Journal of Law, Medicine & Ethics 38 (2):365-373 (2010)
The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This “subjects' condition” requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should be understood
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References found in this work BETA
Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine & Ethics 28 (4):332-343.
The Use of Normal Children as Participants in Research on Therapy.Bruce Gordon, Ernest Prentice & Paul Reitemeier - forthcoming - IRB: Ethics & Human Research.
When Can Children with Conditions Be in No-Benefit, Higher-Hazard Pediatric Studies?Loretta M. Kopelman - 2007 - American Journal of Bioethics 7 (3):15 – 17.
Citations of this work BETA
The Dangers of Using a Relative Risk Standard for Minimal Risk.Seema Shah - 2011 - American Journal of Bioethics 11 (6):22 - 23.
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