Publicación Oficial de la Sociedad Ecuatoriana de Neurología, de la Liga Ecuatoriana Contra la Epilepsia y de la Sociedad Iberoamericana de Enfermedad Cerebrovascular

bioética en el Ecuador

 

Funcionamiento de los Comités de Ética de Investigación en Seres Humanos en Ecuador, 2015

Research Ethics Committees play an important role in securing the quality of interventional studies in humans; in Ecuador, they are in process of becoming stronger. The aim of this observational study was to describe the evolution of Ecuadorian legislation, training processes implemented by the health authority in the period of 2006-2015 and the performance of six committees (Quito and Guayaquil) during 2015. A self-assessment survey and a questionnaire to determine training needs were applied. Each committee was visited to evaluate its performance. The average member number was 10 and, although there was no gender equity, all members had the profile required for membership. The average response time was 26 days and the average quorum at meetings was of six members. Among the weaknesses are, little training in biostatistics and clinical research methodology and a poor follow-up of the studies; concerning strengths, we highlight the willingness of the members to improve the performance of the committees, and the willingness of Ministry of Public Health to support them. This study reports for the first time, the evolution of Ecuadorian legislation regarding ethics committee, its basic characteristics, weakness and strengths.

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