摘要
Abstract
Deep brain stimulation(DBS)has been widely applied in treating neurological disorders such as Parkinson's disease,with corresponding evidence of safety and efficacy.However,when DBS is experimentally applied in the field of mental disorders,the uncertainty of its therapeutic mechanisms and targets becomes prominent,and there are peculiarities such as the lack of substantive informed consent,partial deprivation of autonomy,and the impact on the homogeneity of personality for research participants or patients.In response to the above situations,the current normative documents are still insufficient,the ethical 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 scope and regulatory boundaries are not clear.For the new application of DBS in the field of mental disorders,the principle of prudent supervision should be upheld,and appropriate regulation should be carried out to prevent the dilemma of"Collingridge".Specifically,the ethical review system should be innovated and refined,whole-process informed consent of research participants or patients and guardian assistance in decision-making should be ensured,the legal nature of"experimental treatment"should be clarified,as well as the relevant provisions in the Mental Health Law of the People's Republic of China should be improved,with a view to providing legal theoretical support and practical operational guidelines for the legalization and standardization of DBS's application in mental disorder research.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Key words
brain-computer interface/deep brain stimulation/mental disorder/ethical review re-examination/whole-process informed consent/experimental treatment分类
医药卫生
