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Revista de Bioética y Derecho
versión On-line ISSN 1886-5887
Resumen
GARAU, María Laura et al. Ethics committee's situation facing health emergencies and disease outbreaks, an exploratory study in Latin America and the Caribbean. Rev. Bioética y Derecho [online]. 2023, n.58, pp.93-108. Epub 25-Sep-2023. ISSN 1886-5887. https://dx.doi.org/10.1344/rbd2023.58.39887.
An exploratory study was carried out through a survey of Ethics Committees in Spanish-speaking Latin American and Caribbean countries, to assess their situation in the face of health emergencies and consult the ethical dilemmas faced in research for COVID-19. Responses were obtained from 106 committees, belonging to 14 countries. Only 24% responded that there was an efficient and effective communication network between committees, before the pandemic. 45% responded that there were no specific committees in their regions to evaluate projects linked to health emergencies before the pandemic. The percentage of RECs that had prior procedures to evaluate research in health emergencies was only 7%, although 52% were in the process of being prepared as a result of the pandemic. The percentage of RECs that reasonably expected less than 5 days to evaluate research projects varied by design: 32% for observational studies and 12% for clinical drug or vaccine trials. The three main ethical problems identified in the studies for COVID were related to informed consent, methodological aspects, and little prior information or lack of evidence for investigational products. We believe that we must reformulate the way of thinking about the ethical problems of emergencies towards a global approach, with a preventive approach, where collaboration networks between the RECs will not become the rule.
Palabras clave : research ethics committees; health emergencies; health research; covid-19; research ethics; human challenge studies.