Pediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of Direct Benefit: Challenging 45 CFR 46.406

TitlePediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of Direct Benefit: Challenging 45 CFR 46.406
Publication TypeJournal Article
Year of Publication2007
AuthorsIltis, ANA
JournalAccountability in Research: Policies & Quality Assurance
Volume14
Issue1
Pagination19-34
Type of ArticleArticle
Publication Languageeng
ISSN Number08989621
Accession Number23547839
Keywordschildren , disorder , Human Research Subjects , Law , MEDICINE , minimal , Minor , PEDIATRIC , Pediatrics , research , RISK , SCIENCE , Scientific , Vulnerable Populations
AbstractSubpart D of the Common Rule establishes 4 categories of research that may be conducted on children. One category, 45 CFR 46.406, permits research posing a minor increase over minimal risk and no prospect of direct benefit but expected to yield vital knowledge about the subjects' disorder or condition. This article discusses if and when children should participate in this kind of research. It is widely held that children generally should not be exposed to more than minimal risk in research without the prospect of direct benefit. To justify deviating from this norm, as 406 allows, two claims must be true: (1) When there is vital knowledge to be gained from studying children, it is permissible to expose some children to a minor increase over minimal risk with no prospect of direct benefit; (2) It is permissible for locally reviewed and approved research to expose only children with the disorder or condition under investigation to greater risk with no prospect of direct benefit.
NotesILTIS, ANA 1; Email Address: iltisas@slu.edu; Affiliations: 1: Saint Louis University, Center for Health Care Ethics, St. Louis, Missouri, USA; Issue Info: Jan2007, Vol. 14 Issue 1, p19; Thesaurus Term: RESEARCH; Thesaurus Term: RISK exposure; Thesaurus Term: RISK management; Subject Term: PEDIATRICS; Subject Term: CHILDREN with disabilities; Subject Term: LAW & legislation; Subject Term: SCIENTIFIC knowledge; Author-Supplied Keyword: disorder or condition clause; Author-Supplied Keyword: minimal risk; Author-Supplied Keyword: minor increase over minimal risk; Author-Supplied Keyword: pediatric research; Number of Pages: 16p; Document Type: Article
DOI10.1080/08989620601104782
Short TitlePediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of Direct Benefit: Challenging 45 CFR 46.406
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