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dc.creatorKimmelman, Jonathanen
dc.date.accessioned2011-07-12T18:21:01Zen
dc.date.available2011-07-12T18:21:01Zen
dc.date.created2007-12en
dc.date.issued2007-12en
dc.identifier.bibliographicCitationDeveloping World Bioethics 2007 December; 7(3): 128-135en
dc.identifier.urihttp://hdl.handle.net/10822/511808en
dc.description.abstractRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer's most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied with various international guidelines that require that clinical trials conducted in the developing world be responsive to their populations' health needs. Nevertheless, policies devised to address large scale, late stage trials, such as the AZT short-course placebo trials, map somewhat awkwardly to early phase studies. I argue that interest in conducting translational research in the developing world, particularly in the context of hemophilia trials, should motivate more rigorous ethical thinking around clinical trials involving economically disadvantaged populations.en
dc.formatArticleen
dc.languageengen
dc.source310889en
dc.subjectClinical Trialsen
dc.subjectEthicsen
dc.subjectGuidelinesen
dc.subjectHealthen
dc.subjectHemophiliaen
dc.subjectInvestigatorsen
dc.subjectResearchen
dc.subjectTranslational Researchen
dc.subject.classificationGene Therapy / Gene Transferen
dc.subject.classificationResearch on Foreign Nationalsen
dc.titleClinical trials and SCID row: the ethics of phase 1 trials in the developing worlden
dc.provenanceDigital citation created by the Bioethics Research Library, Georgetown University, for the National Information Resource on Ethics and Human Genetics, a project funded by the United States National Human Genome Research Instituteen
dc.provenanceDigital citation migrated from OpenText Livelink Discovery Server database named GenETHX to DSpace collection GenETHX hosted by Georgetown Universityen


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