Post-trial access to surgically implanted trials of brain computer interfaces: A scoping review of international ethical guidelines

There is currently no agreed upon ethical guidelines for the provision of post-trial access to experimental neurotechnological devices (e.g. deep brain stimulation, cortical implants and brain computer interfaces to restore mobility and sensation). Some studies require the explanation of the device at the end of a trial, even if the device is providing a therapeutic benefit. In other studies, the provision of support for the device is poorly or opaquely described. Responsibility for post-trial access is often shared between a range of stakeholders, including research groups, health care systems, industry, insurance companies and the individual. This scoping review will examine international ethical guidelines for the provision of post-trial access to neurotechnologies. The review will also critically examine international documents (e.g. Declaration of Helsinki) that offer advice on post-trial access to other treatments, such as pharmaceuticals. Findings of this study will be used to develop a set of ethical guidelines for the design and post-trial care in trials of invasive neuortechnologies, and identify areas for further research and agreement.