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The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. TABLE 8.2 Example 2—Variability in IRB Approval of a Multicenter Research Protocol That Includes Children
for bone age be deleted for HIV-negative controls (as a condition for waiver of parental permission). In addition to being frustrating and sometimes costly, inconsistency in IRB judgments may raise ethical concerns. For example, when different IRBs reach different conclusions about research risks or potential benefits and place different conditions on studies, might some children be exposed to higher than acceptable levels of risk? Alternatively, might some children be denied participation in potentially beneficial research? To some extent, the variability in IRB judgments reflects the uncertainties inherent in (and the reason for) much clinical research. It may also reflect, as discussed in Chapter 2 and 4, the limited data on the less-than-
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