The use of human biological specimen has great significance to the development of biomedicine. Meanwhile, the powerful electronic data set with sophisticated analytic techniques creates challenge to the protec-tion of private information. As for the research with human biological specimen, how to facilitate the research con-duct on the basis of ethical principles is one of the key considerations when the US Department of Health and Hu-man Service initiated the revision of Code of Federal Regulations ( CFR) -theCommon Rule for subject protec-tion. The Notice of Proposed Rulemaking ( NPRM) proposed:Respect for autonomy will be enforced by broad con-sent to enforce and waiver of consent intend to be rare;If the research risks only involve privacy protection, review process will be simplified under the premise of ensuring the implementation of privacy laws and other protective measures. The paper introduced the revisions related to the researches using human biological specimen in NPRM, analyzed the terms of broad consent, exemption and exclusion, and explored the elicitation to ethical review prac-tice in China.

Bias in undoubled blind design in the clinical trial of Chinese herb affects the evaluation of efficacy and safety. With two examples, the paper recommended a "segregation" technique to minimize the bias in investigators during undoubled blind trial. The results showed that this method combined other strict means can achieve the conclusions the same as a double blind trial.

Objective: To explore the operating procedure for designing the randomized scheme of multi-center clinical trial. Methods: SAS randomized program was written in accordance with the randomized parameters and stipulated randomized rules of centers, cases and blocks. The design of the SAS randomized program adopts the same seed in multi-hierarchical factors, and the principles of succession and repeatability of the randomized code. Results: This program can produce randomized numbers and complete the design and permutation of randomized codes in a standard and convenient way.

0.05).No adverse reactions were found during the clinical trial. Conclusion Yinhua Jiedu Granule is effective and safe in treating wind-heat syndrome of upper respiratory infection and influenza.

AIM:To research the absorption mechanism of aesculin across Caco-2 monolayer model.METHODS:The Caco-2 cell monolayers drug transport model was assigned to study the double transport mechanism of aesculin to explore the absorption of aesculin according as time and drug concentration determined through HPLC and the P_ app was calcalated.RESULTS:In the Caco-2 monolayer model,the transport of aesculin form Apical to Basolateral was similar to the transport form basolateral to apical.CONCLUSION:The main mechanism of the aesculin intestinal absorption in the Caco-2 monolayer model is passive transference.

It's a hard but imperative research subject for postgraduate to study medical English in TCM colleges.For more than 3 years,Nanjing University of TCM has obtained good effect in such a field and their practices include adopting original edition of textbooks,selecting medical professionals who are good at English as teachers rather than English teachers who have some medical knowledge.Our teaching methodology is continuous,large volume fast reading.

Kidney transplantation is a high-cost and high-risk surgery,thus genuine informed consent from the patients and their family members is indispensable both for protecting rights of patients and ensuring medical safety.Guided by related regulations and ethical guidelines,this paper proposes necessary information which should be provided for patients,one example of Informed Consent Form(ICF) composing of information sheet,and consent signature form offered for reference.The proposed ICF applies three accepted requirements for informed consent,i.e.,completely being informed,fully understood and free to make choice.

Intravenous preparations take more risk than oral preparation and externally applied agent.In phaseⅠtoler- ance trial of intravenous preparations of TCM on human subjects,minimum dose and maximum dose should be decided in light of data derived from preclinical pharmacodynamic and toxicological experiments,combined with practical situation in clinic.Dose-ascending coefficient of the should be reasonable.During the application of intravenous preparations of TCM in tolerance trial,clinical monitoring must be done to ensure the safety of subjects.Overall and integrated observa- tional indices should be designed on the basis of the features of preparation types,administration methods,the nature of medicine,etc.,so as to provide full-scale data for safe dose range,concentration of the preparation,dripping veloci- ty and possible adverse reactions,etc.

[ ABSTRACT] AIM:To investigate the effects of microRNA-378*( miR-378*) on the survival and apoptosis of human mesenchymal stem cells ( hMSCs ) .METHODS: The expression of miR-378* was determined by microRNA arrays and quantitative real-time PCR ( qRT-PCR) .H2 O2 was used to induce hMSCs apoptosis.By transfection of miR-378*mimic or inhibitor, we up-regulated or down-regulated miR-378* expression in hMSCs.The effect of miR-378*and connective tissue growth factor ( CTGF) on hMSC survival and apoptosis were detected by MTT, LDH, caspase-3/7 and TUNEL assays.RESULTS:The expression of miR-378*was up-regulated in the old hMSCs compared with the young hMSCs.H2 O2 increased the expression of miR-378*, decreased the expression of CTGF.Up-regulation of miR-378*re-sulted in increasing apoptosis and decreasing survival of hMSCs.Conversely, down-regulation of miR-378*resulted in de-creasing cell apoptosis and increasing survival.The regulation of miR-378*on hMSC apoptosis and survival was attenuated by inhibiting the expression of miR-378* and CTGF together.Direct repression of CTGF expression inhibited the hMSC survival and increased apoptosis.CONCLUSION:miR-378*enhances apoptosis of hMSCs by repressing the expression of CTGF.

In September 2012, the Assessment for Ethics Review of Traditional Chinese Medicine (TCM) Re-search with Human Participants (named CAP, Chinese medicine assessment human research protection system) was officially commissioned to the World Federation of Chinese Medicine Societies to organize by the State Ad-ministration of TCM. Through the assessment of 20 medical institutions, a comprehensive analysis on ethical re-view platform was conducted. Combined with current regulatory system of ethics in the U.S., this article discussed independent assessment on important CAP features of local brands, the practice and benefit of construction pro-motion based on assessment and continuous improvement, as well as the importance of vigorously promote CAP assessment .