Ethical Issues in International Biomedical Research: A Casebook

Hardcover | March 1, 2007

EditorJames V. Lavery, Christine Grady, Elizabeth R. Wahl

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Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefitsshould be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worldsleading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.

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Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefitsshould be provided to the community after complet...

James V. Lavery is at St. Michael's Hospital and University of Toronto. Christine Grady is at the Department of Clinical Bioethics, The Clinical Center at the National Institutes of Health. Elizabeth R. Wahl is at Yale University Medical School.

other books by James V. Lavery

Format:HardcoverDimensions:400 pages, 6.42 × 9.29 × 0.98 inPublished:March 1, 2007Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0195179226

ISBN - 13:9780195179224

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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, TheClinical 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.

Editorial Reviews

"Provides a wealth of examples, debate, and dilemmas...[an] invaluable book."--Lancet