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Grant Analysis

Purpose & Target

This grant aims to establish or renew Alzheimer's Disease Research Centers (ADRCs). - ADRCs serve as a national resource for research on Alzheimer's Disease (AD) and AD-related dementias (ADRD), focusing on prevention, diagnosis, care, and therapy. - The target recipients are major medical institutions and research organizations. - This is a SECTOR-SPECIFIC grant, focusing on neurodegenerative diseases. - Geographic scope: Across the US only. Foreign institutions are not eligible to apply. - Key filtering criteria: Focus on AD/ADRD research, institutional capacity to host a multi-component research center, location in the US. - Grant frequency: Recurring, reissued from a previous FOA (RFA-AG-21-019). Program context: Aligned with the National Alzheimer's Project Act (NAPA).

Financial Structure

Budget Range: Applications may request a budget of up to $2.925 million in direct costs per year per award.
Total Funding: National Institute on Aging (NIA) intends to commit $32 million in fiscal year (FY) 2024 to fund 7 awards; $65 million in FY 2025 to fund 14 awards; and $65 million in FY 2026 to fund 14 awards.
Matching Fund Requirements: This Funding Opportunity Announcement (FOA) does not require cost sharing.
Eligible Costs:
- Personnel salaries.
- Domestic and foreign travel for Center activities (e.g., semi-annual Center Directors meetings, administrator meetings, ad hoc meetings, inter-Center visits).
- Developmental projects (internal research projects), with costs in the range of $50,000-$100,000 in direct costs per year, for a term of 1-3 years.
- Research patient care costs directly related to ADRC activities, provided there is no overlap of funding.
- Equipment (large items require clear justification for use by core staff and relation to research projects).
- Research Education Component participant costs (salary, fringe benefits, travel, research-project-related expenses).
Ineligible Costs:
- Clinical trials (for the main grant and developmental projects).
- Full-time participant costs for the Research Education Component (RL5) are not allowable, as it is not intended as a substitute for an institutional training program.
Indirect Cost Policies: For the Research Education Component (RL5), indirect costs are reimbursed at 8% of modified total direct costs, exclusive of tuition and fees and expenditures for equipment. Overall Facilities & Administrative (F&A) costs will be provided in accordance with these budgets.
Currency: USD

Eligibility Requirements

Eligible Organizations

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with 501(c)(3) IRS Status, without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other than Small Businesses)
Local Governments (State, County, City or Township, Special District, Federally Recognized Indian/Native American Tribal Governments, Other than Federally Recognized Indian/Native American Tribal Governments)
Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)

Geographic and Organizational Structure

Must be a US institution. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply as the lead institution. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible.
Only one application allowed per institution (identified by Unique Entity Identifier (UEI) number or NIH IPF number).
An ADRC must be an identifiable organizational unit formed by a single institution or a consortium of cooperating institutions.
Must demonstrate strong institutional commitment, with organizational status comparable or superior to departments, and institutional funding.

Registrations and Qualifications

Applicant organizations must be registered and maintain active registration with:
- System for Award Management (SAM) (requires annual renewal).
- Unique Entity Identifier (UEI) (issued as part of SAM.gov registration).
- eRA Commons (for organization and Program Director(s)/Principal Investigator(s) (PD/PIs)).
- Grants.gov.
PD/PIs must have an eRA Commons account.
The PD/PI should be a scientific leader experienced in Alzheimer's Disease (AD) and/or other neurodegenerative disease research.
The grant does not require cost sharing.

Exclusion Criteria

Applications proposing clinical trials are not allowed.
Duplicate or highly overlapping applications under review at the same time are not accepted.

Application Process

Application Deadlines and Submission

Latest Application Due Date: September 26, 2025, by 5:00 PM local time of applicant organization.
Letter of Intent Due Date(s): 30 days before each application due date.
Applications must be submitted electronically through Grants.gov using either the NIH ASSIST system or an institutional system-to-system (S2S) solution.
Applicants are responsible for tracking the status of their application in the eRA Commons to ensure successful submission.
Errors identified during the submission process must be corrected, and a changed/corrected application must be submitted by the due date.

Required Documentation and Materials

The application consists of several distinct components, each with specific content and page limitations:
- Overall Component: Includes the main Project Narrative, Project Summary/Abstract, Facilities and Other Resources, Letters of Support (from institutional officials), and the mandatory Data Management and Sharing Plan.
- Mandatory Core Components: Administrative Core, Clinical Core, Data Management and Statistical Core, Neuropathology Core, Outreach, Recruitment, and Engagement Core, Biomarker Core, and Research Education Component (linked to an RL5 award).
- Optional Additional Cores: May be included if scientifically justified.
Each core component requires specific details regarding its aims, research strategy, and budget.
A Biographical Sketch must be included for each Senior/Key person listed in the application.
The PHS Human Subjects and Clinical Trials Information form is required if human subjects research is involved.
Limited items are allowed in the Appendix, as described in the SF424 (R&R) Application Guide.
All Program Director(s)/Principal Investigator(s) (PD/PIs) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form.

Review and Award Timeline

Scientific Merit Review: Approximately November 2023, November 2024, March 2026.
Advisory Council Review: Approximately January 2024, January 2025, May 2026.
Earliest Start Date: Approximately April 2024, April 2025, July 2026.

Post-Award Requirements and Compliance

Annual Research Performance Progress Reports (RPPR) are required.
Awardees are expected to engage in broad sharing of data and biological samples, analytical methodology, and disease models prior to publication.
This includes timely and routine submission of data to the National Alzheimer’s Coordinating Center (NACC), samples to the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD), and imaging data to Standardized Centralized Alzheimer’s & Related Dementias Neuroimaging (SCAN).

Evaluation Criteria

The overall impact score will assess the likelihood of the project exerting a sustained, powerful influence on the research field. Scored Review Criteria

Significance: Evaluation of the importance of the problem addressed, how the Center's resources will improve scientific knowledge/clinical practice, and the potential for advancing research on normal aging, mild cognitive impairment (MCI), AD, and related disorders. Assesses participation in national collaborative efforts and support for new researchers.
Investigator(s): Assessment of the suitability, experience, and training of PD(s)/PI(s), collaborators, and staff. Evaluates their scientific and administrative leadership, commitment, and evidence of interdisciplinary research and succession planning.
Innovation: Focus on the extent to which the Center and its components demonstrate capacity to develop critical new knowledge and make unique, innovative contributions to AD/dementia research. Considers novel concepts, approaches, methodologies, instrumentation, or interventions.
Approach: Review of the overall strategy, methodology, and analyses. Assesses organization, core management, internal communication, planning, and evaluation strategies. Examines how components collaborate to support the scientific theme and support new investigators. Includes evaluation of human subjects protection and inclusion plans.
Environment: Assessment of whether the scientific environment, institutional support, equipment, and physical resources are adequate and contribute to the probability of success. Evaluates institutional policies supporting team science and long-term commitment through letters of support.

Additional Review Criteria (Not Separately Scored)

Protections for Human Subjects: Justification for involvement and adequacy of proposed protections, importance of knowledge to be gained, and data/safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of plans for inclusion/exclusion based on scientific goals.
Vertebrate Animals: Assessment of procedures, justifications, and measures to minimize discomfort.
Biohazards: Review of potential hazards and proposed protections.
Resubmissions: Consideration of responses to previous comments and changes made.
Renewals: Evaluation of progress made in the last funding period.
Resource Sharing Plans: Review of the reasonableness of plans for sharing model organisms or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Assessment of plans for identifying and ensuring the validity of resources.
Budget and Period of Support: Review for justification and reasonableness in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Must adhere strictly to all instructions in the SF424 (R&R) Application Guide and the specific program-specific instructions provided in this Funding Opportunity Announcement (FOA).
All awards are subject to the terms and conditions and cost principles described in the NIH Grants Policy Statement.
Mandatory compliance with the NIH Data Management and Sharing Policy for all research generating scientific data.
Mandatory compliance with the NIH Genomic Data Sharing Policy.
Research involving human subjects must comply with 45 CFR Part 46, including detailed plans for:
- Protection of human subjects from research risks.
- Justification for inclusion (or exclusion) of individuals based on sex, race, ethnicity, and across the lifespan.
- Obtaining informed consent, including for cognitively-impaired individuals (proxy/surrogate consent), future research participation, data/specimen sharing, and autopsy.
- Compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) for personal health information (PHI).
Research involving live vertebrate animals requires evaluation based on detailed procedures, justification, and interventions to minimize discomfort.
Reviewers will assess potential biohazards and proposed protections.
A plan for instruction in the Responsible Conduct of Research (RCR) is mandatory, addressing:
- Format (no online-only instruction).
- Subject matter breadth (e.g., conflict of interest, data management, human/animal use, research misconduct).
- Faculty participation.
- Duration and frequency of instruction (at least once every four years).

Data and Resource Sharing

A comprehensive Data Management and Sharing Plan is required to ensure accessibility and reusability of all generated datasets.
All disease models and biological samples generated during the award must be made available to qualified investigators.
Awardees are encouraged to utilize NIA-supported repositories such as NACC, NCRAD, NIAGADS, and AMP AD's AD Knowledge Portal for data and resource sharing.

Organizational and Technical Specifics

The grant is specifically for establishing or renewing an Alzheimer's Disease Research Center (ADRC), which must be a multi-component entity.
Mandatory core components include: Administrative, Clinical, Data Management and Statistical, Neuropathology, Outreach, Recruitment, and Engagement, Biomarker, and a Research Education Component (supported by a linked RL5 award).
Additional core components may be proposed if they are scientifically justified and align with the Center's theme.
The Administrative Core must support one to three developmental projects (internal small grants for investigators) ranging from $50,000-$100,000 in direct costs per year for 1-3 years. These developmental projects cannot be clinical trials.
Clinical Core participants must undergo annual Magnetic Resonance Imaging (MRI), Amyloid positron emission tomography (PET), and Tau PET imaging (minimum 24 participants), with data transmitted to the Standardized Centralized Alzheimer’s & Related Dementias Neuroimaging (SCAN) infrastructure.
Emphasis on understanding the heterogeneity of Alzheimer's Disease and AD-related dementias, including mixed dementias, and studying populations most at risk.

Unique Aspects and Challenges

This FOA is explicitly designated as "P30 Clinical Trial Not Allowed," meaning neither the core grant activities nor the developmental projects can involve clinical trials.
Requires significant institutional commitment, including stable long-term support and recognition of team science.
Demands a high level of coordination and integration among the mandated diverse cores.
Focuses on promoting inclusivity by recruiting and retaining participants from varied and understudied backgrounds to address health disparities.

Grant Details