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The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.
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The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.
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Recruitment advertising for clinical trials is a communication carrier of research information prior to participants' participation in the trial, and an important part of the form to recruit and inform subjects. Recruitment advertising should include the necessary information about the clinical trial, but cannot contain the inappropriate content such as those misleading and inducting information, and the content and the modality of advertising must be approved by ethics committee before being used. At present, there are laws and regulations, ethical review, re-searchers' understanding, non-standard operation and other issues in the advertising for recruitment. Therefore, it ' s need to continuously strengthen the ethical review and management of advertising to protect the rights and inter-ests of subjects from the angles of improving relevant laws and regulations, enhancing ethical review ability, raising researchers' awareness and strengthening fighting force on the illegal activities and so on.
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The nanotechnology has been successfully applied in the diagnosis and treatment of diseases and develops rapidly.As a cutting-edge technique,there exist a series of ethical issues when applying nanotechnology in human body,such as risk management,benefit assessment,privacy protection and informed consent.Clinical trials initiated by researchers also face ethical challenges.Therefore,it should study on the ethical issues when using nanotechnology in medicine.To insure the healthy development of nanotechnology in medical application,the regulations and rules should be improved,the assessment of risks and benefits should be strengthened,the ethical review should be reinforced,and the awareness level of the researchers should be enhanced.
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Objective: To evaluate recent prognosis of patients with acute ST elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI), and explore related risk factors.Methods: Clinical data of 168 STEMI patients undergoing primary PCI were retrospectively analyzed.According to occurrence of major adverse cardiovascular events (MACE) within 30d or not, they were divided into poor prognosis group (n=40) and good prognosis group (n=128).Clinical data were compared between two groups.Logistic regression analysis was used to analyze independent risk factors for MACE.Results: Incidence rate of MACE was 23.81% among the 168 STEMI patients.Logistic regression analysis indicated that age (OR=1.326, 95%CI 1.168~1.505), family history of coronary heart disease (OR=1.852, 95%CI 1.369~2.505), number of diseased vessels ≥2 (OR=1.682, 95%CI 1.382~2.047), Killip′s class Ⅲ~Ⅳ (OR=1.693, 95%CI 1.428~2.007) and onset-to-PCI time (OR=1.785, 95%CI 1.425~2.236) were the independent risk factors, P<0.01 all;TIMI grade 3 (OR=0.623, 95%CI 0.518~0.749) and tirofiban application (OR=0.452, 95%CI 0.367~0.557) were independent protective factors for MACE, P<0.01 both.Conclusion: Advanced aged, family history of coronary heart disease, number of diseased vessels ≥2, poor cardiac function and long onset-to-PCI time are independent risk factors, while TIMI grade 3 and tirofiban application are independent protective factors for MACE.
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Objective:To analyze the status of ethical management of biobanks in Shanghai public hospitals. Methods :A questionnaire survey on ethical management of biobanks was conducted in 9 representative ethics com-mittees, which were established in public hospitals with biobanks in Shanghai. Results: The ethics committees in Shanghai public hospitals had paid relatively high attention to ethical review of protocols were related to biobanks. Nonetheless, the ethical supervision and training on biobanks in Shanghai public hospitals should be enhanced. Con-clusion:The unified ethical guideline on biobanks should be developed in Shanghai for strengthening the standard-ized ethical management and ethics training to promote the development and use of biological samples library re-sources.
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The new revision of Declaration of Helsinki in 2013 has adjusted the structure, added or deleted some provisions on the content and modification, and modificated on the details of some words.Revision of the new version has improved the architecture, perfected the content of the declaration, strengthened the protection of the subjects, increased demand for researchers, and cleared the duty of country, research institutions and bidders.The enlighten-ment to our country are:constantly revised involving human clinical trials of the relevant laws and regulations , to pro-tect rights and interests of the subjects;National obligations for protection of the subjects, clinical trials explore the establishment of national compensation system;Ethics committee responsibilities and clearly positioning, exploring to establish an independent ethical review body.
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In China , some ophthalmic new drug clinical trials used placebo as control .Two principles should be con-sidered in ethical review when placebo was used in these ophthalmic new drug clinical trials .Firstly, using placebo couldn't lead to irreversible or permanent vision loss .Secondly , there should be proper risk management in protocol and risk dis-closure in consent process .There are several important factors , including effects of standard treatment , risks of using pla-cebo, risk management in protocol and risk information in informed consent form , which should be used to assess the ra-tionality of placebo in ethical review .
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Objective To understand the status quo of medical graduates' professional faith and to evaluate the education methods. Methods Questionnaire survey combined with expert inter-view were conducted from two aspects: professional faith condition and educational methods. Medical graduates from an affiliated hospital of a university in Shanghai were investigated in this survey and 392 copies of effective questionnaires were analyzed comparatively. Results 92.6%(363/392) students regarded extreme events as the main factor that influence their further employment. 14.8%(58/392) students had career planning. 79.6%(312/392) students achieved self-improvement from strengthening learning and training. Salary was the main factor that affect medical graduates' career choice (4.47 points). 75.5%(296/392) students considered that the existing professional faith education was out of fashion. 85.5%(335/392) of students thought that education methods should be improved. Strengthen-ing relevant education career planning was considered as the most valuable content (4.22 points) and the most effective form was group learning (4.53 points). Conclusions The main reasons for devia-tion and dissatisfaction are:social factor, lack of professional faith, unique status and obsolete way of education. Professional faith education should take the above factors into consideration.
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Using mutation PCR, we cloned the target gene containing 421-480nt (141-160aa) and 598-639nt (200-213aa) of VP1 gene of foot and mouth disease virus (FMDV) into the deleted region (508-532aa) of Nsp2 gene of a highly pathogenic porcine reproductive and respiratory syndrome virus derived vaccine strain (HuN4-F112) that was used as vector. The recombinant cDNA was in vitro transcribed followed by transfection of BHK-21 cells for 36 h. Then, the supernatant of the cell culture was continuously seeded to monolayer of MARC-145 cells for recovery of the recombinant virus. CPE was obviously visible after a couple of passages in the seeded MARC-145, and the rescued virus (designated as rPRRSV-F112-O/VP1ep) was identified by Mlu I digestion, sequencing and immunofluorescence assay. Meanwhile, expression of inserted FMDV epitopes was also detected by indirect immunofluorescence assay with polyclonal antibodies against VP1 protein of FMDV. The analysis of biological characteristics shows that the titer of the rescued recombinant PRRSV (TCID50 = -log10(-6.75)/0.1 mL) was similar to its direct parental virus rHuN4-F112-delta508-532, but higher than rHuN4-F112.
Subject(s)
Animals , Antigens, Viral , Allergy and Immunology , Base Sequence , Capsid Proteins , Allergy and Immunology , Cell Line , Cysteine Endopeptidases , Genetics , Epitopes , Genetics , Foot-and-Mouth Disease , Allergy and Immunology , Foot-and-Mouth Disease Virus , Genetics , Allergy and Immunology , Molecular Sequence Data , Mutation , Porcine respiratory and reproductive syndrome virus , Genetics , Allergy and Immunology , Recombination, Genetic , Swine , Transfection , Vaccines, Attenuated , Genetics , Allergy and Immunology , Viral Envelope Proteins , Genetics , Allergy and Immunology , Viral Vaccines , Genetics , Allergy and ImmunologyABSTRACT
Objective To evaluate the sensitivity and optimized scanning parameter of 64-slice spiral CT in detection of pulmonary nodules with different size and density. Methods Three groups of prosthesis nodules with diameter of 2.5～13 mm and different density (soft-tissue, low density, and ground glass opacity,GGO)were taken into the chest phantom equivalent to human tissue,then scanned with Philips Brilliance 64 scanner in standard dose(tube voltage:120 kV, tube current: 250 mAs)and low-dose(tube voltage:120 kV, tube current: 50, 30,and 21mAs) respectively. The radiation dose(CTDIw and DLP) of the scans, Hounsfield unit(HU) and standard deviation(SD) of CT values in different regions of the phantom, and visibility of the nodules was assessed and recorded.Results The radiation dose of 64-slices spiral CT scanning in low-dose(tube current 21～51 mAs) decreased to 8%～20% of which scanning in standard-dose(250 mAs). There was no statistical difference between the CT values in different regions of the phantom (P>0.05), while the SD of CT values was of statistical significantce (P<0.001) and SD increased with the increment of the density under different scanning parameters. None of the nodules besides of GGO nodules with 2.5 mm and 4 mm in size scanned at 21 mAs was invisible. Conclusion GGO nodules of 2.5 mm in diameter can be detected with 64-slice spiral CT using 30 mAs at experimental study, which might be the optimized dose for detecting pulmonary nodules.
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Objective To detect steroidogenic acute regulatory protein (StAR) expression in apolipoprotein E-deficient mice at different ages and serum lipid levels. Methods Nighty-six C57BL/6J and apoE-/- mice were enrolled, which were divided into 16 groups with 6 mice per group according to age (1 day, 1, 3, 5 months), sex and genotype (C57BL/6J and apoE-/-). The serum lipid levels in C57BL/6J and apoE-/- mice were detected by commercial kits. StAR mRNA and protein expressions in liver were detected by Real-time PCR and Western blot respectively. Results ApoE-/- mice had higher LDL-cholesterol and lower HDL-cholesterol compared with C57BL/6J mice of the same age and sex. StAR mRNA and protein expressions were decreased following with aging in C57BL/6J mice. However, in apoE-/- mice with higher lipid levels, StAR mRNA and protein expressions were changed with the lipid levels other than ages. StAR mRNA and protein increased in the early stage, and then decreased with the increasement of lipids levels. Conclusions StAR could affect lipids levels and may be an effective regulator for atherosclerosis and other cardiovascular diseases.
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Objective To analyze the image noise and artifact of low-dose chest CT scanning and the distribution pattern. Methods A chest phantom equivalent to human tissue was scanned by 64 slices spiral scanner at standard dose (250 mAs) and low-dose (50, 30,and 21 mAs) respectively, HU in sites of the phantom and SD of which was recorded. 200 patients with pulmonary nodules were scanned at 30 or 21 mAs for minimal length. The relationship between severity of noise and artifact in chest low-dose CT scanning and gender or body mass index (BMI) of the patients, as well as the distribution of noise and artifact was evaluated. Results There was no statistical difference between the HU in sites of the phantom: lung (-777.3-- -758.2 HU, F=0.992, P<0.01), chest wall (107.9--111.3 HU, F=2.044, P>0.05), vertebra (835.6--875.3 HU, F=1.453, P>0.05), while the SD of which was of statistical signification: lung (9.5--29.0 HU, F=108.7, P<0.01), chest wall (10.1--32.4 HU, F=84.3, P<0.01), vertebra (19.2--57.1 HU, F=30.6, P<0.01),tbe SD increased with the decrease of the tube current. There was no statistical difference between male (in which 74 cases no or mild, 17 cases severe)and female (81 cases no or mild, and 28 cases severe)in image noise and artifact in low-dose images (X~2=2.294, P>0.05), and significant difference between groups of different BMI(in BMI<18.5 group, 29 cases no or mild,2 cases severe, in group of 18.5≤BMI<24.0, 120 cases no or mild, 13 cases severe, and in group of BMI≥24.0, 6 cases no or mild, 30 cases severe, X~2=128.274, P<0.01). The noise andartifact was greater in the upper (80 cases no or mild, 38 cases severe, X~2=18.918, P<0.01) and dorsal field (89 cases no or mild, 33 cases severe, X~2=6.760, P<0.05). Conclusions The image noise and artifact was significant in low-dose CT, especially in the dorsal and upper field of the lung, which might be attributed to the distribution of skeleton in the chest. It was recommended that scanning protocol (mAs value) be individualized adjusted in according to the patients BMI.
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Objective Analysis of the operational efficiency trends of and problems with the public tertiary hospitals. Methods A retrospective statistics analyzed the indicators of ten public tertiary general hospitals in Shanghai during 1997-2006. Results The outpatients number per capita for the hospital staff maintains an rising trend, averaging 12.2% per year prior to year 2000; The yearly-averaged total assets turnover of the hospitals decreases from 0.89 in 1997 to 0.69 in 2003, then maintaining unchanged; The yearly-averaged receivables turnover began to fall since 1999, falling from 21.4 in 1999 to 9.7 in 2006; hospital income growth fluctuated during the years, yet with a high level of total assets growth; given the fluctuations in asset-liability ratio, such ratio has been growing slowly, maintaining at 20 % since 2004. Conclusion Problems are found with the operational efficiency of these public tertiary general hospitals as follows: the rapid growth of productivity in such hospitals finds no concurrent improvements in assets related indicators. Against a low income ratio, high debt ratio will plague hospital development to some extent.
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The effects of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) on proliferation of bovine coronary artery endothelial cells (BCAEC) and smooth muscle cells (BCASMC) were studied in vitro. BCAEC and BCASMC were isolated and cultured and divided into control group, VEGF (50ng/ml) group and HGF (50ng/ml) group. Cells proliferation was measured using MTT method. The results showed that the OD values of control, VEGF, and HGF group in BCAEC cultures were 0.23?0.02, 0.58?0.10, and 0.42?0.12, respectively, and those in BCASMC were 0.31?0.08, 0.45?0.09, and 0.40?0.11, respectively. The proliferation ratios of BCAEC and BCASMC induced by HGF were 152.2%?33.8% and 45.2%?25.3%, respectively, and that by VEGF were 82.6%?18.7% and 29.0%?20.4%, respectively. The results suggested that HGF could promote proliferation and migration of BCAEC and BCASMC, while VEGF could promote proliferation of BCAEC but not BCASMC. The effect of HGF on BCAEC was stronger than that on BCASMC, and the induction strength of HGF was higher than VEGF.
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This paper is to study the clinical characteristics of Brugada syndrome (BrS) in Chinese by analyzing clinical and ECG data of BrS patients. Data were included by computerized and manual research, and was analyzed by 2 doctors alone. The data of repetition and of non-Chinese were rejected. Forty-nine BrS patients were included (45 males and 4 females). Main manifestations included sudden death in 29 and syncope in 27 patients. Malignant ventricular arrhythmia (MVA) occurred in 14 of 17 patients with family history of sudden death or syncope and in 15 out of 32 ones without family history. Occurrence of MVA in 11 of 14 patients was within the period from 7pm to 7am. ECG revealed that sloped ST segment elevation appeared mainly in V1, V2 leads and coved ST segment elevation appeared mainly in V3 lead. BrS is not rare in Chinese people,and its clinical characteristics is similar to that overseas data.
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This paper investigates 240 cases of medical disputes and interviews involved patients with questionnaires,explores patients′ behaviors,attitudes,and complaints in medical disputes,and analyzes the reasons and motivations for those behaviors and attitudes,in order to provide reference for reduce medical disputes and improve physician-patient relationship.
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Medical students' education of medical ethics is now influenced by many unfavorable factors,such as absence of humanities quality,weakening belief in ideality and shock from the market economy.General education may play an important role in strengthening humanities quality and belief in ideality among medical students,and correcting their cognition of the market economy.Therefore,it is necessary to deepen general education on strengthening medical students' education of medical ethics.
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The effects of hepatocyte growth factor(HGF) on the secretion of vascular endothelial growth factor(VEGF) in cultured bovine coronary artery endothelial cells(BCAEC), bovine coronary artery smooth muscle cells(BCASMC) and mouse cardiomyocytes were observed in vitro . The concentrations of VEGF in BCAEC control and HGF group at 12h were 10.51?2.90pg/ml and 9.31?2.78pg/ml, respectively. The concentrations of VEGF at 12h in BCASMC control and HGF group were 3.35 and 3.93 times of that at 3h respectively, the concentration of VEGF at 3h and 12h in BCASMC HGF group was 2.06 and 2.42 times respectively, of that in control group. The concentrations of VEGF at 12h in cardiomyocyte control and HGF group were 5.43 and 4.09 times, respectively, of that at 3h, and the concentrations of VEGF at 3h and 12h in cardiomyocyte HGF group was 2.74 and 2.06 times, respectively, of that in control group. These results indicated that BCAEC, BCASMC and mouse cardiomyocytes could secrete VEGF, and HGF could promote VEGF secretion in BCASMC and cardiomyocytes, but not in BCAEC.