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The ethics of sham surgery on research subjects with cognitive impairments that affect decision-making capacity
1National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC 27709, USA. resnikd@niehs.nih.gov
Abstract:
Populations recruited to participate in sham surgery clinical trials sometimes include patients with cognitive impairments that affect decision-making capacity. In this commentary we examine arguments for and against including these patients in sham surgery clinical trials. We argue that patients with cognitive impairments that affect decision-making capacity should not be excluded from a sham surgery clinical trial if there are scientific reasons for including them in the study and basic ethical requirements for clinical research are met.
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