David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
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
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
|Through your library||Configure|
References found in this work BETA
No references found.
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.
Similar books and articles
Valarie Blake, Steve Joffe & Eric Kodish (2011). Harmonization of Ethics Policies in Pediatric Research. Journal of Law, Medicine and Ethics 39 (1):70-78.
Carson Strong (2011). Minimal Risk in Research Involving Pregnant Women and Fetuses. Journal of Law, Medicine and Ethics 39 (3):529-538.
Jonathan Kimmelman (2004). Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal 14 (4):369-393.
Andrew D. McRae & Charles Weijer, Lessons From Everyday Lives: A Moral Justification for Acute Care Research.
Celia B. Fisher, Susan Z. Kornetsky & Ernest D. Prentice (2007). Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations. American Journal of Bioethics 7 (3):5 – 10.
David Wendler (2012). A New Justification for Pediatric Research Without the Potential for Clinical Benefit. American Journal of Bioethics 12 (1):23 - 31.
Eric Chwang (2010). Against Risk-Benefit Review of Prisoner Research. Bioethics 24 (1):14-22.
Paul Litton, Non-Beneficial Pediatric Research and the Best Interests Standard: A Legal and Ethical Reconciliation.
David Wendler (2004). Risk Standards for Pediatric Research: Rethinking the Grimes Ruling. Kennedy Institute of Ethics Journal 14 (2):187-198.
Added to index2009-01-28
Total downloads8 ( #138,461 of 1,088,370 )
Recent downloads (6 months)0
How can I increase my downloads?