Single Source: Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Coordinating Center (U01 Clinical Trial Required)

The National Institutes of Health (NIH), through the National Human Genome Research Institute (NHGRI), is announcing a single-source funding opportunity titled "Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Coordinating Center." This opportunity is a continuation of the previous eMERGE Coordinating Center award (RFA-HG-19-015) and is intended solely for Vanderbilt University Medical Center, which has served as the coordinating center for the eMERGE Network. The funding is issued under the U01 cooperative agreement mechanism, which involves substantial NIH scientific and programmatic collaboration throughout the project. The award aims to support the continued coordination and outcome analysis for the approximately 25,000 participants previously enrolled in the eMERGE Network, all of whom have received Genomic Informed Risk Assessment (GIRA) reports. The eMERGE Network has advanced the development and use of electronic medical records (EMRs) combined with genomic data to improve health outcomes. In its fourth phase (2020–2026), the Network focused on validating polygenic risk scores (PRS) across ancestries, combining genomic and clinical data for risk assessment, and assessing how genomic risk information influences patient care. The extension through 2030 will allow the Coordinating Center (CC) to oversee longer-term follow-up—extending from a minimum of one to four years—of patients who received GIRA. This longitudinal analysis will assess uptake and sustainability of risk-reduction strategies, adherence to clinical recommendations, and differences in outcomes across demographics and healthcare settings. The CC will be responsible for a variety of tasks including data harmonization across clinical sites, analysis of clinical and cost-effectiveness outcomes, implementation of protocol updates, and data sharing through platforms such as AnVIL, dbGaP, and ClinVar. The CC must also support clinical sites in patient retention efforts, especially for populations traditionally harder to retain, and track patients no longer receiving care at participating sites. Additional duties include managing the eMERGE website, supporting genomic decision support tools, and ensuring data is securely and effectively shared. The CC may optionally involve community input mechanisms such as advisory boards or focus groups to enhance participant engagement and interpretation of research findings. Applications must adhere strictly to NIH instructions and will undergo a peer-review process, with additional administrative review of the Data Management and Sharing (DMS) Plan. The proposed work must include a clinical trial, and applicants are required to register the study with ClinicalTrials.gov. The application budget is capped at $687,000 in direct costs per year, with a total program commitment of $1.2 million annually for fiscal years 2026 to 2029. The award duration is four years. This grant does not require cost sharing. Key dates include an open date of February 6, 2026, and a submission deadline of March 6, 2026. Scientific merit reviews will occur in July 2026, with advisory review in October 2026 and awards anticipated in December 2026. Only one application is allowed from the eligible entity (Vanderbilt University Medical Center). Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or institutional system-to-system tools. All NIH and HHS requirements for registration and application submission must be met, and non-compliant applications will not be reviewed. Eligibility is highly specific to Vanderbilt University Medical Center as the only entity previously funded under RFA-HG-19-015. No other applicants will be considered. The CC must demonstrate prior coordination of multi-site research, expertise in genomic medicine and data systems, and capacity to manage diverse elements such as quality assurance, EMR data capture, and stakeholder communication. NHGRI will provide programmatic support and governance via a Steering Committee, including NIH scientists and awardee representatives. The CC will work collaboratively with clinical sites and the NIH to conduct longitudinal research on the impact of genomic risk assessments.

Focus on high-quality outcome data, longitudinal follow-up, support for retention, and collaborative governance with NHGRI and sites.