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Ensayos clínicos controlados y ética médica
Lancet (London, England)
|December 23, 1978
Resumen
Las cuestiones legales y éticas que rodean los ensayos clínicos controlados en Alemania son una preocupación creciente. La introducción de un contrato para la experimentación puede resolver conflictos entre el beneficio individual del paciente y los requisitos del ensayo.
Área de la Ciencia:
- Derecho médico Derecho médico.
- Bioética y bioética.
Sus antecedentes:
- La atención pública en Alemania se ha centrado en los aspectos legales y éticos de los ensayos clínicos controlados en los últimos cinco años.
- Las obligaciones del médico en virtud de los contratos de tratamiento pueden entrar en conflicto con los requisitos éticos de los ensayos controlados, lo que podría obstaculizar su ejecución.
Objetivo del estudio:
- Examinar los desafíos legales y éticos planteados por los ensayos clínicos controlados en la República Federal de Alemania.
- Explorar posibles soluciones para superar las barreras éticas y legales en la conducción de ensayos clínicos.
Principales métodos:
- Análisis de los marcos legales y éticos que rigen los ensayos clínicos.
- Revisión de los contratos de tratamiento médico-paciente existentes y sus implicaciones para la investigación.
Principales resultados:
- Los contratos de tratamiento estándar pueden crear dilemas éticos para los médicos en ensayos controlados.
- El principio de beneficio individual en los contratos de tratamiento puede entrar en conflicto con la necesidad de datos comparativos en los ensayos.
Conclusiones:
- Puede ser necesario un "contrato de experimentación" distinto para navegar las complejidades legales y éticas de los ensayos clínicos controlados.
- La implementación de un contrato especializado podría ayudar a conciliar las obligaciones del médico con los protocolos de ensayo, asegurando la conducta ética y el cumplimiento legal.
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