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Grant Analysis

Purpose & Target

This grant, the 'New Investigator Gateway Awards for Collaborative T1D Research', aims to support New Investigators (NI) and Early Stage Investigators (ESI) in Type 1 Diabetes (T1D) research. Its core objective is to foster innovative preliminary research and integrate these emerging scientists into large, ongoing collaborative T1D research programs, facilitating their career development and contributing new ideas to existing networks. This is a SECTOR-SPECIFIC grant focused on biomedical research related to diabetes. Applicant organizations must be based in the United States, though foreign components within U.S. organizations are allowed for project activities. This is a recurring grant program, reissued from a previous RFA, and is associated with the Special Diabetes Program.

Financial Structure

Funding Amounts

Total Program Funding: NIDDK intends to commit $4,000,000 in FY 2026 and $4,000,000 in FY 2027, for a total of $8,000,000 across both fiscal years.
Maximum Award Amount per Project: Applications may request budgets of up to $100,000 in direct costs per year.
Project Period: The maximum project period is 2 years.

Cost Sharing and Co-financing

No Cost Sharing Required: This funding opportunity explicitly states that cost sharing is NOT required.

Eligible Costs

Direct Costs: The grant covers direct costs up to the stated maximum.
Travel Costs: Applicants should budget for travel to one meeting of the proposed affiliated consortium or network per year. A specific allowance of $2,000 per year for travel should be described in the budget justification section, even if there isn't a specific line item in the modular budget format. Only the PD/PI is generally supported for this travel.
Pre-award Costs: Allowable as described in the NIH Grants Policy Statement.

Ineligible Costs

Not explicitly listed, but the R03 small grant format implies focus on direct research expenses rather than extensive infrastructure or personnel costs beyond the immediate project needs.

Financial Reporting and Audit

Reporting: Recipients are required to submit the Research Performance Progress Report (RPPR) annually. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for award closeout.
Audit: Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is required, which includes audit requirements for certain award thresholds.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types: A wide range of U.S.-based organizations are eligible to apply, including:
- Higher Education Institutions: Public/State Controlled, Private.
- Nonprofits: With or without 501(c)(3) IRS Status.
- For-Profit Organizations: Small Businesses and other For-Profit Organizations.
- Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized or Other).
- Federal Governments: Eligible Agencies of the Federal Government, U.S. Territory or Possession.
- Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations.
Geographic Location: Only U.S.-based organizations are eligible to apply. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, foreign components (project activities conducted outside the U.S.) are allowed.
Required Registrations: Applicant organizations must complete and maintain active registrations with the System for Award Management (SAM), Unique Entity Identifier (UEI) (issued via SAM), eRA Commons, and Grants.gov prior to application submission. Foreign organizations must obtain an NCAGE code for SAM registration.

Individual (PD/PI) Eligibility

Investigator Status: The Program Director(s)/Principal Investigator(s) (PD/PIs) must meet the definition of a New Investigator (NI) or Early Stage Investigator (ESI) at the time of application.
- New Investigator: A PD/PI who has not successfully competed for a significant NIH independent research award.
- Early Stage Investigator: A New Investigator who is within 10 years of completing their terminal research degree or end of post-graduate clinical training.
eRA Commons Account: All PD/PIs must have an eRA Commons account and ensure it is affiliated with their applicant organization.
Single PD/PI: This funding opportunity does not allow multiple PD(s)/PI(s) for a single application.

Project-Specific Eligibility

Clinical Trial Status: Applications proposing clinical trials are NOT allowed.
Consortium Affiliation: The proposed research must fit conceptually within the scope and goals of one of the following NIDDK consortia, and applicants must demonstrate how their project is related to, but distinct from, ongoing studies within that chosen consortium:
- Human Islet Research Network (HIRN)
- Type 1 Diabetes TrialNet
- The Environmental Determinants of Diabetes in the Young (TEDDY) Study
- The Diabetic Foot Consortium (DFC) (studies limited to DFUs in T1D, alone or in comparison to T2D)
- Cardiovascular Repository - Type 1 Diabetes (CaRe-T1D)

Application Process

Submission Method: Applications must be submitted electronically through one of the following systems:
- NIH ASSIST system (online preparation, submission, tracking)
- Institutional system-to-system (S2S) solution (check with institutional officials)
- Grants.gov Workspace
Required Registrations: Ensure all necessary registrations (SAM, UEI, eRA Commons, Grants.gov) are completed well in advance, as they can take 6 weeks or more.
PD/PI eRA Commons ID: The PD/PI's eRA Commons ID must be included in the 'Credential' field of the 'Senior/Key Person Profile' form for successful submission.
Duplicate/Overlapping Applications: NIH will not accept duplicate or highly overlapping applications under review at the same time.

Key Dates and Deadlines

Letter of Intent Due Dates (encouraged, not binding):
- May 26, 2025
- February 6, 2026
Application Due Dates (by 5:00 PM local time of applicant organization):
- June 26, 2025
- March 06, 2026
Expiration Date: March 07, 2026
Earliest Start Dates:
- For June 26, 2025 applications: April 2026
- For March 06, 2026 applications: December 2026

Required Documentation and Materials

Standard NIH Application Forms: Including SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget) and PHS forms (398 Cover Page Supplement, 398 Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form).
Mandatory Proposed Affiliation Letter: A one-page PDF letter titled 'Proposed_Affiliation_Ltr.pdf' is required. This letter must:
- Identify the specific NIDDK consortium/network (HIRN, TrialNet, TEDDY, DFC, or CaRe-T1D) within the scope of the proposed aims.
- Outline how the application's objectives and design are related to, but distinct from, ongoing studies in the chosen consortium/network.
- Describe how developing a relationship with the consortium/network would facilitate the applicant's research and career goals.
- Applications lacking this letter will be considered incomplete and will not be peer-reviewed.
Resource Sharing Plan: Required for sharing and distribution of non-data resources (models, protocols, tools, biomaterials, reagents).
Data Management and Sharing Plan: Required for research generating scientific data, adhering to the 2023 NIH Policy.
Appendix: Only limited materials are allowed (e.g., blank questionnaires/surveys). Publications are not allowed.

Support and Assistance

Application Submission Contacts: eRA Service Desk for system issues, General Grants Information for instructions, Grants.gov Customer Support for registration/Workspace.
Scientific/Research Contacts: Specific contacts are provided for inquiries related to HIRN, TrialNet, TEDDY, CaRe-T1D, and DFC.
Peer Review Contact: For questions regarding the review process.
Financial/Grants Management Contact: For budget and award administration inquiries.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through a peer review system, ultimately leading to an overall impact score. The R03 small grant program expects discrete, well-defined projects that are feasible within two years and require limited funding. Preliminary data is not required, especially for pilot or feasibility studies. Scored Review Criteria Reviewers will assign separate scores for these three factors, which heavily influence the overall impact score: * Importance of the Research (Significance and Innovation): Assesses the project's significance to the field and its innovative aspects. * Rigor and Feasibility (Approach): Evaluates the scientific rigor of the proposed methods and the feasibility of the approach. * Expertise and Resources (Investigator(s) and Environment): Considers the qualifications and experience of the investigator(s) and the adequacy of the research environment and resources available. Additional Review Criteria (Considered for Overall Impact, Not Scored Separately)

Protections for Human Subjects: Assessment of proposed safeguards for human participants.
Vertebrate Animals: Evaluation of the ethical and humane use of vertebrate animals.
Biohazards: Review of measures to manage biohazards.
Resubmissions/Renewals/Revisions: Appropriateness of proposed changes or expansions if applicable.

Additional Review Considerations (Not Scored, Not for Overall Impact Score)

Authentication of Key Biological and/or Chemical Resources: Plans for ensuring the validity of key resources.
Budget and Period of Support: Assessment of whether the requested budget and duration are justified and reasonable for the proposed research.

Selection Criteria Funding decisions are based on: * The scientific and technical merit of the proposed project (as determined by peer review). * Availability of funds. * Relevance of the proposed project to program priorities.

Compliance & Special Requirements

Regulatory and Ethical Compliance

NIH Grants Policy Statement: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Federal Regulations: Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is mandatory.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Human Subjects and Vertebrate Animals: If applicable, strong protections and ethical standards for human subjects and vertebrate animals are required and will be reviewed.
Mandatory Disclosure: Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Data, Technology, and Intellectual Property

Data Management and Sharing: A Data Management and Sharing Plan is required for projects generating scientific data, consistent with the 2023 NIH Policy. Recipients must implement the approved plan.
Resource Sharing: Tools and reagents generated by the project are expected to be broadly available and distributed at minimal cost, without undue intellectual property constraints. Applicants should register resources with the NIDDK Information Network (dkNET) and use Research Resource Identifiers (RRID).
Health IT Compliance: If the award involves implementing, acquiring, or upgrading health IT, it must meet standards in 45 CFR part 170, Subpart B, and potentially be ONC Health IT Certified.
Cybersecurity: If recipients have ongoing access to HHS information or operational technology systems, or handle PII/PHI from HHS, they must develop plans and procedures modeled after the NIST Cybersecurity framework.

Unique Aspects and Strategic Opportunities

New/Early Stage Investigator Focus: This grant is specifically tailored to support the career development of junior faculty, providing a crucial stepping stone towards competitive R01 submissions.
Integration with Consortia: A key and unique feature is the mandatory affiliation with a large, established T1D research consortium (HIRN, TrialNet, TEDDY, DFC, CaRe-T1D). This provides unparalleled opportunities for:
- Networking: Direct interaction with leading experts and established scientific frameworks.
- Access to Resources: Potential access to existing data, biosamples, infrastructure, and ongoing studies within the chosen consortium.
- Career Advancement: Mentorship and collaboration that can propel a new investigator's career in T1D research.
R03 Small Grant Program: This grant type supports discrete, well-defined projects of limited scope, making it suitable for preliminary research or feasibility studies that can be completed within the two-year timeframe and budget.
Clinical Trial Exclusion: By excluding clinical trials, the grant focuses on basic, translational, and observational research, allowing for a concentrated effort on foundational T1D mechanisms.

Grant Details