Concern about the biological hazards involved in microbiological research, especially research involving laboratory animals, has increased in recent years. Working in an animal biosafety level 2 facility (ABSL-2), commonly used for research on infectious diseases, poses various biological hazards. Here, the regulations and standards related to laboratory biosafety in China are introduced, the potential biological hazards present in ABSL-2 facilities are analyzed, and a series of strategies to control the hazards are presented.
Animal Diseases ; epidemiology ; prevention & control ; Animals ; Biomedical Research ; legislation & jurisprudence ; China ; epidemiology ; Containment of Biohazards ; methods ; standards ; Government Regulation ; Laboratories ; legislation & jurisprudence ; standards ; Safety Management ; legislation & jurisprudence ; standards

The evaluation on clinical efficacy of traditional Tibetan medicine (TTM) is an important scientific subject during the development of TTM. Firstly, the authors introduced the current situations and problems in evaluation on clinical efficacy of traditional Tibetan medicine both at home and abroad in this study. Secondly, they compared the similarities and differences between TTM and traditional Chinese medicine (TCM) in evaluation on clinical efficacy, define their differences in details but not in nature, and proposed that TTM could selectively learn TCM's experiences in clinical research and build a specific methodology system for evaluation on clinical efficacy according to its own characteristics. Thirdly, they discussed the methodological challenges in evaluation on clinical efficacy of TTM, including the pending clinical research guidelines and disease diagnosis standards according to its own characteristics. Finally, they propound some suggestions for promoting the evaluation on clinical efficacy of TTM, including the comprehensive application of multiple research methods, overall research-based evaluation on efficacy of TTM complex intervention and selection of accepted and objective outcome indexes for efficacy evaluation.
Biomedical Research ; Clinical Trials as Topic ; Drug Evaluation ; methods ; standards ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Tibetan Traditional ; Treatment Outcome

Medicinal materials research and development of new drug of traditional Chinese medicine (TCM) research is the premise and foundation of new drug research and development, it throughout the whole process of new drug research. Medicinal materials research is one of the main content of the pharmaceutical research of new drug of TCM, and it is also the focus of the new medicine pharmaceutical evaluation content. This article through the analysis of the present problems existing in the development of TCM research of new drug of TCM, from medicine research concept, quality stability, quality standard, etc are expounded, including medicine research idea value medicine study should focus on the important role and from the purpose for the top-level design of new drug research problem. Medicinal materials quality stability should pay attention to the original, medicinal part, origin, processing, storage, planting (breeding), and other aspects. Aspect of quality standard of medicinal materials should pay attention to establish the quality standards of conform to the characteristics of new drug of TCM. As the instruction of TCM new drug research and development and the scientific nature of the review, and provide the basis for medicinal material standards.
Biomedical Research ; methods ; standards ; China ; Drug Stability ; Drug Storage ; Drugs, Chinese Herbal ; chemistry ; standards ; Medicine, Chinese Traditional ; methods ; standards ; Quality Control

BACKGROUND: Intra-class correlation coefficients (ICCs) provide a statistical means of testing the reliability. However, their interpretation is not well documented in the orthopedic field. The purpose of this study was to investigate the use of ICCs in the orthopedic literature and to demonstrate pitfalls regarding their use. METHODS: First, orthopedic articles that used ICCs were retrieved from the Pubmed database, and journal demography, ICC models and concurrent statistics used were evaluated. Second, reliability test was performed on three common physical examinations in cerebral palsy, namely, the Thomas test, the Staheli test, and popliteal angle measurement. Thirty patients were assessed by three orthopedic surgeons to explore the statistical methods testing reliability. Third, the factors affecting the ICC values were examined by simulating the data sets based on the physical examination data where the ranges, slopes, and interobserver variability were modified. RESULTS: Of the 92 orthopedic articles identified, 58 articles (63%) did not clarify the ICC model used, and only 5 articles (5%) described all models, types, and measures. In reliability testing, although the popliteal angle showed a larger mean absolute difference than the Thomas test and the Staheli test, the ICC of popliteal angle was higher, which was believed to be contrary to the context of measurement. In addition, the ICC values were affected by the model, type, and measures used. In simulated data sets, the ICC showed higher values when the range of data sets were larger, the slopes of the data sets were parallel, and the interobserver variability was smaller. CONCLUSIONS: Care should be taken when interpreting the absolute ICC values, i.e., a higher ICC does not necessarily mean less variability because the ICC values can also be affected by various factors. The authors recommend that researchers clarify ICC models used and ICC values are interpreted in the context of measurement.
Adolescent ; Biomedical Research/*methods/*standards ; Cerebral Palsy ; Child ; Child, Preschool ; Computer Simulation ; Databases, Factual ; Female ; Humans ; Male ; Models, Theoretical ; Orthopedics/*methods/*standards ; Physical Examination ; Range of Motion, Articular ; Reproducibility of Results ; Research Design ; Statistics as Topic ; Young Adult

Through introduction of the methodological mechanism and comparison with classic randomized controlled trial, the status and the applicability of the expertise-based randomized controlled trials in clinic are explored, and its characteristics in acupuncture clinical application are analyzed. It is held that expertise-based randomized controlled trial is more suitable for the acupuncture clinical research, especially for acupuncture practice which emphasizes manipulations and different schools.
Acupuncture Therapy ; standards ; Biomedical Research ; standards ; Humans ; Randomized Controlled Trials as Topic ; methods ; standards

Through clinical practice and theory of acupuncture, three aspects are expounded in this article, namely whether the sham acupuncture is in reality as well as in name or not, whether the topics assigned as real and sham acupuncture exists or not, and whether the effect of acupuncture equals to placebo or not. It is held that the research method which separates the biological availability and psychological effect does not confirm to the theory of integration of the physical and the psychological in Chinese medicine. It also does not meet the new medical model of biology-psychology-society of the modern society. Therefore, the western research module which separates the physical and psychological should not be repeated. Sham acupuncture as a control method is still immature, which is not appropriate to be taken as a standard model for acupuncture research. If the research method which takes modern medicine as the control method in Chinese Acupuncture and Moxibustion can be promoted, and the most effective and the most advanced methods and results which are general accepted can be taken as the control, the differences and the advantages of acupuncture-moxibustion can be discovered directly with greater value
Acupuncture Therapy ; instrumentation ; methods ; standards ; Biomedical Research ; instrumentation ; methods ; standards ; Humans ; Placebo Effect

While there is an ethical obligation to improve clinical outcomes by developing better therapies, surgical innovation has largely progressed without the strict regulations required of novel pharmaceutical products. We explore the reasons why new surgical techniques are frequently introduced without the benefit of randomised controlled trials, and present an approach to the ethical evaluation of novel surgical procedures.
Biomedical Research ; ethics ; Clinical Competence ; Diffusion of Innovation ; Ethics, Medical ; General Surgery ; ethics ; methods ; standards ; Humans ; Informed Consent ; Medical Audit ; Medicine ; Singapore ; Specialty Boards

Drawing on recent publications in English and Chinese, this article explores reactions to the use of randomized controlled trials (RCTs) and the standards of evidence-based medicine (EBM) to evaluate Chinese medicine. Some authors contend that RCTs should not be used to evaluate Chinese medicine, but a far greater number of authors advocate their use. This paper describes the position of the RCT detractors and points out how their arguments contain oversimplified representations of Chinese medicine, biomedicine, EBM, and RCTs. In describing the position of the RCT proponents, the article discusses how challenges of standardization and control in Chinese medicine research have been met with important innovations in clinical trial design. Overall, the article argues that not only Chinese medicine is modified in meeting the demands of RCTs and EBM, but clinical trial design is being transformed through the innovations of Chinese medicine researchers.
Biomedical Research ; standards ; Evidence-Based Medicine ; Medicine, Chinese Traditional ; methods ; Randomized Controlled Trials as Topic

Since "Budapest Open Access Initiative" signed in 2002, there have been more and more open-access journals coming out on Internet, thus brining the best condition to the researchers. It has made better the phenomenon of not having enough foreign language periodicals in our country. The present author has selected part of free biomedicine periodical websites: High Wire Press; PubMed Central; BioMed Central; BioLine International; Free Medical Journals Site; Scientific Electronic Library; Hindawi; Academic Journals Inc; Biomedical Journals from India. And then, analysis and demonstration are made with respect to the search channels of 3 main free electronic periodical websites. It is the intent of this paper to make things convenient for researchers to get information from the websites quickly.
Access to Information ; Biomedical Research ; Information Storage and Retrieval ; methods ; standards ; Online Systems ; trends ; PubMed

In order to explore the problems and countermeasure in the methodology of acupuncture and moxibustion clinical researches at present, clinical research literatures about acupuncture and moxibustion (Acup-Mox) published in recent years in our country were reviewed. For the urgent need of the current internationalization of Acup-Mox, the authors proposed the model of clinical research on Acup-Mox, which should strictly stick to the international standard and fully embody traditional Chinese medicine characteristics in the intervention measures of acupuncture. It is indicated that innovation of the methodology about clinical researches of Acup-Mox has great significance in improving the quality of clinical research on Acup-Mox in our country and promoting internationalization of Acup-Mox.
Acupuncture ; methods ; standards ; Biomedical Research ; methods ; standards ; Humans ; International Educational Exchange ; Medicine, Chinese Traditional ; methods ; standards ; trends ; Moxibustion ; methods ; standards ; Review Literature as Topic