From The New England Journal of Medicine
The Ethics of Biomedical Research is 1 of 11 recent books by renowned scholars of bioethics that have been published by Oxford University Press. The title might suggest that the book addresses the implementation of multinational trials. In fact, this book focuses on the ethics of biomedical research and is organized along familiar lines, with chapters on topics such as the use of animals in research, genetic research, and clinical trials. A discussion of relevant historical, ethical, legal, and regulatory material is presented. Although much of this information is available elsewhere, Brody adds his personal perspective based on a philosophical approach called pluralistic casuistry, which he discusses in the final chapter, entitled "Philosophical Reflections." In addition, his analysis of issues of concern such as epidemiologic research, research on zygotes created ex utero ("preimplantation zygotes"), and the recent changes in policies regarding the inclusion of children and women in research reflects the contemporary nature of these controversial issues, with references published as recently as 1997.
Brody examines how these ethical issues are addressed by nations in North America, Western Europe, and the Pacific. The appendixes are a valuable component of this book, and their inclusion alone justifies its moderate price. With difficulty, because much of the information is not in the indexed literature, Brody has compiled 38 critical international, transnational, and national (U.S., British, German, French, Canadian, Australian, and Japanese) policies, regulations, and guidelines. The collated material begins with the seminal Nuremberg Code (1947) and extends through the 1996 revision of the World Medical Association's Declaration of Helsinki. The less well publicized policies developed by the Council for International Organizations of Medical Sciences are of particular interest. They address such issues as the vulnerability of research subjects in less affluent and less developed societies, the need to respect social mores by being sensitive to different cultures, and concern that standards central to recommendations that emphasize individual informed consent may conflict with cultures in which the role of the leader in making communal decisions must be considered.
The convergence of different statements based in part on certain universally accepted principles is not surprising. In other instances in which the ethical basis may not be as firm, recommendations may arise out of pragmatic compromises that permit biomedical research to proceed in an acceptable manner. At times, the differences between documents can be more revealing than the similarities. The discrepancies can bring into focus differences between various codes of ethical behavior and the weaknesses in the underlying ethical arguments or emphasize the lack of firm ethical foundations for the recommendations.
Comprehensive and lucid presentations of historical and philosophical positions pertaining to the use of animals in research and research involving preimplantation zygotes emphasize the differences in regulations of different countries, especially the United States and Britain. Analysis of these two issues emphasizes that the recommendations are not always consistent within a country or between two countries. On the basis of his approach of pluralistic casuistry, Brody concludes that "the best way to understand many of the official policies is to see them as attempts to balance a variety of legitimate but conflicting values and principles," which should be viewed not as "a reflection of the incompleteness of moral reasoning that is not grounded in a single fundamental moral value but a reflection of the realities of moral reasoning."
The author's unique analysis provides an original contribution to the literature and should be read by anyone interested in the philosophical principles that guide biomedical research and by those involved in the development of guidelines and policies. For those who participate in research involving humans or animals and for anyone involved in multinational research, this book should be kept readily available as an important resource.
Reviewed by Irwin Light, M.D.
"...the first time this material has been brought together, it must be considered an important contribution to the literature itself."--The Journal of the American Medical Association
"This informative book offers a superb comparative ethico-legal analysis of international biomedical research policies.... This book is appropriate for all persons concerned with ethics in biomedical research, and is especially useful for those with an interest in comparative bio-policy."--Religious Studies Review
This is a book where I strongly recommend to a broad audience of readers. Written by the well-known American bioethicist Baruch Brody, it summarizes the results of more than a decade of research. To conclude, Brody's book is a most valuable contribution to biochemical research ethics and bioethics. It provokes philosophical inquiry about the meaning of research policies in particular, and moral reasoning in general. It also provides an unprecedented international perspective as well as an illuminating and critical analysis of the specific problems of biomedical research. These features makes this book one of the most promising in the field of research ethics.--Medicine, Health Care and Philosophy
"...identifies and summarizes the evolution of policies and emerging issues in research ethics...useful resource...could be used as a core text for the human subjects portion of a research ethics class...discusses a wide range of policies."--Journal of Health Politics, Policy, and Law Vol 25, No. 5, Oct. 2000
"...a good volume...will acquaint a North American readership with hard to find and useful resources."--Hastings Center Report