미국 임상시험심사위원회(Institutional Review Board)에 대한 인간피험자보호국(Office for Human Research Protection, OHRP)의 확약 = A Study on Federalwide Assurance(FWA) for the Protection of Human Subjects Institutional Component, Office for Human Research Protection(OHRP)

다국어 초록 (Multilingual Abstract)

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 (Table of Contents)

• Ⅰ. 머리말
• II. OHRP 확약의 역사적 배경
• III. OHRP 확약의 소개와 성격
• IV. FWA 현황과 실태 조사
• V. 마무리