Evaluation of the first standardized registry of approved research studies by the research ethics committees in Ecuador

Abstract

BackgroundEthical regulation of biomedical research is essential to safeguard the rights and well-being of participants. In Ecuador, Research Ethics Committees (RECs) have undergone progressive growth. This study describes and evaluates the performance of the RECs of Ecuador using the first standardized registry of approved research studies implemented by the Ministry of Public Health.MethodsAn observational, descriptive, and retrospective study was conducted using administrative records corresponding to the first year of implementation of the First Standardized Registry of Approved Research Studies (September 2021-October 2022). All functional RECs and approved research projects were included, characterizing variables related to geographical distribution, institutional affiliation, researcher profiles, study type, review modality, response times, and protocol follow-up.ResultsA total of 957 projects approved by 21 RECs were evaluated. Of these, 52% were concentrated in Quito, and 62% were affiliated with higher education institutions. Most studies were observational (96%), with a predominance in Medicine and Nursing (63%), followed by Psychology (15%) and Sociology (10%). Geographical distribution revealed a high concentration in Azuay (52%) and Pichincha (43%). Only 3% of the projects had a unique identification code, 40% involved vulnerable populations, and 9% used biological samples. The average waiting time to obtain a resolution was 31 days (95% CI: 28.5-34.2).ConclusionsDespite regulatory advancements and the implementation of the First Standardized Registry of Approved Research Studies, challenges persist in terms of decentralization, operational efficiency, and follow-up. Optimizing the regulatory framework, strengthening RECs training, and fostering public-private collaboration are crucial to consolidating a robust and adaptable ethical system capable of addressing emerging challenges.