Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required) | RFA DK 25 004

Opportunity Information: Apply for RFA DK 25 004

This funding opportunity from the National Institutes of Health (NIH) supports the continued operation of the Type 1 Diabetes TrialNet Coordinating Center (TNCC) under a U01 cooperative agreement mechanism, meaning NIH will have substantial involvement in the funded activities rather than acting only as a passive funder. TrialNet is a large clinical research network focused on identifying people who are at risk for type 1 diabetes or who are in the earliest stages of the disease, then enrolling them into studies and clinical trials intended to prevent or delay progression to clinical (symptomatic) type 1 diabetes and to preserve the body’s ability to produce insulin. The Coordinating Center functions as the operational backbone of this national network, helping keep multiple clinical sites, laboratories, and studies aligned under a consistent set of procedures, timelines, and quality standards.

The core purpose of the TNCC described in the announcement is twofold. First, it must support a broad portfolio of research activities across the full life cycle of clinical research: planning and protocol development, study start-up, recruitment and enrollment, study conduct, and closeout. This includes both ongoing TrialNet studies and intervention trials already in motion, as well as the design and launch of new studies and intervention trials. Second, the TNCC is expected to provide robust data and biospecimen management for the network. That includes standardized methods for acquiring data and samples, applying quality control and assurance procedures, managing storage and tracking, enabling appropriate sharing and dissemination, and ensuring that resulting resources are made publicly accessible in line with NIH expectations and TrialNet policies.

A major emphasis of the opportunity is network administration and operations. The TNCC will be responsible for evaluating, selecting, and supporting the network’s participating components, including Clinical Centers and centralized support units such as core laboratories that are needed to carry out TrialNet clinical studies. Importantly, this support is expected to flow through subcontracts issued by the TNCC, so the awardee must be capable of managing a complex subcontracting structure, coordinating performance across multiple external entities, and maintaining consistent regulatory, operational, and scientific standards across the network. The TNCC also plays a leadership role: the Program Director/Principal Investigator (PD/PI) for the Coordinating Center will serve as a voting member of the TrialNet Executive and Steering Committees, meaning the awardee is expected to actively shape network strategy, study prioritization, and overall governance, not just provide back-office logistics.

The notice also highlights a specific application requirement that applicants need to treat as non-negotiable: a Plan for Enhancing Diverse Perspectives (PEDP). This plan is not optional and is explicitly part of the scientific and technical peer review. If an application does not include a PEDP, NIH will treat it as incomplete and will withdraw it without review. In practice, this means applicants need to describe concrete, credible steps to broaden and strengthen diversity of perspectives in the project, which can include how the coordinating center will engage diverse scientific, clinical, community, and participant viewpoints across network leadership, study design and operations, recruitment approaches, and dissemination practices. The announcement strongly encourages applicants to follow the NOFO instructions closely and to use NIH’s PEDP guidance materials to avoid disqualification.

Eligibility is broad and includes many common NIH applicant categories such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit entities (other than small businesses), small businesses, state and local governments, special district governments, independent school districts, public housing authorities, and federally recognized tribal governments and other tribal organizations. The announcement also explicitly calls out additional eligible applicant types such as 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), as well as faith-based or community-based organizations and U.S. territories or possessions. However, foreign organizations are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are also not eligible to apply; at the same time, foreign components (as NIH defines them in policy) may be allowed, which typically means certain discrete project activities could occur outside the U.S. if they are justified, permitted under NIH rules, and properly described.

Administratively, the opportunity is identified as RFA-DK-25-004, falls under the NIH Assistance Listing (CFDA) number 93.847, and is categorized under health-related research (listed as Food and Nutrition, Health in the provided data). The original application due date shown is October 17, 2024, and the opportunity was created on April 26, 2024. The award ceiling and expected number of awards are not specified in the provided source details, so prospective applicants would need to consult the full NOFO text and any linked budget guidance to understand the anticipated funding level, project period, and any caps or constraints. Overall, this NOFO is aimed at organizations with demonstrated capacity to run a large, multi-site clinical trials network, including governance participation, subcontract oversight, standardized data and biospecimen infrastructure, and the operational discipline needed to support prevention and early-intervention research in type 1 diabetes at scale.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required)" 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 2024-04-26.
• 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.

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