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:
"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
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