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.

  • 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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