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Marco ético para FACILITATE: una base para la devolución de los datos de los ensayos clínicos a los participantes

Ciara Staunton1,2, Johanna M C Blom3,4, Deborah Mascalzoni1,5

  • 1Eurac Research, Institute for Biomedicine, Bolzano, Italy.

Frontiers in medicine
|August 1, 2024
PubMed

Este artículo analiza la importancia de la devolución de los datos de los ensayos clínicos a los pacientes en el contexto del proyecto FACILITATE, cuyo objetivo es desarrollar un enfoque centrado en el participante para la devolución sistemática de los datos individuales de los ensayos clínicos. Reflexiona sobre la necesidad de un marco ético que respalde la devolución de dichos datos. La discusión gira en torno al marco ético en desarrollo de FACILITATE, centrándose específicamente en los principios éticos que constituyen la base del marco y en las directrices sobre cómo implementar esos principios en la práctica.

Palabras clave:
ensayos clínicostoma de decisionesintercambio de datos de saludconsentimiento informadodevolución de los datos de ensayos clínicos

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