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

BMC Medical Ethics

Noelia Cabrera¹  Ana Palmero²  Sarah Carracedo³  Alahí Bianchini⁴ 

[1] Center for the Study of State and Society, Buenos Aires, Argentina;Directorate of Research for Health, Ministry of Health, 1925 9 de Julio Av, 1091, Buenos Aires, Argentina;Pontifical Catholic University of Peru, Lima, Peru;School of Law, University of Buenos Aires, Buenos Aires, Argentina;

关键词: Research;    Ethics;    COVID-19;    Pandemic;    Ethics review;    Epidemic;    Preparedness;   

DOI  :  10.1186/s12910-021-00715-2

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY