Life science and medical research involving human beings cannot be separated from the support of research participants.The safety,health,and rights and interests of research participants are the primary considerations in clinical research,and their rights and interests include the right of compensation,privacy protection,health and so on.Protecting the compensation rights of research participants is a necessary responsibility of the research-related departments and personnel.Based on laws and regulations and literature review,and combined with practical experience,this paper made an in-depth discussion on compensation rights.It puts forward the types of compensation(conventional compensation,research-related damage compensation),compensation principles(necessity,timeliness,appropriateness,fairness),compensation elements(method,amount,plan,consent,notification,and reference of compensation),compensation under special circumstances(compensation for participants without or with limited informed consent ability and withdraw from the study midway),protection measures of compensation right(sponsor/contract research organizations,research institutions,research management departments,(main)researchers and research teams,ethics(review)committee).The compensation rights should be implemented to protect research participants.

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.

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.

Objective:To investigate the English learning efficacy and autonomous learning proficiency of postgraduates in universities of Traditional Chinese Medicine (TCM), explore whether there is a correlation between English learning efficacy and autonomous learning ability, and to analyze the influence of English learning efficacy on autonomous learning ability.Methods:A questionnaire survey was carried out to assess the levels of English learning efficacy and English autonomous learning in two levels of belief and behavior among 207 postgraduates in TCM universities. Statistical methods such as independent sample t-test, one-way ANOVA, nonparametric Mann-Whitney U-test, and Kruskal Wallis H-test were applied to analyze the data collected in the questionnaire survey. Results:The average score of subjects' English learning efficacy was 2.82 ± 0.60 (1 ≤ ≤ 5), and the average score of subjects' English autonomous learning ability was 3.24 ± 0.53 (1 ≤ ≤ 5). The scores of their autonomous English learning in the level of belief was significantly higher than those of the level of behavior ( t =14.10, P < 0.001). The scores of autonomous learning ability of subjects in Batch 2020 were significantly lower than those in Batch 2021 ( t = 2.64, P = 0.009). Linear correlation analysis showed that there was a moderately positive correlation between English learning efficacy and autonomous learning ability. Conclusion:The English learning efficacy of postgraduates in TCM universities is at the middle-low level and their English autonomous learning ability is at the middle level. Moreover, their English autonomous learning in the level of behavior underperforms the English autonomous learning in the level of belief, and the English autonomous learning ability decreases with the increase of the grades. In addition, the English learning efficacy has a moderate positive influence on autonomous English learning ability.

Objective:To investigate the relationship between cumulative fasting blood glucose(cumFPG)exposure and all-cause mortality.Methods:The prospective cohort study included 56 845 subjects of Kailuan Group who participated in physical examinations from 2006 to 2007, 2008 to 2009, and 2010 to 2011 with complete data and a median of 7.77 years of follow up. The end point event was all-cause mortality. The incidence of all-cause mortality was compared in various groups divided by four quartile of cumFPG. The Cox proportional hazards model and natural spline were used to analyze the effect of cumFPG on all-cause mortality.Results:During the average(7.77±1.05)years of follow-up, the incidence density of all-cause mortality was on the rise with the increase of cumFPG(4.93, 5.87, 8.48, and 14.02 per 1 000 person-years), with statistically significant difference by Log- rank test( P<0.001). Cox proportional hazards model showed that after adjusting for potential confounding factors(age, sex, body mass index, hypertension, baseline fasting plasma glucose), the HR value(95% CI)of all-cause mortality in the fourth quartile group was 1.28(1.15-1.42)compared to the first quartile. When cumFPG increased every standard deviation, the risk of all-cause mortality increased by 17%. Natural spline analysis exhibited a similar J curve relationship between cumFPG and all-cause mortality. Conclusion:High cumFPG is a risk factor of all-cause mortality.

Objective:To explore the application effect of a structured education program in children with asthma and their parents.Methods:Using the convenient sampling method, a total of 102 asthmatic children and their parents who were treated in the outpatient department in the First Affiliated Hospital of Xinxiang Medical University from June 2020 to December 2020 were selected as the control group, and the conventional asthma education program was used for intervention. A total of 102 asthmatic children and their parents who were treated in the outpatient department of the First Affiliated Hospital of Xinxiang Medical University from January to June 2021 were selected as the observation group, and a structured education program was used for intervention. Before the intervention and 6 months after the intervention, the asthma control effect, quality of life and the family self-management ability of patients in the two groups were evaluated by using Children's Asthma Control Test Scale, Asthma Children's Quality of Life Scale and Family Self-Management Scale.Results:After intervention, the overall control rate of asthma in the observation group was 97.06% (99/102) , which was higher than 85.29% (87/102) in the control group, and the difference was statistically significant ( P<0.05) . After the intervention, the scores and total scores of each dimension of Asthma Children's Quality of Life Scale and the scores and total scores of each dimension of Family Self-Management Scale of the observation group were higher than those of the control group, and the differences were statistically significant ( P<0.05) . Conclusions:The application of structured education program in children with asthma and their parents can improve the effect of asthma control, improve quality of life and family self-management ability of children, which is worthy of clinical promotion and application.

Objective To investigate the effect of insulin pump combined with dipeptidyl peptidase-Ⅳ (DPP-Ⅳ) inhibitor on the treatment of newly diagnosed type 2 diabetes mellitus (T2 DM). Methods Totally 51 newly diagnosed patients with T2 DM were randomly divided into experimental group (insulin pump combined with DPP-Ⅳ inhibitor) and control group (insulin pump alone). After 15 days of treatment, the clinical effect was compared between two groups. Results After treatment, the blood sugar related indexes in both groups significantly improved (P ＜ 0. 05), and the blood sugar control of the experimental group was significantly better than that of the control group (P ＜ 0. 05). The pancreatic β cell function index, area under curve of C-peptide and insulin resistance index in the experimental group were significantly better than those in the control group (P ＜0. 05). The dosage of insulin, the ratio of patients with blood sugar reaching the standard completely, the time of blood sugar reaching the standard and the increase value of body mass in the experimental group were significantly better than those in the control group (P ＜ 0. 01). The incidence rate of hypoglycemia was 8. 00％ (2/26) in the experimental group and 12. 00％ (3/25) in the control group, and there was no significant difference between the two groups (P＞ 0. 05). During the treatment, no severe hypoglycemic events and liver and kidney function damage occurred in both groups. Conclusion Insulin pump combined with DPP-Ⅳ inhibitor is effective in the treatment of newly diagnosed T2 DM, which can effectively control blood sugar, reduce insulin resistance and weight gain.

Objective To investigate the effect of insulin pump combined with dipeptidyl peptidase-Ⅳ (DPP-Ⅳ) inhibitor on the treatment of newly diagnosed type 2 diabetes mellitus (T2 DM). Methods Totally 51 newly diagnosed patients with T2 DM were randomly divided into experimental group (insulin pump combined with DPP-Ⅳ inhibitor) and control group (insulin pump alone). After 15 days of treatment, the clinical effect was compared between two groups. Results After treatment, the blood sugar related indexes in both groups significantly improved (P ＜ 0. 05), and the blood sugar control of the experimental group was significantly better than that of the control group (P ＜ 0. 05). The pancreatic β cell function index, area under curve of C-peptide and insulin resistance index in the experimental group were significantly better than those in the control group (P ＜0. 05). The dosage of insulin, the ratio of patients with blood sugar reaching the standard completely, the time of blood sugar reaching the standard and the increase value of body mass in the experimental group were significantly better than those in the control group (P ＜ 0. 01). The incidence rate of hypoglycemia was 8. 00％ (2/26) in the experimental group and 12. 00％ (3/25) in the control group, and there was no significant difference between the two groups (P＞ 0. 05). During the treatment, no severe hypoglycemic events and liver and kidney function damage occurred in both groups. Conclusion Insulin pump combined with DPP-Ⅳ inhibitor is effective in the treatment of newly diagnosed T2 DM, which can effectively control blood sugar, reduce insulin resistance and weight gain.

OBJECTIVE: To determine the incidence and genotypes of glucose-6-phosphate dehydrogenase (G6PD) deficiency in Dongguan region of Guangdong Province and assess the efficacy and feasibility of flow-through hybridization. METHODS: Peripheral blood samples were randomly selected and detected by modified G6PD/6PGD ratio method. Flow-through hybridization was used to detect 14 G6PD mutations among all samples. RESULTS: In total 1005 samples were collected, the detection rate for modified G6PD/6PGD ratio method and flow-through hybridization were 2.79% and 20.90%, respectively. The consistency of the two methods was poor(Kappa=0.187). When c.1311C>T mutation is excluded, the consistency of the two methods was good for males (Kappa=0.952) but still poor for females (Kappa=0.194). The most common mutations were c.1376G>T, c.1388G>A and c.95A>G. No G6PD deficiency was found among those only carrying the c.1311C>T mutation. CONCLUSION Flow-through hybridization can simultaneously detect 14 loci, covering over 90% of common mutations in Chinese population, and can be easily expanded. The routine method may miss many females carrying homozygous, compound heterozygous and heterozygous mutations, but the detection rate for male hemizygous mutation was much higher.
China ; DNA Mutational Analysis ; Female ; Genetic Testing ; Genotype ; Glucosephosphate Dehydrogenase ; genetics ; Glucosephosphate Dehydrogenase Deficiency ; diagnosis ; Humans ; Male ; Mutation

Dyskinesia is one kind of motor complications caused by prolonged administration of levodopa to patients affected by Parkinson's disease. The mechanisms of dyskinesia in Parkinson's disease are still unknown. Recent research suggests the prevalence of dyskinesia mainly depends on genetic factors, levodopa therapy,clinical subtype, body weight and gender. Accumulating evidence indicates that assessment scales, functional magnetic resonance imaging and biomarkers could improve the clinical diagnosis and assessment of dyskinesia. In addition, a number of clinical trials of dyskinesia have indicated that new drugs such as an extended-release formulation of adamantine, and physical therapy such as repetitive transcranial magnetic stimulation are beneficial to the treatment of dyskinesia.