Resnik D B
National Institute of Environmental Health Science, National Institute of Health, Box 12233, NH06, Research Triangle Park, NC 27709, USA.
J Med Ethics. 2005 Jan;31(1):35-8. doi: 10.1136/jme.2004.010470.
The phrase "minimal risk," as defined in the United States' federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the "daily life risks" standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that "minimal risk" should be defined as simply "the probability and magnitude of the harm or discomfort anticipated in research are not greater than those encountered during the performance of routine physical or psychological examinations or tests".
在美国联邦研究法规中定义的“最小风险”这一短语含糊不清且定义不明确。本文认为，人们在该短语中发现的大多数含糊之处源于最小风险定义中的“日常生活风险”标准。在本文中，作者主张应摒弃日常生活风险标准，并且“最小风险”应简单定义为“研究中预期的伤害或不适的概率和程度不大于进行常规身体或心理检查或测试时所遇到的概率和程度”。
