Characterization of a Group of Research Ethics Committees in Colombia ; Caracterización de un grupo de comités de ética en investigación en Colombia ; Caracterização de um grupo de comitês de ética em pesquisa na Colômbia

Caracterización de un grupo de comités de ética en investigación en ColombiaCaracterização de um grupo de comitês de ética em pesquisa na ColômbiaIn 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.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 ; Characterization of a Group of Research Ethics Committees in ColombiaCaracterização de um grupo de comitês de ética em pesquisa na ColômbiaEn 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 ...