Ienca Marcello, Valle Giacomo, Raspopovic Stanisa
Laboratory of Ethics of Artificial Intelligence and Neuroscience, Institute for Ethics and History of Medicine, School of Medicine, Techniche Universität München, Munich, Germany; College of Humanities, École Polytechnique Fédérale de Lausanne, Lausanne, Switzerland.
Laboratory for Neuroengineering, Department of Health Science and Technology, Institute for Robotics and Intelligent Systems, ETH Zürich, Zürich, Switzerland; Department of Organismal Biology and Anatomy, University of Chicago, Chicago, IL, USA; Department of Electrical Engineering, Chalmers University of Technology, Gothenburg, Sweden.
Lancet Digit Health. 2025 Mar;7(3):e216-e224. doi: 10.1016/S2589-7500(24)00222-X. Epub 2025 Jan 9.
Neuroprosthetics research has entered a stage in which animal models and proof-of-concept studies are translated into clinical applications, often combining implants with artificial intelligence techniques. This new phase raises the question of how clinical trials should be designed to scientifically and ethically address the unique features of neural prostheses. Neural prostheses are complex cyberbiological devices able to acquire and process data; hence, their assessment is not reducible to only third-party safety and efficacy evaluations as in pharmacological research. In addition, assessment of neural prostheses requires a causal understanding of their mechanisms, and scrutiny of their information security and legal liability standards. Some neural prostheses affect not only human behaviour, but also psychological faculties such as consciousness, cognition, and affective states. In this Viewpoint, we argue that the technological novelty of neural prostheses could generate challenges for technology assessment, clinical validation, and research ethics oversight. To this end, we identify a set of methodological and research ethics challenges specific to this medical technology innovation. We provide insights into relevant ethical guidelines and assess whether oversight mechanisms are well equipped to ensure adequate clinical and ethical use. Finally, we outline patient-centred research ethics requirements for clinical trials involving implantable neural prostheses.
神经假体研究已进入一个阶段，即动物模型和概念验证研究被转化为临床应用，通常将植入物与人工智能技术相结合。这个新阶段引发了一个问题，即临床试验应如何设计，才能科学且符合伦理地应对神经假体的独特特性。神经假体是能够获取和处理数据的复杂的 cyberbiological 设备；因此，它们的评估不能像在药理学研究中那样仅简化为第三方的安全性和有效性评估。此外，对神经假体的评估需要对其机制有因果理解，并审查其信息安全和法律责任标准。一些神经假体不仅会影响人类行为，还会影响诸如意识、认知和情感状态等心理能力。在本观点文章中，我们认为神经假体的技术新颖性可能会给技术评估、临床验证和研究伦理监督带来挑战。为此，我们确定了一组针对这项医疗技术创新的方法学和研究伦理挑战。我们深入探讨了相关的伦理准则，并评估监督机制是否具备确保临床和伦理合理使用的充分能力。最后，我们概述了涉及植入式神经假体的临床试验以患者为中心的研究伦理要求。
