Book Review

The Ethics and Politics of Human Experimentation

N Engl J Med 1993; 329:1748December 2, 1993

Article

The Ethics and Politics of Human Experimentation
By Paul M. McNeill. 315 pp. New York, Cambridge University Press, 1993. $59.95. ISBN: 0-521-41627-2

If the unexamined life is not worth living, it would seem to follow that the unexamined practice is not worth carrying out. In this engaging book, Paul McNeill, an Australian teacher of medical law and ethics, examines the examiners: the committee process of ethical review of research on human subjects. Wide-ranging chapters examine the genesis and evolution of ethical codes for conducting research and committee review of research; current practices of research-ethics committees; and to a limited degree, the legal and ethical principles underlying research review. One of the book's many strengths is that the information it presents is based on a survey of the practice of research review in most European countries as well as North America and the British Commonwealth -- too much on the ethics of human research has been written by and for Americans.

McNeill's Australian perspective serves him well. In a discussion of notorious ethical lapses in research on human subjects, the well-known tales of Nazi research are accompanied by the less familiar history of Japanese research on Chinese citizens (at least 11 Chinese cities were the targets of experiments in biologic warfare) and prisoners of war in World War II. (Experiments in Unit 731, resulting in the deaths of more than 3000 people, included transfusions of blood from horses and attempts to induce gas gangrene by exploding fragmentation bombs next to the exposed legs and buttocks of prisoners.) Similarly, the U.S. Tuskegee study of the natural history of untreated syphilis in black men (1932-1972) is juxtaposed with a New Zealand study of the natural history of untreated cervical carcinoma in situ. (This study, which began in 1966 and was active through the mid-1970s, was the subject of a judicial inquiry in 1987-1988, which found that the research had never been officially terminated [C. Paul. The New Zealand cervical cancer study: could it happen again? British Medical Journal 1988;297:533]). Its international perspective makes this book a useful adjunct to the classic American work in this area, Robert J. Levine's Ethics and Regulation of Clinical Research (2nd ed. Baltimore: Urban and Schwarzenberg, 1986).

McNeill concludes from his survey that reform is needed: “Review of experimentation on human subjects by a research ethics committee is a political process as much as it is an ethical process.” Considered as a political process, research review is undemocratic; for example, too few laypersons serve on committees, and research that McNeill has done with his colleagues indicates that laypersons who do serve are often relatively silent and powerless. Several changes are suggested, including a requirement that research studies be reviewed for scientific validity before they are submitted to research-ethics committees, the addition of lay committee members nominated by public groups concerned with health issues, required monitoring of the conduct of research studies, and provision of support -- educational, administrative, and financial -- to research-ethics committees and their members.

Although many of McNeill's suggestions are sensible, taken as a whole they would substantially increase the time and expense involved in reviewing experimental protocols, as well as generate distrust between committee and investigator. McNeill admits that “there is little evidence to suggest that unethical experimentation has been conducted on human subjects as a part of research approved by an ethics committee.” Revolution is not needed in a system that works reasonably well in the mainstream research community. Nevertheless, there are some situations in which a review of research ethics may be seriously deficient. These include studies involving the military or national security, which historically have been a source of research horror stories. Also worrisome are clinical studies done by “research factories” -- the privately managed, for-profit facilities where many phase 1 studies are currently conducted, under review by a company or other proprietary institutional review board. In these cases and perhaps a few others, it may be worth implementing the package of changes that McNeill has outlined.

Benjamin Freedman, Ph.D.
McGill Centre for Medicine, Ethics and Law, Montreal, QC H3A 1W9, Canada