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

Abstract BackgroundStrong governance and regulatory supervision are required to conduct research in an emergency context and ensure compliance with ethical standards. Preparedness and response rely on the formalization, structure, and function of national research ethics systems. The Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic (GoEtiCA) study is a regional effort addressing research ethics governance challenges during the pandemic. This study describes the ethics governance that addresses specific humanitarian and health challenges caused by COVID-19; it also analyzes the regulatory oversight of research, and preparedness response to the pandemic in Central America and the Dominican Republic. The study aimed to inform the development of a policy brief to advancing international ethical standards adoption. MethodsA qualitative study was conducted following a participatory approach. Research ethics stakeholders in Central America and the Dominican Republic were mapped; a regional webinar and three virtual workshops were conducted discussing research governance, ethics review, and collaborative practices during the pandemic. A roundtable session presented results and obtained feedback on a draft of a policy to strengthen regional research ethics governance. ResultsCountries across Central America and the Dominican Republic are at different stages in their development of governance structures and regulations for research ethics systems. Countries that had more established systems before COVID-19, were better organized and prepared to respond. This finding argues against improvisation and supports further work on research ethics systems. Strong international scientific cooperation and collaborative practices are lacking within and amongst the countries. Collaborative structures and practices for research, community engagement in policymaking, and ethics review are scarce; however, there are incipient initiatives, including the Central America Network of Research Ethics Committees. ConclusionNational and regional research ethics governance structures in Central America and the Dominican Republic were not prepared to respond to the COVID-19 pandemic with research oversight and effective collaboration. In most cases, national research ethics governance structures are weak and regional research collaboration is ineffective. To promote collaboration, efforts that identify implementation gaps and share knowledge and best practices are needed.