Operational criteria related to biobank research practices: Mesoamerican Project.

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Title: Operational criteria related to biobank research practices: Mesoamerican Project.
Authors: Basagoitia-Echalar, Armando1, Domínguez-Esponda, Rosalinda1 rdominguez@insp.mx, López-Ridaura, Ruy2, Ángeles-Llerenas, Angélica3
Source: Salud Pública de México. may/jun2025, Vol. 67 Issue 3, p239-247. 9p.
Subjects: TRAINING needs, DATA warehousing, RESEARCH ethics, ETHICS committees, INTERNET surveys
Abstract (English): Objective. To investigate the implementation of international ethics guidelines in Research ethics committees (RECs) to address ethical considerations in biobank research in Mesoamerican countries, given the importance of biobank research and the role of RECs in its evaluation. Materials and methods. Based on a 2018 study that used an online survey to assess training needs of RECs in Colombia, Costa Rica, Guatemala, and Mexico, this paper describes information on RECs operating procedures related to biobank research reported by 55 participants. Results. More than 70% of participants reported frequently requesting key components of biobank research. Specifying the time and location of sample and data storage was the least reported. 43.6% used a specific consent form, while 41.8% identified gaps in knowledge regarding the inclusion of residual samples. Recontact policies varied across countries and were limited by sample anonymity. Conclusión. RECs in Mesoamerican countries lack clear policies on biobanks and have deficiencies in informed consent and governance. Regulatory advances and ongoing training are needed to protect participants' rights. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Objetivo. Investigar la implementación de lineamientos éticos internacionales en los Comités de ética en investigación (CEI) para abordar consideraciones éticas en la investigación con biobancos en países mesoamericanos, dada la importancia de la investigación con biobancos y el rol de los CEI en su evaluación. Material y métodos. Con base en un estudio de 2018 en donde se utilizó una encuesta en línea para evaluar necesidades de capacitación de los CEI en Colombia, Costa Rica, Guatemala y México, se describe la información sobre los procedimientos operativos de los CEI en relación con la investigación con biobancos, reportada por 55 participantes. Resultados. Más de 70% de los participantes reportaron solicitar frecuentemente componentes clave en la investigación con biobancos. La especificación de tiempo y lugar de almacenamiento de muestras y datos fue la menos reportada; 43.6% usó un formato de consentimiento específico, mientras que 41.8% identificó lagunas en el conocimiento sobre la inclusión de muestras residuales. Las políticas de recontacto variaron entre países y se limitaron por el anonimato de las muestras. Conclusión. Los CEI en países mesoamericanos carecen de políticas claras sobre biobancos y presentan deficiencias en consentimiento informado y gobernanza. Se requieren avances regulatorios y capacitación continua para proteger los derechos de los participantes. [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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  Data: <searchLink fieldCode="JN" term="%22Salud+Pública+de+México%22">Salud Pública de México</searchLink>. may/jun2025, Vol. 67 Issue 3, p239-247. 9p.
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  Data: <searchLink fieldCode="DE" term="%22TRAINING+needs%22">TRAINING needs</searchLink><br /><searchLink fieldCode="DE" term="%22DATA+warehousing%22">DATA warehousing</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="%22INTERNET+surveys%22">INTERNET surveys</searchLink>
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  Data: Objective. To investigate the implementation of international ethics guidelines in Research ethics committees (RECs) to address ethical considerations in biobank research in Mesoamerican countries, given the importance of biobank research and the role of RECs in its evaluation. Materials and methods. Based on a 2018 study that used an online survey to assess training needs of RECs in Colombia, Costa Rica, Guatemala, and Mexico, this paper describes information on RECs operating procedures related to biobank research reported by 55 participants. Results. More than 70% of participants reported frequently requesting key components of biobank research. Specifying the time and location of sample and data storage was the least reported. 43.6% used a specific consent form, while 41.8% identified gaps in knowledge regarding the inclusion of residual samples. Recontact policies varied across countries and were limited by sample anonymity. Conclusión. RECs in Mesoamerican countries lack clear policies on biobanks and have deficiencies in informed consent and governance. Regulatory advances and ongoing training are needed to protect participants' rights. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: Objetivo. Investigar la implementación de lineamientos éticos internacionales en los Comités de ética en investigación (CEI) para abordar consideraciones éticas en la investigación con biobancos en países mesoamericanos, dada la importancia de la investigación con biobancos y el rol de los CEI en su evaluación. Material y métodos. Con base en un estudio de 2018 en donde se utilizó una encuesta en línea para evaluar necesidades de capacitación de los CEI en Colombia, Costa Rica, Guatemala y México, se describe la información sobre los procedimientos operativos de los CEI en relación con la investigación con biobancos, reportada por 55 participantes. Resultados. Más de 70% de los participantes reportaron solicitar frecuentemente componentes clave en la investigación con biobancos. La especificación de tiempo y lugar de almacenamiento de muestras y datos fue la menos reportada; 43.6% usó un formato de consentimiento específico, mientras que 41.8% identificó lagunas en el conocimiento sobre la inclusión de muestras residuales. Las políticas de recontacto variaron entre países y se limitaron por el anonimato de las muestras. Conclusión. Los CEI en países mesoamericanos carecen de políticas claras sobre biobancos y presentan deficiencias en consentimiento informado y gobernanza. Se requieren avances regulatorios y capacitación continua para proteger los derechos de los participantes. [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: 10.21149/16734
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        Text: English
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        PageCount: 9
        StartPage: 239
    Subjects:
      – SubjectFull: TRAINING needs
        Type: general
      – SubjectFull: DATA warehousing
        Type: general
      – SubjectFull: RESEARCH ethics
        Type: general
      – SubjectFull: ETHICS committees
        Type: general
      – SubjectFull: INTERNET surveys
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      – TitleFull: Operational criteria related to biobank research practices: Mesoamerican Project.
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            NameFull: Basagoitia-Echalar, Armando
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              M: 05
              Text: may/jun2025
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              Y: 2025
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