Autoimmunity Centers of Excellence, Basic Research Program (U19 Clinical Trial Not Allowed) | RFA AI 18 002

Frequently Asked Questions (FAQs)

What is the Autoimmunity Centers of Excellence (ACE) Basic Research Program?

The Autoimmunity Centers of Excellence (ACE), Basic Research Program is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) funding opportunity (RFA AI 18-002) that supports a coordinated, multi-institutional research network focused on autoimmune diseases. The program is designed to improve understanding of autoimmune disease biology and accelerate progress toward better prevention and treatment strategies.

What is the overall goal of the ACE network?

The ACE network aims to improve understanding of autoimmune disease biology and speed progress toward better strategies for prevention and treatment. A central concept is that tightly organized collaboration between basic and clinical scientists, with mechanistic laboratory work linked to clinical observations and therapeutic testing within the same network, can move the field faster than isolated projects.

Which component does this funding opportunity support: basic research or clinical research?

This announcement solicits applications specifically for the Basic Research Program component of ACE. A separate companion announcement supports the Clinical Research Program.

What type of NIH award mechanism is used for this opportunity?

This opportunity uses a cooperative agreement mechanism (U19). Under a cooperative agreement, NIAID staff typically have substantial programmatic involvement to help keep the network aligned around common goals and to facilitate multi-site collaboration and sharing of data and resources.

How is a U19 cooperative agreement different from a standard research grant?

In a standard research grant, the investigator generally has primary control over the scientific direction and management. In a U19 cooperative agreement, there is substantial programmatic involvement from NIAID staff, reflecting an intent to actively coordinate the network, encourage collaboration across sites, promote data/resource sharing, and ensure that basic research meaningfully informs clinical research directions within ACE.

What kinds of research activities are expected under the Basic Research Program?

Funded teams are expected to conduct innovative studies of human autoimmunity through a structured set of activities that can include Principal Projects, Pilot Projects, and Collaborative Projects. The emphasis is on mechanistic and pathogenesis-oriented research in human autoimmune disease.

What is meant by “mechanistic and pathogenesis-oriented” research in this context?

Based on the program description, the Basic Research Program emphasizes studies that clarify how autoimmune diseases develop and function biologically in humans (pathogenesis) and the underlying mechanisms driving immune responses and disease processes (mechanistic research).

Does the program prioritize collaboration across institutions and across basic and clinical teams?

Yes. A defining idea behind ACE is that tightly organized collaboration between basic and clinical scientists can accelerate progress. Applicants are expected to show how their projects will integrate with other ACE sites and with the Clinical Research Program to address shared questions in autoimmunity.

Are applicants expected to contribute to the broader ACE network beyond their own projects?

Yes. The Basic Research FOA expects projects to be designed in a way that benefits from, and contributes to, the larger ACE collaborative environment, including integration with other ACE sites and with the Clinical Research Program.

How does the Basic Research Program connect to the Clinical Research Program?

Basic and Clinical ACE investigators are expected to work together on studies that clarify autoimmune disease pathogenesis and explain mechanisms of action for immune-modulating agents being tested in ACE clinical trials. Basic research teams are expected to interface with and support the clinical trial efforts under the companion clinical program, such as helping interpret immune responses, biomarkers, or mechanistic signals observed in trial participants.

This FOA says “Clinical Trial Not Allowed.” What does that mean for applicants?

Within this Basic Research FOA, clinical trials are not allowed under the terms described. However, basic research groups are still expected to collaborate with and support clinical trial efforts occurring within the ACE network under the companion clinical program, for example by helping interpret immunologic or biomarker findings from trial participants.

What is the primary scientific focus: animal models, human studies, or both?

The description emphasizes innovative studies of human autoimmunity and highlights mechanistic laboratory studies intentionally linked to clinical observations and therapeutic testing within the network. The stated emphasis is on mechanistic and pathogenesis-oriented research in human autoimmune disease.

Is this a single-project grant or a multi-project center-style program?

The program is framed as supporting coordinated, multi-project centers within a larger network rather than funding single, stand-alone studies. The Basic Research Program structure can include Principal Projects, Pilot Projects, and Collaborative Projects, consistent with a multi-project approach.

What kinds of organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations. Eligible applicants include various levels of government (state, county, city/township, special districts), tribal governments (federally recognized), tribal organizations (including those other than federally recognized tribal governments), public and private institutions of higher education, independent school districts, public housing authorities/Indian housing authorities, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.

Are small businesses eligible?

Yes. Small businesses are included in the eligible applicant categories listed for this opportunity.

Are for-profit organizations eligible?

Yes. For-profit organizations are eligible as described, including for-profit organizations other than small businesses, and small businesses (which are listed separately) are also eligible.

Are nonprofit organizations eligible even if they do not have 501(c)(3) status?

Yes. The eligibility list explicitly includes nonprofit organizations with or without 501(c)(3) status.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized tribal governments are eligible, and tribal organizations (including those other than federally recognized tribal governments) are also listed as eligible.

Are U.S. territories or possessions eligible to apply?

Yes. The announcement includes U.S. territories or possessions among the highlighted eligible categories.

Does the FOA specifically encourage or highlight certain institution types (such as HBCUs or HSIs)?

Yes. The announcement explicitly highlights categories often emphasized in NIH outreach and inclusion efforts, including 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). It also highlights faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can a non-U.S. (foreign) organization apply?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply under this FOA.

Can a U.S. organization include a non-domestic (foreign) component in the project?

No. Non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.

What do the foreign involvement restrictions mean in practice?

They mean the proposed work must be led and carried out within eligible U.S. organizational structures without foreign components, even if the scientific questions are globally relevant.

What is the opportunity category and activity category?

The opportunity category is discretionary, and the activity category is health.

What is the funding instrument type?

The funding instrument type is a cooperative agreement.

Which NIH institute is sponsoring this opportunity?

This opportunity is sponsored by the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).

What is the CFDA number for this opportunity?

The CFDA number provided is 93.855.

What are the key dates listed for this funding opportunity?

The creation date is March 8, 2018, and the original closing date is June 22, 2018.

Does the summary specify an award ceiling or the expected number of awards?

No. The summary information provided does not specify an award ceiling or the expected number of awards.

What is the central strategy behind the ACE program design?

The central strategy is that structured collaboration between basic and clinical scientists, with mechanistic studies linked to clinical observations and therapeutic testing within the network, can accelerate progress more effectively than isolated projects.

What is expected regarding data and resource sharing across the network?

The cooperative agreement structure is intended to facilitate multi-site collaboration and encourage sharing of data and resources across the ACE network, supported by substantial programmatic involvement from NIAID staff.