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Navigating The Research-Clinical Interface In Genomic Medicine: Analysis From The Cser Consortium, Ellen Wright Clayton, Susan M. Wolf, Laura M. Amendola, Et Al.
Navigating The Research-Clinical Interface In Genomic Medicine: Analysis From The Cser Consortium, Ellen Wright Clayton, Susan M. Wolf, Laura M. Amendola, Et Al.
Vanderbilt Law School Faculty Publications
Purpose: 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 …