Clinical Study Grant Application

Supporting research that advances the health and resilience of the Naval Special Warfare community

The Navy SEAL Foundation (NSF) is a 501(c)(3) public charity that provides immediate and ongoing support to the Naval Special Warfare (NSW) community, its veterans, and their families. Through this Clinical Study Grant program, NSF funds rigorous, ethically conducted research focused on the medical, psychological, and physiological conditions that disproportionately affect SEALs, Special Warfare Combat Crewmen (SWCC), and other special operators, including traumatic brain injury, post-traumatic stress, sleep disorders, neuroendocrine dysfunction, musculoskeletal injury, blast exposure sequelae, and related conditions.

Applicants must complete every section of this application. Incomplete applications will not be reviewed. Submit any questions to grants@navysealfoundation.org.

Section A. Applicant Organization

Legal Name of Organization:

EIN / Tax ID:

Name of Authorized Signatory:

Authorized Signatory Title:

Postal Street Address:

City:

State:

Zip Code:

Signatory Phone Number:

Signatory Email Address:

Grants/Finance Contact Name:

Website Address:

If applicable

Please indicate the institution's tax status and provide evidence of such tax status as set forth below:

Institution is a domestic tax-exempt organization described in Section 501(c)(3) of the Internal Revenue Code.Institution is a domestic organization described in Section 170(c)(1) or Section 511(a)(2)(B) of the Internal Revenue Code.Other: Please explain.

Please explain the institution's other tax status below:

Please attach current evidence that the applicant organization is recognized as exempt under section 501(c)(3) by the Internal Revenue Service if applicable.

Please attach current evidence that the applicant organization is recognized as exempt under section 501(c)(3) by the Internal Revenue Service.

Please provide a copy of the correspondence, if any, from the Internal Revenue Service stating that fact or a copy of the legislation establishing the applicant organization.

Section B. Principal Investigator / Project Manager

Principal Investigator Name:

Principal Investigator Title:

Principal Investigator Degree(s):

Principal Investigator Institutional Affiliation:

Principal Investigator Email Address:

Principal Investigator Phone Number:

Project Manager Name (if different):

Project Manager Email:

Project Manager Phone Number:

Co-Investigators / Key Personnel. List names, roles, and percent effort:

Attach NIH-format biosketches for PI and each Co-I.

Section C. Project Overview

Project Title:

Project Purpose:

e.g., observational, prospective cohort, randomized controlled trial, retrospective analysis.

Period of Performance:

Start date and end date. NSF grants are typically awarded for a period not to exceed twenty-four (24) months.

Total Project Cost:

Amount Requested from NSF:

Other Funding Sources:

List all confirmed and pending sources, amounts, and status.

Scope of Work

In no more than two (2) pages, attach a Scope of Work that addresses: (i) specific aims and hypotheses; (ii) background and significance to the NSW population; (iii) study design and methodology; (iv) inclusion and exclusion criteria; (v) recruitment plan and target enrollment; (vi) primary and secondary endpoints; (vii) statistical analysis plan; (viii) timeline with quarterly milestones; (ix) anticipated outcomes and dissemination plan; and (x) team qualifications.

Section D. Relevance to NSW Population

In 250 words or fewer, describe how this study will directly benefit active-duty special operators, NSW veterans, and/or their families. Identify the specific condition(s) addressed and the gap in current evidence the study will fill.

Section E. IRB (Institutional Review Board) and Regulatory Compliance

IRB of Record:

IRB Protocol Number:

If not yet assigned, indicate "pending" and provide expected submission date.

IRB Approval Status:

Attach current IRB approval letter or pending submission documentation. No NSF funds will be released until IRB approval is documented.

DoD HRPO / SOCOM Approval (if applicable):

Required when active-duty personnel are enrolled or DoD facilities are used.

FDA / IND or IDE (if applicable):

Conflicts of Interest:

Disclose all financial or non-financial conflicts for PI and Key Personnel.

Section F. Budget

Provide line-item totals below. Indirect costs are capped at 10% of direct costs.

Personnel (salaries, benefits) total project cost:

Personnel (salaries, benefits) amount requested from NSF:

Clinical/Patient Costs total project cost:

Clinical/Patient Costs amount requested from NSF:

Equipment & Supplies total project cost:

Equipment & Supplies amount requested from NSF:

Data Management & Analysis total project cost:

Data Management & Analysis amount requested from NSF:

IRB / Regulatory Fees total project cost:

IRB / Regulatory Fees amount requested from NSF:

Travel total project cost:

Travel amount requested from NSF:

Indirect Costs (cap: 10%) total project cost:

Indirect Costs (cap: 10%) amount requested from NSF:

Other Costs total project cost (please specify):

Other Costs amount requested from NSF:

Total project cost (totals from above):

Total amount requested from NSF (totals from above):

Section G. Use of Grant Funds

If awarded, the Grantee agrees that all funds received from the Navy SEAL Foundation (the "Grant") will be used in accordance with the following terms. These terms will be incorporated into the executed Grant Agreement.

The Grant shall be used to fund research in a manner consistent with NSF's mission of providing immediate and ongoing support and assistance to the Naval Special Warfare community and its families.
All of Grantee's actions with respect to the Grant shall be consistent with the laws and regulations to which it and NSF are subject, including but not limited to the laws and regulations governing public charities exempt from taxation pursuant to Section 501(c)(3) of the Internal Revenue Code (the "Code").
Grantee shall be responsible for issuing IRS Form W-2 or Form 1099 (where applicable) to all individuals receiving honoraria or other forms of compensation from NSF funds hereunder and shall be responsible for withholding and paying all required federal and state payroll taxes with regard to such compensation.
No part of the Grant shall be used for purposes other than the charitable, educational, scientific, or literary purposes described in Section 170(c)(2)(B) of the Code.
No part of the Grant may be used to participate or intervene in any political campaign on behalf of or in opposition to any candidate for public office, or to otherwise directly or indirectly support or oppose candidates for public office or political parties.
No part of the Grant may be expended on activities that constitute attempts to influence legislation within the meaning of Section 501(c)(3) ("lobbying"). Should additional funds be granted under an amendment, none of those funds shall be expended on lobbying unless specifically provided for in the amendment.
No part of the Grant shall be used for any personal attack on, or vilification of, any person (whether by name or business affiliation), company, or governmental agency, whether individually or collectively.
No part of the Grant shall be used for a grant to another organization, individual, or entity without the express prior written approval of NSF.
Grantee shall require each organization, entity, or individual to which it distributes any portion of the Grant to enter into a written agreement with Grantee obligating such organization or entity to comply with the terms of this Agreement, and shall implement appropriate measures to monitor and enforce such compliance.
No part of the Grant shall be used to provide material support or resources to any individual or entity (or an agent) that Grantee knows or has reason to know advocates, plans, sponsors, engages in, or has engaged in illegal or terrorist activity, or may otherwise be deemed associated with terrorism under Executive Order 13224, as amended, the USA PATRIOT Act, or related laws and regulations.

Section H. Reporting Requirements

Grantee shall submit the following written reports to NSF. Reports must be signed by the PI and an authorized signatory of the Grantee organization.

Quarterly Progress Reports: due within thirty (30) days of the end of each calendar quarter during the Period of Performance. Reports shall describe progress against milestones, enrollment status, IRB status, deviations or amendments, and any adverse events.
Quarterly Financial Reports: due with each Progress Report. Reports shall include expenditures by budget category, cumulative spend, and remaining balance.
Final Programmatic Report: due within sixty (60) days of the end of the Period of Performance. The Final Report shall summarize findings, deliverables, publications, presentations, and the disposition of any remaining funds.
Final Financial Report and Certification: due with the Final Report, certifying that all funds were used in accordance with this Agreement. Any unexpended funds shall be returned to NSF unless an extension or repurposing is approved in writing.
Publications and Presentations: Grantee shall provide NSF with copies of all manuscripts, abstracts, and presentations resulting from the Grant prior to or concurrent with public release.

Section I. Recognition & Acknowledgment

Grantee shall acknowledge NSF as a funder of the study in all publications, presentations, posters, press releases, websites, and other public-facing materials describing the research. The standard acknowledgment language is:

"This research was supported, in whole or in part, by a Clinical Study Grant from the Navy SEAL Foundation."

Use of the Navy SEAL Foundation name or trademarks beyond standard acknowledgment requires prior written approval from NSF's Director of Programs. Grantee shall provide NSF with advance notice of any media coverage related to the funded research.

Section J. Grant Termination

NSF may terminate the Grant at any time, effective immediately upon written notice, if:

Grantee uses any portion of the Grant funds for any purpose other than those specified in the Grant Agreement or otherwise breaches any of the terms of the Agreement;
The Grant funds are not used for proper purposes within the time specified in the approved Scope of Work and Period of Performance, or within any extension of said time period approved by NSF in writing;
In NSF's sole judgment, Grantee ceases to be able to carry out or accomplish the purposes of the Grant in an appropriate manner; or
In NSF's sole judgment, the Grant might jeopardize NSF's Code Section 501(c)(3) status or result in an excise tax under Chapter 42 of the Code.

Upon termination, Grantee shall immediately cease expenditure of Grant funds and shall, within thirty (30) days of the notice of termination, return to NSF all unexpended funds along with a final financial accounting.

Section K. Required Attachments

IRS Determination Letter confirming 501(c)(3) status
Most recent audited financial statements (or Form 990 if audit not available)
Detailed Scope of Work (≤ 2 pages)
Detailed Budget Narrative
NIH-format Biosketches for PI and all Key Personnel
IRB Approval Letter or Pending Submission Documentation
DoD HRPO / SOCOM approval documentation, if applicable
Letters of Support from collaborating institutions, if applicable
Conflict of Interest Disclosure Form (signed)

Miscellaneous Attachments (if needed)

Section L. Applicant Certification

By signing below, the authorized signatory certifies that: (i) all information provided in this application is true, complete, and accurate to the best of their knowledge; (ii) the applicant organization is in good standing as a public charity exempt from taxation under Section 501(c)(3) of the Code; (iii) the applicant has read and agrees to the Use of Grant Funds, Reporting, Recognition, and Termination provisions set forth in this application; and (iv) the applicant is not debarred, suspended, or otherwise excluded from federal grant programs and is not associated with any individual or entity covered by Executive Order 13224.

Authorized Signatory:

Title:

Date:

Contact Information