Navigating the Research-Clinical Interface in Genomic Medicine: Analysis from the CSER Consortium

Abstract

Purpose The Clinical Sequencing Exploratory Research (CSER) Consortium includes 9 NIH-funded U-award projects investigating translation of genomic sequencing into clinical care. Prior literature has distinguished norms and rules governing research vs. 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 9 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 vs. 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. Though research has traditionally been differentiated from clinical care, respondents pointed to factors blurring the distinction and strategies to differentiate the domains. Conclusions: These results illustrate the difficulty in applying the traditional bifurcation of research vs. clinical care to translational models of clinical research, including in genomics. Our results suggest new directions for ethics and oversight.