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Navigating the Research Clinic--Clinical Interface in Genomic Medicine

dc.contributor.authorClayton, Ellen W.
dc.contributor.authorWolf, Susan M.
dc.contributor.authoret al.
dc.date.accessioned2019-04-30T21:53:56Z
dc.date.available2019-04-30T21:53:56Z
dc.date.issued2018
dc.identifier.citation20 Genetics in Medicine 545 (2018)en_US
dc.identifier.urihttp://hdl.handle.net/1803/9464
dc.descriptionarticle published in a medical journal of researchen_US
dc.description.abstractPurpose: The Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health–funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research–clinical interface. Methods: A CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research–clinical interface. Results: Survey responses described how studies approached the research–clinical interface, including in consent practices, recording results, and using a research versus clinical laboratory. Responses revealed four characterizations of the interface: clear separation between research and clinical care, interdigitation of the two with steps to maintain separation, a dynamic interface, and merging of the two. All survey respondents utilized at least two different characterizations. Although research has traditionally been differentiated from clinical care, respondents pointed to factors blurring the distinction and strategies to differentiate the domains. Conclusion: These results illustrate the difficulty in applying the traditional bifurcation of research versus clinical care to translational models of clinical research, including in genomics. Our results suggest new directions for ethics and oversight.en_US
dc.format.extent1 PDF (9 pages)en_US
dc.format.mimetypeapplication/pdf
dc.language.isoen_USen_US
dc.publisherGenetics in Medicineen_US
dc.relation.ispartofseriesNo. 5en_US
dc.subjectexome sequencingen_US
dc.subjectgenome sequencingen_US
dc.subjectresearch ethicsen_US
dc.subjecttranslational ethicsen_US
dc.subjecttranslational genomicsen_US
dc.subject.lcshhealth law and policyen_US
dc.subject.lcshlegal ethics and professional responsibilityen_US
dc.subject.lcshlawen_US
dc.titleNavigating the Research Clinic--Clinical Interface in Genomic Medicineen_US
dc.title.alternativeAnalysis from the CSER Consortiumen_US
dc.typeArticleen_US


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