Ethical and regulatory aspects of clinical research: readings and commentary



Leonardo D. de Castro

Department of Philosophy, University of the Philippines, Diliman, Quezon City, 1104 Philippines (



Editors: Ezekiel J. Emanuel, Robert A. Crouch, John D. Arras, Jonathan D. Moreno, & Christine Grady
Publisher: Johns Hopkins University Press, Baltimore, MD, USA; 2004
ISBN: 0-8018-7813-6; paperback; 528 pages; price US$ 39.95

It was quite propitious that this book arrived for review just as we were preparing to conduct another training course in research ethics at the University of the Philippines for health researchers and members of Ethics Review Committees in the Asia–Pacific region. The book begins with a history of human subjects research and then covers various aspects of clinical trial process, including: designing the trial, recruiting participants, ensuring informed consent, and studying special populations. Conflicts of interest and scientific misconduct are also covered. Examining the contents of the book in terms of reviewing our curriculum and putting together assigned reading material for the participants in the course, we thought that many of the chapters easily deserved to be required reading — not only for the particular course module that we were about to give but for subsequent modules that were to follow. The book's contents easily fit the requirement for a single volume that contains most of the materials that one would have wanted — providing an introduction, current international guidelines, theoretical analyses, as well as excellent selections on specialized issues and the most recent controversies.

Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics. Also they chronicle the advances in ethical theory that have come about in response to the controversy-ridden strides that have been made in biomedical research over the past half century. However, there can be drawbacks to elegance and sophistication in thought if the objective in mind is the practical application of information. Classical writings do not necessarily constitute the best materials for educating people who have different levels of scholarly commitment and practical involvement in research and review of research ethics. For example, participants in our training courses have occasionally told us that they are more interested in being given specific rules or guidelines that they can refer to in making decisions to approve — or to conduct — proposed biomedical research projects. Scholarly discussion tends to confuse them and to leave them still hoping for clear guidelines regarding particular decisions that have to be made. Some of the participants in our courses may tend to have such feelings upon reading Ethical and regulatory aspects of clinical research. Such feelings cannot, however, be ascribed to the book itself. Perhaps it should be the responsibility of regulatory bodies to show how materials such as those in monographs such as this relate directly to the work of ethics reviewers and researchers, and to particular positions that they may take with respect to certain issues.

The book is clearly primarily intended for an American audience, which is understandable, since the editors are American academics. Also, the individual contributors are from developed country institutions. One wonders whether this reflects a bias in favour of authors who could be appreciated by an American readership; a dearth of relevant material written by scholars from other parts of the world; a lack of appreciation for perspectives expounded by developing country authors; or, as we hope, a simple oversight that the editors will attempt to rectify in a subsequent edition. Nevertheless, the compendium of articles in this book is, on the whole, relevant internationally, with some qualification.



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