title: The ethics of sham surgery on research subjects with cognitive impairments that affect decision-making capacity.
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.
authors.affiliation: National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC 27709, USA. resnikd@niehs.nih.gov
authors.forename: David B
authors.initials: DB
authors.lastname: Resnik
authors.forename: Frank
authors.initials: F
authors.lastname: Miller
mesh_terms: D016223:Advance Directives; D002986:Clinical Trials as Topic / Q000941:ethics; D003072:Cognition Disorders / Q000523:psychology*; D003657:Decision Making / Q000941:ethics*; D032984:Ethics, Research; D013502:General Surgery; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D010919:Placebos; D035842:Research Subjects
chemical_list: D010919:Placebos