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From the perspective of medical institutions, this paper sorted out the background of the promulgation and important changes of Measures for Ethical Review of Life Science and Medical Research Involving Humans, and summarized the changes that may significantly affect the ethical review of medical institutions. It involved terminology changes and expansion of the scope of ethic review, clarification of the responsibilities and independence of the ethics committee, the refinement of the ethical review process, the emphasis on the protection of personal information and the rights and interests of subjects, and first proposal to exempt from ethical review. In addition, based on the concept of strengthening the ethical governance of science and technology in the new version of regulations, this paper shared the consideration on the governance of ethical review within medical institutions, including safeguarding the dignity and rights of subject, clarifying the role and position of ethical review, exempting the implementation of ethical review, and managing entrusted ethical review. With a view to providing a certain reference for the ethics practitioners and researchers in various medical institutions.
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From the perspective of medical institutions, this paper sorted out the contents of Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human regarding "exemption from ethical review". At the same time, combined with domestic and foreign regulations, this paper deeply considered and analyzed the applicable premise and special circumstances of the provisions from the implementation level, and then put forward suggestions from the perspective of practical operation of medical institutions, with a view to providing some practical guidance and reference for ethical practitioners of medical institutions.
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To reduce the burden of researchers, Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human issued in February 2023 proposed that the review could be exempted. Normative exemption from review can not only relieve the burden of researchers, but also reduce the work pressure of the ethics committee, and devote limited time and energy to the review and supervision of high-risk research. This paper analyzed the four criteria for exemption from review first, and then summarized the situation of exemption from ethics review in the International Ethical Guidelines for Health-related Research Involving Humans and in the United States. In view of the fact that there are no relevant regulations on exemption from ethics review, though some medical and health institutions have implemented exemption from ethics review for some studies, the ethics committee often lacks standard operating procedures, corresponding documents, and experience for exemption from ethics review, researchers lack training for exemption from ethics review, and institutions have no supporting measures for exemption from review. To effectively implement the exemption from review, this paper proposed the following suggestions:developing standard operating procedures for exemption from review, and clarifying the review process, which can be simplified to secretary reviews, with senior secretaries or office directors judging whether they meet the exemption criteria, and the chairman reviewing and signing to convey the review decision. Refining the criteria that meet the exemption from ethics review, and providing cases and explanations as necessary, which will help researchers accurately understand the connotation of each criterion, and also provide reference for researchers to make their own preliminary judgments. Strengthening the training of researchers’ exemption from review criteria. The study should obtain the project proposal first, and provide scientific demonstration opinions. To explore the implementation of continuing review, institutions should accelerate the standardized construction of biological sample banks and databases to ensure the provision of compliant sources of biological samples and information data. Exemption from ethics review should not be abused, and the relationship between reducing the burden on researchers and ensuring the quality of ethical review should be balanced.
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Research-oriented hospitals are the currently development direction of large hospitals, and their research ethics management has played an important role in China’s scientific and technological innovation and clinical research development through years of practice. However, at present, China’s overall scientific and technology ethics governance framework system is still incomplete, governance authority is insufficient, ethics committee members lack ethical professional technical training, and the awareness and understanding of science and technology ethics among medical staff still need to be improved, which indicates that the level of technology ethics governance in research-oriented hospitals needs to be improved. It is suggested to improve from the aspects of regulatory system, governance responsibilities, training of ethical practitioners, supervision and punishment measures, and ethical education of scientific and technological research talents, so as to better protect subjects and promote the construction of scientific and technological ethics in the research-oriented hospitals.
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Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain. Extensive clinical trials have both medical and scientific attributes, which are significantly different from registered clinical trials and require special ethical attention. At present, the extended clinical trials in China are still in the initial stage, laws, regulations and supporting management methods are not perfect, and there is a lack of experience in ethical governance of such special clinical trials. This paper took the expanded clinical trial of medical devices as an example, referred to the current laws and regulations at home and abroad, analyzed their characteristics, and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance, the first review approval strategy and the key points in continuing review.
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In recent years, the issue of conflicts of interest in the transformation of scientific and technological achievements in medical institutions in China has become prominent, mainly manifested as personal and institutional conflicts of interest, with the characteristics of complexity and sustainability. At present, there were some problems in the conflict management of scientific and technological achievements transformation of medical institutions, such as insufficient support of relevant laws, regulations and policies, insufficient supervision of medical institutions, and the lack of industry management atmosphere. The author suggestted that government departments should strengthen the formulation of relevant policies and regulations, medical institutions should establish an interest conflict management system and an independent management department, and industry associations should give full play to their role in assisting, so as to provide reference for promoting medical institutions to effectively manage interest conflicts in the transformation of scientific and technological achievements.
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Objective:This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV.Methods:Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020.Results:The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55); and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15); and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits.Conclusion:The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.
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To report a case of fructose-1, 6-bisphosphatase deficiency child with delayed diagnosis for seven years, and review the literature. A 13-year-old boy presented with recurrent episodes of hypoglycemia after infection since 6 years old, he also had convulsion and short stature. The laboratory finding revealed ketotic hypoglycemia, lactic acidosis, transient elevated ALT and UA. The genetic analysis showed compound heterozygous mutations of c. 960-961insG and c. 355G> A in FBP1 gene. Among eighteen patients reported in China, 88.9% had convulsion, 16.7% had growth retardation, the average delayed diagnosis spent 2.8 years, which could result in permanent brain damage and high death risk. The most common mutation was c. 960-961insG, followed by c. 355G>A and c. 490G>A, these mutations maybe hot spot sites of FBPl gene in China.
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Interrupted time-series (ITS) is a quasi-experimental design which evaluates the effectiveness of an intervention based on time-series outcome variables. Compared with the single group of ITS, the two groups of ITS can better control the influence of pre-interventional confounding factors and evaluate the effectiveness of the intervention. This paper summarizes the principles and statistical methods of two groups of ITS by an example of evaluating vaccine effect on the incidence of a disease in two cities. The regression model is fitted by Prais-Winsten method and Newey-West method and the results are explained and compared in detail. When the intervention is performed with other confounding interventions at the same time, the two groups of ITS can be more effective to balance the existing trends before the intervention, and evaluate the effectiveness of intervention. The method of two groups of ITS has important practical significance, providing new insights in program evaluation.
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The laboratories of National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, have developed a series of experimental method . These method have unique advantages over the national standard method and industry standard method . How to make these method become public products through legal procedures to serve disease prevention and control more extensively is an obligatory task for national virological laboratories. This article explores the establishment, verification, validation, and examination of virological non-standard method under laboratory certification and accreditation conditions through empirical research on the " RT-RAA method for detecting EV71/CA16 and other viruses" .
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Objective@#To clarify the potential pathogen for fever of unknown origin (FUO) in serum samples for which pathogenic agents were hardly identified with conventional exainatins.@*Methods@#Random capturing the nucleic acid of pathogen was performed by utilizing the property of sequence non-dependence of next generation sequencing (NGS), followed by enrichment of nucleic acid with multiple displacement amplification (MDA). After sequencing, metagenomic analysis was applied to the raw data and the phylogenetic tree was built to identify the potential pathogen.@*Results@#The result did not indicate common pathogens for FUO but showed the existence of Torque teno Viurs (TTV). Assembly was carried out to all sequencing reads. The coverage of consensus sequence on reference was calculated. Phylogenetic result indicated that all confidence sequences belonged to 3 genera (α TTV, β TTV and γ TTV).@*Conclusions@#The characteristics of genome, phylogenesis of TTV and TTV as signal at immunology level were analyzed and clarified. The possible explanation for detection of TTV in 3 genera may be that TTV itself or non-infectious factors caused the immunosuppression, which finally result e in rise of TTV detection.
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Objective To investigate the effect of the Shaofu zhuyu decoction on the changes of the body writhing behavior,inflammatory reaction and COX-2 expression of the rats with the primary dysmenorrhea. Methods Fifty SD female rats were randomly divided into blank control group,model control group,high,middle and low dose of Shaofu zhuyu decoction groups,10 in each group.Dysmenorrhea rat model was established by treating with estradiol benzoate and oxytocin.Effect of Shaofu zhuyu decoction of different doses on writhing behavior,changes of endometritis cells and COX-2 expression in uterine smooth muscle of dysmenorrhea rats were observed. Results In the model control group,latency of the body writhing behavior was shortened and the total score was high,many inflammatory cells (especially for neutrophils) infiltrated in endometrium and uterine smooth muscle,immunohistochemistry showed that brown granules were found in the cytoplasm of smooth muscle cells of uterus,and COX-2 expression was positive in uterine smooth muscle cells.As compared with the model control group,writhing latency increased,total score decreased in both the high and middle dose of Shaofu zhuyu decoction groups,and infiltration of a small number of inflammatory cells was seen in the endometrium and smooth muscle(P<0.01);COX-2 expression was decreased (P<0.01) especially for the high dose of Shaofu zhuyu decoction group.As compared with the model control group,the latency of the low dose of Shaofu zhuyu decoction group was significantly increased,and the total score was decreased(P<0.01),but there was no significant difference in inflammatory cell infiltration and COX-2 expression (P>0.05). Conclusion A potential mechanism by which Shaofu zhuyu decotion treats primary dysmenorrhea may be related with alleviating pain,inhibiting inflammatory responses,and down-regulating expression of COX-2.