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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 . . . [Full Text of this Article]

Todd H. Wagner, PhD
VA Palo Alto Health Care System &
Stanford University School of Medicine
Palo Alto, Calif

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