Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research
Can you apply?
This grant is for researchers and research institutions conducting biomarker validation studies in Type 1 Diabetes. Eligible applicants typically include academic medical centers, research hospitals, and nonprofit research organizations with capacity to conduct rigorous clinical research and laboratory assays. Institutions must have access to patient cohorts, EHR systems, and laboratory facilities capable of implementing standardized assay methodologies. Single investigators without institutional affiliation are generally not eligible; applicants must be part of an NIH-registered institution.
Key dates
- Feb 4, 2026 Applications open
- Jun 25, 2026 Application deadline in 12 days
- Apr 1, 2027 Award announced
- May 1, 2027 Project start
Program description
The main goal of this initiative is to establish a consortium with the overarching goal to advance the systematic identification, rigorous evaluation, validation, and assays harmonization of biomarkers that are critical to the prevention, diagnosis, and clinical management of Type 1 Diabetes (T1D). Despite significant advances in T1D research, there remains an urgent need for reliable and reproducible biomarkers that can capture the complexity of autoimmune processes, metabolic dysregulation, and individual patient variability. This initiative will leverage state-of-the-art methodologies in clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging, coupled with longitudinal patient cohorts and mining of Electronic Health Records (EHR). Within this consortium major efforts will be devoted to: 1) Harmonize established assays for biomarkers such as HbA1c and c-peptide, making sure that these assays are performed in a rigorous and reproducible manner in the clinical research community and in clinical practice. For this purpose, reference methods and materials will use a metrology approach and will be made available to the community; 2) Identify and validate other biomarkers that can be used for the prevention, diagnosis, and clinical management of T1D. It has been reported that the assays for several biomarkers routinely used in clinical research such as glucagon, amylin, chromogranin, insulin, pro-insulin and other pro-hormones are not reproducible across platforms or laboratories. For this purpose, this consortium will ensure that all assays for biomarkers routinely used in clinical research and for newly identified biomarkers are rigorously validated and assessed for reproducibility across several laboratories following a metrology approach.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative (research strategy and biomarker validation plan)
- Detailed Budget and Budget Justification
- Biographical Sketches (key personnel)
- Letters of Institutional Commitment (from collaborating laboratories)
- Descriptions of available patient cohorts and EHR capacity
- Letters of Support (from clinical sites and reference labs)
Program contact
- 👤 Division of Diabetes, Endocrinology and Metabolic Diseases
- 📧 NIDDK_DEM@nih.gov
- 📞 NIDDK_DEM@nih.gov
Funding track record
Recent awards under CFDA 93.847 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$152,979,352
-
$112,529,392
-
$66,521,567
-
$45,186,589
-
$37,867,943
-
$37,490,770
-
$34,242,949
-
$31,624,784
-
$31,124,496
-
$31,065,476
Top States by Funding
- FL 2 awards $184.1M
- MA 6 awards $165.7M
- PA 6 awards $165.0M
- NY 4 awards $143.8M
- MD 2 awards $143.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.847). How funding has trended year over year.
| 2024 | $1,971,472,000 | |
| 2025 | $2,043,166,000 | |
| 2026 est. | $111,289,000 |
FAQ
Who can apply for this grant?
Research institutions, universities, and medical centers with NIH registration and established clinical research infrastructure. Individual researchers must have institutional sponsorship.
What is the deadline?
The fixed deadline is June 25, 2026. Check the NIH STEM-H portal for any re-opening or continuation opportunities.
What types of biomarker activities are supported?
Harmonization and validation of established biomarkers like HbA1c and c-peptide, identification of new biomarkers, and assay standardization across laboratories using metrology approaches.
How competitive is this funding?
This is highly competitive NIH funding. Applications must demonstrate rigorous study design, strong preliminary data, and institutional capacity for multi-laboratory validation work.
What is the funding range?
The total pool is $5.2 million, but individual award amounts are not specified in the solicitation.
💡 Tips for applicants
- Emphasize institutional capacity for coordinating multi-laboratory validation efforts and access to standardized reference materials.
- Highlight preliminary biomarker validation data and laboratory quality assurance protocols already in place.
- Include letters of commitment from collaborating institutions and core biomarker laboratories demonstrating readiness to participate.
- Describe your EHR infrastructure and patient cohort diversity, including longitudinal follow-up capability.
- Use the metrology framework and ISO standards as the conceptual foundation for your assay validation plan.
⚠️ Common mistakes
Underestimating the complexity of multi-laboratory coordination. Failing to address reproducibility across different platforms and laboratory settings. Proposing biomarker validation without adequate preliminary data or established reference methods.
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