Washington University in St. Louis, USA.
J Law Med Ethics. 2012 Winter;40(4):802-8. doi: 10.1111/j.1748-720X.2012.00708.x.
Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.
新型纳米医学干预措施需要进行人体试验以评估其安全性和有效性。为了为人体试验建立适当的证据基础，纳米医学创新必须首先经过动物和其他实验室测试。但是，传统的实验室安全性评估方法是否会为人类提供有关纳米技术风险的充分信息尚不确定。这种不确定性，再加上纳米医学创新的其他特征，增加了进行首次人体纳米试验的伦理挑战。
