Exploitation and Developing Countries: The Ethics of Clinical Research - Softcover

Softcover

ISBN 10: 0691126763 ISBN 13: 9780691126760

Verlag: Princeton University Press, 2008

Inhaltsangabe

When is clinical research in developing countries exploitation? Exploitation is a concept in ordinary moral thought that has not often been analyzed outside the Marxist tradition. Yet it is commonly used to describe interactions that seem morally suspect in some way. A case in point is clinical research sponsored by developed countries and carried out in developing countries, with participants who are poor and sick, and lack education. Such individuals seem vulnerable to abuse. But does this, by itself, make such research exploitative?



Exploitation and Developing Countries is an attempt by philosophers and bioethicists to reflect on the meaning of exploitation, to ask whether and when clinical research in developing countries counts as exploitative, and to consider what can be done to minimize the possibility of exploitation in such circumstances. These reflections should interest clinical researchers, since locating the line between appropriate and inappropriate use of subjects--the line between exploitation and fair use--is the central question at the heart of research ethics. Reflection on this rich and important moral concept should also interest normative moral philosophers of a non-Marxist bent.


In addition to the editors, the contributors are Richard J. Arneson, Alisa L. Carse, Margaret Olivia Little, Thomas Pogge, Andrew W. Siegel, and Alan Wertheimer.

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Über die Autorin bzw. den Autor

Jennifer S. Hawkins is assistant professor of philosophy at the University of Toronto. Ezekiel J. Emanuel is chairman of the Department of Bioethics at the Clinical Center of the National Institutes of Health.

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"This is an outstanding contribution to the growing literature on the ethics of research with human subjects, and a fine example of what bioethics can offer at its best. Anyone with a serious interest in these issues will need to read this book from start to finish."--Daniel Wikler, Harvard School of Public Health

"This book contributes significantly to the literature on exploitation in clinical research conducted in the developing world."--Patricia Marshall, Case Western Reserve University

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Exploitation and Developing Countries

The Ethics of Clinical Research

Princeton University Press

Copyright © 2008 Princeton University Press
All right reserved.
ISBN: 978-0-691-12676-0

Contents

Introduction: Why Exploitation? JENNIFER S. HAWKINS AND EZEKIEL J. EMANUEL.................................................11. Research Ethics, Developing Countries, and Exploitation: A Primer JENNIFER S. HAWKINS...................................212. Case Studies: The Havrix Trial and the Surfaxin Trial...................................................................553. Exploitation in Clinical Research ALAN WERTHEIMER.......................................................................634. Testing Our Drugs on the Poor Abroad THOMAS POGGE.......................................................................1055. Broadly Utilitarian Theories of Exploitation and Multinational Clinical Research RICHARD J. ARNESON.....................1426. Kantian Ethics, Exploitation, and Multinational Clinical Trials ANDREW W. SIEGEL........................................1757. Exploitation and the Enterprise of Medical Research ALISA L. CARSE AND MARGARET OLIVIA LITTLE...........................2068. Exploitation and Placebo Controls JENNIFER S. HAWKINS...................................................................2469. Addressing Exploitation: Reasonable Availability versus Fair Benefits EZEKIEL J. EMANUEL................................286Index......................................................................................................................315

Chapter One

Research Ethics, Developing Countries, and Exploitation: A Primer

JENNIFER S. HAWKINS

As the AZT trials demonstrated, questions about the ethical conduct of clinical research in developing countries are anything but simple. Informed judgments about the cases in this book, and about future directions for policy, require familiarity with both the details of clinical research and significant moral distinctions. This chapter aims to provide some background material relevant to understanding the complexities of the current debates.

The first section provides a basic overview of the fundamental concepts of research ethics as they relate to developing country research—informed consent, randomized controlled trials (RCTs), standard of care, and clinical equipoise. It is intended for readers who are familiar with ethical theory but less familiar with the peculiar concerns of clinical research. It aims to familiarize them with the concepts and clearly articulate the disputed questions currently relevant for the discussions of international research that follow.

The second section provides an overview of the concept of exploitation to help orient those less familiar with philosophy to the ways in which philosophers have approached the topic. Exploitation is commonly associated with Marxism, but there is, in addition to the Marxist tradition, a robust tradition of non-Marxist accounts of exploitation of which the essays in this book are representative. This section will briefly introduce readers to both the Marxist and the non-Marxist understandings of the concept, and set out the central questions about exploitation that remain open for debate.

Brief Background to Clinical Research Ethics

Medical research aims to generate knowledge that will hopefully, in turn, lead to improvements in medical practice. It is a long process. Often there is an initial phase of basic scientific research conducted in laboratories. Animal studies are then usually conducted before new agents are tried out in a human body. "Clinical research" refers to the later phases of medical research, when human bodies enter the equation. Even here there are multiple stages. "Phase I" is the name traditionally given to the first studies of an agent in humans. Such studies are usually very small, and hence cannot reveal anything general about how effective an agent is at curbing disease. Instead, the aim is to first learn about "toxicity, metabolism, and other drug dynamics." Many such studies are carried out on healthy volunteers, though research on new cancer drugs is an exception.

Phase II and Phase III studies are generally randomized controlled trials where the new agent is compared with something else. Unlike Phase I trials, they are usually conducted on subjects with the illness for which an improvement in treatment is being sought. Phase II studies are generally much smaller than Phase III, and still largely concerned with gaining understanding about safety and side effects. It is the large Phase III clinical trials that enroll hundreds and sometimes thousands of human subjects that aim to determine whether a new agent will indeed prove to be a useful general treatment for the illness in question. The controversies described here are all related to the conduct of Phase III trials.

Informed Consent

Informed consent is almost universally recognized as a requirement for the ethical conduct of clinical research. Indeed, the more common danger in discussions of research ethics is for people to reduce all moral concerns about research to concerns about consent. While consent is important, it is only one of the key components of ethical research.

Valid informed consent has four requirements. First, only those potential subjects who pass the requirements for decision-making competence should be asked to give consent. When it is necessary to enroll incompetent subjects, consent must be obtained from an appropriate surrogate. Three additional requirements must be satisfied with respect to either the competent subject or the incompetent subject's surrogate. There must be full disclosure of all the relevant information, the subject or surrogate must understand the information, and he or she must then consent freely or voluntarily. Force, coercion, and undue inducement are all recognized as undermining the voluntariness, and hence the validity, of informed consent.

In the context of research in developing countries, a number of distinct and sometimes contradictory concerns have been raised about informed consent. Most recent discussion has emphasized the difficulties of obtaining genuine informed consent in developing countries. Another, older concern is that informed consent may not be culturally appropriate in all parts of the world. Whereas the first group is concerned that consent is not being obtained often enough, the second thinks that consent may not even be necessary. Let us consider first the concerns of those who think genuine consent is not obtained often enough.

Some of the concerns that arise here are concerns about understanding. In 1997, for example, a New York Times article that focused specifically on one of the controversial AZT trials in Côte d'Ivoire sponsored by the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) raised worries about the true level of subject understanding. One subject singled out by the reporter clearly did not understand the concept of a placebo despite repeated explanations and questionings. She is quoted as saying:

They gave me a bunch of pills to take, and told me how to take them. Some were for malaria, some were for fevers, and some were supposed to be for the virus. I knew that there were different kinds, but I figured that if one of them didn't work against AIDS, then one of the other ones would.

Although there is no evidence...

Details zur Ausgabe

• Verlag: Princeton University Press
• Erscheinungsdatum: 2008
• Sprache: Englisch
• ISBN 10: 0691126763
• ISBN 13: 9780691126760
• Einband: Taschenbuch
• Auflage: 1
• Anzahl der Seiten: 327
• Herausgeber: Hawkins Jennifer S., Emanuel Ezekiel J. Ph.D.
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: Buchbär; info@buchbaer.de; ; Weberstr. 67; Osnabrück; 49084; Deutschland