BackgroundOver the past decade, China has witnessed a sharp increase in clinical trials, exceeding 4,000 in 2023. Yet, this growth has brought emerging ethical challenges and concerning researcher misconduct. Despite growing scholarly attention to clinical trial regulation, a critical knowledge gap remains regarding the ethical world of clinical researchers. This study investigates ethical challenges in clinical research, their contributing factors, and pathways for improvement.MethodsThe research design involved mixed methods, specifically a nationwide questionnaire survey (quantitative) and semi-structured interviews (qualitative). Using stratified random sampling from China's Clinical Trial Registry (ChiCTR), 1,800 questionnaires were distributed and 287 valid responses analyzed descriptively with SPSS 22 to identify key challenges. Subsequently, 37 clinical researchers were interviewed, and transcripts thematically analyzed with NVivo 11 to explore underlying causes and triangulate the survey findings, thereby identifying potential pathways for improvement.ResultsThe descriptive analysis of the questionnaire results, triangulated with interview findings, reveals that general misconduct is common despite the rarity of severe violations; ethical behavior often lags behind ethical cognition and attitude; researchers show blunted moral sensitivity; and most adopt a passive stance toward ethical compliance rather than active engagement. The thematic analysis identifies two core contributors to these challenges: individual factors-including personal traits, dulled moral sensitivity, limited ethical knowledge, and low ethical awareness; and environmental factors-including weak ethical oversight, an inadequate ethical climate, unhealthy research competition, and researcher-subject knowledge asymmetry.ConclusionsEthical challenges in China's clinical research persist due to the interaction of personal ethical limitations and structurally weak oversight systems. To mitigate these challenges, a dual approach is proposed, integrating internal moral cultivation and external oversight. Internally, efforts should focus on creating an ethical space for dialogue, promoting moral consensus, fostering ethical identity and sensitivity, and cultivating a sense of ethical responsibility through moral practice. Externally, improvements are needed in post-approval ethical monitoring, targeted training programs, research climate, and public understanding of clinical trials and ethics.
目的:基于Brusselator模型探究医学伦理委员会可持续发展的影响因素,为医学伦理委员会组织能力评价和建设提供可量化的新思路.方法:在前人开发的问卷基础上,进一步完善和调整设计出包含52个指标的李克特量表问卷,并在我国东部地区97家三甲医院中开展调查.通过转义法建立医学伦理委员会Brusselator模型.结果:伦理委员会独立性、秘书配置、委员任命条件、意外问题的审查、患者诊疗伦理审查质量和培训总体质量对医学伦理委员会内部环境有不利影响,权重在0.0139~0.0190之间;相关群体消费水平、技术进步程度、相关政策稳定性、相关法律法规健全性和未来发展生命力对医学伦理委员会外部环境产生负面影响,权重在0.1071~0.1296之间.结论:医学伦理委员会组织能力建设受到内外部双重环境影响,应该内外兼修、协同提升,为我国医学伦理委员会可持续发展注入动力.
智能时代的数字医疗正在快速改变着传统的就医模式,由此产生的伦理问题和伦理冲突集聚并超越人类的想象,如何理性地对待数字医疗的发展?数字医疗能否"道德物化"?我们该如何构建数字医疗伦理?本文基于维贝克"道德物化"理论,在解析数字医疗面临系列伦理困境的同时,试图将数字医疗作为一种信息技术和医疗活动融合的整体进行道德能动性的审视,以道德规范和价值嵌入人工物来启发数字医疗的"道德转向",并对数字医疗的发展作负责任的理性思考,从而探析数字医疗伦理标准、原则和实现公共善的可行路径.
BACKGROUND:Institutional Review Boards (IRBs) play a vital role in safeguarding the rights and interests of both research participants and researchers. However, China initiated the establishment of its own IRB system relatively late in comparison to international standards. Despite commendable progress, there is a pressing need to strengthen the organizational capacity building of Chinese IRBs. Hence, this study aims to analyze the key factors driving the enhancement of organizational capacity within these committees.METHOD:The cross-sectional survey for this research was conducted from July 2020 to January 2022. Following the statistical grouping based on the "2020 China Health Statistical Yearbook", a systematic investigation of IRBs in various provinces of China was carried out. In-depth interviews and questionnaire surveys were conducted with the chairpersons and administrative executives (or secretaries) of highly cooperative IRBs. Subsequently, data were collected from 107 IRBs. Qualitative Comparative Analysis (QCA) was employed as the method to analyze the factors influencing the organizational capacity of medical ethics committees and explore the diverse combinations of these factors.RESULTS:Through a singular necessary condition analysis, the variable "protection of rights and interests" emerges as a critical factor contributing to the robust construction of Institutional Review Boards Institutional Review Boards (IRBs). Conversely, the variables of "lack of member ability, absence of review process, and deficiency in the supervision mechanism" collectively constitute a sufficient condition leading to weaker IRB construction. The state analysis uncovers three interpretation modes: member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3).CONCLUSIONS:The results of this study are effectively explicable using the "Triangular Force" model proposed for the hypothesis of IRBs' organizational capacity, which provides a solid foundation for the development of organizational capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the competence of committee members and strengthen team development. This can be achieved by establishing a comprehensive regulatory framework and refining procedural protocols. Moreover, clarifying the organizational structure and optimizing resource allocation are essential steps in bolstering the overall organizational capabilities of these committees.
人工智能赋能教育是技术发展的时代必然,但在智能技术与教育的融合过程中,教育技术、师生关系以及教育环境等方面也会产生新的伦理风险.从理论上说,教育技术运用方面的伦理风险,主要根源于由认知受限而导致的算法黑箱、由文化偏见而引致的算法歧视、由智能技术法制缺位而引发的伦理治理受阻;师生关系方面的伦理风险,主要根源于教师、学生以及师生等伦理关系的错位;教育环境方面的伦理风险,主要根源于由价值歧视导致的社会公平正义缺失,从而引发更深层次的教育不公平.因而,在人工智能赋能教育过程中,一方面要理性看待已经出现或可能会出现的伦理困境,另一方面要在倡导智能技术和教育融合共生的基础上,从加强技术支撑和伦理规范建设、构建新型师生伦理空间、明晰智能教育伦理责任和提升师生智能素养等四个方面,构建人工智能教育伦理治理新范式,以防患于未然.
目的:通过对我国基层医疗资源进行分析评价,为我国进一步优化卫生资源配置提供科学的实证依据.方法:采用DEA-BBC模型和DEA-Malmquist对数据进行静态和动态分析.结果:我国基层医疗资源总量呈上升趋势,但还存在规模效率不足、规模投入不平衡问题;基层医疗资源配置效率整体呈下降趋势,技术进步成为限制全要素生产效率的关键因素;基层医疗配置效率表现为我国中部最优,东部次之,西部最后.结论:政府在加大对基层医疗卫生机构资源规模投入的同时,也需要积极探寻适合当地的发展规模.在此过程中,要不断加强技术革新、组织管理体制改善以及基层卫生人员的培养,从而推动基层医疗资源优化,提升基层医疗技术水平,形成优质的基层医疗服务,最终达到合理的卫生资源配置效率.
Abstract Predicting patients with major depression (MDD) is currently a difficult task. Magnetic resonance imaging (MRI) data analysis may provide insight into individual patient responses, allowing for more customized treatment decisions. Due to the absence of brain MRI data for MDD patients, a transfer learning (TL) method developed is used using calculation criteria. Combining an Inception‐v3 neural network with a typical pre‐trained neural network, the move learning‐based Inception‐v3 was proposed for the classification of MDD MRI datasets. An experiment was performed on the classification of eight semantic emotions (defined by IMAPS). Compared to other methods, the proposed method performs high efficiency for 90–10% and 80–20% (positive and negative classes), normal (N), unnormal (UN), and average/total sets, and for 70–30%, accuracy (A) is 92.90%, area under the curve (AUC) is 94.23%, and average precision score (APS) is 95.75%. Individual patients' responses to emotional stimulation can be predicted using the proposed methods, which can provide guidance in diagnosis and prognosis.
科技发展与科技伦理的关系,在时代更迭的大背景下,变得愈加复杂.如何有效地解决二者间的"二元对立",保留人们对丰富多样的"意义"和"价值"的敏锐触觉,对于解析科技伦理未来发展具有重要的指导作用.引入"高概念"主张,旨在阐明科技伦理通过其祛魅、统合和自觉而实现与科技发展的并行统一、过程与结果的并重、滞后与先验的调和.以人工智能伦理的具象化场景应用为例,将"高概念"主张嵌入至人工智能伦理中,不仅有利于客观地呈现科技发展与伦理之间的全新关系,而且有利于完成科技伦理自身在时代背景下的反思与重构,即在再认知策略共同体的基础上促使科技发展与科技伦理的均衡发展,进而助力科技伦理发展全新环境的营造.
Functional magnetic resonance imaging (fMRI) is widely used for clinical examinations, diagnosis, and treatment. By segmenting fMRI images, large-scale medical image data can be processed more efficiently. Most deep learning (DL)-based segmentation typically uses some type of encoding–decoding model. In this study, affective computing (AC) was developed using the brain fMRI dataset generated from an emotion simulation experiment. The brain fMRI dataset was segmented using an attention model, a deep convolutional neural network-32 (DCNN-32) based on Laplacian of Gaussian (LoG) filter, called ADCNN-32-G. For the evaluation of image segmentation, several indices are presented. By comparing the proposed ADCNN-32s-G model to distance regularized level set evolution (DRLSE), single-seeded region growing, and the single segNet full convolutional network model (FCN), the proposed model performs well in segmenting mass fMRI datasets. The proposed method can be applied to the real-time monitoring of patients with depression, and it can effectively advise human mental health.
Objective::To detect the main problems in the formation of ethics committees in eye hospitals in China and to provide relevant solutions for them by investigating the current status and understanding the establishment and operation at these hospitals.Methods::This was a cross-sectional study. Convenience sampling combined with online distribution was adopted to investigate 33 ethics committees in eye hospitals all over the country from October 2018 to October 2019. The contents included the profile, formation, and operation of these ethics committees. Valid questionnaire data were selected and analyzed using descriptive statistical analysis.Results::A total of 21(64%) eye hospitals had established ethics committees, and the other 12(36%) had not. Of the 21 hospitals with ethics committees, 12 hospitals had independent ethics committees, 9 hospitals had full-time secretaries or staff, 4 hospitals did not have outside committee members, 7 hospitals had not established the presiding censorship, 4 hospitals had not conducted annual or regular follow-up reviews, and 3 hospitals had not organized ethics-related training for their researchers.Conclusions::There are problems in ethics committees in eye hospitals, such as chaotic subordinate relationships, inappropriate membership, inadequate training of committee members, and a lack of the whole course of ethics censorship. Specialized eye hospitals still need to strengthen the establishment of ethics committee setup, personnel composition, effective guaranteed conditions, effective training mechanisms, and normalized ethical review procedures. Mean while, it is recommended to establish a collaborative ethics censor alliance in eye hospitals, to actively promote a more normalized formation of ethics committees in the alliance, and to revise and improve standard operating procedures. While increasing the efficiency of ethical reviews, there are benefits in promoting the development, normalization and high quality of these ethics committees in eye hospitals.
Objective:To understand the ethical misconduct of Chinese medical researchers and its influencing factors, so as to provide a reference for regulating such misconduct in clinical research.Methods:From September to November 2021, a stratified random sampling method was adopted to select medical researchers from the China Clinical Trial Registration Platform as interview objects, and semi-structured interviews were made on ethical misconduct and its influencing factors in clinical trials. The interview data were analyzed using NVivo11 software.Results:A total of 28 interviewees were included, 57%( n=16) of whom holding that medical researchers accept research ethics passively in most cases. The influencing factors of ethical misconduct of medical researchers are summarized into 7 secondary nodes and 43 tertiary nodes, including 248 reference points. The environmental factors included poor ethical supervision, great research pressure information asymmetry between subjects and researchers, and insufficient ethical atmosphere, including 54, 40, 38, and 29 reference points respectively. The self-factors included lack of ethical knowledge, weak ethical awareness, and individual characteristics of researchers, including 48, 21 and 18 reference points respectively. Conclusions:The attitude and behavior of clinical research ethics of Chinese medical researchers are generally in the transitional stage from passive acceptance to positive compliance, and there are many factors influencing ethical misconduct. In order to further standardize the ethical behavior of medical researchers, the authors suggest relevant authorities to improve ethical review and supervision, establish systematic ethical training, improve the scientific research environment, and actively carry out clinical trials and science popularization.
Abstract BackgroundCompared with international Institutional Review Board, China started late; however, in recent years, under the promotion of Chinese government departments, academic organizations, and experts and scholars at all levels, Chinese Institutional Review Board have made great achievements in the protection of rights and interests, systems, and procedures, Chinese Institutional Review Board are still weak in their organizational capacity building. The organizational capacity building of Institutional Review Board is a subject with complex causality, and it is difficult to offer a completely reasonable explanation for all aspects. MethodIn this article, we analyzed the influencing factors that affect the current status of the operation of Chinese Institutional Review Board, using literature analysis to refine the conditional variables and analyze the cases of 107 tertiary hospitals in China through crisp-set qualitative comparative analysis (csQCA) to explore the impact of medical ethics. Using the necessary conditions and combination of committee construction, combined with the “Yang Triangle” model of organizational capabilities, we designed a “Triangle force” model of the organizational capabilities of Institutional Review Board and proposed solutions from the perspective of organizational capabilities, reflecting on and analyzing the current management status of Chinese Institutional Review Board. ResultsWe found that the protection of rights and interests was a necessary condition for a medical ethics committee. A lack of member ability, lack of review process, and lack of a supervision mechanism were sufficient conditions for a poor construction of a medical ethics committee. ConclusionsWe analyzed seven interpretation paths for this organization to operate well and they can be summarized into three typical paths: member ability-oriented, institutional process-oriented, and resource system-oriented, which are consistent with the “Triangle force” model hypothesis of the medical ethics committee’s organizational capabilities as constructed in this article. The driving factors and supporting forces of an ethics committee provide a theoretical basis and policy suggestions for the organization of Chinese Institutional Review Board.
Objective:Given the indispensable role played by medical ethics committees in protecting the rights and interests of subjects and researchers, such committees in China are found with weak organizational capacity. This study was designed to analyze the driving factors to improve their organizational capacity.Methods:Form July to September 2020, a survey and interview of 71 tertiary A hospitals in eastern China were conducd, and a total 60 valid samples were obtained. Through crisp-se qualitative comparative analysis(csQCA), the medical ethics committees of 60 tertiary hospitals were analyzed, and the factors affecting the organizational capabilities of the medical ethics committees and their combinations were explored.Results:Protection of rights and interests was key to medical ethics committee′s organizational capacity, while incompetency of the members and the irregular review process were sufficient reasons for the weak organizational capacity. There were six combinations of sufficient conditions for the medical ethics committee to be strong in organizational capacities, which could be explained by the three models of member capacity-orientation, system-process-orientation, and resource-system-orientation.Conclusions:The medical ethics committees are recommended to enhance members capacity, enhance team building; complete rules and regulations, and process mechanism; clarify organization structure, and optimize resource matching, in an effort to enhance the organizational capacity of these committees in China.
同情用药是指在特定情况下允许对穷尽现有治疗手段的危重症患者使用可能具有疗效但尚未上市的药品.我国同情用药制度起步较晚仍存在诸多挑战,欧盟、美国同情用药制度发展较早,在经历不断地发展完善后,日臻成熟.梳理国内外同情用药制度发展沿革,并结合我国现有国情,从建立完备的制度保障,设立申请同情用药的多种通道,重视伦理委员会的建设,保障患者知情同意等方面提出针对性建议,以期对我国有序推进同情用药制度提供参考.
目的 探讨高频聚焦超声联合双极射频治疗对女性腹部脂肪肥厚和皮肤松弛的临床疗效.方法 回顾性分析2017年6月至2021年5月在本院采用高频聚焦超声联合射频技术进行腹部融脂紧肤治疗的女性病例,按照是否有妊娠分娩史分为妊娠分娩组和无妊娠分娩组,所有患者均接受3组次治疗,1次高频聚焦超声和1次双极射频治疗为1组,每次治疗间隔1周,交替进行.在治疗前和最后一次治疗后2周测量脐周腹围和最粗腹围,并对患者的治疗结果满意度评分.结果 妊娠分娩组和无妊娠分娩组治疗前后的脐周腹围、最粗腹围相比,差异均有统计学意义(P<0.05),而有无妊娠分娩组患者治疗满意度的组间差异无统计学意义.患者均未发生不良反应.结论 高频聚焦超声联合双极射频治疗是减轻腹部皮下脂肪和紧致皮肤的一种安全有效的方法.
This study uses the structure–conduct–performance analytical framework in industrial organization theory to analyze Chinese startups’ corporate social responsibility (CSR) assuming normalization after the COVID-19 pandemic. Specifically, we take the external impact of the pandemic on startups during the pandemic as a starting point for analyzing the changes in the structure of startups and their CSR performance. We find a positive correlation between the pandemic and the performance of startups. We propose that the CSR of startups is not simply altruism but must involve an “altruistic and self-interested” mechanism. Therefore, this study proposes that during the pandemic, startups need to rebuild their CSR model. Furthermore, the company’s “economic man” and “social man” are interdependent; economic, ethical, and legal responsibilities are parallel and charitable responsibilities remain the highest pursuit amid the pandemic. The social responsibility of startups as the COVID-19 pandemic normalizes is a strategic choice.
<span id="ChDivSummary" name="ChDivSummary" class="abstract-text">医学是科学,更是人学,归根结底是一门关于"人"的学问。马克思从人的历史发展过程开始考察人的发展,阐述了丰富的人学思想,指引了社会科学和精神科学研究,形成了科学的马克思人学。深入学习马克思人学理论对全面地把握医学伦理思想的演进、正确地引领医学伦理思想的构建、有力地促进医学发展具有重要的时代价值。</span>
<span id="ChDivSummary" name="ChDivSummary" class="abstract-text">医学伦理审查是对医学科研和医疗临床实践进行审核和监督,确保其符合伦理、道德的要求。随着制度的改革和社会的觉醒,医学伦理审查制度不断被完善,其制度和理论体系渐趋丰满,但从目前来看,不管是国内还是国外的伦理审查都迎来了瓶颈。文章综述了医学伦理审查制度的产生与发展背景,讨论了西方医学伦理审查制度的现实困境,最后在对国内医学伦理审查研究进展基础上对我国的医学伦理审查制度进行了反思,提出须以传统文化为基底,构建中国特色医学伦理审查制度,才是正解。</span>
随着医学模式由生物医学向生物—心理—社会模式的转变,医学院校亟需通过“课程思政”改革,使高校思想政治教育融入专业课教学的各个环节,实现专业课从“教学”到“教育”的转变,培养复合型全能人才.生命教育倡导认识生命、珍爱生命、敬畏生命、尊重生命,其内容与思想政治教育有重合之处,本质上都是为了帮助学生建立正确的人生观、价值观和自我身份认同,又与医学专业密切相关,弥补了思想政治教育难以与医学专业课结合的缺陷.以生命教育为切入点,将医学生专业课程和思想政治课程紧密联系起来,探索用生命教育的内容和方式提升医学院校“课程思政”教学效果的策略.
生命家族中的所有成员,首先都是来缔结生物链,构筑生命系统的.所以,每个物种都应有基本的生存权.从这一点讲,生命都是平等的;而生命又是有差别的,不同的生命所具有的生命价值大小也不尽相同.从这个角度讲,生命又是不平等的.生命的平等与不平等原则,最终统一于生命的公正原则,即基本权利平等与非基本权利比例平等原则的统一.这一原则也同样适用于人类社会,它是生命伦理学和生态伦理学的基本原则之一,为人体移植器官的多样性获取等提供了理论指导.