Collaborative Research Using Biosamples and/or Data from Type 1 Diabetes Clinical Studies (R01 - Clinical Trial Not Allowed)

The National Institutes of Health (NIH) invites applications for research utilizing biosamples and data from clinical studies on type 1 diabetes (T1D). Administered by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), this funding opportunity focuses on collaborative projects to study the etiology and pathogenesis of T1D using existing data and biosamples from well-characterized clinical trials and studies. The program aims to deepen understanding of disease mechanisms, inform preventative strategies, and foster durable disease prevention. A mandatory Plan for Enhancing Diverse Perspectives (PEDP) must accompany applications to ensure inclusivity in research perspectives and approaches. This funding opportunity emphasizes leveraging samples and data from NIH-supported T1D studies like the Diabetes Prevention Type 1 trial (DPT-1), TrialNet, and the Environmental Determinants of Diabetes in the Young (TEDDY). Research may involve cross-sectional or longitudinal studies, including exploratory projects to generate hypotheses and definitive studies with strong preliminary data. Examples of potential topics include biomarker discovery, immune response mechanisms, and environmental triggers of T1D. However, applications proposing animal model studies, clinical efficacy trials, or using restricted sample collections are ineligible. Eligible applicants include institutions of higher education, nonprofits, for-profit entities, tribal and local governments, and foreign organizations. Applications from diverse researchers and institutions are strongly encouraged. Projects should involve large collaborative teams and align with NIH’s policies on data sharing and inclusivity. Budgets are capped at $1,200,000 in direct costs annually for a maximum project period of three years. NIDDK anticipates funding three to four projects annually with $5.5 million allocated per fiscal year for FY 2026 and FY 2027. Applications must adhere to NIH submission guidelines, including registration in multiple federal systems like SAM, eRA Commons, and Grants.gov. Key application requirements include a detailed research plan, PEDP, data-sharing strategies, and documentation of access to required biosamples. Letters of intent are optional but encouraged by May 26, 2025, and February 6, 2026. Applications are due June 26, 2025, and March 6, 2026, with expected project start dates in April 2026 and December 2026, respectively. Applications will be evaluated on their significance, innovation, rigor, feasibility, and alignment with program goals. Reviewers will assess the scientific impact and the potential for the proposed work to advance understanding of T1D mechanisms. The inclusion of diverse perspectives and plans for data management will also play critical roles in the evaluation. Funding decisions will consider scientific merit, alignment with program priorities, and availability of funds. Further details on submission, review criteria, and program contacts are available in the full Notice of Funding Opportunity (NOFO). Applicants are encouraged to reach out to designated scientific, peer review, and financial contacts for guidance during the application process.