Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023
Descripción del Articulo
Introduction: The Declaration of Helsinki recognizes the importance of Institutional Research Ethics Committees (IREC) in experimental studies for consideration, comments and guidance; which has been included in international and Peruvian legislation as a standard of good clinical practice. This stu...
Autores: | , , , |
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Formato: | artículo |
Fecha de Publicación: | 2025 |
Institución: | Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo |
Repositorio: | Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo |
Lenguaje: | español |
OAI Identifier: | oai:cmhnaaa_ojs_cmhnaaa.cmhnaaa.org.pe:article/2500 |
Enlace del recurso: | https://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/2500 |
Nivel de acceso: | acceso abierto |
Materia: | Comité de Ética en Investigación Ensayo Clínico Acreditación Perú Ethics Committees, Research Clinical Trial Accreditation Peru |
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Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023Comités Institucionales de Ética en Investigación que han Evaluado Ensayos Clínicos Contemplados en el Reglamento Peruano 2010-2023Rojas-Quiche, Katherine MilagrosRojas-Cama, Luis FelipeFuentes-Delgado, Duilio JesúsRoque-Henriquez, Joel ChristianComité de Ética en InvestigaciónEnsayo ClínicoAcreditaciónPerúEthics Committees, ResearchClinical TrialAccreditationPeruIntroduction: The Declaration of Helsinki recognizes the importance of Institutional Research Ethics Committees (IREC) in experimental studies for consideration, comments and guidance; which has been included in international and Peruvian legislation as a standard of good clinical practice. This study seeks to characterize the IREC that have evaluated clinical trials (CT) framed in the Peruvian Regulation, period 2010-2023. Material and methods: Secondary source. The population was the CT submitted to the National Institute of Health. Inclusion criteria: CT registered in the Peruvian Registry of Clinical Trials, and as exclusion criteria: i) CT with repeated registration, ii) registry without information on the IREC. A descriptive analysis was performed. Results: 927 CT were analyzed, which were evaluated by 36 IREC. The three IREC with the highest number of CT evaluated were private. The private IREC had as their main users private clinics that did not have IREC. Conclusion: There were 36 IREC that evaluated CT in the period 2010-2023. The three IREC that have evaluated the most CT are private. Private IREC do not usually have the research institutions to which they belong as users.Introducción: La Declaración de Helsinki reconoce la importancia de los Comités Institucionales de Ética en Investigación (CIEI) en estudios experimentales para su consideración, comentarios y orientación; el cual ha sido incluido en la legislación internacional y peruana como norma de buena práctica clínica. Este estudio busca caracterizar los CIEI que han evaluado ensayos clínicos (EC) enmarcados en el Reglamento peruano, periodo 2010-2023. Material y métodos: Estudio de fuente secundaria. La población fueron los EC sometidos al Instituto Nacional de Salud. Criterio de inclusión: EC registrado en el Registro Peruano de Ensayos Clínicos, y como criterios de exclusión: i) EC con registro repetido, ii) registro sin información sobre los CIEI. Se realizó un análisis descriptivo. Resultados: Se analizaron 927 EC, los cuales fueron evaluados por 36 CIEI. Los tres CIEI con mayor número de EC evaluados fueron privados. Los CIEI privados tuvieron como principales usuarios a clínicas particulares que no contaban con CIEI. Conclusión: Fueron 36 CIEI que evaluaron EC en el periodo 2010-2023. Los tres CIEI que más EC han evaluado son privados. Los CIEI privados no suelen tener a las instituciones de investigación a la cual pertenecen como usuarios.Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo2025-04-19info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/250010.35434/rcmhnaaa.2025.181.2500Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo; Vol. 18 No. 1 (2025): Early Publication; e2500Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo; Vol. 18 Núm. 1 (2025): Publicación Anticipada; e25002227-47312225-510910.35434/rcmhnaaa.2025.181reponame:Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjoinstname:Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjoinstacron:HNAAAspahttps://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/2500/1042https://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/2500/1044Derechos de autor 2025 Katherine Milagros Rojas Quiche, Luis Felipe Rojas Cama, Duilio Jesús Fuentes Delgado, Joel Christian Roque Henriquezhttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessoai:cmhnaaa_ojs_cmhnaaa.cmhnaaa.org.pe:article/25002025-03-25T06:19:50Z |
dc.title.none.fl_str_mv |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 Comités Institucionales de Ética en Investigación que han Evaluado Ensayos Clínicos Contemplados en el Reglamento Peruano 2010-2023 |
title |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 |
spellingShingle |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 Rojas-Quiche, Katherine Milagros Comité de Ética en Investigación Ensayo Clínico Acreditación Perú Ethics Committees, Research Clinical Trial Accreditation Peru |
title_short |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 |
title_full |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 |
title_fullStr |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 |
title_full_unstemmed |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 |
title_sort |
Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023 |
dc.creator.none.fl_str_mv |
Rojas-Quiche, Katherine Milagros Rojas-Cama, Luis Felipe Fuentes-Delgado, Duilio Jesús Roque-Henriquez, Joel Christian |
author |
Rojas-Quiche, Katherine Milagros |
author_facet |
Rojas-Quiche, Katherine Milagros Rojas-Cama, Luis Felipe Fuentes-Delgado, Duilio Jesús Roque-Henriquez, Joel Christian |
author_role |
author |
author2 |
Rojas-Cama, Luis Felipe Fuentes-Delgado, Duilio Jesús Roque-Henriquez, Joel Christian |
author2_role |
author author author |
dc.subject.none.fl_str_mv |
Comité de Ética en Investigación Ensayo Clínico Acreditación Perú Ethics Committees, Research Clinical Trial Accreditation Peru |
topic |
Comité de Ética en Investigación Ensayo Clínico Acreditación Perú Ethics Committees, Research Clinical Trial Accreditation Peru |
description |
Introduction: The Declaration of Helsinki recognizes the importance of Institutional Research Ethics Committees (IREC) in experimental studies for consideration, comments and guidance; which has been included in international and Peruvian legislation as a standard of good clinical practice. This study seeks to characterize the IREC that have evaluated clinical trials (CT) framed in the Peruvian Regulation, period 2010-2023. Material and methods: Secondary source. The population was the CT submitted to the National Institute of Health. Inclusion criteria: CT registered in the Peruvian Registry of Clinical Trials, and as exclusion criteria: i) CT with repeated registration, ii) registry without information on the IREC. A descriptive analysis was performed. Results: 927 CT were analyzed, which were evaluated by 36 IREC. The three IREC with the highest number of CT evaluated were private. The private IREC had as their main users private clinics that did not have IREC. Conclusion: There were 36 IREC that evaluated CT in the period 2010-2023. The three IREC that have evaluated the most CT are private. Private IREC do not usually have the research institutions to which they belong as users. |
publishDate |
2025 |
dc.date.none.fl_str_mv |
2025-04-19 |
dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.none.fl_str_mv |
https://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/2500 10.35434/rcmhnaaa.2025.181.2500 |
url |
https://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/2500 |
identifier_str_mv |
10.35434/rcmhnaaa.2025.181.2500 |
dc.language.none.fl_str_mv |
spa |
language |
spa |
dc.relation.none.fl_str_mv |
https://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/2500/1042 https://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/2500/1044 |
dc.rights.none.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo |
publisher.none.fl_str_mv |
Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo |
dc.source.none.fl_str_mv |
Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo; Vol. 18 No. 1 (2025): Early Publication; e2500 Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo; Vol. 18 Núm. 1 (2025): Publicación Anticipada; e2500 2227-4731 2225-5109 10.35434/rcmhnaaa.2025.181 reponame:Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo instname:Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo instacron:HNAAA |
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Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo |
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HNAAA |
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Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo |
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Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo |
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Nota importante:
La información contenida en este registro es de entera responsabilidad de la institución que gestiona el repositorio institucional donde esta contenido este documento o set de datos. El CONCYTEC no se hace responsable por los contenidos (publicaciones y/o datos) accesibles a través del Repositorio Nacional Digital de Ciencia, Tecnología e Innovación de Acceso Abierto (ALICIA).
La información contenida en este registro es de entera responsabilidad de la institución que gestiona el repositorio institucional donde esta contenido este documento o set de datos. El CONCYTEC no se hace responsable por los contenidos (publicaciones y/o datos) accesibles a través del Repositorio Nacional Digital de Ciencia, Tecnología e Innovación de Acceso Abierto (ALICIA).