Ruth Macklin
Cambridge University Press, £22.99, pp 288 ISBN 0 521 54170 0
Ruth Macklin, a senior bioethicist with a longstanding interest in research ethics, has produced a very readable overview and analysis of the main issues in one of the most acrimonious international debates the field of ethics has seen in recent times. Unlike the excited bickering about stem cell research and reproductive cloning, this debate affects the lives of real people and is quite unlike those interminable debates about the moral standing of accumulations of a few hundred cells that some people still misleadingly call "persons."
At the heart of the debate lies this question: what standards of care are ethically required when commercial organisations and investigators from the developed world (or sponsored by agencies in the developed world) undertake research in the developing world? This book, which is based on earlier published works by Macklin, tackles this difficult issue from a variety of angles, including justice, human rights, and drug prices.
Macklin's analyses are mostly insightful and are certainly to be recommended to the uninitiated interested reader. However, I doubt that those involved in these debates will find much by way of new thought, but that is probably not the book's aim. The arguments of the various sides in this conflict are well known to experts, and Macklin's review provides little that is new to this audience. I found the discussion of human rights concepts tremendously valuable, and indeed it made me rethink long held views on the usefulness of deploying arguments that are based on human rights. As an easily digested overview this book could well become the standard textbook for researchers and students in postgraduate courses in biomedical ethics. Also relevant is Macklin's discussion of the difficult issues of funding research into neglected diseases and the impact of this issue on the debate on standards of care.
My main quarrel with this book is that it doesn't deal adequately with the political dimensions of the debate. For instance, Macklin insists that one of the organisations issuing "ethical" guidelines on research in developing countries—namely, the Council for International Organizations of Medical Sciences (CIOMS), of which she is a vice president—had followed a "transparent, iterative process" in its deliberations. The reality, as I and some of those directly involved in the CIOMS process have perceived it, is somewhat different. Similarly, Macklin discusses the guidelines of organisations such as the UK's Nuffield Council at great length without questioning the legitimacy of the organisations and their processes or the relevance of their guidelines. Simply put, why should any developing country bother about the views of CIOMS or the Nuffield Council or other players in the field? Macklin takes for granted that they should but offers little justification.
Similarly, the book offers no reflection on the politics, as opposed to the ethics, of bioethicists working for the US National Institutes of Health (NIH). Currently, the published views of the bioethics staff of the NIH uniformly call for lower standards of care for trial participants from the developing world. That these professionals, defending their employer's interests in this regard, as Macklin acknowledges, travel the developing world with generously funded training programmes in research ethics is clearly a political problem. It is also a problem with regard to the professional independence of bioethicists employed by the US government. Macklin is silent on this issue.
Would I buy this book, despite its shortcomings in political analysis? I would, and probably so should you if you are interested in the topic.
Rating: ***
Udo Schuklenk, professor of bioethics and human rights
University of the Witwatersrand, Johannesburg, South Africa schuklenku@medicine.wits.ac.za