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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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23896,"journal":{"name":"World Journal of Psychiatry","volume":"15 8","pages":"107593"},"PeriodicalIF":3.4000,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12362645/pdf/","citationCount":"0","resultStr":"{\"title\":\"Informed consent competency assessment for brain-computer interface clinical research and application in psychiatric disorders: A systematic review.\",\"authors\":\"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\",\"doi\":\"10.5498/wjp.v15.i8.107593\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Aim: </strong>To analyze the assessment of ICC and form a framework with multi-dimensional elements involved in ICC of BCI clinical research among psychiatric disorders.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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. 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引用次数: 0
摘要
背景：脑机接口（BCI）技术在精神病学领域发展迅速。精神科患者知情同意能力评估是临床研究中的一个关键问题。目的：分析ICC的评估情况，形成精神障碍BCI临床研究ICC涉及的多维要素框架。方法：对6种精神障碍患者脑机接口的ICC评估临床研究进行系统综述。使用PubMed、ScienceDirect和Web of Science进行系统的文献检索。同行评议的文章和全文研究被纳入分析。没有日期限制，纳入了截至2025年2月27日发表的所有研究。结果：本综述共纳入103项研究。58项研究纳入ICC因素，其中45项被归类为6种精神障碍脑机接口研究中ICC相关伦理问题。执行功能障碍被广泛认为是影响ICC的最重要因素，在精神分裂症、情绪障碍和阿尔茨海默病中观察到处理速度缺陷。记忆功能障碍，特别是情景记忆和工作记忆，会导致ICC受损。脑机接口研究应解决的五个核心伦理问题是：脑机接口的特异性、脆弱性、自主性、动态ICC、全面性和不确定性。结论：构建了一个包括临床、伦理、社会文化、法律和程序维度的五维评估框架，并为未来涉及精神障碍的脑机接口临床研究中的ICC研究提出了建议。
Informed consent competency assessment for brain-computer interface clinical research and application in psychiatric disorders: A systematic review.
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.
期刊介绍：
The World Journal of Psychiatry (WJP) is a high-quality, peer reviewed, open-access journal. The primary task of WJP is to rapidly publish high-quality original articles, reviews, editorials, and case reports in the field of psychiatry. In order to promote productive academic communication, the peer review process for the WJP is transparent; to this end, all published manuscripts are accompanied by the anonymized reviewers’ comments as well as the authors’ responses. The primary aims of the WJP are to improve diagnostic, therapeutic and preventive modalities and the skills of clinicians and to guide clinical practice in psychiatry.
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