The Electronic Medical Records and Genomics (eMERGE): Genomic Risk Assessment and Management Network - Enhanced Diversity Clinical Sites (U01 Clinical Trial Required) | RFA HG 19 014

Opportunity Information: Apply for RFA HG 19 014

The Electronic Medical Records and Genomics (eMERGE): Genomic Risk Assessment and Management Network - Enhanced Diversity Clinical Sites (U01 Clinical Trial Required) is an NIH funding opportunity (RFA-HG-19-014) that supports participation in the long-running eMERGE network, which links biorepositories to electronic medical records (EMRs) to enable large-scale genomic and clinical research. The central purpose of this round is to move beyond discovery alone and focus on building, testing, and spreading practical genomic risk assessment and clinical management tools that can be used in real health care settings. Because it is a U01 cooperative agreement, awardees are expected to work closely with NIH program staff and with other eMERGE sites as part of a coordinated network effort, rather than operating as completely independent projects. The announcement also specifies that a clinical trial is required, meaning applicants should be prepared to conduct and report a prospective clinical study component consistent with NIH definitions.

A defining feature of this FOA is its emphasis on improving diversity and equity in genomic medicine. Applicants funded under this "Enhanced Diversity Clinical Sites" opportunity are expected to recruit at least 75 patients from groups that have historically been underrepresented in research or that experience worse health outcomes, including racial or ethnic minority populations, underserved communities, and populations with poorer medical outcomes. The FOA explicitly contrasts this requirement with a companion announcement (RFA-HG-19-013), which has a lower minimum recruitment expectation (35 such patients), signaling that this mechanism is designed to bring in sites that can substantially strengthen representation and generalizability in the eMERGE research and implementation activities.

From a project standpoint, the work centers on using existing or newly developed biorepositories that are linked to EMR data, allowing researchers and clinicians to connect genomic findings with real-world clinical histories, diagnoses, medications, laboratory results, and outcomes. Within the eMERGE framework, awardees are expected to contribute to the development, evaluation, and dissemination of tools that translate genomic information into actionable assessments of disease risk and corresponding management strategies. In practical terms, this can involve designing and validating genomic risk models, integrating risk information into clinical workflows, studying how clinicians and patients use these tools, and measuring outcomes that show whether genomic risk assessment improves care, decision-making, or health results across diverse patient populations.

Eligibility is broad and reflects the program's interest in reaching many types of clinical and community settings. Eligible applicants include state, county, and local governments; 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also highlights additional eligible applicants that align with diversity and community reach, including 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, non-U.S. (foreign) entities, and U.S. territories or possessions. This wide eligibility list underscores that NIH is open to a range of clinical sites and partner organizations capable of recruiting and supporting diverse participants and implementing genomics-informed care approaches.

Administratively, this is a discretionary NIH opportunity in the health category, using the cooperative agreement funding instrument (U01) under CFDA 93.172. The opportunity was created on May 23, 2019, and the original closing date was August 2, 2019. While the excerpt does not provide an award ceiling or the expected number of awards, the key takeaways are the network-based cooperative structure, the requirement for a clinical trial component, and the explicit recruitment emphasis on enrolling at least 75 participants from underrepresented or underserved populations to strengthen the evidence base and real-world applicability of genomic risk assessment and management.

• 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 - Enhanced Diversity 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 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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