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Grant Analysis

Purpose & Target

This grant, the NIA Academic Leadership Career Award (K07), aims to support established investigators who possess the expertise and leadership necessary to enhance aging and/or Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) research capacity within their academic institutions. The core objective is to develop crucial research and educational infrastructure, mentorship programs, and career development activities to advance new or emerging areas in these fields. This is a SECTOR-SPECIFIC grant, focusing primarily on healthcare and biomedical research related to aging and dementia. The geographic scope is limited to U.S.-based organizations and their components; foreign entities are not eligible. Key filtering criteria for initial screening include the applicant's status as an established investigator with an active R01-equivalent NIA grant or multi-component sub-project, and the institution's strong research environment. This is a recurring grant program with multiple application cycles, representing a reissue of a previous funding opportunity to align with current agency priorities.

Financial Structure

The financial structure for the NIA Academic Leadership Career Award focuses on supporting the individual PD/PI and institutional capacity building, with specific annual caps for different cost categories:

Budget Range: This grant does not specify a total project budget but rather annual direct cost caps for components. The total project period may not exceed 5 years.
Maximum Annual Direct Costs: The total direct costs for the career award recipient's salary, research development support, and curriculum development or research coordinator salary combined may not exceed $150,000 per year, inclusive of fringe benefits.
Eligible Costs and Limitations (Annual):
- Career Award Recipient Salary: NIH will contribute up to $75,000 per year towards the recipient's salary. The total salary must align with the institution's established salary structure. Institutional supplementation from non-federal funds is permitted, provided it doesn't create extra duties that interfere with the award's purpose. The NIH salary contribution cannot exceed the legislatively mandated salary cap.
- Research Development Costs: Up to $50,000 per year may be requested for research development expenses. These funds can cover:
  - Tuition and fees related to career development.
  - Research-related expenses (e.g., supplies, equipment, technical personnel).
  - Travel to research meetings or training.
  - Statistical services, including personnel and computer time.
- Curriculum Development or Research Coordinator Salary: Up to $25,000 per year may be requested for the salary of a dedicated curriculum development or research coordinator.
Ineligible Costs:
- Salary for mentors.
- Salary for secretarial and administrative assistants.
- Clinical practice, professional consultation, or other comparable activities, unless directly required by the objectives of this program.
- Federal funds for salary supplementation, unless explicitly authorized by the specific federal program.
Matching Fund Requirements: This NOFO does not require cost sharing or matching funds.
Indirect Costs (F&A Costs): Reimbursed at 8% of modified total direct costs.
Financial Reporting: Recipients are required to submit financial statements annually, along with the Research Performance Progress Report (RPPR). A final RPPR, invention statement, and expenditure data are required for award closeout.
Financial Guarantees: No explicit financial guarantees or security requirements are mentioned.

Eligibility Requirements

To be considered for this grant, both the applying organization and the individual Program Director/Principal Investigator (PD/PI) must meet specific, non-negotiable criteria: Organizational Eligibility

Eligible Organization Types: A wide range of U.S.-based entities are eligible, provided they can support the grant's objectives. These include:
- Higher Education Institutions: Public/State Controlled and Private Institutions.
- Nonprofits: With or without 501(c)(3) IRS Status (other than Institutions of Higher Education).
- For-Profit Organizations: Small Businesses and other For-Profit Organizations.
- Local Governments: State, County, City/Township Governments, Special District Governments, and Indian/Native American Tribal Governments (Federally Recognized and Other).
- Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, and Regional Organizations.
Geographic Requirement: Only domestic (U.S.) organizations are eligible to apply. Non-domestic (non-U.S.) entities and non-domestic components of U.S. Organizations are specifically excluded. Foreign components, as defined by NIH, are also not allowed.
Institutional Environment: The applicant institution must demonstrate a strong, well-established record of research and career development activities and have faculty qualified in biomedical, behavioral, or clinical research who can collaborate with the applicant.
Required Registrations: Before application submission, organizations must complete and maintain active registrations with:
- System for Award Management (SAM), including obtaining a Unique Entity Identifier (UEI).
- eRA Commons: Identifying at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov.

Individual (PD/PI) Eligibility

Established Investigator Status: The individual applicant (PD/PI) must be a named PD/PI on an active R01 or R01-equivalent NIA grant or on a sub-project of a multi-component NIA research project (e.g., P30, P01, U54, U19) at the time of application submission.
Doctoral Degree: Candidates must possess a clinical, research, or health-professional doctoral degree. This includes, but is not limited to, PhD, MD, DO, DDS, DMD, OD, DC, DSW, DPH, PharmD, ND, or a doctoral degree in nursing research or practice.
Citizenship/Residency: By the time of award, the individual must be a citizen or non-citizen national of the United States, or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification).
Full-Time Appointment: At the time of award, the candidate must hold a 'full-time' appointment at the academic institution.
Level of Effort: A minimum of 25% (3 person-months) but not more than 50% (6 person-months) of full-time professional effort must be dedicated to the program annually.
Exclusion Criteria: Individuals proposing to lead an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial are not eligible for this specific NOFO.

Application Process

Applying for the NIA Academic Leadership Career Award involves a structured electronic submission process with specific deadlines and required documentation: Application Deadlines and Timeline

Application Due Dates: The program operates on multiple cycles. The latest overall deadlines are:
- New applications: October 12, 2027
- Renewal/Resubmission/Revision applications: November 12, 2027
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Grace Period: If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
Submission Encouragement: Applicants are encouraged to submit early to allow time for correcting any errors found during the submission process.
Project Period: The total project period for an award may not exceed 5 years.

Required Documentation and Materials Applicants must follow instructions in the NIH 'How to Apply - Application Guide' unless specifically directed otherwise by this NOFO. Key forms and sections include: * SF424(R&R) forms: Including Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, and R&R Budget. * PHS 398 Cover Page Supplement. * PHS 398 Career Development Award Supplemental Form: Comprised of: * Candidate Section: Includes Candidate Information and Goals for Career Development (demonstrating leadership, scientific expertise, commitment, and ability to develop curricula), Career Goals and Objectives, and Candidate's Plan for Career Development/Training Activities During Award Period (detailing curriculum development, pedagogical experience, structured activities, and plans for evaluating program process/progress). * Research Plan Section: Describes the quality of candidate's research, strategy to implement the program, justification for proposed program elements, and plans for program continuation after the award ends (as K07 awards are non-renewable). * Other Candidate Information Section: Includes Candidate's Plan to Provide Mentoring (for early career investigators) and record of mentoring. Must also include a plan for Training in the Responsible Conduct of Research (RCR). * Mentor, Co-Mentor, Consultant, Collaborators Section: Requires signed statements from collaborators and consultants confirming their participation and roles. Mentor/Co-mentor statements are not required for this NOFO. * Environmental and Institutional Commitment to the Candidate Section: Requires a description of the institutional environment and a statement of commitment from the sponsoring institution regarding the integration of proposed courses/curricula and protected time for the candidate. * Other Plan(s): As of January 25, 2023, a Data Management and Sharing Plan is required for all applications involving research that generates scientific data. * Appendix: Limited items allowed; do not use to circumvent page limits. * PHS Human Subjects and Clinical Trials Information form: Required if human subjects research is involved. Section 4 (Protocol Synopsis) and Section 5 (Other Clinical Trial-related Attachments) should not be completed for this NOFO as independent clinical trials are not allowed. * PHS Assignment Request Form. Application Procedure and Submission

Applications must be submitted electronically via Grants.gov using one of the following systems:
- NIH ASSIST system.
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Applicants must track the status of their application in eRA Commons.
It is critical that required organizational and individual registrations (SAM, UEI, eRA Commons, Grants.gov, ORCID for PD/PI) are completed prior to submission.

Support Types Offered

Monetary Funding: Support for salary of the career award recipient, curriculum development/research coordinator, and research development expenses.
Capacity Building: Funds and expectations for developing research and educational infrastructure, new curricula, and networks.
Mentorship Support: The award supports the PD/PI in providing mentorship to early career investigators.

Project Implementation and Reporting

Reporting Schedule: Recipients are required to submit a Research Performance Progress Report (RPPR) annually and financial statements as required by NIH policy. For mentored awards, the Mentor's Report must include an annual evaluation of the candidate's progress.
Post-Award Requirements: A final RPPR, invention statement, and expenditure data are required for award closeout. Recipients must comply with all terms and conditions outlined in the Notice of Award and applicable federal regulations.

Evaluation Criteria

Applications are rigorously evaluated for scientific and technical merit through NIH's peer review system. The review focuses on both the individual candidate's capabilities and the proposed program's impact: Scored Review Criteria Reviewers assign a separate score for each of these key areas, contributing to the overall impact score:

Candidate: Assessment of the applicant's demonstrated scientific expertise, leadership skills, commitment to an academic research career in aging/AD/ADRD, and capacity to develop and implement effective courses or curricula. Reviewers evaluate the quality of the candidate's prior research and their ability to carry out the proposed program.
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring: Evaluation of the candidate's career goals, how the award aligns with past and future research development, and the plan's contribution to expanding aging/AD/ADRD academic or research capacity at the institution. This includes plans for pedagogical experience, structured activities (coursework, seminars), and clear plans for mentoring early career investigators, including recruitment, selection, supervision, and support for their research.
Research Plan: Focuses on the strategy to implement the program at the institution. This involves justifying proposed elements (courses, curricula, research support, pilot funding, travel awards, visiting scholars, networks) with evidence of their effectiveness and alignment with sound research concepts and educational principles. Also assessed is how the program complements existing training and the plan for the program's continuation after the award ends (as K07 awards are not renewable).
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): Though mentors are not required to provide statements for this NOFO, the role and contributions of collaborators and consultants are evaluated. Signed statements confirming their participation and roles are required for collaborators/consultants.
Environment & Institutional Commitment to the Candidate: Review of the sponsoring institution's strong, well-established research and career development program, its high-quality research environment, and the availability of faculty for collaboration. Crucially, the institution must provide a statement of commitment confirming the integration of the proposed courses/curricula into academic offerings and protected time for the candidate to meet their effort commitment.

Additional Review Criteria These items are evaluated but do not receive separate scores. They contribute to the overall impact score where applicable:

Protections for Human Subjects: If human subjects research is involved.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Relevance to health disparities and broad participation are specifically encouraged by NIA.
Vertebrate Animals: If applicable.
Biohazards: If applicable.
Resubmissions: For resubmitted applications, evaluation includes responses to previous review comments and changes made.

Additional Review Considerations These items are considered but do not receive scores and do not impact the overall score directly:

Training in the Responsible Conduct of Research (RCR): The adequacy of the proposed RCR training plan is assessed as 'ACCEPTABLE' or 'UNACCEPTABLE', requiring specific components (face-to-face format, subject matter breadth, faculty participation, minimum 8 contact hours, frequency).
Select Agent Research: If applicable, assessment of plans for use, monitoring, biosafety, biocontainment, and security.
Resource Sharing Plans: Reviewers comment on the reasonableness of resource sharing plans or the rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: For relevant projects, plans for identifying and ensuring resource validity are reviewed.
Budget and Period of Support: Reviewers consider whether the requested budget and project period are fully justified and reasonable.

Compliance & Special Requirements

This grant involves several key compliance obligations and unique aspects tailored to its objective: Regulatory Compliance Requirements

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Compliance with 42 CFR Part 52 and 45 CFR Part 75 (Public Health Service Act and Federal Regulations).
Adherence to all applicable nondiscrimination laws; recipients must submit an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance, including NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Data Protection and Privacy Regulations

NIH Data Management and Sharing Policy (effective January 25, 2023): When applicable, recipients must adhere to this policy and implement an approved Data Management and Sharing Plan.
Health IT and Cybersecurity: If award funding involves implementing, acquiring, or upgrading health IT, recipients must use IT that meets 45 CFR part 170, Subpart B standards and, for certain clinicians/settings, technology certified under the ONC Health IT Certification Program.
Cybersecurity Act of 2015: For recipients with ongoing access to HHS information/operational technology systems or PII/PHI from HHS, plans and procedures modeled after the NIST Cybersecurity framework are required to protect HHS systems and data.

Ethical Standards

Responsible Conduct of Research (RCR): All applications must include a plan to fulfill NIH requirements for RCR instruction. This training must include specific components: face-to-face instruction, breadth of subject matter (e.g., conflict of interest, data management, research ethics), faculty involvement, at least eight contact hours of instruction, and occur at least once every four years.

Intellectual Property Policies

Not explicitly detailed in the provided grant materials; standard NIH IP policies would apply, likely outlined in the NIH Grants Policy Statement.

Unique Aspects and Potential Challenges

Focus on Capacity Building: This award is distinctly designed to support an established investigator in building institutional research and educational capacity in aging/AD/ADRD, rather than primarily supporting their individual research project or a new clinical trial.
Clinical Trial Exclusion: This NOFO explicitly does not allow independent clinical trials, clinical trial feasibility studies, or ancillary clinical trials. This is a critical distinction for applicants.
Non-Renewable Award: K07 awards are not renewable. Applicants must describe plans and milestones for how the proposed program will continue at the institution after the award ends, emphasizing sustainability.
Pre-existing Grant Requirement: A significant hurdle is the requirement for the individual PD/PI to be a named PD/PI on an active R01 or R01-equivalent NIA grant or a sub-project of a multi-component NIA research project at the time of application submission.
Level of Effort: The requirement for a minimum of 25% to a maximum of 50% dedicated effort to the program (3-6 person-months annually) must be managed carefully by the PD/PI and the institution.

Strategic Opportunities

Addressing Health Disparities: Applications that promote broad participation and address health disparities among older adults are strongly encouraged.
Mentorship and Network Development: A key opportunity lies in strengthening institutional mentorship frameworks for early career investigators and establishing research networks.
Curriculum Development: The grant supports the development of new courses and curricula, fostering innovation in aging/AD/ADRD education.

Cross-cutting Themes

Inclusion and Diversity: Emphasized through the encouragement of projects that promote broad participation and address health disparities.
Sustainability: A clear requirement to plan for the continuation of programs beyond the award period.
Responsible Conduct of Research: Mandatory training components ensure ethical research practices.

Grant Details