涉及脑机接口临床研究的多学科伦理审查专家共识  

Expert consensus on multidisciplinary ethical review of clinical research involving brain-computer interfaces

作　　者：北京大学第六医院 北京医学伦理学会 王雪芹[2,3] 孟丽君 孙洪强[2,5] 刘芳[5,6] Peking University Sixth Hospital;Beijing Medical Ethics Committee

机构地区：[1]不详 [2]北京大学第六医院 [3]北京医学伦理学会医学技术伦理研究分会 [4]中国康复研究中心北京博爱医院/首都医科大学康复研究院 [5]北京医学伦理学会 [6]首都医科大学

出　　处：《中国医学伦理学》2024年第9期1119-1124,F0003,共7页Chinese Medical Ethics

基　　金：中华人民共和国科学技术部科技创新2030“脑科学与类脑研究”重大项目(2021ZD0201900)课题5(2021ZD0201905)。

摘　　要：作为一项新兴的生物医学工程技术,脑机接口为脑疾病诊疗、神经康复、精神障碍与心理健康等医疗健康领域提供了突破性技术。脑机接口临床研究发展迅速,涉及脑科学、工程学、计算科学、人工智能等学科,面临诸多伦理挑战,亟待规范。伦理审查是有效应对风险,促进各类科研主体实现负责任创新的重要保障,基于目前已有脑机接口临床研究的伦理审查实践,北京大学第六医院与北京医学伦理学会合作,广泛征求专家意见,包括伦理学、神经病学、精神医学、康复医学、工程学、计算科学及信息科学等多学科专家,经过多轮专家研讨形成初稿,应用德尔菲专家咨询法修订完成,制定了“涉及脑机接口临床研究的多学科伦理审查专家共识”:在《脑机接口研究伦理指引》的指导下,对重大伦理风险防控等方面提出建议,厘清各方责任,从多维度为涉及脑机接口临床研究伦理审查的实质内容及程序提供参考。As an emerging biomedical engineering technology,the brain-computer interface(BCI)provides breakthrough technology for medical and health fields such as brain disease diagnosis and treatment,neurological rehabilitation,psychiatric disorders,and mental health.Clinical research on BCI is rapidly advancing,involving disciplines such as neuroscience,engineering,computational science,and artificial intelligence.It faces many ethical challenges and urgently needs to be standardized.Ethical review is an important guarantee for effectively responding to risks and promoting responsible innovation among various scientific research entities.Based on the ethical review practices of existing clinical research on BCI,Peking University Sixth Hospital collaborated with the Beijing Medical Ethics Committee to extensively solicit expert opinions,including experts from multiple disciplines such as ethics,neurology,psychiatry,rehabilitation medicine,engineering,computational science,and information science.After multiple rounds of expert discussions,a preliminary draft was formed,and the Delphi consultation method was applied to revise and develop an“expert consensus on multidisciplinary ethical review of clinical research involving BCI”.Guided by the Ethical Guidelines for Brain-Computer Interface Research,suggestions were proposed for the prevention and control of major ethical risks,clarifying the responsibilities of all parties,and providing a reference for the substantive content and procedures of ethical review in clinical research involving BCI from multiple dimensions.

关 键 词：脑机接口 临床研究 基本原则 伦理审查 专家共识 

分 类 号：R-052[医药卫生]