HT942526SCIRPIIRA_GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Spinal Cord Injury Research Program Investigator-Initiated Research Award

Funding Opportunity Number: HT942526SCIRPIIRA

Pre-Application Due: August 03, 2026

Application Due: November 12, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Spinal Cord Injury Investigator-Initiated Research Award 2

Content Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Investigator-Initiated Research Award;

provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

FY26 Spinal Cord Injury Investigator-Initiated Research Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:%7E:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Spinal Cord Injury Investigator-Initiated Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Spinal Cord Injury Research Program (SCIRP) Investigator-Initiated Research Award (IIRA) supports studies that have the potential to make an important contribution to spinal cord injury (SCI) research, patient care and/or quality of life. May focus on any phase of research from basic through translational science, though studies that focus solely on identifying intervention targets are discouraged.

Distinctive Features:

• This funding opportunity contains an Early-Career Partnership Option, which allows for two Principal Investigators (PIs). If this option is selected, at least one of the named PIs must be an early-career investigator. Only the initiating PI will submit a pre-application, but all PIs will need to submit full applications. The partnering PI’s application is an abbreviated package specific to their distinct portion of the research project. If recommended for funding, each PI will be named on a separate award to the recipient organization(s). Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn.

• **NEW for FY26** An investigator may be named on only one FY26 SCIRP IIRA application as a PI.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.96M to fund approximately 6 Investigator-Initiated Research Award applications with total cost caps of $0.8M for a Single PI, or $0.96M for the Early-Career Partnership Option, per award. The maximum period of performance is 3 years. It is anticipated that awards made from this fiscal year 2026 (FY26) funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), August 03, 2026

• Invitation to Submit an Application: September 18, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 12, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 16, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027 Announcement Type: Initial Funding Opportunity Number: HT942526SCIRPIIRA Assistance Listing Number: 12.420

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Investigators affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

An investigator may be named on only one fiscal year 2026 (FY26) Spinal Cord Injury Research Program (SCIRP) Investigator-Initiated Research Award (IIRA) application as a PI.

Single PI Option: Independent investigators at all career levels may be named by the organization as the PI on the application.

Early-Career Partnership Option: If this option is selected, at least one of the named PIs (Initiating or Partnering) must be an investigator with at least three years' research experience (independent or non-independent) beyond a terminal degree, but no more than seven years within their first faculty appointment or an equivalent independent research position (excluding time spent on family medical leave). Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application. The other PI (Initiating or Partnering) may be an independent investigator at any career level.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Spinal Cord Injury Research Program (SCIRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the SCIRP in 2009 to provide support for traumatic spinal cord injury (SCI)-related research of exceptional scientific merit that has the potential to make a significant impact on improving the health and well-being of military Service Members, Veterans, and other individuals living with SCI. Appropriations for the SCIRP from FY09 through FY25 totaled $477.85 million (M). The FY26 appropriation is $33M.

Mission of the SCIRP: To fund research and encourage interdisciplinary collaborations for the development and translation of more effective strategies to improve the health and well-being of Service Members, Veterans, and other individuals with spinal cord injury Vision of the SCIRP: Advance the treatment and management of spinal cord injury and ameliorate its consequences The FY26 SCIRP challenges the scientific community to design research that will advance the development, translation and ultimate adoption of health care solutions for people living with SCI, their families and/or care partners. The SCIRP encourages impactful and well-reasoned research across the continuum of care, at time of injury and throughout the lifespan.

Additionally, to ensure alignment with current program priorities, applicants to SCIRP funding opportunities should consider the following:

• Innovative research that investigates new directions or addresses neglected issues in the field of traumatic SCI is supported, although studies focused exclusively on identifying intervention targets are discouraged.

• Mechanism-focused studies must be specific to SCI and demonstrate a clear path from increased understanding to advancing treatments.

• Applications proposing interventions must demonstrate a clinically feasible window for treatment and more than incremental improvement over existing therapies.

• Studies addressing critical questions essential for advancing research toward clinical use, such as study population selection, dosing, and safety, are allowable.

• Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is significant to Service Members, Veterans, their Families and the American Public.

3.1. Program Priority Areas With Programmatic Goals

For FY26, the SCIRP identified near-term and long-term programmatic goals for program-supported research outcomes and products, which align to four key priority areas within the SCI field. Research supported by the FY26 SCIRP must address at least one of the program priority areas and undertake an associated near-team programmatic goal listed below.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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Additionally, applicants will be asked to describe the steps the research team will take to further advance the project’s outcome(s)/product(s) in accordance with the long-term programmatic goal of the same priority area.

Priority Area: Acute Injury Intervention

• Near-Term Goal: Develop and/or test interventions, e.g., surgical, device, pharmacologic, that protect spinal cord tissue from further damage shortly after injury and can be administered on a timeline suitable for acute trauma care in both battlefield and civilian settings.

• Long-Term Goal: Adoption of management/stabilization practices into the standard of care for acute spinal cord injury, leading to meaningfully improved outcomes within the prehospital, hospital, or deployed environments.

Priority Area: Secondary Health Effects

• Near-Term Goal: Develop and/or test interventions to prevent or manage the secondary health effects of spinal cord injury that impact injury survivors throughout their lifespan.

• Long-Term Goal: Adoption of interventions into the standard of care that significantly reduce the burden of secondary health effects and improve the lifelong health of SCI survivors.

Priority Area: Psychosocial Well-Being

• Near-Term Goal: Develop and/or test psychosocial interventions that are specifically tailored to the unique needs of individuals with SCI, their families, and/or care partners.

• Long-Term Goal: Adoption of interventions into the standard of care that promote psychosocial well-being for people with SCI, their families, and/or care partners.

Priority Area: Rehabilitation and Regeneration

• Near-Term Goal: Develop and/or test rehabilitation, regenerative, or neuroplastic interventions for individuals with spinal cord injury that can be implemented at any stage of life post-injury.

• Long-Term Goal: Adoption of validated rehabilitation and regenerative therapies into the standard of care that meaningfully improve function, independence, and quality of life after

SCI.

3.2. Award History

The SCIRP Investigator-Initiated Research Award (IIRA) mechanism was first offered in FY09.

Since then, 981 Investigator-Initiated Research Award applications were received, and 161 were recommended for funding.

3.3. Intent of the Investigator-Initiated Research Award

The SCIRP IIRA is intended to support studies that have the potential to make an important contribution to SCI research, patient care, and/or quality of life.

IIRA applications may focus on any phase of research from basic through translational, though studies focused exclusively on target identification are discouraged. Permitted research includes preclinical studies in animal models, research with human subjects or human anatomical substances, as well as ancillary studies associated with an existing clinical trial.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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3.3.1. Key Elements for the IIRA

• Impact: Applications must articulate how the proposed research will advance at least one of the FY26 SCIRP priority areas and help achieve its associated near-term programmatic goal identified in Section 3.1

• Community-Informed Research: Research funded by the FY26 SCIRP IIRA must be responsive to the needs of people with SCI, their families and/or their care partners. To this end, applicants are encouraged to leverage patient perspectives research to inform the proposed research question or study design.

• Early-Career Partnership Option: To promote enhanced research capacity within the SCI field, the FY26 IIRA includes an option specifically for partnership with or among early-career investigators. The Partnership Option is structured to accommodate two PIs who will work together on a single research project. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. At least one of the PIs (Initiating or Partnering) must be an early-career investigator. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on a separate award to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, refer to Section 5.3, Submission Instructions.

3.3.2. Other Important Considerations for the IIRA

Allowable Research: Clinical research is allowed within this funding opportunity, but clinical trials are disallowed. Applications requesting funding for a clinical trial or combination of preclinical research and clinical trial may be more suited to one of the other FY26 SCIRP funding opportunities being offered.

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE and ARRIVE 2.0 guidelines.

Use of Common Data Elements (CDEs): Use of the National Institute of Neurological Disorders and Stroke SCI CDEs is strongly encouraged for all human subjects research.

Relevance to Military Health: To help elucidate the realities of treating and managing SCIs while in a deployed environment, a resource document is now available that outlines Spinal Cord Injury Management within the Military Health System (MHS). Applicants are encouraged to read and consider this document before preparing applications. Furthermore, applicants are encouraged to integrate and/or align their research projects with DOW and/or VA research laboratories and programs. Collaboration with the DOW and/or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://cdmrp.health.mil/funding/scirp https://cdmrp.health.mil/funding/scirp https://www.strobe-statement.org/ https://arriveguidelines.org/arrive-guidelines https://commondataelements.ninds.nih.gov/cde-catalog https://cdmrp.health.mil/scirp/pdfs/Beginner's%20Guide%20to%20Military%20Health%20System.pdf https://cdmrp.health.mil/scirp/pdfs/Beginner's%20Guide%20to%20Military%20Health%20System.pdf

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Spinal Cord Injury Investigator-Initiated Research Award 9 areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

3.4. Funding Instrument

The funding instrument for awards made under the program announcement will be grants

(31 USC 6304).

3.5. Funding Details

Period of Performance: The maximum period of performance is 3 years.

3.5.1. Application Submissions With a Single PI

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $0.8M.

3.5.2. Application Submissions With the Early-Career Partnership Option

Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI should not exceed $0.96M.

A separate award will be made to each PI’s organization.

The PIs are expected to be partners in the research, and direct cost funding should be divided accordingly unless otherwise warranted and clearly justified.

Any application that requests the higher level of funding and that does not an eligible early career PI will have its budget reduced as appropriate.

3.5.3. For Both Options Within This Award Mechanism

If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Data and research resource sharing costs.

• Travel in support of multi-institutional collaborations.

• Costs for one investigator, per award, to travel to one scientific/technical meeting per year.

The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 SCIRP IIRA.

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Must not be requested for:

• Clinical trial costs.

• Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

The PI, or Initiating PI if selecting the Early-Career Partnership Option, must submit the following pre-application components.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (one-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Background/Rationale: State the scientific rationale on which the proposed research project is based. Clearly demonstrate that there is sufficient rationale, background data, and readiness to support the study. Indicate how the research question or study design is informed by the lived-experience community and/or patient perspectives research.

○ Specific Aims and Study Design: Concisely state the project’s specific aims and describe the scientific approach to address them. Include the animal model proposed, if applicable, along with its relevance to human SCI.

○ Impact: Describe the potential impact of the proposed research on at least one of the FY26 priority areas. Indicate how the proposed research will help to achieve a near-term programmatic goal identified in Section 3.1.

○ Relevance to Military Health: Describe whether/how the proposed research project is applicable to spinal cord-injured military Service Members, Veterans, and/or their Family members and care partners. Applicants are encouraged to review the Relevance to Military Health section of this program announcement prior to preparing this section.

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• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative.

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

Early-Career Partnership Option: The CDMRP requires separate full application package submissions for the Initiating PI and Partnering PI, even if the PIs are located within the same organization. The application submission process for the Partnering PI uses an abbreviated full application package.

4.3.1. Full Application Components for the PI or Initiating PI

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (10-page limit): Upload as

“ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background: Present the ideas and scientific reasoning behind the proposed research project. Provide a review and analysis of relevant literature and completed/ ongoing studies, including community/patient perspectives research as appropriate.

If applicable, discuss how the proposed project builds off previous research efforts.

This section should establish the relevance of the study and explain the applicability of the proposed findings to the SCI community and at least one of the FY26 SCIRP Program Priorities and associated near-term goal.

– Objectives/Specific Aims/Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested and detail the specific aims that will address the hypothesis/research question. Only describe aims that the SCIRP award would fund.

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– Study Design and Feasibility: Describe the research strategy, methods, and analyses, including controls, in sufficient detail for evaluation of their appropriateness and feasibility. Describe how the study is designed to achieve the project aims.

Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported. Address potential problem areas, and present alternative methods and approaches where appropriate. Indicate whether and how the study design is informed by the lived-experience community and/or patient perspectives research.

As appropriate, describe the statistical model and data analysis plan with respect to the study objectives. If applicable, include power analysis calculations. Further information describing the strategy for how sex will be considered as a biological variable will be requested in Attachment 2.

If applicable, briefly describe the use of animal model(s) within the study. Include a rationale for the choice of animal model and the model’s relevance to human SCI.

Full details will be required in the Animal Research Plan (Attachment 8).

If human subjects, human anatomical samples or data will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples or data, including evidence that the research team has access to subjects, samples and/or data. Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial, and ethnic group, and an accompanying rationale for the selection of subjects. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race, and ethnicity should be provided as part of the application’s Supporting Documentation (Attachment 2). This award may not be used to conduct clinical trials.

If applicable, describe the SCI CDEs to be collected.

– Research Team Composition: Describe the composition of the research team in enough detail to demonstrate that the study team has appropriate expertise to accomplish the goals of the proposed research.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial,-%3A%20As%20defined https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Spinal Cord Injury Investigator-Initiated Research Award 14

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Sex as a Biological Variable Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health Data Management and Sharing Plan or duplicate the Data Management Plan, which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

Inclusion Enrollment Plan (only required if clinical research is proposed):

Provide an anticipated enrollment table(s) for the inclusion of women and minorities https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the

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FY26 Spinal Cord Injury Investigator-Initiated Research Award 15 using the Public Health Service (PHS) Inclusion Enrollment Report, a three-page fillable PDF form that can be downloaded from eBRAP. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex, race and ethnicity.

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the scientific rationale behind the proposed research project.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached.

Specific Aims: State the specific aims of the study.

Study Design: Briefly describe the study design, including appropriate controls.

Impact: Briefly describe the impact of this study on one or more FY26 SCIRP priority areas. Indicate how the proposed research will help to achieve a near-term programmatic goal identified in Section 3.1.

Military Relevance: Describe how the study is relevant to military health.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

– Summarize the objectives and rationale for the proposed research.

– Describe the intervention(s), if applicable.

– What population will the research help, and how will it help them?

– What are the potential applications, benefits, and risks of the anticipated outcomes?

– If the research is too basic for immediate clinical applicability, describe the interim outcomes.

– What is the projected time it may take to achieve a person-related outcome?

– Describe how the proposed study will directly address an FY26 SCIRP priority area and contribute to the associated near-term programmatic goal identified in Section 3.1.

– What is the potential benefit of the proposed study and the anticipated outcome to Service Members, Veterans and/or their Families?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to the Example: Assembling a Generic Statement of Work. Include milestones for data or research resource(s) sharing.

Include the name(s) of the key personnel and contact information for each study site/subaward site. The contributions of the key personnel, including the PI or Initiating https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Spinal Cord Injury Investigator-Initiated Research Award 16

PI, Partnering PI (if applicable), and SCI Lived-Experience Consultants or community partners, should be noted for each task.

Early-Career Partnership Option: Each PI must submit an identical copy of a jointly created SOW.

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”. The impact statement summarizes the potential short- and long-term impact of the proposed research for the SCI lived-experience community and for the broader SCI research field.

The statement should address the points outlined below written in a manner that will be readily understood by readers without a background in science or medicine.

Detail the anticipated research outcome(s) that will be directly attributed to the results of the proposed study and describe the anticipated benefits of these outcomes for individuals with SCI and the broader SCI research field. Explain how the proposed project will advance at least one of the FY26 SCIRP priority areas and help achieve its associated near-term programmatic goal, as identified in Section 3.1.

To demonstrate how the study is grounded in the needs of the SCI community, describe how the lived-experience community and/or patient perspectives research informed the research question or study design.

Assess the likelihood that a successful outcome of the proposed research project will lead to practical application in individuals living with SCI. If applicable, state whether/ how the proposed project builds off previous research efforts to advance a product, outcome or finding closer to clinical utility.

If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

Describe whether/how the proposed research project is applicable to the unique health care needs and quality of life concerns of spinal cord-injured military Service Members, Veterans, and/or their Family members and care partners. Applicants are encouraged to review the Relevance to Military Health section of this program announcement prior to preparing this section.

○ Attachment 7: Long-Term Goal (three-page limit): Upload as “Longterm.pdf”. The purpose of this attachment is to create a high-level roadmap detailing the steps needed to eventually translate outcomes of SCIRP-funded research into the standard of care, consistent with the long-term programmatic goals of the FY26 SCIRP. The long-term goal attachment should include the points listed below.

Near-Term Action: Outline the immediate next steps to be taken by the research team after successful completion of the proposed research project, including plans for dissemination of results, further outcome validation if applicable and engagement with end-users (e.g., patients, clinicians).

Intermediate Objectives: Discuss the unresolved questions that must be answered for the outcome to be adopted within the standard of care, considering the following as a starting place:

What additional research is necessary?

What is the likely regulatory pathway?

What is the commercial potential of the outcome?

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FY26 Spinal Cord Injury Investigator-Initiated Research Award 17

What is the intellectual property strategy? If the intellectual property rights are not owned by the study team, how will the final product become accessible to the SCI community?

Long-Term Strategy: Describe the long-term implementation and adoption strategy for the research outcome, outlining key milestones on the path to adoption.

Identify the key collaborations (e.g., clinical partners, commercial entities, patient groups, professional societies) required to execute the strategy. Be specific about the types of partners needed, and name them if possible.

Concisely explain how successfully executing this strategy will lead to the integration of the research outcome into the standard of care and directly fulfill the specific long-term programmatic goal for the relevant FY26 SCIRP priority area.

○ Attachment 8: Animal Research Plan (three-page limit): Upload as “AnimalResPlan.pdf”. (Applications proposing animal studies only.) The purpose of this attachment is to provide additional details regarding the proposed animal research beyond what was included within the project narrative. Consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for. The Animal Research Plan may not be an exact replica of the protocol(s) submitted to the Institutional Animal Care and Use Committee (IACUC). The Animal Research Plan should address the following points to achieve reproducible and rigorous results for each proposed animal study:

– Describe the research objective(s) of the animal study. Explain how and why the animal species, strain, and model(s) being used can address the scientific objectives and, where appropriate, the study’s relevance to human biology. Be specific as to why an animal model is necessary to address the study aims, why the specific animal SCI model was chosen over other models, including any relevance of the model specific to military health, and how it is optimal for addressing the study aims. The model’s relevance to human SCI should also be detailed.

– Summarize the procedures to be conducted and the outcome measures to be collected. Describe how the study will be controlled.

– Describe the randomization and blinding procedures for the study, and any other measures to be taken to minimize the effects of subjective bias during animal treatment and assessment of results. If randomization and/or blinding will not be utilized, provide justification.

– Provide a sample size estimate for each study arm and the method by which it was derived, including power analysis calculations.

– Describe how data will be handled, including rules for stopping data collection, criteria…