Summer/Fall 1999

Book Review

by Michael McDonald
Maurice Young Professor of Applied Ethics and Director of the Centre for Applied Ethics, University of British Columbia

Vanderpool, Frederick Y., ed. The Ethics of Research Involving Human Subjects: Facing the 21 st Century. Frederick, MD: University Press Group, 1996 xii + 531 pages. $91.18.

Brody, Baruch, ed. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press, 1998. xiii + 396 pages. $73.95.

anderpool offers a collection of papers that were first presented at a 1993 Texas conference on "The ethics of clinical research". The volume has four main parts. Despite its title, "Current debate over research ethics and regulations," Part I reviews longstanding debates in clinical ethics over the balance to be struck between protecting research participants and advancing research. The articles by Robert Veatch, Albert Jonsen, and Terrence Ackerman cover familiar ground in clinical research ethics (e.g., principled versus casuistic ethical reasoning) as does Carol Levine’s article on AIDS and the inclusion of vulnerable subjects.

With the exception of La Puma’s article on "Physicians’ Conflicts of Interest in Post-Marketing Research", I found Part II, "Conflicts of Interest," fairly pedestrian. La Puma aptly describes the conflict of interests inherent in much of Phase IV clinical trials thus:

Owing a simultaneous duty to both the research sponsor and an unforeseen, future population of patients is one ball in the air too many for most physician-investigators. Charged with loyalty to one patient at a time in the office and to the needs of his or her other patients yet to come, physicians quadruple their loyalties (p. 208).

This is an area that has received insufficient attention. Since many Phase IV trials take place in the private offices, there is usually no independent review by university or hospital review and with the exception of Alberta no review by professional medical bodies.

Partly for reasons of personal interest, I found the most interesting part of the book to be Part III, "Controversy over cross-cultural research." The controversy between ethical pluralism and ethical universalism is nicely represented in the articles by Robert Levine and Nicholas Christakis on the one hand and Carel Ijsselmuiden and Ruth Faden on the other. The latter argue for individual informed consent on universalistic principles. However, I have significant reservations about their suggestion that Western researchers demanding individual consent is an appropriate form of medical and cultural interventionism. A major part of their article relies on a false dichotomy between either respect for oppressive traditional authorities or respect for free individuals. This, I think, considerably underestimates the human capacity to reshape cultures and the need for Western researchers to respect individuals as socially and culturally located human beings rather than imposing their own cultural values. That is, there needs to be sensitivity on the part of researchers to the evolving social institutions in which individuals locate themselves. I should also note that the articles in this section do not directly address the particular issues presented when research involves a collectivity per se, e.g., research on a group’s private records.

In Part IV, "Critical issues in specialized areas", there are essays on a number of areas: cancer trials, pædiatric research, fœtal and embryo research, and genome research. The outstanding article in this section and perhaps in the volume is by the late Benjamin Freedman. Freedman’s article arose from a SSHRC-sponsored project on multi-centre cancer trials. The article centres on REBs acquiring the right expertise and asking the right questions about eligibility criteria. This goes to the heart of ethics review for higher-risk research projects in general, and not just cancer trials, in that often the most troubling ethical issues are buried in the scientific or scholarly parts of the proposal that are often unquestioningly accepted as "normal" science or scholarship.

While I found the Vanderpool volume somewhat uneven, I very much liked Baruch Brody’s book. Brody offers a careful comparative assessment of international policies for the ethics of bio-medical research involving humans and also considers the ethics of biomedical research involving animals.

Brody’s work examines policies that were in place as of July 1, 1997. Nonetheless, he does include the proposed Code of Conduct for Ethical Research Involving Humans and has in some places quite high praise for it — particularly on the topic of inclusiveness, describing it as "an advance over what has happened in most countries" (p. 189). Unfortunately, this was one of several parts of the Code substantially watered down by the Councils in producing the current Policy Statement.

Brody misunderstands the intention of the Code’s ‘Collectivities’ section by describing it as aimed mainly at aboriginal communities. Rather the aim was to ask that researchers treat all human communities respectfully and have special concern for vulnerable groups. Finally on matters Canadian, it is worth noting Brody’s acknowledgement of the leadership position of Canada in the area of research involving animals.

Brody provides a systematic and careful review and comparison of the principal international documents covering a wide range of areas beyond those already mentioned; including the following areas of research: epidemiological, genetic, fœtal and reproductive, vulnerable subjects, clinical trials, and drugs and devices. In his final chapter, "Philosophical Reflections", Brody sees a significant degree of ‘convergence’ and ‘consensus’ in many areas of research ethics. The main divergences occur where "the moral status of the subject is involved," e.g., zygotes (p. 202). Methodologically, Brody argues that the form of reasoning followed in policy-making is "pluralistic casuistry" (which recognises "as legitimate a variety of different values that are not derivable from some fundamental value") and not value fundamentalism, e.g., of a Kantian or utilitarian kind (pp. 205-206). Brody uses "analogies between the process whereby scientists develop generalisations and scientific theories on the basis of empirical observations and the process by which ethicists develop principles and ethical theories on the basis of moral intuitions" to argue for the soundness of the views thus discovered in casuistic reasoning (p.209).

Finally, Brody’s volume has an extensive collection of international and national policies and regulations that takes up nearly half the volume. While it is outside the ambit of Brody’s book, I would have liked to see a consideration of the larger economic, social and intellectual factors at work that are driving convergence and consensus, including the commercialization of research, the growth of a global biomedical culture and a substantial biomedical economy. This might cast a different light on the themes of convergence and consensus. But I say this not by way of criticism of Brody’s work. His volume is an important one that should be not only of interest to specialists in research ethics but also useful for REB members who sometimes have to grapple with a wide range of policies, e.g., in looking at research being conducted in other countries.

Recent Publications

Freedman, Benjamin, ed. Duty and Healing: Foundations of a Jewish Bioethic’ New York: Routledge, 1999, 352 pp. Pb. Price: Can. $34.99 ; US $24.99. The book is a sustained examination of contemporary moral problems, including caring for family members, consent, competency, and the assumption of risk. It is a remarkable synthesis of contemporary bioethics and traditional Jewish sources and demonstrates the important contribution that a framework of duty brings to moral analysis.

Hornblum, Allen M., ed. Acres of Skin. New York: Routledge, 1999, Pb. 320pp. Price: Can. $24.00 ; US $16.00. On the same scale as the syphilis experiments at Tuskegee and the horrifying use of mentally handicapped children at Willowbrook, Acres of Skin sheds light on yet another dark episode of American medical history. In this disturbing account, Allen M. Hornblum tells the story of Philadelphia’s Holmesburg Prison: For more than two decades, from the mid-1950s through the mid-1970s, inmates were used, in exchange for a few dollars, as guinea pigs in a host of medical experiments. According to Hornblum’s sources, hundreds of prisoners were used to test products from facial creams, and skin moisturizers to perfumes, detergent, and anti-rash treatments. Others took part in far more hazardous, even potentially lethal, tests using substances such as radioactive isotopes, LSD, and chemical warfare agents, without being informed about the risks involved in these dangerous experiments.

Lage, Dietmar, ed. Subject to Consent: the Ethics of Human Subjects Research in Canada. Winnipeg: Wuerz Publishing Ltd., 1998, 391pp. Cloth. Price: Can. $74.37. This book examines international, and especially Canadian, attempts to protect research subjects by means of peer review mechanisms, ethical guidelines, regulations and legislation. Central to all these attempts to protect human subjects is the doctrine of consent. This dynamic and evolving doctrine, which has undergone significant development during recent decades as a result of an increasing sensitivity to civil rights issues, is the primary focus of this work.

Tjeltveit, Alan, ed. Ethics and Values in Psychotherapy. New York: Routledge, 1999, 352 pp. Pb. Price: Can. $31.99 ; US $22.39. The book examines the ways in which the ethical convictions of both therapist and client contribute to the practical process of psychotherapy. Practitioners are increasingly focussing on the issue of their extensive — and often problematic — ethical influence on clients as they attempt to agree on guidelines and standards for professional practice. Alan C. Tjeltveit argues that any discussion of ethical practice in psychotherapy must be carried out in connection with traditional ethical theories. This comprehensive study is a significant contribution to the debate on the ethical character of psychotherapy.

From the Journals:

Clark, Steve. "Justifying Deception in Social Science Research", Journal of Applied Philosophy, 16 (1999): 151-66. The author examines various justifications for the use of deception, including consequentialist arguments, and exemptions from or alternatives to informed consent.

Salmon, Merrilee H., "Introduction — Ethics in Science: Special Problems in Anthropology and Archaeology," Science and Engineering Ethics, 3 (1999): 307-310. Salmon, a professor of history and philosophy of science, organized a symposium on "Ethics in Science: Special Problems in Anthropology and Archaeology"at the 1998 Annual Meeting of the American Association for the Advancement of Science (AAAS).

Shapiro, Harold T., "Ethical Considerations and Public Policy — A Ninety-Day Exercise in Practical and Professional Ethics: Cloning Human Beings," Science and Engineering Ethics, 1 (1999): 3-16. In early June of 1997, the U.S. National Bioethics Advisory Commission (NBAC) presented to President Clinton a report entitled Cloning Human Beings. The Commission faced a number of practical issues in attempting to respond to President Clinton’s request to report, within ninety days, on the legal and ethical issues surrounding the cloning of human beings from fully differentiated (i.e., "adult") somatic cells — that is, cells not destined to become eggs or sperm. The report refers to this technique for cloning animals as somatic-cell nuclear transfer. In the end, the 18 diverse and independent members of the Commission achieved a considerable degree of agreement. The principal recommendations of this report were to enact through federal legislation a temporary injunction on public- or private-sector efforts to use this new cloning technique to create human beings, and second, to call for further public deliberation on the subject. This temporary injunction would both address reasonable safety concerns and allow time for serious national reflection on a range of deeply contested issues.