| Volume 8 Number 2 |
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Winter/Spring 1998 |
by Gordon L. Crelinsten, MD, FRCPC, FACC Associate Professor of Medicine, McGill University; Member of NCEHR Executive Committee and Chair of NCEHR Evaluation Committee Lock, Stephen, and Frank Wells, editors. Fraud and Misconduct in Medical Research. 2nd edition. 293 pp. London, UK: BMJ Publishing Group, 1996. UK £33.00; Can. $74.25.
This multi-authored book offers insight into the problem of fraud and misconduct in medical research from an international perspective, and emphasizes that the problem is widespread. The British experience is similar to the United States experience and to the German experience. The motives for fraudulent behaviour are shared across borders. The national responses of the authorities responsible for monitoring the behaviour are carefully described. The pharmaceutical industry and contract research organizations have strong commercial reasons to be at the leading edge of the fight against fraud. Drug development is costly, the race to market is very competitive and the bottom line is a compelling incentive to get it right. For these reasons, it is clear that industry has developed mechanisms to uncover deviant behaviour. The creation of standard operating procedures for the handling of suspected fraud and the diligent surveillance by industry of industry-sponsored research can teach those who are searching for methods of effective research monitoring. The book is peppered with vignettes of research misadventure in various settings. These read like mini-detective stories and are not only informative but also entertaining. Stephen Lock’s chapter, Fraud and the Editor, is worth the price of the book. It recognizes the crucial position of publication in the propagation of fraudulent work and describes eloquently the editor’s role in recognizing and preventing this "important blemish on the face of research". Lock’s piece should be read by all who do research or train researchers. The editors have tried to outline a problem, discuss its causes and propose a solution. They have done this well by finding a group of informed and articulate authors and by compiling their thoughts in a coherent and complementary manner. by Jean-Noël Ringuet, Department of Philosophy, Collège de Chicoutimi, Applied Ethics Group, Collège de Chicoutimi, member of a research ethics committee in the hospital environment Marie-Luce Delfosse, (ed.), Les comités de la recherche biomédicale: exigences éthiques et réalités institutionnelles. Belgique—France—Canada et Québec. "Travaux de la Faculté de droit de Namur", Presses Universitaires de Namur, 1997, 204 p.
The aim of this work is to set out a range of viewpoints and practices on the place and role of ethics in biomedical research. The contributors focus on the following three issues, which determine the divisions of the book: first, what is the appropriate role for the research subject? Second, what are the requirements for implementing the committees responsible for approving research protocols? Third, who should take part in these committees? What is the appropriate role for the subject of research? The first section is comprised of three presentations dealing with the role and place of the research subject in medical activity. The first two authors clearly take the side of the subject, citing his or her right to information and self-medication, arguing that bioethical committees should include more people working "in the field" (as opposed to "experts"), and making a case for the integration of the subjective and social dimension of the individual with the objective study of the human body. The latter direction is defended by the Belgian philosopher Joseph Duchêne, who following the lead of Paul Ricœur and Alain Touraine, proposes an ethic of responsibility capable of surmounting the duality of State totalitarianism and the indivi-dualistic self. The need for "projects negotiated in terms of human finality" (p. 43) belongs to the subject, who must play the role of a citizen who can both dissident and be responsible. On the other hand, Patricia Palermini believes that the research subject should not occupy too great a place, as "the inflation of subjective rights inherent in the rise of individualism has led to an affirmation of individual rights to the detriment of the rights of society as a whole" (p. 51). Reiterating the theses put forth by Pierre Legendre, the psychoanalyst and specialist in Roman law who defends the subordination of the individual to the State on issues of inheritance and reproduction, she unequivocally attacks the pre-eminence of the subject: "individual will, inasmuch as it is strictly individual, is subjective and therefore arbitrary" (p. 60). Ethics committees should act as an "intermediary body" between the general interest of the State and individual wishes. The relationship between ethics and law The second and largest section of this compilation deals with the imple-mentation of research ethics committees: to what extent should the legal system intervene to provide a framework for research and define the mandate of ethics committees? This problem is approached by author, either in the context of a particular aspect or from an overall perspective, paper on clinical ethics committees in Québec. The contributions covering Belgium show two opposing points of view on the respective roles of ethics and law: one states that the legal framework should not go beyond legislation on human experimentation, and the other states that legislators should intervene firmly, not only at the level of research, but also in the structure and subject matter of ethics committees. It should be noted that the situation in Belgium is compli-cated by the fact that legal invol-vement has existed for a very short time (since 1994) where constraints had been established solely by the code of medical ethics and rules of research established by the Conseil de l’Ordre des médecins. France, however, is where State intervention in the area of research and ethics has been most prescriptive, since the adoption of the Huriet-Sérusclat Act in 1988. This act defines the rules of experimentation very precisely and appoints advisory committees for the protection of individuals in biomedical research. The act sets out in detail the functions and responsibilities of sponsors, researchers, subjects and committees. The advisory committees report to the minister of health, and inspectors ensure that their work complies with the provisions of the law. Marie-Hélène Parizeau, a philosopher from Université Laval, presents the situation in Canada and Québec from a historical perspective. In the North American tradition, the author favours self-regulation as opposed to legislative intervention. She opposes the concentration of functions and power in research ethics committees, seeing therein a danger of bypassing existing authorities (administrative, profes-sional, scientific). She also fears that adding responsibilities may lead to the transformation of these committees into arenas in which overlapping jurisdictions will conflict with each other, to the detriment of their primary objective, which is essentially ethical. Composition of the committees The last part of the book rounds out the numerous references in previous chapters to the composition of ethics committees by country. This section sets out the rules applied in Belgium, the United States and Denmark (an original experiment in regional representation and equality between scientists and lay people), and a doctor, Dr Jocelyn Bérubé of Rimouski, describes an experiment in a Québec hospital environment. Despite unanimity in international recommendations on the participation of people other than doctors in ethics committees, there are divergent viewpoints over representation on these committees. Positions range from very restrictive (some doctors fear a breach of doctor-patient confidentiality) to very open, going as far as equality for non-doctors. Conclusion This collection of texts has the strengths and weaknesses inherent in works of this kind. There is an evident lack of balance in the breadth and depth of thought from one paper to the next, and there is some question as to the appropriateness of the content of some articles to the themes of the sections they appear in. However, the wide range of viewpoints presented makes the work quite intellectually stimulating. Marie-Luce Delfosse, who is responsible for the introduction, the introductory notes and the conclusion, succeeds in weaving a coherent fabric, and in preventing her material from unravelling. The philosophical paper are developed and contrasted sufficiently to satisfy readers interested in comparing arguments at the heart of the major currents in bioethics. The review of the situation in various countries (historical backgrounds, traditions, legislation) given in the documentary papers adds to the overall interest of the work and to its usefulness as reference a work. Recent publications of potential interest to Communiqué readers Close B et al, ed.Volunteers in research and testing. London: Taylor & Francis, 1997. + x 198 pp. Price: UK Hb £45.00. One purpose of this book is to review the extent to which human volunteer studies in, primarily, medical research may help reduce the number of animals used in experiments. It is valuable to those that consider Phase I and II drug research or other human volunteer studies. Comité Consulatif National d’Éthique Pour les Sciences de la vie et de la Santé, de Sous la direction de Jean-Pierre Changeux. Une même éthique pour tous? France: Odile Jacob, 1997, 220 pp. Price: 135FF. The authors ask if it is possible to educate people to become tolerant and how to achieve it, in contemporary society which is torn by serious economic or cultural conflicts; despite the fact that people benefit from the progress made in science and new technologies (particularly in biology and medicine). What role will ethics committee play in this education? Conseil de la santé et du bien-être, ed. Enjeux éthiques dans le secteur de la
santé et du bien-être: besoin d’intervention? Québec: Gouvernement du Québec,
1997. One section of the report is on clinical research and related issues. For a free
copy, contact: Mme Line Vézina, Conseil de la santé et du bien-être. Davis Anne J., RN, PhD, Mila Aroskar, RN, EdD, FAAN, Joan Liaschenko, RN, PhD, and Theresa S. Drought, RN, PhD. Ethical Dilemmas & Nursing Practice, Fourth Edition. Stampford, CT: Appleton & Lange, 1997. This book reflects contemporary issues such as informed consent, abortion, dying and death, behaviour control, and mental retardation. DeCew Judith Wagner, ed. In Pursuit of Privacy: Law, Ethics, and the Rise of Technology. Ithaca, N.Y.: Cornell University Press, 1997. Price: US Hb $39.95 ; US Pb $15.95. The author aims to situate privacy within American law by examining the history and evolution of notions of privacy in the United States. Duchênes J et al., eds. Éthique et Handicap Mental(Ethics and Mental Disability). Namur, Belgium: Presses Universitaires de Namur, 1997, 261 pp. Price: Pb 600 Bfr. This book considers what is meant, from the ethical, sociopolitical, and psycho-logical standpoints, by the concepts of education and re-education, rehabilitation and readjustment, and integration and participation in social life with regard to mentally deficient persons. Gert Bernard, Charles M. Culver, and K. Danner Clouser. Bioethics: A Return to Fundamentals. Oxford University Press, 1997, 320 pp.Price: Can. Hb $50.00 ; US Hb $34.95. The authors provide an explicit account of common morality and show how it applies to, and is modified by, the realities of clinical medicine. The book is richly illustrated with discussions of clinical cases. Grmek M.D, ed. Le chaudron de Médée. L’expérimentation sur le vivant dans
l’antiquité. France: Édition Synthélabo (collection: Les empêcheurs de penser
en rond), 1997. Health Canada, ed. Good Clinical Practice: Consolidated Guideline.
Ottawa, Ontario: Health Canada Publications, 1997, 64 pp.ISBN 0-662-25953-X. International
Conference on Harmonisation of Technical Requirements for the Registration of
Pharmaceuticals for Human Use. Also, available in French. Contact: Therapeutic Products
Directorate. Hoshino Kazumosa. Japanese and Western Bioethics: Studies in Moral Diversity. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1997. Price: US $127.00. This collection of essays contributes to the "emerging international dialogue" in bioethics by studying similarities and differences in the way that Japanese and Western bioethics consider such moral questions as the just allocation of scarce medical resources and the appropriate allocation of new genetic technologies. International Journal of Bioethics. Byk Christian and Dominique Folscheid, eds. La recherche biomédicale face à ses juges.France: Éditions Alexandre Lacassagne, 1997; 8(3), 143 pp. Price: 155FF. The main subject of this journal is on the false trial of Prof. Mandarin. On March 21, 1996, the International Association of Law, Ethics and Science organized a false trial at the Paris Law Courts to demonstrate that promoters and investigators should not relax their attention when conducting research involving humans. In the present case, the Court came to the conclusion that Xavier Leroy, the late patient of Prof. Mandarin, was not fully informed by the investigators of the possible consequences of the placebo treatment he was taking instead of his regular pills for his essential high blood pressure. Prof. Mandarin, as well as Sylvain Martin, his colleague in that biomedical research, both failed to recognize the alarming signs in the deterioration of Xavier Leroy’s health. Hence, the Court charged them both in the manslaughter death of Xavier Leroy. There are also two articles in the last section of the journal . The first article entitled AIDS Clinical Trials: Ethical and Design Issues asks whether legislators are ethically entitled to prevent people with terminal illnesses from accessing experimental drugs in order to promote their participation in clinical trials research. The other article is a survey involving hospital psychiatrists, which was carried out in Alsace, France in 1994 to analyse the legal aspect of informed consent for the mentally ill. Korn James H. Illusions of Reality: A History of Deception in Social Psychology. Albany, NY: State University of New York Press, 1997, 256 pp. The book examines the origins and the development of the use of deception in psychological research to create illusions of reality. The ethical issues raised by this research are discussed, and the practice of using deception in research is placed in the context of American cultural values. Fax orders:1-800-688-2877; Email orders: orderbook@cupserv.org Murphy Edmond A., MD, ScD, James J. Butzow, PhD, and Edward L. Suarez-Murias, MD. Underpinnings of Medical Ethics. The Johns Hopkins University Press, 1997, 520 pp. Price: US Hb $49.95.This book is about the scope and methodology of medical ethics, and its scientific and philosophical basis. The authors offer much-needed clarification of the purview, ontological basis, and methodology of a medical ethics that is to be comprehensive and yet readily accepted by all. Nigel J. Dent, ed. Good Research Practices: A Practical Guide to the Implementation of the GxPs. Oxford: Butterworth-Heinemann, 1997. Xv & 522 pp. This book is designed as a practical guide to Good Manu-facturing Practice, Good Laboratory Practice, and Good Clinical Practice. It stresses the importance of profes-sionalism in the biomedical industry and provides hands-on assistance to the most recent guidelines and their backgrounds. Poupart, Deslauriers, Groulx, Laperrière, Mayer, Pires. Groupe de recherche interdisciplinaire sur les méthodes qualitatives. La recherche qualitative: Enjeux épistémologiques et méthodologiques. Boucherville, Québec: Gaëtan Morin éditeur, 1997, 454 pp. Price: Can. $45, 225 FF. Poupart, Deslauriers, Groulx, Laperrière, Mayer, Pires. Groupe de recherche interdisciplinaire sur les méthodes qualitatives. La recherche qualitative: diversité des champs et des pratiques au Québec. Boucherville, Québec: Gaëtan Morin éditeur, 1997, 454 pp. Price: Can. $42, 210 FF. Shapiro Arthur K., MD. and Elaine Shapiro, PhD. The Powerful Placebo. From Ancient Priest to Modern Physician. Baltimore, Maryland: The Johns Hopkins University Press, 1997, 312 pp. Price: US Hb $39.95. Ranging from antiquity to modern times, this history of the placebo effect is especially timely in light of renewed interest in the mind-body relationship. United Nations Educational, Scientific and Cultural Organization, ed. Universal Declaration on the Human Genome and Human Rights. Paris, France: UNESCO, 1997, 10 pp. The booklet is published in Arabic, Chinese, English, French, Russian and Spanish. For a free copy, contact: Georges B. Kutukdjian, Director, Bioethics Unit, 1 rue Miollis, 75732 Paris Cedex 15, France. Tel: + 33 (0)1 45 68 38 58 /39 39; Web Site: http://www.unesco.org/ibc Wayne C. Booth, Gregory G. Colomb and Joseph M. Williams. The Craft of Research. Chicago, Illinois: The University of Chicago Press, 1995, 294 pp. Price: US Hb $25.00 ; US Pb $12.95. This guidebook offers practical advice on the fundamentals of research to college and university students in all fields of study. It teaches much more than the mechanics of fact gathering: it explains how to approach a research project as an analytical process. Weckert John, and Douglas Adeney. Computer and Information Ethics. Westport, Conn.: Greenwood Press, 1997. Price: US $59.95. The authors pose questions regarding the nature of computer ethics and consider questions of morality within information technology such as privacy, property, and accountability.
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