1.Ethical challenges and countermeasures in the transformation of scientific and technological achievements in medical institutions
Tengfei XU ; Shuilong GUO ; Hong YOU
Chinese Medical Ethics 2024;37(5):499-506
Medical institutions are not only the research and development end,but also the application end of innovative achievements,which makes the transformation of medical scientific and technological achievements different from the others in colleges and universities.It also faces new problems and challenges in ethical governance.Meanwhile,the ethics of promoting the transformation of medical scientific and technological achievements also needs to be paid attention to and maintained.Improving people's health level and quality of life are the ultimate ethical goals of process supervision.The objectives,systems,and behaviors of ethical evaluation need to have their own emphasis to avoid repeated evaluation,improve evaluation efficiency,and ensure the ethics of evaluation work itself.This paper discusses the specific classification and common forms of ethical challenges in the supervision of the transformation process of achievements in medical institutions.It is suggested to focus on ethical values to improve the legal system,clarify the relationship between the public welfare and transformation profitability of medical institutions,and explore new positions of the transformation advantages in medical institutions.
2.Analysis of the current situation, advantages and difficulties of standardized management of Investigator Initiated Clinical Trials
Yingshuo HUANG ; Xu ZUO ; Yue LI ; Lihan XING ; Shuilong GUO ; Zhenchang WANG ; Shutian ZHANG
Chinese Journal of Medical Science Research Management 2024;37(1):70-74
Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.
3.Practice and exploration of safe export of medical-related scientific research data
Yingshuo HUANG ; Shuilong GUO ; Hongwei YAO ; Lihua WANG ; Xian ZHAO ; Zhenchang WANG ; Zhongtao ZHANG ; Shutian ZHANG
Chinese Journal of Hospital Administration 2024;40(4):310-315
Faced with the increasing demand for technological innovation, how to effectively carry out and regulate the export of medical-related scientific research data has become an urgent issue. The author reviewed the current requirements and status of data export in China and abroad, as well as the relevant requirements for medical data management in China, and introduced the practical experience of the first data compliance export case of medical field in China. In view of the main difficulties in the management of medical-related scientific research data export, such as the lack of multi-professional background members of the project team, the difficulty in writing professional documents, the relatively single template, the lack of personalized templates suitable for different professional field, and the need for homogenization of regulatory standards and requirements, it is proposed to rely on a qualified third-party platform in the form of entrusted business, adopt the optional mode under the general declaration template, establish unified regulatory standards, pay attention to the important data and national core data involved in the data export, pay attention to the ethical issues, and replace the original data with derivative data, and keep to " necessity principle" and " minimization principle", so as to provide reference for medical institutions and management departments to strengthen the standardized management and security guarantee of medical-related scientific research data export.
4.Development, application and practical experience of clinical research integration platform of a third-class hospital in Beijing
Yingshuo HUANG ; Xu ZUO ; Yue LI ; Lihan XING ; Lihua WANG ; Xu ZHANG ; Yongqian TIAN ; Jingyi SHEN ; Shuilong GUO
Chinese Journal of Medical Science Research Management 2023;36(4):293-299
Objective:To explore the development, application and practical experience of investigator-initiated integrated clinical research information platform.Methods:The process of developing and constructing an integrated clinical research platform in a tertiary hospital in Beijing was introduced, the functions and advantages of the platform were described and displayed, and the main problems and risk points in the development and construction process were analyzed.Results:The integrated clinical research platform meets the management requirements of clinical research initiated by investigators, and the standardized management of the whole life cycle of the project can be realized through the platform, and the key issues of data security, information capture, sharing and interoperability need to be further explored in terms of platform docking.Conclusions:The integrated clinical research platform effectively improves the standardization, management quality and efficiency of investigator-initiated clinical research.
5.Reflection and Practice on Exemption from Ethical Review
Yingshuo HUANG ; Xu ZUO ; Yue LI ; Lihan XING ; Shuilong GUO ; Miaorong XIE
Chinese Medical Ethics 2023;36(10):1116-1121
According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.
6.Practice of building a research hospital in a general tertiary hospital in Beijing
Yingshuo HUANG ; Xu ZUO ; Shuilong GUO ; Hong YOU ; Zhenchang WANG ; Shutian ZHANG
Chinese Journal of Hospital Administration 2023;39(9):645-650
To meet China′s requirements for scientific and technological innovation and high-quality development in the new era, it is imperative to actively implement the innovation-driven development strategy and build high-level research hospitals. Beijing Friendship Hospital, Capital Medical University has been working to build a research hospital since 2018. The hospital promoted discipline construction through the development mode of discipline clusters, made the research wards as a platform, adopted the " shared comprehensive service" mode to improve the quality and efficiency of clinical research, and strengthened talent cultivation through such key measures as a new talent recruitment system. The mode has proved successful in such aspects as improving the ranking of scientific and technological value of hospitals and disciplines, introducing high-level talents, and outputting scientific and technological achievements, supporting by research wards for other departments of the hospital, and improving the efficiency and quality of clinical trials. Such a mode can provide reference for general hospitals in building research hospitals.
7.The importance of "Four Beams and Eight Pillars" matching theory
Yan ZHANG ; Shuilong MAO ; Zengjun GUO ; Han ZHANG ; Xinxin ZHANG ; Boxin JING ; Ping YAN ; Xingjun WANG
International Journal of Traditional Chinese Medicine 2022;44(8):846-848
This paper summarizes the current situation and problems of the research on the theory of "Taibai Seven Medicines" through literature summary and surveys. Although the "Four Beams and Eight Pillars" theory of compounding has a long history, the current research progress of "Taibai Seven Medicines" is mostly focused on plant resources. There lacks researches on the theory of compounding, or development of compounding and large varieties based on "Taibai Seven Medicines". We call for the inheritance and protection of folk experience, and hope that the "Four Beams and Eight Pillars" theory can guide the application and development of the seven Taibai medicines. Therefore, increasing the research on the theory and teaching in undergraduate courses formulary in Chinese medicine are necessary in our province.
8.Ethical Issues and Ethical Review of Human Genetic Resource Management in Real-world Studies
Lihan XING ; Yingshuo HUANG ; Yan CUI ; Yue LI ; Xu ZUO ; Shuilong GUO
Chinese Medical Ethics 2022;35(12):1341-1345
Human genetic resources are an important strategic resource for the development of science and technology in China. In order to fully utilize and effectively protect human genetic resources in real-world studies, through analyzing the status and characteristics of real-world studies, this study found that the number of real-world studies was increasing year by year, and with some characteristics, such as many uncontrollable factors, strict requirements for evidence formation, and easy information acquisition and disclosure. Combined with the characteristics of real-world studies, the ethical issues of human genetic resource management in real-world studies were summarized into three aspects, including scientific and value of research development, informed consent and privacy protection of subjects, and fairness and justice in benefit sharing. Accordingly, the key points of ethical review were proposed as scientific rationality, fully informed consent and privacy, as well as data security and stakeholders. In addition, it is necessary to give full play to the role of ethical review in research access and process supervision responsibilities, guide researchers to make full use of human genetic resources by strengthening training and process management, and further promote the standardization of real-world studies.
9.Construction of collaborative development system of medical disciplines with dominant disciplines as the domi -nant disciplines :Taking the department of the digestive medical coordinated development center of Beijing Mu -nicipal Administration of Hospitals as an example
Qiuping LI ; Xiaofeng LI ; Mo LIU ; Huitong ZHAO ; Shuilong GUO
Chinese Journal of Medical Science Research Management 2019;32(4):289-292
Objective Taking the Digestive Medical Coordinated Development Center of Beijing Municipal Administration of Hospitals (hereinafter referred to as the "Digestive Medical Coordinated Development Center") as an example ,this paper aims to ex-plore the idea of building a collaborative development system of medical disciplines dominated by advantageous disciplines .Methods Summarizing the construction experience of the Digestive Medical Coordinated Development Center to illustrate the significance ,identify existed challenges and construction pathways of the center .Results The Digestive Medical Coordinated Development Center has built a series of public service platforms for its member institutions ,and improved the system and incentive mechanism to gather the develop-ment synergy of the center .Conclusions Based on the advantages of the collectivized management of Beijing Municipal Administration of Hospital ,the Digestive Medical Coordinated Development Center advances synchronously in the dimensions of scientific research , medical treatment ,information construction and talent ,as well as formed its own development characteristics and accumulated valuable experience for the construction of discipline collaboration center of municipal hospitals .
10.Gastric cancer related miR-148 a targets gastrin receptor CCKBR
Shuilong GUO ; Shengtao ZHU ; Peng LI ; Yongjun WANG ; Min WANG ; Jie XING ; Qingdong GUO ; Xiumei SUN ; Shutian ZHANG
Chinese Journal of Comparative Medicine 2014;(9):1-4
Objective To investigate the regulation role of gastric cancer related miR-148a on gastrin receptor CCKBR expression, and find the correct binding sites of miR-148a in CCKBR 3’UTR.Methods The potential binding sites of miR-148a in the CCKBR 3’UTR were predicted with the bioinformatic tools;The miR-148a expressing plasmid was constructed by PCR, and miR-148a expression was verified by Northern Blot;The luciferase report plasmids containing the wild type and mutated binding sites of CCKBR 3’ UTR were constructed, and were used to study the regulation mechanism and identify the binding sites of miR-148a by luciferase activity analysis; The regulation effect of miR-148a on CCKBR protein expression was checked by Western Blot.Results Three potential binding sites of miR-148a in the CCKBR 3’ UTR were found; The miR-148a expressing plasmid was constructed successfully, and highly expressed miR-148a after transfected to gastric cancer cells;The inhibitory effect of miR-148a on CCKBR protein expression was checked by Western Blot.Over-expression of miR-148a inhibited CCKBR expression by directly binding to the binding site in CCKBR 3’UTR 423bp.Conclusion CCKBR is a target of miR-148a, and its expression is inhibited by the binding of miR-148a on its 3’ UTR, indicating that miR-148a may participates in the progression of gastric cancer by regulating CCKBR expression.

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