Achieving ethical integration in the development of novel neurotechnologies

项目摘要/摘要 调节大脑功能的新技术在减轻持续存在的负担方面具有巨大的潜力 抑郁症和其他神经精神障碍，但也提出了具有挑战性的伦理和社会问题 关于自我拥有和对我们的思想、情感和行为的控制。出于这些原因， 总统的生物伦理委员会和其他专家呼吁将伦理和 神经科学从研究的最早阶段开始。这种整合需要跨人文主义的合作 和科学学科；为了这项工作有效地塑造该领域未来的道德发展，它 还必须积极让患者和研究人员站在新神经技术的前沿。需要 神经科学中的伦理整合将由一个具有以下专长的具有凝聚力的跨学科团队来解决 神经科学、临床护理、法律、哲学和社会科学。这项工作将被嵌入到两个中的一个 作为大脑倡议的一部分，由美国国防部高级研究计划局资助的团队开发可植入的“闭环系统”设备，将 两者都监控并自适应地修改参与情绪和行为调节的大脑系统。是这样的 嵌入将有助于实现成功开发和采用所需新技术的总体目标 通过认识、沟通和纳入伦理关切来治疗神经精神疾病 患者和其他利益相关者参与神经技术疗法的设计。创新比较 人种学技术将在人类神经技术临床前沿的人群中应用， 追求三个具体目标：1)在现有的闭环系统临床应用中引起伦理关注 神经调节；2)在闭环神经调节的调查研究中引起伦理学关注 评估学科背景对侦查人员道德评价的影响 担忧。目的1将重点放在临床上接受NeuroPace刺激的耐药癫痫患者， 目前批准用于临床的唯一形式的闭环系统大脑调制。目标2将专注于研究 在DARPA赞助的一项研究项目中，帕金森病患者和共病抑郁症患者 使用一种新型植入的大脑深部刺激器测量和修正情绪的神经关联。目标3 阐述如何将这些患者的体验和关切纳入临床医生和研究人员的 对神经技术的伦理发展的看法。这种方法是创新的，因为嵌入一个 拥有高级定性方法专业知识的跨学科团队直接在DARPA资助的 神经技术计划将促进在早期阶段纳入伦理关切 技术发展。这项拟议的研究意义重大，因为它涉及核心伦理和社会问题 担心会影响情绪的闭环神经调节的可接受性，这是 大脑倡议，而且很可能会随着我们操纵人类能力的提高而继续增长 大脑。

PROJECT SUMMARY/ABSTRACT New technologies that modulate brain function have tremendous potential for alleviating the persistent burden of depression and other neuropsychiatric disorders, but also raise challenging ethical and societal questions regarding self-ownership and control over our thoughts, emotions and actions. For these reasons, the President’s Bioethics Commission and other experts have called for the integration of ethics and neuroscience from the earliest stages of research. Such integration requires collaboration across humanistic and scientific disciplines; and for this work to effectively shape the future ethical development of the field, it must also actively engage patients and researchers at the forefront of novel neurotechnologies. The need for ethical integration in neuroscience will be addressed by a cohesive interdisciplinary team with expertise in neuroscience, clinical care, law, philosophy and social science. This work will be embedded in one of the two teams funded by DARPA as part of the BRAIN Initiative to develop implantable “closed-loop” devices that will both monitor and adaptively modify brain systems involved in mood and behavior regulation. Such embedding will facilitate the overall goal of enabling the successful development and adoption of needed new treatments for neuropsychiatric illness by recognizing, communicating, and incorporating the ethical concerns of patients and other stakeholders into the design of neurotechnological therapies. Innovative comparative ethnographic techniques will be applied in populations at the clinical frontier of human neurotechnology, in pursuit of three specific aims: 1) Elicit ethical concerns in existing clinical applications of closed-loop neuromodulation; 2) Elicit ethical concerns in investigational research on closed-loop neuromodulation of mood; and 3) Assess the influence of disciplinary backgrounds on investigators’ evaluation of ethical concerns. Aim 1 will focus on clinic patients with drug-resistant epilepsy undergoing NeuroPace stimulation, the only form of closed-loop brain modulation currently approved for clinical use. Aim 2 will focus on research patients with Parkinson’s disease and comorbid depression in a DARPA-sponsored research project to measure and modify neural correlates of mood using a novel implanted deep brain stimulator. Aim 3 addresses how these patient experiences and concerns can be incorporated in clinicians’ and researchers’ views about the ethical development of neurotechnology. The approach is innovative, as embedding an interdisciplinary team with expertise in advanced qualitative methods directly in a DARPA-funded neurotechnology program will facilitate the incorporation of ethical concerns in the earliest stages of technology development. The proposed research is significant, because it addresses core ethical and societal concerns that will affect the acceptability of closed-loop neuromodulation of mood, a core element of the BRAIN Initiative, and that will likely continue to grow along with our advancing ability to manipulate the human brain.