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병원 진단검사의학부의 공간구조와 설비기준에 대한 조사 - 미국, 영국, 독일을 중심으로 -
김영애 ( Kim Youngaee ) 한국의료복지건축학회(구 한국의료복지시설학회) 2016 의료·복지 건축 Vol.22 No.3
Purpose: As medicare services have gotten spreaded, clinical laboratory has been dominant position. So, it has been acted for quality control and clinical pathology accreditation. But there has been quite deficient information to evaluate working space and technical standards of medical laboratory for accreditation. This study goals to figure out accreditation standard and design guideline for clinical laboratory, and to give safe and efficient design information. Methods: This study has been searched by literature for accreditation standards and design guidelines of clinical pathology in USA, UK, and Germany. Results: Three countries have accredited based on working lab space, staff space, storage space, patient space and health and safety equipment. Design guidelines of three countries commonly have focused on worktable layout, worktable distance and module, and specific laboratory biosafety level. And USA guidelines stress on the architectural design such as design process and passage distance for escape, UK stress on the efficiency as functional work flow and construction cost, lastly Germany design guidelines stress on the operator’s safety distance and workstation. Three countries have not only accreditation standards but also design guidelines for more specific quality management, separating from accrediting institute. Implications: In korea, it has been needed to make clinical laboratory design guideline for the safe and efficient environment and reliable and competitive medical service.
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임상시험심사위원회와 기관생명윤리심의위원회의 개선방향에 관한 고찰
백수진,권복규 이화여자대학교 생명의료법연구소 2007 생명윤리정책연구 Vol.1 No.2
Institutional Review Board and Institutional Bioethics Review Board are primary Research Ethics Committees in Korea. Institutional Review Board(IRB) is the mandatory organization which reviews and has authority to approve, secure approval, or disapprove IND (Investigational New Drug) clinical research activities conducted in the institution( most hospitals) covered by Korea Good Clinical Practice(KGCP). Institutional Bioethics Review Board(IBRB) is the committee which reviews research activities conducted in the institution(Institutions related to Production Embryo, Cloning by somatic cell nuclear transfer, Dealing with Gene, and Human Tissue Bank etc.) regulated by the Law on Bioethics and Biosafety. IRB and IBRB in Korea have a similar structure and function. Nevertheless, there are some differences. IBRBs focus on the review of ethical perspective of the particular scientific research, whereas IRBs emphasize on the protection of the human subject. These roles and status of these two committees play an important role in determining how these two committees should be managed in both legal and institutional frameworks. This study, through the comparison of IRB and IBRB, seek to find a way to prepare standard of practice, development of educational program for investigators and IRB members, development of accreditation program, which will contribute to the promotion of IRB.
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