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Grant Analysis

Purpose & Target

The core objective of this grant is to support the implementation of investigator-initiated, hypothesis-driven clinical trials that require an extended project period of 6 or 7 years. These trials, which can be of any phase and include associated mechanistic studies, must align with the research missions and high-priority areas of the participating NIH Institutes/Centers (specifically the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute on Aging (NIA)). The grant aims to advance scientific knowledge and potentially change clinical practice by providing valuable information from long-term studies. It is a SECTOR-SPECIFIC grant focused on biomedical and health research. Target recipients include a broad range of U.S. and foreign organizations capable of conducting rigorous clinical trials. Key filtering criteria for initial screening are the strict requirement for an NIH-defined clinical trial, the justification for a 6- or 7-year duration, and readiness to implement the trial upon award. This is a recurring funding opportunity under the NIH R01 Research Project Grant program.

Financial Structure

Budgetary Information

Budget Range: Application budgets are not limited to a specific amount. However, the requested budget must clearly and accurately reflect the actual needs of the proposed project.
Budget Justification: Reviewers will carefully consider whether the budget and the requested 6 or 7-year period of support are fully justified and reasonable in relation to the proposed research.
Pre-Award Costs: Pre-award costs are allowable, subject to the conditions outlined in the NIH Grants Policy Statement.

Funding Type and Mechanisms

This opportunity provides grant funding.
Awards issued under this FOA will be incrementally funded for project periods of up to seven years. This means funds are typically disbursed in stages based on progress and approval, rather than as a single lump sum.
Multi-year funded awards will not be awarded under this FOA.

Cost Sharing and Co-financing

No cost sharing is required for this funding opportunity.
If parts of the costs of the clinical trial are to be borne by sources other than NIH (e.g., from consortium partners), these contributions must be presented in detail as part of supporting letters signed by individuals with signatory authority. It's important to note that these external contributions do not constitute cost sharing as defined by NIH and should not be presented as part of the requested budget or as 'Estimated Project Funding'.

Financial Management and Reporting

Carryover Policy: Grants awarded under this FOA are excluded from automatic carryover. All carryover requests must be approved by NIH.
Extension Policy: The authority to automatically extend the final budget period one time for up to 12 months beyond the original expiration date does not apply. All extensions, including the first, will require approval.
Fund Expenditure: All funds must be expended within the approved project period.
Reporting Requirements: Recipients are required to submit:
- Research Performance Progress Reports (RPPR) annually.
- Financial statements as required by the NIH Grants Policy Statement.
- A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report (FFR) for closeout of the award.
- Information about first-tier subawards over $25,000 to the Federal Subaward Reporting System (FSRS).
- If applicable, recipients with cumulative Federal awards greater than $10,000,000 must report and maintain current information in the System for Award Management (SAM) regarding civil, criminal, and administrative proceedings.

Eligibility Requirements

Organizational Eligibility This grant is open to a very wide array of organizations, including: * Higher Education Institutions: Both Public/State Controlled and Private Institutions of Higher Education. * Nonprofits: With or without 501(c)(3) IRS Status (other than Institutions of Higher Education). * For-Profit Organizations: This includes Small Businesses and other For-Profit Organizations. * Local Governments: State, County, City or Township, Special District Governments, and Indian/Native American Tribal Governments (Federally Recognized and Other). * Federal Government: Eligible Agencies of the Federal Government and U.S. Territories or Possessions. * 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, and Non-domestic (non-U.S.) Entities (Foreign Institutions). This means organizations outside the U.S. are eligible to apply and receive funding, as are non-domestic components of U.S. organizations. Project-Specific Requirements

Clinical Trial Focus: Applications must propose an NIH-defined clinical trial(s). Only applications proposing clinical trials will be accepted.
Extended Project Period: The proposed clinical trial must require an extended project period of 6 or 7 years. Applicants must provide a clear justification for this longer duration, linking it to the project's specific aims and delineated milestones.
Readiness for Implementation: All clinical trial planning activities, such as development of study design, identification of collaborators/sites, clinical protocol, statistical analysis plan, data management plan, and investigator's brochure, must be completed by the time of application submission. Investigators must be ready to implement the proposed trial at the time of award.

Exclusion Criteria (Applications considered Non-Responsive) Applications will be considered non-responsive and will not be reviewed if they propose to: * Conduct more than one clinical trial. * Conduct studies that are not appropriate as an investigator-initiated 6- or 7-year clinical trial. * Are multi-year funded awards (this FOA supports incrementally funded awards). * Involve the collection of preliminary data and conduct of pilot and feasibility studies. * Are observational studies that do not involve an intervention. * Are epidemiological studies. * Involve clinical trial planning tasks (as these must be completed prior to submission). Required Registrations & Accounts To be eligible to apply for or receive an award, applicant organizations must complete and maintain active registrations for: * System for Award Management (SAM): This includes obtaining a Unique Entity Identifier (UEI). Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code instead of a CAGE Code. * eRA Commons: Organizations need at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. * Grants.gov. Registrations can take 6 weeks or more, so it's crucial to start this process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission. Cost Sharing This funding opportunity does not require cost sharing. Application Limits Applicant organizations may submit more than one application, provided that each application is scientifically distinct. However, NIH will not accept duplicate or highly overlapping applications under review at the same time.

Application Process

Key Dates and Deadlines There are multiple application due dates for new, renewal, resubmission, and revision applications. The latest final application due date for this opportunity is January 13, 2026, by 5:00 PM local time of the applicant organization. Applicants are strongly encouraged to submit their applications early to allow time for corrections if any errors are found during submission. If a due date falls on a weekend or a federal holiday, the deadline is automatically extended to the next business day. Application Submission Methods Applications must be submitted electronically using one of the following methods: * NIH ASSIST system: An online system for preparing, submitting, and tracking your application. * Institutional system-to-system (S2S) solution: Check with your institutional officials for availability. * Grants.gov Workspace: For preparing and submitting your application, with tracking via eRA Commons. Required Documentation and Materials It is critical to follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, as well as the program-specific instructions below. Incomplete or non-compliant applications will not be reviewed. Key Application Components: * PHS 398 Research Plan: This includes: * Specific Aims: Clearly state the trial's goals, expected outcomes, and primary/secondary endpoints. * Research Strategy: Discuss the significance of the problem, the need for the trial, preliminary data, and the overall strategy, methodology, and analyses. You must clearly justify the need for a 6- or 7-year project period. Describe plans for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). * Letters of Support: Provide appropriate letters, especially for consortium/site participants, cores, laboratories, pharmacies, and other collaborators. If non-NIH sources contribute financially, these contributions must be detailed in supporting letters. * Resource Sharing Plan: As per SF424 (R&R) Application Guide instructions. * Data Management and Sharing Plan: Required for due dates on or after January 25, 2023. This plan must be attached in the 'Other Plan(s)' section of FORMS-H application packages. * Appendix: Only limited materials are allowed. This must include a Complete Clinical Protocol. Applications submitted without the Complete Clinical Protocol will be considered incomplete and will not be reviewed. * PHS Human Subjects and Clinical Trials Information Form: Required if human subjects are involved. This form will include: * 6- or 7-Year Milestone Plan: A detailed plan outlining project performance and timeline objectives, including milestones for regulatory approvals, participant enrollment (25%, 50%, 75%, and 100%), data collection, primary/secondary endpoint data analyses, final study report, and initial manuscript submission. Applications lacking this milestone plan will not be reviewed. * Overall Structure of the Study Team: Description of the study organization, administration, committee structures, and the roles and qualifications of sites/personnel. * FDA-regulated Intervention Information: If applicable, describe the Investigational Product (IP) and IND/IDE status, including FDA letters if IND/IDE approval is not required. * Other Clinical Trial-related Attachments: If applicable, this section should include copies of data collection forms, Investigator's Brochure, the GCP/GLP/GMP plan, Table of Contents of the Manual of Operations (MOPS), a comprehensive Laboratory Plan, and informed consent/assent forms. Pre-Application Requirements and Recommendations

Consultation for Large Budgets: If your application requests $500,000 or more in direct costs in any single year (excluding consortium F&A), you must contact a Scientific/Research Contact at least 6 weeks before submitting your application.
Strongly Encouraged Consultation: For all applications (new and resubmission), it is strongly encouraged to contact relevant NIH Institute/Center (IC) staff at least 10 weeks prior to the application due date. This consultation helps determine if your proposed clinical trial meets the IC's goals, mission, high-priority research areas, and if it's ready for implementation and compliant with regulations. While IC staff will not evaluate scientific merit, they can provide guidance and confirm appropriateness for this FOA.
Registrations: Ensure all required organizational and individual registrations (SAM, UEI, NCAGE for foreign, eRA Commons, Grants.gov) are completed and active well in advance of the deadline, as they can take significant time.

Application Assistance

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors, warnings, submission issues). Toll-free: 1-866-504-9552 (Press 1).
General Grants Information: For questions on application instructions, processes, NIH grant resources. Email: [email protected].
Grants.gov Customer Support: For Grants.gov registration and Workspace issues. Telephone: 800-518-4726.
Scientific/Research Contact(s): Specific contacts for NIAID divisions (DAIDS, DAIT, DMID) are provided in the FOA for scientific inquiries.

Evaluation Criteria

Applications are rigorously evaluated for scientific and technical merit to assess their potential for significant and sustained impact on the research field. Reviewers will assign an Overall Impact score based on the following equally weighted Scored Review Criteria:

Significance: This criterion assesses whether the project addresses an important problem or a critical barrier. It considers the rigor of prior research supporting the proposal and how the project will improve scientific knowledge, technical capability, or clinical practice. Reviewers specifically evaluate if the scientific rationale for the clinical trial is well-supported and if the trial is necessary to advance scientific understanding or change clinical practice, community behaviors, or healthcare policy.
Investigator(s): This evaluates the qualifications of the Program Director(s)/Principal Investigator(s) (PD/PIs), collaborators, and other researchers. Key considerations include their expertise, experience, and ability to organize, manage, and implement the clinical trial and meet milestones. For multi-PD/PI or collaborative projects, the complementary expertise, leadership approach, governance, and organizational structure are assessed.
Innovation: This criterion examines whether the application challenges current research or clinical practice paradigms through novel theoretical concepts, approaches, methodologies, instrumentation, or interventions. It looks for both broad novelty and refinements or new applications of existing concepts, and assesses if the design includes innovative elements that enhance its potential for information or to advance scientific knowledge/clinical practice.
Approach: This is a critical assessment of the overall strategy, methodology, and analyses. Reviewers determine if they are well-reasoned, appropriate for the specific aims, and if weaknesses in prior research are addressed. It scrutinizes the plans for a robust and unbiased approach, how potential problems are addressed, and whether relevant biological variables (like sex) are adequately considered. For human subjects, protection plans and inclusion/exclusion justifications are reviewed. Importantly, for this FOA, reviewers explicitly assess if the complete Clinical Protocol is appropriate and well-described.
Environment: This evaluates whether the scientific environment, institutional support, equipment, and physical resources are adequate for the project's success. It considers if the project benefits from unique features of the scientific environment, subject populations, or collaborative arrangements. For multi-site or international trials, the appropriateness of administrative, data coordinating, enrollment, and laboratory/testing centers, and the capability of individual sites to perform tasks like enrollment and data collection, are evaluated.

In addition to these scored criteria, reviewers will consider the following Additional Review Criteria without assigning separate scores: * Study Timeline: Detailed, feasible, and justified timeline, including start-up activities, enrollment rates, and follow-up. It also considers the incorporation of efficiencies and strategies for potential challenges (e.g., enrollment shortfalls). * Protections for Human Subjects: Justification for human subject involvement, adequacy of protection against risks, potential benefits, importance of knowledge, and data/safety monitoring for clinical trials. * Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion or exclusion based on scientific goals and research strategy. * Vertebrate Animals / Biohazards: Assessment of involvement and proposed protections, if applicable. * Resubmissions: Reviewers consider responses to comments from previous scientific reviews and changes made to the project. * Applications from Foreign Organizations: Assessment of whether the project presents special opportunities (e.g., unusual talent, resources, populations) not readily available in the United States. * Resource Sharing Plans: Reviewers will comment on the reasonableness of data sharing plans or the rationale for not sharing. For due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) are commented on but not scored. * Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources. * Budget and Period of Support: Reviewers assess whether the requested budget and the 6 or 7-year project period are fully justified and reasonable in relation to the proposed research. Funding Decisions Final funding decisions are made based on the scientific and technical merit as determined by peer review, the availability of funds, the relevance of the proposed project to program priorities, and the sufficiency of the proposed budget to support the research.

Compliance & Special Requirements

Regulatory and Ethical Compliance

ClinicalTrials.gov Registration: If your award includes one or more clinical trials, the 'responsible party' must register and submit results information for certain 'applicable clinical trials' on the ClinicalTrials.gov Protocol Registration and Results System. NIH expects registration and results reporting for all trials, whether legally required or not.
IRB/IEC Approval: Recipient institutions must ensure that all clinical trial protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC). NIH requires copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring: All NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) require ongoing oversight and monitoring to ensure participant safety and the validity and integrity of the data.
Investigational New Drug (IND)/Investigational Device Exemption (IDE): Clinical research involving investigational therapeutics, vaccines, or medical interventions (including licensed products used for an off-label purpose) must be performed under an FDA IND or IDE, if applicable.
Quality Standards: Applicants must include plans to implement and monitor Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), as appropriate to the trial design and scope.
Data Management and Sharing: For due dates on or after January 25, 2023, a Data Management and Sharing Plan is required for all research generating scientific data. Once approved, recipients are required to implement this plan as described.

Administrative and Legal Requirements

HHS Civil Rights Compliance: Recipients of Federal Financial Assistance (FFA) from HHS must comply with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, and disability. This includes ensuring meaningful access for persons with limited English proficiency and effective communication with persons with disabilities. Programs must also be administered in an environment free of sexual harassment.
Integrity and Performance Reporting: Awards are subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. Federal awarding officials will review an applicant's integrity and performance record before making an award. Recipients must report and maintain current information about civil, criminal, and administrative proceedings related to federal awards.
Subaward Reporting: All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) on all subawards over $25,000.

Unique Aspects and Strategic Considerations

Extended Project Period Justification: A key distinguishing feature of this FOA is the requirement for a 6- or 7-year project period. Applicants must provide a robust, clear rationale for this extended duration, specifically linking it to the project's aims and delineated milestones. This is a critical filter for eligibility and review.
Milestone-Driven and Strict Monitoring: Projects awarded under this FOA are milestone-driven. This means specific, measurable events and timelines are agreed upon. NIH staff will closely monitor progress, accrual goals (especially for participant recruitment), and safety. If recruitment falls significantly below projected milestones, the NIH Institute/Center (IC) may consider ending support and negotiating a phase-out of the award.
Incremental Funding and Financial Flexibility: While funded as a grant, awards are incrementally funded, meaning funds are released in stages. This grant mechanism explicitly excludes automatic budget carryover and automatic one-time extensions of the final budget period. All carryover requests and all extensions (even the first) will require explicit approval.
Potential Conversion to Cooperative Agreement (U01): A grant awarded under this FOA may be converted to a cooperative agreement (U01) if the NIH determines that substantial scientific programmatic staff involvement is needed. This implies a higher level of NIH oversight and collaboration during the project's implementation than typically seen with standard grants.

Grant Details