Science and Engineering Ethics 10 (1):157-166 (2004)

Franklin Miller
Columbia University
Surgical clinical trials have seldom used a “sham” or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.
Keywords sham surgery  surgical clinical trials  ethics of clinical research  informed consent
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DOI 10.1007/s11948-004-0073-x
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References found in this work BETA

What Makes Placebo-Controlled Trials Unethical?Franklin G. Miller & Howard Brody - 2002 - American Journal of Bioethics 2 (2):3 – 9.
Unnecessary Holes in the Head.G. R. Gillett - 2001 - IRB: Ethics & Human Research 23 (6):1.

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The Real Problem with Equipoise.Winston Chiong - 2006 - American Journal of Bioethics 6 (4):37 – 47.

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