Interpretation of the Subjects' Condition Requirement: A Legal Perspective

Journal of Law, Medicine & Ethics 38 (2):365-373 (2010)
Abstract
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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DOI 10.1111/j.1748-720X.2010.00495.x
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Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine & Ethics 28 (4):332-343.

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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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