title: Surgical innovation or surgical evolution: an ethical and practical guide to handling novel neurosurgical procedures.
abstract: OBJECTIVE
  Surgical innovation is an important driver of improvements in technique and technology, which ultimately translates into improvements in patients' outcomes. Nevertheless, patients may face new risks of morbidity and mortality when surgical innovation is used, and well-intentioned surgical "experimentation" on patients must be regulated and monitored. In this paper the authors examine the challenges of defining surgical innovation and briefly review the literature on this challenging subject.
  
  
  METHODS
  Using examples from the field of neurosurgery and in part from the personal experience of the senior author, the authors develop a model of levels of experimental acuity of surgical procedures and offer recommendations on how these procedures would best be regulated.
  
  
  CONCLUSIONS
  The authors propose guidelines for determining the need for regulation of innovation. The potential role of institutional review boards in this process is highlighted.
authors.affiliation: Division of Neurosurgery, Toronto Western Hospital, Ontario, Canada. mark.bernstein@uhn.on.ca
authors.forename: Mark
authors.initials: M
authors.lastname: Bernstein
authors.forename: Joseph
authors.initials: J
authors.lastname: Bampoe
mesh_terms: D004059:Diffusion of Innovation; D006801:Humans; D009493:Neurosurgery / Q000941:ethics* / Q000592:standards*; D019635:Neurosurgical Procedures / Q000941:ethics* / Q000592:standards*; D017410:Practice Guidelines as Topic