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)
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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.
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.