Immune Drivers of Autoimmune Disease (IDAD) (U01 Clinical Trial Not Allowed) | RFA AI 22 012

Opportunity Information: Apply for RFA AI 22 012

The Immune Drivers of Autoimmune Disease (IDAD) funding opportunity (RFA AI 22 012) is a National Institutes of Health (NIH) cooperative agreement that supports collaborative, multi-party research aimed at pinpointing the immune system conditions and changes that actually drive autoimmune disease. The program is centered on identifying and characterizing the immunologic "states" people move through over time, and linking those states to real clinical outcomes. In practical terms, the goal is to move beyond static snapshots of immune activity and instead map the dynamics of immune behavior that correspond to key disease moments such as flare-ups, periods of remission, and longer-term disease progression.

A major emphasis of IDAD is understanding how autoimmune disease unfolds along a timeline, including both people who already have diagnosed disease and people who are not yet diagnosed but may be at elevated risk. The FOA highlights several clinically important transitions the research should help explain: what immune processes precede and accompany a flare, what immune features align with remission or sustained control, what changes signal worsening or progression in established disease, and what immunologic events mark the shift from an at-risk state to a first clinical diagnosis. By focusing on these transitions, the program aims to help the field clarify cause-and-effect relationships rather than simply documenting associations, ultimately supporting better prediction of disease activity and more precise intervention strategies in the future.

This opportunity uses the U01 mechanism, meaning it is a cooperative agreement rather than a standard research grant. In a cooperative agreement, NIH typically expects substantial scientific involvement from program staff, with awardees working as part of a coordinated research effort. While individual projects may have distinct aims, the overall structure is designed to function as a program, with shared goals and an expectation of collaboration, consistency, and alignment with the program's core objective of defining immune drivers. The FOA is explicitly labeled "Clinical Trial Not Allowed," which generally means applicants should not propose studies that meet NIH's definition of a clinical trial (for example, prospectively assigning human participants to an intervention to evaluate effects on health-related outcomes). Observational human studies, mechanistic studies, and analyses focused on immune profiling and disease course may fit, but proposals should be framed to avoid crossing into clinical trial territory.

The activity area is health research under CFDA 93.855, and the award instrument is categorized as discretionary funding. The listed award ceiling is $750,000, indicating the maximum budget level anticipated per award (as presented in the source data). The FOA expected awards field is not provided in the supplied data, so the number of awards cannot be confirmed from the excerpt alone. The original closing date shown is July 1, 2022, with a creation date of February 24, 2022, placing the opportunity within that funding cycle.

Eligibility is broad and includes many types of organizations that can contribute to biomedical and immunology research. Eligible applicants include state, county, and local 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 and 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 entities. The FOA also calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal agencies; faith-based or community-based organizations; regional organizations; U.S. territories or possessions; and non-domestic (non-U.S.) entities, meaning foreign organizations may apply as well.

Overall, IDAD is designed to accelerate progress on a central bottleneck in autoimmune disease research: understanding which immune patterns are merely correlated with disease and which ones actually drive meaningful clinical changes. By supporting coordinated, mechanistic, and time-aware immune research across diverse institutions and organization types, the program aims to generate insights that can improve how autoimmune disease is predicted, monitored, and eventually prevented or better controlled, especially around the pivotal shifts of flare, remission, progression, and transition from risk to diagnosis.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Immune Drivers of Autoimmune Disease (IDAD) (U01 Clinical Trial Not Allowed)" 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 2022-02-24.
• Applicants must submit their applications by 2022-07-01. (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 $750,000.00 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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