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The cognition and attitude of scientific research ethics consciousness affect the willingness and degree of individual researchers to follow research ethics norms. This study investigated the awareness, access and training needs of Chinese medical researchers (n=11 164) on the knowledge of scientific research ethics. The survey found that more than 50.0% of people were aware of the "golden rice incident" and "skull transplantation"; 80.0% of people were knew of Operational Quideline for the Ethic Review of Biomedical Research Involving Human Subject; 90.0% said that "respecting people" and "not harming" were the basic ethical principles, but 42.8% and 75.1% chose "beneficial" and "fair" respectively; more than 60.0% of people have acquired scientific research ethics knowledge through "self-study", "special training organized by units" or "words and deeds taught by mentors or colleagues", but still 30.0% have not participated in scientific research ethics lectures in recent three years; In terms of training needs, more than 50.0% chose "ethical norms for research and application", followed by "frontier ethical issues" (41.0%) and "ethical review" (36.7%). Based on this, this paper puts forward some suggestions to improve the content and form of scientific research ethics education and training in China.
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The construction of the scientific and technological ethics management system is crucial to ensure the healthy development of scientific research, and is also the premise and foundation for the scientific and technological innovation and "double first-class" construction of colleges and universities. This paper through the investigation of college life science and medical research ethics committees’ relevant situation, concentrated on the comparative analysis of the construction of ethics training system to identify problems and shortcomings, combined with the work example of Peking University and the current development trend of life science and medical research, some suggestions, including take advantage of the combination of medical services, teaching and research at universities, were put forward to provide possible reference for further updating of the science and technology ethics management in colleges and universities.
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For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
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@#The World Health Organization (WHO) released the “Global report on hypertension” on September 19, 2023. This report systematically summarizes the prevalence, mortality, diagnosis and treatment of hypertension in various countries, and elucidates the current situation of hypertension management, and gives a series of suggestions on how to manage hypertension, providing new thinking and inspiration for countries to optimize hypertension management. Through the summary of relevant studies and reports, this paper further reviews the present situation, early identification and management of hypertension.
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Anti neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) is a systemic disease characterized by small vessel wall inflammation and cellulose necrosis mediated by ANCA. Renal injury caused by AAV is called ANCA-associated glomerulonephritis (AAGN). The paper reported a case of AAV with renal damage combined with human immunodeficiency virus (HIV) infection. The patient was an elderly male with clinical manifestations of hematuria and uremia. Renal pathological examination showed AAV and renal injury. This case is the first report in China while reviewing the relevant literature, and it is still inconclusive whether this is an overlap of the two diseases or a specific pathological type of HIV-associated nephritis. We believe that AAV has the potential to occur in HIV-infected patients, so clinicians should not ignore the phenomenon of ANCA positivity in HIV-infected patients, and the follow-up of such patients needs to be enhanced. Clinical and renal pathological examinations are the main methods to diagnose HIV infection with AAV. At the same time, there are no clear guideline guidelines on how to administer immunosuppressive therapy for such patients who have immunodeficiency and are at higher risk of opportunistic infections, and in whom to make the best possible outcomes.
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@#The Chinese Guidelines on Diagnosis and Management of Atrial Fibrillation, jointly formulated by the Chinese Society of Cardiology, Chinese Medical Association and the Heart Rhythm Committee of Chinese Society of Biomedical Engineering, was first released on June 15, 2023. The guidelines elaborate the various aspects of atrial fibrillation management, in which emergency management of atrial fibrillation is also an integral part. This article interpreted the emergency management part in the guidelines in detail by reviewing relevant literature.
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【Objective】 To investigate the changes in complement content in component blood before blood transfusion. 【Methods】 180 samples from 20 plasma donors were collected at different stages of the preparation process, stored at different temperatures and time periods, and tested in the same batch to observe the changes in complement C3 and C4 levels under different storage temperatures and process stages. 【Results】 The same sample was used to test C3 and C4 levels, and the test results were sorted into nine groups for comparison according to different storage temperatures and preparation process stages. C3: 0.994 1; C4: 0.957 1, with no significant difference in storage at -40℃ and -60℃(P>0.05); C3: 0.133 3, 0.224 06(P>0.05); C4: 0.027 3, 0.025 1(P<0.05), storing at 4℃ for 7 days may significantly reduce complement levels, which needs further verification; C3: 0.047 0, 0.038 3; C4: 0.042 6, 0.012 1(P<0.05), virus inactivation preparation process can significantly reduce complement levels, repeated freeze-thawing during frozen plasma processing can change complement levels. The correlation analysis of C3 and C4 content determination experiment shows that they are significantly positively correlated under different storage temperature, preparation process and storage time(P<0.05). 【Conclusion】 Storage temperature, storage time, preparation process of frozen plasma such as repeated freeze-thawing, centrifugal concentration and light inactivation have an impact on complement content.
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OBJECTIVE To explore the role and underlying mechanism of tournefolic acid B （TAB） on the improvement of glucose metabolism and renal function in diabetic nephropathy （DN） model mice. METHODS DN model mice were established by high-fat diet combined with streptozotocin， and then randomly divided into model group， positive control group （vitamin E， 20 mg/kg）， TAB low-dose， medium-dose and high-dose groups （1， 2， 4 mg/kg）， with 12 mice in each group； normal control group was given regular diet. Each group was given relevant medicine or normal saline intragastrically， once a day， for 4 consecutive weeks. The glucose metabolic function was estimated by fasting blood glucose， glucose tolerance test， insulin tolerance test and serum insulin concentration. The renal coefficients and biochemical indicators related to renal function [serum uric acid， blood urea nitrogen， creatinine levels， and ratio of urine microalbumin to creatinine] were detected in mice； the contents of biochemical indicators related to oxidative stress [superoxide dismutase （SOD）， glutathione peroxidase （GSH-Px）， malondialdehyde （MDA）， 8-hydroxydeoxyguanosine （8-OHdG）] were determined in renal tissue of mice； the pathological morphology of renal tissue was observed； the expressions of extracellular matrix （ECM） deposition related factors [transforming growth factor β1 （TGF- β1）， fibronectin （Fn）， type Ⅳ collagen （Col Ⅳ）] and protein kinase B （Akt）/nuclear factor erythroid 2-related factor 2 （Nrf2）/heme oxygenase-1 （HO-1） pathway related proteins were determined in renal tissue of mice. RESULTS Compared with normal control group， fasting blood glucose， area under glucose tolerance curve， area under insulin tolerance curve， serum insulin content， the levels of uric acid， urea nitrogen and creatinine @qq.com and ratio of urinary microalbumin to creatinine in serum， the contents of MDA and 8-OHdG and the protein expressions of TGF-β1， Fn and Col Ⅳ were increased significantly in model group （P＜0.05）， while the contents of SOD， GSH-Px and the protein expressions of p-Akt， Nrf2， HO-1 in renal tissue were decreased significantly （P＜0.05）； the significant thickening of the basement membrane， accumulation of mesangial matrix， glomerulosclerosis and interstitial fibrosis of the renal tubules were all found. Compared with model group， above indexes of mice were all reversed significantly in TAB groups （P＜0.05）， and pathological changes were alleviated in a dose-dependent manner. CONCLUSIONS TAB can improve blood glucose metabolism and kidney function and alleviate renal tubulointerstitial fibrosis in DN model mice， the mechanism of which may be associated with activating the Akt/Nrf2/HO-1 signaling pathway and suppressing ECM deposition.
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Objective:To sort out the new requirements for the initial ethical review application materials put forward by the Measures for the Ethical Review of Life Science and Medical Research Involving Humans that issued in 2023, to explore the ethical considerations behind these new requirements, and to put forward feasible suggestions on the key details and practical operations that should be paid attention to in the preparation of various initial ethical review application materials, so as to provide a certain reference for researchers, ethical review committees and institutions to standardize and promote ethical review.Methods:Compared with the relevant provisions of the 2016 Measures for the Ethical Review of Biomedical Research Involving Humans, this paper discusses the frontier hotspots of ethical theory and the practice of ethical review.Results:The preparation of application materials for initial ethical review should be based on an accurate understanding of the Measures, emphasize compliance, and avoid formally implementing regulatory requirements and increasing unnecessary burdens.Conclusions:It is the responsibility of researchers to prepare high-quality ethical review application materials, but institutions and ethical review committees must provide corresponding support, including clarifying the latest requirements of policies and regulations, updating the standard operating procedures of ethical review of their institutions, and ensuring timely and continuous ethical training and ethics consultation for researchers. The standardization and improvement of ethical review work requires a more comprehensive perspective and systematic planning to strengthen the responsibility of all parties.
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Objective:This study aims to critically assess the 2023 updates in the governance of Conflicts of Interests (COIs) as outlined in the Ethical Review Measures for Life Sciences and Medical Research Involving Human Beings. It seeks to delve into the ethical implications of these new mandates and offers concrete strategies for effectively integrating them into ethics review practices.Methods:We conducted a comparative analysis of the COIs-related provisions in the 2016 Ethical Review Measures for Biomedical Research Involving Humans, examining them alongside current trends and challenges in COIs governance and ethics review practices.Results:The study identified key challenges posed by COIs to medical research ethics and addresses three principal areas for normative application: the declaration process for conflicts of interest, enhancing the COIs management framework, and the critical review points for COIs by ethics committees.Conclusions:In light of the international consensus on COIs governance, we advocate for the advancement of conflict of interest management at the institutional level. This includes a focus on informed consent processes, the development of robust systems within medical institutions, and the facilitation of ethical corporate collaborations.
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Objective:To investigate the clinical features and risk factors of infection in patients with heat stroke (HS).Methods:The patients with HS who were admitted to the emergency departments of seven hospitals, including West China Hospital of Sichuan University, the Second Affiliated Hospital of Chengdu Medical College and so on, between July 01, 2020 and September 30, 2022 were retrospectively analyzed. The basic characteristics and laboratory test results of the patients were collected. The patients were divided into infected group and non-infected group according to the etiological results, and the differences in clinical characteristics between the different groups were compared. Multivariate logistic regression was used to screen variables, and the predictive model was established and ROC curve was performed to compare the predictive efficiency with SOFA score.Results:During the study period, a total of 183 patients with HS were included, and 156 patients were finally included for analysis according to the inclusion and exclusion criteria. Among them, 58 cases (37.2%) were in the infected group. The mortality of infected group was significantly higher than that of non-infected group (41.4% vs. 25.5%, P < 0.05). Compared with the patients in non-infected group, the infected gourp serum procalcitonin, direct bilirubin, alanine transaminase (ALT), creatinine, lactate dehydrogenase (LDH), creatine kinase isoenzymes, myoglobin, activated partial thromboplastin time (APTT) and respiratory support ratio at admission were significantly higher and albumin level was lower in infected group (all P < 0.05). Multivariate logistic regression analysis showed that myoglobin, ALT, APTT and respiratory support required at admission were independent risk factors for HS co-infection. A prediction model was constructed based on these four indicators, and the area under ROC curve of the prediction model was 0.846, which was better than SOFA score (0.732, P < 0.05). Conclusions:The prognosis of patients with heat stroke complicated with infection were obviously poor. Myoglobin, ALT, APTT and need for respiratory support at admission are risk factors for HS complicated with infection. The prediction model based on these four indicators is better than SOFA score for the early identification of the HS patients with infection.
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Objectives: To assess the extent of the readiness for hospital discharge and the correlation with discharge teaching quality among parents of premature infants' in the NICU. Background: Low readiness for discharge from the hospital can lead to negative outcomes in healthcare for infants born prematurely and their parents. Discharge guidelines are a basic approach to ensure the readiness of the parents for discharge from the hospital. No investigation has ever been conducted into the sufficiency of hospital discharge guidelines for premature infants and their impact on parental readiness for hospital discharge. Design: Data was collected from four hospitals in China using a correlational descriptive study. Methods: Two hundred and eight parents of premature NICU-hospitalized infants of four tertiary hospitals in Henan Province from May to October 2020 were enrolled. The general information questionnaire, the readiness for hospital discharge scale- (RHDS-) parent form, and the quality of discharge teaching scale- (QDTS-) parent form were used for data collection. Spearman correlation analysis and descriptive statistics were used to analyze the data. Results: The total score for hospital discharge readiness was high (8.05 ± 1.11). The total score of the quality of discharge guidelines was moderate (7.44 ± 1.44). Moreover, the discharge teaching quality was positively correlated with the parents' readiness. Positive correlations were found between PRHDS and QDTS subscales, including content received and delivery, physical-emotional status, knowledge, and expected support. Conclusion: The quality of the discharge guidelines perceived by parents of premature infants was moderate, which may have reduced their readiness for hospital discharge. Relevance to Clinical Practice. This study furnishes basic information on the importance of readiness of discharge for the parents of premature infants. The teaching guides nurses to enhance the quality of discharge teaching and the readiness of parents for discharge from the hospital.
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Background: The aim of the study was to examine the clinical incidence rate of vertebral body fractures after percutaneous vertebroplasty (PVP) with and without brace wearing and provide a new guiding ideology for preventing vertebral fractures after clinical surgeries. Methods: The retrospective analysis included 100 outpatients who underwent PVP between January 2017 and December 2018 without bracing after PVP surgeries (non-brace-wearing group). In total, 100 patients were paired into the rigid brace group and 100 patients were paired into the soft braces group according to propensity score matching. Seven independent variables were used in the soft and rigid brace group: age, sex, body mass index (BMI), visual analog scale (VAS), Oswestry Disability Index (ODI), and Cobb angle. The VAS, ODI, and Japanese Orthopaedic Association (JOA) scores were recorded preoperatively on the second day, after 1 month, after 3 months, and during the last follow-up postoperatively. We recorded the incidence of vertebral refracture in each of the three groups of patients and evaluated the effect of braces on postoperative fractures based on the ODI, VAS, and JOA scores. Results: All patients were followed up for 8-24 months (mean 22.4 months). Compared with the preoperative values, the age, sex, BMI, bone density, ODI, VAS, and Cobb angle between refracture and non-refracture were not statistically significant. The VAS, ODI, and JOA scores significantly increased in the brace-wearing group compared with those of the non-brace-wearing group (p < 0.05). The incidence of vertebral refracture in the brace-wearing group was lower than that in the non-brace-wearing group, between which there was a significant difference (p < 0.05). Three months postoperatively, the JOA score of the soft brace group was significantly higher than that of the rigid brace group (p < 0.05). During the last follow-up, it was found that there was no difference in the VAS score, the incidence of refracture, or ODI between the soft brace group and the rigid brace group (p > 0.05). The improvement in the JOA score of the soft brace group was better than that of the rigid brace group, between which there was a significant difference (p < 0.05). Conclusion: Braces can improve the prognosis of quality of life and postoperative subjective perception, whose presence can relieve postoperative residual pains. In contrast, patients can have a better medical experience wearing a soft brace.
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The cognition and attitude of scientific research ethics consciousness affect the willingness and degree of individual researchers to follow research ethics norms. This study investigated the awareness, access and training needs of Chinese medical researchers (n=11 164) on the knowledge of scientific research ethics. The survey found that more than 50.0% of people were aware of the "golden rice incident" and "skull transplantation"; 80.0% of people were knew of Operational Quideline for the Ethic Review of Biomedical Research Involving Human Subject; 90.0% said that "respecting people" and "not harming" were the basic ethical principles, but 42.8% and 75.1% chose "beneficial" and "fair" respectively; more than 60.0% of people have acquired scientific research ethics knowledge through "self-study", "special training organized by units" or "words and deeds taught by mentors or colleagues", but still 30.0% have not participated in scientific research ethics lectures in recent three years; In terms of training needs, more than 50.0% chose "ethical norms for research and application", followed by "frontier ethical issues" (41.0%) and "ethical review" (36.7%). Based on this, this paper puts forward some suggestions to improve the content and form of scientific research ethics education and training in China.
ABSTRACT
The construction of the scientific and technological ethics management system is crucial to ensure the healthy development of scientific research, and is also the premise and foundation for the scientific and technological innovation and "double first-class" construction of colleges and universities. This paper through the investigation of college life science and medical research ethics committees’ relevant situation, concentrated on the comparative analysis of the construction of ethics training system to identify problems and shortcomings, combined with the work example of Peking University and the current development trend of life science and medical research, some suggestions, including take advantage of the combination of medical services, teaching and research at universities, were put forward to provide possible reference for further updating of the science and technology ethics management in colleges and universities.
ABSTRACT
For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
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Objective:To investigate the influencing factors of goiter in school-age children aged 8 to 10 in non-high iodine areas of Shijiazhuang City.Methods:In April 2018, 9 non-high iodine counties (cities) were selected as monitoring sites in Shijiazhuang City, and capacity proportional probability sampling (PPS) method was used. Each monitoring site was divided into five sampling areas according to five orientations: east, west, south, north, and middle, one township was selected from each area, one elementary school was selected from each township, and 40 school-age children aged 8 to 10 (balanced age, half males and half females) were selected from each school as respondents. Urine samples from any one time of children and drinking water samples from their village were collected, and urinary iodine and water iodine were detected by arsenic cerium catalytic spectrophotometry; the thyroid volume of children was measured by B ultrasound method; at the same time, the height and weight of children were measured and the body mass index was calculated. The influencing factors of goiter were analyzed by logistic regression analysis.Results:A total of 1 867 urine samples of school-age children were collected, and the median urinary iodine was 190.65 μg/L, which was in the suitable level of iodine. A total of 1 046 drinking water samples were collected, water iodine ranged from 0.11 to 87.91 μg/L, and the median water iodine was 3.01 μg/L. A total of 1 867 school-age children were tested thyroid, the median thyroid volume was 3.01 ml. The medians thyroid volume of boys and girls (928 and 939 cases) were 2.90 and 3.13 ml, respectively, the difference was statistically significant between sex ( U = 2.09, P < 0.05); the medians thyroid volume of children aged 8, 9, and 10 years old (622, 629, 616 cases) were 2.47, 2.87, and 3.13 ml, respectively, the differences were statistically significant among ages ( H = 203.96, P < 0.01); the medians thyroid volume of normal, overweight and obese children (1 231, 300, 336 cases) were 2.61, 3.05 and 3.16 ml, respectively, the differences were statistically significant among body mass index ( H = 65.55, P < 0.01). The results of multifactorial logistic regression analysis showed that female and obesity were risk factors of goiter in school-age children [odds ratio ( OR) = 2.08, 2.86, 95% confidence interval ( CI): 1.05 - 4.12, 1.39 - 5.88, P < 0.05]. Conclusion:Female and obesity are risk factors of goiter in school-age children aged 8 to 10 in non-high iodine areas of Shijiazhuang City.
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Objective:To explore the risk factors of recurrence after laparoscopic myomectomy and provide references for clinical prevention and treatment.Methods:The clinical data of 216 patients who underwent laparoscopic myomectomy in Ningjin County People′s Hospital from June 2016 to December 2018 were analyzed retrospectively. The recurrence rate at 12 months after the operation was followed up, and the risk factors influencing the recurrence after laparoscopic myomectomy were screened by univariate analysis and multivariate Logistic regression model.Results:After followed up for 12 months after the operation, 24 cases had recurrence, with a recurrence rate of 11.11%(24/216). Univariate analysis showed that the recurrence after laparoscopic myomectomy was significantly correlated with surgical age, age at menarche, number of fibroids, uterine size, and gonadrotropin releasing hormone agonist (GnRH-a) treatment after the operation ( P<0.05), but was not significantly correlated with body mass index, fibroid size, fibroid type, and pregnancy after the operation ( P>0.05). Multivariate Logistic regression analysis showed that surgical age ≥ 35 years old ( OR=1.289, 95% CI 1.013-1.641), age at menarche <13 years old ( OR=1.765, 95% CI 1.167 - 2.669), and number of fibroids ≥ 2 ( OR=2.487, 95% CI 1.442 - 4.288) were independent risk factors for recurrence after laparoscopic myomectomy ( P<0.05), while GnRH-a treatment after the operation ( OR = 0.696, 95% CI 0.510-0.951) was its protective factor ( P<0.05). Receiver operating characteristic (ROC) curve analysis showed that the area under the curve of surgical age ≥ 35 years old, menarche age <13 years old, and number of fibroids ≥ 2 for predicting recurrence after laparoscopic myomectomy was 0.641 (95% CI 0.573 - 0.705), 0.719 (95% CI 0.654 - 0.778) and 0.622 (95% CI 0.554 - 0.687), and age at menarche had the greatest diagnostic efficiency. Conclusions:Surgical age ≥ 35 years old, age at menarche <13 years old, and number of fibroids ≥ 2 are independent risk factors for recurrence after laparoscopic myomectomy. Intraoperative ultrasound and postoperative GnRH-a treatment can help reduce the risk of postoperative recurrence.
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Objective:Conduct comprehensive analysis of the regulatory requirement of ethical review regarding to the response of public health emergency, illustrate particular ethical review and ethical administration strategies for COVID-19 Emergency Research.Methods:Theoretical discussion, case study and interpretation of international guidelines were adopted to explore challenges and possible best practices for ethical review of such research.Results:The ethical review of COVID-19 emergency research should comply with regulatory requirement in general, combined with contextual background.Conclusions:The ethical review approval criteria of COVID-19 emergency research should take into full consideration of its urgency to make sure efficient and high quality initial review, meanwhile, more attention should be paid on continuing ethical review and ethical consultation during the whole life-circle of COVID-19 Emergency Research.
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Objective@#Conduct comprehensive analysis of the regulatory requirement of ethical review regarding to the response of public health emergency, illustrate particular ethical review and ethical administration strategies for COVID-19 Emergency Research.@*Methods@#Theoretical discussion, case study and interpretation of international guidelines were adopted to explore challenges and possible best practices for ethical review of such research.@*Results@#The ethical review of COVID-19 emergency research should comply with regulatory requirement in general, combined with contextual background.@*Conclusions@#The ethical review approval criteria of COVID-19 emergency research should take into full consideration of its urgency to make sure efficient and high quality initial review, meanwhile, more attention should be paid on continuing ethical review and ethical consultation during the whole life-circle of COVID-19 Emergency Research.