Is It Possible to Protect Pediatric Research Subjects Without Blocking Appropriate Research?
Journal of Pediatrics 2008 April; 152(4): 467-470
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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 ...
Wendler, David (2004-06)In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has ...