Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica

The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law...

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Autores principales:	Oyarzún G,Manuel, Pinto C,María Eugenia, Raineri B,Gina G, Amigo,Hugo, Cifuentes O,Lucía, González,María Julieta, Horwitz,Nina, Marshall F,Claudia, Orellana V,Gricel
Lenguaje:	Spanish / Castilian
Publicado:	Sociedad Médica de Santiago 2014
Materias:	Ethics Committees, research Ethics, research Professional staff committees
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872014000700009
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spelling	oai:scielo:S0034-988720140007000092014-12-10Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médicaOyarzún G,ManuelPinto C,María EugeniaRaineri B,Gina GAmigo,HugoCifuentes O,LucíaGonzález,María JulietaHorwitz,NinaMarshall F,ClaudiaOrellana V,Gricel Ethics Committees, research Ethics, research Professional staff committees The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.142 n.7 20142014-07-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872014000700009es10.4067/S0034-98872014000700009
institution	Scielo Chile
collection	Scielo Chile
language	Spanish / Castilian
topic	Ethics Committees, research Ethics, research Professional staff committees
spellingShingle	Ethics Committees, research Ethics, research Professional staff committees Oyarzún G,Manuel Pinto C,María Eugenia Raineri B,Gina G Amigo,Hugo Cifuentes O,Lucía González,María Julieta Horwitz,Nina Marshall F,Claudia Orellana V,Gricel Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica
description	The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.
author	Oyarzún G,Manuel Pinto C,María Eugenia Raineri B,Gina G Amigo,Hugo Cifuentes O,Lucía González,María Julieta Horwitz,Nina Marshall F,Claudia Orellana V,Gricel
author_facet	Oyarzún G,Manuel Pinto C,María Eugenia Raineri B,Gina G Amigo,Hugo Cifuentes O,Lucía González,María Julieta Horwitz,Nina Marshall F,Claudia Orellana V,Gricel
author_sort	Oyarzún G,Manuel
title	Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica
title_short	Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica
title_full	Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica
title_fullStr	Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica
title_full_unstemmed	Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica
title_sort	experiencia del comité de ética de investigación en seres humanos de la facultad de medicina de la universidad de chile y los desafíos que impone la nueva legislación chilena en la investigación médica
publisher	Sociedad Médica de Santiago
publishDate	2014
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872014000700009
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Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica

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