Copyright
©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
Informed consent competency assessment for brain-computer interface clinical research and application in psychiatric disorders: A systematic review
Jia-Yue Si, Zi-Yan Lin, Di-Ga Gan, Xin-Yang Zhang, Yan-Nan Liu, Yu-Xin Hu, Yan-Ping Bao, Xue-Qin Wang, Hong-Qiang Sun, Xin Yu, Lin Lu
Jia-Yue Si, Di-Ga Gan, Xin-Yang Zhang, Yan-Nan Liu, Yu-Xin Hu, Xue-Qin Wang, Hong-Qiang Sun, Xin Yu, Lin Lu, Department of Psychiatry, Peking 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), Peking University, Beijing 100191, China
Zi-Yan Lin, Department of Psychology, University of Toronto, Toronto M5S 1A1, Ontario, Canada
Yan-Ping Bao, Department of Epidemiology, National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing 100191, China
Yan-Ping Bao, Department of Epidemiology, School of Public Health, Peking University, Beijing 100191, China
Lin Lu, Department of Psychiatry, Peking-Tsinghua Centre for Life Science and Peking University-International Development Group/McGovern Institute for Brain Research, Peking University, Beijing 100871, China
Co-first authors: Jia-Yue Si and Zi-Yan Lin.
Author contributions: Wang XQ, Si JY and Lin ZY helped plan and carry out the review; Wang XQ and Si JY led in designing the study and writing the manuscript; Si JY, Lin ZY, and Wang XQ had a key role in the study’s main ideas and revising the manuscript; Gan DG ensured that the data used were reliable and drafted the figures; Zhang XY, Liu YN, and Hu YX participated in drafting the manuscript; Bao YP guided and certificated the biostatistics; Sun HQ, Yu X, and Lu L provided comprehensive expertise in reviewing and editing the manuscript; and all authors have carefully reviewed and given their approval for the final manuscript.
Supported by the Ministry of Science and Technology of the People's Republic of China (2021ZD0201900) Project 5, No. 2021ZD0201905, and Capital’s Funds for Health Improvement and Research, No. CFH 2022-2-4115.
Conflict-of-interest statement: There are no conflicts of interest.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Xue-Qin Wang, MD, Associate Professor, Department of Psychiatry, Peking 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), Peking University, No. 51 Huayuanbei Road, Haidian District, Beijing 100191, China.
wangxueqin@bjmu.edu.cn
Received: March 27, 2025
Revised: April 29, 2025
Accepted: July 1, 2025
Published online: August 19, 2025
Processing time: 134 Days and 20.1 Hours
BACKGROUND
Brain-computer interface (BCI) technology is rapidly advancing in psychiatry. Informed consent competency (ICC) assessment among psychiatric patients is a pivotal concern in clinical research.
AIM
To analyze the assessment of ICC and form a framework with multi-dimensional elements involved in ICC of BCI clinical research among psychiatric disorders.
METHODS
A systematic review of studies regarding ICC assessments of BCI clinical research in patients with six kinds of psychiatric disorders was conducted. A systematic literature search was performed using PubMed, ScienceDirect, and Web of Science. Peer-reviewed articles and full-text studies were included in the analysis. There were no date restrictions, and all studies published up to February 27, 2025, were included.
RESULTS
A total of 103 studies were selected for this review. Fifty-eight studies included ICC factors, and forty-five were classified in ICC related ethical issues of BCI research in six kinds of psychiatric disorders. Executive function impairment is widely recognized as the most significant factor impacting ICC, and processing speed deficits are observed in schizophrenia, mood disorders, and Alzheimer’s disease. Memory dysfunction, particularly episodic and working memory, contributes to compromised ICC. Five core ethical issues in BCI research should be addressed: BCI specificity, vulnerability, autonomy, dynamic ICC, comprehensiveness, and uncertainty.
CONCLUSION
A Five-Dimensional evaluative framework, including clinical, ethical, sociocultural, legal, and procedural dimensions, is constructed and proposed for future ICC research in BCI clinical research involving psychiatric disorders.
Core Tip: Informed consent among psychiatric patients is a major concern in brain-computer interface (BCI) clinical research. This review identifies informed consent competency (ICC) assessment as the main challenge, particularly in patients with schizophrenia, mood disorders, anorexia nervosa, alcohol dependence, and neurocognitive disorders due to Alzheimer’s disease and Parkinson’s disease. The MacArthur Competence Assessment Tool evaluates four clinical aspects of ICC. Six psychiatric disorders have common and disorder-specific factors and ethical issues related to ICC. The Five-Dimension BCI-specific ICC framework is constructed in psychiatric disorders. Future research should develop dynamic evaluation systems and enhance ICC of psychiatric patients in BCI clinical studies.
