Ethical Safeguards for Exit and Withdrawal from Implanted Neurotechnology Research

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PROJECT SUMMARY Research participants face complex decisions about the surgical removal of implanted devices upon exiting clinical trials of implanted neurotechnology. Ethical safeguards are needed to ensure consent practices and exit procedures respect the bodily integrity of research participants while minimizing risks associated with exposure to novel neurotechnologies. The current research will first characterize and evaluate existing safeguards through a review of regulations and research practices related to exit from neurotechnology research protocols. This research will then systematically describe the experiences of research participants exiting ongoing and completed clinical trials of deep brain stimulation. Through innovative application of legal and ethical analysis in combination with empirical, qualitative research methods, the proposed research will evaluate legal protections and research practices for responsiveness to the concerns of research participants in four clinical trials of deep brain stimulation. In accordance with the goals of the BRAIN Initiative, the proposed research will support the development of evidence-based guidelines to ensure brain research is conducted according to the highest ethical standards.