Knowledge of Regulations Governing Pediatric Research: A Pilot Study

TitleKnowledge of Regulations Governing Pediatric Research: A Pilot Study
Publication TypeJournal Article
Year of Publication2008
AuthorsStroustrup, A, Kornetsky, S, Joffe, S
JournalIRB: Ethics & Human Research
Type of ArticleArticle
Publication Languageeng
ISSN Number01937758
Accession Number34698486
KeywordsClinical , etc. , Institutional , manuals , Medical , Pediatrics , United
AbstractThe article discusses the study on knowledge of regulations governing pediatric research protocols in the U.S. The study evaluated self-reported preparedness for clinical research review, both in general and with respect to pediatric protocols, among Institutional Review Board (IRB) members. It reveals that problems with knowledge of regulations governing pediatric research may partly explain the consistent heterogeneity in IRB review of research involving children.
NotesStroustrup, Annemarie 1 Kornetsky, Susan 2 Joffe, Steven 3; Affiliation: 1: Division of Newborn Medicine, Kravis Children's Hospital, Mount Sinai Medical Center, New York, NY 2: Director, Clinical Research Compliance, Children's Hospital Boston, Boston, MA 3: Assistant Professor of Pediatrics, Children's Hospital Boston, and Dana-Farber Cancer Institute, Boston, MA; Source Info: Sep/Oct2008, Vol. 30 Issue 5, p1; Subject Term: PEDIATRICS -- Research; Subject Term: MEDICAL protocols; Subject Term: INSTITUTIONAL review boards (Medicine); Subject Term: CLINICAL medicine -- Handbooks, manuals, etc.; Subject Term: UNITED States; Number of Pages: 7p; Illustrations: 4 Charts, 1 Graph; Document Type: Article
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