Abstract

Once a neural implant has shown some efficacy during initial research trials, it begins to enter the world of clinical application. This culminates when the implant becomes approved for a particular indication. However, the ethical challenges continue as the technology is adopted as a standard of practice. Patient eligibility criteria, as documented by inclusion and exclusion criteria with any new treatment, are not always clearly quantified and defined. These vagaries can result in considerable debate regarding who should or should not proceed with surgery. There is often considerable room for clinical judgment that can result in extension of the treatment to a wider range of patients. The ethical questions that arise in clinical decisionmaking differ significantly from those inherent in engineering design and research development