Valdés HI, Martínez TE, Más BP, Montalvo ÁAM, González RD, Montalvo VMC, Cabrera CN, Gato AR, Fernández LR

Language: Spanish
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ABSTRACT

Introduction: ethical evaluation of research projects at Pedro Kouri Tropical Medicine Institute in Havana has both a tradition and a history. In the year 2008 this activity was reorganized and the Research Ethics Committee created.
Objectives: carry out a document review of the work done by the Research Ethics Committee at Pedro Kouri Tropical Medicine Institute during the past decade and evaluate its contributions to the value training of its professionals.
Methods: a review was conducted of the archives of the Research Ethics Committee at Pedro Kouri Tropical Medicine Institute (2008-June 2017). The review served as background to classify the research projects, evaluate the quality of documents, review the follow-up of clinical assays, and identify the training activities.
Results: evaluation was performed of 407 documents about a wide range of topics. The most frequent research type was basic research, followed by studies related to the strengthening of capacities. The main deficiencies detected in the process were the following: description of the impact of the research in the community, statistical processing, informed consent, receipt of endorsements for multicenter studies, and description of procedures related to the use of laboratory animals, among others. These were discussed with the authors and compliance was fostered via bioethical principles (autonomy, beneficence, non-maleficence and justice). Review of the follow-up of clinical assays reaffirmed the scientific cooperation of the institute with renowned Cuban and foreign institutions. It was found that the committee performs intense training work, notably the development of workshops for the discussion of key documents related to the ethical analysis of research.
Conclusions: resolution of the main deficiencies in compliance with ethical principles and fostering of ethical values among researchers and members of the Research Ethics Committee at Pedro Kouri Tropical Medicine Institute positively impacted the quality of research.