European Journal of Health Law 11 : 153-174, 2004. 153 © 2004 Koninklijke Brill N.V. Printed in the Netherlands CIOMS’ Placebo Rule and the Promotion of Negligent Medical Practice TRUDO LEMMENS, DOMINIQUE SPRUMONT, HERMAN NYS, JEROME SINGH & KATHLEEN CRANLEY GLASS * Introduction In research ethics, few ethical issues are more hotly debated than the use of placebo controls in clinical trials. Most commentators agree that these trials are acceptable when aimed at testing a new treatment for a disease for which no treatment is currently available. They are, however, deeply divided about the appropriateness of placebo-controlled trials involving patients when an effective treatment already exists for their conditions. Opponents of these trials have invoked the ethical significance of the notion of clinical equipoise, 1 or more generally the ethical and legal duties of clinical investigators towards patients, 2 while proponents have emphasized the role of individual liberty and informed consent to support a more flexible use of placebo controls. 3 The moral arguments on both sides are to some extent irreconcilable, since they reflect fundamentally different premises about the obligations of physician/ researchers and the meaning and limits of individual liberty. Not surprisingly, substantive arguments have often
European Journal of Health Law – Brill
Published: Jan 1, 2004
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