio de
author2_role author
author
dc.contributor.author.fl_str_mv Silva, Cecilia Ferreira
Ventura, Miriam
Castro, Claudia Garcia Serpa Osorio de
dc.subject.por.fl_str_mv Biomedical research
pharmaceutical preparations
social justice
ethics
research.
Investigación biomédica. Preparaciones farmacéuticas. Justicia social. Ética en Investigación.
Pesquisa biomédica. Preparações farmacêuticas. Justiça social. Ética em pesquisa.
topic Biomedical research
pharmaceutical preparations
social justice
ethics
research.
Investigación biomédica. Preparaciones farmacéuticas. Justicia social. Ética en Investigación.
Pesquisa biomédica. Preparações farmacêuticas. Justiça social. Ética em pesquisa.
description Brazil has a welcoming setting for clinical trials, with national regulations and a well-developed and institutionalized monitoring system. Resolution 466/2012 of the Conselho Nacional de Saúde (Brazilian National Health Council) adopted the principle of justice as a fundamental requirement for ethics in research. The aim of the present study was to investigate the bioethical meanings attributed to this principle in clinical trials with drugs in the country. The study was conducted through a thorough literature review, which was performed in twophases: understanding trial regulations and systematically researching the issue. Discussions regarding the principle of justice vary greatly when addressing the different stages of trials. The authors’ perceptions were organized into three categories, which are interchangeable to a certain degree. Empirical studies and discussions must be conducted in relation to the application of this principle during the ethical analysis of clinical trials, while also addressing the adequacy and effectiveness of this principle in reducing social injustices in the health sector.
publishDate 2016
dc.date.none.fl_str_mv 2016-07-20
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
Avaliado por Pares
Revisão narrativa da literatura sobre ética em pesquisa e análise da regulamentação ética vigente
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119
url https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119
dc.language.iso.fl_str_mv por
eng
spa
language por
eng
spa
dc.relation.none.fl_str_mv https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119/1499
https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119/1500
https://revistabioetica.cfm.org.br/revista_bioetica/article/view/1119/1501
dc.rights.driver.fl_str_mv Copyright (c) 2016 Revista Bioética
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2016 Revista Bioética
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv CFM
publisher.none.fl_str_mv CFM
dc.source.none.fl_str_mv Revista Bioética; Vol. 24 No. 2 (2016): Rev. bioét. (Impr.). 2016; 24 (2)
Revista Bioética; Vol. 24 Núm. 2 (2016): Rev. bioét. (Impr.). 2016; 24 (2)
Revista Bioética; v. 24 n. 2 (2016): Rev. bioét. (Impr.). 2016; 24 (2)
1983-8034
1983-8042
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instname_str Conselho Federal de Medicina (CFM)
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reponame_str Revista Bioética (online)
collection Revista Bioética (online)
repository.name.fl_str_mv Revista Bioética (online) - Conselho Federal de Medicina (CFM)
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