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February 15, 2006

Pediatric Research and the Federal Minimal Risk Standard

Author Affiliations

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

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

To the Editor: In their Special Communication, Dr Wendler and colleagues1 discuss quantifying the federal minimal risk standard. We agree that the appropriate implementation of the minimal risk standard for pediatric research requires both a clear interpretation of the standard and empirical data on the risks that children face during daily life and routine examinations. However, we find their presentation of this standard misleading.