Clinical Trials in Latin America: Where Ethics and Business Clash (Research Ethics Forum Book 2)

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. A Review And Critique Of International Ethical Principles / Nuria Homedes And Antonio Ugalde -- Globalization And Clinical Research In Latin America / Nuria Homedes And Antonio Ugalde -- The Regulatory Framework And Case Studies From Argentina / Antonio Ugalde And Nuria Homedes -- Politics And Clinical Trials In The Province Of Cordoba / Antonio Ugalde And Nuria Homedes -- Brazil : The System For The Protection Of Voluntary Participants In Research / Corina Bontempo Duca De Freitas, William Saad Hossne, And Susie Dutra -- Progress And Challenges Of Clinical Research With New Medications In Brazil / Corina Bontempo Duca De Freitas And Bruno R. Schlemper Jr. -- A Small Country For Big Pharma : Costa Rica / Antonio Ugalde And Nuria Homedes -- Cervical Cancer And The Development Of Hpv Vaccines In Guanacaste, Costa Rica / Nuria Homedes And Antonio Ugalde -- Ethical Guidelines For Clinical Trials In Mexico : Theory And Practice / Emma Verástegui And Edith Váldez-martínez -- Who Decides? Informed Consent Among Cancer Patients In Mexico / Alonso Cerdán, Alejandro González-arreola, And Emma Verástegui -- A View From Inside : Regulation And Ethical Conflicts In Peru / Gabriela Minaya-martínez, Susi Y. Olave-quispe, And Duilio Fuentes-delgado. Nuria Homedes, Antonio Ugalde, Editors. Includes Bibliographical References And Index. Mode Of Access: World Wide Web. Front Matter....Pages i-xvi Introduction....Pages 1-6 A Review and Critique of International Ethical Principles....Pages 7-53 Globalization and Clinical Research in Latin America....Pages 55-78 The Regulatory Framework and Case Studies from Argentina....Pages 79-111 Politics and Clinical Trials in the Province of Cordoba....Pages 113-129 Brazil: The System for the Protection of Voluntary Participants in Research....Pages 131-149 Progress and Challenges of Clinical Research with New Medications in Brazil....Pages 151-171 A Small Country for Big Pharma: Costa Rica....Pages 173-193 Cervical Cancer and the Development of HPV Vaccines in Guanacaste, Costa Rica....Pages 195-216 Ethical Guidelines for Clinical Trials in Mexico: Theory and Practice....Pages 217-236 Who Decides? Informed Consent for Cancer Patients in Mexico....Pages 237-249 A View from Inside: Regulation and Ethical Conflicts in Peru....Pages 251-274 Conclusion....Pages 275-282 Back Matter....Pages 283-291