Interpretation of the Subjects' Condition Requirement: A Legal Perspective.

Autor:	Shah, Seema, Wendler, David
Předmět:	FEDERAL government RESEARCH & development PEDIATRIC research CHILDREN'S health INSTITUTIONAL care of children
Zdroj:	Journal of Law, Medicine & Ethics; Summer2010, Vol. 38 Issue 2, p365-373, 9p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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