Autoimmunity Centers of Excellence, Clinical Research Program (UM1 Clinical Trial Required) | RFA AI 22 071

Opportunity Information: Apply for RFA AI 22 071

The Autoimmunity Centers of Excellence, Clinical Research Program (UM1 Clinical Trial Required) funding opportunity (RFA-AI-22-071) is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) cooperative agreement designed to bring research teams into the established Autoimmunity Centers of Excellence (ACE) network. The ACE network is built around the idea that tightly coordinated collaboration between clinical investigators and basic scientists can speed up progress in understanding autoimmune disease biology and translating that knowledge into better strategies to prevent, diagnose, and treat autoimmune conditions. This specific announcement is focused on the clinical side of the network, while a companion announcement supports the basic research program, with both programs meant to work in parallel and in close coordination.

Under this FOA, applicants are expected to conduct innovative, human-focused autoimmunity studies through Clinical Projects and Collaborative Projects. A central emphasis is on clinical trials and other well-designed clinical research that can directly test immune-modulating interventions and generate meaningful insights from patients and human samples. Because this is a UM1 mechanism with a clinical trial requirement, the program is structured for complex, multi-component clinical research efforts that benefit from active NIH involvement. As a cooperative agreement, awardees should expect substantial coordination with NIAID and with other ACE sites, including shared planning, harmonized approaches when appropriate, and participation in network-level activities intended to maximize cross-center learning and impact.

A key feature of the ACE model is integration between clinical and basic research. Clinical awardees do not operate in isolation; instead, they are expected to interact with Basic and Clinical ACE investigators to design studies that not only evaluate outcomes in patients, but also probe disease pathogenesis and clarify mechanisms of action for the immune-targeting therapies being tested. In practice, this means clinical trials and related human studies are expected to incorporate strong scientific questions about immune function, biomarkers, and mechanistic endpoints, so the work advances both immediate clinical knowledge and deeper understanding of autoimmune biology.

The opportunity is categorized as discretionary funding and falls under the health funding activity category (CFDA 93.855). The listed award ceiling is $1,500,000. The original closing date was May 19, 2023, and the opportunity record was created on December 22, 2022. While the notice lists "ExpectedAwards:" without a number in the provided text, the intent is to add selected sites into a coordinated national research network rather than to fund a large volume of unrelated projects.

Eligibility is broad across U.S.-based organizations and includes 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 Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant types 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 (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, there are clear limits on foreign participation. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicants. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which generally means a U.S. applicant organization may include certain well-justified foreign elements within the overall project structure when permitted under NIH policy and when they meaningfully contribute to the proposed research.

In short, this FOA supports membership in a mature, collaborative NIAID network focused on human autoimmunity, with a strong expectation of conducting clinical trials and related clinical research that ties patient-centered investigation to mechanistic discovery. The overall aim is to produce clinically relevant evidence while simultaneously improving scientific understanding of autoimmune disease pathways and how immune-modulating treatments exert their effects.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Autoimmunity Centers of Excellence, Clinical Research Program (UM1 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2022-12-22.
• Applicants must submit their applications by 2023-05-19. (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 $150,000.00 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.

Apply for RFA AI 22 071

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: