Research ethics committees in Latin America: What do they accomplish?

Abstract

The outsourcing of clinical trials to Latin America began in the mid-1940s under the sponsorship of universities and the National Institutes of Health of the United States of America. The number of studies was relatively low and remained stagnant until the late 1990s, when the pharmaceutical industry began outsourcing ECs to the region. The history and experience of the Latin American research ethics committees is quite short, but during these 25 years we have seen many changes in the regulations that determine their organization, responsibilities and performance. In this article, we examine some of the problems faced by the Latin American research ethics committees, their needs, their performance and their future, taking into account the rapid increase in the complexity of protocols and health technologies. After analyzing the work of the research ethics committees and the difficulties faced to comply with their responsibilities, we discuss some initiatives to improve their performance. We believe that is time to redesign the responsibilities of these committees.

Keywords

• research ethics committees
• irbs
• clinical trials
• latin america
• conflicts of interest
• informed consent