RÉSUMÉ
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.
RÉSUMÉ
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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Objective To study the clinical effect of Self-made Sanjin-Weiwei decoction for patinets with upper urinary tract calculi after extracorporeal shock wave lithotripsy (ESWL). Methods A total of 200 patients with upper urinary tract calculi after ESWL in our hospital from January 2015 to Octomber 2016 were enrolled in this study. The subjects were divided into the control group (n=100) and the treatment group (n=100) randomly. The control group were treated with conventional treatment after ESWL, and the treatment group were treated with conventional treatment plus the Self-made Sanjin-Weiwei decoction after ESWL,and the two groups were treated for 45 days. The clinical effects of both groups were compared. The first time average row stone time and renal colic average frequency of both groups after treatment was compared. The stone platoon net rate of both groups after 1 month, 2 months, 3 months were compared. The incidence of adverse reactions, like dry mouth, nausea, painful urination, blood in urine, of both groups during the treatment were compared. Results The total effect rate of the treatment group was 86.0%, significantly higher than 62.0% of the control group(χ 2=14.969,P<0.001).The first time average row stone time(4.18 ± 1.30 d vs.7.52 ± 2.08 d,t=13.617)and renal colic average frequency(0.67 ±0.21 vs.1.55 ±0.87,t=9.833)of the treatment group were significantly lower than the control group (P<0.05). The stone platoon net rate of the treatment group after 1 month (93.0% vs.74.0%,χ 2=13.101),2 months(98.0% vs.82.0%,χ 2=14.222),3 months(100.0% vs.84.0%,χ 2=17.391)were significantly higher than the control group (P<0.05). The incidence of adverse reactions (7.0% vs. 15.0%, χ2=4.735)of the treatment group were significantly lower than the control group(P<0.05).Conclusions The Self-made Sanjin-Weiwei decoction for patinets with upper urinary tract calculi after ESWL has a good effect and low incidence of adverse reactions, can reduce the renal colic and improve the stone platoon net rate.
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To explore how to create and optimize a promotion index system of medical quality evaluation, this article focuses on the hospital visiting process from patients, using analyzing collected those index system from couples of Grade Ⅲ hospitals in Beijing, and combining the results of literal study, field study and specialist consult, according to the different situation of general hospitals and specially hospitals, with the spirit of "maintaining the patients benefits, safeguarding the patients safety,and enhancing the medical quality", introduces the framework of the promotion index system, the rules to select the indicator, and so on, and discusses several problerns related to creating the index system.
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Objective To observe the antibacterial activity of artificial antimicrobial peptides (AMPs) to Blastomyces albicans, E. coli and Staphylococcus aureus in oral infection in vitro. Methods The AMPs were dissolved into PBS or sterilized saliva, then the inhibi-tion of different concentration AMPs to E. coil was evaluated by tube testing. The inhibition effect of different concentration of AMPs to Staph-ylococcus aureus and Blastomyces albicans were evaluated by antibiotic-susceptive test paper. Results When the concentration of AMPs added to broth of E. coli is from 150μmol/L to 300μmol/L , the bacterium count is 0 while the number in control is 6700 ～ 9200cfu/ml. At 100μg/tablet AMPs, the diameter of inhibitor zones of Staphylococcus aureus and Blastomyces albicans are 13mm and 11 mm. At 300μg/ tablet, the diameter are 16 mm and 17mm. AMPs dissolved in PBS and saliva have similar antimicrobial activity. Gonclusions The AMPs is effective to prevent Blastomyces albicans, E. coli and Staphylococcus aurcus in oral infection in vitro.