Letters Section Editor: Robert M. Golub, MD, Senior Editor.
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.
Ross LF, Nelson RM. Pediatric Research and the Federal Minimal Risk Standard. JAMA. 2006;295(7):759-760. doi:10.1001/jama.295.7.759-a