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Grant Analysis

Purpose & Target

Grant's core objective: To support research that enhances understanding of the fundamental mechanisms and biomarkers of 'trained immunity' (innate immune memory), and its functional implications for immune system development, immunity to vaccines or natural infections, or allergic diseases, autoimmunity, and organ/tissue/cell transplantation rejection.
Target recipient type and size: A broad range of organizations including higher education institutions, non-profits, for-profit businesses (small to large), and various governmental entities. Organizational size is not defined by employee count but by entity type.
SECTOR-SPECIFIC/SECTOR-AGNOSTIC: SECTOR-SPECIFIC (Healthcare, Immunology, Infectious Diseases, Autoimmunity, Transplantation Research).
Geographic scope: Organizations from the U.S. and non-U.S. (Foreign Organizations) are eligible to apply.
Key filtering criteria for initial grant screening:
- Focus must be on basic mechanisms and biomarkers of trained immunity.
- Clinical trials are not allowed.
- Studies of adaptive immunity are non-responsive unless clearly connected to trained immunity.
- Projects focusing only on applications of trained immunity without novel characterizations of molecular mechanisms or biomarkers are non-responsive.
- Studies in non-mammalian model systems are non-responsive unless there are clear plans for translation to mammalian immunology.
- Applications related to HIV/AIDS are non-responsive.
Grant frequency: Recurring funding opportunity with multiple annual application due dates until January 08, 2027.

Financial Structure

Budget: Application budgets are not limited but must accurately reflect the actual needs of the proposed project.
Maximum project period: Five years.
Cost sharing: Cost sharing as defined by NIH policy is not required.
Pre-award costs: Allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Currency: Implied USD.
Financial reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required for multi-year awards. A final RPPR, invention statement, and expenditure data are required for closeout.
Specific budget requirement: Applicants requesting $500,000 or more in direct costs in any single year (excluding consortium F&A) must contact a Scientific/Research Contact at least 6 weeks prior to submitting the application.

Eligibility Requirements

Eligible Organization Types

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (Other than Small Businesses)
State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
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
Non-domestic (non-U.S.) Entities (Foreign Organizations)

Required Registrations

System for Award Management (SAM) with an active registration, requiring annual renewal. Domestic organizations receive a Commercial and Government Entity (CAGE) Code.
NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (in lieu of a CAGE code) to register in SAM.
Unique Entity Identifier (UEI) issued as part of the SAM.gov registration process. The same UEI must be used across all registrations and the grant application.
eRA Commons registration for organizations. This requires identifying at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov registration, requiring an active SAM registration.
All PD(s)/PI(s) must have an eRA Commons account, affiliated with the applicant organization.

Project Restrictions and Requirements

Applications must not propose clinical trials.
Applications proposing studies of antigen-specific forms of immune memory (adaptive immunity) are non-responsive unless a clear connection to trained immunity is established.
Projects must focus on improving understanding of basic aspects of trained immunity; applications solely focused on applications of trained immunity without novel characterizations of molecular mechanisms or biomarkers will be considered non-responsive.
Studies of innate immune memory in non-mammalian model systems are non-responsive if they lack plans for translating research findings to advance understanding of mammalian immunology.
Applications proposing studies on HIV/AIDS are non-responsive.
Preliminary data, including observational data, is required to support hypotheses and/or justify any descriptive studies.

Application Process

Application Process and Deadlines

Application Submission: Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Application Due Date (latest for new applications): 2026-10-05 17:00:00+00:00 (5:00 PM local time of applicant organization).
Letter of Intent: Due 30 days prior to the application due date (optional, but encouraged).
Submission Encouragement: Applicants are advised to submit early to allow ample time for any necessary corrections during the submission process.
Review and Award Cycle for latest due date: Scientific Merit Review (March 2027), Advisory Council Review (May 2027), Earliest Start Date (July 2027).

Required Documentation and Materials

SF424(R&R) forms package: Must be used for the application submission.
PHS 398 Research Plan: Follow instructions in the Application Guide with specific additions:
- Research Strategy: Describe knowledge gaps, how the proposed studies advance understanding of trained immunity, highlight innovation, and include preliminary/observational data to support hypotheses.
- Resource Sharing Plan: Required as per the SF424 (R&R) Application Guide.
- Data Management and Sharing Plan: Required for all research generating scientific data, effective for due dates on or after January 25, 2023.
- Appendix: Only limited materials allowed (e.g., blank questionnaires or surveys); publications or other general materials are not permitted.
PHS Human Subjects and Clinical Trials Information form: Required if human subjects research is involved (note: clinical trials are not allowed for this NOFO).

Post-Award Requirements and Reporting

Annual Reporting: Recipients of multi-year awards must submit the Research Performance Progress Report (RPPR) annually, along with financial statements.
Closeout Requirements: A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for award closeout.
Subaward Reporting: Recipients must report subawards over a specified threshold to the Federal Subaward Reporting System (FSRS).
Integrity and Performance Reporting: Recipients with cumulative Federal awards exceeding $10,000,000 must report and maintain current information in the System for Award Management (SAM) regarding civil, criminal, and administrative proceedings.

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the relevant research field(s), considering all review criteria.

Scored Review Criteria

Significance: Does the project address an important problem or knowledge gap? How will the project improve scientific knowledge or clinical practice?
Investigator(s): Are the PD(s)/PI(s) and other key personnel well-suited and appropriate for the project? Do they possess the necessary experience and expertise?
Innovation: Does the project challenge existing paradigms or develop new methodologies or technologies? Does it apply novel concepts or approaches to address the research question?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate for the objectives? Are potential problems addressed, and alternative strategies presented? For descriptive studies, reviewers consider the justification for defining immune signatures and phenotypes.
Environment: Does the scientific environment contribute to the probability of success? Are unique investigative resources or collaborative arrangements available? Is there institutional support for the project?

Additional Review Criteria (Not Scored, but Considered)

Protections for Human Subjects: Evaluation of justification for involvement, proposed protections against risks, potential benefits, importance of knowledge to be gained, and data/safety monitoring (if applicable).
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Assessment of proposed plans for inclusion or exclusion based on sex, race, ethnicity, and age, ensuring justification aligns with scientific goals.
Vertebrate Animals: Evaluation of descriptions of procedures, justification for species choice, and interventions to limit discomfort.
Biohazards: Assessment of potential hazards to research personnel or the environment and adequacy of proposed protections.
Applications from Foreign Organizations: Reviewers assess if the project offers unique opportunities (talent, resources, populations, environmental conditions) that are not readily available in the U.S. or augment existing U.S. resources.
Select Agent Research: Assessment of information regarding select agent use, registration, monitoring, biosafety, biocontainment, and security.
Resource Sharing Plans: Review of the reasonableness of proposed sharing plans (e.g., for model organisms) or the rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Comment on brief plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Consideration of whether the requested budget and project duration are fully justified and reasonable in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

General Compliance: All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement, along with Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690) upon award acceptance.
Integrity and Performance: Awards are subject to Federal Awardee Performance and Integrity Information System (FAPIIS) requirements, which involves review of an applicant's integrity, ethics, and performance record.
IRB/IEC Approval: Recipient institutions must ensure that protocols involving human subjects are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Data Protection and Sharing

Data Management and Sharing Policy: Compliance with the 2023 NIH Policy for Data Management and Sharing is required. An approved Data Management and Sharing Plan must be implemented by recipients.

Risk Management and Security

Hazardous Materials: Reviewers will assess potential hazards of proposed materials or procedures to research personnel and/or the environment, and whether adequate protection is proposed.
Select Agent Research: Specific information and adherence to procedures regarding the use, monitoring, biosafety, biocontainment, and security of Select Agent(s) are required.

Special Considerations

Grant Type: This R01 NOFO specifically targets more developed research projects (up to 5 years), distinguishing it from the companion R21 (PAR-24-111) which supports shorter-term exploratory research.
Clinical Trials: Explicitly not allowed for this funding opportunity.
Multiple Applications: Applicant organizations may submit more than one application, provided each is scientifically distinct; duplicate or highly overlapping applications are not accepted.
Intergovernmental Review: This initiative is not subject to intergovernmental review (E.O. 12372).
Funding Decisions: Final funding decisions are based on scientific and technical merit (as determined by peer review), availability of funds, and relevance to program priorities.
Foreign Organizations: The grant specifically notes that foreign organizations' applications will be reviewed for special opportunities they may present (e.g., unique talent, resources, populations, or environmental conditions).

Grant Details