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dc.creatorAmin, Sanjiv B.en
dc.creatorMcDermott, Michael P.en
dc.creatorShamoo, Adil E.en
dc.date.accessioned2016-01-08T23:11:49Zen
dc.date.available2016-01-08T23:11:49Zen
dc.date.created2008-07en
dc.date.issued2008-07en
dc.identifierdoi:10.1080/08989620802194392en
dc.identifier.bibliographicCitationAccountability in Research 2008 July-September; 15(3): 168-187en
dc.identifier.urihttp://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=Clinical+trials+of+drugs+used+off-label+in+neonates:+ethical+issues+and+alternative+study+designs&title=Accountability+in+Research+&volume=15&issue=3&date=2008-07&au=Amin,+Sanjiv+B.;+McDermott,+Michael+P.;+Shamoo,+Adil+E.en
dc.identifier.urihttp://dx.doi.org/10.1080/08989620802194392en
dc.identifier.urihttp://hdl.handle.net/10822/956534en
dc.description.abstractThe use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:317438en
dc.subjectChildrenen
dc.subjectClinical Trialsen
dc.subjectDrugsen
dc.subjectFooden
dc.subjectHealthen
dc.subjectInfantsen
dc.subjectLabelingen
dc.subjectNeonatesen
dc.subjectOff-Label Useen
dc.subjectResearchen
dc.subject.classificationDrugs and Drug Industryen
dc.subject.classificationHuman Experimentation Policy Guidelines / Institutional Review Boardsen
dc.subject.classificationResearch on Newborns and Minorsen
dc.titleClinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designsen
dc.provenanceCitation prepared by the Library and Information Services group of the Kennedy Institute of Ethics, Georgetown University for the ETHXWeb database.en
dc.provenanceCitation migrated from OpenText LiveLink Discovery Server database named EWEB hosted by the Bioethics Research Library to the DSpace collection EthxWeb hosted by DigitalGeorgetown.en


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