Research without informed patient consent in incompetent patients

被引:5
作者
Dobb, G. J. [1 ,2 ]
机构
[1] Royal Perth Hosp, Intens Care Unit, Perth, WA 6001, Australia
[2] Univ Western Australia, Sch Med & Pharmacol, Perth, WA 6009, Australia
关键词
research; informed consent; incompetent patients; SURROGATE DECISION-MAKERS; ENROLLMENT; EMERGENCY; PERSPECTIVES; TRIALS;
D O I
10.1177/0310057X1504300305
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
Most patients needing intensive care cannot give informed consent to participation in research. This includes the most acutely and severely ill, with the highest mortality and morbidity where research has the greatest potential to improve patient outcomes. In these circumstances consent is usually sought from a substitute decision maker, but while survivors of intensive care believe substitute decision makers will look after their interests, evidence suggests substitute decision makers are poorly equipped for this task. Various models have been suggested for research without patient informed consent when intervention is urgent and cannot wait until first person consent is possible, including a waiver of consent if conditions are met. A nationally consistent model is proposed for Australia with a robust process for initial waiver of consent followed by first person consent to further research-related procedures or ongoing follow-up when this can be competently provided.
引用
收藏
页码:313 / 316
页数:4
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