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January 2008

Empirical Data and the Acceptability of Research RiskA Commentary on the Charitable Participation Standard

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Copyright 2008 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2008

Arch Pediatr Adolesc Med. 2008;162(1):88-90. doi:10.1001/archpediatrics.2007.4

In “Children’s and Their Parents’ Views on Facing Research Risks for the Benefit of Others,” Wendler and Jenkins1 address the important ethical question of the appropriate risk exposure for children who participate in nonbeneficial research. Wendler, in collaboration with a number of coauthors, has been writing about risk and pediatric research participation for some time, focusing on problems with the interpretation of minimal risk and minor increase over minimal risk. US federal regulations permit children to participate in nonbeneficial studies when the risks are minimal, that is, when “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”2,3 Under additional circumstances, children with a disorder or condition may also participate in nonbeneficial research that presents no more than a “minor increase” over minimal risk. There is well-documented variability in the application by institutional review board chairpersons of these risk categories for pediatric research.4 To address this variability, Wendler and colleagues4 have recommended guidance on applying the federal risk and benefit categories and the collection of data on the risks children face in daily life and during routine physical or psychological tests.

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