title: Elective inactivation of total artificial heart technology in non-futile situations: inpatients, outpatients and research participants.
abstract: Total artificial heart technology as a potential clinical therapy raises the issue of elective device inactivation in both futile and non-futile situations. This article explores elective device inactivation in non-futile situations. In reply to such requests for inactivation, the medical team should reflect on the individual's decision-making capacity, the clinical appropriateness of the therapy, and the setting of the request (clinical research vs. clinical practice). A decision-making flowchart is presented as a guide for managing inactivation requests. In the research setting, current U.S. federal regulations are murky as to the matter of study withdrawal made by participants who lack decision-making capacity. This compared with clear legal and ethical approaches in the non-research setting (clinical practice).
authors.affiliation: Department of Bioethics, The Cleveland Clinic Foundation, Cleveland, Ohio, USA. bioethics@go.com
authors.forename: Katrina A
authors.initials: KA
authors.lastname: Bramstedt
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics; D003657:Decision Making; D006354:Heart, Artificial / Q000941:ethics*; D006801:Humans; D016743:Mental Competency; D026684:Personal Autonomy; D012297:Right to Die / Q000941:ethics*; D016312:Treatment Refusal / Q000941:ethics*; D014481:United States