Obtaining certified human cells. A challenge of biometrology

Detalhes bibliográficos
Autor(a) principal: Carias, Rosana Bizon
Data de Publicação: 2014
Outros Autores: Borojevic, Radovan, Granjeiro, José Mauro
Tipo de documento: Artigo
Idioma: por
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/311
Resumo: Biotechnology applied to health requires human cells for quality controls of products and for toxicological assessment of molecules that enter in contact with human body. Validated alternative methods allowed reduction and/or replacement of animal use in toxicology, but the Brazilian legislation on the use of biological materials of human ori-gin does not provide human cells with controlled and certified quality.The critical analysis conducted in the Brazilian’ legislation on legal ways of access to human biological materials for obtaining, characterization and availability of hu-man cells, from the period of the Federal Constitution in 1988 until May 2014, showed that Brazilian society lacks rules for collection and use of human biological materials, including supply of cells, either for therapeutic use or for in vitro assays including the alternative methods for toxicology.We propose a model for providing human biological materials such as cells, tissues, organs or body parts for research, toxicological or therapeutic use similar to the model of the surplus production of blood and its derivatives.
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spelling Obtaining certified human cells. A challenge of biometrologyObtenção de células humanas certificadas. Um desafio da biometrologiaHealth LegislationRegulationAlternative MethodsOrgan DonationBiotechnologyBlood ProductsTransplantationLegislação SanitáriaRegulaçãoMétodos AlternativosDoação de ÓrgãosBiotecnologiaHemoderivadosTransplanteBiotechnology applied to health requires human cells for quality controls of products and for toxicological assessment of molecules that enter in contact with human body. Validated alternative methods allowed reduction and/or replacement of animal use in toxicology, but the Brazilian legislation on the use of biological materials of human ori-gin does not provide human cells with controlled and certified quality.The critical analysis conducted in the Brazilian’ legislation on legal ways of access to human biological materials for obtaining, characterization and availability of hu-man cells, from the period of the Federal Constitution in 1988 until May 2014, showed that Brazilian society lacks rules for collection and use of human biological materials, including supply of cells, either for therapeutic use or for in vitro assays including the alternative methods for toxicology.We propose a model for providing human biological materials such as cells, tissues, organs or body parts for research, toxicological or therapeutic use similar to the model of the surplus production of blood and its derivatives.A biotecnologia aplicada à saúde necessita de células humanas para controle de qualidade de produtos e para análise toxicológica das moléculas que entram em contato com o corpo humano. Métodos alternativos validados promovem redução e substituição do uso de animais nos ensaios toxicológicos, mas a legislação brasileira referente ao uso de material biológico humano não prevê disponibilização de células com qualidade controlada e certificada.A análise crítica da legislação brasileira sobre vias de acesso legal a materiais biológicos humanos para obtenção, caracterização e disponibilização de células humanas, abrangendo o período da Constituição Federal de 1988 até o mês de maio de 2014, evidencia que a sociedade Brasileira carece de regulamentação para coleta e uso de material biológico humano incluindo o fornecimento de células para fins terapêuticos ou para utilização na aplicação dos métodos alternativos.Propomos como modelo para disponibilização de materiais biológicos humanos como células, tecidos, órgãos ou partes do corpo humano para fins de pesquisa, ensaios toxicológicos e uso terapêutico o mesmo modelo de oferta do excedente de sangue e seus derivados.Instituto Nacional de Controle de Qualidade em Saúde2014-08-28info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/31110.3395/vd.v2n3.311Health Surveillance under Debate: Society, Science & Technology ; Vol. 2 No. 3 (2014): August; 2-12Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 3 (2014): Agosto; 2-12Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 3 (2014): Agosto; 2-122317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/311/129Copyright (c) 2014 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessCarias, Rosana BizonBorojevic, RadovanGranjeiro, José Mauro2023-06-27T14:57:33Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/311Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T14:57:33Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Obtaining certified human cells. A challenge of biometrology
Obtenção de células humanas certificadas. Um desafio da biometrologia
title Obtaining certified human cells. A challenge of biometrology
spellingShingle Obtaining certified human cells. A challenge of biometrology
Carias, Rosana Bizon
Health Legislation
Regulation
Alternative Methods
Organ Donation
Biotechnology
Blood Products
Transplantation
Legislação Sanitária
Regulação
Métodos Alternativos
Doação de Órgãos
Biotecnologia
Hemoderivados
Transplante
title_short Obtaining certified human cells. A challenge of biometrology
title_full Obtaining certified human cells. A challenge of biometrology
title_fullStr Obtaining certified human cells. A challenge of biometrology
title_full_unstemmed Obtaining certified human cells. A challenge of biometrology
title_sort Obtaining certified human cells. A challenge of biometrology
author Carias, Rosana Bizon
author_facet Carias, Rosana Bizon
Borojevic, Radovan
Granjeiro, José Mauro
author_role author
author2 Borojevic, Radovan
Granjeiro, José Mauro
author2_role author
author
dc.contributor.author.fl_str_mv Carias, Rosana Bizon
Borojevic, Radovan
Granjeiro, José Mauro
dc.subject.por.fl_str_mv Health Legislation
Regulation
Alternative Methods
Organ Donation
Biotechnology
Blood Products
Transplantation
Legislação Sanitária
Regulação
Métodos Alternativos
Doação de Órgãos
Biotecnologia
Hemoderivados
Transplante
topic Health Legislation
Regulation
Alternative Methods
Organ Donation
Biotechnology
Blood Products
Transplantation
Legislação Sanitária
Regulação
Métodos Alternativos
Doação de Órgãos
Biotecnologia
Hemoderivados
Transplante
description Biotechnology applied to health requires human cells for quality controls of products and for toxicological assessment of molecules that enter in contact with human body. Validated alternative methods allowed reduction and/or replacement of animal use in toxicology, but the Brazilian legislation on the use of biological materials of human ori-gin does not provide human cells with controlled and certified quality.The critical analysis conducted in the Brazilian’ legislation on legal ways of access to human biological materials for obtaining, characterization and availability of hu-man cells, from the period of the Federal Constitution in 1988 until May 2014, showed that Brazilian society lacks rules for collection and use of human biological materials, including supply of cells, either for therapeutic use or for in vitro assays including the alternative methods for toxicology.We propose a model for providing human biological materials such as cells, tissues, organs or body parts for research, toxicological or therapeutic use similar to the model of the surplus production of blood and its derivatives.
publishDate 2014
dc.date.none.fl_str_mv 2014-08-28
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/311
10.3395/vd.v2n3.311
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/311
identifier_str_mv 10.3395/vd.v2n3.311
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/311/129
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 2 No. 3 (2014): August; 2-12
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 3 (2014): Agosto; 2-12
Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 3 (2014): Agosto; 2-12
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
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