Research involving the newly dead: An institutional response
Research involving the newly dead: An institutional response
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DOI：
10.1097/01.ccm.0000065142.41379.5c
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发表时间：
2003-05-01
影响因子：
8.8
通讯作者：
Schold, C
中科院分区：
文献类型：
--
作者：
DeVita, MA;Wicclair, M;Schold, C
一所大学医院的研究人员在完成了对几种大型动物的测试后，希望在人类身上测试一种新设备。因为这是一项新技术，他们希望将对人类的风险降到最低。因此，他们决定对不符合器官捐赠资格的脑死亡个体进行研究。他们将项目提交给机构审查委员会（IRB），该委员会宣布该项目不属于他们的职权范围。研究人员希望获得行政批准，将情况提交给医院的伦理委员会。
Investigators at a university hospital, having completed testing on several types of large animals, want to test a new device on humans. Because this is a new technology, they want to minimize risk to humans. Therefore, they decide to perform the research on brain-dead individuals who are ineligible for organ donation. They submit the project to the institutional review board (IRB), which declares that the project does not fall under their purview. The investigators, wanting administrative approval for the study, present the situation to the hospital’s ethics committee.