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February 15, 2006

Pediatric Research and the Federal Minimal Risk Standard—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2006;295(7):759-760. doi:10.1001/jama.295.7.759-b

In Reply: To avoid confusion, discussions of minimal risk in pediatric research should distinguish between risks that qualify as minimal under the US federal definition vs risks that commentators regard as appropriate for pediatric research participants. The primary goal of our article was to provide the data necessary to determine which risks qualify as minimal under the federal definition. These data are crucial to assessing individual pediatric research interventions and assessing whether the federal definition of minimal risk provides appropriate protection for pediatric participants.