The Ethical Problems with Sham Surgery in Clinical Research

Macklin, Ruth

doi:10.1056/nejm199909233411312

Cited by 289 publications

(161 citation statements)

References 37 publications

(25 reference statements)

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“…This has led renowned ethicist Ruth Macklin to conclude that "performing surgery in research subjects that has no potential of therapeutic benefit fails to minimize the risk of harm" [23]. Opponents of sham operations argue that, if an intervention of proven effectiveness already exists, and if there is genuine disagreement among medical experts as to whether the new intervention is equally or more effective, then the new intervention must be compared against the established treatment rather than a placebo.…”

Section: Sham Surgerymentioning

confidence: 99%

Surgery for Placebo Effect?

MacKenzie

Matava²,

Carroll³

2012

AMA Journal of Ethics

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Section: Sham Surgerymentioning

confidence: 99%

Surgery for Placebo Effect?

MacKenzie

Matava²,

Carroll³

2012

AMA Journal of Ethics

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“…The ethical use of placebos in risky clinical trials is a matter of heated controversy (Macklin, 1999;Weijer, 2002;Horng and Miller, 2002;London and Kadane, 2002;Miller, 2003;Polgar and Ng, 2005). Because of their inability to fully participate in making autonomous choices, when the research subjects are children the use of placebos raises even more ethical concerns (Flynn, 2003;Miller et al, 2003;Derivan et al, 2004;Lynch, 2007;Martin and Robert, 2007;Morton, 2008).…”

Section: Placebo Usementioning

confidence: 99%

“…Exposing subjects to excessive risks simply for the sake of scientific advancement, as would be the case for subjects in the sham surgery group, is ethically unjustifiable (Macklin, 1999;Weijer, 2002;Miller and Brody, 2002). Indeed, such would be a paradigmatic case of using a person merely as means to someone else's ends.…”

Section: Placebo Usementioning

confidence: 99%

When Ethics Constrains Clinical Research: Trial Design of Control Arms in “Greater Than Minimal Risk” Pediatric Trials

2011

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For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

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“…2 Unlike pharmacologic placebos, sham procedures and surgery sometimes require that an investigator actively mislead participants into believing that the active intervention is being performed, in order to maintain the blind and control for the placebo effect. In the sham acupuncture trial published by Linde et al, 35 acupunc-turists were trained to perform the sham procedure with oral instructions, a videotape, and a brochure.…”

Section: Informed Consent and The Use Of Deceptionmentioning

confidence: 99%

“…[1][2][3][4] Ethical discourse on placebo or sham surgery was initiated in a 1961 commentary by Henry Beecher, who argued for its utility in randomized trials to control for evaluator bias and the placebo effect. 5 Sham surgery under double-blind conditions exposed mammary artery ligation as no more effective than a placebo intervention in treating angina.…”

Section: Introductionmentioning

confidence: 99%

Placebo-Controlled Procedural Trials for Neurological Conditions

Horng

Miller

2007

Neurotherapeutics

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Summary:Neurological disease has been a central focus in the ongoing ethical debate over the use of invasive placebo controls, especially sham surgery. The risk to research subjects and necessary use of deception involved in these procedures must be balanced against the methodological need to control for bias and the placebo effect. We review a framework formulated for the ethical assessment of sham surgery in the context of research evaluating novel procedures for neurological conditions. Special issues raised include the growing evidence of expectation and conditioning effects in a number of neurological diseases, the escalating scale of risk from different types of invasive placebo interventions, and the increasing use of cross-over designs, which allow a switch from placebo to active intervention without additional procedures.

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The Ethical Problems with Sham Surgery in Clinical Research

Cited by 289 publications

References 37 publications

Surgery for Placebo Effect?

Surgery for Placebo Effect?

When Ethics Constrains Clinical Research: Trial Design of Control Arms in “Greater Than Minimal Risk” Pediatric Trials

Placebo-Controlled Procedural Trials for Neurological Conditions

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