Type 1 Diabetes TrialNet Clinical Network Hub (U01 Clinical Trial Not Allowed) | RFA DK 25 005

Opportunity Information: Apply for RFA DK 25 005

The Type 1 Diabetes TrialNet Clinical Network Hub (U01 Clinical Trial Not Allowed) funding opportunity (RFA-DK-25-005) is an NIH cooperative agreement designed to keep the TrialNet “Hub” in place as the central coordination unit that supports TrialNet clinical research focused on preventing type 1 diabetes and intervening early in the disease process. Rather than funding a standalone clinical trial site or allowing applicants to propose an independent clinical trial, this award supports the infrastructure and operational backbone that helps TrialNet run more smoothly and effectively across its participating network. The Hub is positioned as a screening and clinical activities coordination center, meaning its day-to-day purpose is to help the network find, engage, and keep participants, and to make sure that communications and operational processes across TrialNet are efficient and consistent.

The core objective of the Hub is to increase overall network efficiency and productivity. In practical terms, that means coordinating communications and outreach across TrialNet, and creating or improving tools and approaches that raise performance on three major metrics: screening, recruitment, and retention. Screening is critical in TrialNet’s prevention and early-intervention model because identifying at-risk individuals and those in early stages of type 1 diabetes (often based on autoantibodies and related criteria) is the gateway to enrolling appropriate participants into prevention or early-intervention studies. Recruitment then depends on strong, coordinated messaging and streamlined workflows across sites and partners. Retention is equally important because prevention and early-intervention studies can involve long follow-up periods, complex visit schedules, and high participant burden; the Hub is expected to develop strategies that keep participants engaged and reduce drop-off over time.

This NOFO is explicitly “Clinical Trial Not Allowed,” which signals that the application should not be structured around proposing or running a new clinical trial as the primary activity. Instead, applicants should focus on network coordination functions that enable trials and screening activities to operate better, faster, and with stronger reach. Because the mechanism is a cooperative agreement (U01), NIH typically anticipates substantial programmatic involvement, meaning the awardee should be prepared to work closely with NIH staff and TrialNet leadership, align with network priorities, and participate in coordinated planning and reporting rather than operating fully independently as in a traditional grant.

A notable and mandatory requirement in this NOFO is the Plan for Enhancing Diverse Perspectives (PEDP). NIH will assess the PEDP during scientific and technical peer review, and applications that do not include a PEDP will be considered incomplete and withdrawn without review. In effect, this makes the PEDP a non-negotiable component of the application package. While the NOFO text here does not list the detailed PEDP elements, the intent is to ensure applicants meaningfully address how they will bring in and support diverse perspectives in the work tied to screening, outreach, recruitment, retention, tool development, communications, and broader network coordination. Applicants are urged to follow the NOFO’s PEDP instructions carefully and use NIH’s PEDP guidance materials to avoid disqualification.

Eligibility is broad and includes many types of domestic organizations and governments: state, county, and city/township 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 and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations (other than small businesses); and small businesses, among others. The NOFO also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it draws clear boundaries around foreign involvement: non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, “foreign components” are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S.-based applicant may include certain justified foreign activities or elements under NIH rules, even though the applicant organization itself must be domestic.

The opportunity is listed under NIH with an activity category spanning health (and referenced as Food and Nutrition, Health in the listing context) and is associated with CFDA number 93.847. The original closing date shown is October 17, 2024, and the NOFO was created on April 29, 2024. The listing does not specify an award ceiling or expected number of awards in the provided data, so applicants would need to consult the full NOFO text for budget limits, project period details, and any caps or expectations about staffing, deliverables, and coordination scope. Overall, the opportunity is best understood as funding for the operational center that helps TrialNet function as a unified, high-performing network, with a particular emphasis on improving how people are identified, brought into studies, and supported through participation, and with a strict requirement to include a PEDP as part of the application.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Type 1 Diabetes TrialNet Clinical Network Hub (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): 93.847.
• This funding opportunity was created on 2024-04-29.
• Applicants must submit their applications by 2024-10-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 DK 25 005

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