Opportunity Information: Apply for RFA HG 17 010

Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Coordinating Center (RFA HG 17 010) is a National Institutes of Health (NIH) funding opportunity aimed at building the central hub for the IGNITE II Pragmatic Clinical Trials Network. The broader IGNITE II effort is designed to move genomic medicine beyond pilot projects and into routine care by running pragmatic clinical trials in real-world health care settings. Those trials are intended to generate practical, generalizable evidence about when genomic interventions actually help patients, what they cost, and how to implement them effectively across different types of clinics and health systems.

The core purpose of the network is to measure the clinical utility and cost-effectiveness of genomic medicine interventions, while also testing how these interventions can be integrated into everyday clinical workflows. A key emphasis is on pragmatic clinical trials, meaning studies that are embedded in typical care environments rather than tightly controlled research-only settings. The goal is to learn not only whether genomic tools work under ideal conditions, but whether they work in the messy reality of busy clinics, diverse patient populations, and varying levels of infrastructure. The network also aims to clarify which kinds of genomic medicine interventions truly require randomized clinical trials and to identify the most effective and efficient ways to run those trials at scale.

This particular FOA focuses specifically on the Coordinating Center (CC), which is intended to serve as the operational and scientific backbone of the network. While the announcement text provided does not spell out every duty, the CC role in a pragmatic trials network typically includes coordinating across multiple participating clinical sites, harmonizing protocols and common data elements, supporting consistent trial operations, facilitating communications and governance, and helping ensure that results are comparable and broadly usable. The Coordinating Center is also positioned to support the production of generalizable knowledge by helping standardize approaches, track progress across studies, and enable network-wide learning.

IGNITE II is structured to include multiple Clinical Groups (CGs), including “enhanced diversity” Clinical Groups, alongside a single Coordinating Center. This FOA runs in parallel with companion announcements that solicit applications for the Clinical Groups (RFA-HG-17-008) and the enhanced diversity Clinical Groups (RFA-HG-17-009). In other words, applicants to this FOA are applying to run the centralized coordinating function, while the companion FOAs cover the on-the-ground clinical research teams that will enroll participants and implement interventions.

The award mechanism is a cooperative agreement, reflecting that NIH expects substantial involvement during the project rather than a more hands-off grant relationship. The activity category is health, and the CFDA number listed is 93.172. The opportunity is categorized as discretionary funding. The original closing date for applications was 2017-11-03, and the FOA was created on 2017-07-25. An award ceiling and expected number of awards are not specified in the provided source details.

Eligibility is broad and includes many common U.S.-based applicant types such as state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also highlights additional eligible applicant categories 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 government agencies, and U.S. territories or possessions. At the same time, it clearly restricts 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 defined by NIH policy) are not allowed.

In practical terms, the opportunity is geared toward organizations capable of managing complex, multi-site pragmatic clinical trials in genomic medicine, especially in a way that supports consistent methods across varied health care environments and ensures the evidence generated is broadly applicable. The network-wide emphasis on diverse clinical settings, including enhanced diversity clinical groups, signals that the overall program is meant to produce findings that reflect the full range of patients and care contexts found in real U.S. health systems.

  • 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 Coordinating Center" 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.
Apply for RFA HG 17 010

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Frequently Asked Questions (FAQs)

What is the IGNITE II: Pragmatic Clinical Trials Coordinating Center funding opportunity?

Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Coordinating Center (RFA HG 17 010) is a National Institutes of Health (NIH) funding opportunity to establish and operate the Coordinating Center (CC) for the IGNITE II Pragmatic Clinical Trials Network. The CC is intended to function as the central hub that supports network-wide trial coordination and learning across multiple clinical sites.

What is the overall goal of the IGNITE II Pragmatic Clinical Trials Network?

The broader IGNITE II effort is designed to move genomic medicine beyond pilot projects and into routine clinical care by running pragmatic clinical trials in real-world health care settings. The network aims to generate practical, generalizable evidence about when genomic interventions help patients, what they cost, and how to implement them effectively across different clinics and health systems.

What types of studies does IGNITE II emphasize?

IGNITE II emphasizes pragmatic clinical trials, meaning studies embedded in typical care environments rather than tightly controlled, research-only settings. The intent is to assess how genomic tools perform in the real conditions of busy clinics, diverse patient populations, and varying levels of health system infrastructure.

What is meant by "pragmatic clinical trials" in this program?

In this context, pragmatic clinical trials are studies designed to fit into everyday clinical workflows and real-world care delivery. The focus is not only whether an intervention can work under ideal conditions, but whether it works in routine practice and how it can be implemented effectively at scale.

What is the specific focus of this FOA compared with the broader IGNITE II program?

This FOA focuses specifically on the Coordinating Center (CC). Companion announcements solicit applications for the Clinical Groups (RFA-HG-17-008) and the enhanced diversity Clinical Groups (RFA-HG-17-009). In practical terms, this FOA supports the centralized coordinating function, while companion FOAs support the clinical research teams that enroll participants and implement interventions.

What is the role of the Coordinating Center (CC) in IGNITE II?

The CC is intended to serve as the operational and scientific backbone of the network. While the provided text does not list every duty, a coordinating center in a pragmatic trials network typically coordinates across participating clinical sites, harmonizes protocols and common data elements, supports consistent trial operations, facilitates communications and governance, and helps ensure results are comparable and broadly usable across studies.

How does the Coordinating Center support "generalizable knowledge" across the network?

The CC is positioned to support generalizable knowledge by helping standardize approaches across sites and studies, tracking progress across trials, and enabling network-wide learning so that evidence generated can be broadly applicable across varied health care settings.

What outcomes is IGNITE II trying to measure?

The core purpose of the network is to measure the clinical utility and cost-effectiveness of genomic medicine interventions, while also testing how these interventions can be integrated into everyday clinical workflows.

Does IGNITE II only study whether genomic interventions work?

No. In addition to whether genomic interventions help patients, IGNITE II is designed to study what they cost and how to implement them effectively across different types of clinics and health systems.

Does IGNITE II address whether randomized clinical trials are always needed?

Yes. The network aims to clarify which kinds of genomic medicine interventions truly require randomized clinical trials and to identify efficient ways to run trials at scale.

How is IGNITE II organized?

IGNITE II is structured to include multiple Clinical Groups (CGs), including enhanced diversity Clinical Groups, alongside a single Coordinating Center.

What are "enhanced diversity" Clinical Groups?

The provided information indicates that enhanced diversity Clinical Groups are part of the network structure and signal an emphasis on producing findings that reflect the full range of patients and care contexts found in real U.S. health systems. Specific operational details about these groups are not provided in the text.

What funding mechanism does this opportunity use?

The award mechanism is a cooperative agreement, which means NIH expects substantial involvement during the project rather than a more hands-off relationship typical of some grant types.

What is the activity category for this opportunity?

The activity category is health.

What is the CFDA number for this opportunity?

The CFDA number listed is 93.172.

Is this funding considered discretionary?

Yes. The opportunity is categorized as discretionary funding.

When was this FOA created, and what was the application closing date?

The FOA was created on 2017-07-25, and the original closing date for applications was 2017-11-03.

Is the award ceiling provided in the information shown?

No. An award ceiling is not specified in the provided source details.

Is the expected number of awards provided in the information shown?

No. The expected number of awards is not specified in the provided source details.

Who is eligible to apply?

Eligibility is broad and includes state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities.

Are specific institution types and community-based organizations included in eligibility?

Yes. The FOA highlights additional eligible applicant categories 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 government agencies, and U.S. territories or possessions.

Are foreign organizations eligible to apply?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.

Can a U.S. organization apply if part of the work is a non-domestic component?

No. Non-domestic components of U.S. organizations are not eligible.

Are foreign components allowed under NIH policy for this opportunity?

No. Foreign components (as defined by NIH policy) are not allowed.

What kind of applicant is this opportunity best suited for?

Based on the description provided, the opportunity is geared toward organizations capable of managing complex, multi-site pragmatic clinical trials in genomic medicine, including coordinating consistent methods across varied health care environments and supporting evidence that is broadly applicable.

What is the relationship between this Coordinating Center FOA and the Clinical Group FOAs?

This FOA supports the centralized Coordinating Center function. Companion FOAs (RFA-HG-17-008 and RFA-HG-17-009) solicit applications for Clinical Groups, including enhanced diversity Clinical Groups, which are the on-the-ground teams that enroll participants and implement interventions.

Does the provided information list every specific duty of the Coordinating Center?

No. The provided text notes that it does not spell out every duty, but it describes typical coordinating center responsibilities such as cross-site coordination, protocol and data harmonization, operational support, communications and governance facilitation, and ensuring comparability and usability of results.

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