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Pediatric Research and the Federal Minimal Risk Standard
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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.
To argue in favor of an objective standard that defines minimal risk as indexed to the risks experienced by healthy children does not mean that the empirical data are sufficient. The minimal risk standard is both a statistical and a normative concept2 and cannot be reduced to the simplistic claim that because children experience certain risks in daily life, we should be able to expose these children to a similar level of risk within research. The empirical data could permit much greater risk than would be . . . [Full Text of this Article]
Lainie Friedman Ross, MD, PhD
lross@uchicago.edu
Department of Pediatrics
University of Chicago
Chicago, Ill
Robert M. Nelson, MD, PhD
Department of Anesthesiology and Critical Care
The Children's Hospital of Philadelphia
Philadelphia, Pa
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