The Office of Human Research Protections

The Office of Human Research Protections
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人类研究保护办公室

DOI:
10.1097/01.nur.0000325380.14965.39
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发表时间:
2008
影响因子:
1.2
通讯作者:
B. Chamberlain
B. Chamberlain
中科院分区:
医学4区
文献类型:
--
作者:
B. Chamberlain

文献摘要

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机构审查委员会(IRB)负责保护参与研究的人类受试者的权利和福利。当研究受联邦法规约束时,机构必须遵守《联邦法规》。大多数研究机构都在这些条例的框架内制定自己的政策和程序。与IRB有关的两个联邦政府机构是人类研究保护办公室(OHRP)和食品药品监督管理局。1本文将重点介绍OHRP。
The institutional review board (IRB) is charged with protecting the rights and welfare of human subjects who participate in research. When research is subject to federal regulations, institutions must follow the Code of Federal Regulations. Most research institutions customize their policies and procedures within the framework of these regulations. Two agencies of the federal government that are involved with the IRB are the Office of Human Research Protections (OHRP) and the Food and Drug Administration. 1 This article will focus on the OHRP.