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Evaluar los riesgos de la investigación clínica.

Annette Rid1, Ezekiel J Emanuel, David Wendler

  • 1Department of Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA.

JAMA
|October 7, 2010
PubMed
Resumen

La protección de los participantes de la investigación clínica requiere un enfoque sistemático para la evaluación de riesgos. El método de Evaluación Sistemática de Riesgos de Investigación (SERR) minimiza los sesgos cognitivos para una mejor seguridad de los participantes.

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Área de la Ciencia:

  • Ética de la investigación clínica Ética de la investigación clínica
  • Metodologías de evaluación de riesgos Metodologías de evaluación de riesgos.
  • El sesgo cognitivo en la investigación.

Sus antecedentes:

  • La investigación clínica ética depende de proteger a los participantes de riesgos indebidos.
  • La evaluación de riesgos actual se basa en juicios intuitivos, susceptibles a sesgos cognitivos.
  • La falta de un marco sistemático compromete la protección de los participantes.

Objetivo del estudio:

  • Introducir un nuevo método, la Evaluación Sistemática de Riesgos de la Investigación (SERR, por sus siglas en inglés), para evaluar objetivamente los riesgos de la investigación.
  • Mitigar el impacto de los sesgos cognitivos en la evaluación de la seguridad de los participantes.
  • Mejorar el rigor ético de la supervisión de la investigación clínica.

Principales métodos:

  • SERR implica un proceso de 4 pasos para evaluar los riesgos de las intervenciones de investigación.
  • Paso 1: Identificar los daños potenciales de la intervención de investigación.
  • Paso 2: Categorizar la magnitud del daño utilizando una escala de 7 niveles.
  • Paso 3: Cuantificar o estimar la probabilidad de cada daño.
  • Paso 4: Compare las probabilidades de daño de la investigación con las actividades de comparador aceptables.

Principales resultados:

  • SERR proporciona un marco estructurado para la evaluación de riesgos.
  • Delinear, cuantificar y comparar explícitamente los riesgos reduce el sesgo subjetivo.
  • El método facilita evaluaciones de riesgos más consistentes y confiables.

Conclusiones:

  • SERR ofrece un enfoque sistemático para minimizar el sesgo cognitivo en la evaluación de riesgos de la investigación.
  • Este método mejora la protección de los participantes de la investigación clínica de riesgos excesivos.
  • La implementación de SERR puede mejorar la supervisión ética de los estudios de investigación.