Project Summary The goals of this administrative supplement are to advance implementation science research related to, and build technical capacities in ethical access to human genomic data. Genomic and associated phenotypic data fuel the engines of scientific discovery in the precision medicine era, but data are being generated at a pace and in volumes that overwhelm the ability of many institutions to enable their secure and efficient access. Existing strategies for governing access rely on institution- specific procedures guiding data access committee (DAC) review and manual verification of data use restrictions. Both strategies are incompatible with the shift towards cloud-based research environments exemplified by the AnVIL Data Ecosystem and insufficient to meet high demand for dynamic, real-time adjudication of access requests. The parent grant to this supplement developed the Data Use Ontology System (DUOS) to innovatively solve this problem. DUOS is a service which provides software-enabled workflows and policies for DACs, including semi-automating two steps in the existing DAC workflow using global standards. In the course of our preliminary evaluations, however, we recognized that DACs affiliated with publicly funded genomic data repositories in the U.S. and abroad will require additional technical and adaptive capacities to facilitate successful implementation of DUOS and future semi-automated workflow solutions similar to it. The criticalness of secure, compliant, and efficient data access management to the speed of science, and lack of standard procedures and policies to do so, creates clear opportunities to (i) study relevant factors that influence whether and how DACs implement workflow solutions that improve consistency and efficiency of data access review and to (ii) develop procedural standards for DACs using an international, consensus deliberation approach. To accomplish these aims, the AnVIL team will collaborate with three co-leads of the Data Access Committee Review Standards Working Group (DACReS WG), whose members represent DACs from the NIH and the largest publicly funded genomic data repositories in the world. Taken together, the AnVIL and DACReS create a uniquely interdisciplinary team whose collaboration will generate a novel evidence basis to inform how future DAC policies account for machine-assisted review of access requests to valuable genomic data resources and that will develop and validate procedural standards upon which current, new and prospective DACs can refer.

Project Narrative Data access committees (DAC) play critical gatekeeping roles that ensure sensitive genomic data involving humans are used only by authorized users with appropriate permissions and for ethically approved purposes. Current strategies for reviewing data access requests vary considerably across DACs and heavily rely on manual verification. These currently existing strategies are incompatible with the shift towards cloud-based data environments and are inadequate to meet growing demand for dynamic, real-time, and automated access decisions. This administrative supplement will support the development of operational standards for DACs at the NIH and internationally, as well as build technical capacities in implementing automated workflows that help to improve the quality and efficiency of data access review for large, publicly funded genomic data repositories.