Department of Medicine, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
J Law Med Ethics. 2011 Fall;39(3):529-38. doi: 10.1111/j.1748-720X.2011.00619.x.
The concept of minimal risk plays a key role in federal regulations on the protection of human research subjects. Although there has been considerable discussion of the meaning of minimal risk, the question of how this concept should be interpreted in research involving pregnant women and fetuses has not been addressed. This essay reviews the literature on minimal risk and argues for an interpretation of that concept in the context of research involving pregnant women and fetuses.
最小风险概念在保护人类研究对象的联邦法规中起着关键作用。尽管已经对最小风险的含义进行了相当多的讨论，但在涉及孕妇和胎儿的研究中应如何解释这一概念的问题尚未得到解决。本文回顾了关于最小风险的文献，并就涉及孕妇和胎儿的研究中这一概念的解释提出了看法。
