Institutional Review Board Practices Regarding Assent in Pediatric Research
Pediatrics 2004 June; 113(6): 1747-1752
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How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research? Shah, Seema; Whittle, Amy; Wilfond, Benjamin; Gensler, Gary; Wendler, David (2004-01-28)CONTEXT: Federal regulations allow children in the United States to be enrolled in clinical research only when the institutional review board (IRB) determines that the risks are minimal or a minor increase over minimal, ...