Pediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of Direct Benefit: Challenging 45 CFR 46.406
Accountability in Research 2007 January-March; 14(1): 19-34
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Qualifying the Federal Minimal Risk Standard: Implications for Pediatric Research Without a Prospect of Direct Benefit Wendler, David; Belsky, Leah; Thompson, Kimberly M.; Emanuel, Ezekiel J. (2005-08-17)United States federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer participants a "prospect of direct" benefit only when the risks are minimal or a "minor" increase ...
Determining Risk in Pediatric Research With No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations Fisher, Celia B.; Kornetsky, Susan Z.; Prentice, Ernest D. (2007-03)United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or ...