Working through the public disclosure process mandated by use of 21 CFR 50.24 [exception to informed consent]: Guidelines for success

被引：30

作者：

Santora, TA ^{[1
]}

Cowell, V ^{[1
]}

Trooskin, SZ ^{[1
]}

机构：

[1] Allegheny Univ Hlth Sci, Dept Surg, Philadelphia, PA 19129 USA

来源：

JOURNAL OF TRAUMA-INJURY INFECTION AND CRITICAL CARE | 1998年 / 45卷 / 05期

关键词：

D O I：

10.1097/00005373-199811000-00012

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

New Food and Drug Administration guidelines allow research to be done under an "exception to informed consent." These guidelines mandate advance public disclosure (PD) but provide no specifics for how to accomplish this task. This report outlines the history of informed consent in emergency care situations, highlights the Food and Drug Administration regulations for an exception to informed consent, and describes a stepwise approach with specific details of a PD program for a study using a blood substitute. This descriptive report can serve as a guideline for subsequent emergency care investigators in the development of a strategic plan for PD.

引用

页码：907 / 913

页数：7

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