title: Eliminating the daily life risks standard from the definition of minimal risk.
abstract: 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".
authors.affiliation: National Institute of Environmental Health Science, National Institute of Health, Box 12233, NH06, Research Triangle Park, NC 27709, USA. resnikd@niehs.nih.gov
authors.forename: D B
authors.initials: DB
authors.lastname: Resnik
mesh_terms: D002648:Child; D032921:Consensus; D032984:Ethics, Research; D005333:Fetus; D040261:Harm Reduction / Q000941:ethics; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D011329:Prisoners; D018570:Risk Assessment / Q000941:ethics* / Q000379:methods; D012449:Safety; D009626:Terminology as Topic; D014481:United States