• Title/Summary/Keyword: Act of Clinical Research

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A study on the proposed amendment bill of Bioethics and Safety Law (2010): focusing on the meaning of significant contents related to the clinical research ("생명윤리 및 안전에 관한 법률" 전부개정안의 내용과 의의: 임상연구와의 관계를 중심으로)

  • Kim, Eun-Ae
    • The Korean Society of Law and Medicine
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    • v.12 no.1
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    • pp.99-131
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    • 2011
  • To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

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Biosafety and Biosecurity Programme: Its Implementation, Requirements and Continuous Development at the Nanyang Technological University in Singapore

  • Tun, Tin;Preiser, Peter Rainer
    • Korean Journal of Clinical Laboratory Science
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    • v.50 no.2
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    • pp.77-84
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    • 2018
  • In Singapore, biosafety and biosecurity measures are controlled by the Biological Agents and Toxins Act (BATA) and other requirements by regulatory agencies. The law prohibits and otherwise regulates the possession, use, import, transhipment, transfer, and transportation of biological agents, inactivated biological agents, and toxins that are of public health concern. The law also defines the facility requirements for high risk biological agents and toxins. The containment facility (BSL 3) is a minimum requirement to handle biological agents that falls under Schedule 1 (Risk Group 3). The Nanyang Technological University School of Biological Sciences Biosafety Level 3 Facility (NTU-SBS BSL 3) was designed specifically for research involving potential hazardous biological materials. The facility requires yearly re-certification by an approved facility certifier to meet the local requirements and international biosafety standards for a containment facility in many instances. On the other hand, most NTU researchers conduct biological projects involving biological agents with low or moderate risk groups (Risk Groups 1 and 2 or biological agents described in schedule 3 and 4 of BATA) and GMOs, which need only a BSL 2 laboratory. BSL 2 laboratories are yet to be legally certified or registered in Singapore. Institutional Biosafety Committee (IBC) identifies the requirements; defines a minimum standard in the safe control of biological risks and registers all BSL 2 laboratories in the NTU. Therefore, under the guidance of the IBC, the University Biosafety and Biosecurity Programme includes the audit and certification program as a unique and an internal exercise to bring NTU biosafety to a higher level.

Study on Legal Issues and Scope of Medical Technologist's Practice (임상병리사 업무 범위와 법률적 고찰)

  • Shim, Moon-Jung;Koo, Bon-Kyeong;Park, Chang-Eun
    • Korean Journal of Clinical Laboratory Science
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    • v.49 no.2
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    • pp.55-68
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    • 2017
  • In recent years, medical practice has seen a drastic change due to the rapid, exponential expansion of scientific and medical technologies. Specially, the role of medical technologists (also known as medical laboratory scientists and/or clinical laboratory scientists) are increasing in the development of science of medical technology. As such, their responsibility has also been increasing. Therefore, given their highly specialized knowledge and skills, they are not regarded solely as doctor's assistants. Their independence and deeper specialization have been increasing, as they perform medial practices under the guidance of doctors or dentists pursuant to the "Act on Medical Service Technologists." From a legal point of view, medical guidance and scope of work were examined. As a conclusion, the definition of doctor's superintendency on the "Act on Medical Service Technologists" is required, and the qualification for the Korean license examination and their roles should be stated clearly. Moreover, communications among health professions regarding the roles of medical technologists are necessary to further facilitate clarification of their role. There is a need for independent legislation to expand the field of medical technologists and to strengthen their professionalism.

Harnessing the Power of IL-7 to Boost T Cell Immunity in Experimental and Clinical Immunotherapies

  • Jung-Hyun Park;Seung-Woo Lee;Donghoon Choi;Changhyung Lee;Young Chul Sung
    • IMMUNE NETWORK
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    • v.24 no.1
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    • pp.9.1-9.21
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    • 2024
  • The cytokine IL-7 plays critical and nonredundant roles in T cell immunity so that the abundance and availability of IL-7 act as key regulatory mechanisms in T cell immunity. Importantly, IL-7 is not produced by T cells themselves but primarily by non-lymphoid lineage stromal cells and epithelial cells that are limited in their numbers. Thus, T cells depend on cell extrinsic IL-7, and the amount of in vivo IL-7 is considered a major factor in maximizing and maintaining the number of T cells in peripheral tissues. Moreover, IL-7 provides metabolic cues and promotes the survival of both naïve and memory T cells. Thus, IL-7 is also essential for the functional fitness of T cells. In this regard, there has been an extensive effort trying to increase the protein abundance of IL-7 in vivo, with the aim to augment T cell immunity and harness T cell functions in anti-tumor responses. Such approaches started under experimental animal models, but they recently culminated into clinical studies, with striking effects in re-establishing T cell immunity in immunocompromised patients, as well as boosting anti-tumor effects. Depending on the design, glycosylation, and the structure of recombinantly engineered IL-7 proteins and their mimetics, recombinant IL-7 molecules have shown dramatic differences in their stability, efficacy, cellular effects, and overall immune functions. The current review is aimed to summarize the past and present efforts in the field that led to clinical trials, and to highlight the therapeutical significance of IL-7 biology as a master regulator of T cell immunity.

Screening of Crude Drugs for the Inhibitory Effect on $NF-{\kappa}B$ Activation in Transfectant HaCaT Cells (형질전환된 각질형성세포에서 생약추출물에 의한 $NF-{\kappa}B$ 활성화 억제효과 탐색)

  • Ahn, Kwang-Seok;Kim, Seong-Kie;Moon, Ki-Young;Hahn, Bum-Soo;Kang, Sam-Sik;Kim, Yeong-Shik
    • Korean Journal of Pharmacognosy
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    • v.34 no.2 s.133
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    • pp.156-160
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    • 2003
  • $NF-{\kappa}B$ (nuclear factor-kappa B) plays a particularly central role in epidermal biology. It has been established that ultraviolet radiation (UVR) is one of the mechanisms to induce the activation of $NF-{\kappa}B$ in human skin. We previously demonstrated that melanogenic inhibitors may act through the inhibition of $NF-{\kappa}B$ activation in keratinocytes. In order to find another type of melanogenic inhibitors of $NF-{\kappa}B$ activation, various kinds of the extracts from crude drugs $(30\;{\mu}g/ml)$ were preincubated with transfectant HaCaT cells for 3 hrs and then UVR $(60\;mj/cm^2)$ was irradiated. UVR-exposed cells were incubated for another 6 hrs to measure the $NF-{\kappa}B$ activity. $NF-{\kappa}B$ activation was measured with the secreatory alkaline phosphates (SEAP) reporter gene assay using a fluorescence detection method. Among natural products, Lycium chinense, Acanthopanax senticosus, Angelica koreana, Kalopanax pictus and Asparagus cochinchinensis were the most potent inhibitors of $NF-{\kappa}B$ activation by UVR. These observations suggest that some crude drugs might act partially through the modulation of the synthesis of melanotrophic factors to decrease melanogenesis in keratinocytes.

Pathophysiology of Oral Mucositis induced by Anticancer Therapy (항암치료 후 발생하는 구강 점막염의 병태생리)

  • Yoon, Jung-Hoon;Choj, Jong-Hoon
    • Journal of Oral Medicine and Pain
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    • v.25 no.4
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    • pp.365-369
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    • 2000
  • Oral mucositis or stomatitis produced by stomatotoxic chemotherapy and/or radiation therapy are painful, restrict oral intake and, importantly, act as sites of secondary infection and potals of entry for the endogenous oral microflora often leading to bacteremias or sepsis. A number of clinical observations and studies of animal model suggests a pathophysiological complexity in the development of mucositis. The condition appears to represent a sequential interaction of the oral mucosal cells and tissues, pro-inflammatory cytokines, and local environmental factors in the mouth. This article discussed and reviewed biological process of the mucositis and, the role of cytokines as initiators and amplifiers of the process. The recognition that the pathophysiology of mucositis is a multifactorial process has presented opportunities for intervention based upon biological attenuation.

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Review of US Health Policy on Acupuncture Application for Opioid Abuse Crisis (침술의 마약성 진통제 남용 해결을 위한 미국 의료정책 고찰)

  • Kim, Juchul;Hyun, Eunhye;Kim, Dongsu
    • The Journal of Korean Medicine
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    • v.41 no.2
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    • pp.137-149
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    • 2020
  • Background: Opioids are a class of drugs found in the opium poppy, and used primarily as a pain reliever. About 130 people die every day from opioid abuse in the U.S., and the number of deaths was 6 times higher than it was 20 years ago. Objectives: To derive the implications on Korean Medicine(KM), this study aimed to investigate the current state of opioids abuse in the U.S. and analyze cases to solve opioids abuse using acupuncture. Methods: Literature on opioids abuse in the U.S. were searched through the websites of government, agency, and research institute. Results: There were several cases using acupuncture on opioids abuse. First, the Act on the use of acupuncture was enacted. Second, the clinical practice guidelines by the American College of Physicians recommended using acupuncture. Third, a large clinical study was conducted on whether acupuncture could replace opioids. Fourth, Vermont and Washington State conducted pilot projects on insurance coverage of acupuncture. Conclusions: As opioids issues are also valid in Korea, KM can serve a critical role in pain management to pursue expanded insurance coverage. In order to do so, building the discourses of KM in opioid issues is critical by defining its medical advantage, conducting large-scale clinical researches and implementing pilot projects to tackle social problems.

Development of Curriculum for the Emergency Clinical Nurse Specialist (응급전문간호사의 교육과정안 개발)

  • 김광주;이향련;김귀분
    • Journal of Korean Academy of Nursing
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    • v.26 no.1
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    • pp.194-222
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    • 1996
  • Various accidents and injuries are currently occurring in Korea at increasingly high rates. Good quality emergency care service is urgently needed to cope with these various forms of accidents and injuries. In order to develop a sound emergency care system, there need to be a plan to educate and train professionals specifically in emergency care. One solution for the on going problem would be to educate and train emergency clinical nurse specialists. This study on a strategy for curriculum development for emergency clinical nurse specialist was based on the following five content areas, developed from literature related to the curriculum of emergency nursing and emergency care situation : 1. Nurses working in the emergency rooms of three university hospitals were analyzed for six days to identify categories of nursing activities. 2. Two hundreds and eleven nurses working in the emergency rooms of 12 university hospitals were surveyed to identify needs for educational content that should be included in a curriculum for the clinical nurse specialist. 3. Examination of the environment in which emergency management was provided. 4. Identification of characteristics of patients in the emergency room. 5. The role of emergency clinical nurse specialist was identified through literature, recent data, and research materials. The following curriculum was formulated using the above mentioned process. 1. The philosophy of education for emergency clinical nurse specialist was established through a realistic philosophical framework. In this frame, client, environment, health, nursing, and learning have been defined. 2. The purpose of education is framed on individual development, social structure, nursing process and responsibility along with the role and function of the emergency clinical nurse specialist. 3. The central theme was based on human, environment, health and nursing. 4. The elements of structure in the curriculum content were divided to include two major threads, I, e., vertical and horizontal : The vertical thread to consist of the client, life cycle, education, research, leadership and consultation, and the horizontal thread to consist of level of nursing (prevention to rehabilitation), and health to illness based on the health care system developed by Betty Neuman system model. 5. Behavioral objectives for education were structured according to the emergency clinical nurse specialist role and function as a master degree prepared in various emergency settings. 6. The content of the curriculum consisted of three core courses(9 credits), five major courses(15 credits), six elective courses(12 credits) and six prerequisite courses (12 credits). Thus 48 credits are required. Recommendations : 1. To promote tile quality of the emergency care system, the number of emergency professionals, has to be expanded. Further the role and function of the emergency clinical nurse specialist needs to be specified in both the medical law and the Nursing Practice Act. 2. In order to upgrade the qualification of emergency clinical nurse specialists, the course should be given as part of the graduate Program. 3. Certification should be issued through the Korean Nurses Association.

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Approach Toward Integrated Curriculum for Dental Hygienist (치과위생사 통합교육과정을 위한 접근)

  • Hwang, Mi-Yeong
    • Journal of Korean society of Dental Hygiene
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    • v.3 no.1
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    • pp.59-72
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    • 2003
  • The purpose of this study was to examine what the role of denial hygienist was. The subjects were 751 dental hygienists from dental clinics, dental hospitals, general hospitals, public dental clinics and their branches throughout the nation. After a survey was conducted, the collected data were analyzed with SPSS WIN 10.0, and variance analysis and post-analysis were implemented. And Forgarty's 8th integrated model, out of 10 ones, was selected to delve into the practical role of dental hygienist in detail. The findings of this study were as follows: 1. The three age groups had a significantly different opinion on the significance of individual subjects. The dental hygienists of thirty six and over found the basic and preventive public dental care courses most important, and the 31~35 age group placed most stock in education and research. Overall, the post-analysis results showed that prevention and clinical courses were considered most vital, followed by education and fundamental courses. 2. There was a significant gap between four groups from the different work places in their view of the weight of the individual subjects. According to the post-analysis, the dental hygienists from the general hospitals, public dental clinics and their branches gave more weight to fundamental, education and research areas. Those who were with the dental clinics, dental hospitals and general hospitals put higher value on clinical course than the dental hygienists from the public dental clinics and their branches. 3. Two groups with a different career also had a different outlook on the importance of the individual subjects. The post-analysis results illustrated that the dental hygienists who had worked for three years or more put higher stress on the fundamental course than those with a less career, and the dental hygienists with a five-year or higher career attached more importance to the education and research field than those with a smaller career. 4. There was a significant difference between the three age groups in their clinical role. The post-analysis results indicated thai the younger dental hygienists were more of assistants than of professionals, as they chiefly took X-ray photograph, handled treatment materials or performed treatment-related works. Overall, handling treatment materials was most common. 5. The three groups from the different work places significantly varied in their clinical role. According to the post-analysis, those from the dental clinics and dental hospitals took more x-ray photographs, handled more treatment materials and performed more relevant works, compared to those from the general hospitals, public dental clinics and their branches. 6. The two groups with a different career differed significantly in their clinical role. The post-analysis results suggested that the dental hygienists with a less career played an assistant role more, which handled treatment materials or carried out other relevant works. 7. The fundamental courses (I) and (II), preventive class (I) and (II) and its practice course were regarded as integrated subjects that they should take 10 offer preventive treatment, which was one of the dental hygienist missions. What's needed to act as dental-care educators was the basic courses (I) and (II), dental hygiene education and its practice. Finally, integrated clinical courses (I) and (II) and clinical practice were viewed as necessary for their role performance as dental treatment collaborators.

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Effects of Panax ginseng and ginsenosides on oxidative stress and cardiovascular diseases: pharmacological and therapeutic roles

  • Hyun, Sun Hee;Bhilare, Kiran D.;In, Gyo;Park, Chae-Kyu;Kim, Jong-Hoon
    • Journal of Ginseng Research
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    • v.46 no.1
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    • pp.33-38
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    • 2022
  • Traditionally, Asian ginseng or Korean ginseng, Panax ginseng has long been used in Korea and China to treat various diseases. The main active components of Panax ginseng is ginsenoside, which is known to have various pharmacological treatment effects such as antioxidant, vascular easing, anti-allergic, anti-inflammatory, anti-diabetes, and anticancer. Most reactive oxygen species (ROS) cause chronic diseases such as myocardial symptoms and cause fatal oxidative damage to cell membrane lipids and proteins. Therefore, many studies that inhibit the production of oxidative stress have been conducted in various fields of physiology, pathophysiology, medicine and health, and disease. Recently, ginseng or ginsenosides have been known to act as antioxidants in vitro and in vivo results, which have a beneficial effect on preventing cardiovascular disease. The current review aims to provide mechanisms and inform precious information on the effects of ginseng and ginsenosides on the prevention of oxidative stress and cardiovascular disease in animals and clinical trials.