To the Editor: In their survey of institutional review board (IRB) chairpersons, Dr Shah and colleagues1 found that the chairpersons were quite variable in their application of the federal risk and benefit categories for pediatric research, and that their judgments were sometimes contradicted by the available data on risks and the regulations themselves. However, these problems are not confined to pediatric research,2 which raises larger questions about variability across all IRBs. Although some variation may be acceptable, inappropriately high variability can impede the progress of research and may add extra cost.3
Unfortunately, there are no empirical data that describe the processes by which IRBs review protocols. These process data could then lead to best practices and higher-quality IRBs. Cost and outcomes data would also be important. Although IRBs oversee how researchers apply evidence-based methods to improve medical care, lack of such data may prevent IRBs from actually improving their own processes.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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