Changing the paradigm: New directions in federal oversight of human research

被引：3

作者：

Koski, G

机构：

[1] Off Human Res Protect, Dept Hlth, Washington, DC USA

[2] Off Human Res Protect, Human Serv, Washington, DC USA

来源：

JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION | 2003年 / 37卷

关键词：

research ethics; clinical research oversight; office for human research protections; protection of human subjects in research;

D O I：

10.1097/00005176-200311001-00002

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

The system of institutional review boards (IRBs) was established about 30 years ago for the protection of human subjects and as a mechanism for assuring an independent peer review of research activities. To keep pace with an evolving environment, a new model for human research oversight is needed that focuses less on achieving regulatory compliance and more on applying our conscience to the responsible conduct of research. The recent implementation of a unified federal registration system for IRBs and a new assurance system point the way to a more effective structure for the oversight of clinical trials.

引用

页码：S2 / S6

页数：5

共 13 条

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