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

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.

Chinese Ethics Review System and Chinese Medicine Ethical Review:Past,Present,and Future

The Chinese medical ethics committee and the ethical review system have made the following achievements： （1） enabled the institutionalization of medical ethics, （2） carried out the ethics review of Chinese medicine （CM） and integrative medicine extensively, （3） trained a large number of ethical professionals, （4） supported and protected the interests of patients and subjects, and （5） ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways： （1） to refine the relevant rules of ethical review, （2） to develop the relevant standards of the CM and integrative medicine ethical review, （3） to enhance the independence and authority of ethics committee, （4） to emphasize innovation and to discover and solve new problems, and （5） to increase international exchanges and improve relevant research.

Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine

Three features of ethics review in Chinese medicine（CM） and integrative medicine（IM） were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

Principles of Ethics Review on Traditional Medicine and the Practice of Institute Review Board in China

As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture.Therefore,in the practice of ethics review on CM research protocols,besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study,we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values.In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics,and then attempted to summarize the key points for the bioethics review to CM researches in China,so as to serve as reference for the bioethics review to traditional and alternative medicine researches.

上海疾病预防控制机构人员公共卫生伦理审查认知现况和改进策略

目的了解上海市疾病预防控制机构(以下简称“疾控机构”)从业人员公共卫生伦理审查认知现况,为提升疾控机构从业人员伦理认知水平、加强疾控机构伦理审查委员会建设和规范公共卫生伦理审查工作提供依据。方法采用问卷调查,调查疾控机构从业人员的人口学与职业特征、公共卫生伦理审查相关认知等情况,对上海市、区两级疾病预防控制机构的从业人员按比例发放电子问卷,回收有效问卷146份。结果受调查者认为在业务实践和科研活动开展中有必要构建公共卫生伦理审查规定与机制的分别有87.7%、89.7%;有必要构建公共卫生伦理审查评估体系的分别有86.3%、88.4%;有必要开展形式审查、跟踪审查和结题审查的分别有90.4%、92.5%、90.4%;伦理审查委员会有助于业务实践和科研开展的有93.2%。设有伦理审查委员会的机构受调查者与未设有伦理审查委员会的机构受调查者在开展形式审查的必要性认知、医学伦理相关规则对公共卫生伦理价值判定的体现程度认知、公共卫生伦理知识对目前工作或课题研究的帮助程度认知、在机构业务实践或科研开展中构建公共卫生伦理审查规定与机制或评估体系的必要性认知等方面差异有统计学意义;参加伦理培训的受调查者与未参加伦理培训的受调查者在公共卫生伦理知识对工作或课题研究的帮助程度认知差异有统计学意义。结论疾控机构从业人员高度认可全过程伦理管理和公共卫生伦理审查制度建设的必要性,伦理审查委员会建设、人员培训参加情况可能影响公共卫生伦理审查认知。建议强化疾控机构科研项目的全过程伦理管理,加强疾控项目伦理审查制度建设,探索建立疾控机构纵向型伦理审查体系;强化伦理培训,增强从业人员伦理意识,提高从业人员伦理认知。

公共卫生研究的伦理审查要素表构建和审查启示

目的针对公共卫生研究的特点构建伦理审查要素表,为今后相关伦理审查工作提供切实可行的参考依据。方法采用文本分析的方法结合公共卫生学科特点及相关文献资料,将本机构的公共卫生研究项目进行分类。采用文献回顾的方法查阅国内外相关法律法规和回顾既往文献研究的基础上,结合工作实际需求咨询相关伦理专业专家初步构建公共卫生研究的伦理审查要素表。结果将公共卫生研究根据学科特点进行分类:使用现有人体生物样本或信息数据的研究、不涉及干预且采集人体健康信息的前瞻性研究、涉及健康行为干预(饮食、运动等)的研究、不涉及干预且采集人体生物样本的前瞻性研究、临床试验研究(疫苗、化妆品或体外诊断试剂效果检验)。使用现有人体生物样本或信息数据研究的伦理审查主要从研究的设计与实施、研究参与者的隐私保护两方面进行考虑。涉及健康行为干预的前瞻性研究的伦理审查主要从干预研究的设计与实施、知情同意、隐私保护、研究风险与获益评估、研究参与者的补偿和医疗保护、研究参与者的招募、弱势群体的保护等方面进行考虑。不涉及干预且采集人体生物样本或者信息数据的前瞻性研究的审查重点为生物样本及信息数据的采集、储存、使用的过程。结论伦理委员会可以根据不同的公共卫生研究类型特点有针对性地进行伦理审查,提高审查效率和质量,重视对知情同意、隐私保护、弱势群体的保护、权益和风险的评估等方面的考量,保护研究参与者的身心安全和合法权益。

公共卫生干预研究知情同意书伦理审查问题分析

目的 提高公共卫生干预研究知情同意书的完整性和规范性,保障研究参与者的合法权益。方法 汇总整理本机构2016年1月—2023年8月进行初始审查的公共卫生干预研究项目的伦理委员会审议决议,根据自拟的“知情同意书审查要素表”,对相关问题进行统计分析。结果 进行初始审查的39项公共卫生干预研究项目,知情同意书存在问题的项目共有36项(占92.3%)。主要问题包括干预试验内容告知不全(占91.7%),干预试验费用承担者及补偿措施的告知模糊(占38.9%),权益和风险的告知不充分(占55.6%),个人信息和生物样本收集、使用及保护措施的告知不全(占30.6%),知情同意书语言表达不规范(占27.8%)。结论 本机构公共卫生干预研究的知情同意书撰写仍存在很多问题,干预试验的相关各方可采取多种措施以提高知情同意书的完整性和规范性。伦理委员会可以向研究者提供知情同意书撰写模板,加强审查能力,根据审查要素表编写伦理审查指引,提高审查效率和质量,保护研究参与者的合法权益。

Purpose, Composition and Function of the Research Ethical Committee in the Sarah Rehabilitation’s Hospital

Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant and its relevant social participation.

Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance

The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus(HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE’s genetic experiments. China’s guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE’s human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist’s self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.

An Ethical Evaluation Index System for Clinical Approval of Medical Technology in China:A Structural Equation Model Study

Objective： To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. Methods： Exploratory factor analysis （EFA） and first-order confirmatory factor analysis （CFA） based on a structure equation model （SEM）, higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre 15.3. Results： There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. Conclusion： This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.