Limited Competition: Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Clinical Sites (U01, Clinical Trial Required) | RFA HG 25 012

Opportunity Information: Apply for RFA HG 25 012

This funding opportunity is a limited-competition NIH Notice of Funding Opportunity (NOFO) for the next phase of the Electronic Medical Records and Genomics (eMERGE) program, focused specifically on outcomes. The program is titled "Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Clinical Sites" and uses the U01 cooperative agreement mechanism, meaning NIH will have substantial involvement in how the project is carried out compared with a typical investigator-initiated grant. It is also labeled "Clinical Trial Required," which signals that applicants are expected to conduct activities that meet NIH's definition of a clinical trial, such as prospective assignment or evaluation of interventions related to genomic risk assessment and management in real-world clinical settings.

The core purpose of the NOFO is to continue and expand follow-up for patients who previously received genomically informed risk assessment (GIRA) and related management recommendations through earlier eMERGE clinical site awards. The key emphasis is on collecting longer-term outcome data to understand what happens after genomic information is delivered and acted on in clinical care. NIH indicates that the eMERGE Network will extend through April 2030, with follow-up and outcome-data collection on roughly 25,000 patients. In practice, this is about moving beyond initial implementation and looking carefully at downstream clinical results, care processes, and the real-world impact of genomics integrated into electronic medical records.

Eligibility is tightly restricted. This is not an open competition; only organizations that were funded under the earlier eMERGE clinical site announcements RFA-HG-19-013 and RFA-HG-19-014 may apply. Applications will still go through standard NIH peer review, and only those deemed scientifically and operationally strong will be considered for funding, but the applicant pool is intentionally limited to existing, previously funded eMERGE clinical sites.

Several restrictions relate to foreign involvement. Non-U.S. entities (foreign organizations) cannot apply, and non-U.S. components of U.S. organizations are also not eligible to apply. The NOFO notes that "foreign components" as defined in the NIH Grants Policy Statement are allowed, which generally refers to certain project elements conducted outside the U.S. under specific NIH rules and disclosures. At the same time, NIH policy effective May 1, 2025 adds a major constraint: NIH will not issue awards that involve foreign subawards or subcontracts unless the application is submitted to a NOFO explicitly designed for funded international collaborations. As a result, any application to this NOFO that includes foreign subawards/subcontracts will be considered noncompliant and will not be funded. The policy does not forbid all international interaction; it still allows unfunded collaborations, foreign components where permissible, paying foreign consultants in allowable ways, or purchasing specialized equipment or supplies from foreign vendors. The main line NIH draws here is against sending grant funds to foreign institutions through subawards or subcontracts under this particular NOFO.

From an administrative and funding standpoint, the opportunity is issued by the National Institutes of Health (NIH) under CFDA (Assistance Listing) 93.172, and it is categorized as a discretionary health-related program. The opportunity number is RFA-HG-25-012, and the funding instrument is a cooperative agreement (U01). The original application closing date is January 30, 2026. NIH anticipates making about 10 awards, and the listed award ceiling is $330,000 (as presented in the source information), indicating an upper bound on the amount NIH expects to provide per award under the terms described.

Overall, the NOFO is essentially a continuation-and-outcomes phase for established eMERGE clinical sites: keep the network operating, continue following the previously enrolled cohort, and systematically collect outcome data through 2030 to determine the longer-term clinical and implementation effects of embedding genomic risk assessment and management into routine care via electronic medical records, all within a structured NIH-led cooperative agreement framework.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Clinical Sites (U01, Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172.
• This funding opportunity was created on 2025-12-23.
• Applicants must submit their applications by 2026-01-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $330,000.00 in funding.
• The number of recipients for this funding is limited to 10 candidate(s).
• Eligible applicants include: Others.

Apply for RFA HG 25 012

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