Risk Standards for Pediatric Research: Rethinking the Grimes Ruling
Kennedy Institute of Ethics Journal 2004 June; 14(2): 187-198
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 implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective interpretation). The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well.
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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, ...