Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Clinical Groups (U01) | RFA HG 17 008

Opportunity Information: Apply for RFA HG 17 008

Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials - Clinical Groups (U01) is a National Institutes of Health (NIH) funding opportunity (RFA-HG-17-008) that supports participation in the IGNITE II Pragmatic Clinical Trials Network. The overall aim of this network is to move genomic medicine beyond tightly controlled research environments and into everyday clinical care, using pragmatic clinical trials that reflect real-world practice. Through these trials, funded groups are expected to generate practical, generalizable evidence about whether specific genomic medicine interventions actually improve patient outcomes and whether they do so in a way that is cost-effective for health systems and payers.

The core purpose of the FOA is to build and test approaches for implementing genomic interventions across diverse healthcare settings, not just large academic medical centers. The emphasis on pragmatic clinical trials signals that NIH is looking for studies designed to work under routine clinical conditions, where workflows, staffing, patient populations, and resource constraints vary widely. The network is intended to measure clinical utility (how genomic information changes clinical decisions and improves outcomes) and cost-effectiveness (whether benefits justify costs in real clinical deployment). Just as importantly, the program is meant to produce broader lessons about which types of genomic medicine interventions truly require randomized clinical trials to establish value, and what trial methods are most effective for running these studies in busy healthcare environments.

A central requirement is meaningful inclusion of populations that have historically been left out of genomic research and that often experience worse health outcomes. Applicants under this specific FOA are expected to recruit at least 35 patients from racial or ethnic minority populations, underserved populations, or groups that experience poorer medical outcomes. The announcement explicitly contrasts this with the companion opportunity (RFA-HG-17-009), which carries a higher minimum expectation of 75 such patients, making clear that NIH is setting concrete enrollment expectations tied to equity and representativeness rather than treating diversity as a purely aspirational goal.

The award mechanism is a U01 cooperative agreement, which generally means the funded project will involve substantial NIH program involvement compared with a standard research grant. In practice, this often aligns with network-style research where NIH may coordinate across sites, harmonize measures, encourage shared protocols or data elements, and guide collaborative activities that help the overall network achieve its objectives. The activity category is health, and the CFDA listing provided is 93.172.

Eligibility is broad and includes many types of U.S.-based organizations that can run clinical research and implement changes in healthcare delivery. Eligible applicants listed 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 and other tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also calls out additional eligible applicant categories that are especially relevant to serving diverse communities, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, and U.S. territories or possessions.

At the same time, the announcement is strict about foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed. This means the work and organizational structure must remain domestic, and applicants cannot rely on overseas components to carry out key parts of the project.

Administrative details in the source data indicate the funding opportunity was created on July 25, 2017, with an original closing date of November 3, 2017. The funding instrument is listed as a cooperative agreement, and while the source text does not provide an award ceiling or the expected number of awards, the intent is clearly to fund clinical groups that will function as part of a coordinated national network focused on real-world genomic medicine trials and implementation science in diverse care settings.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Clinical Groups (U01)" 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 2017-07-25.
• Applicants must submit their applications by 2017-11-03. (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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