Objective:This study aims to critically assess the 2023 updates in the governance of Conflicts of Interests (COIs) as outlined in the Ethical Review Measures for Life Sciences and Medical Research Involving Human Beings. It seeks to delve into the ethical implications of these new mandates and offers concrete strategies for effectively integrating them into ethics review practices.Methods:We conducted a comparative analysis of the COIs-related provisions in the 2016 Ethical Review Measures for Biomedical Research Involving Humans, examining them alongside current trends and challenges in COIs governance and ethics review practices.Results:The study identified key challenges posed by COIs to medical research ethics and addresses three principal areas for normative application: the declaration process for conflicts of interest, enhancing the COIs management framework, and the critical review points for COIs by ethics committees.Conclusions:In light of the international consensus on COIs governance, we advocate for the advancement of conflict of interest management at the institutional level. This includes a focus on informed consent processes, the development of robust systems within medical institutions, and the facilitation of ethical corporate collaborations.
Objective:Against the backdrop of the rapidly changing biomedical field and the expanding scope of ethical review, targeted acceleration of institutional ethics committee review efficiency is needed to alleviate the contradiction between innovative development and ethical speed limits.Methods:Through literature research and work practice, the main influencing factors on the efficiency of the current ethical review were analyzed, and suggestions and countermeasures were proposed.Results:The factors affecting the efficiency of institutional ethics committee review were mainly reflected in the imbalance of ethical review resources, incomplete ethical management system, insufficient management support of the ethics office, and inadequate attention paid by hospitals. To improve the efficiency of institutional ethics committee review, in combination with the recently released ″The Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings″ (hereinafter referred to as the ″New Measures″) and work practices, the hierarchical filing system was promoted, the top-level design of the organization was strengthened, the overall operational system of the committee was optimized, and measures such as integrating review resources, standardizing hierarchical management, exploring conditional consent, and innovating the operational mechanism of the Ethics Office were conducted to ensure the quality of review and improve the efficiency of ethical review.Conclusions:According to the new methods, targeted promotion of the hierarchical filing system, strengthening the top-level design of the institutions, integrating resource platforms, and optimizing the overall operational system of institutional committees, were conducive to improving the efficiency of institutional ethics committees based on the premise of reviewing quality, and promoting the innovative development of biomedicine.
Objective:In the context of strengthening joint research and development projects between hospitals and innovative enterprises (referred to as hospital-enterprise joint R&D), we studied the role of focused and systematic integrated management strategies in facilitating the implementation of joint R&D projects between hospitals and enterprises, and to continuously improve project management capabilities.Methods:This study analyzed the basic data of a grade A tertiary hospital in Beijing before and after the systematic optimization of the hospital-enterprise joint R&D project management strategy, including the differences in project quantity, quality, funding level, collaborators, type, and duration to analyze the significance of optimizing management strategy to improve project management capabilities.Results:Compared with the period before the optimization of management strategy, the number of joint R&D projects and the total amount of R&D funding by medical enterprises increased year by year, and the proportion of high-investment and high-level projects was getting higher and higher. At the same time, the subject of cooperation showed a diversified development trend, and the core position of hospitals in the R&D process became increasingly obvious. The proportion of investigator-initiated innovation research exceeded 69% in all 3 years. Management efficiency improved significantly, the proportion of project approval within two weeks.Conclusions:The development of all-around process management measures and integrated promotion and implementation of hospital-enterprise joint R&D are effective in guaranteeing the efficiency and quality of projects. However, the amount and results of high-quality innovative projects are still relatively small and disorganized, and the process of project management also has shortcomings. There is still a long way for researchers to further explore and improve the support platform and guarantee mechanisms.
Objective:With the rapid increase in the number of real world studies, especially the use of health data in medical institutions, ethical issues such as the use of patient health data and the protection of patient′s privacy rights and the right to know have been gradually exposed. To strike a good balance between promoting data sharing and maintaining subjects′ personal privacy, the mode of informed consent appears to be crucial. This paper provided guidance for the selection of informed consent models for real world research health data utilization.Methods:The authors extensively studied the relevant laws and regulations of health data utilization worldwide, conducted extensive searches in Chinese and English databases, sorted out and analyzed various alternative informed consent models, and summarized their characteristics and applications.Results:At present, five alternative informed consent models were used to conduct real world research based on health data utilization. Researchers can choose informed consent models according to the research purpose, research design, research risk, operability of informed consent, and vulnerable groups.Conclusions:Different alternative informed consent models have varied characteristics. Researchers need to choose informed consent models based on the above factors to ensure the maximum protection of patients' privacy rights while using health data.
Objective:This study aims to identify and enhance management strategies for fostering the conversion of scientific and technological advancements in tertiary general hospitals in Beijing.Methods:A questionnaire survey was conducted to pinpoint and organize the areas needing improvement in the transformation process of scientific and technological achievements at Beijing Tiantan Hospital. This involved aspects such as organization, leadership, investment, incentives, and service guarantees. The data were then analyzed and summarized, taking into account the hospital's management, research activities, and the specific circumstances of the institution.Results:The primary drivers for successful achievement transformation in Beijing's tertiary general hospitals were identified across six key indicators: proficiency of professional and technical managers, allocation of special funds, access to market and industry resources, criteria for job title evaluation and promotion, a culture promoting diligence and fault tolerance, and comprehensive transformation training programs.Conclusions:The study concludes that implementing effective incentives and refining the institutional environment for innovation and transformation are crucial. Additionally, it's vital to adjust work focus and enhance management in weaker areas, in line with the hospital's actual situation. Moreover, boosting service efficiency and providing full life cycle services have emerged as pivotal measures to augment the efficacy of hospital innovation and transformation efforts.
Objective:This study aims to investigate how hospital libraries can leverage their institutional repositories to enhance the quality of nursing research by providing tailored subject services.Methods:We analyzed the various modules and functionalities of institutional repositories, drawing insights from practical experiences. From this, we developed a model that enables hospital libraries to offer precise subject services to nursing management departments and nursing researchers.Results:Utilizing the institutional repository, libraries were able to provide detailed profiles of nursing research activities to research management departments for more refined management. We established precise, tiered subject services, including the collection of nursing research literature, targeted training, and additional research support services. These measures significantly enhanced the research capabilities of nursing staff.Conclusions:Adapting to the needs of our readers, the application of the institutional repository has broadened the scope of subject services, bolstered their effectiveness, and contributed to the high-quality progression of nursing research management in hospitals.
ChatGPT的火爆，带动了各种大模型层出不穷。在行业领域，通用医疗健康人工智能大模型尤为引人关注，这种模型不但可以灵活地解析不同医学模态组合，包括医学成像、电子健康档案、临检结果、基因组学、图表和医学文献数据等，而且还能产生富有表现力的多形态输出，包括规范文本的书写和解释、口头建议或展示高级逻辑推理能力的图像注释等。这类大模型可以应用到临床决策、疾病预防、生物医学研究、药物开发、医疗系统的管理与规划等不同领域。
Objective:This article focused on the medical social R&D institutions abroad and analyzed their construction mode to provide a reference for the construction and development of new medical R&D institutions in China.Methods:Through multiple case studies, this article analyzed the construction mode of 6 foreign medical social R&D institutions from the aspects of attribute positioning, management mechanism, and output value, and compared them with the construction of new medical R&D institutions in China.Results:The construction mode of foreign medical social R&D institutions mainly included: the registration attributes were independent legal entities, positioned as non-profit research institutions; focusing on scientific research, while actively exploring the path of transformation of achievements; managed by boards of directors, academic committees and administrative departments; financed by external donations and competitive government grants; recruiting scientific research talents through three methods: open recruitment, dual employment and independent training; generating strong academic and social influence to support its sustainable development.Conclusions:Referring to the foreign experience, the construction of new medical R&D institutions in China requires stable governmental financial support, while need to explore diversified financing channels. Meanwhile, the institutions need to adopt scientific internal management systems and sustainable personnel training models and form multiple value outputs to achieve long-term stable development.
Objective:This study aims to explore the feasibility of ethical review and mutual recognition, focusing on the operational efficiency and review processes of the Ethics Committees in Tianjin′s third-level hospitals.Methods:A thorough online survey was conducted across tertiary hospitals in Tianjin, utilizing a detailed questionnaire. The survey primarily examined the operations and reviews of Ethics Committees from 2019 to 2022, evaluating the efficiency of ethical reviews, the effectiveness of clinical research administration, and the hospitals′ perspectives on mutual recognition of ethical reviews. From 29 collected responses, 28 were deemed suitable for in-depth statistical analysis.Results:In Tianjin′s 28 surveyed tertiary hospitals, 16 routinely hold ethics review meetings monthly. Nine hospitals have established pre-ethics review processes, and three have achieved mutual recognition of their ethical review outcomes. Additionally, five hospitals have integrated electronic information systems. From 2019 to 2021, there has been an increase in clinical trials and Investigator-Initiated Trials (IITs) under initial review, with a significant presence of multi-center clinical trials (90%) and multi-center IIT studies (75%). The timeframe for clinical research review opinions ranged from 18.84 to 20.69 days between 2019 and September 2022, while the duration for clinical research review approvals varied from 22.03 to 23.68 days. During the same period, clinical trial management efficiency spanned from 48.42 to 62.65 days, and IIT study management efficiency was between 25.54 to 28.17 days. Participants identified the main factors influencing management efficiency as stemming from research institutions and sponsors.The majority of hospitals expressed support for the advancement of mutual recognition of ethical reviews and the implementation of a unified submission checklist and template.Conclusions:The Ethics Committees in Tianjin′s third-level hospitals have progressively evolved towards standardization. There is a marked improvement in the efficiency of ethical reviews and overall management of clinical research, indicating a positive development towards more streamlined and effective ethical governance in clinical studies.
银发浪潮与数字化、智能化浪潮的叠加，推动我国养老服务智慧化革新，重塑养老服务新生态。党的二十大报告中强调实施推进积极应对人口老龄化国家战略，推动实现全体老年人享有基本养老服务。《"十四五"国家老龄事业发展和养老服务体系规划》提出大力发展银发经济，促进老年服务科技化、智能化升级，推广智慧健康养老产品应用。持续推动智慧健康养老产业发展，拓展信息技术在养老领域的应用是推进基本养老服务体系建设及养老服务高质量发展的重要支撑，也是缓解社会养老压力、提高养老服务质效的可行路径。
Objective:This study aims to analyze of the quality of diagnosis and treatment data of community medical institutions on the national health information platform in a district of Beijing from the perspective of scientific research informatization, to provide experience and reference for promoting the informatization construction of primary medical units and tapping the scientific research potential of the regional data platform.Methods:Based on the data backup database of the national health information platform in the region, the data quality was analyzed and evaluated mainly in three dimensions: integrity, integration, and consistency.Results:Through the construction of the national health information platform, the district successfully achieved the effective collection of diagnosis and treatment data from community medical institutions, covering the main data such as patients′ basic information, visit information, test information, prescription information, etc. However, the data collected so far were still insufficient in terms of data integration and consistency.Conclusions:A regional medical data center is suggested to construct to break down the barriers between data systems, conduct pre-structuring of diagnosis and treatment data, improve data integration and consistency, and at the same time, carry out effective scientific research prospective design to promote the effective transformation of clinical data to scientific research data.
Objective:This study aims to identify and enhance management strategies for fostering the conversion of scientific and technological advancements in tertiary general hospitals in Beijing.Methods:A questionnaire survey was conducted to pinpoint and organize the areas needing improvement in the transformation process of scientific and technological achievements at Beijing Tiantan Hospital. This involved aspects such as organization, leadership, investment, incentives, and service guarantees. The data were then analyzed and summarized, taking into account the hospital′s management, research activities, and the specific circumstances of the institution.Results:The primary drivers for successful achievement transformation in Beijing′s tertiary general hospitals were identified across six key indicators: proficiency of professional and technical managers, allocation of special funds, access to market and industry resources, criteria for job title evaluation and promotion, a culture promoting diligence and fault tolerance, and comprehensive transformation training programs.Conclusions:The study concludes that implementing effective incentives and refining the institutional environment for innovation and transformation are crucial. Additionally, it′s vital to adjust work focus and enhance management in weaker areas, in line with the hospital′s actual situation. Moreover, boosting service efficiency and providing full life cycle services have emerged as pivotal measures to augment the efficacy of hospital innovation and transformation efforts.
Objective:Exploring the establishment of an objective and scientific evaluation index system for the construction of key medical disciplines in medical institutions in Shanxi Province.Methods:Literature review, Delphi method, and analytic hierarchy process were jointly adopted to screen the indicators and construct the evaluation index system of key medical disciplines in medical institutions in Shanxi province.Results:Two rounds of expert consultation were carried out, and the response rate was higher than 90%, and the expert authority coefficient was ≥0.75. Four primary indicators, 10 secondary indicators, and 41 tertiary indicators were established and given weights at all levels. The four primary indicators were medical operation 25.46%, scientific research management 36.01%, medical education 27.36%, and basic conditions 11.17%. The medical operation showed no significant difference from the original indicators, but its specific content was closer to the core indicator system of public hospitals′ performance evaluation reflecting social service capacity. The proportion of scientific research management increased by 12.5% and medical education increased by 17.39%. The results of the comprehensive quantitative evaluation of medical education and basic condition were P<0.05, respectively. The average score of discipline construction increased from 78.8, with excellent disciplines accounting for 56.66%, good accounting for 23.3%, qualified accounting for 6%, and unqualified accounting for 13.3%, to an overall average of 85.89, of which 76.7% were excellent, subjects accounting for 16.7% were good, 3% were qualified, and 3% were unqualified. Conclusions:The evaluation index system provided a quantitative tool for the evaluation of the construction of key medical disciplines in medical institutions in Shanxi Province. The expert authority and consistency were high and the index system was scientific. The weight coefficient of ″scientific research management″ in the index system was the highest, followed by medical education, in line with the evaluation purpose. The application of the system clarified the goal of current discipline construction, motivated the construction of scientific research management, promoted the transformation of achievements to a certain extent, and improved social service capacity.
Objective:This study aims to summarize the construction and operation results of a clinical research support platform in a large grade A tertiary hospital in Beijing, and to explore the top-level design, functional positioning, and operation management based on research wards, thereby providing a reference for improving the clinical research support system in China.Methods:Guided by the needs of clinical research, the clinical research support platform consisted of seven core functional units, including the clinical trial platform, medical ethical review platform, medical experiment and clinical testing platform, clinical research big data platform, clinical research methodology platform, scientific and technological achievements transformation platform, and biobank.Results:The clinical research support platform with perfect functions, scientific management, and efficient operation can provide strong technical support for efficient operation of research wards, high-quality development of clinical trials, and rapid transformation of innovative results.Conclusions:A high-level clinical research support platform can effectively integrate medical resources, promote resource sharing and cooperation, promote the deep integration of industry, academia, research, and medicine, and enhance the collaboration and scientific level of clinical research.
Objective:To focus on the publicity of medical research in medical colleges and universities in the new era, analyze the current practices and problems, and think how to promote scientific and technological innovation in medical colleges and universities.Methods:Through case analysis and data statistics, suggestions were put forward for medical colleges and universities to further promote medical research publicity by using the example of Peking University Health Science Center.Results:Strengthening medical scientific research publicity is part of the national development strategy as well as the high-quality development of medical colleges and universities.Peking University Health Science Center does well in meeting the new development requirements and makes solid progress from the perspective of the content, topics, characters and platforms of scientific research publicity, but there is still room for improving management, popularizing fundamental research achievements and raising social impact.Conclusions:Scientific research publicity is an important aspect of scientific research management. It is suggested to promote the role of scientific research publicity in scientific research management of medical colleges and universities from the aspects of improving management mode, strengthening correct orientation, improving content quality, establishing brand thinking, and making good use of integrated communication, so as to promote the innovative and high-quality development of medical research, and better serve the national scientific and technological development and construction of Healthy China.
Objective:To summarize the existing problems in the follow-up management of the clinical research project on cerebrovascular diseases at the National Clinical Research Center for Neurological Diseases, Affiliated Beijing Tiantan Hospital, Capital Medical University, and propose solutions and strategies to improve the level of follow-up management in clinical research, this study provided a reference basis.Methods:A comprehensive quality control system was established based on the follow-up management platform, data collection platform, quality control platform, and project management platform.Results:Strategies were proposed for key points in each stage of clinical research follow-up, quality control of the follow-up process, and follow-up progress. Furthermore, a follow-up assistant software management system was established.Conclusions:The follow-up management platform established by this study can timely address the issues encountered during follow-up, help standardize the follow-up management of clinical research, improve the follow-up rate, and ensure the quality of follow-up data.
Objective:This study is to understand the hot spots and trends in the recruitment of clinical trial subjects in China over the past 20 years, explore the existing problems and countermeasures, and provide scientific ideas for domestic clinical trial institutions to effectively solve the problem of subject recruitment.Methods:Bibliometric analysis was used to study the relevant literature from three major domestic databases from 2001 to 2021, analyzing key indicators such as annual publication volume, journal distribution, institutional distribution, regional distribution, and high-frequency keyword co-occurrence.Results:A total of 162 articles were selected. The results showed that the overall publication volume in this field showed an upward trend, and the research institutions were diversified, with a concentration of medical and pharmaceutical institutions and universities. The current research hotspots in this field focused on quality and efficiency improvement of subject recruitment, with themes of subject protection, ethical review, regulation development, standardized management, etc.Conclusions:The research in this field has made significant progress, but the overall research level is still relatively weak. Therefore, it is suggested that the country should play a role in macro-regulation, on the one hand, starting with top-level design, promoting the construction of a standardized management system for subject recruitment, continuously strengthening subject protection, and enhancing the effectiveness of scientific recruitment. On the other hand, releasing the potential of grassroots institutions and giving full play to the volume advantage by promoting the sinking of advantageous resources. Meanwhile, great importance should be attached to the development of Phase I clinical trials, giving full play to the strong internal energy of traditional medicine and promoting the development of Chinese traditional medicine. These multi-measures should provide a theoretical basis for exploring the transformation of ′clinical research hospitals′, and promote the high-quality development of new drug research and development in China.
Objective:In order to strictly prevent academic misconduct, effectively improve the understanding and judgment ability of researchers on medical ethics issues involved in papers, and ensure scientific and standardized research results, strict ethical review is crucial.Methods:It mainly reviews whether the clinical research paper to be submitted has obtained an ethical approval certificate, whether the content of the paper exceeds the scope of ethical approval permission or violates research ethical standards, etc., and establishing a sound paper ethics review mechanism.Results:This paper summarizes the issues, points and considerations of ethical review before submission of clinical research papers, hoping to provide some practical methods and references for the ethical review of clinical research papers in China.Conclusions:Medical and health institutions mostly carry out biomedical research involving humans, and should pay more attention to ethical norms and requirements, educate and guide researchers to strengthen ethical awareness, and improve their attention and judgment ability to medical ethical issues in papers.
Objective:To change the current situation of the relatively weak management of periodic follow-up review, and further to improve the continuous review capacity of the ethics committee.Methods:Through sorting out and analyzing the problems existing in the periodic follow-up review, corresponding solutions are taken: to detail management requirements; to strengthen daily supervision; special ethics training and communication to enhance the ethical awareness of researchers; to optimize the division of labor in the ethics office to improve work efficiency and the quality of committee review; the information review system helps strengthen tracking and reminding.Results:In one year′s practice, the omission of periodic follow-up has been significantly reduced, and the supervision ability of the Ethics Committee on periodic follow-up review has been improved.Conclusions:In periodic follow-up review, research institutions, ethics committees and researchers pay enough attention to fulfill their responsibilities and actively cooperate can effectively improve the quality of periodic follow-up review.
Objective:Public health emergencies expose a significant threat to human life and health. How to efficiently conduct biomedical research while complying with ethical norms is an important way to response to public health emergent events such as pandemic outbreak. In 2023, the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine jointly issued the " Measures for Ethical Review of Life Sciences and Medical Research Involving Human Subjects", which requires the ethics committee to construct an ethical review system in advance, including, generally, the ethics committee should conduct ethical review and provide review opinions within 72 hours. Is this measure feasible and does it have any unreasonable aspects?Methods:Literature review and status quo analysis are two main methods, this article combs the international guidelines issued by World Health Organization, the Council for International Organizations of Medical Sciences and the Nuffield Council of Bioethics, selects the content related to research under the circumstances of public health emergencies, take the Hofstede′s Cultural Dimensions Theory into consideration of the complexity of quality and quantity of research during the COVID-19 pandemic in China.Results:After analyzing, this article argues preliminarily that the requirement and emphasize on ethical review system development issued by the four ministries in China is very timely and necessary. However, the requirements for review time limits is inconsistent with international consensus, and might pose substantive challenges to the independence of the ethics committee's work.Conclusions:Scientificity and ethics are the soul of biomedical research, and the basic requirements of these two aspects cannot be undermined due to the special nature of public health emergencies. However, procedures simplifiable are worth exploring.
