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


Palabras clave

Ensayos Clínicos
Comités de Ética

Cómo citar

Homedes, N., & Ugalde, A. (2019). Los Comités de Ética en Investigación y la Protección de los Sujetos que Participan en Ensayos Clínicos. Revista Colombiana De Bioética, 14(1). https://doi.org/10.18270/rcb.v14i1.2430


Introducción. La responsabilidad por proteger a los seres humanos que participan en investigación recae sobre los Comités de Ética de Investigación. La industria y los investigadores consideran que los CEIs retrasan innecesariamente el inicio de la investigación y los bioeticistas dicen que no tienen los recursos para realizar sus funciones. El objetivo del estudio es identificar las carencias y problemas que afectan el desempeño de los CEIs 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 CEIs ubicados en países de altos ingresos, y que revisan ensayos clínicos financiados por la industria, su desempeño y las sugerencias de fortalecimiento.


Resultados. Los problemas que afectan el funcionamiento de los CEIs 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 CEIs, ni se les haya dotado de recursos para monitorear adecuadamente la implementación de los ensayos.


Conclusiones. La necesidad de profesionalizar los CEIs beneficia a la industria, pues al hacer el monitoreo 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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