Institutional Review Boards in the City of Buenos Aires and its Metropolitan Area

Abstract

INTRODUCTION: The ethical evaluation of research protocols is a regulatory requirement. In Argentina, there is no information about how many institutional review boards (IRB) exist or how they work. OBJECTIVE: To survey IRB of the Autonomous City of Buenos Aires and its metropolitan area, in order to know how they function and which difficulties arise during the field monitoring of approved studies. METHODS: A semi-structured survey was conducted to the 38 IRB that agreed on participating in the study. Values were expressed as percentages for categorical variables, as median and interquartile range 25-75 for continuous ones. RESULTS: 65.8% of the IRB started working at least 10 years ago. 47.4% consists of 10 or more members, most of them physicians. Most institutions do not remunerate IRB members, which are not exempted in any case from their normal duties to attend meetings. 37.1% of the institutions stopped at least one protocol for security aspects. 65% of IRB had difficulties to track research protocols after approval. CONCLUSIONS: The composition of the IRBs is inadequate. For example, too many members are physicians and not enough of them are community representatives, methodologists, etc. There are also problems related to lack of time, resources and consideration by researchers and institutions. Therefore, the field monitoring of approved studies turns to be difficult in most of the cases.