1.Risk identification and intervention efficacy evaluation of hospital-acquired infections in neurosurgery department based on failure mode and effect analysis
Puyu YANG ; Ye QIU ; Ya YANG ; Zhimin WEI ; Jingru ZHAO ; Weiping ZHU ; Yifeng SHEN ; Yuanping WANG
Shanghai Journal of Preventive Medicine 2026;38(2):159-164
ObjectiveTo establish a regional risk assessment system for hospital-acquired infections in neurosurgery department of general hospital, and to evaluate its prevention and control effectiveness. MethodsFailure mode and effect analysis (FMEA) was used to identify the core risk factors for infections in neurosurgery department. The risk priority number (RPN) of each risk factor was calculated to determine the priority intervention targets. Targeted interventions were developed and continuously refined through the plan-do-check-act (PDCA) cycles. Data from January to June 2023 (control group) and July to December 2023 (intervention group) were collected to compare the differences in environmental hygiene monitoring qualification rate, incidence rate of hospital-acquired infections among inpatients, and detection rate of bacterial antimicrobial resistance. ResultsHigh-risk factors for hospital-acquired infections in neurosurgery department included patient-related risk factors, inadequate implementation of isolation measures for special infections, and poor compliance with surgical site infection (SSI) prevention protocols. After intervention, the environmental hygiene qualification rate significantly increased from 81.55% to 100.00% (χ²=120.49, P<0.001). The overall hospital-acquired infection rate among inpatients decreased from 2.62% to 2.45%, the infection rate of per case declined from 3.12% to 2.84%, and the detection rate of multidrug-resistant organism infections reduced from 43.72% to 36.79%. Additionally, antimicrobial utilization rate decreased from 48.75% to 42.53% (χ²=34.09, P<0.001). ConclusionThe FMEA-based risk assessment system can effectively identify critical infection risks in neurosurgery department, and targeted interventions can significantly improve infection prevention and control performance.
2.The mediating effect of psychological resilience between perceived stress and job burnout in standardized gastroenterology nursing training students
Yan FENG ; Ye QIU ; Ping WANG ; Jingru PEI ; Jing CHANG
Chinese Journal of Medical Education Research 2025;24(6):853-857
Objective:To explore the mediating effect of psychological resilience between perceived stress and job burnout among standardized gastroenterology nursing training students.Methods:A total of 156 nursing trainees who received standardized training in the Department of Gastroenterology at Shaanxi Provincial People's Hospital between December 2022 and July 2024 were selected by the convenience sampling method. Data were collected using a general information questionnaire, the Connor-Davidson Resilience Scale, the Chinese Perceived Stress Scale, and the Maslach Burnout Inventory-General Survey. A Pearson correlation analysis was used to examine the relationship among perceived stress, psychological resilience, and job burnout in standardized gastroenterology nursing training students. AMOS 24.0 statistical software was used to construct a structural equation model to analyze the mediating effect of psychological resilience between perceived stress and job burnout in standardized gastroenterology nursing training students. The bias-corrected bootstrap method was applied to test the mediating effect of psychological resilience.Results:The averaged total scores of 156 standardized gastroenterology nursing training students were (29.89±0.30) for perceived pressure, (62.45±2.44) for psychological resilience, and (57.85±3.44) for job burnout. Of the trainees, 88 (56.41%) exhibited job burnout, including 39 (25.00%) with mild burnout, 41 (26.28%) with moderate burnout, and 8 (5.13%) with severe burnout. The Pearson correlation analysis showed that perceived stress was positively correlated with job burnout ( r=0.543, P<0.05) and negatively correlated with psychological resilience ( r=-0.443, P<0.05), and psychological resilience was negatively correlated with job burnout ( r=-0.478, P<0.05). The results of bias-corrected bootstrap test showed that psychological resilience had a partial mediating effect between perceived stress and job burnout among standardized gastroenterology nursing training students ( P<0.05), accounting for 32.63% of the total effect. Conclusions:Moderate job burnout was observed in standardized gastroenterology nursing training students. Job burnout was closely related to perceived stress and psychological resilience. Psychological resilience partly mediated the relationship between perceived stress and job burnout. Therefore, clinical managers may alleviate the perceived psychological pressure and subsequently reduce the occurrence of job burnout among standardized nursing training students by increasing psychological resilience.
3.Olive Intake and Coronary Heart Disease: A Mendelian Randomization Study
Xinyu WU ; Huan CHENG ; Chaguo LI ; Jingru LI ; Luqiao WANG
Cardiology Discovery 2025;05(3):191-201
Objective::This study aimed to explore the causal link between olive intake and the occurrence of coronary heart disease (CHD) using Mendelian randomization (MR).Methods::In this study, genome-wide association study data from IEU OpenGWAS were employed. A 2-sample MR analysis was used to determine the causal association of olive intake with CHD and cardiovascular outcomes (myocardial infarction, heart failure, stroke, and death due to cardiac causes). The data for olive intake included 64,949 samples and 9,851,867 single nucleotide polymorphisms (SNPs), the data for CHD included 361,194 samples and 13,295,130 SNPs; The data for myocardial infarction included 361,194 samples and 12,640,541 SNPs, the heart failure include 208,178 samples and 16,380,422 SNPs, the data for stroke included 361,194 samples and 12,404,026 SNPs, and the data for death due to cardiac causes included 361,194 samples and 10,071,648 SNPs. Additionally, a 2-step, 2-sample MR approach was used for mediation analysis to determine whether lipid traits mediate the causal association between olive intake and CHD. The data for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, apolipoprotein B, and apolipoprotein A1 included 115,078 samples and 12,321,875 SNPs, while the data for triglycerides included 21,545 samples and 11,871,391 SNPs. Cochran’s Q test was applied to examine potential heterogeneity, and the MR-Egger method was used to assess horizontal pleiotropy among SNPs. Leave-one-out analysis was performed as a sensitivity analysis to evaluate the robustness of the results. Results::For each standard deviation increase in olive intake, the risk of CHD decreased by a substantial 1.9% (odds ratio (OR) = 0.981, 95% confidence interval (CI): 0.963 to 0.998, P = 0.031), the risk of myocardial infarction was significantly reduced by 1.6% (OR = 0.984, 95% CI: 0.969 to 0.999, P = 0.032), and the risk of heart failure declined by 62.1% (OR = 0.379, 95% CI: 0.192 to 0.746, P = 0.005). Furthermore, mediation analysis with MR indicated that lipid traits did not mediate the causal relationship between olive intake and CHD. Conclusion::There is a negative correlation between olive intake and the incidence of CHD, and this relationship is not mediated by lipid traits. Olive intake was also negatively associated with some cardiovascular outcomes, suggesting that increasing olive intake holds significant value in preventing the onset and progression of CHD.
4.Huanglian Jiedu Decoction:A traditional Chinese medicine recipe for disrupting platelet-neutrophil cross-talk and regulating inflammatory response
Miao WANG ; Fenglin ZHU ; Jingru CHEN
Chinese Journal of Immunology 2025;41(7):1743-1751
Objective:To investigate the effect and mechanism of Huanglian Jiedu Decoction(HLJDD)on platelet-neutrophil crosstalk in inflammatory response.Methods:The rat model of inflammatory reaction was induced by lipopolysaccharide(LPS),and HLJDD was used to intervene LPS rats.Proinflammatory factors and platelet-neutrophil cross-talk were detected.Immunofluorescence and HE staining were used to observe the platelet-neutrophil adhesion rate in lung tissue and lung histopathology.Transcriptomics was used to explore the potential signaling pathways and targets of HLJDD in platelet-neutrophil crosstalk and verified them.Results:Com-pared with the control group,the white blood cell count,platelet count,plasma TNF-α,IL-1β,SLEP,sC5b-9 and ICAM-1 levels in the model group were significantly increased,and the positive expression rates of CD62p,MPO and CD61+CD62p+MPO coincidence in the lung tissue of the model group were also significantly increased(P<0.001 or P<0.05).The inflammatory injury was severe in the model group.Compared with the model group,the white blood cell count,plasma levels of TNF-α,IL-1β,SLEP,sC5b-9 and ICAM-1 in the HLJDD group were decreased(P<0.001 or P<0.05),the positive expression rates of CD62p and MPO and the coincident posi-tive expression rates of CD61+CD62p+MPO in the lung tissue of the HLJDD group were decreased(P<0.05),and LPS-induced lung tis-sue injury was alleviated.Transcriptomics results showed that high-dose HLJDD could down-regulate differential genes on oxidative phosphorylation pathways.Conclusion:HLJDD ameliorates LPS-induced inflammatory response and reduces platelet-neutrophil cross-talk,which may be related to the down-regulation of oxidative phosphorylation.
5.Two-sample Mendelian randomization analysis of the causal relationship between human immune cell phenotypes and keloids
Wenjun GAN ; Jingru WANG ; Jia HE ; Xiaodong CHEN
Chinese Journal of Burns 2025;41(1):84-93
Objective:To explore the causal relationship between human immune cell phenotypes and keloids.Methods:This study was based on a two-sample Mendelian randomization (MR) analysis. Human immune cell phenotypes were considered as the exposure factors, and keloid was the outcome. Data on immune cell phenotypes (3 757 samples) and keloids (668 samples) were obtained from the genome-wide association study database. Using single nucleotide polymorphisms (SNPs) significantly associated with immune cell phenotypes as instrumental variables with the influence of weak instrumental variables being excluded, two-sample MR analysis was employed to evaluate the causal relationship between 731 human immune cell phenotypes and keloids. The inverse variance weighted (IVW) method was used to infer causal relationships, and the MR-Egger, weighted median, and weighted mode methods were used for validation. For SNPs of immune cell phenotypes meeting the hypothesis, the Cochran Q test was used to assess heterogeneity, and the MR-Egger regression and MR-PRESSO outlier tests were used to evaluate horizontal pleiotropy.Results:A total of 18 204 SNPs meeting the significant threshold ( P<1×10??) were selected as instrumental variables for 731 immune cell phenotypes, and none of these SNPs were weak instrumental variables (with F values all >10). According to the IVW method, 21 immune cell phenotypes were identified with potential causal relationships to keloids, among which the CD62L - monocyte absolute count, CD19 on naive-mature B cell, CD19 on IgD + B cell, CD27 on plasma blast-plasma cell, CD86 on CD62L + myeloid dendritic cell, CD45 on natural killer T cell, CD25 on CD39 + CD4 + regulatory T cell, CD45 on monocytic myeloid-derived suppressor cells, CD8 on effector memory CD8 + T cell, and CD45RA on resting CD4 + regulatory T cell showed significant positive correlations with keloids (with odds ratios of 1.12, 1.09, 1.08, 1.21, 1.13, 1.12, 1.17, 1.11, 1.10, and 1.07, respectively, 95% confidence intervals of 1.03-1.23, 1.02-1.16, 1.01-1.15, 1.06-1.38, 1.02-1.25, 1.01-1.24, 1.03-1.33, 1.00-1.23, 1.00-1.20, and 1.01-1.13, respectively, P<0.05), while the activated and secreted CD4 + regulatory T cell absolute count, CD25 on unswitched memory B cell, plasmacytoid dendritic cell absolute count, CD14 on monocytic myeloid-derived suppressor cells, CD8 on natural killer T cell, CD20 on IgD + CD38 + B cell, CD11c + CD62L - monocyte absolute count, CD66b ++ myeloid cell absolute count, CD11c on granulocytes, CD14 on CD14 + CD16 + monocyte, and CD3 on central memory CD8 + T cell showed significant negative correlations with keloids (with odds ratios of 0.95, 0.93, 0.93, 0.93, 0.91, 0.89, 0.89, 0.88, 0.87, 0.86, and 0.85, respectively, 95% confidence intervals of 0.90-1.00, 0.87-0.99, 0.88-0.99, 0.87-0.99, 0.84-1.00, 0.81-0.98, 0.81-0.98, 0.79-0.99, 0.78-0.96, 0.75-0.99, and 0.74-0.96, respectively, P<0.05). MR-Egger method confirmed the potential causal relationship existing respectively between CD25 on CD39 + CD4 + regulatory T cell, CD86 on CD62L + myeloid dendritic cell, CD19 on IgD + B cell, CD45RA on resting CD4 + regulatory T cell, CD3 on central memory CD8 + T cell and keloids (with odds ratios of 1.32, 1.22, 1.11, 1.09, and 0.73, respectively, 95% confidence intervals of 1.03-1.70, 1.04-1.44, 1.02-1.21, 1.01-1.19, and 0.55-0.95, respectively, P<0.05). The weighted median method confirmed the potential causal relationship existing respectively between CD45 on natural killer T cell, activated and secreted CD4 + regulatory T cells absolute count, CD20 on IgD + CD38 + B cell, CD66b ++ myeloid cell absolute count and keloids (with odds ratios of 1.15, 0.93, 0.87, and 0.83, respectively, 95% confidence intervals of 1.01-1.31, 0.86-1.00, 0.77-0.98, and 0.71-0.96, respectively, P<0.05). Among them, the potential causal relationship between CD20 on IgD + CD38 + B cell and keloids was further verified by the weighted mode method (with odds ratio of 0.86, 95% confidence interval of 0.77-0.97, P<0.05). According to the aforementioned IVW method analysis results, the SNPs associated with the 21 immune cell phenotypes that had a significant causal relationship with keloids showed no significant heterogeneity ( P>0.05) or significant horizontal pleiotropy ( P>0.05). Conclusions:From a genetic perspective, the potential causal relationships between 21 human immune cell phenotypes and keloids have been revealed, of which 10 immune cell phenotypes may be risk factors for keloids, while 11 immune cell phenotypes may act as protective factors for keloids.
6.Influence of human induced pluripotent stem cell derived skin organoid-conditioned culture medium on the function of human dermal fibroblasts induced by high glucose
Zhixin LIU ; Kaizhen QIU ; Jia HE ; Jingru WANG ; Bilai LIU ; Qi XIN ; Guiqiang LI ; Xiaodong CHEN
Chinese Journal of Burns 2025;41(3):286-294
Objective:To explore the influence of human induced pluripotent stem cell (iPSC) derived skin organoid-conditioned culture medium (SO-CM) on the function of human dermal fibroblasts (Fbs) induced by high glucose, with the aim of providing treatment ideas for diabetic wounds.Methods:This study was an experimental research. Human iPSCs were induced into skin organoids. Human iPSC-derived skin organoids and human dermal Fbs were seeded into skin organoid culture medium (SOM) and cultured for three days, respectively. Then the cell culture supernatants were collected as SO-CM and Fb-conditioned culture medium (Fb-CM), respectively. The content of tumor necrosis factor-α (TNF-α), interleukin-10 (IL-10), IL-18, C-C motif chemokine ligand 2 (CCL-2), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), epidermal growth factor (EGF), and VEGF-β in SOM, Fb-CM, and SO-CM was detected by enzyme-linked immunosorbent assay. Human Fbs of passage 8 and 9 induced by high glucose were divided into SOM group, Fb-CM group, and SO-CM group according to the random number table method, and were cultured with SOM, Fb-CM, and SO-CM all containing glucose at final molarity of 35 mmol/L, respectively. After 24 hours of culture, the Ki67 positive ratio of cells was calculated after immunofluorescence staining, and the cell absorbance value was detected by using cell counting kit-8, representing cell proliferation activity. The cell scratch test was performed to calculate the cell migration rate at 13 hours after scratching. After 48 hours of culture, the expression of reactive oxygen species in cells was detected by fluorescent probe method, and the rate of β-galactosidase-positive staining of cells was detected by β-galactosidase staining kit, representing cellular senescence. The sample size was three.Results:There was no statistically significant difference in the content of TNF-α, PDGF, and TGF-β among the three culture media ( P>0.05). Compared with that in SOM, the content of IL-10 and EGF in Fb-CM and SO-CM was significantly decreased ( P<0.05), while the content of CCL-2 in FB-CM and VEGF in SO-CM was significantly increased ( P<0.05). After 24 hours of culture, the Ki67 positive ratio ((45.2±6.0)% and (57.4±4.0)%) and absorbance values (124±5 and 158±12) of cells in the Fb-CM group and the SO-CM group were significantly higher than those in the SOM group ((29.6±2.1)% and 100±6, P<0.05), and the Ki67 positive ratio and absorbance value of cells in the SO-CM group were significantly higher than those in the Fb-CM group ( P<0.05). At 13 hours after scratching, the cell migration rates in the Fb-CM group and the SO-CM group were significantly higher than that in the SOM group ( P<0.05). After 48 hours of culture, the level of reactive oxygen species in the SO-CM group was significantly higher than that in the SOM group and the Fb-CM group (with both P values <0.05). After 48 hours of culture, there was no statistically significant difference in the rate of β-galactosidase-positive staining of cells among the three groups ( P>0.05). Conclusions:The SO-CM has high content of VEGF and can significantly promote the proliferation, migration, and expression of reactive oxygen species in human dermal Fbs induced by high glucose, but has no significant effect on cell senescence.
7.The mediating effect of psychological resilience between perceived stress and job burnout in standardized gastroenterology nursing training students
Yan FENG ; Ye QIU ; Ping WANG ; Jingru PEI ; Jing CHANG
Chinese Journal of Medical Education Research 2025;24(6):853-857
Objective:To explore the mediating effect of psychological resilience between perceived stress and job burnout among standardized gastroenterology nursing training students.Methods:A total of 156 nursing trainees who received standardized training in the Department of Gastroenterology at Shaanxi Provincial People's Hospital between December 2022 and July 2024 were selected by the convenience sampling method. Data were collected using a general information questionnaire, the Connor-Davidson Resilience Scale, the Chinese Perceived Stress Scale, and the Maslach Burnout Inventory-General Survey. A Pearson correlation analysis was used to examine the relationship among perceived stress, psychological resilience, and job burnout in standardized gastroenterology nursing training students. AMOS 24.0 statistical software was used to construct a structural equation model to analyze the mediating effect of psychological resilience between perceived stress and job burnout in standardized gastroenterology nursing training students. The bias-corrected bootstrap method was applied to test the mediating effect of psychological resilience.Results:The averaged total scores of 156 standardized gastroenterology nursing training students were (29.89±0.30) for perceived pressure, (62.45±2.44) for psychological resilience, and (57.85±3.44) for job burnout. Of the trainees, 88 (56.41%) exhibited job burnout, including 39 (25.00%) with mild burnout, 41 (26.28%) with moderate burnout, and 8 (5.13%) with severe burnout. The Pearson correlation analysis showed that perceived stress was positively correlated with job burnout ( r=0.543, P<0.05) and negatively correlated with psychological resilience ( r=-0.443, P<0.05), and psychological resilience was negatively correlated with job burnout ( r=-0.478, P<0.05). The results of bias-corrected bootstrap test showed that psychological resilience had a partial mediating effect between perceived stress and job burnout among standardized gastroenterology nursing training students ( P<0.05), accounting for 32.63% of the total effect. Conclusions:Moderate job burnout was observed in standardized gastroenterology nursing training students. Job burnout was closely related to perceived stress and psychological resilience. Psychological resilience partly mediated the relationship between perceived stress and job burnout. Therefore, clinical managers may alleviate the perceived psychological pressure and subsequently reduce the occurrence of job burnout among standardized nursing training students by increasing psychological resilience.
8.Olive Intake and Coronary Heart Disease: A Mendelian Randomization Study
Xinyu WU ; Huan CHENG ; Chaguo LI ; Jingru LI ; Luqiao WANG
Cardiology Discovery 2025;05(3):191-201
Objective::This study aimed to explore the causal link between olive intake and the occurrence of coronary heart disease (CHD) using Mendelian randomization (MR).Methods::In this study, genome-wide association study data from IEU OpenGWAS were employed. A 2-sample MR analysis was used to determine the causal association of olive intake with CHD and cardiovascular outcomes (myocardial infarction, heart failure, stroke, and death due to cardiac causes). The data for olive intake included 64,949 samples and 9,851,867 single nucleotide polymorphisms (SNPs), the data for CHD included 361,194 samples and 13,295,130 SNPs; The data for myocardial infarction included 361,194 samples and 12,640,541 SNPs, the heart failure include 208,178 samples and 16,380,422 SNPs, the data for stroke included 361,194 samples and 12,404,026 SNPs, and the data for death due to cardiac causes included 361,194 samples and 10,071,648 SNPs. Additionally, a 2-step, 2-sample MR approach was used for mediation analysis to determine whether lipid traits mediate the causal association between olive intake and CHD. The data for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, apolipoprotein B, and apolipoprotein A1 included 115,078 samples and 12,321,875 SNPs, while the data for triglycerides included 21,545 samples and 11,871,391 SNPs. Cochran’s Q test was applied to examine potential heterogeneity, and the MR-Egger method was used to assess horizontal pleiotropy among SNPs. Leave-one-out analysis was performed as a sensitivity analysis to evaluate the robustness of the results. Results::For each standard deviation increase in olive intake, the risk of CHD decreased by a substantial 1.9% (odds ratio (OR) = 0.981, 95% confidence interval (CI): 0.963 to 0.998, P = 0.031), the risk of myocardial infarction was significantly reduced by 1.6% (OR = 0.984, 95% CI: 0.969 to 0.999, P = 0.032), and the risk of heart failure declined by 62.1% (OR = 0.379, 95% CI: 0.192 to 0.746, P = 0.005). Furthermore, mediation analysis with MR indicated that lipid traits did not mediate the causal relationship between olive intake and CHD. Conclusion::There is a negative correlation between olive intake and the incidence of CHD, and this relationship is not mediated by lipid traits. Olive intake was also negatively associated with some cardiovascular outcomes, suggesting that increasing olive intake holds significant value in preventing the onset and progression of CHD.
9.Construction and validation of a prediction model for coronary artery stenosis based on LASSO regression
Yikang XU ; Lei LIU ; Limin LIU ; Jingru MA ; Jiayu WANG ; Jun MA ; Ziyi ZHEN
Journal of China Medical University 2025;54(2):139-143,149
Objective To analyze the risk factors for moderate-to-severe coronary artery stenosis in the population of Tacheng,Xinjiang Uygur Autonomous Region,and to construct and verify a nomogram prediction model for the degree of coronary artery ste-nosis.Methods We retrospectively selected 629 patients who were hospitalized in the Cardiovascular Department of Tacheng Peo-ple's Hospital from January 2021 to June 2023.Using R language software,the sociodemographic data,disease-related data,and va-rious laboratory indicators of the 629 patients were included in the initial screening of risk factors for use in the LASSO regression analysis using a random number table method.The 629 patients were divided into a training group(n=440)and a validation group(n=189)in a 7:3 ratio.Data from the training group were used for model construction,with the degree of coronary artery stenosis as the dependent variable,and the variables selected by LASSO regression as independent variables in the logistic regression model.The validation group was used for model validation.Based on the results of the logistic regression analysis,a visual nomogram for predicting the degree of co-ronary artery stenosis was constructed using R language software.The discriminability,calibration,and clinical utility of the model were evaluated using the area under the receiver operating characteristic curve(AUC),a calibration curve,and decision curve analysis(DCA).Results Age,non-Han ethnicity,hypertension,hyperlipidemia,and a history of cerebrovascular disease were risk factors for mode-rate-to-severe coronary artery stenosis and were included in the risk prediction model.The AUC of the training group and the validation group were 0.905(95%CI:0.790-0.863)and 0.864(95%CI:0.744-0.861),respectively.The predicted values of the calibration curve were consistent with the actual values(Brier scores of the training and validation group:0.03 and 0.14,respectively).The predictive per-formance of the model was good,and the DC A results indicated that the model had net clinical benefits.Conclusion The risk prediction model for coronary artery stenosis in the population of the Tacheng area constructed in this study has good predictive performance and can provide a simple,feasible,economical,and easy-to-promote evaluation tool for medical personnel to screen patients with moderate-to-se-vere coronary artery stenosis.
10.Revision and enlightenment of the 2024 version of the Declaration of Helsinki
Shiyu LIU ; Jingru MA ; Mingxu WANG
Chinese Medical Ethics 2025;38(4):412-419
In October 2024, the 75th World Medical Association General Assembly adopted the tenth revised version of the Declaration of Helsinki. Using textual analysis, this paper systematically compared the changes between the 2024 version and the 2013 version of the Declaration of Helsinki. This study found that, while maintaining the original framework, the new version incorporated the common achievements of the values and civilizational development of human society in recent years, mainly presenting changes in three aspects. First, the core terms were updated, and new concepts such as vulnerability, structural inequality, and environmental sustainability were introduced to further emphasize human dignity, rights and interests, and autonomy in terms of values. Second, the contents of the provisions were refined, especially focusing on the vulnerability of research subjects, free and full informed consent, ethical principles in public health emergencies, and the responsibilities of the ethics committee, as well as the standardization of implementation continued to be improved in the research process. Third, mandatory expressions were strengthened, and the justice of value pursuit was further reinforced in terms of research responsibilities. The revised contents reflected the “human-oriented” fundamental principle in medical research ethics, indicating the direction for future ethical development in medical research. In the future, China should strengthen the construction of ethics committees, actively build a protection system for research participants, and continuously promote international cooperation in medical ethics, to contribute Chinese wisdom to global medical research.

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