title: The placebo phenomenon and medical ethics: rethinking the relationship between informed consent and risk-benefit assessment.
abstract: It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk-benefit assessment and informed consent.
authors.affiliation: Department of Bioethics Clinical Center, National Institutes of Health, Building 10, Bethesda, MD 20892-1156, USA. fmiller@nih.gov
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
authors.forename: Luana
authors.initials: L
authors.lastname: Colloca
mesh_terms: D003118:Color Perception; D018849:Controlled Clinical Trials as Topic / Q000941:ethics*; D004992:Ethics, Medical; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000523:psychology; D058748:Pain Perception; D026684:Personal Autonomy; D015990:Placebo Effect; D035842:Research Subjects / Q000523:psychology; D018570:Risk Assessment; D014342:Truth Disclosure