Clinical Trials in Latin America Introduction推荐.pdfVIP

Chapter 1 Introduction Nuria Homedes and Antonio Ugalde 1.1 The Origins and Development of This Project The tension between the need to develop better treatments and protect human research participants is particularly acute in low and middle income countries, where the number of clinical trials with pharmaceuticals is on the rise and the systems to protect the research participants are relatively new and tend to be poorly devel- oped. While, Latin American volunteers have been participating in international research and in clinical trials since the beginning of the twentieth century, most Latin American countries did not have regulatory agencies or a regulatory framework guiding the implementation of clinical research until the mid- 1990s or early 2000s. As editors of an electronic bulletin aimed at improving the use of pharmaceuticals among the Spanish-speaking populations (), the editors of this collection became aware of reports describing violations of ethical research principles in Costa Rica and Argentina (Vargas 2006; Orchuela 2006a, b). Later, during meetings in Peru, Costa Rica and Argentina we learned that Colombian research participants did not understand the concept of informed consent; Argentinean psychiatric patients had been included in research projects without obtaining the informed consent from guardians or, in their absence, from the judiciary; and concerned Costa Ricans had unveiled problems with a very large clinical trial (over 13,000 participants) to study the effectiveness of a vaccine against human papilloma virus. Ethical research concerns are common through- out the world, but what was striking about the situation in Latin America was the insularity of the bioethicists and concerned researchers that were unveiling these issues. Researchers in other countries did not know about any of the cases described above. N. Homedes (*) School of Public Health, Division o