A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects

Detalhes bibliográficos
Autor(a) principal: Lamas, Eugenia
Data de Publicação: 2010
Outros Autores: Ferrer, Marcela, Molina, Alberto, Salinas, Rodrigo, Hevia, Adriana, Bota, Alexandre, Feinholz, Dafna, Fuchs, Michael, Schramm, Fermin Roland, Tealdi, Juan-Carlos, Zorrilla, Sergio
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/25537
Resumo: INSERM. Paris, France
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spelling Lamas, EugeniaFerrer, MarcelaMolina, AlbertoSalinas, RodrigoHevia, AdrianaBota, AlexandreFeinholz, DafnaFuchs, MichaelSchramm, Fermin RolandTealdi, Juan-CarlosZorrilla, Sergio2018-03-27T18:37:43Z2018-03-27T18:37:43Z2010LAMAS, Eugenia et al. A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects. Journal of Medical Ethics, v.36, n.12, p.750-753, 20100306-6800https://www.arca.fiocruz.br/handle/icict/2553710.1136/jme.2009.0350971473-4257engInstitute of Medical EthicsÉtica de Pesquisa BiomédicaBiomedical Research EthicsPesquisa BiomédicaÉticaA comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjectsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleINSERM. Paris, FranceCEDEA. Universidad de Chile. Santiago, ChileINSERM. Paris, FranceMinistry of Health of Chile. School of Public Health. Universidad de Chile. Santiago, ChileCIBISAP. Universidad de Santiago. Santiago, ChileFundacion EPSON. Barcelona, EspañaNational Commission of Bioethics. Mexico DF, MexicoInstitut für Wissenschaft und Ethik. Bonn, GermanyFundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, BrasilBIO&SUR. Buenos Aires, ArgentinaCIBISAP. Universidad de Santiago. Santiago, ChileThe European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1748https://www.arca.fiocruz.br/bitstream/icict/25537/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51ORIGINALComparative.pdfapplication/pdf419821https://www.arca.fiocruz.br/bitstream/icict/25537/2/Comparative.pdfbd3d3648262f91f2a311cb853ee792fcMD52TEXTComparative.pdf.txtComparative.pdf.txtExtracted texttext/plain21867https://www.arca.fiocruz.br/bitstream/icict/25537/3/Comparative.pdf.txt596581b3a3df44e264e1de845f5a0400MD53icict/255372023-01-10 16:21:33.994oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-01-10T19:21:33Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
title A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
spellingShingle A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
Lamas, Eugenia
Ética de Pesquisa Biomédica
Biomedical Research Ethics
Pesquisa Biomédica
Ética
title_short A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
title_full A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
title_fullStr A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
title_full_unstemmed A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
title_sort A comparative analysis of biomedical research ethics regulation systems in Europe and Latina America with regard to the protection of human subjects
author Lamas, Eugenia
author_facet Lamas, Eugenia
Ferrer, Marcela
Molina, Alberto
Salinas, Rodrigo
Hevia, Adriana
Bota, Alexandre
Feinholz, Dafna
Fuchs, Michael
Schramm, Fermin Roland
Tealdi, Juan-Carlos
Zorrilla, Sergio
author_role author
author2 Ferrer, Marcela
Molina, Alberto
Salinas, Rodrigo
Hevia, Adriana
Bota, Alexandre
Feinholz, Dafna
Fuchs, Michael
Schramm, Fermin Roland
Tealdi, Juan-Carlos
Zorrilla, Sergio
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Lamas, Eugenia
Ferrer, Marcela
Molina, Alberto
Salinas, Rodrigo
Hevia, Adriana
Bota, Alexandre
Feinholz, Dafna
Fuchs, Michael
Schramm, Fermin Roland
Tealdi, Juan-Carlos
Zorrilla, Sergio
dc.subject.other.pt_BR.fl_str_mv Ética de Pesquisa Biomédica
topic Ética de Pesquisa Biomédica
Biomedical Research Ethics
Pesquisa Biomédica
Ética
dc.subject.en.pt_BR.fl_str_mv Biomedical Research Ethics
dc.subject.decs.pt_BR.fl_str_mv Pesquisa Biomédica
Ética
description INSERM. Paris, France
publishDate 2010
dc.date.issued.fl_str_mv 2010
dc.date.accessioned.fl_str_mv 2018-03-27T18:37:43Z
dc.date.available.fl_str_mv 2018-03-27T18:37:43Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv LAMAS, Eugenia et al. A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects. Journal of Medical Ethics, v.36, n.12, p.750-753, 2010
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/25537
dc.identifier.issn.pt_BR.fl_str_mv 0306-6800
dc.identifier.doi.none.fl_str_mv 10.1136/jme.2009.035097
dc.identifier.eissn.none.fl_str_mv 1473-4257
identifier_str_mv LAMAS, Eugenia et al. A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects. Journal of Medical Ethics, v.36, n.12, p.750-753, 2010
0306-6800
10.1136/jme.2009.035097
1473-4257
url https://www.arca.fiocruz.br/handle/icict/25537
dc.language.iso.fl_str_mv eng
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dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Institute of Medical Ethics
publisher.none.fl_str_mv Institute of Medical Ethics
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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