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Grant Analysis

Purpose & Target

The STRONG-RLI program aims to support Resource-Limited Institutions (RLIs) in conducting comprehensive needs assessments of their biomedical research capacity. The grant's core objective is to then enable these institutions to develop actionable plans to address identified needs, ultimately increasing their competitiveness for research funding. - Explicitly targets Higher Education Institutions that qualify as Resource-Limited Institutions (RLIs). - RLIs are defined by their average annual NIH Research Project Grant (RPG) support over the past three fiscal years ($0 to $25 million total costs). - This is a SECTOR-SPECIFIC grant focused on biomedical research and health sciences within higher education. - Geographic Scope: United States based institutions only; foreign institutions or components of U.S. organizations abroad are not eligible. - Key filtering criteria: Must be a degree-granting institution in health professions or STEM, and meet specific NIH RPG funding thresholds. - Grant frequency: Recurring (latest deadline in September 2025 indicated a program that runs for several years, though specific recurring nature beyond that is not explicitly stated as annual), part of an ongoing NIH initiative.

Financial Structure

Award Budget: Application budgets for direct costs should not exceed $250,000 per year.
Maximum Funding: The maximum project period is three years, implying a maximum direct cost award of $750,000 over the entire project period.
Currency: United States Dollars (USD).
Eligible Costs: Direct costs related to needs assessment activities and action plan development. Travel costs for attending in-person meetings and STRONG Executive Steering Committee (SESC) meetings must be included.
Ineligible Costs: Funds may not be used for research infrastructure (e.g., laboratory supplies, equipment), alterations or renovations, or research projects/pilot projects (as the grant focuses on assessment and planning, not direct research or infrastructure purchase).
Cost Sharing: This funding opportunity does not require cost sharing.
Indirect Costs: Not explicitly detailed, but generally NIH allows indirect costs based on the applicant institution's negotiated rate.
Financial Reporting: Recipients will be required to submit financial statements as required in the NIH Grants Policy Statement.

Eligibility Requirements

Organizational Type and Status

Eligible Organizations: Higher Education Institutions, including Public/State Controlled and Private Institutions of Higher Education.
Resource-Limited Institutions (RLIs) Definition: Institutions that award degrees in health professions (and related sciences) or STEM fields (including social and behavioral sciences), and have received an average of $0 to $25 million per year (total costs) of NIH Research Project Grant (RPG) support for the past three fiscal years.
RLI Categories (must fit one):
- Low Research Active (LRA): Undergraduate or graduate degree-granting institution with less than $6 million (total costs) in NIH RPG support per year in three of the last five years. Additionally, undergraduate granting institutions must have at least 35% of undergraduate students supported by Pell grants.
- High Research Active (HRA): Doctoral degree-granting institution with between $6 million and $25 million (total costs) in NIH RPG support per year in three of the last five years.
Foreign Institutions: Not eligible to apply. Non-U.S. components of U.S. organizations are also not eligible.

Geographic and Legal Requirements

Geographic Location: Must be located within the United States.
Registrations: Applicant organizations must complete and maintain active registrations with:
- System for Award Management (SAM) (annual renewal required).
- eRA Commons (must have at least one Signing Official and one Program Director/Principal Investigator account).
- Grants.gov.
- Unique Entity Identifier (UEI), issued through SAM.gov.
All registrations must be completed prior to application submission (can take 6+ weeks).

Application Limitations

Number of Applications: Only one application per institution (identified by unique UEI or NIH IPF number) is allowed.
Overlap: No duplicate or highly overlapping applications allowed under review concurrently.

Application Process

Application Deadlines and Submission

Open Date (Earliest Submission Date): August 18, 2023.
Application Due Dates: Multiple submission dates are provided, with the latest being September 18, 2025.
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Application System: Applications must be submitted electronically via Grants.gov using one of the following methods:
- NIH ASSIST system.
- Institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
eRA Commons: Applicants must track their application status in eRA Commons.
Corrections: Applicants are encouraged to submit early to allow time for corrections; errors must be corrected and a changed/corrected application resubmitted by the due date.

Pre-Application Requirements

Letter of Intent (LOI): Although not required or binding, submission is requested by August 18, 2023, for the first cycle, and by corresponding dates for subsequent cycles. LOI should include descriptive title, PD/PI name(s), key personnel, participating institutions, and funding opportunity number.
Registrations: Required SAM, UEI, eRA Commons, and Grants.gov registrations must be active before submission (can take 6+ weeks).

Required Documentation and Materials

SF424 (R&R) Application Guide: Applicants must follow instructions in this guide, except where specified otherwise in the NOFO.
Research Plan (PHS 398): Must include detailed sections on:
- Significance: Explain needs for institutional research capacity.
- Innovation: Describe innovative aspects of proposed needs assessment plans.
- Approach: Detail methods for institutional needs assessment (including physical facilities, faculty support, human resources, sponsored programs, tools, outcomes measurement, existing capacity-building grants) and the development of institutional action plans.
- Governance and structure of steering committees: Describe composition, activities, expertise, and meeting frequency of the institutional Steering Committee (SC).
- Timeline and Milestones: Realistic timeline for needs assessment and action plan activities, aligned with goals.
Letters of Support: Two specific letters are required:
- Institutional Eligibility Letter (1-page max): From the Provost or similar official, certifying the institution's RLI category (LRA or HRA) and providing verifying information.
- Institutional Commitment Letter: From the President or designated high-ranking official (Provost, VP, Dean), describing how the project aligns with institutional vision and committing to achieving project goals. Applications lacking this letter will be considered incomplete and withdrawn.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications or other material.
Data Management and Sharing Plan: Not applicable for this NOFO.

Post-Award Requirements and Reporting

Project Period: Maximum of three years.
Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required.
Closeout: A final RPPR, invention statement, and expenditure data are required for award closeout.
Subaward Reporting: Recipients must report information about first-tier subawards over the threshold in the Federal Subaward Reporting System (FSRS).
Transparency: Reporting on civil, criminal, and administrative proceedings in SAM if cumulative Federal awards exceed $10,000,000.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved. Scored Review Criteria

Significance:
- How well the project addresses an important problem or critical barrier to progress in institutional research capacity.
- How it will improve scientific knowledge, technical capability, or clinical practice by enhancing biomedical research capacity.
- The clarity of pathways between needs assessment/action plan development and future research efforts.
- The vision for how the project serves as a foundation for future capacity building.
Investigator(s):
- Expertise of Program Director(s)/Principal Investigator(s) (PD/PIs), collaborators, and other researchers to conduct the needs assessment, implement the project, analyze outcomes, and develop action plans.
- Appropriateness of leadership, governance, and organizational structure for collaborative projects.
Innovation:
- The novelty of approaches or methods used to fulfill the grant's purpose.
- How well the applicant adapts or creates approaches/tools to fit their specific institutional context and needs.
- Innovation is considered the use of existing products, tools, or processes, or creating/adapting evidence-based tools.
Approach:
- Soundness and appropriateness of the overall strategy, methodology, and analyses for the needs assessment and action plan development.
- Adequacy of tools and instruments for needs assessment, monitoring, and evaluation of research capacity development.
- Identification of metrics and indicators of success.
- Feasibility of goals and alignment with yearly milestones within the award timeline.
- Sufficiency of the initial needs assessment stage duration to develop action plans.
- Likelihood of the proposed governance and structure plan to lead to successful implementation.
Environment:
- Contribution of the scientific environment to project success, including institutional support and resources.
- Strength of institutional commitment, including administrative and scientific support, for project success.
- How well letters of support demonstrate strong commitment.

Additional Review Considerations (Not Scored, but Impact Overall Impact)

Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, benefits, knowledge gained, data/safety monitoring.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Justification for inclusion/exclusion based on sex, race, ethnicity, and age.
Vertebrate Animals: Justification for use of animals, appropriateness of species, measures to minimize discomfort, and justification of euthanasia method (if applicable).
Biohazards: Assessment of potential hazards and adequacy of protection measures.
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.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period in relation to proposed research.

Compliance & Special Requirements

Compliance and Regulatory Requirements

NIH Grants Policy Statement: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Federal Civil Rights Laws: Recipients must comply with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, and disability. This includes providing meaningful access for persons with limited English proficiency and effective communication with persons with disabilities.
Sexual Harassment: Programs must be administered in an environment free of sexual harassment.
Federal Awardee Performance and Integrity Information System (FAPIIS): Federal awarding officials will review information about applicants in FAPIIS prior to making an award.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Approval: Recipient institutions must ensure protocols are reviewed by their IRB/IEC, especially if human subjects are involved (though clinical trials are not allowed for this grant, human subjects research may still occur).

Unique Aspects and Special Conditions

Cooperative Agreement (UC2): This is a cooperative agreement, signifying substantial Federal scientific or programmatic involvement from NIH. NIH staff will assist, guide, coordinate, or participate in project activities, but the recipient retains the dominant role.
Substantial NIH Involvement: NIH Project Coordinators will facilitate collaborations, coordinate approaches among recipients, advise on activities, and guide the program (e.g., through participation in Steering Committees).
STRONG-RLI Executive Steering Committee (SESC): PIs of awarded grants, NIH Project Coordinators, and other NIH staff will form the SESC. This committee oversees program activities, shares progress, best practices, and addresses common challenges. PDs/PIs are required to participate in SESC meetings.
Dispute Resolution: A specific dispute resolution panel process is in place for disagreements between award recipients and NIH regarding scientific or programmatic matters.
Focus on Assessment and Planning: This grant is explicitly not for funding research projects, infrastructure acquisition (like lab equipment or renovations), or institutional climate/culture assessment, but strictly for needs assessments and action plan development for research capacity.

Risk Management and Ethical Standards

Human Subjects Protections: For any research involving human subjects, plans for protection from research risks and inclusion/exclusion criteria must be justified.
Biohazards: If applicable, adequate protection measures for personnel and the environment must be proposed.
Intellectual Property: Recipients retain custody and primary rights to data and software developed, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

Grant Details