中华医学科研管理杂志Pub Date : 2019-06-21DOI: 10.3760/CMA.J.ISSN.1006-1924.2019.03.003
Miaomiao Ye, Hailing Liu, Yuan Chen
{"title":"Current situation analysis and countermeasures of informed consent and ethical review about clinical trial involving human subject in hospitals","authors":"Miaomiao Ye, Hailing Liu, Yuan Chen","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.03.003","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.03.003","url":null,"abstract":"Objective \u0000To explore the current situation of informed consent and ethical review of clinical trial involving human subject in hospitals, and provide related countermeasures. \u0000 \u0000 \u0000Methods \u0000This 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. \u0000 \u0000 \u0000Results \u0000(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 projects. (6) Papers published in core periodical focus more on informed consent and ethical review than papers published in other periodical. \u0000 \u0000 \u0000Conclusions \u0000Currently, 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. \u0000 \u0000 \u0000Key words: \u0000Ethical review; Informed consent of subjects; Biomedical research; Clinical trial involving human subject; Subjects","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"169-175"},"PeriodicalIF":0.0,"publicationDate":"2019-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46455179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Investigation on the status quo of research ability of joint surgeons and analysis of influencing factors","authors":"Jinqing Zhang, Jing Xu, Liang Zhang, Hao Wu, Yixin Zhou","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.03.006","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.03.006","url":null,"abstract":"Objective \u0000To analyze the status quo of joint surgeons′ research level, explore possible influence factors for their research capacity. \u0000 \u0000 \u0000Methods \u0000A total of 140 joint surgeons from third-grade hospital andsecondary hospital in Beijing were selected. The self-rating scale of scientific research was used for evaluation. Subjects were divided into two groups according to the high and low level of scientific research ability. In the middle and low level group, factors including age, working years, job title, education level, training opportunities, team situation, research activity time, hospital level, and job satisfaction were analyzed. \u0000 \u0000 \u0000Results \u0000The total scores of the research subject were distributed from 12 to 115, with a median of 69.5 (40~90). The four dimensions, accounted from low to high were statistical knowledge, software operation, scientific research basis and thesis writing. According to the single factor analysis, age, education level, chance of training, presence or absence of team, time of scientific research activities, hospital level, satisfaction with work were related to the level of scientific research capacity of joint surgeons (P<0.05); multiple regression results shows that the impact level of scientific research, from large to small, is whether there are scientific research teams, job satisfaction, and time for scientific research activities. These three factors can explain the change of scientific research ability by 60.5% (R2=0.605). \u0000 \u0000 \u0000Conclusions \u0000The joint surgeon's research capacity is at a relatively high level, while the statistical knowledge and software operation scores are low, which calls for more study and mastery. Increasing the construction of scientific research teams, improving job satisfaction, and increasing the time for scientific research activities can improve the scientific research capacity. \u0000 \u0000 \u0000Key words: \u0000Joint surgeon; Research ability; Influencing factor","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"183-187"},"PeriodicalIF":0.0,"publicationDate":"2019-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48047312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中华医学科研管理杂志Pub Date : 2019-06-21DOI: 10.3760/CMA.J.ISSN.1006-1924.2019.03.014
Qingxi Huang
{"title":"Design of information management system for scientific research projects based on time management","authors":"Qingxi Huang","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.03.014","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.03.014","url":null,"abstract":"Objective \u0000To develop an information system for time management of scientific research projects and promote efficient time management of scientific research projects. \u0000 \u0000 \u0000Methods \u0000The time management mode of scientific research projects was constructed by using information management system, WBS was used to decompose scientific research tasks, Gantt chart was used to annotate and visually display project time and duration, and the calculation logic and process of project time management were designed. \u0000 \u0000 \u0000Results \u0000The information management process the complicated data and data, reduce the workload of scientific research managers, and improve the management efficiency. \u0000 \u0000 \u0000Conclusions \u0000Time management of scientific research projects is very important for promoting project development and punctual conclusion. The research and development of information management system has broad application prospects. \u0000 \u0000 \u0000Key words: \u0000Medical research management; Information management; Time management; Progress management","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"220-225"},"PeriodicalIF":0.0,"publicationDate":"2019-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49633117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Investigation and analysis of scientific research multidisciplinary team collaboration intention among young researchers in a Grade-A Hospital","authors":"Bi Zhang, Miao Miao, Lingling Yu, Qiang Gao, Huifang Zhang, Pengjun Zhang","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.03.013","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.03.013","url":null,"abstract":"Objective \u0000To understand the intention and needs of young researchers in a Grade-A Hospital to carry out the Multidisciplinary Team (MDT), to provide references for hospital to condense the direction of scientific research, set up Multidisciplinary resear Teams, as well as conduct innovative medical research. \u0000 \u0000 \u0000Methods \u0000A questionnaire survey was conducted among 196 young researchers under 45 years old in Grade-A Hospital, collected data were analyzed statistically. \u0000 \u0000 \u0000Results \u0000The total understanding and comparative understanding of the MDT model among the respondents was 52.05%.The differences in the MDT pattern recognition were statistically significant(P<0.05) in different ages, titles and departments, and nearly 100% of the respondents expressed their willingness to participate in the research MDT.68.37% believed that cooperation should be carried out according to the research direction.56.63% believed that the distribution of results should be based on the uniform norms issued by hospitals, and the allocation plan should be refined according to the project.61.73% believed that a consistent cooperative goal was important to set up MDT, and 46.43% emphasis on the role of academic leader in organizing and leading MDT. \u0000 \u0000 \u0000Conclusions \u0000The enthusiasm of young researchers in a Grade-A Hospital is very high, and there isstrong willingness to cooperate with MDT. Hospitals should bring in more effective organization mode of MDT research collaboration and incentive measures to future condense the direction of scientific research, focus on direction, solve scientific problems in depth, and ultimately promote the substantiality formation of multidisciplinary research collaboration and output. \u0000 \u0000 \u0000Key words: \u0000Medicine; Scientific research; Multidisciplinary team","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"214-219"},"PeriodicalIF":0.0,"publicationDate":"2019-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47286332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中华医学科研管理杂志Pub Date : 2019-04-21DOI: 10.3760/CMA.J.ISSN.1006-1924.2019.02.015
Chongya Dong, L. Yang, Hongbin Han, Xiaoyan Yan, C. Yao
{"title":"Deepen the transparency concept of clinical research and strengthen whole-process supervision and administration of research","authors":"Chongya Dong, L. Yang, Hongbin Han, Xiaoyan Yan, C. Yao","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.02.015","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.02.015","url":null,"abstract":"Objective \u0000To acquire specific suggestions for improving the transparency of clinical research. \u0000 \u0000 \u0000Methods \u0000Summarize main challenges for transparency in clinical research, propose possible solutions. \u0000 \u0000 \u0000Results \u0000Currently the common practice of clinical research transparency is to promote study registration in the beginning phase, and reporting guildlines, data sharing in the end phase of the study. The main challenges identified in clinical research transparency are (1) lacking awareness of transparency among investigators, (2) poor data integrity and traceability of research data resulted by the ignorance of transparency during study implementation process. To face the challenges, investigator should be more proactive and related research administration should be streamlined. \u0000 \u0000 \u0000Conclusions \u0000To improve the transparency of clinical research, better understandings of the concept of clinical research transparency for investigators and whole-process supervision from the administrative aspect should be strengthened. Furthermore, advanced information technology should be adopted to construct a hospital-based source data platform for complete clinical research process management, it helps in promoting research data quality and could become a suitable tool for clinical research administration in hospitals. Ultimately, full research transparency would be achieved. \u0000 \u0000 \u0000Key words: \u0000Clinical research; Transparency; Source data; Process supervision; Traceability","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"146-150"},"PeriodicalIF":0.0,"publicationDate":"2019-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41324946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Analysis and evaluation of peer review results of a fund’s three year research project","authors":"Kangda Yu, X. Zhang, Xu Zhang, Ruimin Guo, Chang Xiao, Wanling Wu, Xiaodi Hao, Qing Shen, Wei Cao, Ruihua Sun","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.02.005","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.02.005","url":null,"abstract":"Objective \u0000Based on the three years’ peer review data of a project fund, the results of fund peer review were analyzed and evaluated, to provide references for further improvement of the peer review and management. \u0000 \u0000 \u0000Methods \u0000Based on the fund′s peer review results of 2145 projects in three years, descriptive statistics, single-item identification index were adopted, as well as RJ normality test, t-test and other statistical methods, to analyze and assess the overall data of fund, project categories, individual scores, etc. \u0000 \u0000 \u0000Results \u0000The score distribution of the three year peer review project of the fund is almost normal distribution, and the overall consistency of peer review shows a better trend. The analysis shows that the peer review experts of the fund have better consistency in terms of project innovation, rationality and characteristics. While there were differences in the peer review of applicability. \u0000 \u0000 \u0000Conclusions \u0000The three year peer review data of the fund show that three years' evaluation results are reliable, reasonable, and the quality of evaluation is good, showing a better development trend in both project quality and expert consistency. \u0000 \u0000 \u0000Key words: \u0000Peer review; Analysis and evaluation; Research project","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"97-100"},"PeriodicalIF":0.0,"publicationDate":"2019-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48016826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中华医学科研管理杂志Pub Date : 2019-04-21DOI: 10.3760/CMA.J.ISSN.1006-1924.2019.02.013
Xiaoqiong Luo, Xitao Ma, Yanqiao Wang, Qing He
{"title":"Investigation on the development and ethical review of experimental animals’ welfare","authors":"Xiaoqiong Luo, Xitao Ma, Yanqiao Wang, Qing He","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.02.013","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.02.013","url":null,"abstract":"Objective \u0000Animal experiment is indispensible for the progress of medicine and medical research. Experimental animals deserve basic respect and care. This paper reviewed the history and status of the experimental animal welfare nationally and internationally to identify the ethical problems existed in animal experiments, and finally discuss the establishing of ethical review system of experimental animals. \u0000 \u0000 \u0000Methods \u0000According to literature review, as well as summarizing the operating practice in the affiliated hospital of Chengdu university of TCM, this study analyzed the problems in the field of experimental animal welfare protection. \u0000 \u0000 \u0000Results \u0000Many countries, such as Britain, Germany and the United States, have legislation on the welfare of experimental animals. There are no such laws in China while departmental regulations has formulated. At present, the weak cognition of bioethics among medical personnel, lack of corresponding certification system, lack of the ethical review system of laboratory animal are still unsolved problems. This paper summarizes the principles of ethical review, the documents of review and the elements of review. \u0000 \u0000 \u0000Conclusions \u0000The protection of experimental animals is a systematic project, and ethical review as the first link of animal experiments can play a good role in promoting animal experiment. \u0000 \u0000 \u0000Key words: \u0000Experimental animal; Welfare; Ethics review","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"139-142"},"PeriodicalIF":0.0,"publicationDate":"2019-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44296186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中华医学科研管理杂志Pub Date : 2019-04-21DOI: 10.3760/CMA.J.ISSN.1006-1924.2019.02.014
Lijue Wang, Huaying Fan, Zhenwei Xie, Hao Wang
{"title":"Strengthening the management of funds to improve the quality of drug clinical trials","authors":"Lijue Wang, Huaying Fan, Zhenwei Xie, Hao Wang","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.02.014","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.02.014","url":null,"abstract":"Objective \u0000The funding management of drug clinical trials is one of the most important step in the management of clinical trials. Strengthening the management of clinical trial funds can improve the efficiency of fund utilization and ensure the smooth implementation of clinical trials. \u0000 \u0000 \u0000Methods \u0000This paper summarizes the problems of clinical trial fund management, proposes some main strategies for fund management based on root cause analysis. \u0000 \u0000 \u0000Results \u0000Through the establishment and improvement of the drug clinical trial fund management system in our hospital, the management of funds is strengthened, the trial carry out more smoothly and the result is more accurate. \u0000 \u0000 \u0000Conclusions \u0000Improving the management system of drug clinical trial funds and standardizing the management of clinical trials is of great significance to ensure the quality of clinical trials. Also it will improve the clinical trial management level of our hospital. \u0000 \u0000 \u0000Key words: \u0000Clinical trial; Fund management; Financial system","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"143-145"},"PeriodicalIF":0.0,"publicationDate":"2019-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44930087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中华医学科研管理杂志Pub Date : 2019-04-21DOI: 10.3760/CMA.J.ISSN.1006-1924.2019.02.006
Xiangsen Li
{"title":"Analyzing the patent applications of top 10 hospitals in China during 2008-2017","authors":"Xiangsen Li","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.02.006","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.02.006","url":null,"abstract":"Objective \u0000Analyzing the patent applications of top 10 hospitals in China during past 10 years, to provide reference for hospital management departments and researchers, propose possible suggestions. \u0000 \u0000 \u0000Methods \u0000Selecting the top 10 hospitals of China, and searching their patent application data during the period of 2008-2017 based on China Intellectual Property Right Net. Analyze the age distribution, patent type distribution, patent effective rate, IPC distribution, as well as the relationship between patents and the CSCD papers. \u0000 \u0000 \u0000Results \u0000The top 10 hospitals have applied 5430 patents in past 10 years, including 2188 inventions, 3197 utility models and 45 design patents. \u0000 \u0000 \u0000Conclusions \u0000Patent applications increased year by year. The main direction of the patents is innovation and improvement to surgical instruments or technology. The level of patents is not high, utility model patent is in the majority. Hospitals need to put equal emphasis on patents and papers. Proposed suggestions including: improving the patent consciousness of medical staff; cooperating with the patent agency; improving the quality of patents on creativity; encouraging staffs to apply invention patent, and increasing the proportion of invention patents when promotion and evaluation. \u0000 \u0000 \u0000Key words: \u0000Top 10 hospitals; Patent; Statistical analysis","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"101-105"},"PeriodicalIF":0.0,"publicationDate":"2019-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43685353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
中华医学科研管理杂志Pub Date : 2019-04-21DOI: 10.3760/CMA.J.ISSN.1006-1924.2019.02.012
Pengjun Zhang, Qiang Gao, B. Peng, Lingling Yu, Miao Miao
{"title":"Research on scientific research integrity cognition of medical scientific research management workers","authors":"Pengjun Zhang, Qiang Gao, B. Peng, Lingling Yu, Miao Miao","doi":"10.3760/CMA.J.ISSN.1006-1924.2019.02.012","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1006-1924.2019.02.012","url":null,"abstract":"Objective \u0000To understand the status quo of scientific research integrity cognition and the satisfaction of scientific research integrity construction among medical research management workers. \u0000 \u0000 \u0000Methods \u0000The questionnaire survey was conducted, 115 management workers for research and education from medical schools, research institutes and hospitals were surveyed, and statistic data analysis was conducted. \u0000 \u0000 \u0000Results \u0000The average score of scientific research management workers' knowledge was (43.09±10.41), and the overall awareness rate was 46.77%; Factors that influencing the cognition of integrity include academic qualifications, professional titles, project hosting or participation, paper publication, paper reviewing, and project/science and technology achievement review experience. The overall satisfaction of the status quo of scientific research integrity construction were 41.65%. Medical research management workers thought that the main factors influencing scientific research integrity in medical field were academic evaluation system (81.74%), social environment (78.26%), personal achievement motivation (76.52%) and self-moral accomplishment (73.04%). \u0000 \u0000 \u0000Conclusions \u0000The cognition level of scientific research integrity of medical scientific research management workers is not enough, and the satisfaction of scientific research integrity construction should be improved. It is suggested to strengthen the training and learning of scientific research integrity knowledge of medical scientific research management workers, and enhance the integrity literacy and concept; departments at all levels working together to strengthen the construction of scientific research integrity, update the academic evaluation mechanism, and cultivate a good cultural atmosphere of scientific research integrity. \u0000 \u0000 \u0000Key words: \u0000Medicine; Scientific research management; Scientific research integrity; Cognition; Satisfaction","PeriodicalId":59555,"journal":{"name":"中华医学科研管理杂志","volume":"32 1","pages":"133-138"},"PeriodicalIF":0.0,"publicationDate":"2019-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42145668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}