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

Abstract

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.

Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees

“…In the African context, research also often takes place in the context of historical inequities and ongoing power imbalances. People who are most disadvantaged or vulnerable, through poverty, marginalisation, or lack of access to healthcare are often disproportionately affected [ 4 , 32 , 34 ].…”

Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic: a qualitative study

“…The CA-DR region has significant potential for developing strong and solid mechanisms for sharing experiences to improve research ethics governance. This potential is evident in examples of progress across the different countries in the region in terms of regulatory frameworks, prioritization of initiatives, funding, ethics committee networks, ethics committee training and community representation in research [ 16 , 22 – 24 ]. The GoEtiCA participatory action research project allowed a broad audience to meet virtually and provide insight, experiences and recommendations.…”

“…Despite the existence of the Council for International Organizations of Medical Sciences (CIOMS) Ethical Guideline 20 on Research in Disaster and Disease Outbreak Situations [ 18 ], implementation of operating procedures based on this guideline has been limited. Palmero et al [ 22 ] concluded that “[c]ontinuing efforts should be directed to strengthen [Latin American] countries’ research capacity to respond timely and ethically to future health emergencies”. In this study we confirm that there is a clear need to improve ethics review practices in light of the difficulties identified by study participants.…”

Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic: a qualitative study

“…The CA-DR region has signi cant potential for developing strong and solid for sharing experiences to improve ethical governance. This potential can be seen in examples of progress across the different countries in the region in terms of regulatory frameworks, prioritization of initiatives, funding, ethics committee networks, ethics committee training, and community representation in research (13,20).…”

“…However, research ethics structures have not been studied consistently, evidenced by a scarcity of publications on the topic across Central American countries. More recently, research priorities for the COVID-19 pandemic were identi ed with participants from various countries; however, the Central American response to these recommendations is unclear (13,14,15). Scienti c development, collaboration, and cooperation mechanisms among research stakeholders are urgently needed to promote the full adoption of international research ethics standards.…”