Ethical Safeguards for Exit and Withdrawal from Implanted Neurotechnology Research

项目摘要 研究参与者面临着关于手术取出植入设备的复杂决定 在退出植入神经技术的临床试验后。需要道德保障， 确保同意做法和退出程序尊重研究的身体完整性 参与者，同时最大限度地降低与接触新型神经技术相关的风险。的 目前的研究将首先通过审查现有的保障措施， 与退出神经技术研究协议相关的法规和研究实践。这 然后，研究将系统地描述研究参与者的经历， 正在进行并已完成的脑深部电刺激临床试验。通过创新应用 法律的和伦理分析相结合的实证，定性研究方法， 拟议的研究将评估法律的保护和研究实践， 四项脑深部电刺激临床试验的研究参与者的担忧。在 根据BRAIN计划的目标，拟议的研究将支持 制定以证据为基础的指导方针，以确保大脑研究是根据 最高的道德标准。

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.