title: Deep Brain Stimulation as Clinical Innovation: An Ethical and Organizational Framework to Sustain Deliberations About Psychiatric Deep Brain Stimulation.
abstract: Deep brain stimulation (DBS) for psychiatric disorders needs to be investigated in proper research trials. However, there are rare circumstances in which DBS could be offered to psychiatric patients as a form of surgical innovation, therefore potentially blurring the lines between these research trials and health care. In this article, we discuss the conditions under which surgical innovation may be accepted as a practice falling at the frontiers of standard clinical care and research per se. However, recognizing this distinction does not settle all ethical issues. Our article offers ethical guideposts to allow clinicians, surgical teams, institutions, and institutional review boards to deliberate about some of the fundamental issues that should be considered before surgical innovation with psychiatric DBS is undertaken. We provide key guiding questions to sustain this deliberation. Then we review the normative and empirical literature that exists to guide reflection about the ethics of surgical innovation and psychiatric DBS with respect to general ethical questions pertinent to psychiatric DBS, multidisciplinary team perspectives in psychiatric DBS, mechanisms for oversight in psychiatric DBS, and capacity and consent in psychiatric DBS. The considerations presented here are to recognize the very specific nature of surgical innovation and to ensure that surgical innovation in the context of psychiatric DBS remains a limited, special category of activity that does not replace appropriate surgical research or become the standard of care based on limited evidence.
  
  
  
  DBS, deep brain stimulationIRB, institutional review boardOCD, obsessive-compulsive disorder.
authors.affiliation: *Neuroethics Research Unit, Institut de recherches cliniques de Montréal (IRCM), Montréal, Quebec, Canada; ‡Division of Neurosurgery, University of Alberta, Edmonton, Alberta, Canada; §Department of Medicine and Department of Social and Preventive Medicine, Université de Montréal, Montréal, Quebec, Canada; ¶Departments of Neurology and Neurosurgery, Experimental Medicine & Biomedical Ethics Unit, McGill University, Montréal, Quebec, Canada.
authors.forename: Emily
authors.initials: E
authors.lastname: Bell
authors.forename: Philip
authors.initials: P
authors.lastname: Leger
authors.forename: Tejas
authors.initials: T
authors.lastname: Sankar
authors.forename: Eric
authors.initials: E
authors.lastname: Racine
mesh_terms: D046690:Deep Brain Stimulation / Q000941:ethics / Q000379:methods*; D028744:Ethics Committees, Research; D006801:Humans; D001523:Mental Disorders / Q000628:therapy*; D009771:Obsessive-Compulsive Disorder; D009938:Organizations; D035703:Therapies, Investigational / Q000941:ethics*