A scoping review of ethical frameworks for the responsible innovation of neurotechnology

There has been an explosion in research and innovation of neurotechnologies (e.g. deep brain stimulation, cortical implants and brain computer interfaces to restore mobility and sensation). in recent years. There are 7 large scale global brain research initiatives running worth over USD7 billion. The commercial neurotechnology market is estimated at over USD30 billion per annum. The use of these sophisticated technologies raise complex and challenging ethical, social and legal issues including: the challenge in obtaining informed consent from patients desperate for a cure, managing patient’s expectation of therapeutic benefit from the trial, agency and moral reasonability in cases involving technologies that modulate brain function and behaviour, coercive pressures that may affect decisions to use a technology, and the responsibility of the research team to provide ongoing care and device management over the lifetime of the device in the context of short-term project funding. A number of ethical guidelines and frameworks have been developed in order to address these issues, but a consensus remains elusive. These frameworks can also be difficult to apply in specific instances. This scoping review will identify and critically examine international ethical frameworks and guidelines for the responsible innovation of neurotechnologies. The study will examine who developed the guidelines, what social factors may influence their development, and what strategies for stakeholder engagement were employed. The study will have a particular focus on frameworks developed by low and middle income countries or that address issues faced by priority populations. Findings of this scoping review will be used to develop a set of consensus ethical frameworks for the responsible research and innovation of neuortechnologies, and identify areas for further research and agreement.