Immune Tolerance Network (UM1 Clinical Trial Required) | RFA AI 19 068

Frequently Asked Questions (FAQs)

What is the Immune Tolerance Network (UM1 Clinical Trial Required) funding opportunity?

RFA-AI-19-068 is a National Institutes of Health (NIH) cooperative agreement (UM1) intended to support a coordinated, multi-site clinical research network focused on developing and testing approaches to induce and sustain immune tolerance in people.

What is the overall goal of this program?

The central goal is to move beyond broadly immunosuppressive strategies by evaluating approaches that can retrain or recalibrate immune responses to prevent or treat disease, with a strong emphasis on rigorous human clinical evaluation.

Which clinical areas does the Network focus on?

The Network concentrates on three main clinical areas: (1) asthma and allergic diseases, (2) autoimmune diseases, and (3) immune-mediated complications of allotransplantation (such as transplant rejection and related immune effects).

Are clinical trials required under this opportunity?

Yes. The opportunity is labeled "UM1 Clinical Trial Required," and applicants are expected to be able to design and execute clinical trials as a core function of the proposed Network.

What phases of clinical trials are expected to be supported?

The Network is expected to plan and run clinical trials across all phases, from early-stage trials through later-stage trials, including assessments of both safety and efficacy of investigational products or other tolerance-inducing interventions.

Are trials expected to focus only on clinical outcomes?

No. Trials are expected to be tightly integrated with mechanistic research to help explain how and why an intervention works (or does not work). The program emphasizes translational components that measure tolerance-related processes in humans.

What kinds of mechanistic and translational components are expected within trials?

Examples described include immune monitoring, biomarker development, and other translational research components designed to evaluate immune tolerance mechanisms in humans alongside clinical endpoints.

What scientific infrastructure is the Network expected to provide?

The Network is expected to build and manage scientific infrastructure needed for tolerance research at scale, including mechanistic studies and the development, standardization, and application of tolerance assays as core elements of the clinical trial programs.

Does the FOA require a laboratory consortium?

Yes. The Network is expected to establish and oversee a consortium of laboratories to support standardized and scalable mechanistic and assay work tied to the clinical trial programs.

Are biospecimen repositories part of the expected scope?

Yes. The Network is expected to create and/or manage one or more biospecimen repositories so that samples collected during trials can be processed consistently, stored appropriately, and used for current and future analyses.

What data and bioinformatics capabilities are expected?

Strong bioinformatics and data capabilities are expected, including systems for data collection, validation, management, and statistical analysis. This reflects the expectation that the Network will generate complex clinical and immunologic datasets requiring high-quality, reproducible handling.

Does the opportunity allow any nonclinical or product development work?

Yes, but only in a limited and targeted way. The FOA allows focused product development and selected nonclinical studies when essential to enable subsequent human testing of promising tolerance-inducing approaches.

What nonclinical study types are mentioned as examples?

Examples include toxicology, pharmacology, and pharmacokinetics, particularly when these studies are needed to address regulatory or safety requirements before testing an intervention in people.

Is nonclinical work considered the main purpose of the Network?

No. Any nonclinical support is framed as selective and enabling rather than a primary purpose. The core deliverable is well-designed human clinical research with integrated mechanistic insight.

What does it mean that this is a UM1 cooperative agreement?

UM1 is the activity code used, and the award mechanism is a cooperative agreement. This typically indicates NIH expects substantial programmatic involvement during the award period compared with a standard research project grant.

What is the CFDA listing for this opportunity?

The opportunity is categorized under health and is associated with CFDA 93.855.

When was this funding opportunity created and when did it originally close?

It was created on December 6, 2019, and had an original closing date of March 3, 2020.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled and 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 or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.

Are specific institution types highlighted as eligible?

Yes. The FOA highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions.

Are faith-based and community-based organizations eligible?

Yes. Faith-based or community-based organizations are included among the eligible applicant categories described.

Are federal agencies and regional organizations eligible?

Yes. Eligible federal agencies and regional organizations are included among the eligible applicant categories described.

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

Yes. U.S. territories or possessions are included among the eligible applicant categories described.

Can foreign institutions apply as the applicant organization?

No. Foreign institutions and other non-U.S. entities are not eligible to apply under this opportunity.

Are non-domestic components of U.S. organizations eligible?

No. Non-domestic components of U.S. organizations are also not eligible.

Are foreign components allowed at all?

Yes. Foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S.-based applicant may include certain defined international collaborations or activities as part of the overall project when permitted under NIH policy.

What is the "full-spectrum" expectation for this Network?

The opportunity is aimed at supporting a trial-driven tolerance research enterprise that selects or develops promising tolerance strategies, tests them rigorously in humans through phased clinical trials, embeds deep mechanistic and biomarker work within those trials, and maintains the laboratory, biorepository, and informatics backbone needed to make the resulting data and biospecimens maximally informative and reusable.