The Ethics of Sham Surgery on Research Subjects With Cognitive Impairments That Affect Decision-Making Capacity
Resnik, David B
Contemporary clinical trials 2010 Sep; 31(5): 407-10
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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