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.Apply for RFA DK 25 005
- 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.
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Frequently Asked Questions (FAQs)
What is the funding opportunity?
This opportunity is the Type 1 Diabetes TrialNet Clinical Network Hub (U01, Clinical Trial Not Allowed) funding opportunity, RFA-DK-25-005. It is an NIH cooperative agreement intended to maintain the TrialNet "Hub" as the central coordination unit that supports TrialNet clinical research focused on preventing type 1 diabetes and intervening early in the disease process.
What is the main purpose of the TrialNet "Hub" being funded?
The Hub is designed to serve as the infrastructure and operational backbone for TrialNet, helping the network run more smoothly and effectively across participating sites. Its day-to-day role is positioned as a screening and clinical activities coordination center that supports participant finding, engagement, and ongoing participation, while also standardizing and improving communications and operational processes across the network.
Is this grant meant to fund a standalone clinical trial site?
No. The opportunity is described as supporting the network coordination functions rather than funding a standalone clinical trial site. The emphasis is on maintaining and improving the central operational unit that enables TrialNet screening and studies to run efficiently across the network.
Can applicants propose an independent clinical trial under this opportunity?
No. The NOFO is explicitly labeled "Clinical Trial Not Allowed," which means the application should not be structured around proposing or running a new clinical trial as the primary activity. The focus should be on coordination and infrastructure functions that enable trials and screening activities to operate better, faster, and with stronger reach.
What does "Clinical Trial Not Allowed" mean in practical terms for an application?
It means the proposed work should concentrate on operational coordination, communications, outreach, and tools or approaches that improve how TrialNet functions, rather than on launching or leading a new clinical trial. The Hub supports the network that conducts studies, but the award is not for proposing a new trial as the main project.
What kind of award mechanism is this?
This is an NIH cooperative agreement (U01). Cooperative agreements typically involve substantial programmatic involvement from NIH, meaning the awardee should expect to work closely with NIH staff and TrialNet leadership and align activities with network priorities.
How involved is NIH expected to be during the project?
Because this is a U01 cooperative agreement, NIH generally anticipates substantial programmatic involvement. The awardee should be prepared for coordinated planning and reporting and to work closely with NIH staff and TrialNet leadership rather than operating fully independently.
What are the core objectives of the Hub?
The core objective is to increase overall network efficiency and productivity. The Hub is expected to coordinate communications and outreach across TrialNet and create or improve tools and approaches that raise performance on three major metrics: screening, recruitment, and retention.
What does the opportunity emphasize about screening?
Screening is described as critical to TrialNet's prevention and early-intervention model. Identifying at-risk individuals and those in early stages of type 1 diabetes (often using autoantibodies and related criteria) is presented as the gateway to enrolling appropriate participants into prevention or early-intervention studies.
What does the opportunity emphasize about recruitment?
Recruitment is framed as depending on strong, coordinated messaging and streamlined workflows across TrialNet sites and partners. The Hub is expected to coordinate communications and outreach to strengthen recruitment performance across the network.
What does the opportunity emphasize about retention?
Retention is highlighted as essential 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 to keep participants engaged and reduce drop-off over time.
What is the Hub's role in communications and outreach?
The Hub is expected to coordinate communications and outreach across TrialNet to improve network performance, with the stated goal of boosting efficiency and productivity, particularly as it relates to screening, recruitment, and retention.
What kinds of improvements or deliverables does the Hub support?
Based on the description provided, the Hub supports creating or improving tools and approaches that increase performance on key network metrics (screening, recruitment, retention) and making communications and operational processes across TrialNet more efficient and consistent.
What is the Plan for Enhancing Diverse Perspectives (PEDP)?
The PEDP is a mandatory plan required by this NOFO. NIH will assess the PEDP during scientific and technical peer review. The intent is for applicants to meaningfully address how they will bring in and support diverse perspectives in work tied to screening, outreach, recruitment, retention, tool development, communications, and broader network coordination.
Is the PEDP required, or optional?
The PEDP is mandatory. Applications that do not include a PEDP will be considered incomplete and withdrawn without review.
How will the PEDP affect application review?
NIH will assess the PEDP during scientific and technical peer review. If it is missing, the application will be deemed incomplete and will be withdrawn without review.
Does the listing include the detailed PEDP elements required?
The information provided states that the NOFO text here does not list the detailed PEDP elements. Applicants are urged to follow the NOFO's PEDP instructions carefully and use NIH PEDP guidance materials to avoid disqualification.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic (U.S.) organizations and governments. Examples listed include 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.
Are institutions serving specific populations explicitly mentioned as eligible?
Yes. The information highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, and also mentions faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization apply if it has a non-domestic component?
The information states that non-domestic components of U.S. organizations are not eligible to apply.
Are any foreign activities allowed at all?
Yes, "foreign components" are allowed as defined in the NIH Grants Policy Statement. This 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.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.847.
Which agency is offering this opportunity?
The opportunity is listed under NIH.
What is the opportunity focused on (topic area)?
It is focused on supporting TrialNet clinical research coordination related to preventing type 1 diabetes and intervening early in the disease process. The listing context also references an activity category spanning health (and referenced as Food and Nutrition, Health).
What is the closing date shown in the listing?
The original closing date shown is October 17, 2024.
When was the NOFO created?
The NOFO was created on April 29, 2024.
Does the provided information include the award ceiling or number of awards?
No. The listing data provided does not specify an award ceiling or the expected number of awards. 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.
What should applicants do if they need budget or project period details?
The information provided indicates applicants should consult the full NOFO text to find budget limits, project period details, and expectations about staffing, deliverables, and coordination scope.
What is the simplest way to describe what this opportunity funds?
It funds the operational center (the Hub) that helps TrialNet function as a unified, high-performing network, with a particular emphasis on improving how participants are identified (screening), brought into studies (recruitment), and supported through participation over time (retention), along with a strict requirement to include a PEDP in the application.
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