The Electronic Medical Records and Genomics (eMERGE): Genomic Risk Assessment and Management Network - Coordinating Center (U01 Clinical Trial Required) | RFA HG 19 015

Opportunity Information: Apply for RFA HG 19 015

The opportunity titled "The Electronic Medical Records and Genomics (eMERGE): Genomic Risk Assessment and Management Network - Coordinating Center (U01 Clinical Trial Required)" (Funding Opportunity Number RFA HG 19 015) is a National Institutes of Health (NIH) funding announcement designed to sustain and advance genomic implementation research within the long-running eMERGE Network. The central goal is to fund a single Coordinating Center (CC) that will serve as the operational and scientific hub for the broader network, with responsibility for providing shared infrastructure, day-to-day coordination, centralized support services, and network-level data analysis. The emphasis is on enabling the network to function as an integrated program rather than a loose collection of individual projects, which means the Coordinating Center is expected to harmonize processes, promote consistency across sites, and ensure the network can collectively generate rigorous evidence on how genomic risk assessment can be used and managed in real-world healthcare settings, particularly through electronic medical records.

This announcement uses the cooperative agreement mechanism (U01), which generally means NIH will have substantial programmatic involvement throughout the award period. In practical terms, applicants should expect an interactive relationship with NIH staff, including shared decision-making on key scientific and operational issues, active coordination with other funded components of eMERGE, and ongoing participation in network governance and working groups. The activity category is health, and the program is tied to CFDA 93.172. The title indicates "Clinical Trial Required," signaling that the Coordinating Center is not simply an administrative or data warehouse function; it is expected to support and participate in a program that includes clinical trial elements or clinical trial-like evaluation of implementation approaches. The Coordinating Center role typically includes support for protocol coordination, oversight of study operations across sites, standardization of measures and workflows, facilitation of regulatory and ethical compliance processes, and ensuring that clinical and genomic data can be analyzed in ways that support the network's research questions.

The scope of work described focuses on four core functions: centralized support, infrastructure, coordination, and data analysis. Centralized support often includes project management, meeting coordination, communications infrastructure, documentation, and shared tools that allow multiple institutions to execute aligned workplans. Infrastructure generally refers to the technical and procedural backbone needed for multi-site genomic implementation research, such as secure data transfer processes, common data models or harmonization strategies, analytics platforms, quality control pipelines, and standardized reporting. Coordination covers the network-wide orchestration needed to keep sites aligned, including timelines, deliverables, cross-site troubleshooting, and facilitation of collaboration among clinical sites, laboratories, informatics teams, and investigators. Data analysis highlights that the Coordinating Center is expected to play a major scientific role in compiling, cleaning, harmonizing, and analyzing data generated across the network, supporting both interim monitoring and final outcomes analyses that evaluate genomic risk assessment and management in clinical care.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education where noted); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly notes additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions.

At the same time, the FOA places clear limits on foreign involvement. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, are allowed. This distinction matters because it permits U.S. applicants to include certain foreign collaborations or elements when justified and compliant with NIH policy, while keeping the primary award and applicant organization domestic.

Key administrative details included in the source information are that the agency is NIH, the opportunity category is discretionary, and the FOA was created on May 23, 2019, with an original closing date of August 2, 2019. The award ceiling and expected number of awards are not specified in the provided text. Overall, the opportunity is best understood as funding a central backbone organization for a complex, multi-site genomic medicine program, with responsibilities that span operational leadership, informatics and data coordination, and network-wide analytic support to help translate genomic risk information into actionable clinical practice through electronic medical record-enabled implementation research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "The Electronic Medical Records and Genomics (eMERGE): Genomic Risk Assessment and Management Network - Coordinating Center (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 2019-05-23.
• Applicants must submit their applications by 2019-08-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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