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Grant Analysis

Purpose & Target

GRANT PURPOSE AND TARGET

Single, clear statement of grant's core objective:
To support innovative research projects that represent a significant change in research direction for Early Stage Investigators (ESIs), specifically projects for which no preliminary data exist.
Explicit identification of target recipient type and size:
Target recipients are Early Stage Investigators (ESIs), defined by NIH, affiliated with a wide range of organizations including higher education institutions, non-profits, for-profit organizations (including small businesses), and various government entities.
Organization size is not explicitly limited, but recipients must have the capacity to conduct research projects.
SECTOR-SPECIFIC
Geographic scope and any location requirements:
Limited to organizations within the United States.
Foreign organizations are not eligible to apply; however, foreign components (collaborations) of U.S. organizations are permitted.
Key filtering criteria for initial grant screening:
Applicant must be an Early Stage Investigator (ESI) as defined by NIH.
Proposed research must represent a new research direction for the ESI (and all MPIs, if applicable).
The application must not include preliminary data.
Clinical trials are not allowed.
Project must align with the mission of one or more participating NIH Institutes and Centers (ICs).
Grant frequency and program context:
This is a recurring grant opportunity (reissue of a previous PAR) with multiple application cycles through 2026.

Financial Structure

FINANCIAL STRUCTURE

Budget range and limitations:
Application budgets are not limited but must reflect the actual needs of the proposed project.
Eligible and ineligible costs:
Eligible costs generally follow NIH Grants Policy Statement guidelines. Specific eligible/ineligible cost categories are not detailed here, but will be consistent with NIH R01 grant policies.
Matching fund requirements and percentages:
No cost sharing is required.
Co-financing requirements:
No co-financing requirements explicitly stated.
Payment schedule and mechanisms:
Payments are made through a grant mechanism.
Financial reporting requirements:
Recipients are required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required by the NIH Grants Policy Statement.
A final RPPR, invention statement, and expenditure data are required for closeout.

Eligibility Requirements

ELIGIBILITY REQUIREMENTS

Eligible Organization Types:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (including Small Businesses and other For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments)
Federal Government (Eligible Agencies)
Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations)
Geographic Requirements:
Organizations must be located in the United States.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply for direct funding, but foreign components (e.g., subcontracts) are allowed.
Individual Qualifications (PD/PIs):
All Program Directors/Principal Investigators (PDs/PIs) must be designated Early Stage Investigators (ESI) by NIH (as defined in NOT-OD-17-101).
If multiple PDs/PIs are proposed, all must be ESIs.
The proposed project must represent a change in research direction for the ESI (and for all MPIs, if applicable).
Technical/Project Requirements:
Applications must not include preliminary data. Preliminary data are defined as data not yet published.
The proposed project must not be a clinical trial.
The project's direction must be different from the ESI's previous research focus and/or training experience; it cannot be an incremental advancement.
Registration Requirements:
Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM) (requires annual renewal).
- Unique Entity Identifier (UEI) (issued as part of SAM.gov registration).
- eRA Commons (requires at least one Signing Official and one PD/PI account).
- Grants.gov (requires active SAM registration).
Registration processes can take 6 weeks or more and must be completed prior to submission.
All PDs/PIs must have an eRA Commons account.
Exclusion Criteria:
Applications proposing clinical trials.
Applications that include preliminary data.
Foreign organizations as primary applicants.

Application Process

APPLICATION PRACTICAL INFORMATION

Application Deadlines and Submission Windows:
Latest New Application Due Date: 2026-09-28 17:00:00 (5:00 PM local time of applicant organization).
Other recurring deadlines are: January 26, 2024; May 29, 2024; September 26, 2024; January 28, 2025; May 28, 2025; September 26, 2025; January 27, 2026; May 27, 2026.
Applicants are encouraged to apply early to allow time for corrections.
Required Documentation and Materials:
SF424 (R&R) Application Guide instructions must be followed.
Required attachment: A separate document titled 'New Research Direction' (limited to one page; if MPIs, one page per PD/PI) describing how the proposed research is a change from prior work.
Research Strategy section must address Significance, Innovation, and Approach in the context of a new direction and without preliminary data.
Data Management and Sharing Plan is required for all applications generating scientific data.
Resource Sharing Plan.
Biographical Sketch: Should emphasize experience, training, and skillset for innovative new research and intellectual risk-taking.
References and data must have a Digital Object Identifier (DOI).
Submission Format and Platform:
Applications must be submitted electronically through:
- NIH ASSIST system.
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Paper applications are not accepted.
Project Implementation Timeline:
The maximum project period is 5 years.
Applicants should provide a timeline for the proposed research.
Reporting Obligations:
Annual Research Performance Progress Report (RPPR).
Financial statements as required.
A final RPPR, invention statement, and expenditure data at closeout.
Reporting to Federal Subaward Reporting System (FSRS) for subawards over $25,000.
Reporting to System for Award Management (SAM) regarding civil, criminal, and administrative proceedings for cumulative awards > $10,000,000.
Pre-application Requirements:
For requests of $500,000 or more in direct costs in any year, applicants must contact a Scientific/Research Contact at least 6 weeks before submission.
Application Assistance Availability:
eRA Service Desk for system questions.
General Grants Information email/phone for application instructions.
Grants.gov Customer Support for registration/Workspace issues.
Scientific/Research Contacts and Grants Management Contacts are listed for specific ICs.

Evaluation Criteria

EVALUATION CRITERIA Reviewers will provide an Overall Impact Score based on the likelihood for the project to exert a sustained, powerful influence on the research field, considering the following scored criteria: Scored Review Criteria

Significance:
Does the project address an important problem or a critical barrier to progress?
Is prior research supporting the proposed project rigorous?
How will successful completion improve scientific knowledge, technical capability, or clinical practice?
How will it change concepts, methods, technologies, treatments, services, or interventions that drive the field?
Potential to transform understanding within the field.
For unconventional hypotheses, how does it challenge or create a standard paradigm?
Investigator(s):
Are PD(s)/PI(s), collaborators, and other researchers well suited to the project?
Does the proposed research represent a change in research direction for all PD(s)/PI(s)?
For collaborative/multi-PD/PI projects, do investigators have complementary and integrated expertise?
Are leadership, governance, and organizational structures appropriate?
Do selected collaborators enhance feasibility for the new research direction?
Innovation:
Does the application challenge and seek to shift current research or clinical practice paradigms?
Does it utilize novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
Is the novelty specific to one field or broad?
Is a refinement, improvement, or new application of concepts/approaches proposed?
Importance of clearly stating what makes the project unique and innovative beyond just a new direction for the PD/PI(s).
Approach:
Given no preliminary data, is there a robust conceptual framework, premise, logical approach, and/or justification?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate?
Are there plans to address weaknesses in the rigor of prior research?
Are strategies presented to ensure a robust and unbiased approach (e.g., addressing biological variables like sex)?
Are potential problems, alternative strategies, and benchmarks for success presented?
For higher-risk approaches, explanation of potential benefits/rewards offsetting risks.
Description of collaborators' roles and contributions for areas outside ESI's expertise.
Environment:
Will the scientific environment contribute to success?
Are institutional support, equipment, and physical resources adequate?
Will the project benefit from unique features (e.g., subject populations, collaborative arrangements)?

Additional Review Criteria (Not Scored, but Considered):

Protections for Human Subjects: Evaluation of justifications for involvement, protection against risks, benefits, knowledge gained, and data/safety monitoring (if applicable).
Inclusion: Evaluation of plans for inclusion/exclusion of individuals based on sex, race, ethnicity, and age (including children/older adults), justified by scientific goals.
Vertebrate Animals: Evaluation of proposed procedures, species justification, and methods to limit discomfort.
Biohazards: Assessment of potential hazards and proposed protections.
Resource Sharing Plans: Reasonableness of sharing plans or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.

Compliance & Special Requirements

COMPLIANCE AND SPECIAL REQUIREMENTS

Regulatory Compliance Requirements:
All NIH awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Compliance with Federal-wide Standard Terms and Conditions for Research Grants.
Compliance with Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment.
Compliance with Acknowledgement of Federal Funding.
Compliance with non-discrimination laws and submission of Assurance of Compliance (HHS-690).
Data Protection and Privacy Regulations:
Compliance with the 2023 NIH Policy for Data Management and Sharing for research generating scientific data.
Implementation of the Data Management and Sharing Plan upon approval.
Ethical Standards and Requirements:
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required for human subjects research.
Adherence to guidelines for the protection of human subjects from research risks.
Adherence to guidelines for the inclusion of women, racial and ethnic minorities, and individuals across the lifespan in human subjects research.
Compliance regarding the care and use of vertebrate animals.
Risk Management Expectations:
Applicants are encouraged to clearly explain why the new knowledge to be gained is beyond incremental and how potential impact offsets higher inherent risk due to lack of preliminary data.
If approaches entail higher risk, plans for addressing unsuccessfulness and benefits offsetting risks should be presented.
Unique Aspects/Challenges:
The defining feature is the prohibition of preliminary data and the requirement for a change in research direction for the ESI.
This presents a unique challenge for applicants to justify scientific and technical feasibility through conceptual framework, literature, published data, and publicly available databases rather than own preliminary findings.
Encourages ESIs to pursue entirely new, potentially higher-risk, innovative avenues of research.

Grant Details