Limited Competition: Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Clinical Sites (U01, Clinical Trial Required)

The Limited Competition: Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Clinical Sites is a targeted funding initiative issued by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services. This Notice of Funding Opportunity (NOFO), labeled RFA-HG-25-012, is specifically open to previously funded organizations under RFA-HG-19-013 and RFA-HG-19-014. The funding opportunity aims to support continued work within the eMERGE Network, which explores how genomic risk assessments can be effectively integrated into clinical practice. The primary goal is to extend the follow-up of approximately 25,000 patients who received Genomic Informed Risk Assessments (GIRA), collecting outcome data through at least April 2030. NHGRI's focus is to support the development and application of genomics-based methods to improve public health outcomes. The eMERGE initiative is a multi-site research network combining genomic data with electronic medical records (EMRs) to guide risk assessment and clinical management. In its current phase, the Network's objectives include validating polygenic risk scores (PRS) across diverse ancestry groups, developing EMR-based tools for communicating risk, and evaluating the implementation and impact of GIRA on healthcare decisions. The follow-up work funded by this NOFO will involve a minimum of four years of longitudinal data collection and analysis. The outcomes will assess long-term adherence to genomic-based interventions, patient and clinician understanding of risk, and the effectiveness of risk reduction strategies. The allowable use of funds includes implementing risk management recommendations, patient retention activities, and data extraction and harmonization in accordance with eMERGE protocols. Each Clinical Site is responsible for retaining and tracking their patient cohorts, analyzing EMR and questionnaire data, and participating in collaborative data analysis using the AnVIL platform. The maximum award budget is $330,000 per year in direct costs, with a project period of up to four years. NHGRI anticipates funding ten awards per fiscal year from FY 2026 to FY 2029, totaling up to $5.8 million annually. There is no cost sharing or matching requirement. Applicants must submit a renewal application, as only organizations with prior funding under specific eMERGE RFAs are eligible. Applications must include a detailed research strategy, budget, and resource-sharing plans aligned with NHGRI and NIH data-sharing expectations. The application period opens on December 30, 2025, with a submission deadline of January 30, 2026, at 5:00 PM local time. The earliest possible start date for funded projects is December 2026. Applications must be submitted via ASSIST, institutional system-to-system portals, or Grants.gov Workspace. All components must conform to NIH's standard application guide, and deviations must follow program-specific instructions outlined in this NOFO. Evaluation criteria include significance, innovation, rigor, feasibility, investigator expertise, and institutional environment. Reviewers will also consider plans for data quality control, harmonization, long-term patient follow-up, and community engagement strategies. A Steering Committee (SC) will govern the overall eMERGE Network, with oversight from an External Scientific Panel (ESP). The Coordinating Center (CC) will manage data standardization, deposition into repositories like AnVIL and ClinVar, and coordinate Network-wide activities. Key contacts for inquiries include the NHGRI Division of Genomic Medicine ([email protected]) for scientific matters and the NHGRI Grants Administration Branch ([email protected]) for financial or administrative questions. The program is governed by cooperative agreement terms, with substantial NIH involvement in project oversight. Following peer review, applications will undergo Council review in August 2026, with awards expected by December 2026.

Align plans with eMERGE GIRA protocol; ensure data quality, retention strategy, and collaboration with CC and SC.