David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
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Science and Engineering Ethics 10 (1):41-48 (2004)
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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References found in this work BETA
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Peter A. Clark (2002). Placebo Surgery for Parkinson's Disease: Do the Benefits Outweigh the Risks? Journal of Law, Medicine & Ethics 30 (1):58-68.
W. Dekkers (2001). Sham Neurosurgery in Patients with Parkinson's Disease: Is It Morally Acceptable? Journal of Medical Ethics 27 (3):151-156.
G. R. Gillett (2001). Unnecessary Holes in the Head. IRB: Ethics & Human Research 23 (6):1.
Citations of this work BETA
Winston Chiong (2006). The Real Problem with Equipoise. American Journal of Bioethics 6 (4):37 – 47.
Jonathan Pugh, Guy Kahane, Hannah Maslen & Julian Savulescu (forthcoming). Lay Attitudes Towards Deception in Medicine: Theoretical Considerations and Empirical Evidence. Ajob Empirical Bioethics:00-00.
Mary Jean Walker & Wendy Rogers (2014). What Can Feminist Epistemology Do for Surgery? Hypatia 29 (2):404-421.
Wendy Rogers, Katrina Hutchison, Zoë C. Skea & Marion K. Campbell (2014). Strengthening the Ethical Assessment of Placebo-Controlled Surgical Trials: Three Proposals. BMC Medical Ethics 15 (1):78.
Chalmers C. Clark (2004). Design and Direction in Research Ethics: A Question of Direction. American Journal of Bioethics 4 (3):78-80.
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Charles J. Kowalski (2003). Sham Surgery: Not an Oxymoron. American Journal of Bioethics 3 (4):8 – 9.
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