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2019, Número 1

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Revista Colombiana de Bioética 2019; 14 (1)


Los Comités de Ética en Investigación y la Protección de los Sujetos que Participan en Ensayos Clínicos

Homedes N, Ugalde A

Idioma: Español
Referencias bibliográficas: 59
Paginas: 146-160
Archivo PDF: 263.04 Kb.


RESUMEN

Introducción: La responsabilidad por proteger a los seres humanos que participan en investigación ha sido delegada a los Comités de Ética de Investigación. La industria y los investigadores consideran que los CEI retrasan innecesariamente el inicio de la investigación y los bioeticistas dicen que no tienen los recursos para realizar sus funciones. El objetivo de este artículo es identificar las carencias y problemas que afectan el desempeño de los CEI que aprueban protocolos de ensayos clínicos financiados por la industria y las soluciones propuestas.
Métodos: Revisión de la literatura que describe las características de los CEI ubicados en países de altos ingresos que revisan ensayos clínicos financiados por la industria, su desempeño y las sugerencias de fortalecimiento.
Resultados: Los problemas que afectan el funcionamiento de los CEI se conocen desde finales del siglo pasado, tanto entidades reguladoras como investigadores han propuesto formas de fortalecerlos, pero solo unas pocas se han intentado y ninguna se ha institucionalizado. Llama la atención que todavía no haya estándares de formación mínima para los miembros de los CEI, ni se les haya dotado de recursos para monitorear adecuadamente la implementación de los ensayos.
Conclusiones: La necesidad de profesionalizar los CEI beneficia a la industria. Los CEI, al revisar protocolos y monitorear la implementación de los ensayos clínicos y hablar con los sujetos, pueden detectar comportamientos que afectan la calidad de la información recabada y la seguridad de los voluntarios.


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