Contributions of the Research Ethics Committee at Pedro Kouri Tropical Medicine Institute during one decade

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

[学科分类] 传染病学

[关键词] Research Ethics Committee;value training;clinical assays;ethical review;ethical principles;the Helsinki Declaration.