Zusammenfassung

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’’.

https://doi.org/10.1136/jme.2004.010470