The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges

Carracedo, Sarah; Palmero, Ana; Neil, Marcie; Hasan-Granier, Anisa; Saénz, Carla; Revéiz, Ludovic

doi:10.26633/rpsp.2020.177

Cited by 13 publications

(15 citation statements)

References 7 publications

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“…It has been widely discussed the need to evaluate different organizational models to accelerate ethics review during health emergencies [16,20,25], yet 4 countries remained under the same ethics review structure. Even though it is not necessary for countries to implement a whole different organization of their ethics review processes, it is of relevance to establish mechanisms for the coordination and communication between research stakeholders, especially considering that these countries host several multicenter studies [3].…”

Section: Organization and Coordinationmentioning

confidence: 99%

Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study

et al. 2021

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Background Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. Methods We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. Results 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. Conclusion LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.

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Section: Organization and Coordinationmentioning

confidence: 99%

Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study

et al. 2021

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“…It has been widely discussed the need to evaluate different organizational models to accelerate ethics review during health emergencies [16,20,24], yet 4 countries remained under the same ethics review structure. Even though it is not necessary for countries to implement a whole different organization of their ethics review processes, it is of relevance to establish mechanisms for the coordination and communication between research stakeholders, especially considering that these countries host several multicenter studies [3].…”

Section: Organization and Coordinationmentioning

confidence: 99%

“…Among the responses to the COVID-19 pandemic, the conduct of research has been essential. Since the beginning, countries of LA have been actively contributing to the development of vaccines and treatments for COVID-19, despite their limited research capacity and scarce resources [3]. However, implementing research during the pandemic poses the challenge of integrating research into broader outbreak response efforts to produce valuable knowledge rapidly while upholding research ethical standards [4].…”

Section: Introductionmentioning

confidence: 99%

Governance Frameworks for COVID-19 Research Ethics Review and Oversight in Latin America: An Exploratory Study

Palmero¹,

Carracedo

Cabrera

et al. 2021

Preprint

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Background Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance.Methods We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research.Results 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplated strategies with recommendations for concrete actions for a timely and rigorous review.ConclusionLA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies of international concern.

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“…En términos del lugar de origen de los autores de los documentos se encontró que doce de ellos eran provenientes de Norteamérica: nueve de los Estados Unidos (11)(12)(13)(14)(15)(16)(17)(18)(19) y tres de Canadá (20)(21)(22). China aporta dos (23,24), y Latinoamérica dos referencias (6,25); Europa aportó 4 documentos, dos de Francia (26,27), uno de Italia (28) y otro de Reino Unido (29); Asia aporta siete documentos: dos de China previamente mencionados, dos de la India (30,31), un documento de Jordán (32), uno de Emiratos Árabes (33) y uno de Filipinas (34). Finalmente, África tuvo un documento proveniente de Sudáfrica (35).…”

Section: Referencias Que No Cumplieron Los Criterios De Inclusion N=959unclassified

“…La ciencia y la academia fueron llamadas a responder de manera oportuna y adecuada a los retos y las incógnitas planteadas por el nuevo virus (5). Por todo esto, durante el 2020 y el 2021 se generó a nivel internacional una cantidad importante de literatura científica sobre la epidemiología, fisiopatología, métodos diagnósticos, intervenciones preventivas y tratamientos para el SARS, como también respecto a la experiencia de investigar dentro de este contexto (6).…”

Section: Introductionunclassified

Barreras y facilitadores para la investigación en ciencias de la salud durante la crisis del COVID-19: una revisión de alcance

Neira-Fernández

Lee

Gómez-Ramírez

2021

Rev. Colomb. Obstet. Ginecol.

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Objetivo: la pandemia ocasionada por el Covid-19 ha significado un gran desafío para la investigación en salud por la necesidad de dar una respuesta oportuna y efectiva a esta situación de crisis. Es importante proveer una visión panorámica sobre las principales barreras y facilitadores encontrados en la conducción de estudios en ciencias de la salud durante la crisis del Covid-19, así como también de las iniciativas en investigación sugeridas por autoridades en salud de investigación a nivel global, regional o local. Materiales y métodos: se desarrolló una revisión sistemática de alcance. Se hizo una búsqueda de la literatura en Medline, Cochrane library, Lilacs y Google Scholar. Se incluyeron estudios de investigación originales, artículos de revisión, de opinión y editoriales disponibles en texto completo, publicados entre enero de 2020 y mayo de 2021 en español, inglés o portugués. Se hizo selección de los documentos y extracción de los datos por dos autores de manera independiente. Las barreras y facilitadores identificados fueron descritos y organizados en cuatro categorías a partir de la literatura: socioculturales, administrativos, organizacionales y metodológicos. Asimismo, se incluyeron documentos y comunicados oficiales de autoridades en salud e investigación a nivel global, regional y local. Los resultados se presentan de manera narrativa y en tablas. Resultados: se seleccionaron 26 documentos para el análisis y síntesis de la información. Las barreras mencionadas más frecuentemente en la literatura incluyen las dificultades en cuanto al acceso a los participantes, a los trámites asociados a los comités de ética; así como el riesgo biológico para los investigadores y la falta de coordinación inter e intrainstitucional. Por su parte, los facilitadores identificados incluyen la adopción de soluciones virtuales, el trabajo cooperativo entre los actores de la investigación y la flexibilidad en el proceso de obtención del consentimiento informado. Frente a las iniciativas difundidas por las autoridades en salud e investigación, se identificaron cuatro estrategias relacionadas con la priorización de preguntas de investigación, el fomento de la cooperación y la inclusión en la investigación, la lucha contra la infodemia y el fortalecimiento de la calidad metodológica de los estudios. Conclusiones: para la investigación en el contexto de la pandemia representa un desafío continuar con la cooperación e interoperabilidad entre las instituciones, los países y las disciplinas, con el fin de facilitar los procesos investigativos en el futuro; del mismo modo, cobra importancia mantener la ciencia abierta y la financiación de estudios cooperativos cuando surjan otras prioridades. Asimismo, es evidente la necesidad de desarrollar y sostener mecanismos que gestionen la información de manera eficiente para la toma de decisiones. Se requiere evaluar de manera continua los efectos que ha dejado esta pandemia en la práctica de la investigación en ciencias de la salud para comprender de manera integral lo que debemos aprender como sociedad a partir de las crisis.

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The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges

Cited by 13 publications

References 7 publications

Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study

Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study

Governance Frameworks for COVID-19 Research Ethics Review and Oversight in Latin America: An Exploratory Study

Barreras y facilitadores para la investigación en ciencias de la salud durante la crisis del COVID-19: una revisión de alcance

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