Opportunity Information: Apply for RFA RM 16 019
The NIH Health Care Systems Research Collaboratory Demonstration Projects for Pragmatic Clinical Trials (UG3/UH3) opportunity (RFA-RM-16-019) is a National Institutes of Health cooperative agreement program designed to fund large, efficient pragmatic clinical trials that take place in real-world care settings. The central goal is to generate practical evidence that health care systems can actually use, rather than running tightly controlled studies that do not reflect routine clinical practice. To qualify, proposed trials must be conducted across two or more health care systems and must be carried out as part of the NIH Health Care Systems Research Collaboratory, a Common Fund effort that provides a national framework, resources, and expertise for doing pragmatic trials embedded in health care delivery.
A key feature of this funding opportunity is its two-phase UG3/UH3 structure, submitted as a single combined application. The first phase (UG3) supports a one-year, milestone-driven planning period focused on proving feasibility and readiness to launch a full-scale pragmatic trial. During this planning year, applicants are expected to lock down critical elements such as final study protocols, health system partnerships, data sources and workflows (often involving electronic health records), recruitment and implementation logistics, regulatory and ethical approvals, and any operational procedures needed to run the study across multiple systems. Transition to the second phase (UH3) is not automatic. After the UG3 planning period, NIH conducts an administrative review to determine whether the project has met its predefined milestones and feasibility requirements. Only UG3 projects that clear that bar, and only if funds are available, can rapidly move into the UH3 implementation phase, where the pragmatic clinical trial is executed at scale.
Because this is a cooperative agreement, NIH expects a more hands-on partnership than in a typical research grant. Awardees generally work closely with NIH program staff and align with Collaboratory expectations, which can include using shared tools, following common approaches to pragmatic trial challenges, and participating in Collaboratory activities intended to improve trial efficiency and cross-project learning. The emphasis is on demonstrating how to run complex, system-embedded trials in ways that are scalable, sustainable, and informative for health care decision-making.
Eligibility is broad across domestic U.S. organizations and government entities. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it places strict limits on foreign involvement: non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply, and foreign components are not allowed under NIH policy for this FOA.
From an administrative standpoint, the opportunity falls under NIH’s discretionary funding category and uses the cooperative agreement instrument. It is listed under multiple CFDA numbers associated with NIH research programs. The original posting dates indicate it was created on November 23, 2016, with an original closing date of June 2, 2017. The source data lists an award ceiling of $500,000, signaling an upper bound on costs as represented in the listing. Overall, the opportunity targets teams that can partner with multiple health care systems, plan quickly and rigorously during the UG3 year, and then deliver a full pragmatic clinical trial during the UH3 phase that meaningfully tests an intervention under routine clinical conditions.Apply for RFA RM 16 019
- The National Institutes of Health in the education, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "NIH Health Care Systems Research Collaboratory - Demonstration Projects for Pragmatic Clinical Trials (UG3/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.233, 93.279, 93.310, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.865, 93.866.
- This funding opportunity was created on 2016-11-23.
- Applicants must submit their applications by 2017-06-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- 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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Frequently Asked Questions (FAQs)
What is the NIH Health Care Systems Research Collaboratory Demonstration Projects for Pragmatic Clinical Trials (UG3/UH3) opportunity?
This opportunity (RFA-RM-16-019) is a National Institutes of Health (NIH) cooperative agreement program that funds large, efficient pragmatic clinical trials conducted in real-world health care settings. The focus is on producing practical evidence that health care systems can use in routine decision-making.
What is the main goal of this funding opportunity?
The central goal is to generate practical, usable evidence by running pragmatic clinical trials embedded in everyday care delivery, rather than tightly controlled studies that may not reflect routine clinical practice.
What types of studies does this program support?
It supports pragmatic clinical trials that are embedded within health care delivery settings and designed to operate under routine clinical conditions. The trials are expected to be large and efficient and to produce results that matter for health care decision-making.
Where must the trials take place?
Trials must take place in real-world care settings and be conducted across two or more health care systems.
Is participation in the NIH Health Care Systems Research Collaboratory required?
Yes. Proposed trials must be carried out as part of the NIH Health Care Systems Research Collaboratory, a Common Fund effort that provides a national framework, resources, and expertise for pragmatic trials embedded in health care delivery.
What is the UG3/UH3 structure?
The funding uses a two-phase UG3/UH3 structure that is submitted as a single combined application. The first phase (UG3) supports a one-year planning period. The second phase (UH3) supports implementation of the full-scale pragmatic clinical trial if planning milestones are met and funds are available.
How long is the UG3 planning phase, and what is it for?
The UG3 phase is a one-year, milestone-driven planning period intended to demonstrate feasibility and readiness to launch the pragmatic trial at full scale.
What kinds of activities are expected during the UG3 planning year?
During UG3, applicants are expected to finalize key elements needed to run a multi-system pragmatic trial, including final study protocols, health system partnerships, data sources and workflows (often involving electronic health records), recruitment and implementation logistics, regulatory and ethical approvals, and operational procedures needed for execution across multiple systems.
Is transition from UG3 to UH3 automatic?
No. Transition is not automatic. After the UG3 planning period, NIH conducts an administrative review to determine whether predefined milestones and feasibility requirements have been met.
What determines whether a project can move from UG3 to UH3?
Only UG3 projects that meet the predefined milestones and feasibility requirements, and only if funds are available, may move into the UH3 phase.
What happens during the UH3 phase?
During the UH3 phase, the pragmatic clinical trial is executed at scale in real-world health care systems.
What does it mean that this is a cooperative agreement?
A cooperative agreement indicates a more hands-on partnership with NIH than a typical research grant. Awardees generally work closely with NIH program staff and align with Collaboratory expectations.
What kinds of expectations come with being part of the Collaboratory under a cooperative agreement?
Expectations can include using shared tools, following common approaches to pragmatic trial challenges, and participating in Collaboratory activities designed to improve trial efficiency and encourage cross-project learning.
Why does the program emphasize pragmatic trials in routine care settings?
The emphasis is on demonstrating how to run complex trials embedded in health care systems in ways that are scalable, sustainable, and informative for real health care decisions.
Who is eligible to apply?
Eligibility is broad across domestic U.S. organizations and government entities. Eligible applicants include various levels of U.S. government (state, county, city, township, special district), independent school districts, public and private institutions of higher education, federally recognized Native American tribal governments, non-federally recognized tribal organizations, public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations other than small businesses, and small businesses.
Are there additional specific institution types highlighted as eligible?
Yes. The announcement highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Are non-U.S. organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply under this opportunity.
Can a U.S. organization include non-U.S. components in the application?
No. Non-U.S. components of U.S. organizations are not eligible to apply, and foreign components are not allowed under NIH policy for this funding opportunity.
What is the funding category and instrument type for this opportunity?
It falls under NIH discretionary funding and uses the cooperative agreement instrument.
Are there CFDA numbers associated with this opportunity?
Yes. The listing indicates it is associated with multiple CFDA numbers connected to NIH research programs.
What are the original posting and closing dates listed for this opportunity?
The original posting date listed is November 23, 2016, and the original closing date listed is June 2, 2017.
Is there an award ceiling mentioned?
Yes. The source data lists an award ceiling of $500,000, indicating an upper bound on costs as represented in the listing.
What kind of project teams is this opportunity aiming to support?
It targets teams that can partner with multiple health care systems, complete rigorous feasibility and readiness work during the UG3 year, and then deliver a full pragmatic clinical trial during the UH3 phase that tests an intervention under routine clinical conditions.
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