Comités Institucionales de Ética en Investigación que han Evaluado Ensayos Clínicos Contemplados en el Reglamento Peruano 2010-2023.
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| Title: | Comités Institucionales de Ética en Investigación que han Evaluado Ensayos Clínicos Contemplados en el Reglamento Peruano 2010-2023. |
|---|---|
| Alternate Title: | Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023. |
| Authors: | Rojas-Quiche, Katherine Milagros1, Rojas-Cama, Luis Felipe1, Fuentes-Delgado, Duilio Jesús1, Roque-Henriquez, Joel Christian2 jroqueh@cientifica.edu.pe |
| Source: | Revista del Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo. ene-mar2025, Vol. 18 Issue 1, p1-21. 20p. |
| Subjects: | CLINICAL trials, RESEARCH ethics, ETHICS committees, BEST practices, RECORDING & registration |
| Geographic Terms: | PERU |
| Abstract (English): | 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. [ABSTRACT FROM AUTHOR] |
| Abstract (Spanish): | 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. [ABSTRACT FROM AUTHOR] |
| Copyright of Revista del Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo is the property of Cuerpo Medico del Hospital Nacional Almanzor Aguinaga Asenjo and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | MedicLatina |
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| Items | – Name: Title Label: Title Group: Ti Data: Comités Institucionales de Ética en Investigación que han Evaluado Ensayos Clínicos Contemplados en el Reglamento Peruano 2010-2023. – Name: TitleAlt Label: Alternate Title Group: TiAlt Data: Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Rojas-Quiche%2C+Katherine+Milagros%22">Rojas-Quiche, Katherine Milagros</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Rojas-Cama%2C+Luis+Felipe%22">Rojas-Cama, Luis Felipe</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Fuentes-Delgado%2C+Duilio+Jesús%22">Fuentes-Delgado, Duilio Jesús</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Roque-Henriquez%2C+Joel+Christian%22">Roque-Henriquez, Joel Christian</searchLink><relatesTo>2</relatesTo><i> jroqueh@cientifica.edu.pe</i> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Revista+del+Cuerpo+Médico+del+Hospital+Nacional+Almanzor+Aguinaga+Asenjo%22">Revista del Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo</searchLink>. ene-mar2025, Vol. 18 Issue 1, p1-21. 20p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22CLINICAL+trials%22">CLINICAL trials</searchLink><br /><searchLink fieldCode="DE" term="%22RESEARCH+ethics%22">RESEARCH ethics</searchLink><br /><searchLink fieldCode="DE" term="%22ETHICS+committees%22">ETHICS committees</searchLink><br /><searchLink fieldCode="DE" term="%22BEST+practices%22">BEST practices</searchLink><br /><searchLink fieldCode="DE" term="%22RECORDING+%26+registration%22">RECORDING & registration</searchLink> – Name: SubjectGeographic Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22PERU%22">PERU</searchLink> – Name: Abstract Label: Abstract (English) Group: Ab Data: 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. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Abstract (Spanish) Group: Ab Data: 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Revista del Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo is the property of Cuerpo Medico del Hospital Nacional Almanzor Aguinaga Asenjo and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Languages: – Code: spa Text: Spanish PhysicalDescription: Pagination: PageCount: 20 StartPage: 1 Subjects: – SubjectFull: CLINICAL trials Type: general – SubjectFull: RESEARCH ethics Type: general – SubjectFull: ETHICS committees Type: general – SubjectFull: BEST practices Type: general – SubjectFull: RECORDING & registration Type: general – SubjectFull: PERU Type: general Titles: – TitleFull: Comités Institucionales de Ética en Investigación que han Evaluado Ensayos Clínicos Contemplados en el Reglamento Peruano 2010-2023. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Rojas-Quiche, Katherine Milagros – PersonEntity: Name: NameFull: Rojas-Cama, Luis Felipe – PersonEntity: Name: NameFull: Fuentes-Delgado, Duilio Jesús – PersonEntity: Name: NameFull: Roque-Henriquez, Joel Christian IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 01 Text: ene-mar2025 Type: published Y: 2025 Identifiers: – Type: issn-print Value: 22255109 Numbering: – Type: volume Value: 18 – Type: issue Value: 1 Titles: – TitleFull: Revista del Cuerpo Médico del Hospital Nacional Almanzor Aguinaga Asenjo Type: main |
| ResultId | 1 |
