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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Immune Drivers of Autoimmune Disease (IDAD) - FAQ

What is the Immune Drivers of Autoimmune Disease (IDAD) funding opportunity?

IDAD (RFA AI 22 012) is a National Institutes of Health (NIH) cooperative agreement opportunity supporting collaborative, multi-party research focused on identifying the immune system conditions and changes that actually drive autoimmune disease.

What is the main purpose of the IDAD program?

The program aims to move beyond one-time "snapshots" of immune activity and instead map how immune behavior changes over time. The goal is to identify and characterize immunologic "states" people move through and link those states to real clinical outcomes such as flare-ups, remission, and long-term progression.

What does IDAD mean by immunologic "states"?

In this context, immunologic "states" refer to patterns or conditions of immune system activity that people transition through over time. IDAD emphasizes identifying these states and tying them to meaningful clinical moments in autoimmune disease.

What kinds of disease timepoints or transitions does the FOA emphasize?

The FOA highlights several key clinically important transitions that research should help explain, including:

  • Immune processes that precede and accompany a flare
  • Immune features associated with remission or sustained disease control
  • Changes that signal worsening or progression in established disease
  • Immunologic events marking the shift from an at-risk state to a first clinical diagnosis

Does IDAD focus only on people who already have autoimmune disease?

No. A major emphasis is understanding autoimmune disease across a timeline that includes both people with diagnosed disease and people who are not yet diagnosed but may be at elevated risk.

Why does the program emphasize timelines and dynamics instead of static immune measurements?

IDAD is designed to clarify cause-and-effect relationships by connecting changing immune patterns to key disease moments. By focusing on transitions over time, the program aims to go beyond documenting associations and instead help identify immune patterns that drive clinical change.

What funding mechanism does IDAD use?

The opportunity uses the U01 mechanism, which is a cooperative agreement rather than a standard research grant.

What does it mean that this is a cooperative agreement (U01)?

In a cooperative agreement, NIH typically expects substantial scientific involvement from program staff. Awardees are expected to work as part of a coordinated research effort with shared goals, collaboration, and consistency aligned with the program objective of defining immune drivers.

Is a clinical trial allowed under this FOA?

No. The FOA is explicitly labeled "Clinical Trial Not Allowed."

What does "Clinical Trial Not Allowed" imply for proposed research?

It generally means applicants should not propose studies that meet NIH's definition of a clinical trial, such as prospectively assigning human participants to an intervention to evaluate effects on health-related outcomes. Projects should be framed to avoid crossing into clinical trial territory.

What kinds of studies may fit under this FOA (based on the description provided)?

Based on the provided description, observational human studies, mechanistic studies, and analyses focused on immune profiling and disease course may fit, as long as they do not meet NIH's definition of a clinical trial.

What is the anticipated maximum budget per award?

The listed award ceiling is $750,000, indicating the maximum budget level anticipated per award in the provided source data.

How many awards will NIH make under this opportunity?

The number of expected awards is not provided in the supplied excerpt, so it cannot be confirmed based on the information provided.

What is the activity area and assistance listing information?

The activity area is health research under CFDA 93.855.

What type of funding instrument is this?

The award instrument is categorized as discretionary funding.

When was this opportunity created and when did it close?

The creation date shown is February 24, 2022, and the original closing date shown is July 1, 2022.

What organizations are eligible to apply?

Eligibility is broad and includes many organization types, including:

  • 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
  • Other entities

Are minority-serving institutions and similar categories included in eligibility?

Yes. The FOA 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); and Tribally Controlled Colleges and Universities (TCCUs).

Can federal agencies apply?

Yes. Eligible applicants include eligible federal agencies, as stated in the provided eligibility list.

Can faith-based or community-based organizations apply?

Yes. The eligibility list explicitly includes faith-based or community-based organizations.

Are organizations outside the United States eligible?

Yes. The eligibility list includes non-domestic (non-U.S.) entities, meaning foreign organizations may apply.

Are U.S. territories or possessions included in eligibility?

Yes. The FOA includes U.S. territories or possessions among eligible applicant categories.

What is IDAD trying to change or improve in autoimmune disease research?

IDAD is designed to address a central bottleneck: distinguishing immune patterns that are merely correlated with autoimmune disease from immune patterns that actually drive meaningful clinical changes. By supporting coordinated, mechanistic, and time-aware research, the program aims to improve prediction and monitoring of disease activity and support more precise future intervention strategies.

Which clinical outcomes are specifically referenced as targets for linking immune states?

The description specifically mentions linking immune states to outcomes such as flare-ups, remission, and longer-term disease progression, as well as the transition from at-risk status to a first clinical diagnosis.

How does collaboration factor into IDAD-funded projects?

Collaboration is built into the structure. Although individual projects may have distinct aims, the overall effort is designed to function as a coordinated program with shared goals, alignment, and consistency focused on defining immune drivers.

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