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  1. HHS
  2. OHRP
  3. Education & Outreach
  4. Participating in Human R…
  5. Protegiendo A Los Voluntarios Que …
  6. Otras Investigaciones
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¿Hay investigaciones que no sean controladas por la Common Rule?

Esta página proporciona una descripción general de las leyes y regulaciones que proyectan voluntarios que participan en estudios de investigación clínica. Las pestañas dentro de la página describen por qué tenemos regulaciones para proteger a los participantes de la investigación; cuáles son las principales regulaciones que protegen a los participantes de la investigación; qué oficina federal supervisa y hace cumplir las regulaciones del HHS; qué investigación no está regulada por la Regla Común, la ley que gobierna la investigación que involucra humanos; y cómo proteger a los humanos en la investigación clínica es una responsabilidad compartida.
¿Por qué tenemos reglamentos para proteger a las personas que participan en investigaciones?
¿POR QUÉ LOS REGLAMENTOS?
¿Cuáles son los reglamentos más importantes que protegen a los participantes?
REGLAMENTOS PRINCIPALES
¿Qué oficina federal supervisa y hace cumplir los reglamentos del HHS?
¿QUIÉN SUPERVISA
Y HACE CUMPLIR?
¿Hay investigaciones que no sean controladas por la Common Rule?
OTRAS INVESTIGACIONES
La protección de los voluntarios es una responsabilidad compartida
RESPONSABILIDAD COMPARTIDA
 

¿Hay investigaciones que no sean controladas por la Common Rule?

Muchas investigaciones no caen bajo la Common Rule. Un ejemplo de esto son las investigaciones patrocinadas por fondos privados, tal como compañías privadas, fundaciones caritativas, o individuos adinerados. Puede que hasta algunas investigaciones que son auspiciadas con fondos estatales o federales tampoco caigan bajo la Common Rule.

Printable PDF

Algunas investigaciones no caen bajo la supervisión de OHRP


Aun cuando no se requiere que ciertas investigaciones cumplan con la Common Rule, puede que hayan otros reglamentos que provean protecciones.

Por ejemplo, las compañías farmacéuticas que estudian medicamentos nuevos y planifican venderlos en los EEUU tienen que cumplir con los reglamentos para proteger a los seres humanos de la Administración de Alimentos y Fármacos (FDA) de los EEUU. Los reglamentos del FDA son similares a los de la Common Rule. El FDA protege la salud pública a mediado de la supervisión de la seguridad y eficacia de los medicamentos, productos biológicos, y dispositivos médicos, tales como las válvulas cardíacas. También es responsable de promover la salud pública, ayudándole al público en general a recibir la información que necesita para usar productos médicos y mantener o mejorar su salud de manera correcta y basada en datos científicos.

Por último, muchas instituciones aplican voluntariamente las protecciones de la Common Rule, aun cuando sus investigaciones no caen bajo la supervisión de la OHRP.
 
PREVIAPREVIA
PRÓXIMAPRÓXIMA
HHS y OHRP
Protegiendo a los seres humanos que participan en investigacione
Content last reviewed October 16, 2023
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