NIH Health Care Systems Research Collaboratory - Pragmatic and Implementation Trials of Embedded Interventions (UG3/UH3, Clinical Trials Optional) | RFA AT 22 001

Opportunity Information: Apply for RFA AT 22 001

The NIH Health Care Systems Research Collaboratory funding opportunity (RFA-AT-22-001) supports large, practical studies designed to improve health outcomes for underserved patient populations in the United States. It is aimed at generating real-world evidence about health care strategies, clinical practices, and care delivery procedures as they are actually used in everyday health care settings, rather than in tightly controlled academic or laboratory environments. The expectation is that findings will be useful not only to researchers, but also to policy makers, payers, clinicians, and patients across a wide range of care settings, especially where communities have experienced disproportionate disease burden and persistent gaps in care.

The award uses a phased UG3/UH3 cooperative agreement structure. Applicants submit one combined application that covers both phases. The first phase (UG3) is a one-year, milestone-driven planning and feasibility period where teams finalize key elements needed for a successful embedded pragmatic trial or implementation study, such as operational readiness, workflow integration, data access and quality, recruitment and retention approaches in routine care, and coordination across participating systems. Only projects that meet predefined scientific milestones and feasibility requirements during UG3 are eligible to transition to the second phase (UH3), which supports the full implementation and conduct of the pragmatic trial or implementation study. Because this is a cooperative agreement, NIH has an active partnership role, meaning awardees should expect ongoing collaboration, shared problem-solving, and coordinated expectations rather than a fully hands-off grant mechanism.

A central requirement is that the intervention being tested must be embedded within health care delivery, meaning it needs to fit into real-world workflows and systems of care. Studies can test the integration of one intervention or multiple components, including multi-modal approaches, as long as the underlying strategies have demonstrated efficacy and the proposed work focuses on pragmatic evaluation or implementation at scale. Projects may also focus on health care system changes that increase adherence to evidence-based guidelines, such as clinical decision support, care pathway redesign, team-based care modifications, population health management processes, or other system-level approaches that improve uptake and consistent delivery of proven practices.

The FOA emphasizes multi-system, scalable research. Proposed trials or studies must be conducted across three or more health care systems that provide care to underserved populations. Awardees become part of and work with the NIH Health Care Systems Research Collaboratory, a national program designed to strengthen how embedded research is planned and executed in partnership with health care systems. The Collaboratory includes a Collaboratory Coordinating Center (CCC) that provides leadership and technical expertise across major domains of embedded research in health care systems, helping projects address common challenges such as stakeholder engagement, ethics and regulatory considerations in pragmatic trials, data harmonization and quality, operational integration, and dissemination planning.

Eligibility is broad within the United States and includes many types of domestic organizations and governmental entities. Eligible applicants listed include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other 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. The FOA also highlights participation by institutions and organizations that often serve underserved communities, such as 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, as well as faith-based or community-based organizations and certain regional organizations.

Foreign participation is not allowed under this announcement. 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) are not permitted. In short, the work is intended to be designed, led, and carried out within U.S.-based systems serving U.S. patient populations.

Administratively, the opportunity is offered by the National Institutes of Health as a discretionary program using the cooperative agreement funding instrument, within education and health-related activity categories. It references multiple CFDA numbers (93.213, 93.233, 93.307, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.866), reflecting the multi-institute nature of NIH support for pragmatic and implementation research topics. The original closing date listed for this FOA was June 17, 2022, and the FOA was created on October 14, 2021.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "NIH Health Care Systems Research Collaboratory - Pragmatic and Implementation Trials of Embedded Interventions (UG3/UH3, Clinical Trials Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.233, 93.307, 93.361, 93.837, 93.838, 93.839, 93.840, 93.846, 93.866.
• This funding opportunity was created on 2021-10-14.
• Applicants must submit their applications by 2022-06-17. (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 AT 22 001

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