1.Analysis and prevention of ethical issues related to biomedical research in retracted journal articles
Jiamin ZHANG ; Nuoyou CHENG ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2023;36(5):364-368
Objective:To analyze the specific reasons for journal articles being retracted due to biomedical research-related ethical issues after publication and propose corresponding preventive measures.Methods:Journal articles that were retracted between January 1, 2021, and January 1, 2023, were retrieved from PubMed, a literature database in the biomedical field. The retraction statements of those articles that were retracted due to ethical-related issues were analyzed with a summarization of detailed reasons and types.Results:A total of 77 and 128 articles were retracted due to ethical issues in 2021 and 2022 respectively, accounting for 3.9% and 5.4% of all retracted articles in the same period. The major ethical issue was the lack of valid ethical approval. Among articles retracted for ethical issues related to human trials, the proportion of articles retracted due to lack of valid ethical approval increased from 45.9% in 2021 to 57.0% in 2022, which also increased from 50.0% in 2021 to 67.3% in 2022 among retracted articles related to animal experiments. Other ethical issues included problems in the informed consent process, delay in obtaining ethical approval, inconsistency between ethical approvals and the content of the article, and violation of the principles of laboratory animal welfare.Conclusions:The ethical review of medical research involving humans and laboratory animal welfare needs to be strengthened. By promoting the construction of an institutional ethical review system, encouraging researchers to study ethics-related knowledge, standardizing ethical applications and approvals, improving the informed consent process, and attaching importance to the welfare of laboratory animals, the retraction due to ethical issues can be prevented.
2.Research progress of intestinal intervention in patients with neurogenic bowel dysfunction after spinal cord injury
Chunxia WANG ; Xueqiong ZHU ; Yifan ZHAO ; Meiyun ZHANG
Chinese Journal of Practical Nursing 2022;38(28):2229-2233
Neurogenic bowel dysfunction is one of the common complications after spinal cord injury. Long-term constipation and fecal incontinence can cause great troubles in the daily life of patients and seriously affect their quality of life. The key to the solution is effective intestinal intervention, including the establishment of defecation patterns, dietary interventions, and drug interventions, enema, electromagnetic stimulation, and enterostomy, etc. At the same time, a personalized bowel management plan is formulated based on the specific conditions of the patient to better manage the bowel and improve the patient′s quality of life.
3.Problems and countermeasures in the management of scientific research funds
Shuyao MIAO ; Yuan CHEN ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2021;34(1):73-76
Objective:In order to improve the management level of scientific research funds, strengthen the risk prevention and control of scientific research, ensure that scientific research funds are used reasonably and efficiently in compliance with regulatory requirement.Methods:Based on literature review, this article explores the current status and existing problems of scientific research project management from three perspectives: scientific research management systems, principal investigation (PI), and information systems.Taking the construction of the scientific research management work system of the Second Affiliated Hospital of Wenzhou Medical University as an example, discuss measures and countermeasures dealing with existing problems in the management of scientific research funds.Results:The establishment of the scientific research management system to some extent has improved the hospital's scientific research management level and solved the existing problems.Conclusions:Optimization suggestions are provided to further improve the management of funds of scientific research projects.Meanwhile, it provides reference for the management of scientific research funds of other hospitals.
4.Cross-cultural adaptation and reliability and validity of Return-To-Work Scale in the young and middle-age stroke patients
Xueqiong ZHU ; Lihua HUANG ; Yanru CHAI ; Li WANG ; Liliang ZOU ; Daming WANG
Chinese Journal of Practical Nursing 2021;37(30):2353-2359
Objective:To translate the English version and cross-cultural adaptation of Readiness for Return-To-Work Scale (RRTW) into Chinese and tested the reliability and validity of the Chinese version of RRTW in young and middle-aged stroke patients.Methods:RRTW was translated into Chinese with standard translation-retroversion. From August to December 2020, 235 stroke patients in the First Affiliated Hospital, College of Medicine, Zhejiang University were recruited by convenient sampling. The scale was tested by the reliability and validity.Results:The Chinese version of RRTW for stroke was composed of two parts: The first part was divided into four dimensions, with a total of 13 entries; For the unworked stroke population, the second part was divided into two dimensions, with a total of nine entries for the reworked stroke population. The content validity index (CVI) for each item was from 0.875 to 1.000. The total CVI for all items was 0.994. The Pearson correlation coefficient between dimension and scale was from 0.523 to 0.876. Four common factors were obtained from the first part and the cumulative contribution rate was 62.563%. Two common factors were obtained from the second part and the cumulative contribution rate was 49.908%. The Cronbach α coefficient in the first part was 0.760 and in the second part was 0.693.Conclusions:The Chinese version of RRTW for stroke patients has good reliability and validity, which can be used to assess the readiness level of stroke patients to return to work in Chinese society.
5.Current situation analysis of ethical review and implementation of animal welfare about animal experiments in hospitals
Hailing LIU ; Miaomiao YE ; Yuan CHEN ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2020;33(1):64-69
Objective This paper analyzes the situation and problems of animal experiments in hospitals,which including the ethical review,regulatory compliance of animal welfare and animal experimental use,proposing possible measurements for reference.Methods We retrospectively searched Wanfang database,used specific search terms and classification methods to analyze the current situation and problems of ethical review in conducting animal experiment in hospitals.Results In all papers,71 mentioned that the experiment got ethical review approval,accounting for 9.2%;411 mentioned about content of animal welfare,accounting for 53.3%;and 75 referred to the laws and regulations of animal experiments,taking up 9.7%.70 (9.6%) papers focused on both feeding conditions and euthanasia.However,339 (46.4%) papers did not mention any of them.In reference to the approval of animal welfarecommittee,there was a significant difference between funded papers and non-funded papers.In animal welfare,there was no significant difference between papers with funds or not.In the laws and regulations of animal experiment,there were significant differences between state-funded papers and non-state-funded papers.Conclusions So far,when carrying out animal experiments in hospitals,little attention has been paid to the ethical review,so was to the regulatory compliance of animal welfare and animal experimental use.Researchers should constantly strengthen their awareness of animal protection,make sure compliance with the welfare principles of experimental animals,animal protection laws and regulations,and further standardize animal research.
6.Current situation analysis and countermeasures of informed consent and ethical review about clinical trial involving human subject in hospitals
Miaomiao YE ; Hailing LIU ; Yuan CHEN ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2019;32(3):169-175
Objective To explore the current situation of informed consent and ethical review of clinical trial involving human subject in hospitals,and provide related countermeasures.Methods This study searches the website (http://med.wanfangdata.com.cn/Paper),selects "hospital" as the search term,and uses "all fields" as the search criteria.Collected papers were about clinical trial involving human subject that published during Jan.2018 to Feb.2018 in internal medicine,surgery,obstetrics and gynecology,pediatrics.The current situation of informed consent and ethical review of these papers were analyzed from various aspects,including the hospital grades,medical institutions types,clinical research methods,study types,fund projects,periodical category.Results (1) Among 1964 papers,only 538 (27.4%) papers obtained informed consent of subjects and the ethical review approval.(2) There are no significant differences between different hospital grades,and different medical institutions about informed consent and ethical review.(3) Experimental studies focus more on informed consent and ethical review than observational studies.(4) Drug clinical trials focuses more on informed consent and ethical review than non-drug related clinical study.(5) Fund projects focus more on informed consent and ethical review than non-fund pro jects.(6) Papers published in core periodical focus more on informed consent and ethical review than papers published in other periodical.Conclusions Currently,conducting clinical trial involving human subject still does not pay enough attention to the informed consent of subjects and ethical review,more countermeasures are needed to change the current situation and to standardize human clinical trials.
7.Exploration of the ethical review mechanism of serious adverse events in hospital clinical trials
Miaomiao YE ; Yuan CHEN ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2019;32(4):318-321
Objective To continuingly update the ethical review mechanism of Serious Adverse Events (SAE) in hospital clinical trials .Methods The definition of serious adverse events and the status quo of SAE review was analyzed ,considering the standard operating procedures of SAE review in our hospital ,as well as related measurements for improvement .Results At present ,there still exists some disadvantages in the report and ethical review of SAE ,which the ethical review committee should pay more attention .Conclusions It is important that the ethics committee review of SAE happened in clinical trial effec-tively and efficiently ,which helps to maximize the protection of the subject's health and rights .
8.Analyze the reasons for the retraction of journal papers after publishing and take prevent measures
Xiaohui XU ; Yuan CHEN ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2019;32(1):73-77
Objective To analyze the reasons for the retraction of journal papers after publishing,take preventive measures,provide countermeasures for establishing research integrity.Methods Search the PubMed Database (https://www.ncbi.nlm.nih.gov/pubmed/) with search type "Retracted Publication" [Publication Type] OR "Retraction of Publication" [Publication Type],from 2016/01/01 to 2017/06/01,to acquire the retracted publications,and to summarize the reasons for retraction.Results Initially extracted 1 098 results,and ultimately 895 papers were included in the analysis.The reasons for retraction were divided into two categories:unintentional errors and academic misconduct.The main reasons of academic misconduct were fabrication and falsification,accounted for 30.17%,followed by plagiarism,accounted for 20.22%.Conclusions Main reason for the retraction of journal papers was academic misconduct.We can establish scientific integrity through the following ways,such as strengthening the research ethics education and enhancing the awareness of research integrity;improving the scientific evaluation system and creating free atmosphere of scientific research;establishing long-term system of management,supervision and punishment of scientific research;taking rigorous review of manuscripts by editor.
9.The development and improvement of ethical review of multi-center clinical trial
Miaomiao YE ; Yuan CHEN ; Xiaohui XU ; Yuanhai ZHANG ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2018;31(1):69-72
Objective Improve the ethical review models of multi-center clinical trial.Methods Analyze the ethical review models of multi-center clinical trial in China,and summarize advantages and disadvantages of the different methods.Then,clarify the development of ethical review methods of multi-center clinical trial in our hospital.Results Four methods were used to review the multi center clinical trial in China,including independent ethical review,central institutional ethical review,central review made by committee cooperation,collaborative review.Each method has its advantages and disadvantages.Collaborative review about multi-center clinical trial is adopted now in our hospital.Conclusions Using collaborative review model of multi-center clinical trial,the ethical review could achieve timely and uniformly.
10.Analysis of patent application and authorization in a hospital and countermeasures
Miaomiao YE ; Yuan CHEN ; Shengjie ZHU ; Xueqiong ZHU
Chinese Journal of Medical Science Research Management 2018;31(4):274-278
Objective To share the experience of the patent application,authorization,and transfer in a hospital in last five years,this study aims to improve the patent application and authorization in hospitals.Methods Using data from China Patent Infonet and State Intellectual Property Office of People's Republic of China,we searched the patent application and authorization during Jan.2012 to Dec.2016,and included those that patentee was our hospital or the employee of our hospital.Results The number of patent applications was 215,including 151 service intention-creation applications,and 64 non-service intention-creation applications.Patent application and authorization in our hospital have been increasing year by year,covering internal medicine,surgery,obstetrics and gynecology,pediatrics and so forth.Conclusions We accumulated some experience in patent application,authorization and transfer which provide reference for further,more comprehensive and integrated,patent management system.

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