미국 임상시험심사위원회(Institutional Review Board)에 대한 인간피험자보호국(Office for Human Research Protection, OHRP)의 확약

• 영문명: A Study on Federalwide Assurance(FWA) for the Protection of Human Subjects Institutional Component, Office for Human Research Protection(OHRP)
• 발행기관: 이화여자대학교 생명의료법연구소
• 저자명: 김수정(Soo-Jung KIM)
• 간행물 정보: 『생명윤리정책연구(제 9권 제 3호 이전)』제1권 제2호, 115~130쪽, 전체 16쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2007.12.30

영문 초록

The purpose of this study is to investigate current status and role of human subject protection program in the clinical trials in the United States. This paper will introduce Federalwide Assurance of Office for Human Research Protection as major governmental oversight system. Department of Health and Human Services have codified federal human subjects research regulations as Title 45(Public Welfare), Part 46(Protection of Human Subjects), 45 CFR 46 on 30 May, 1974. It also mandates IRB in the individual institutions which seek for federal funds for their research and let the Office for Human Research Protections take in charge of its administration. This paper also examines characteristics of Federalwide Assurance and assesses its advantages and disadvantages. Furthermore, it will find out the scope and limit of governmental oversight system on human subject research protection program.

목차

Ⅰ. 머리말

II. OHRP 확약의 역사적 배경

III. OHRP 확약의 소개와 성격

IV. FWA 현황과 실태 조사

V. 마무리

키워드

임상시험심사위원회(Institutional Review Board, IRB) 임상시험(Crinical Research) 연방차원의 법령준수확약(Federalwide Assurance) 인간피험자보호국(Office for Human Research Protection, OHRP)