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Clinical Trials in Latin America: Where Ethics and Business Clash

  • Book
  • © 2014

Overview

Editors:
  1. Nuria Homedes

    1. School of Public Health, Division of Management, Policy and Community Health, University of Texas Houston, Health Science Center, El Paso, USA

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    You can also search for this editor in PubMed   Google Scholar

  2. Antonio Ugalde

    1. Department of Sociology, University of Texas at Austin, Austin, USA

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    You can also search for this editor in PubMed   Google Scholar

  • First book to give an overview of the outsourcing of clinical trials in Latin America
  • Raises questions about the quality of data obtained from the trials and the violation of human rights during their implementation
  • Addresses the economic reasons as to why clinical trials happen more frequently in certain parts of the world?

Part of the book series: Research Ethics Forum (REFF, volume 2)

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Table of contents (13 chapters)

  1. Front Matter

    Pages i-xvi
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  2. Introduction

    • Nuria Homedes, Antonio Ugalde
    Pages 1-6

  3. A Review and Critique of International Ethical Principles

    • Nuria Homedes, Antonio Ugalde
    Pages 7-53

  4. Globalization and Clinical Research in Latin America

    • Nuria Homedes, Antonio Ugalde
    Pages 55-78

  5. The Regulatory Framework and Case Studies from Argentina

    • Antonio Ugalde, Nuria Homedes
    Pages 79-111

  6. Politics and Clinical Trials in the Province of Cordoba

    • Antonio Ugalde, Nuria Homedes
    Pages 113-129

  7. Brazil: The System for the Protection of Voluntary Participants in Research

    • Corina Bontempo Duca de Freitas, William Saad Hossne, Susie Dutra
    Pages 131-149

  8. Progress and Challenges of Clinical Research with New Medications in Brazil

    • Corina Bontempo Duca de Freitas, Bruno R. Schlemper Jr.
    Pages 151-171

  9. A Small Country for Big Pharma: Costa Rica

    • Antonio Ugalde, Nuria Homedes
    Pages 173-193

  10. Cervical Cancer and the Development of HPV Vaccines in Guanacaste, Costa Rica

    • Nuria Homedes, Antonio Ugalde
    Pages 195-216

  11. Ethical Guidelines for Clinical Trials in Mexico: Theory and Practice

    • Emma Verástegui, Edith Váldez-Martínez
    Pages 217-236

  12. Who Decides? Informed Consent for Cancer Patients in Mexico

    • Alonso Cerdán, Alejandro González-Arreola, Emma Verástegui
    Pages 237-249

  13. A View from Inside: Regulation and Ethical Conflicts in Peru

    • Gabriela E. Minaya-Martínez, Susy Y. Olave-Quispe, Duilio J. Fuentes-Delgado
    Pages 251-274

  14. Conclusion

    • Antonio Ugalde, Nuria Homedes
    Pages 275-282

  15. Back Matter

    Pages 283-291
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Keywords

About this book

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. ​        

Editors and Affiliations

  • School of Public Health, Division of Management, Policy and Community Health, University of Texas Houston, Health Science Center, El Paso, USA

    Nuria Homedes

  • Department of Sociology, University of Texas at Austin, Austin, USA

    Antonio Ugalde

Bibliographic Information

  • Book Title: Clinical Trials in Latin America: Where Ethics and Business Clash

  • Editors: Nuria Homedes, Antonio Ugalde

  • Series Title: Research Ethics Forum

  • DOI: https://doi.org/10.1007/978-3-319-01363-3

  • Publisher: Springer Cham

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer International Publishing Switzerland 2014

  • Hardcover ISBN: 978-3-319-01362-6Published: 13 December 2013

  • Softcover ISBN: 978-3-319-34700-4Published: 17 September 2016

  • eBook ISBN: 978-3-319-01363-3Published: 29 November 2013

  • Series ISSN: 2212-9529

  • Series E-ISSN: 2212-9537

  • Edition Number: 1

  • Number of Pages: XVI, 291

  • Number of Illustrations: 9 b/w illustrations

  • Topics: Theory of Medicine/Bioethics, Health Economics, Health Promotion and Disease Prevention, Ethics

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