A Review and Critique of International Ethical Principles; Nria Homedes and Antonio Ugalde
Globalization and Clinical Research in Latin America; Nria Homedes and Antonio Ugalde
The Regulatory Framework and Case Studies from Argentina; Antonio Ugalde and Nria Homedes
Politics and Clinical Trials in the Province of Cordoba; Antonio Ugalde and Nria Homedes
Brazil: The System for the Protection of Voluntary Participants in Research; Corina Bontempo D de Freitas, William Saad Hossne and Susie Dutra
Progress and Challenges of Clinical Research with New Medications in Brazil; Corina Bontempo D de Freitas and Bruno Schlemper Junior
A Small Country for Big Pharma: Costa Rica; Antonio Ugalde and Nria Homedes
Cervical Cancer and the Development of HPV Vaccines in Guanacaste, Costa Rica; Nria Homedes and Antonio Ugalde
Ethical Guidelines for Clinical Trials in Mexico: Theory and Practice; Emma Verstegui and Edith Valds-Martnez
Who Decides? Informed Consent among Cancer Patients in Mexico; Alonso Cerdn, Alejandro Gonzlez and Emma Verstegui
A View from Inside: Regulation and Ethical Conflicts in Peru; Gabriela Minaya Martnez, Susi Olave Quispe and Duilio Fuentes Delgado
Conclusion; Antonio Ugalde and Nria Homedes.
The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.