Evaluating the Ethical Shortcomings of the Current Regulatory State of Neurosurgical Innovation.

摘要

Neurosurgeons are constantly evolving their field, developing new processes to approach old problems and implementing them in their day-to-day practices. Unlike most specializations in medicine, neurosurgical innovation is highly unregulated. This thesis explores the inadequacies of the two systems most commonly used to oversee innovative neurosurgery: the Regulatory Ethics Paradigm and self-regulation. When neurosurgical innovations are but one component in complex translational trials, neither system proves effective for protecting patients from risks of surgical adverse events. The results of an extensive systematic review of surgically-related adverse events in clinical trials involving the implantation of electrodes or inoculation of tissues to the deep brain regions are presented. The review demonstrates the relatively high baseline level of risk to patients undergoing neurosurgical interventions. It provides evidence of the need for a new model of standardized regulatory oversight for neurosurgical innovations.