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Persona y Bioética

versión impresa ISSN 0123-3122

Resumen

SUAREZ-OBANDO, Fernando et al. Characterization of a Group of Research Ethics Committees in Colombia. pers.bioét. [online]. 2018, vol.22, n.2, pp.303-318. ISSN 0123-3122.  http://dx.doi.org/10.5294/pebi.2018.22.2.8.

In 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.

Palabras clave : Research Ethics Committees; research; ethical review; clinical protocols.

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