侵入式脑机接口技术临床试验的伦理考量  

Ethical Considerations on Clinical Trials of Invasive Brain-computer Interface Technology

作　　者：金莎日娜 翟晓梅[1] JIN Sharina;ZHAI Xiaomei(School of Population Medicine and Public Health,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China)

机构地区：[1]中国医学科学院/北京协和医学院群医学及公共卫生学院,北京100730

出　　处：《医学与哲学》2025年第2期6-11,共6页Medicine and Philosophy

摘　　要：侵入式脑机接口在临床上有巨大应用价值,尤其在神经及精神疾病方面。然而,其临床试验提出不同于传统的特殊伦理挑战,在内涵和优先次序上与其他新兴生物技术的看似相同实则不同。研究参与者多为病情无现有可行治疗措施或晚期患者,试验目的在获取知识的同时解决其健康问题;试验在遵循风险最小化原则基础上,还需使风险与疾病严重程度相称;人脑有创试验可能影响人的自主性,需采用动态知情同意模式;此外,试验暴露更多隐私泄露风险。基于上述,研究者需对侵入式脑机接口临床试验保持高度关注。Invasive brain-computer interface(BCI) technology holds immense clinical application value,especially in neurological and psychiatric disorders.However,clinical trials involving this technology present unique ethical challenges that differ from traditional trials,in terms of both scope and priorities,despite superficial similarities to other emerging biotechnologies.Majority of research participants are patients with conditions for which there are no available treatments or who are at an advanced stage of the disease.And the purpose of the trial is both to gain knowledge and to address their health concerns.The trials not only need to follow the principle of risk minimization,but also need to be proportional to the severity of the disease.Invasive experiments on the human brain may affect the autonomy of the individual,therefore trials need to adapt the way of informed consent which called dynamic informed consent.In addition,the trial exposes more privacy leakage potential.Based on the above,researchers need to maintain heightened attention to the ethical considerations of invasive BCI clinical trials.

关 键 词：侵入式脑机接口临床试验 风险受益 自主性 隐私保护 知情同意方式 

分 类 号：R-05[医药卫生]