Interpretation of the subjects' condition requirement: A legal perspective

Seema Shah*, David Wendler

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)365-373
Number of pages9
JournalJournal of Law, Medicine and Ethics
Issue number2
StatePublished - Jun 2010

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy


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