임상시험심사위원회와 기관생명윤리심의위원회의 개선방향에 관한 고찰

• 영문명: A Study on Improving Institutional Bioethics Review Board by Comparison of Institutional Review Board
• 발행기관: 이화여자대학교 생명의료법연구소
• 저자명: 백수진(Su-Jin BAIK) 권복규(Ivo KWON)
• 간행물 정보: 『생명윤리정책연구(제 9권 제 3호 이전)』제1권 제2호, 141~156쪽, 전체 16쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2007.12.30

영문 초록

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.

목차

Ⅰ. 국내 심의기구의 운영현황

II. 국내 심의기구의 문제점

III. 미국의 IRBs와 ESCRO/SCRO Commitees의 운영현황

IV. 국내 심의위원회의 문제점 및 개선방향

V. 맺음말