LAS INVESTIGACION CON RIESGO ___________Son aquellas en que las probabilidades de afectar al sujeto son significativas, entre las que se consideran: estudios radiológicos y con microondas, ensayos con nuevos dispositivos, estudios que incluyan procedimientos quirúrgicos, extracción de sangre 2% del volumen circulante en neonatos, amniocentesis y otras técnicas invasoras.
En él se establecen criterios científicos, éticos, tecnológicos y administrativos obligatorios en la elaboración, integración, uso, manejo, archivo, conservación, propiedad, titularidad y confidencialidad
La_____________ del sujeto de investigación: Asegurar que el sujeto de investigación continúe recibiendo el cuidado y tratamiento sin costo alguno, hasta que se tenga la certeza de que no hubo daños directamente relacionados con la investigación
profesional de la salud con la formación académica y experiencia probada en la materia, que le permitan dirigir la investigación que pretenda realizar
Es el encargado de revisar y aprobar la carta de consentimiento informado en materia de investigación, formulada por el investigador principal. Son multidisciplinarios, con profesionales de la salud de distintas especialidades
Esta norma, define los elementos mínimos que deben cumplir de manera obligatoria los investigadores que realizan esta actividad en seres humanos.
Verticales
Empleo de medicamentos o materiales, respecto de los cuales aún no se tenga evidencia científica suficiente de su eficiencia terapéutica se pretenda la modificación de las indicaciones terapéuticas
en un sujeto de investigación, con la finalidad de obtener información científica
La_________________________del sujeto de investigación: Se refiere al derecho a la protección de los datos personales del sujeto, al acceso, rectificación y cancelación de los mismos, así como a manifestar su oposición, en los términos que fijen la ley
INVESTIGACIÓN________Estudios prospectivos que emplean el riesgo de datos a través de procedimientos comunes en exámenes físicos o psicológicos de diagnósticos o tratamiento rutinarios.
INVESTIGACIÓN:___________-Estudios que emplean técnicas y métodos de investigación documental retrospectivos y aquéllos en los que no se realiza ninguna intervención o modificación intencionada en las variables fisiológicas, psicológicas y sociales de los individuos que participan en el estudio.
Define los criterios legales de la investigación en seres humanos en México
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