The Ethics of Biomedical Research: An International Perspective

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9780195090079: The Ethics of Biomedical Research: An International Perspective

This book analyzes the major issues of research ethics through a careful review of the treatment in official policies on research ethics developed throughout the world (especially North America, Western Europe, and the Pacific Rim). Among the issues covered are animal research, research on human subjects, epidemiological research, genetic research, reproductive research, research on vulnerable subjects, clinical trials, drug approval and the research process, and research on women and minorities. Brody also evaluates the content and the methods of developing these policies in light of his philosophical position of pluralistic casuistry.
This is the only book that analyzes all the major issues in research ethics. It is the only book which deals with these issues from an international perspective rather than just a US perspective. Major official policies from important research-intensive countries are reprinted in the appendix (close to 200 plates of otherwise difficult material).

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About the Author:

Baruch A. Brody is at Baylor College of Medicine.

From The New England Journal of Medicine:

Worldwide fears arising from an outbreak of Ebola virus in Africa, the controversy generated in the genetics community resulting from the eugenics law in China, and the turmoil on the editorial pages of the Journal provoked by AIDS research in third-world countries (Marcia Angell. "The Ethics of Clinical Research in the Third World." 1997;337:847-9.) are reminders of international issues related to biomedical research. Similarly, multinational pharmaceutical corporations have become active participants in discussions once limited to researchers, ethicists, and regulatory agencies.

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.

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Descripción Oxford University Press Inc, United States, 1998. Hardback. Estado de conservación: New. New.. Language: English . Brand New Book ***** Print on Demand *****.This book analyses the major issues of research ethics through a careful review of the treatment in official policies on research ethics developed throughout the world (especially North America, Western Europe, and the Pacific Rim). Among the issues covered are animal research, research on human subjects, epidemiological research, genetic research, reproductive research, research on vulnerable subjects, clinical trials, drug approval and the reserch process, and research on women and minorities. Brody also evaluates the content and the methods of developing these policies in light of his philosophical position of pluralistic casuistry. This is the only book that analyses all the major issues in research ethics. It is the only book which deals with these issues from an international perspective rather than just a US perspective. Major official policies from important research-intensive countries are reprinted in the appendix (close to 200 plates of otherwise difficult material). Nº de ref. de la librería APC9780195090079

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