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La revisión de 2000 de la Declaración de Helsinki: ¿un paso adelante o más confusión?
H P Forster1, E Emanuel, C Grady
1Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Lancet (London, England)
|November 14, 2001
Resumen
La Asociación Médica Mundial es el organismo
Área de la Ciencia:
- Ética médica y ética médica.
- Ética en la investigación clínica Ética en la investigación clínica
Sus antecedentes:
- La Declaración de Helsinki guía las prácticas éticas de la investigación.
- Las revisiones anteriores ocurrieron en 1975.
- La revisión de 2000 siguió a la controversia pública en la investigación clínica.
Objetivo del estudio:
- Para analizar el proceso de revisión de 2000 de la Declaración de Helsinki.
- Examinar los principales cambios en la quinta revisión.
- Proporcionar un examen exhaustivo de la evolución de las normas éticas.
Principales métodos:
- Análisis del proceso de revisión de la Quinta Declaración de Helsinki.
- Examen de la quinta revisión adoptada en octubre de 2000.
- Revisión del contexto histórico y las controversias públicas.
Principales resultados:
- La quinta revisión (2000) representa los cambios más sustanciales desde 1975.
- El proceso de revisión tuvo como objetivo corregir las deficiencias y la evolución de las normas éticas.
- La revisión de 2000 dio lugar a una versión controvertida de la declaración.
Conclusiones:
- La revisión de la Declaración de Helsinki de 2000 requiere un examen exhaustivo más allá de los ensayos controlados con placebo.
- Comprender el proceso de revisión es crucial para la supervisión ética de la investigación.
- Las normas éticas en la investigación médica están sujetas a continua evolución y debate.
Palabras clave:
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