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Consentimiento informado para la investigación basada en la población que involucra genética.

L M Beskow1, W Burke, J F Merz

  • 1Office of Genetics and Disease Prevention, Centers for Disease Control and Prevention, 4770 Buford Hwy NE, MS K-28, Atlanta, GA 30341-3724, USA. laura_beskow@unc.edu

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El desarrollo de directrices para la investigación genética es crucial. Este enfoque asegura que los participantes comprendan los riesgos y beneficios de la variación genética en los estudios de población.

Palabras clave:
Investigaciones biomédicas y conductuales.Genética y reproducción.

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Área de la Ciencia:

  • Genética La genética.
  • Bioética y bioética.
  • Salud Pública La salud pública.

Sus antecedentes:

  • La investigación genética basada en la población requiere directrices éticas específicas distintas de los estudios basados en la familia.
  • La comprensión de las variantes genéticas y las interacciones entre genes y entorno es clave para la predicción del riesgo de enfermedad.
  • Las variantes genéticas de menor penetración presentan consideraciones únicas en la investigación genética.

Objetivo del estudio:

  • Desarrollar un enfoque de consentimiento informado para la investigación genética basada en la población.
  • Abordar la necesidad de directrices sobre la integración de datos de variación genética en la investigación.
  • Facilitar la toma de decisiones informadas para los participantes en estudios genéticos.

Principales métodos:

  • Convocó a un grupo multidisciplinario en los Centros para el Control y la Prevención de Enfermedades.
  • Utilizó la opinión de expertos, las regulaciones federales y los informes éticos y la literatura existentes.
  • Se desarrolló un lenguaje sugerido para documentos de consentimiento informado y folletos complementarios.

Principales resultados:

  • Creó un marco de consentimiento informado que enfatiza el vínculo entre la interpretación de los resultados y los resultados de salud.
  • Propuso que los procesos de consentimiento deberían evaluar la probabilidad de generar intervenciones procesables y basadas en evidencia.
  • Lenguaje generado para formularios de consentimiento y folletos para ayudar a la comprensión de los participantes.

Conclusiones:

  • El enfoque de consentimiento informado propuesto tiene como objetivo mejorar la comprensión de los participantes en la investigación genética.
  • Alienta a la discusión sobre las mejores prácticas para el consentimiento informado en genética de poblaciones.
  • Proporciona consideraciones para los patrocinadores de la investigación, IRBs e investigadores con respecto a la ética de la investigación genética.