脑深部电刺激技术应用于精神障碍的法律挑战和应对

[关键词]脑机接口；脑深部电刺激；精神障碍；伦理审查复核；全过程知情同意；试验性治疗 [中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）10-1298-08 DOI:10.12026/j. issn.1001-8565.2025.10.10

Legal challnges and responses in theapplication of deep brain stimulation technology in mental disorders

RENJing,LI Xiaoyong,LIANGHengyu

(School ofMedical Humanities，Capital Medical University，Beijing 1Ooo69,China)

Abstract: Deep brain stimulation（DBS） has been widely applied in treating neurological disorders such as Parkinson’s disease，with corresponding evidenceof safetyand eficacy.However，when DBS is experimentaly applied in the fieldof mental disorders，the uncertainty of itstherapeutic mechanisms and targets becomes prominent，and there are peculiarities such as the lack of substantive informed consent，partial deprivation of autonomy，and the impacton the homogeneityof personality for research participants or patients.In response to the above situations，the currentnormative documentsare stillinsuffcient,theethical review re-examination procedure has not yet formed a perfect system，the substantive informed consent of research participants or patients has not yet been clearly guaranteed，as well as the technical scopeand regulatory boundariesare not clear.For the new application of DBS in the field of mental disorders，the principle of prudent supervision should beupheld，and appropriate regulationshould becaried outto prevent the dilemmaof“Colingridge".Specifically,the ethical review system should be innovated and refined，whole-processinformed consent of research participants or patients and guardianassistance in decision-making should be ensured，the legal nature of“experimental treatment”should be clarified，as wellas the relevant provisions intheMental Health Law ofthePeople's Republic of China should be improved，witha view to providing legal theoretical supportand practical operational guidelines forthe legalization and standardization of DBS's application in mental disorder research.

Keywords:brain-computer interface；deep brain stimulation；mental disorder；ethical reviev re-examination；whole-process informed consent；experimental treatment

脑机接口（brain-computer interface,BCI)是在大脑与外部设备之间建立直接交互的通信和控制通道。（剩余14086字）