The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems
The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems
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DOI：
10.1017/s0963180116000359
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发表时间：
2016-10-01
影响因子：
1.8
通讯作者：
Biller-Andorno, Nikola
中科院分区：
文献类型：
--
作者：
Kellmeyer, Philipp;Cochrane, Thomas;Biller-Andorno, Nikola
脑机接口等闭环医疗设备是一种新兴且快速发展的神经技术。脑机接口（BCI）的目标患者通常患有严重瘫痪，因此在个人自主性、决策能力和代理能力方面特别脆弱。在这里，我们分析闭环医疗设备对人员（作为患者或研究参与者）和神经技术闭环医疗系统的自主性和责任感的影响。我们表明，尽管脑机接口可以通过保留或恢复沟通能力和/或运动控制来增强患者的自主权，但闭环设备也可能对道德和法律责任造成挑战。我们主张制定全面的道德和法律框架，以应对脑机接口等新兴闭环神经技术的挑战，并强调知情同意和拒绝作为促进问责制手段的核心地位。我们建议成立一个国际神经伦理工作组，成员包括医学神经科学、神经工程学、计算机科学、医学法和医学伦理学的成员，以及患者权益团体和公众的代表。
Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.