脑机接口临床研究伦理审查的挑战与建议

doi:10.24920/004377

Chinese Medical Sciences Journaldoi: 10.24920/004377

脑机接口临床研究伦理审查的挑战与建议

王雪芹¹, 孙洪强¹, 司佳玥², 林子琰³, 翟晓梅⁴, 陆林^1,5,*

¹北京大学第六医院,北京大学精神卫生研究所,NHC 精神健康重点实验室,国家精神疾病临床研究中心,北京 100191,中国;
²加洲大学,心理学系,戴维斯 95616,美国;
³多伦多大学,圣迈克尔学院,多伦多 M4S 1A1, 加拿大;
⁴群医学与公共卫生学院,中国医学科学院北京协和医学院,北京 100730,中国;
⁵北大-清华生命科学联合中心,北京大学IDG麦戈文脑科学研究所,北京 100871,中国

收稿日期:2024-05-15 接受日期:2024-06-03 发布日期:2024-06-12
通讯作者: *陆林,E-mail：linlu@bjmu.edu.cn

Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces

WANG Xue-Qin¹, SUN Hong-Qiang¹, SI Jia-Yue², Lin Zi-Yan³, ZHAI Xiao-Mei⁴, LU Lin^1,5,*

¹Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital, Beijing 100191, China;
²Department of Psychology, University of California, Davis 95616, USA;
³St. Michael's College, University of Toronto, Toronto M5S 1A1, Canada;
⁴School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;
⁵Peking-Tsinghua Centre for Life Sciences and Peking University-International Development Group/McGovern Institute for Brain Research, Peking University, Beijing 100091, China

Received:2024-05-15 Accepted:2024-06-03 Online:2024-06-12
Contact: *E-mail: linlu@bjmu.edu.cn

摘要/Abstract

摘要： 脑机接口技术在医学研究和应用中发展迅速。作为一种新兴的生物医学工程技术,脑机接口研究及其发展在医疗领域潜力巨大,在脑疾病的诊断与治疗、神经康复、精神障碍与心理健康等领域的临床研究备受关注,同时也引发了诸多伦理挑战和问题。本文作者探讨了临床研究领域脑机接口伦理的三个方面：伦理治理的现状、临床研究面临的多维伦理挑战,提出脑机接口临床研究伦理审查的若干建议。尽管医疗领域机接口研究和开发具有巨大潜力，脑机接口技术的前沿性、临床研究及脑网络的复杂性使临床研究伦理审查成为脑机接口伦理学的重要内容。为保障脑机接口临床研究“负责任的创新”，我们建议制定脑机接口前沿临床研究的指南，建立脑机接口伦理治理的全球框架和评估系统。

关键词: 脑机接口, 临床研究, 生命伦理学, 伦理治理, 伦理审查

Abstract: Brain-computer interface (BCI) technology is rapidly advancing in medical research and application. As an emerging biomedical engineering technology, it has garnered significant attention in the clinical research of brain disease diagnosis and treatment, neurological rehabilitation, and mental health. However, BCI also raises several challenges and ethical concerns in clinical research. In this article, the authors investigate and discuss three aspects of BCI in medicine and healthcare: the state of ethical governance, multidimensional ethical challenges pertaining to BCI in clinical research, and suggestive concerns for ethical review. Despite the great potential of frontier BCI research and development in the field of medical care, the ethical challenges induced by itself and the complexity of clinical research and brain function have put forward new special fields for ethics on BCI. To ensure “responsible innovation” in BCI research in healthcare and medicine, the creation of an ethical global governance framework and system, along with special guidelines for cutting-edge BCI research in medicine, is suggested.

Key words: brain computer interface, clinical research, bioethics, ethical governance, ethical review

基金资助: 科技部脑科学与类脑研究重大项目（ 2021ZD0201900）子课题5 （2021ZD0201905）

WANG Xue-Qin, SUN Hong-Qiang, SI Jia-Yue, Lin Zi-Yan, ZHAI Xiao-Mei, LU Lin. Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces[J/OL].Chinese Medical Sciences Journal, .DOI:10.24920/004377.[Epub ahead of print].

参考文献

1. Emmady PD, Anilkumar AC. EEG Abnormal Waveforms. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. [Updated 2023 May 1].Available from: https://www.ncbi.nlm.nih.gov/books/NBK557655/
2. Zelmann R, Paulk AC, Basu I, et al.CLoSES: A platform for closed-loop intracranial stimulation in humans. Neuroimage 2020;223:117314. doi: 10.1016/j.neuroimage.2020.117314.
3. Li C, Zhao W.Progress in the brain-computer interface: an interview with Bin He. Natl Sci Rev 2020; 7(2):480-3. doi: 10.1093/nsr/nwz152.
4. UNESCO University of Milan-Bicocca (Italy), State University of New York. Downstate Health Sciences University. The risks and challenges of neurotechnologies for human rights. Paris: the Organization and the universities; 2023. Available from: https://www.unesco.org/en/articles/risks-and-challenges-neurotechnologies-human-rights?hub=83294. doi:10.54678/POGS7778
5. Liu XX, Gao T, Lu TS, et al.China Brain Project: from bench to bedside. Sci Bull (Beijing) 2023; 68(5): 444-7.
6. Lu L, Liu XX, Yuan K.Progress of Chinese Brain Science program. J Peking University (Med) 2022; 54(5): 791-5.
7. The brain neural regulation of frontier development white paper machine interaction (2022). (2023-02-12) [2024-04-07]. Available from https://zhuanlan.zhihu.com/p/605777220
8. Pizzolato C, Gunduz M A, Palipana D, et al.Non-invasive approaches to functional recovery after spinal cord injury: Therapeutic targets and multimodal device interventions. Exp Neurol 2021;339:113612.
9. Zhang S J, Zhao C L, Ning W C, et al.Ethical risks and countermeasures of brain-computer interface technology. Chin J Med Ethics, 2024, 37(01): 61-68. (in Chinese)
10. State Council of the People's Republic of China. Outline of the "13th Five-Year" Plan [EB/OL]. (2016-03-17) [2022-06-01]. https://www.gov.cn/xinwen/2016-03/17/content_5054992.htm.
11. DiLuca M, Olesen J. The cost of brain diseases: a burden or a challenge? Neuron 2014; 82(6):1205-8.
12. Feigin VL, Vos T, Nichols E, et al.The global burden of neurological disorders: translating evidence into policy. Lancet Neurol 2020; 19(3): 255-65.
13. International Bioethics Committee. Report of the International Bioethics Committee of UNESCO (IBC) on the ethical issues of neurotechnology. (2021-12-15) [2024-04-07]. Available from: https://unesdoc.unesco.org/ark:/48223/pf0000378724?posInSet=2&queryId=8145220a-103e-415d-9b01-1992d70de059.
14. Release of the first ethical principles and governance recommendations document for the brain-computer interface field in China. (2023-05-30) [2023-06-17]. Available from: https://baijiahao.baidu.com/s?id=1767296061170347956&wfr=spider&for=pc.
15. National Science and Technology Ethics Committee. Guidelines on the Ethics of Brain-Computer Interface Research.(2024-02-06)[2024-02-27]. https://www.gov.cn/lianbo/bumen/202402/content_6930611.htm.
16. Xiao F.From technical ethics to brain-computer interface ethics. Stud Dialectics Nat 2023; 39(8): 63-68. doi:10.19484/j.cnki.1000-8934.2023.08.009.
17. Burwell S, Sample M, Racine E.Ethical aspects of brain computer interfaces: a scoping review. BMC Med Ethics 2017; 18(1): 60. doi: 10.1186/s12910-017-0220-y.
18. Zhang Z, Chen YX, Zhao X, et al.Ethical considerations of medical applications of implantable brain-computer interfaces. J Biomed Eng 2024; 41(01): 177-183.
19. Jarosiewicz B, Sarma AA, Bacher D, et al. Virtual typing by people with tetraplegia using a self-calibrating intracortical brain-computer interface. Sci Transl Med2015; 7(313):313ra179. doi: 10.1126/scitranslmed.aac7328.
20. Downey JE, Schwed N, Chase SM, et al. Intracortical recording stability in human brain-computer interface users. J Neural Eng 2018; 15(4): 046016.
21. Milekovic T, Sarma AA, Bacher D, et al. Stable long-term BCIenabled communication in ALS and locked-in syndrome using LFP signals. J Neurophysiol 2018; 120(1): 343-60.
22. Perge JA, Zhang S, Malik WQ, et al. Reliability of directional information in unsorted spikes and local field potentials recorded in human motor cortex. J Neural Eng 2014; 11(4): 046007.
23. Perge JA, Homer ML, Malik WQ, et al. Intra-day signal instabilities affect decoding performance in an intracortical neural interface system. J Neural Eng 2013; 10(3): 036004
24. Kumar A.Risk and benefit analysis of medicines. J Int Med Res 2020;48(1):300060518771424. doi: 10.1177/0300060518771424. Erratum in: J Int Med Res 2020;48(2):300060518793548.
25. Saal J, Ottenhoff MC, Kubben PL, et al.Towards hippocampal navigation for brain-computer interfaces. Sci Rep 2023;13(1):14021. doi: 10.1038/s41598-023-40282-7.
26. Kuzovkin I, Tretyakov K, Uusberg A, et al.Mental state space visualization for interactive modeling of personalized BCI control strategies. J Neural Eng 2020; 17(1):016059. doi: 10.1088/1741-2552/ab6d0b.
27. Klein E, Ojemann J.Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices. J Neural Eng 2016; 13(4):043001. doi: 10.1088/1741-2560/13/4/043001.
28. Agarwal A, Dowsley R, McKinney ND, et al. Protecting Privacy of Users in Brain-Computer Interface Applications. IEEE Trans Neural Syst Rehabil Eng 2019;27(8):1546-55. doi: 10.1109/TNSRE.2019.2926965.
29. Wu X, Zhang D, Li G, et al.Data augmentation for invasive brain-computer interfaces based on stereo-electroencephalography (SEEG). J Neural Eng 2024; 21(1). doi: 10.1088/1741-2552/ad200e.
30. Ajrawi S, Rao R, Sarkar M.Cybersecurity in Brain Computer Interfaces: RFID-based design-theoretical framework. Inform Med Unlocked 2021; 22: 100489. doi:10.1016/j.imu.2020.100489.
31. Pugh J, Pycroft L, Sandberg A, et al.Brainjacking in deep brain stimulation and autonomy. Ethics Inf Technol. 2018;20(3):219-32. doi: 10.1007/s10676-018-9466-4.
32. Specker Sullivan L, Illes J. Ethics in published brain-computer interface research. J Neural Eng. 2018;15(1):013001. doi: 10.1088/1741-2552/aa8e05.
33. Mitchell P, Lee SCM, Yoo PE, et al. Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch (SWITCH) Study. JAMA Neurol 2023; 80(3):270-8. doi: 10.1001/jamaneurol.2022.4847.
34. Jiang L, Stocco A, Losey DM, et al. BrainNet: A Multi-Person Brain-to-Brain Interface for Direct Collaboration Between Brains. Sci Rep 2019; 9(1):6115. doi: 10.1038/s41598-019-41895-7.
35. Hildt E. Multi-Person Brain-To-Brain Interfaces: Ethical Issues. Front Neurosci 2019; 13:1177. doi: 10.3389/fnins.2019.01177.
36. Klein E. Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. Sci Eng Ethics. 2016; 22(5):1299-1317. doi: 10.1007/s11948-015-9712-7.
37. Wang XQ, Meng LJ, Sun HQ, et al. Consensus of multidisciplinary ethical review experts on brain computer interface clinical research. Chin Med Ethics; 2024: 1-13. in Chinese. （2024-4-29）[2024-05-11]. Available from: http://kns.cnki.net/kcms/detail/61.1203.r.20240428.1839.002.html.
38. Rodrigues PLC, Congedo M, Jutten C. Dimensionality Transcending: A Method for Merging BCI Datasets With Different Dimensionalities. IEEE Trans Biomed Eng 2021; 68(2):673-84. doi: 10.1109/TBME.2020.3010854.
39. Bai Jing. Ethical Considerations of Cross Kidney Transplants.Shanxi University's 2008 National Doctoral Forum on the Philosophy of Science and Technology. Ed: Graduate School of Chinese Academy of Sciences, Department of Social Sciences of the Faculty of Humanities. 2008, 479-487. In Chinese.
40. Zhao H. The conflict of missions between technology and humanities. Chinese Hospital Director 2011; (8):14.
41. Tang SK, Zhong YM. Observations on the integration and dissemination model of teams within and outside the scientific community based on "dialogue theory". China Science Fund 2023; 37(6):986-95. doi:10.16262/j.cnki.1000-8217.2023.06.011.
42. van Stuijvenberg OC, Broekman MLD, Wolff SEC, et al. Developer perspectives on the ethics of AI-driven neural implants: a qualitative study. Sci Rep 2024; 14(1):7880. doi: 10.1038/s41598-024-58535-4.

优先出版

当期目次

过刊浏览

虚拟专题

作者中心

评阅者中心