Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Palmero, Ana, Carracedo, Sarah, Cabrera, Noelia, Bianchini, Alahí
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8571668/
https://www.ncbi.nlm.nih.gov/pubmed/34742278
http://dx.doi.org/10.1186/s12910-021-00715-2
_version_ 1784595073096220672
author Palmero, Ana
Carracedo, Sarah
Cabrera, Noelia
Bianchini, Alahí
author_facet Palmero, Ana
Carracedo, Sarah
Cabrera, Noelia
Bianchini, Alahí
author_sort Palmero, Ana
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12910-021-00715-2.
format Online
Article
Text
id pubmed-8571668
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-85716682021-11-08 Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study Palmero, Ana Carracedo, Sarah Cabrera, Noelia Bianchini, Alahí BMC Med Ethics Research 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12910-021-00715-2. BioMed Central 2021-11-06 /pmc/articles/PMC8571668/ /pubmed/34742278 http://dx.doi.org/10.1186/s12910-021-00715-2 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Palmero, Ana
Carracedo, Sarah
Cabrera, Noelia
Bianchini, Alahí
Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study
title Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study
title_full Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study
title_fullStr Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study
title_full_unstemmed Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study
title_short Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study
title_sort governance frameworks for covid-19 research ethics review and oversight in latin america: an exploratory study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8571668/
https://www.ncbi.nlm.nih.gov/pubmed/34742278
http://dx.doi.org/10.1186/s12910-021-00715-2
work_keys_str_mv AT palmeroana governanceframeworksforcovid19researchethicsreviewandoversightinlatinamericaanexploratorystudy
AT carracedosarah governanceframeworksforcovid19researchethicsreviewandoversightinlatinamericaanexploratorystudy
AT cabreranoelia governanceframeworksforcovid19researchethicsreviewandoversightinlatinamericaanexploratorystudy
AT bianchinialahi governanceframeworksforcovid19researchethicsreviewandoversightinlatinamericaanexploratorystudy