Discovery of Early Type 1 Diabetes Disease Processes in the Human Pancreas [HIRN Consortium on Beta Cell Death and Survival (CBDS)] (U01 Clinical Trial Not Allowed) | RFA DK 23 007

Opportunity Information: Apply for RFA DK 23 007

This NIH funding opportunity (RFA-DK-23-007) supports cooperative agreement (U01) projects aimed at uncovering what happens in the human pancreas during the earliest, often symptom-free stages of type 1 diabetes (T1D). The central idea is to study human pancreatic tissue and the associated immune compartment to pinpoint the biological pathways, cellular stress responses, and immune interactions that set the stage for beta cell dysfunction and loss before or around diagnosis. The program is positioned within the Human Islet Research Network (HIRN) and specifically adds new awardees to HIRN's Consortium on Beta Cell Death and Survival (CBDS), a coordinated team effort focused on understanding and ultimately interrupting the processes that drive beta cell stress, destruction, and progression toward autoimmunity in humans.

The research emphasis is firmly on human disease biology rather than animal modeling. Applicants are expected to use human-relevant samples and approaches to discover signaling or processing pathways that contribute to early T1D pathogenesis, especially during the asymptomatic phase. Projects can also focus on identifying early biomarkers that reflect underlying disease mechanisms, with the goal of improving early detection and staging. Another major thrust is translational: developing or refining diagnostic tools that could be used to detect and classify early T1D in at-risk individuals or those recently diagnosed, and identifying therapeutic targets that can be biologically validated to support prevention strategies or treatments that preserve remaining beta cell mass as early as possible.

Because this is a U01 cooperative agreement, awardees should expect substantial programmatic coordination and active collaboration as part of the CBDS/HIRN framework rather than operating as fully independent, stand-alone grants. The long-term vision is to generate actionable insights that help the field detect beta cell distress sooner, slow or stop immune-mediated destruction earlier, and prevent progression to overt autoimmunity and clinical disease when feasible. This means projects that simply describe phenomena without tying them to mechanisms, measurable markers, or plausible intervention points may be less aligned than studies that connect human tissue findings to clear pathways, candidate biomarkers, or targetable biology.

Clinical trials are not allowed under this announcement. In practical terms, the work can involve human samples, observational analyses, and development or validation activities consistent with human-subjects research, but it cannot propose an intervention study designed to evaluate clinical outcomes. The NOFO is structured to push discovery and early translational development up to, but not including, clinical trial testing.

Eligible applicants are broad and include many U.S.-based entities: state, county, and city governments; special districts; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); and other organizations. The announcement explicitly highlights eligibility for a range of mission-driven and capacity-building institution types, including 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, as well as faith-based and community-based organizations and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined under the NIH Grants Policy Statement are allowed, which typically means certain discrete, well-justified activities may occur abroad under a U.S. applicant organization if they meet NIH policy requirements.

The opportunity is listed under CFDA 93.847 and is categorized within health-related research. The posted award ceiling is $550,000, and the original closing date was July 9, 2024. Overall, the program is best suited for teams that can access and interrogate human pancreatic and immune-relevant materials with modern mechanistic and biomarker-focused methods, and that are prepared to work in a consortium setting where data sharing, coordination, and collective progress toward earlier detection and beta cell preservation are core expectations.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Discovery of Early Type 1 Diabetes Disease Processes in the Human Pancreas [HIRN Consortium on Beta Cell Death and Survival (CBDS)] (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 2024-04-01.
• Applicants must submit their applications by 2024-07-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $550,000.00 in funding.
• 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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