title: Interpretation of the subjects' condition requirement: a legal perspective.
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.
authors.affiliation: Department of Bioethics, National Institutes of Health, USA.
authors.forename: Seema
authors.initials: S
authors.lastname: Shah
authors.forename: David
authors.initials: D
authors.lastname: Wendler
mesh_terms: D026683:Advisory Committees / Q000458:organization & administration; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D002648:Child; D002651:Child Advocacy / Q000331:legislation & jurisprudence*; D018849:Controlled Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D033242:Minors / Q000331:legislation & jurisprudence*; D033281:Nontherapeutic Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D018579:Patient Selection / Q000941:ethics; D012660:Semantics; D036302:Therapeutic Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D014481:United States; D018172:United States Office of Research Integrity / Q000458:organization & administration