脑机接口临床研究伦理审查的挑战与建议

doi:10.24920/004377

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 international 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 complexities of clinical research and brain function have put forward new special fields for ethics in 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

Funding:

This work was supported by the Ministry of Science and Technology of the People's Republic of China (2021ZD0201900), Project 5 (2021ZD0201905).

Xue-Qin Wang, Hong-Qiang Sun, Jia-Yue Si, Zi-Yan Lin, Xiao-Mei Zhai, Lin Lu. Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces[J].Chinese Medical Sciences Journal, 2024, 39(2): 131-139.

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