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

BACKGROUND: Good governance and regulatory supervision are required to conduct research in an international public health emergency context and to ensure compliance with ethical standards. The "Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic" study is a regional effort in which research ethics stakeholders participated in addressing research ethics governance and preparedness response challenges to the COVID-19 pandemic in Central America and the Dominican Republic. METHODS: A qualitative action research 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 ethics governance, ethics review and collaborative research practice during the pandemic. A roundtable session presented results and obtained feedback on a draft of a policy to strengthen regional research ethics governance. RESULTS: Countries across Central America and the Dominican Republic are at different stages in their development of research ethics systems. Countries with more established systems before COVID-19 were better organized and prepared to respond. This finding argues against improvisation and supports further work on strengthening governance of research ethics systems. Community engagement in research ethics public policy-making is practically absent in the region. Research and research ethics collaboration schemes are lacking amongst the countries; however, there are incipient initiatives in the region, such as the Central America and Caribbean Network of Research Ethics Committees. A policy brief with recommendations on how to advance towards strengthening the governance of research ethics systems was prepared and submitted to the Central American Integration System for analysis and possible approval. CONCLUSION: National research ethics systems in Central America and the Dominican Republic were unprepared to respond to the COVID-19 pandemic with respect to research oversight and effective collaboration. In most cases, national research ethics systems were found to be weak, and regional research collaboration was practically absent. To promote collaboration, a joint strategy needs to be developed with a regional vision towards sharing knowledge and best practices.

Diagnóstico de la esferocitosis hereditaria con pruebas de glicerólisis / Diagnosis of hereditary spherocytosis with glicerolysis tests

Se analizó a 18 pacientes con esferositosis, 30 mujeres embarazadas, 3 pacientes bajo hemodiálisis y 51 controles normales, mediante de 3 pruebas de glicerólisis. La prueba de vettore (pink test) resultó tener un 100%de especificidad y sensibilidad con sangre fresca y con sangre encubada, durante 24 horas a temperatura ambiente.La glicerólisis ácida presentó una especificidad que decayó al 85.7 por ciento tras la incubación a temperatura ambiente, pero fue un 100 por ciento específica y sensible con sangre fresca. Sólo con esta prueba se obtuvo valores tipo esferocitosis en mujeres embarazadas con más de 26 semanas de gestación. Debido a su baja sensibilidad y específicidad, no se recomienda usar la prueba original de glicerolisis a pH 7,4. La prueba clásica de fragilidad osmótica resultó ser más sensible postincubación (94.1%) que al fresco (88.2%), con una especificidad global del 100 por ciento. Por lo anterior, se recomienda el método de Vettore et al como método de elección para el diagnóstico de la esferocitosis hereditaria, por su especifidad y sensibilidad elevadas, su bajo costo, la facilidad para su realización y la ventaja de poder realizarse igualmente en sangre fresca o en sangre incubada a temperatura ambiente durante 24 horas.