Caracterización de un grupo de comités de ética en investigación en Colombia

Fernando Suárez Obando; Humberto Reynales; Miguel Urina; Jairo Camacho; Mónica Viteri

doi:10.5294/pebi.2018.22.2.8

Autores

Fernando Suárez Obando Autor Pontificia Universidad Javeriana http://orcid.org/0000-0001-6336-5347
Humberto Reynales Autor CAIMED – Clinical Research Institute, Bogotá D.C, Colombia http://orcid.org/0000-0002-2301-7716
Miguel Urina Autor Fundación del Caribe para la Investigación Biomédica/ Universidad Simón Bolívar, Barranquilla, Colombia http://orcid.org/0000-0001-6003-4622
Jairo Camacho Autor Asociación de Laboratorios Farmacéuticos de Innovación y Desarrollo (AFIDRO) http://orcid.org/0000-0001-8960-2718
Mónica Viteri Autor Asociación para el avance de la investigación clínica en Colombia (AVANZAR) http://orcid.org/0000-0002-0054-9699

DOI:

https://doi.org/10.5294/pebi.2018.22.2.8

Palavras-chave:

Comités de ética en invetigación, investigación, revisión ética, protocolos clínicos

Resumo

Caracterización de un grupo de comités de ética en investigación en Colombia

Characterization of a Group of Research Ethics Committees in Colombia

Nas 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.

Para citar este artículo / To reference this article / Para citar este artigo

Suárez-Obando F, Reynales H, Urina M, Camacho J, Viteri M. Caracterización de un grupo de comités de ética en investigación en Colombia. pers. bioét. 2018; 22(2): 303-318. DOI: 10.5294/pebi.2018.22.2.8

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Biografia do Autor

Fernando Suárez Obando, Pontificia Universidad Javeriana

Profesor investigador de la Facultad de Medicina de la Pontificia Universidad Javeriana.

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