CAPÍTULO 4. Informatización del registro y la evaluación de los comités de ética en investigación: experiencia en el ámbito de la ciudad de Buenos Aires, Argentina.
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Date
2024
Authors
Garau, María Laura
Vukotich, Claudia Teresa
Roitman, Adriel Jonas
Advisors
Editors
Journal Title
Journal ISSN
Volume Title
Publisher
Corporación Universitaria Minuto de Dios - UNIMINUTO
Universidad de San Buenaventura
Globethics Publications
Universidad de San Buenaventura
Globethics Publications
Type
Book chapter
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)
Abstract
Incluir la investigación en salud en un registro de acceso público equivale
a brindar transparencia y confiabilidad a la actividad para todos los actores involucrados. Con ese objetivo primordial se llevó a cabo en el 2019 un
verdadero proceso de transformación en el trabajo de los Comités de Ética
en Investigación en Salud de la ciudad de Buenos Aires (Argentina), con el
desarrollo de la Plataforma de Registro Informatizado de Investigaciones en
Salud de la ciudad de Buenos Aires (PRIISA.BA). A través de esta, se gestiona
la evaluación ética y metodológica de los comités hasta la efectiva emisión del
dictamen, incorporando sus decisiones en un registro de acceso público para
toda la población. La experiencia demuestra que por medio del uso obligatorio de la plataforma se ha eliminado el subregistro, dotando a los CEI de una
herramienta de gestión y comunicación, cuya implementación ha facilitado
su labor. Por lo tanto, el objetivo de este trabajo radica en compartir la experiencia y etapas del proceso por medio del cual se desarrolló, implementó
y consolidó la utilización de la plataforma para todos los comités de ética en
investigación de la ciudad de Buenos Aires.
Including health research in a publicly accessible registry provides transparency and reliability for all stakeholders. With this in mind, a transformation process was carried out in the way Research Ethics Committees (RECs) perform their activity in Buenos Aires City, Argentina. In 2019 the Computerized Registry Platform for Health Research of the City of Buenos Aires (PRIISA.BA) was developed. Through it, the ethical and methodological evaluation of the protocols is managed, until the effective issuance of the Committees’ opinion. The platform allows REC to make observations and interact with principal investigators and sponsors. After a study is approved or rejected, it is incorporated into a public access registry. Since its use is mandatory, experience has shown that underreporting has been eliminated, providing the RECs with a management and communication tool, which facilitates their activity. The objective of this work is to share the experience and review the different stages of the process, through which the use of the platform was developed, implemented and consolidated for all the research ethics committees of the public and private sector, from the Ministry of Health of the City of Buenos Aires.
Including health research in a publicly accessible registry provides transparency and reliability for all stakeholders. With this in mind, a transformation process was carried out in the way Research Ethics Committees (RECs) perform their activity in Buenos Aires City, Argentina. In 2019 the Computerized Registry Platform for Health Research of the City of Buenos Aires (PRIISA.BA) was developed. Through it, the ethical and methodological evaluation of the protocols is managed, until the effective issuance of the Committees’ opinion. The platform allows REC to make observations and interact with principal investigators and sponsors. After a study is approved or rejected, it is incorporated into a public access registry. Since its use is mandatory, experience has shown that underreporting has been eliminated, providing the RECs with a management and communication tool, which facilitates their activity. The objective of this work is to share the experience and review the different stages of the process, through which the use of the platform was developed, implemented and consolidated for all the research ethics committees of the public and private sector, from the Ministry of Health of the City of Buenos Aires.
Description
Capítulo completo en acceso abierto que hace parte de la obra Bioética y diálogo de saberes.
Keywords
Comités de ética, Investigación en salud, Registro de investigaciones, Gestión, Acceso a la información, Ethics committees, Health research, Research registry, Management, Access to information