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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.

We based our data on the widely accepted "objective" interpretation of the federal definition, according to which risks qualify as minimal when they do not exceed the risks faced by healthy children in daily life or during routine tests.^1-5 Drs Ross and Nelson criticize these data as misleading, arguing that "the minimal risk standard . . . cannot be reduced to the simplistic claim that because children experience certain risks . . . [Full Text of this Article]

David Wendler, PhD
dwendler@nih.gov

Leah Belsky, AB
Department of Clinical Bioethics
NIH Clinical Center
National Institutes of Health
Bethesda, Md

Kimberly M. Thompson, ScD
KidsRisk Project
School of Public Health
Harvard University
Boston, Mass

Ezekiel J. Emanuel, MD, PhD
Department of Clinical Bioethics
NIH Clinical Center
National Institutes of Health

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