title: Regulatory misconception muddies the ethical waters: challenges to a qualitative study.
abstract: In "Potential Subjects' Responses to an Ethics Questionnaire in a Phase I Study of Deep-Brain Stimulation in Early Parkinson's Disease," Finder, Bliton, Gill, Davis, Konrad, and Charles undertake informed consent research on what they describe as a Phase I trial of deep brain stimulation (DBS) for Parkinson's disease. We argue that the authors should have more carefully characterized the nature of the DBS study at the start of their clinical study.
authors.affiliation: Cleveland Clinic NeuoEthics Program in Cleveland, Ohio, USA.
authors.forename: Kimberly M
authors.initials: KM
authors.lastname: Yee
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Ford
mesh_terms: D032882:Comprehension; D003657:Decision Making; D046690:Deep Brain Stimulation; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D010300:Parkinson Disease / Q000628:therapy*; D010361:Patients / Q000523:psychology*; D035842:Research Subjects / Q000523:psychology*