NIDUS LOI & Application Instructions

1. Focus your application on the NIDUS 2025-2026 Pilot Grant / LOI Priority Area: The Inter-Relationship of Delirium & AD/ADRD
   • This theme is very broad. Examples of projects fulfilling this theme include (but are not limited to) studies focused on:
     • Risk factors or outcomes related to delirium associated with AD/ADRD or long-term cognitive decline
     • Harmonization and refinement of measurement tools that distinguish delirium from AD/ADRD or delirium superimposed on AD/ADRD
     • Biomarker and mechanistic studies to advance our understanding of: (1) the pathophysiology of inter-relationship of delirium and AD/ADRD; (2) how delirium may lead to the development of AD/ADRD; or (3) identifying therapeutic targets at the interface of delirium and AD/ADRD
     • Clinical Trials--Intervention development studies for future clinical trials, especially of delirium prevention or treatment strategies which examine effectiveness for the outcomes of AD/ADRD or long-term cognitive decline
   • Rationale & justification: How does your proposal meet the theme of the Inter-Relationship of Delirium & AD/ADRD?
     • LOI and pilot must include 1 paragraph that justifies how the proposed project addresses the theme of the Inter-Relationship of Delirium & AD/ADRD (Note: This paragraph will not count in page limit)
2. Utilize the NIDUS Cores and resources to accomplish the work
3. Involve a Collaborative Working Group (i.e., an interdisciplinary team of up to 5 investigators from multiple disciplines, across 2-3 institutions (max 3 subcontracts))
   • Joint appointment in another institution does not constitute a second institution
   • Senior investigators that can give in-kind support are encouraged—may be from another institution (if does not require payment/subcontract)
   • Recommend at least one junior investigator (preference will be given for projects that include junior investigator(s))
   • Roles of each investigator involved must be clearly identified and distinct
   • Investigators must be PhD, MD, or doctoral equivalent
     • Post Docs and Clinical Fellows are not eligible to apply for the current NIDUS II Pilot Grants as PIs or CO-Is.
   • US citizenship not required
   • NIDUS PIs, co-I’s, or any personnel receiving salary support from NIDUS grant are not eligible to be a PI on a Pilot application.
   • NIDUS will not fund projects coming from investigators at start-up companies.
4. There can be no overlap with other current applications. The same or closely related Aims should not currently have been submitted elsewhere (or planned for submission elsewhere).

Formatting & Submission Instructions

Please submit your proposal via email to NIDUS@hsl.harvard.edu:

• Formatted as a single PDF
• Email subject line: 2025 NIDUS Pilot Award Letter of Intent
• 11 point Arial font, with 0.5 inch margins on all sides
• Submitted by a single principal investigator

Those principle investigators who are asked to submit a full pilot applications based on their LOI application will each receive a $1,000 LOI award to further support building of the collaborative investigation team

LOI Application Materials:

• Cover Sheet (1 page max)
  • Title of project
  • Principal Investigator: name; institution/organization; contact information (email, phone number, mailing address)
  • Collaborators (full names and their institutions/organizations)
  • Paragraph that justifies how the proposed project addresses the theme of the Inter-Relationship of Delirium & AD/ADRD (see Eligibility criteria for more info)
• Letter of Intent (1 page max)
  • Overview: Scientific Rationale and Innovation (200 words max)
  • Specific Aims and Hypotheses (100 words max)
  • Planned Approach: Brief Summary (200 words max)
  • Significance: Include how this project would lead to a future large project and/or grant (100 words max)
• Appendix (only include the below items; no other attachments will be accepted)
  • NIH Biosketch for Principal Investigator only (follow NIH guidelines)
  • Description of Collaborative Team: Describe each team member and their unique, distinct role on the project (200 words max)
  • Brief Budget Justification: Describe how the $40,000 in direct costs will be used (200 words max)

NIDUS Pilot Award Process

1. Approved Letter of Intent required, which includes feedback on your LOI to be incorporated into full Pilot Application
2. Your team will be assigned a Methods Consultant
   • Completion of at least one 30-minute methods consultation is required to submit a full Pilot Application
   • A biostatistical collaborator on your collaborative team must attend at least one methods consultation
3. Documentation that your IRB application has been submitted at the time of the Pilot Application submission is REQUIRED. Release of awarded funds is contingent on NIDUS receiving documentation of IRB approvals.

Formatting & Submission Instructions

Please submit your proposal via email to NIDUS@hsl.harvard.edu:

• Formatted as a single PDF, including full proposal and appendix
• Email subject line: 2025 NIDUS Pilot Award Application
• 11 point Arial font, with 0.5 inch margins on all sides
• Submitted by a single principal investigator
• Maximum of 4 pages (not including Cover Sheet, NIDUS Supplemental Information, Response to Comments, and Appendix)

Pilot Application Materials

1. Cover Sheet (1 page max)
   • Please download and fill out this Face Page Form to use as the Cover Sheet for your application
2. NIDUS Supplemental Information (1 page max)
   • Please download and fill out this NIDUS Supplemental Information Form to include in your application
3. Response to Comments (1 page max): Respond to Letter of Intent critiques and input from the Methods Consultation
4. Abstract (1/2 page max)
   • Please download and fill out this Abstract Form to include in your application. Follow the below guidelines
     • Limit length to 30 lines or less of text
     • Include the project's broad, long-term objectives and specific aims
     • Include a description of the research design and methods for achieving the stated goals
     • Do NOT include proprietary or confidential information, or trade secrets
     • Write in plain language, so even a non-scientist can understand the importance of the project
     • Be sure that the project summary reflects the key focus of the proposed project
5. Science (3 pages max)
   • Specific aims/hypothesis
   • Background, significance, innovation
   • Research design and methods
     • Study design
     • Sample inclusion and exclusion criteria (describe diversity inclusion)
     • Statistical analyses (including sample size and power considerations)
   • Study strengths and limitations
6. Statement on how the pilot work will lead to a large independent grant (1/2 page max)
7. Appendix (not included in page limit)
   • Literature Cited
   • Applicant’s NIH Biosketch (follow current NIH guidelines)
   • Key research team members’ NIH Biosketches
   • Description of the collaborative team with distinct role of each member (1 page max)
   • Resources and Environment (1 page max)
   • Budget for pilot (Up to $40,000 USD Direct Costs)
     • Please download and fill out these PHS Budget Forms to layout your budget for your application. Be sure to complete both budget pages to accurately outline the direct and indirect costs.
   • Budget justification, including full justification of each budget item (2 page max)
     • The pilot budget should be used preferentially for research resources, assays, etc. to support the project, and not primarily for salary support of investigators
     • Resources may be used for partial salary support and research-related expenses
     • Tuition and training expenses are not eligible
     • Provision must be made for research personnel sufficient to conduct the work, including data analysis and technical support; projects proposing inadequate support for research staff may not be successful
     • Travel expenses are allowable only for one investigator to present at the NIDUS annual meeting
     • Indirect costs are allowable up to 59% (U.S. institutions) or 8% (foreign institutions). If applicant institution has an indirect cost rate less than 59%, they must utilize their own indirect cost rate. Institutions are required to provide a copy of your negotiated indirect cost rate agreement, if applicable. Institutions should outline the indirect cost rate being used in the budget justification and why it may be different from their institutional rate. For U.S. domestic applicants that do not have a federally negotiated rate, NIH allows a 15% indirect cost rate.
   • Pilot timeline with specific objectives to achieve in each quarter (1/2 page max)
   • Letter of Intent to enter into a subcontract signed by your institutional official
     • Using your institutional template would be okay
   • FDP Template Form 3B
     • Please download and fill out Form 3B to include in your application

For both LOI and full Pilot Application review, a review panel will score applications rated on scientific merit and fulfillment of the review criteria outlined below. Solely for the full Pilot Application review, a methods-focused reviewer will provide additional feedback only regarding methodological content of your proposal.

1. NIH Review Criteria: Significance, Investigator(s), Innovation, Approach, & Environment
2. NIDUS-Specific Review Criteria:
   • Relevance to NIDUS 2025-2026 priority area of the Inter-Relationship of Delirium & AD/ADRD [REQUIRED]
   • Feasibility/likelihood of proposed study completion within one year [REQUIRED]
   • Substantive use of NIDUS resources to accomplish the work [REQUIRED]
   • Engagement of an effective interdisciplinary research team [REQUIRED]
   • Evidence that the proposed study will lead to a future large grant proposal or major scientific publication that will ultimately help to advance delirium treatment [REQUIRED]
   • Substantive involvement of a junior faculty investigator [preferred]
   • DEI focus: Inclusion of diverse populations as investigators and participants encouraged [preferred]

Overview/Goal:  The NIDUS II Seed Funding Award has a different purpose than the Pilot Awards. The primary purpose of this grant is to facilitate preliminary work on the proposed collaborative project with mentorship from NIDUS Leaders/Cores. This award is intended to lay the groundwork for a future NIDUS Pilot Grant resubmission, or other grant mechanism. We also hope that a publication might be possible.

Approach:  As selected by the NIDUS II grant review process, some proposals not selected for pilot funding may be provided an alternative opportunity intended to assist in furthering the progress of the project. In these special cases, NIDUS may offer a small Seed Funding Award along with allowable indirect costs (to the maximum allowable by Hebrew SeniorLife). Applicants will be asked to submit a modified (scaled back) research plan and budget request for use of the seed funding.

Award Mechanism: Upon notification of award, a cost reimbursable subcontract will be issued to the awardee institution utilizing the FDP cost reimbursement subaward.

IRB / Data Use Agreements: We don't require IRB approval and Resource Use Agreements at the time of submission. However, these must precede funding of successful applications. We do require that IRB submissions and/or Resource Use Agreements have been instituted upon pilot grant submission. Funding will not be awarded unless either a Resource Use Agreement is already in place or convincing evidence is provided that the data use agreement will be obtained in a timely manner. The subcontract will not be executed until all necessary IRB approvals are in place.

Terms & Conditions: Upon successful award, PIs will need to verify that the research proposed for the pilot has not already been completed and is not currently funded by any source, a standard term and condition of award at NIH.  PIs are responsible for 1) accepting only one award to carry out the proposed research project, and 2) withdrawing any other pending applications that are duplicative.

Progress Reporting: If awarded, then achievement of study milestones will be tracked with mid-point and final progress reports, as well as regular teleconferences between the PI and NIDUS Pilot and Exploratory Studies Core leadership.

Presentations & Publications: We expect awardees to present their findings at the annual NIDUS Scientific Symposium, held in conjunction with the American Delirium Society Annual Meeting, acknowledge all subsequent publications, grants, presentations, or other products resulting directly from this award (NIA grant no. R33AG071744, MPI: Inouye/Jones), and to report subsequent publications or funding that arise from the pilot grant to NIDUS.

Payment Method: These expectations will be included in the subcontract awarded at the start of the funding period. NIDUS will issue pilot awards as subcontracts to the institutions of the involved faculty. Awardee Institutions will be required to invoice no less than quarterly. We will make payments in USD via check on a monthly or quarterly basis.

No Cost Extensions (NCE): NCEs will only be granted for extenuating circumstances and if they are granted they can only be granted once. This does not apply to the upcoming 2025-2026 cycle (there will be no NCEs for this cycle).