情感参与我们的决策、支配我们的行为、并影响我们的人际关系，是我们与 外部世界互动的关键。但极端或失控的情感会演变为情感障碍乃至精神疾病。影 响情感的脑机接口(affective Brain-Computer Interface, aBCI)是脑机接口的分支， 随着计算机科学与人工智能不断发展融合，影响情感的脑机接口逐步进入临床研 究领域，拓展了脑机接口技术的功能边界，为检测情感状态、分析心智状态与脑 活动的联系、调控情感活动及治疗情感障碍提供了新方法。其临床研究主要是两 大方向，情感识别通过对神经信号的检测、测量和分析，从中识别情感的状态和 变化;情感调控则通过影响或刺激情感来实现情感恢复或调节。然而，影响情感 的脑机接口临床研究在改善情感健康、诊治情感障碍展现巨大潜力的同时，也提 出了一系列严峻的伦理挑战。

本文采用文献研究、案例研究与专家访谈相结合的方法，系统梳理 aBCI 在 临床研究过程中引发的核心实质伦理议题，首先，即使没有额外调控，仅仅是监 测本身，就可能对研究参与者不希望分享的心智隐私造成侵犯，其次，隐私在中 外语境下具有不同含义，这可能使得国内研究参与者在心智隐私保护方面可能处 于更为脆弱的地位，如何防止数据泄露并建立有效的神经数据监管机制，已成为 新兴技术伦理中的重要议题;而情感调控在技术干预下可能对自我决策能力削弱， 这可能侵犯参与者的心智完整性、并因决策可能改变而需要不同于传统的知情同 意方式;在闭环系统中人工智能嵌入共同决策可能引发责任归属、数据还原论与 算法偏见的问题以及研究的风险与受益分析问题，文章中对上述问题进行伦理分 析与论证。此外，通过访谈还发现在临床研究中面临研究人员对伦理必要性认识 不足、伦理审查专业性仍需加强、伦理审查复核制度执行不到位、伦理培训无法 满足研究人员实际需求与监管覆盖仍有缺失等问题。在此基础上提出构建 aBCI 临床研究伦理框架的原则时不宜套用生命伦理四原则，而应根据 aBCI 研究的技 术与场景进行讨论，并在伦理治理建设与伦理审查制度完善上给予建议。

由于 aBCI 技术不断迅速发展，新兴生命科学技术的伦理研究迅速发展，本 文希望运用伦理学的理论和原则分析 aBCI 在临床研究中所面临的现实问题，以 期这些问题的讨论有助于在探索新技术对人心智健康提升的同时，技术向善发展， 促进人民生命健康。

Emotions are involved in our decision-making, govern our behaviour, and influence our relationships, and are key to our interaction with the outside world. However, extreme or uncontrolled emotions can evolve into emotional disorders and even mental illnesses. Affective Brain-Computer Interface is a branch of Brain-Computer Interface. With the continuous development and integration of Computer Science and Artificial Intelligence, aBCI has gradually entered into the field of clinical research, expanding the functional boundaries of the BCI technology, and providing a platform for detecting the emotional state, analysing the connection between the state of mind and brain activity, regulating emotional activity and treating mental illness. connection, regulating emotional activities and treating emotional disorders provide new methods. Its clinical research mainly focuses on two major directions: emotion recognition by detecting, measuring and analysing neural signals, from which emotion states and changes are identified; and emotion regulation by influencing or stimulating emotions to achieve emotion recovery or regulation. However, while clinical research on brain- computer interfaces for affective influencing shows great potential for improving emotional health and diagnosing and treating emotional disorders, it also poses a series of serious ethical challenges.

This study adopts a combination of literature research, case studies and expert interviews to systematically sort out the core substantive ethical issues raised by aBCI in the process of clinical research. Firstly, even without additional modulation, the monitoring itself alone may be an infringement of research participants' unwanted sharing of their mental privacy. Secondly, privacy has different meanings in Chinese and foreign contexts, which may make domestic research participants more vulnerable in terms of mental privacy protection, and how to prevent data leakage and establish effective mechanisms for neurodata regulation has become an important issue in the ethics of emerging technologies. And, Emotion regulation may be weakened by technological interventions in self-determination, which may violate participants' mental integrity and require a different approach to informed consent due to the possibility of altered decision-making. What’s more, AI embedded into shared decision making in closed-loop systems may further trigger liability. Embedding shared decision-making in closed-loop systems may further raise issues of attribution of responsibility, data reductionism and algorithmic bias, as well as issues of analysing the risks and benefits of research. In addition, through interviews, it is also found that

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Abstract

researchers' awareness of ethical necessity is insufficient, the professionalism of ethical review still needs to be strengthened, the implementation of the ethical review system is not in place, the ethical training does not meet the actual needs of researchers, and the regulatory coverage is still missing. On this basis, it is proposed that the four principles of bioethics should not be applied to the construction of an ethical framework for aBCI clinical research, but should be discussed according to the technology and scenarios of aBCI research, and suggestions are given to improve the construction of ethical governance and the ethical review system.

As aBCI technology continues to develop rapidly, ethical research in emerging life science and technology is rapidly evolving. This paper hopes to use the theories and principles of ethics to analyse the real-world problems faced by aBCI in clinical research, with the hope that the discussion of these problems will contribute to the development of the technology for the better and the promotion of people's lives and health while exploring the enhancement of the new technology to the health of the human mind.