Object: 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.