Biomedical Research ; legislation & jurisprudence ; Humans ; Oral Medicine ; legislation & jurisprudence

Efficient management of human tissue samples is a critical issue; the supply of samples is unable to satisfy the current demands for research. Lack of informed consent is also an ethical problem. One of the goals of the 2012 revision of Korea's Bioethics and Safety Act was to implement regulations that govern the management of human tissue samples. To remain competitive, medical institutions must prepare for these future changes. In this report, we review two tissue management models that are currently in use; model 1 is the most common system utilized by hospitals in Korea and model 2 is implemented by some of the larger institutions. We also propose three alternative models that offer advantages over the systems currently in use. Model 3 is a multi-bank model that protects the independence of physicians and pathologists. Model 4 utilizes a comprehensive single bioresource bank; although in this case, the pathologists gain control of the samples, which may make it difficult to implement. Model 5, which employs a bioresource utilization steering committee (BUSC), is viable to implement and still maintains the advantages of Model 4. To comply with the upcoming law, we suggest that physicians and pathologists in an institution should collaborate to choose one of the improved models of tissue management system that best fits for their situation.
*Bioethics ; Biomedical Research/*legislation & jurisprudence ; Humans ; Models, Biological ; Republic of Korea

With more and more attention and investment on acupuncture scientific researches, considerable outcomes and achievements has been acquired, but the shortcoming of low transformation rate of acupuncture research achievements is gradually exposed. Nowadays there is no related report on this problem, so based on achievement translational research in other areas and practical situation of acupuncture, the existing problems and solutions are analyzed. As a result, the existing problems include (1) the research content is mainly basic research and clinical research but less acupuncture device research, leading to limited transformation efficiency; (2) the evaluation system and transformation pattern are still needed to be perfect. The solutions are (1) to properly evaluate the research achievements of acupuncture, (2) to advocate the concept and method of translational medicine, (3) to reform the policy and system, and (4) to establish valid platforms covering research, outcomes and transformation.
Acupuncture ; economics ; legislation & jurisprudence ; manpower ; Biomedical Research ; Biotechnology ; economics ; legislation & jurisprudence ; manpower ; China ; Humans ; Technology Transfer

To introduce the international registration condition of acupuncture clinical research. With the examples of World Health Organization International Clinical Trials Registry Platform and the U. S. National Institutes of Health Clinical Registration Platform, the registration method and current condition of acupuncture clinical trials in international clinical trials registration platform were analyzed. The results indicate that the number of acupuncture clinical trials registration is gradually increased and the registration number from China is on the rise as well. But most domestic acupuncture clinical researches haven't been registered arid the researchers' valuing degree for clinical trials registration and methodology research needs to be improved.
Acupuncture Therapy ; standards ; Biomedical Research ; legislation & jurisprudence ; standards ; Clinical Trials as Topic ; legislation & jurisprudence ; standards ; Humans ; Registries

Autopsy ; Biomedical Research ; ethics ; legislation & jurisprudence ; Brain ; pathology ; Humans ; Tissue Banks ; ethics ; legislation & jurisprudence

Advances in biomedical technology has enabled the research and use of novel therapies in cellular transplantation. A number of trials using chondrocyte and autologous skin products are underway and will soon become commercially available for clinical utilization. However, the Korea Food and Drug Administration currently lack systematic regulations for efficacy and safety evaluation of the emerging therapies. Specifically, dose related studies are uncontrolled and availability of clinical research centers is inadequate. Thus, patients are receiving therapy without guidelines for indication, dose, and adequate safety profiles. We propose criteria for cases in which these therapies can be used and advocate IRB determined quality assurance for future research.
Biomedical Research/standards ; Cell Transplantation/*legislation & jurisprudence ; Guidelines ; Humans ; Korea ; Quality Control

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

In 2012, USA Food and Drug Administration (FDA) approved 39 new drugs, however, there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA's industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines, authors investigate current regulation on herbal medicine clinical research, identify challenges conducting clinical trials, and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA, based on the findings and analysis through the literature review and Veregen case study, authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.
Biomedical Research ; legislation & jurisprudence ; Clinical Trials as Topic ; Herb-Drug Interactions ; Herbal Medicine ; legislation & jurisprudence ; Humans ; Plants, Medicinal ; adverse effects ; United States

Traditional Chinese medicine (TCM) injection's safety problems has been paid attention for the country and people, TCM injection's labels described the adverse reactions always shows "unclear" or blank, especially the adverse drug reactions(ADR) rates hardly reported. To save the problem, large-scale safety surveillance of TCM injection research is very important. The article introduces the research aim, research type, simple size, outcomes and ethic problem during make the plan. It is a multi-center, large sample size, registry research program about TCM injections safety monitoring. The aim is to get the ADR's rate of TCM injections. According to the "three rules" , each of the TCM injection will be observed for 30 000 cases which are inpatients. The research adopt to using the barcode system and hospital information system(HIS) & laboratory information management system(LIS) to make sure enroll all patients. Case report file (CRF) is used for record patient's information which contained 3 types(A, B, C) tables. Most of people just need to fill table A, and the patient need to fill table B when they have ADR. The outcome of the research is severe ADR. Abide by the international ethical principle to keep the patient's right.
Biomedical Research ; standards ; China ; Clinical Protocols ; standards ; Clinical Trials as Topic ; Drug Therapy ; standards ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Medicine, Chinese Traditional ; standards ; Outcome Assessment (Health Care) ; legislation & jurisprudence ; standards