Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Enhanced Diversity Clinical Groups (U01) | RFA HG 17 009

Opportunity Information: Apply for RFA HG 17 009

Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Enhanced Diversity Clinical Groups (U01) is a National Institutes of Health (NIH) funding opportunity (RFA HG 17 009) that supports participation in the IGNITE II Pragmatic Clinical Trials Network. The core purpose of this network is to run pragmatic clinical trials in real health care environments to figure out when and how genomic medicine interventions actually improve patient care outside of tightly controlled research settings. The program is designed to generate evidence that is directly usable by health systems, clinicians, payers, and policymakers, with an emphasis on answering practical questions about clinical utility (whether the genomic intervention leads to better health decisions or outcomes) and cost-effectiveness (whether the benefits justify the costs in routine care).

A central feature of this FOA is its strong focus on diversity and equity in clinical research participation. Applicants are expected to recruit at least 75 patients drawn from racial or ethnic minority populations, underserved populations, or groups that experience poorer medical outcomes. This requirement is explicitly higher than the companion announcement (RFA HG-17-008), which expects a minimum of 35 such participants, signaling that this particular opportunity is meant to strengthen the evidence base for genomic medicine in populations that have historically been underrepresented in genomics research and may face barriers to access or benefit. In practice, this means proposed trials should be designed to work in varied, real-world clinical settings and should thoughtfully address recruitment, engagement, retention, and implementation challenges that can disproportionately affect these communities.

The trials supported through the IGNITE II network are intended to be pragmatic, meaning they are embedded in routine clinical workflows and aim to produce generalizable knowledge. The network is expected to evaluate approaches for implementing genomic medicine in diverse health care settings, and to clarify which genomic interventions are ready for randomized clinical trials versus those that may require different evidence-building strategies. Another key objective is to develop and refine effective methods for conducting these kinds of trials, including the practicalities of integrating genomic testing, returning results, supporting clinical decision-making, and measuring downstream outcomes in everyday care.

This opportunity uses a U01 cooperative agreement mechanism, which typically indicates substantial scientific or programmatic involvement by NIH staff compared to standard research project grants. In cooperative agreements, awardees generally collaborate as part of a coordinated program or network, aligning on common goals, shared measures, and cross-site learning. Here, that structure supports the larger IGNITE II goal of producing broadly applicable implementation and outcomes evidence rather than isolated, single-site findings.

Eligibility is broad across U.S.-based organizations and includes many public and private entities such as 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; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant types that are often key partners for reaching underserved communities, including faith-based or community-based organizations; Historically Black Colleges and Universities (HBCUs); Hispanic-serving institutions; Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with U.S. territories or possessions and certain regional organizations.

At the same time, the opportunity clearly restricts foreign participation. Non-domestic (non-U.S.) entities are not eligible to apply as foreign institutions, and non-domestic components of U.S. organizations are not eligible. In addition, foreign components, as defined by the NIH Grants Policy Statement, are not permitted. This means applicants must plan to carry out the supported work entirely through eligible U.S.-based organizations and components.

In terms of administrative details provided, the opportunity is categorized as discretionary funding, uses the cooperative agreement funding instrument, and falls under the health funding activity category (CFDA 93.172). The posting indicates an original closing date of 2017-11-04 and a creation date of 2017-07-25. While the excerpt does not list an award ceiling or expected number of awards, the overall structure indicates NIH intends to build a coordinated set of clinical groups capable of running rigorous, real-world genomic medicine trials with a deliberate emphasis on improving representation and relevance for populations that are often left out of genomics research and that may bear a disproportionate burden of disease.

• 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 Enhanced Diversity 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 2017-11-04. (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.

Apply for RFA HG 17 009

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