Abstract
BackgroundResearch 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.MethodsWe 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.Results10 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.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.
Highlights
The COVID-19 pandemic has severely affected the countries of Latin America (LA) due to social and economic inequalities across their populations, and their deficient health system [1]
We searched for documents, guidelines, recommendations, and any other available instrument on ethics review and oversight of COVID-19 research issued by relevant authorities in national legal databases and governmental websites of national health authorities and national regulatory authorities
The lack of preparedness for research ethics review and oversight in emergency settings is common among governance frameworks of Latin American (LA) countries
Summary
The COVID-19 pandemic has severely affected the countries of Latin America (LA) due to social and economic inequalities across their populations, and their deficient health system [1]. 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]. 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
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