Objective:In order to improve the normativity and integrity of informed consent exemption from ethical review of retrospective clinical trials initiated by investigators in hospital settings, protecting the legitimate rights and interests of research participants, and improving the efficiency of ethical review.Methods:According to the relevant ethical review regulations at all levels and combined with the practical experience of ethical management in the second affiliated hospital of Wenzhou medical university in Zhejiang province, the present research took the primary review of clinical research projects initiated by investigators at the above institution as the research objectives, analyzed the problems existing during the application and ethical review of informed consent exemption, and summarized the construction and implementation effect of the hospital's clinical research ethical management system.Results:Main problems in the application for exemption of informed consent and ethical review were poor understanding of the essence of informed consent, insufficient consideration of privacy protection, the risk of abuse of informed consent exemption and inadequate effort of ethical review. With the aim of improving the standardization of ethical review of exempt consent, it was recommended to clarify the scope of exemption review, formulate strict exemption procedures, and strengthen the ethics training of all relevant personnel.Conclusions:Standardizing the ethical review management of investigator-initiated retrospective clinical trials contributes to protecting the legal rights and interests of research participants, and promoting the high-quality development of the ethical review norms of clinical research.

Upper urinary tract injury is one of the serious complications in patients with neurogenic bladder, which seriously affects the life health and quality of life of patients. Early identification of high-risk patients and active and timely intervention can prevent the occurrence of upper urinary tract injury.In this paper, we reviewed the risk factors and predictive tools of upper urinary tract injury in patients with neurogenic bladder, and introduced and compared the characteristics of different risk prediction tools. The aim is to provide ideas for the construction of a prediction tool with high clinical applicability and prediction accuracy, and provide a basis for the early identification of risk factors of upper urinary tract injury and taking preventive measures.

Objective:In order to improve the normativity and integrity of informed consent exemption from ethical review of retrospective clinical trials initiated by investigators in hospital settings, protecting the legitimate rights and interests of research participants, and improving the efficiency of ethical review.Methods:According to the relevant ethical review regulations at all levels and combined with the practical experience of ethical management in the second affiliated hospital of Wenzhou medical university in Zhejiang province, the present research took the primary review of clinical research projects initiated by investigators at the above institution as the research objectives, analyzed the problems existing during the application and ethical review of informed consent exemption, and summarized the construction and implementation effect of the hospital's clinical research ethical management system.Results:Main problems in the application for exemption of informed consent and ethical review were poor understanding of the essence of informed consent, insufficient consideration of privacy protection, the risk of abuse of informed consent exemption and inadequate effort of ethical review. With the aim of improving the standardization of ethical review of exempt consent, it was recommended to clarify the scope of exemption review, formulate strict exemption procedures, and strengthen the ethics training of all relevant personnel.Conclusions:Standardizing the ethical review management of investigator-initiated retrospective clinical trials contributes to protecting the legal rights and interests of research participants, and promoting the high-quality development of the ethical review norms of clinical research.

Upper urinary tract injury is one of the serious complications in patients with neurogenic bladder, which seriously affects the life health and quality of life of patients. Early identification of high-risk patients and active and timely intervention can prevent the occurrence of upper urinary tract injury.In this paper, we reviewed the risk factors and predictive tools of upper urinary tract injury in patients with neurogenic bladder, and introduced and compared the characteristics of different risk prediction tools. The aim is to provide ideas for the construction of a prediction tool with high clinical applicability and prediction accuracy, and provide a basis for the early identification of risk factors of upper urinary tract injury and taking preventive measures.

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.

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.

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.

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.

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.

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.