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Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project.

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Title: Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project.
Authors: Ángeles-Llerenas, Angélica1, Thrasher, James F.2, Domínguez-Esponda, Rosalinda1, López-Ridaura, Ruy3,4, Macklin, Ruth5 rdominguez@insp.mx
Source: Salud Pública de México. Jan/Feb2022, Vol. 64 Issue 1, p66-75. 10p.
Subjects: RESEARCH ethics, ETHICS committees, MIDDLE-income countries, TRAINING needs, NEEDS assessment
Geographic Terms: COSTA Rica, GUATEMALA, COLOMBIA
Abstract (English): Objective. To attain a better understanding of the structure and processes of Research Ethics Committees (REC) in the low-and middle-income countries of the Mesoamerican region. The objectives are knowing the operational practices of the RECs regarding project evaluation, training needs, and infrastructure. Materials and methods. The REC training and needs assessment involved an online survey of all the RECs (n=55) identified in Colombia (n=11), Costa Rica (n=5), Guatemala (n=5), and Mexico (n=34). Results. Participants reported inadequate infrastructure for its proper operation (only 49.1 %, or 27/55, have an exclusive office to safeguard files); insufficient administrative staff (47.3%, 26/55), or financial resources to conduct active site monitoring (85.6%, 47/55) to ensure the protection of rights and welfare of study participants. Conclusions. Investments in REC member training and infrastructure are needed to ensure compliance of REC evaluations with the standards for ethical conduct of research. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Objetivo. Comprender la estructura y procesos de los Comités de Ética en Investigación (CEI) en países mesoamericanos de ingresos bajos y medios. Conocer las prácticas operativas en evaluación de proyectos, necesidades de capacitación e infraestructura. Material y métodos. Encuesta en línea para evaluar necesidades de capacitación de los CEI (n=55) identificados en Colombia (n=11), Costa Rica (n=5), Guatemala (n=5) y México (n=34). Resultados. Los participantes reportaron una infraestructura inadecuada para su correcto funcionamiento (oficina exclusiva para archivos 49.1%, 27/55); personal administrativo insuficiente (47.3%, 26/55), recursos financieros insuficientes para monitoreo del sitio (85.6%, 47/55), para garantizar protección de derechos y bienestar de los participantes. Conclusiones. Se necesita invertir en capacitación de los miembros e infraestructura del CEI, para garantizar la conducción ética de la investigación. [ABSTRACT FROM AUTHOR]
Copyright of Salud Pública de México is the property of Instituto Nacional de Salud Publica 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.)
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  Label: Title
  Group: Ti
  Data: Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project.
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  Data: <searchLink fieldCode="AR" term="%22Ángeles-Llerenas%2C+Angélica%22">Ángeles-Llerenas, Angélica</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Thrasher%2C+James+F%2E%22">Thrasher, James F.</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Domínguez-Esponda%2C+Rosalinda%22">Domínguez-Esponda, Rosalinda</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22López-Ridaura%2C+Ruy%22">López-Ridaura, Ruy</searchLink><relatesTo>3,4</relatesTo><br /><searchLink fieldCode="AR" term="%22Macklin%2C+Ruth%22">Macklin, Ruth</searchLink><relatesTo>5</relatesTo><i> rdominguez@insp.mx</i>
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  Data: <searchLink fieldCode="JN" term="%22Salud+Pública+de+México%22">Salud Pública de México</searchLink>. Jan/Feb2022, Vol. 64 Issue 1, p66-75. 10p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <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="%22MIDDLE-income+countries%22">MIDDLE-income countries</searchLink><br /><searchLink fieldCode="DE" term="%22TRAINING+needs%22">TRAINING needs</searchLink><br /><searchLink fieldCode="DE" term="%22NEEDS+assessment%22">NEEDS assessment</searchLink>
– Name: SubjectGeographic
  Label: Geographic Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22COSTA+Rica%22">COSTA Rica</searchLink><br /><searchLink fieldCode="DE" term="%22GUATEMALA%22">GUATEMALA</searchLink><br /><searchLink fieldCode="DE" term="%22COLOMBIA%22">COLOMBIA</searchLink>
– Name: Abstract
  Label: Abstract (English)
  Group: Ab
  Data: Objective. To attain a better understanding of the structure and processes of Research Ethics Committees (REC) in the low-and middle-income countries of the Mesoamerican region. The objectives are knowing the operational practices of the RECs regarding project evaluation, training needs, and infrastructure. Materials and methods. The REC training and needs assessment involved an online survey of all the RECs (n=55) identified in Colombia (n=11), Costa Rica (n=5), Guatemala (n=5), and Mexico (n=34). Results. Participants reported inadequate infrastructure for its proper operation (only 49.1 %, or 27/55, have an exclusive office to safeguard files); insufficient administrative staff (47.3%, 26/55), or financial resources to conduct active site monitoring (85.6%, 47/55) to ensure the protection of rights and welfare of study participants. Conclusions. Investments in REC member training and infrastructure are needed to ensure compliance of REC evaluations with the standards for ethical conduct of research. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: Objetivo. Comprender la estructura y procesos de los Comités de Ética en Investigación (CEI) en países mesoamericanos de ingresos bajos y medios. Conocer las prácticas operativas en evaluación de proyectos, necesidades de capacitación e infraestructura. Material y métodos. Encuesta en línea para evaluar necesidades de capacitación de los CEI (n=55) identificados en Colombia (n=11), Costa Rica (n=5), Guatemala (n=5) y México (n=34). Resultados. Los participantes reportaron una infraestructura inadecuada para su correcto funcionamiento (oficina exclusiva para archivos 49.1%, 27/55); personal administrativo insuficiente (47.3%, 26/55), recursos financieros insuficientes para monitoreo del sitio (85.6%, 47/55), para garantizar protección de derechos y bienestar de los participantes. Conclusiones. Se necesita invertir en capacitación de los miembros e infraestructura del CEI, para garantizar la conducción ética de la investigación. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Salud Pública de México is the property of Instituto Nacional de Salud Publica 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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        Value: 10.21149/12588
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        Text: English
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      – SubjectFull: RESEARCH ethics
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      – SubjectFull: ETHICS committees
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      – SubjectFull: MIDDLE-income countries
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      – SubjectFull: TRAINING needs
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      – SubjectFull: COSTA Rica
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      – SubjectFull: GUATEMALA
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      – SubjectFull: COLOMBIA
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              Text: Jan/Feb2022
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