美国大学伦理审查委员会的运作及其制度基础

The Operation and Regulatory Regime of IRBs in American Universities

美国大学伦理审查委员会是各大学对本校研究人员在从事以有生命的个体为受试者进行生物医学、社会学和行为研究时进行审查、监督的机构,其目的是保护那些作为研究对象的受试者的权利和福祉。《纽伦堡法典》、《赫尔辛基宣言》和《贝尔蒙特报告》是其运作的伦理基础,联邦和州的法规法令是其运作的法制基础,学校的科研管理制度是其具体操作的依据。

The Institutional Review Board （IRB）of a university is a group of people formally designated to review and monitor the research involving human subjects. The purpose of the 1RB is to protect the rights and welfare of individuals who are participating as subjects in the research. The ＇Nuremberg Code＇, ＇Declaration of Helsinki＇ and ＇Belmont Report＇ provide the ethical base for its .operation. The federal regulations and state acts＇are its legal foundation. The Research Administration in the university is the ground for IRB＇s operation.