Ethical Issues in International Biomedical Research: A Casebook

by James V. Lavery, Christine Grady, Elizabeth R. Wahl

Overview

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 benefits should 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 worlds leading 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.

Product Details

ISBN-13:	9780195179224
Publisher:	Oxford University Press, USA
Publication date:	02/15/2007
Edition description:	New Edition
Pages:	400
Product dimensions:	9.30(w) x 6.40(h) x 1.00(d)

About the Author

St. Michael's Hospital and University of Toronto

National Institutes of Health

Yale University Medical School

all at the Department of Clinical Bioethics

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.

Editorial Reviews

Reviewer: Ana Smith Iltis, PhD (Saint Louis University)
Description: This book introduces and discusses a range of ethical issues that emerge in conducting international biomedical research from the perspective of researchers and scholars from around the world.
Purpose: It aims to broaden the literature on international research ethics. Through cases and commentaries, the book raises awareness of ethical issues that emerge in the conduct of international biomedical research and successfully presents competing views on how to evaluate and resolve these issues.
Audience: The book is intended for persons engaged in international research as well as for those working in research ethics, including bioethicists, lawyers, and policy makers. The use of cases, the range of issues addressed, and the perspectives included will capture the interests of these different groups and deepen their understanding of international research ethics.
Features: Each of the book's eight parts addresses a condition for the ethical conduct of international research. Each part includes one or more cases that illustrate the ethical issues in context and case commentaries. The use of cases to illustrate the types of ethical issues that arise will enable persons familiar with international research to identify comparable issues in their own areas. For those unfamiliar with international biomedical research, the cases provide a context for situating theoretical concerns in practice. The commentaries, written by authors from developing and developed nations, introduce readers to a range of concerns and possible solutions. Educators and workshop facilitators will find the cases helpful for classroom use.
Assessment: 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 parts 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 Review Service

"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

From the Publisher