Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection
Autor(a) principal: | |
---|---|
Data de Publicação: | 2018 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Cadernos Ibero-Americanos de Direito Sanitário (Online) |
Texto Completo: | https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/465 |
Resumo: | Objective: This article objectives to analyze the legal treatment and the procedure adopted by Brazil on clinical research with basis on the Resolution nº 466/2012 from National Health Council towards the occurrence of damages due to the project. Methodology: The research was carried out in nature bibliographical references, in books and articles of the legal area, in ordinary legislations and related resolutions, as well as in articles published in periodicals of the Health area. Results: Damages must be avoided and, when occurring, must provide also an compensation to those who were harmed. Conclusion: Any damages resulting from the experiments should be avoid and noted during the curse of the project, since the moment of the informed consent’s signature to the stage of inspection from the National Ethics and Research Committee and Research Ethics Committees. The completion of a closest monitoring is essential to prevent this damages and to indemnify the participant. Furthermore, it guarantees that the process of consent is being held on a satisfactory form. |
id |
FIOCRUZ-3_f39fdb3fd6e58f6a95ac5edfcb9f6338 |
---|---|
oai_identifier_str |
oai:ojs.cadernos.prodisa.fiocruz.br:article/465 |
network_acronym_str |
FIOCRUZ-3 |
network_name_str |
Cadernos Ibero-Americanos de Direito Sanitário (Online) |
repository_id_str |
|
spelling |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspectionSalud e investigación científica con seres humanos: la conformación de los daños resultantes y el modelo brasileño de fiscalizaciónSaúde e pesquisa científica com seres humanos: a conformação dos danos decorrentes e o modelo brasileiro de fiscalizaçãoDamage LiabilityEthicsResearchInformed ConsentResponsabilidad CivilÉtica en InvestigaciónConsentimiento informadoResponsabilidade CivilÉtica em PesquisaConsentimento Livre e EsclarecidoObjective: This article objectives to analyze the legal treatment and the procedure adopted by Brazil on clinical research with basis on the Resolution nº 466/2012 from National Health Council towards the occurrence of damages due to the project. Methodology: The research was carried out in nature bibliographical references, in books and articles of the legal area, in ordinary legislations and related resolutions, as well as in articles published in periodicals of the Health area. Results: Damages must be avoided and, when occurring, must provide also an compensation to those who were harmed. Conclusion: Any damages resulting from the experiments should be avoid and noted during the curse of the project, since the moment of the informed consent’s signature to the stage of inspection from the National Ethics and Research Committee and Research Ethics Committees. The completion of a closest monitoring is essential to prevent this damages and to indemnify the participant. Furthermore, it guarantees that the process of consent is being held on a satisfactory form.Objetivos: Trabajo destinado al análisis jurídico de la protección conferida por el ordenamiento brasileño a las investigaciones involucrando a seres humanos en lo que se refiere a los daños a la salud derivados de los experimentos, con base en la Resolución 466/2012 del Consejo Nacional de Salud. Metodología: Se realizó investigación de naturaleza bibliográfica, en libros y artículos del área jurídica, en legislaciones ordinarias y resoluciones relacionadas, así como en artículos publicados en periódicos del área de Salud. Resultados: Los daños resultantes de los experimentos deben ser cuidadosamente evitados y, si ocurren, el participante de la investigación debe ser indemnizado. Conclusión: Eventuales daños resultantes de los experimentos deben ser evitados y observados durante todo el curso de la investigación, iniciándose con la firma del Término de Consentimiento Libre y Esclarecido por el participante y pasando por la fiscalización por el Comité Nacional de Ética e Investigación y por las Comisiones de Ética en Investigación. Es esencial que el seguimiento y la fiscalización se haga de forma más cercana, obstaculizando y resarciendo la ocurrencia de eventuales daños, además de garantizar la regularidad del proceso de consentimiento realizado en el proyecto.Objetivo: Este artigo objetiva analisar o ordenamento jurídico brasileiro às pesquisas envolvendo seres humanos no tocante aos danos à saúde decorrentes dos experimentos, com fundamento na Resolução nº 466/2012 do Conselho Nacional de Saúde. Metodologia: Realizou-se pesquisa de natureza bibliográfica, em livros e artigos da área jurídica, em legislações ordinárias e resoluções relacionadas, bem como em artigos publicados em periódicos da área de Saúde. Resultados: Os danos decorrentes dos experimentos devem ser cuidadosamente evitados e, se ocorrerem, deve o participante da pesquisa ser indenizado. Conclusão: Eventuais danos decorrentes dos experimentos devem ser evitados e observados durante todo o curso da pesquisa, iniciando-se com a assinatura do Termo de Consentimento Livre e Esclarecido pelo participante e perpassando pela fiscalização pelo Comitê Nacional de Ética e Pesquisa e pelas Comissões de Ética em Pesquisa. É essencial que o acompanhamento e a fiscalização sejam feito de forma mais próxima, obstando e ressarcindo a ocorrência de eventuais danos, além de garantir a regularidade do processo de consentimento realizado no projeto.Fundação Oswaldo Cruz Brasília2018-04-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionRevisão de Literaturaapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/46510.17566/ciads.v7i1.465Iberoamerican Journal of Health Law; Vol. 7 No. 1 (2018): (JAN/MAR.2018); 183-202Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 7 Núm. 1 (2018): (JAN/MAR.2018); 183-202Cadernos Ibero-Americanos de Direito Sanitário; v. 7 n. 1 (2018): (JAN/MAR.2018); 183-2022358-18242317-839610.17566/ciads.v7i1reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/465/524Copyright (c) 2018 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIOinfo:eu-repo/semantics/openAccessMeireles Araújo, Ana TherezaAlegria, Lívia2020-03-24T20:35:39Zoai:ojs.cadernos.prodisa.fiocruz.br:article/465Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2020-03-24T20:35:39Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection Salud e investigación científica con seres humanos: la conformación de los daños resultantes y el modelo brasileño de fiscalización Saúde e pesquisa científica com seres humanos: a conformação dos danos decorrentes e o modelo brasileiro de fiscalização |
title |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection |
spellingShingle |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection Meireles Araújo, Ana Thereza Damage Liability Ethics Research Informed Consent Responsabilidad Civil Ética en Investigación Consentimiento informado Responsabilidade Civil Ética em Pesquisa Consentimento Livre e Esclarecido |
title_short |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection |
title_full |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection |
title_fullStr |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection |
title_full_unstemmed |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection |
title_sort |
Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection |
author |
Meireles Araújo, Ana Thereza |
author_facet |
Meireles Araújo, Ana Thereza Alegria, Lívia |
author_role |
author |
author2 |
Alegria, Lívia |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Meireles Araújo, Ana Thereza Alegria, Lívia |
dc.subject.por.fl_str_mv |
Damage Liability Ethics Research Informed Consent Responsabilidad Civil Ética en Investigación Consentimiento informado Responsabilidade Civil Ética em Pesquisa Consentimento Livre e Esclarecido |
topic |
Damage Liability Ethics Research Informed Consent Responsabilidad Civil Ética en Investigación Consentimiento informado Responsabilidade Civil Ética em Pesquisa Consentimento Livre e Esclarecido |
description |
Objective: This article objectives to analyze the legal treatment and the procedure adopted by Brazil on clinical research with basis on the Resolution nº 466/2012 from National Health Council towards the occurrence of damages due to the project. Methodology: The research was carried out in nature bibliographical references, in books and articles of the legal area, in ordinary legislations and related resolutions, as well as in articles published in periodicals of the Health area. Results: Damages must be avoided and, when occurring, must provide also an compensation to those who were harmed. Conclusion: Any damages resulting from the experiments should be avoid and noted during the curse of the project, since the moment of the informed consent’s signature to the stage of inspection from the National Ethics and Research Committee and Research Ethics Committees. The completion of a closest monitoring is essential to prevent this damages and to indemnify the participant. Furthermore, it guarantees that the process of consent is being held on a satisfactory form. |
publishDate |
2018 |
dc.date.none.fl_str_mv |
2018-04-02 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Revisão de Literatura |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/465 10.17566/ciads.v7i1.465 |
url |
https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/465 |
identifier_str_mv |
10.17566/ciads.v7i1.465 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/465/524 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2018 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2018 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Fundação Oswaldo Cruz Brasília |
publisher.none.fl_str_mv |
Fundação Oswaldo Cruz Brasília |
dc.source.none.fl_str_mv |
Iberoamerican Journal of Health Law; Vol. 7 No. 1 (2018): (JAN/MAR.2018); 183-202 Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 7 Núm. 1 (2018): (JAN/MAR.2018); 183-202 Cadernos Ibero-Americanos de Direito Sanitário; v. 7 n. 1 (2018): (JAN/MAR.2018); 183-202 2358-1824 2317-8396 10.17566/ciads.v7i1 reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Cadernos Ibero-Americanos de Direito Sanitário (Online) |
collection |
Cadernos Ibero-Americanos de Direito Sanitário (Online) |
repository.name.fl_str_mv |
Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
cadernos.direitosanitario@fiocruz.br |
_version_ |
1798942494727077888 |