Formas de Revisión Ética de Proyectos de Investigación Biomédica

Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience wi...

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Autores principales: Portales,María Bernardita, Michaud,Patricio, Salas,Sofía P, Beca,Juan Pablo
Lenguaje:Spanish / Castilian
Publicado: Sociedad Médica de Santiago 2017
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Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872017000300014
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spelling oai:scielo:S0034-988720170003000142017-05-18Formas de Revisión Ética de Proyectos de Investigación BiomédicaPortales,María BernarditaMichaud,PatricioSalas,Sofía PBeca,Juan Pablo Bioethics Ethics Committees, Research Ethics, Institutional Ethics, Research Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.145 n.3 20172017-03-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872017000300014es10.4067/S0034-98872017000300014
institution Scielo Chile
collection Scielo Chile
language Spanish / Castilian
topic Bioethics
Ethics Committees, Research
Ethics, Institutional
Ethics, Research
spellingShingle Bioethics
Ethics Committees, Research
Ethics, Institutional
Ethics, Research
Portales,María Bernardita
Michaud,Patricio
Salas,Sofía P
Beca,Juan Pablo
Formas de Revisión Ética de Proyectos de Investigación Biomédica
description Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.
author Portales,María Bernardita
Michaud,Patricio
Salas,Sofía P
Beca,Juan Pablo
author_facet Portales,María Bernardita
Michaud,Patricio
Salas,Sofía P
Beca,Juan Pablo
author_sort Portales,María Bernardita
title Formas de Revisión Ética de Proyectos de Investigación Biomédica
title_short Formas de Revisión Ética de Proyectos de Investigación Biomédica
title_full Formas de Revisión Ética de Proyectos de Investigación Biomédica
title_fullStr Formas de Revisión Ética de Proyectos de Investigación Biomédica
title_full_unstemmed Formas de Revisión Ética de Proyectos de Investigación Biomédica
title_sort formas de revisión ética de proyectos de investigación biomédica
publisher Sociedad Médica de Santiago
publishDate 2017
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872017000300014
work_keys_str_mv AT portalesmariabernardita formasderevisioneticadeproyectosdeinvestigacionbiomedica
AT michaudpatricio formasderevisioneticadeproyectosdeinvestigacionbiomedica
AT salassofiap formasderevisioneticadeproyectosdeinvestigacionbiomedica
AT becajuanpablo formasderevisioneticadeproyectosdeinvestigacionbiomedica
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