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dc.contributor.authorSuárez-Obando, Fernando
dc.contributor.authorReynales, Humberto
dc.contributor.authorUrina, Miguel
dc.contributor.authorCamacho, Jairo
dc.contributor.authorViteri, Mónica
dc.date.accessioned2019-01-15T16:18:45Z
dc.date.available2019-01-15T16:18:45Z
dc.date.issued2018-07
dc.identifier.issn01233122
dc.identifier.urihttp://hdl.handle.net/20.500.12442/2440
dc.description.abstractEn las últimas décadas, los ensayos clínicos controlados patrocinados por la industria farmacéutica han aumentado de manera considerable, lo cual ha llevado a que sea necesario un mayor control y acompañamiento por parte de las entidades reguladoras, y de los comités de ética, para garantizar el adecuado cumplimiento de las normas éticas establecidas y de las buenas prácticas clínicas en general. En Colombia, el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), la entidad reguladora en el país, reglamenta y vigila el funcionamiento de la investigación clínica con medicamentos. En el 2008, esta entidad emitió la Resolución 2378, normatividad bajo la cual se establecen y regulan los diferentes actores de la investigación en Colombia, incluidos los comités de ética. Después de varios años de vigencia de esta norma, es necesario conocer si los comités de ética en investigación en Colombia funcionan de acuerdo con esta normativa, y determinar el estado de la implementación de lo solicitado en la regulación. Con este objetivo se diseñó una encuesta para ser respondida en forma voluntaria y se obtuvo respuesta de 25 de los 69 comités certificados en Colombia. El análisis fue posible en 22 de ellos cuya información estaba completa. En comparación con estudios anteriores, se observaron cambios favorables en el desarrollo y la organización de acuerdo con la norma actual propuesta.spa
dc.description.abstractIn the last decades, controlled clinical trials sponsored by the pharmaceutical industry have increased considerably. This has led to the need for greater control and assistance by regulators and ethics committees to ensure appropriate compliance with established ethical standards and good clinical practices in general. In Colombia, the National Food and Drug Surveillance Institute (INVIMA), the regulator in the country, controls and monitors the operation of clinical research with drugs. In 2008, this entity issued Resolution 2378, which provides and regulates research actors in Colombia, including ethics committees. After being in force for several years, it is necessary to know whether research ethics committees in Colombia operate in accordance with this regulation and to determine the status of implementation of the requirements therein. For this purpose, a survey was designed to be voluntarily answered and a response was obtained from 25 of the 69 certified committees in Colombia. Twenty-two of them could be analyzed because their information was complete. Compared with previous studies, favorable changes in development and organization were observed in accordance with the current proposed regulation.eng
dc.description.abstractNas últimas décadas, os ensaios clínicos controlados patrocinados pela indústria farmacêutica aumentaram consideravelmente, o que levou à necessidade de um maior controle e acompanhamento por entidades reguladoras e comitês de ética, para garantir o cumprimento adequado de normas éticas estabelecidas e boas práticas clínicas em geral. Na Colômbia, o Instituto Nacional de Vigilância de Medicamentos e Alimentos (Invima, na sigla em espanhol), órgão regulador no país, regulamenta e monitora o funcionamento da pesquisa clínica com medicamentos. Em 2008, essa entidade emitiu a Resolução 2378, que estabelece e regulamenta os diferentes atores da pesquisa na Colômbia, incluindo os comitês de ética. Depois de vários anos de vigência dessa norma, é necessário saber se os comitês de ética em pesquisa da Colômbia trabalham de acordo com este regulamento e determinar o estado da implementação do que é solicitado no regulamento. Com esse objetivo, uma pesquisa foi elaborada para ser respondida voluntariamente e uma resposta foi obtida de 25 dos 69 comitês certificados na Colômbia. A análise foi possível em 22 deles, cuja informação estava completa. Em comparação com estudos anteriores, mudanças favoráveis no desenvolvimento e organização foram observadas de acordo com a norma atual proposta.por
dc.language.isospaspa
dc.publisherUniversidad de la Sabanaspa
dc.sourcePERSONA Y BIOÉTICAspa
dc.sourceVol. 22, No. 2 (2018): Julio - Diciembrespa
dc.source.urihttps://doi.org/10.5294/pebi.2018.22.2.8spa
dc.subjectComités de ética en investigaciónspa
dc.subjectInvestigaciónspa
dc.subjectRevisión éticaspa
dc.subjectProtocolos clínicosspa
dc.subjectResearch Ethics Committeeseng
dc.subjectResearcheng
dc.subjectEthical revieweng
dc.subjectClinical protocolseng
dc.subjectComissão de ética em pesquisapor
dc.subjectPesquisapor
dc.subjectRevisão éticapor
dc.subjectProtocolos clínicospor
dc.titleCaracterización de un grupo de comités de ética en investigación en Colombiaspa
dc.title.alternativeCharacterization of a group of research ethics committees in Colombiaeng
dc.title.alternativeCaracterização de um grupo de comitês de ética em pesquisa na Colômbiapor
dc.typearticlespa
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