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Grant Analysis

Purpose & Target

This grant aims to fund research that uncovers the underlying biological, behavioral, and social mechanisms of neuropsychiatric symptoms (NPS) in individuals with Alzheimer's disease (AD) or related dementias (ADRD), with the ultimate goal of developing new treatments. It primarily targets research organizations (such as higher education institutions, nonprofits, for-profit entities including small businesses, and government agencies) capable of conducting advanced biomedical, behavioral, and social sciences research. No specific organizational size is mandated beyond broad categories. This is a SECTOR-SPECIFIC grant focused on health and medical research, particularly neuroscience, aging, and mental health related to AD/ADRD. The geographic scope is global, with U.S. and non-U.S. entities being eligible. Key filtering criteria include a focus on mechanistic research in AD/ADRD-related NPS, the use of the R01 research project grant mechanism (typically not for early-stage ideas), and a requirement for comprehensive data sharing. This is a recurring opportunity, being a reissue of a previous announcement, with multiple submission deadlines until September 2026.

Financial Structure

Funding Amounts and Limitations

Budget: Application budgets are not limited. However, the requested budget must clearly reflect the actual needs of the proposed project.
Minimum/Maximum Funding per Application: No specific minimum or maximum grant amounts are stated, reinforcing that budgets should be justified by project needs.
Maximum Project Period: The maximum duration for a funded project is 5 years.

Co-financing and Matching Fund Requirements

This funding opportunity does not require cost sharing or co-financing, as explicitly defined by the NIH Grants Policy Statement.

Eligible vs. Ineligible Costs

All costs must adhere to the terms and conditions, cost principles, and other considerations outlined in the NIH Grants Policy Statement.
Allowable Costs: Pre-award costs are only allowable as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Ineligible Costs: Studies solely focused on evaluating safety; clinical efficacy, effectiveness, and management; and/or implementation of new interventions are not supported and therefore associated costs for these activities would be ineligible.

Payment Schedule and Mechanisms

Payment schedules and specific mechanisms are not detailed in this NOFO but will follow standard NIH grant disbursement procedures, as authorized by a Notice of Award (NoA).

Financial Reporting and Audit Requirements

Annual Reporting: Recipients are required to submit the Research Performance Progress Report (RPPR) annually.
Financial Statements: Financial statements must be submitted as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.
Closeout Requirements: For grant closeout, a final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required.
Audit Requirements: All awards are subject to the audit requirements outlined in 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

Financial Guarantees

No specific financial guarantees or security requirements are explicitly stated within the grant materials.

Eligibility Requirements

Hard, Non-Negotiable Formal Criteria

Eligible Organization Types: Open to a wide range of organizations, including:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with or without 501(c)(3) IRS Status)
- For-Profit Organizations (Small Businesses, and Other For-Profit Organizations)
- Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized and Other))
- Federal Governments (Eligible Agencies, U.S. Territory or Possession)
- Other organizations such as Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations, and Non-domestic (non-U.S.) Entities (Foreign Organizations).
Registrations: All applicant organizations must complete and maintain active registrations with the following systems before application submission:
- System for Award Management (SAM)
- Unique Entity Identifier (UEI) (issued as part of SAM.gov registration)
- eRA Commons
- Grants.gov
- Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Principal Investigator (PD/PI): All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.
No Cost Sharing: This grant does not require cost sharing.
No Duplicate Applications: The NIH will not accept duplicate or highly overlapping applications under review at the same time. Each application must be 'scientifically distinct'.
Clinical Trial Type: Only 'mechanistic clinical trials' are supported. Studies focused solely on evaluating safety, clinical efficacy, effectiveness, management, and/or implementation of new interventions are not supported by this specific funding opportunity.
Budget Contact (for large requests): If your application requests $500,000 or more in direct costs for any single year (excluding consortium Facilities & Administrative (F&A) costs), you must contact a Scientific/Research Contact from NIH at least 6 weeks prior to the application submission date.

Exclusion Criteria and Disqualifying Factors

Applications that assess potential NPS mechanisms at only a single level of observation and analysis (e.g., without combining genetic, cellular, brain circuit, physiological, behavioral, and self-report data) are not supported.
Studies whose primary purpose is to evaluate the safety, efficacy, effectiveness, management, or implementation of new interventions are explicitly excluded.
Failure to complete required registrations (SAM, UEI, eRA Commons, Grants.gov) in advance of the due date will result in an application not being accepted for review.
Applications that are incomplete or non-compliant with instructions may be delayed or not accepted for review.

Application Process

Complete Application Process Timeline and Deadlines

Open Date (Earliest Submission): January 05, 2025
Application Due Dates (All submissions are by 5:00 PM local time of applicant organization):
- New Applications:
  - February 05, 2025
  - June 05, 2025
  - October 05, 2025
  - February 05, 2026
  - June 05, 2026
- Renewal / Resubmission / Revision Applications:
  - March 05, 2025
  - July 05, 2025
  - November 05, 2025
  - March 05, 2026
  - July 05, 2026
Expiration Date (Latest Potential Submission): September 08, 2026
Review Cycles (Scientific Merit Review & Advisory Council Review):
- July 2025 / October 2025
- November 2025 / January 2026
- March 2026 / May 2026
- July 2026 / October 2026
- November 2026 / January 2027
Earliest Start Dates (Award Cycles):
- December 2025
- April 2026
- July 2026
- December 2026
- April 2027

Required Documentation and Submission Materials Applicants must follow instructions in the 'Research (R) Instructions in the How to Apply - Application Guide', supplemented by specific instructions in this NOFO. Key required documents include: * 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 forms * PHS 398 Cover Page Supplement * PHS 398 Research Plan: Must include detailed sections on Significance, Innovation, and Approach. * Resource Sharing Plan * Data Management and Sharing Plan: Required for all applications that generate scientific data. * PHS Human Subjects and Clinical Trials Information form (if applicable) * PHS Assignment Request Form * Appendix: Only limited materials are allowed; specifically, no publications or other material except for blank questionnaires or blank surveys. Application Procedure and Platform

Applications must be submitted electronically via one of the following methods:
- NIH ASSIST system
- An institutional system-to-system (S2S) solution
- Grants.gov Workspace
Applicants are encouraged to submit early to allow time for corrections if errors are found during submission.

Types of Support Offered

The primary type of support offered is funding through a 'Grant' financial assistance mechanism. The grant is intended for research and development activities.

Project Implementation Timeline and Reporting Obligations

Project Duration: Maximum of 5 years.
Annual Reporting: Research Performance Progress Reports (RPPR) are required annually.
Data Submission: Descriptive/raw data must be submitted semi-annually (January 15 and July 15) to the National Institute of Mental Health Data Archive (NDA). All other data is expected at the time of publication or prior to the end of the grant, whichever comes first.
Clinical Trials Reporting: If the award involves clinical trials, the 'responsible party' must register and submit results information for applicable clinical trials on ClinicalTrials.gov.

Post-Award Requirements and Compliance Obligations

Award recipients must comply with all provisions in effect during the award period, other Department regulations, and applicable statutory provisions.
Notice of Award (NoA): The official document authorizing the award. Activities undertaken before receiving the NoA are at the applicant's own risk.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: All NIH-conducted or -supported human biomedical and behavioral intervention studies must be monitored to ensure participant safety and data integrity.
IND/IDE Requirements: Clinical research projects involving investigational therapeutics, vaccines, or devices must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
Federal Award History Review: Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to assess sound business practices and integrity.
Closeout: Requires submission of a final RPPR, invention statement, and expenditure data.

Evaluation Criteria

Scored Review Criteria Reviewers will provide an Overall Impact score, reflecting the project's likelihood to exert a sustained, powerful influence on the research field(s) involved. This score is determined by assessing the following three core criteria, which also receive separate criterion scores:

1. Importance of the Research (Significance and Innovation):
- Significance: How well the project links mechanisms and/or risk factors to NPS across multiple levels of analysis (e.g., genetic, cellular, brain circuit, physiological, behavioral, self-report) in a way that can inform novel intervention development. It should clarify the neurobiological and/or behavioral mechanisms underlying NPS syndromes in AD/ADRD.
- Innovation: How the proposed paradigm, model, and/or assay offers a significant improvement over the current state of the science, particularly in advancing scientific knowledge towards linking mechanisms and/or risk factors to NPS. This includes integrating multiple levels of analysis to understand the dynamic relationships between NPS symptoms and AD pathogenesis.
2. Rigor and Feasibility (Approach):
- The appropriateness of the theoretical justification for the proposed approach and its potential to advance scientific understanding of NPS mechanisms.
- For imaging studies, the examination of neural circuits involved in NPS in AD/ADRD compared to other neuropsychiatric diseases.
- For animal studies, the use of well-validated models of the involved circuitry with corresponding validated behavioral assays.
- Emphasis on rigor and transparency in experimental design, adhering to guidelines like NOT-OD-15-103 and NOT-MH-14-004.
3. Expertise and Resources (Investigator(s) and Environment):
- The qualifications, experience, and leadership of the Program Director(s)/Principal Investigator(s) and other key personnel.
- The adequacy and appropriateness of the institutional environment and facilities for the proposed research.
- Access to necessary resources for successful project completion.

Additional Review Criteria (Not Scored, but Considered for Overall Impact)

Protections for Human Subjects: Evaluation of plans for participant protection and ethical conduct.
Vertebrate Animals: Assessment of procedures involving animals, justification for use, interventions to minimize discomfort, and justification for euthanasia (if applicable).
Biohazards: Evaluation of hazards to research personnel or the environment and proposed protections.
Resubmissions/Renewals/Revisions: Evaluation of previous feedback, progress, or appropriateness of scope expansion.

Additional Review Considerations (Not Scored)

Authentication of Key Biological and/or Chemical Resources: Plans for validating resources.
Budget and Period of Support: Justification and reasonableness of the requested budget and project duration in relation to the proposed research.

Quality Thresholds and Excellence Benchmarks The grant prioritizes research that is not only scientifically sound but also highly innovative, rigorous, and translatable. This includes: * Utilizing cutting-edge methodologies from fields such as cognitive and affective neuroscience, including neuroimaging, neurophysiology, gene expression, epigenetics, and behavioral intervention research. * Employing constructs from NIMH's Research Domain Criteria (RDoC) initiative or compatible dimensional approaches to assess NPS. * Proposing research that identifies modifiable targets for intervention development. Cross-Cutting Themes Impact on Scoring While not explicit scoring criteria, research that incorporates the following is encouraged and aligns with funder priorities, potentially enhancing the application's overall impact: * Examining molecular mechanisms of NPS in AD/ADRD across populations of diverse ethnic and racial backgrounds. * Focusing on understanding the impact of sex differences on the molecular mechanisms of NPS in AD/ADRD. * Strong commitment to data sharing to enable reproducible and translatable discovery research and facilitate meta-analyses, contributing to scientific sustainability.

Compliance & Special Requirements

Regulatory Compliance Requirements

General Compliance: All awards are subject to the NIH Grants Policy Statement, the Public Health Service Act (Sections 301 and 405), 42 CFR Part 52, and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Mandatory Disclosures: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Data Protection, Environmental, and Ethical Standards

Data Protection & Sharing: A robust Data Management and Sharing Plan is mandatory for all applications generating scientific data. Data must be shared via NIH-designated repositories such as the National Institute of Mental Health Data Archive (NDA) and the NIA-supported AD Knowledge Portal prior to publication. This includes using Global Unique Identifiers (GUIDs) and adhering to NDA's Data Dictionary and Sharing Regimen.
Ethical Standards: Strict adherence to human research protection policies is required, including:
- Data and Safety Monitoring Plans (for human subjects research).
- IRB or IEC Approval for all research protocols involving human subjects.
- Compliance with ethical guidelines for vertebrate animals if applicable.

Intellectual Property Policies

While not detailed in the provided text, NIH awards generally involve intellectual property considerations, and an 'invention statement' is a required document for grant closeout, indicating that any inventions developed under the grant must be reported.

Risk Management and Security Requirements

Projects involving human subjects must have a Data and Safety Monitoring Plan.
NIH reviews applicants' federal award history in SAM.gov to ensure sound business practices, integrity, and performance in managing Federal awards.

Unique Aspects, Potential Challenges, or Strategic Opportunities

Unique Focus on Mechanisms: This NOFO specifically supports mechanistic clinical trials designed to understand biological/behavioral processes or pathophysiology, rather than traditional safety, efficacy, or implementation trials. It explicitly excludes research at only a single level of observation.
Emphasis on RDoC: Encourages the use of constructs from NIMH's Research Domain Criteria (RDoC) initiative or compatible dimensional approaches for assessing NPS.
Advanced Methodologies: Encourages cutting-edge methodology from fields like cognitive and affective neuroscience, neuroimaging, neurophysiology, gene expression, and epigenetics.
Data Sharing Commitment: A significant requirement is the mandatory sharing of all data, analytical methods, and research tools with the broad scientific community through specified NIH repositories prior to publication, which can be resource-intensive.
Strategic Alignment: The grant aligns with the National Plan to Address Alzheimer's Disease, offering a strategic opportunity for researchers to contribute to a national priority.
Collaboration Encouragement: The National Institute on Aging (NIA) strongly encourages applications developed through academic-industry collaborations.
Diversity and Inclusion: NIA encourages research that examines molecular mechanisms of NPS across populations of diverse ethnic and racial backgrounds and studies focused on the impact of sex differences.
Technological Integration: Interest in using passive sensing technology, digital technologies, and machine learning techniques to characterize behavioral patterns and environmental factors related to NPS.
Potential Challenges: Ensuring compliance with rigorous NIH application guidelines and reporting requirements, particularly for data management and sharing, can be complex. The distinction between supported mechanistic trials and excluded efficacy trials requires careful proposal crafting.
Reproducibility: Strong encouragement to incorporate rigor and transparency features into proposed research plans to enhance reproducibility.

Cross-Cutting Considerations Not Covered in Evaluation Criteria

The grant implicitly supports capacity building within the research community by fostering advanced research and data sharing practices.
It aims to generate knowledge that can lead to improved public health outcomes for individuals with AD/ADRD.
The focus on diverse populations and sex differences promotes health equity within research. SDG3 (Good Health and Well-being) is a key UN Sustainable Development Goal supported by this grant's objectives.

Grant Details