Table of Contents

FOREWORD: Gerald T. Keusch, Boston University:
INTRODUCTION: James V. Lavery, St. Michael's Hospital and The University of Toronto; Elizabeth R. Wahl, Yale University Medical School; Christine Grady, Department of Clinical Bioethics, The Clinical Center, National Institutes of Health; Ezekiel J. Emanuel, Department of Clinical Bioethics, The Clinical Center, National Institutes of Health:
SECTION I: COLLABORATIVE PARTNERSHIP:
Case 1. Community involvement in biodiversity prospecting in Mexico:
Case 2. Selling genes: consulting a genetic population database in Tonga:
Case 3: Substantiality of a fluoride varnish feasability study in Nicaragua:
SECTION II: SCIENTIFIC VALIDITY:
Case 4: Malarone testing in pregnant women in Thailand:
Case 5: Neglected diseases: Incentives to Conduct Research in Developing Countries: the case of Pharamomycin for visceral leishmaniasis in India:
SECTION III: SCIENTIFIC VALIDITY:
Case 7. The limitations of knowledge: equipsoise and a randomized treatment strategy for malaria in Ethiopia:
Case 8. Controversy surrounding the scientific value of the Vaxgen/Aventis (RV-144) Phase III:
SECTION IV: FAIR SUBJECT AND COMMUNITY SELECTION:
Case 9. Pharmaceutical research in developing countries: testing a new sufracant in Bolivia:
Case 10: Trading Genes for Toothbrushes: Research with the Aka Pygmy people in the Central African Republic:
Case 11: Test Phase I malaria vaccine: where should the research be conducted?:
SECTION V: FAVOURABLE RISK/BENEFIT ASSESSMENT:
Case 12: Ethical complcations during an investigation of malaria infection in native Amazonian populations in western Brazil:
Case 13: Access to treatment for trial participants who become infected with HIV during the course of Phase I trials of a preventive HIV vaccine in South Africa:
SECTION VI: INDEPENDENT REVIEW:
Case 14: How independent is independent review? Partner notification in a study of sexually-transmitted diseases in Mpumalanga, South Africa:
Case 15: Which regulations protect subjects best: preventing HIV status disclosure in a community-based circumcision study in rural Uganda:
SECTION VII: INFORMED CONSENT:
Case 16: The challenge of informed consent in a genetic epidemiology study of noma in rural Nigeria:
Case 17: Compensation to families who consent to research autopsy for their children in a study of malaria mortality in Malawi: respectful or coercive?:
SECTION VIII: RESPECT FOR ENROLLED SUBJECTS AND THEIR COMMUNITIES:
Case 18: A randomized trial of low-phytate corn for maternal-infant micronutrient deficiency in Guatemala:
Case 19: Obligations to participants harmed in the course of the N-9 multi-centre vaginal microbicide trial in South Africa:
Case 20: Ethical challenges and controversy in a retrospective study of HIV-1 transmission in Uganda:
Case 21: Protecting subjects in a study of domestic violence in South Africa: what services are researchers obligated to provide?:
APPENDIX I: ECONOMIC, SOCIAL, HEALTH AND DEVELOPMENT INDICATORS FOR THE CASE COUNTRIES:

Reviews

"This is a well written book and a must-read for anyone trying to understand the concerns associated with international biomedical research. The cases address research in many part of the world on different disorders and conditions. The commentaries give readers a better appreciation of the breadth and depth of the relevant ethical issues."--Doody's
"Provides a wealth of examples, debate, and dilemmas...[an] invaluable book."--Lancet
"This is a well written book and a must-read for anyone trying to understand the concerns associated with international biomedical research. The cases address research in many part of the world on different disorders and conditions. The commentaries give readers a better appreciation of the breadth and depth of the relevant ethical issues."--Doody's
"Provides a wealth of examples, debate, and dilemmas...[an] invaluable book."--Lancet
"The book is highly recommended for anyone planning a clinical trial with a design or location off the beaten path. It also raises important questions for even the most routine clinical research in developed countries."--Journal of Clinical Research Best Practices