David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
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Kennedy Institute of Ethics Journal 14 (2):187-198 (2004)
: 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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Citations of this work BETA
Ariella Binik, Charles Weijer & Mark Sheehan (2011). Minimal Risk Remains an Open Question. American Journal of Bioethics 11 (6):25 - 27.
David B. Resnik (2011). Reopening Old Divisions. American Journal of Bioethics 11 (6):19 - 21.
Jeremy Snyder, Cari L. Miller & Glenda Gray (2011). Relative Versus Absolute Standards for Everyday Risk in Adolescent HIV Prevention Trials: Expanding the Debate. American Journal of Bioethics 11 (6):5 - 13.
Janet Malek (2011). Uniqueness, Exploitation, and Relative Risk Standards in Adolescent Research. American Journal of Bioethics 11 (6):23 - 25.
Sean Philpott (2011). (Un)Risky Business: Adolescents and HIV Prevention Trials. American Journal of Bioethics 11 (6):17 - 19.
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