Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023

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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...

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Autores: Rojas-Quiche, Katherine Milagros, Rojas-Cama, Luis Felipe, Fuentes-Delgado, Duilio Jesús, Roque-Henriquez, Joel Christian
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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spelling 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
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info:eu-repo/semantics/publishedVersion
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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
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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
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instname_str Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo
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