Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

Informed Consent Template for Clinical Studies

CONSENTIMIENTO INFORMADO

IDENTIFICADORES GENERALES

Nombre del investigador principal:_____________________________________________________

Organización responsable:_____________________________________________________________
Patrocinador:________________________________________________________________________
Título de la investigación:______________________________________________________________
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Versión de la investigación:____________________________________________________________
Grupo al que está dirigido el consentimiento informado:
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PARTE I: INFORMACIÓN

Introducción
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Propósito
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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

Tipo de intervención de investigación

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Selección de participantes
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Participación voluntaria
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Información sobre el fármaco en ensayo o:

 Nombre del fármaco:__________________________________________________________
 Información básica:____________________________________________________________
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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

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Procedimientos y Protocolo
A. Procedimientos desconocidos
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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

B. Descripción del Proceso

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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

Duración
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Efectos secundarios
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Riesgos
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Molestias
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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

Beneficios
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Incentivos
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Confidencialidad
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Compartiendo los Resultados

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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

Derecho a negarse o retirarse

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Alternativas a la participación
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A quién contactar
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Esta propuesta ha sido revisada y aprobada por:

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que es un comité cuya tarea es asegurarse de que se protege de daños a los participantes en la
investigación. Si usted desea averiguar más sobre este comité, contacte a:
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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

PARTE II: FORMULARIO DE CONSENTIMIENTO

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He leído la información proporcionada o me ha sido leída. He tenido la oportunidad de preguntar

sobre ella y se me ha contestado satisfactoriamente las preguntas que he realizado. Consiento
voluntariamente participar en esta investigación como participante y entiendo que tengo el derecho
de retirarme de la investigación en cualquier momento sin que me afecte en ninguna manera mi
cuidado médico.

Firma del Participante ________________________________________

Nombre del Participante_______________________________________

Fecha (Día/mes/año)___________________________________________

Huella dactilar del participante

Consiento voluntariamente que mi niño/a participe en este estudio y entiendo que tengo el derecho
de retirar del estudio mi niño/a en cualquier momento sin que afecte de ninguna forma mi
atención médica ni la de mi niño/a.

Firma del Padre/Madre o Apoderado ___________________________________________________

Nombre del Padre/Madre o Apoderado __________________________________________________

Fecha (Día/mes/año)___________________________________________________________________

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 Nombre del departamento responsable:

Logo Nombre del Proceso:

Código:
institucional
Nombre del Documento: Versión:
Consentimiento informado Fecha:

He sido testigo de la lectura exacta del documento de consentimiento para el potencial participante y
el individuo ha tenido la oportunidad de hacer preguntas. Confirmo que el individuo ha dado
consentimiento libremente.

Firma del testigo _____________________________________________________________________

Nombre del testigo____________________________________________________________________

Fecha (Día/mes/año)___________________________________________________________________

Firma del testigo _____________________________________________________________________

Nombre del testigo____________________________________________________________________

Fecha (Día/mes/año)___________________________________________________________________

He leído con exactitud o he sido testigo de la lectura exacta del documento de consentimiento
informado para el potencial participante y el individuo ha tenido la oportunidad de hacer preguntas.
Confirmo que el individuo ha dado consentimiento libremente.

Firma del Investigador _______________________________________________________________

Nombre del Investigador______________________________________________________________

Fecha (Día/mes/año)__________________________________________________________________

Ha sido proporcionada al participante una copia de este documento de Consentimiento

Informado.

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