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Grant Analysis

Purpose & Target

Grant Purpose and Target

Core objective: To foster the next generation of researchers in Alzheimer's disease and related dementias (AD/ADRD) and to encourage established researchers new to the field to undertake pilot studies, ultimately improving prevention, diagnosis, treatment, and care for individuals with AD/ADRD.
Explicit identification of target recipient type and size: Individual researchers (primarily early stage investigators) affiliated with eligible organizations. Organizations can be diverse (universities, nonprofits, for-profits, governments). No specific size limits mentioned for organizations, but focus is on individual researchers.
MUST state if grant is SECTOR-SPECIFIC or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC
Geographic scope and any location requirements: Global; non-U.S. entities are eligible to apply.
Key filtering criteria for initial grant screening: Focus on AD/ADRD research; applicant must be a 'next generation' researcher or an 'established' researcher without major prior AD/ADRD funding.
Grant frequency and program context: Reissue of previous announcements (PAR-23-179), indicating a recurring program to address the shortage of AD/ADRD researchers and promote interdisciplinary research as per National Alzheimer’s Project Act (NAPA) Milestone 4.J.

Financial Structure

Award Budget: Up to $100,000 in direct costs per year.
Project Period: Maximum of 2 years. Therefore, a total maximum award of $200,000 (2 years x $100,000/year).
Eligible Costs: Direct costs are covered. Specific eligible/ineligible cost categories are not detailed beyond 'direct costs'.
Matching Fund Requirements: No cost sharing required. This implies 100% funding of eligible direct costs up to the stated limits.
Payment Mechanisms: Not explicitly detailed, but NIH grants typically involve regular disbursements.
Financial Reporting: Required as part of annual Research Performance Progress Report (RPPR) and Federal Financial Report (FFR) for closeout.
Currency: USD (United States Dollar) is implied as this is a U.S. federal grant.

Eligibility Requirements

Organizational Eligibility

Eligible organization types:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (501(c)(3) IRS Status and others)
- For-Profit Organizations (Small Businesses and others)
- Local Governments (State, County, City/Township, Special District, Federally Recognized Indian/Native American Tribal, Other Indian/Native American Tribal)
- Federal Governments (Eligible Agencies, 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, Non-domestic (non-U.S.) Entities - foreign organizations are eligible).

Individual Eligibility (Program Director/Principal Investigator - PD/PI)

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research.
Not intended for individuals with substantial experience in AD/ADRD research.
Generally, applicants should not have had prior research funding as an independent PD/PI on a major NIH grant in AD/ADRD research (e.g., DP1, DP2, DP5, R01, R37, R56, RF1, RL1, U01, R35, or serving as a PD/PI in Centers and Program Project grants).
Each PI is eligible to receive up to one award through this program.
Recipients of awards made under PAR-23-179, PAS-19-391, PAS-19-392, and PAS-19-393 (and their predecessors) are not eligible.

Registration Requirements

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM) (requires annual renewal)
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations)
- Unique Entity Identifier (UEI) (issued via SAM.gov registration)
- eRA Commons (organization must identify at least one Signing Official and one PD/PI account)
- Grants.gov (requires active SAM registration)
All PD/PIs must have an eRA Commons account affiliated with the applicant organization.

Application Process

Application Submission Process

Application must be submitted electronically via:
- NIH ASSIST system
- Institutional system-to-system (S2S) solution
- Grants.gov Workspace
Applicants are encouraged to submit early to allow time for corrections.
Applications must comply with instructions in the Research (R) Instructions in the How to Apply - Application Guide and program-specific instructions in the NOFO. Non-compliant applications may be delayed or not accepted.
Applications are checked for completeness and compliance upon submission; errors must be corrected and a changed/corrected application submitted by the deadline.

Key Dates & Deadlines

Open Date (Earliest Submission Date): January 16, 2025
Application Due Dates (by 5:00 PM local time of applicant organization):
- February 16, 2025
- June 16, 2025
- October 16, 2025
- February 16, 2026 (Latest deadline for new applications)
If a due date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
Expiration Date: March 17, 2026

Required Documentation & Materials

SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
R&R or Modular Budget forms.
R&R Subaward Budget (if applicable).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan, including:
- Resource Sharing Plan
- Data Management and Sharing Plan (required for all research generating scientific data)
PHS Human Subjects and Clinical Trials Information form (if human subjects/clinical trials involved), including Study Record or Delayed Onset Study record.
PHS Assignment Request Form.
Limited Appendix materials allowed (e.g., blank questionnaires/surveys, no publications).

Project Implementation & Reporting

Project period: Up to 2 years.
Annual Research Performance Progress Report (RPPR) required.
Final RPPR, invention statement, and expenditure data portion of Federal Financial Report (FFR) required for closeout.
NIH will review and measure performance based on details and outcomes in RPPRs.

Post-Award Requirements & Compliance

ClinicalTrials.gov registration and results reporting for applicable clinical trials.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval for human subjects research.
Data and Safety Monitoring requirements for human biomedical and behavioral intervention studies.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements for clinical research involving investigational products.

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved.
An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Factor 1. Importance of the Research (Significance and Innovation):
- Evaluate significance and how the project addresses important problems.
- Innovation assesses how the project challenges existing paradigms, uses novel concepts, approaches, or instrumentation, and refines or improves current methods.
Factor 2. Rigor and Feasibility (Approach):
- Evaluate the overall strategy, methodology, and analyses, including how the project addresses scientific rigor.
- For clinical trials, evaluate if the design provides an adequate framework to ensure reproducible and robust results.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): Evaluate whether the investigator(s) have demonstrated background, training, and expertise, appropriate for their career stage. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan.
- Environment: Evaluate whether institutional resources are appropriate to ensure successful execution.

Additional Review Criteria (Considered but Not Scored)

Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge to be gained, data and safety monitoring for clinical trials.
Vertebrate Animals: Justifications for use of animals, appropriateness of species, interventions to minimize discomfort, and justification for euthanasia method if applicable.
Biohazards: Adequacy of protection against significant hazards to research personnel and/or environment.
Resubmissions: Evaluate the full application as presented.

Additional Review Considerations (Considered but Not Scored)

Authentication of Key Biological and/or Chemical Resources: Brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support: Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Adherence to NIH Grants Policy Statement.
Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Compliance with all applicable nondiscrimination laws; Assurance of Compliance (HHS-690) may be required.
Compliance with federal statutes and regulations relevant to federal financial assistance, including Public Policy Requirements.

Data Protection & Privacy

Mandatory Data Management and Sharing Plan (consistent with 2023 NIH Policy).
For entities with ongoing access to HHS information systems or PII/PHI: requirement to develop plans and procedures modeled after the NIST Cybersecurity Framework to protect HHS systems and data.

Ethical Standards

Strict requirements for Protections for Human Subjects (including 45 CFR Part 46 exemptions), Vertebrate Animals, and Biohazards.
IRB/IEC approval is required for all protocols.
Data and Safety Monitoring requirements apply to clinical trials.

Risk Management

Projects involving clinical trials are encouraged to contact NIA program staff early due to the limited time and budget of R03 awards (only mechanistic or small pilot trials are likely feasible).
Applicants proposing NIH-defined clinical trials can refer to the NIH Research Methods Resources website for statistical methods and study designs.

Intellectual Property

An invention statement is required for award closeout.

Unique Program Focus

This R03 grant is specifically designed to support:
- Early Stage Investigators (ESIs) committed to AD/ADRD and aging research.
- Established researchers who have not had a major NIH award in AD/ADRD research, to enable pilot studies and generate preliminary data.
The grant explicitly states it is not intended for individuals with substantial experience in AD/ADRD research.
Encourages professional development activities in parallel with the R03 award.
NIA supports a Clinical Research Operations Management System (CROMS); successful applicants are expected to interface with it as necessary.

Grant Details