Book Review

The Oxford Textbook of Clinical Research Ethics

N Engl J Med 2008; 359:982-983August 28, 2008

Article

The Oxford Textbook of Clinical Research Ethics
Edited by Ezekiel J. Emanuel, Christine Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, and David Wendler. 827 pp., illustrated. New York, Oxford University Press, 2008. $150. ISBN: 978-0-19-516865-5

The Oxford Textbook of Clinical Research Ethics is a resource suitable for a course in research ethics and would also be helpful for those starting a career in clinical research. It is an accessible synthesis and discussion of the many facets of research ethics — a massive undertaking, as its size indicates. Scholars and students will find the book valuable, but it is also an important resource for those already conducting clinical research as investigators (or those contemplating becoming investigators), as well as for research team members, reviewers, sponsors, research advocacy groups, and regulators.

The list of 87 contributors includes many leaders in the fields of medical and research ethics. There is a good mix of viewpoints, which keeps the text enlightening and thought provoking. A textbook that compiles chapters written by such a diverse range of contributors — even those as broadly written and experienced as many chapter authors are — requires substantial editorial input and direction to ensure a cohesive whole. The editors of this book, who are well-published and respected authors themselves, were up to the task. The writing is consistently top-drawer. The book can be read from cover to cover without the jarring changes of style and perspective sometimes encountered in multiauthored books. Importantly, each chapter focuses on and solidifies specific concepts and controversies. Thus, the book is a valuable resource when a question arises in practice or when additional foundation is needed in a specific area. Readers will gain a better understanding of complex issues, which will hold them in good stead in discussions with peers, with research subjects, and with people thinking of becoming participants in clinical research.

The book begins with a comprehensive examination of the historical precedents and events that bring us to the present state of research ethics and that shape its probable course in the future. This material is followed by 10 sections covering ethical aspects of areas such as codes and guidance, scientific design issues, review and oversight, selection of subjects, and informed consent. The last two of these sections, which are of particular interest and importance, cover multinational research and investigator behavior, including discussions of conflicts of interest and scientific misconduct.

This book supports physicians who seek to perform real-world research in the most ethical way. To paraphrase Henry Beecher in his seminal article in the Journal, “Ethics and Clinical Research” (N Engl J Med 1966;274:1354-60), the ethical conduct of research principally depends on the researcher acting in a responsible manner. This book gives researchers a good grounding in what those responsibilities are and why they are important.

The attention paid to international perspectives increases the book's appeal. The editors state in their introduction that they intentionally included authors from as many different countries as they could. It is refreshing to see that this enlightened attitude extended even to the selection of the photograph on the cover, which shows not a laboratory with test tubes or a patient sitting on an examination table but instead a researcher interacting with a subject under a tree in a remote village.

The book's format is pleasing as well. There is good use of headings and subheadings to assist the reader who is looking for a specific topic. There are also photographs, tables, and other graphics that maintain interest and help the reader consider ethical issues. Each chapter includes a list of references that supports the text and provides readers interested in further exploration with solid points of departure. Although social scientists and behavioralists may feel somewhat slighted, the book is perfect for an upper-level course on clinical research ethics.

This book is a gem. The editors have admirably met their goal of producing a book that is comprehensive, that provides a systematic analysis, and that does so from a multicultural approach.

Gary L. Chadwick, Pharm.D., M.P.H.
University of Rochester, Rochester, NY 14642
gary_chadwick@urmc.rochester.edu