The death of a healthy volunteer in a human research project: implications for Australian clinical research

被引：37

作者：

Day, RO ^{[1
]}

Chalmers, DRC

Williams, KM

Campbell, TJ

机构：

[1] St Vincents Hosp, Sydney, NSW 2010, Australia

[2] Univ New S Wales, Sch Physiol & Pharmacol, Sydney, NSW, Australia

[3] Univ New S Wales, Clin Trials Ctr, Sydney, NSW, Australia

[4] Univ New S Wales, Res Eth Comm, Sydney, NSW, Australia

[5] Univ New S Wales, Australian Hlth Eth Comm, Sydney, NSW, Australia

来源：

MEDICAL JOURNAL OF AUSTRALIA | 1998年 / 168卷 / 09期

关键词：

D O I：

10.5694/j.1326-5377.1998.tb139026.x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

A healthy 19-year-old United States college student volunteer in a clinical research program underwent a bronchoscopy and died as a result of acute lignocaine toxicity The major contributing factor in the tragedy was that the research protocol failed to specify an upper dose limit for lignocaine spray, although previous versions of the protocol had done so. We look at the implications of this case for Australian institutional ethics committees.

引用

页码：449 / 451

页数：3