El consentimiento informado

-Por la Dra. Lida Sanmartín-

La Organización Panamericana de la Salud describe este momento decisorio y documentado de la relación asistencial encuadrándolo dentro del concepto de «buenas prácticas» definiéndolo como «el proceso mediante el cual un sujeto confirma voluntariamente su deseo de participar en un estudio en particular después de haber sido informado sobre todos los aspectos de éste que sean relevantes para que tome la decisión de participar. El consentimiento informado se documenta por medio de un formulario de consentimiento informado escrito, firmado y fechado .»

El nuevo Código CyC distingue dentro del consentimiento informado entre el que refiere a investigación en ser humanos (investigaciones clínicas o pruebas científicas) y el acto médico en concreto.

En los artículos 58 y 59 no pueden ser entendidos por separado, son el resumen preceptos que ya imperaban en la actividad de médicos y profesionales afines, así como en la investigación clínica, por ello en principio se puede sostener que no traerán aparejados grandes cambios para quienes llevaban a cabo sus actividades dentro de lo normado por esos principios rectores.

«ARTÍCULO 58.- Investigaciones en seres humanos.(también aplicable a todo acto médico) Inc. f. contar con el consentimiento previo, libre, escrito, informado y específico de la persona que participa en la investigación, a quien se le debe explicar, en términos comprensibles, los objetivos y la metodología de la investigación, sus riesgos y posibles beneficios; dicho consentimiento es revocable;…»

El inc. «F» prevé el Consentimiento Informado (CI) condición «sine quanon» de todo lo que seguirá una vez aprobada un protocolo de investigación en seres humanos. Si bien no lo define establece como debe obtenérselo (previo), que requisitos debe cumplir (libre, escrito sobre cada participante en particular), y qué recaudos deben quedar acreditados (informado, explicar comprensiblemente los objetivos, métodos, riesgos y beneficios) por lo que entendemos es una obligación de cumplimiento exclusiva de los profesionales de la salud.

Sostenemos que este es el documento más importante para el paciente, será en el que refleje su decisión y el fundamento de la misma. Es además -a nuestro entender- el momento en que el paciente (sujeto a investigación) sopesará su estado de salud con la información propia de la investigación donde deberá encontrar respuestas a interrogantes tales como: sobre qué, de qué manera, por quienes, con que propósito y con qué expectativa, o qué resultados se espera de la misma.

El consentimiento informado para actos medico. Alcance y revocabilidad.

El artículo 59 del nuevo Código Civil nos coloca frente al documento rector en todo acto médico e investigaciones clínicas: El Consentimiento informado.

El artículo es redactado en un intento de sistematizar la normativa especial procurando un marco normativo orgánico e integrado. Se inspira en las leyes de Derechos del Paciente.

El consentimiento, como ya hemos afirmado, es de vital importancia en la relación del médico con su paciente, pues conlleva para el médico -y demás profesionales de la salud- además de la prestación del servicio profesional, el consecuente trato digno y respetuoso, la información sanitaria, preservar su intimidad y confidencialidad. Estos derechos del paciente son esenciales y no se acota en el accionar del médico sino que se extiende en la relación entre profesionales de la salud, los efectores, los seguros médicos y el paciente. Y la observancia de estos valores en la relación tratado- tratantes será la fuente de éxitos o responsabilidades frente a los tratamientos y actos médicos indicados.

«ARTÍCULO 59.- Consentimiento informado para actos médicos e investigaciones en salud. El consentimiento informado para actos médicos e investigaciones en salud es la declaración de voluntad expresada por el paciente, emitida luego de recibir información clara, precisa y adecuada, respecto a:

  1. su estado de salud;
  2. el procedimiento propuesto, con especificación de los objetivos perseguidos;
  3. los beneficios esperados del procedimiento;
  4. los riesgos, molestias y efectos adversos previsibles;
  5. la especificación de los procedimientos alternativos y sus riesgos, beneficios y perjuicios en relación con el procedimiento propuesto;…»

Entendemos que el legislador en este artículo no soslaya el proceso pero se refiere más concretamente al documento que suscribirá el paciente cuando dice » es la declaración de voluntad expresada» es decir rubricada luego del proceso de información y decisión.

Lo que queda claro es que el legislador ha sido tajante sobre la obligatoriedad del consentimiento informado como base de cualquier práctica en salud al decir: «Nadie puede ser sometido a exámenes o tratamientos clínicos o quirúrgicos sin su consentimiento libre e informado, excepto disposición legal en contrario.»

El artículo es muy concreto y surge indiscutible que para llevar adelante todo acto médico (exámenes o tratamientos diagnósticos, clínicos o quirúrgicos) deberá estarse a su cumplimiento.


Referencias de la autora

Abogada. Asesora. Derecho Universitario. Derecho a la Salud. Facilitadora en temas de derecho Sanitario. Especialista en Administración del Sector Público. Asesora de la Secretaría Asistencial de APUBA. Consultoría de Trabajadores y trabajadoras universitarios del área asistencial. Estudio comparativo, planificación y proyección de reglamentaciones. Capacitación sector Asistencial. Ex Directora de Personal Universidad de Buenos Aires, Facultad de Ciencias Médicas. Dirección de Personal. Áreas de dependencia: DG Administración y Secretaria de Hacienda.

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