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Full-Text Articles in Health Law and Policy
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 …
Seeking Genomic Knowledge: The Case For Clinical Restraint, Ellen Wright Clayton, Wylie Burke, Susan Brown Trinidad
Seeking Genomic Knowledge: The Case For Clinical Restraint, Ellen Wright Clayton, Wylie Burke, Susan Brown Trinidad
Vanderbilt Law School Faculty Publications
Genome sequencing technology provides new and promising tests for clinical practice, including whole genome sequencing, which measures an individual's complete DNA sequence, and whole exome sequencing, which measures the DNA for all genes coding for proteins. These technologies make it possible to test for multiple genes in a single test, which increases the efficiency of genetic testing. However, they can also produce large amounts of information that cannot be interpreted or is of limited clinical utility. This additional information could be distracting for patients and clinicians, and contribute to unnecessary healthcare costs. The potential for genomic sequencing to improve care …