HT942526ERPRPA_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

Epilepsy Research Program

Research Partnership Award

Funding Opportunity Number: HT942526ERPRPA

Pre-Application Due: August 3, 2026

Application Due: August 17, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Epilepsy Research Partnership 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 Research Partnership 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 Epilepsy Research Partnership 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/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~: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 Epilepsy Research Partnership Award 4

1. Basic Information About the Funding Opportunity

Summary: The intent of the Epilepsy Research Program (ERP) Research Partnership Award is to support new or existing research partnerships focused on collaboratively addressing critical questions relevant to post-traumatic epilepsy (PTE) in a manner that would be unachievable through separate efforts. It is expected that investigators will utilize their distinct but complementary perspectives to synergistically address a central problem or question critical to PTE research and those living with PTE, their families and/or their care partners.

Distinctive Features: This funding mechanism requires that a minimum of two investigators partner in one overarching study. Only the Initiating Principal Investigator (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 separate awards 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 ERP Research Partnership Award application as a PI.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $2.0M to fund approximately one Research Partnership Award application with a total cost cap of $2.0M. 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 (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), August 3, 2026

• Application Submission Deadline: 11:59 p.m. ET, August 17, 2026

• End of Application Verification Period: 5:00 p.m. ET, August 20, 2026

• Peer Review: October 2026

• Programmatic Review: December 2026

Announcement Type: Initial

Funding Opportunity Number: HT942526ERPRPA

Assistance Listing Number: 12.420

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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

The Initiating Principal Investigator (PI) and Partnering PI(s) may be independent investigators at any career level. Individuals affiliated with an eligible organization are eligible to be named PI on the application, regardless of ethnicity, nationality or citizenship status.

An investigator may be named on only one Fiscal Year 2026 (FY26) Epilepsy Research Program Research Partnership Award (RPA) application as a PI.

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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

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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 Epilepsy Research Program (ERP). 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 ERP in 2015 to provide support for longitudinal epidemiological research to better understand the incidence of post-traumatic epilepsy (PTE) following a traumatic brain injury (TBI) and to improve patient care and outcomes. The FY26 ERP challenges the research community to (1) investigate topics related to epileptogenesis for the identification of mechanisms by which brain injury produces epilepsy; (2) study the prevention of PTE and concomitant comorbidities; and (3) develop innovative research tools or biomarkers to better detect, diagnose, or predict the development of PTE. Appropriations for the ERP from FY15 through FY24 totaled $97.5 million (M). The FY26 appropriation is $12M.

The ERP encourages collaboration among PTE researchers and urges the scientific community to utilize equitable partnerships with people living with PTE to maximize the translational and impact potential of proposed research. 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 of significance to Service Members, Veterans, their Families and the American Public.

3.1. ERP Focus Areas

Applications submitted to the FY26 ERP must address at least one of the focus areas listed below.

• Markers and Mechanisms of PTE

○ Research focused on understanding the underlying biology of PTE, including:

– Identification of acute or chronic biomarkers that are informed by or correlated with clinical observation and predict the development of epilepsy.

– Investigation of biological mechanisms that can be targeted to prevent or interrupt epileptogenesis and seizure activity.

• Epidemiological Characterization of PTE

○ Population-level research to define the patterns, causes, and public health burden of PTE, including:

– Identifying predictors for the development of epilepsy to inform clinical trial design and pre-clinical research priorities.

– Assessing key patient outcomes, including the latency period before epilepsy onset, associated comorbidities and mortality rates.

– Quantifying the impact of PTE on the quality of life for individuals, their families and/or their care partners.

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• Longitudinal Studies of PTE Progression

○ Studies tracking the evolution of PTE over time in individuals, including:

– Assessing facilitators and barriers to long-term well-being of individuals with PTE, their families and their care partners.

– Evaluating healthcare outcomes, quality of care and responsiveness to different drug therapies.

– Analyzing the onset, progression and interaction of comorbid conditions, including but not limited to psychiatric disorders, cognitive deficits, physical deficits, sleep disorders and fatigue.

• Innovative Research Tools and Technologies

○ Development of novel tools and strategies to advance PTE research and clinical care, including:

– Application of artificial intelligence, bioinformatics, clinical databases and advanced device technologies for improved seizure detection, characterization, visualization or diagnosis.

– New or better-characterized, etiologically relevant models for PTE.

– Tools to enable the design of future clinical trials, such as methods to identify appropriate study populations.

3.2. Award History

The ERP Research Partnership Award mechanism was first offered in FY19. Since then, 61 Research Partnership Award applications were received, and 15 were recommended for funding.

3.3. Intent of the Research Partnership Award

The intent of the FY26 ERP RPA is to support new or existing research partnerships focused on collaboratively addressing critical questions relevant to PTE in a manner that would be unachievable through separate efforts.

This mechanism requires that a minimum of two investigators partner in one overarching study.

The investigators may have experience in similar or disparate scientific disciplines, but each PI is expected to make distinct contributions to the application. The application should demonstrate how the unique skills and contributions of the Initiating PI and Partnering PI(s) will support the meaningful and synergistic success of the project. A proposed project in which a partner merely supplies tissue or access to patients will not meet the intent of this award mechanism.

3.3.1. Key Elements for the RPA

• Preliminary Data: Applications must include preliminary and/or published data that support the proposed research project. Preliminary data may be derived from laboratory discovery, clinical observation, population-based studies or peer-reviewed literature. In addition, applications must demonstrate the research team’s ability to execute the chosen model of TBI and record subsequent seizure activity, if applicable to the research project.

• Partnership: The Research Partnership Award requires more than one PI. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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FY26 Epilepsy Research Partnership Award 8 tasks associated with application submission. The other PI(s) will be identified as Partnering PI(s). All PIs should contribute significantly to the development and execution of the proposed research project. It is expected that investigators will utilize their distinct but complementary perspectives to synergistically address a central problem or question critical to PTE research and those living with PTE, their families and/or their care partners. If recommended for funding, each PI will be named on separate awards 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 PI(s), refer to Section 5.3, Submission Instructions.

• Impact: Applications should articulate the short- and/or long-term impact of the proposed research on the PTE research field, patient care, and/or those living with PTE. Applicants are encouraged to consult with individuals living with PTE during the development and execution of the proposed research project, to ensure research outcomes maximize translational and impact potential (see Community Collaboration).

• Research Team Composition: The PIs on the application can be from any field or discipline; however, it is critical that the application demonstrate that the study team’s experience is appropriate to accomplish the goals of the proposed research with expertise in the fields of both TBI and epilepsy.

3.3.2. Other Important Considerations for the RPA

Allowable Research: Applications may focus on any phase of research from basic through clinical, but clinical trials are not allowed under this funding opportunity. Examples of permitted research include preclinical studies in animal models, observational research with human subjects, or research involving human anatomical substances or data, as well as ancillary studies associated with an existing clinical trial.

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, the 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.

When appropriate, applicants are encouraged to leverage ongoing cohort studies such as Transforming Research and Clinical Knowledge in TBI, TBI-Model Systems and Long-Term Impact of Military-Relevant Brain Injury Consortium Chronic Effects of Neurotrauma Consortium.

Leveraging existing data repositories, such as those included on the National Institutes of Health (NIH) website, is also encouraged. 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.

Community Collaboration: Employing community collaborations to optimize research impact is encouraged but NOT required. Research funded by the FY26 ERP should be responsive to the needs of people with PTE, their families and/or their care partners. Research teams are therefore encouraged to establish and utilize equitable collaborations with consumers and people with lived PTE experience to maximize the translational and impact potential of the proposed research.

Collaborative research approaches, such as community-based participatory research, participatory action research, and integrated knowledge transition, create partnerships between https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial,-%3A%20As%20defined https://tracktbi.ucsf.edu/transforming-research-and-clinical-knowledge-tbi https://msktc.org/tbi/model-system-centers https://www.limbic-cenc.org/ https://www.limbic-cenc.org/ https://sharing.nih.gov/accessing-data/accessing-scientific-data https://www.strobe-statement.org/ https://arriveguidelines.org/arrive-guidelines

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FY26 Epilepsy Research Partnership Award 9 scientific researchers and community members to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and community members collaborate and contribute equitably to all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation and dissemination. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of community members within the research team. Research results are jointly interpreted, disseminated, and fed back to affected communities and may be translated into interventions or policy. These methods are critically important for community-level interventions and can also have important impacts on translational research and prototype development to identify and augment the potential impact of a research program on people living with PTE, their families and/or their care partners.

Collaborative relationships with the lived-experience community are often established through integrating community members into research teams as co-researchers, advisors and/or consultants. Some examples for implementing collaborative research approaches include:

• Lived-Experience Consultation: The research team includes at least one project advisor with lived PTE experience who will provide advice and consultation throughout the planning and implementation of the research project. Lived-experience consultants may include individuals with PTE, their family members or their care partners.

• Partnership with a Community-Based Organization: The research team establishes partnerships with at least one community-based organization that provides advice and consultation throughout the planning and implementation of the research project.

Community-based organizations may include advocacy groups, service providers, policy makers or other formal organizational stakeholders.

• Community Advisory Board Utilization: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of lived-experience consultants to a coalition of community-based organizations or any combination thereof. As with lived-experience consultants and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project.

Additional information on collaborative research approaches can be found here:

• Correa, Daniel J., Churl-Su Kwon, Susan Connors, et al. 2019. “Applying Participatory Action Research in Traumatic Brain Injury Studies to Prevent Post-Traumatic Epilepsy.”

Neurobiology of Disease 123: 137-144. https://doi.org/10.1016/j.nbd.2018.07.007.

• Jull, Janet, Audrey Giles, and Ian D. Graham. 2017. “Community-Based Participatory Research and Integrated Knowledge Translation: Advancing the Co-Creation of Knowledge.”

Implementation Science 12 (1): 150. https://doi.org/10.1186/s13012-017-0696-3.

• Kost, Rhonda G., Andrea Leinberger-Jabari, Teresa H. Evering, et al. 2017. “Helping Basic Scientists Engage With Community Partners to Enrich and Accelerate Translational Research.” Academic Medicine 92 (3): 374-379. https://doi.org/10.1097/ acm.0000000000001200.

Relevance to Military Health: 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 areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

https://doi.org/10.1016/j.nbd.2018.07.007 https://doi.org/10.1186/s13012-017-0696-3 https://doi.org/10.1097/acm.0000000000001200 https://doi.org/10.1097/acm.0000000000001200 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES

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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.

Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and each Partnering PI should not exceed $2.0M. 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.

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.

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):

• Travel in support of multi-institutional collaborations.

• Costs associated with a collaborative research approach (e.g., consultant costs, equitable participation training, capacity-building activities).

• Data and research resources sharing costs.

• Costs for one investigator to travel to one scientific/technical meeting per year to present project information or disseminate project results from the FY26 ERP RPA.

Must not be requested for:

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

• Clinical trial costs.

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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 Initiating PI must submit the following pre-application components.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted. Include the focus area(s) under which the application will be submitted.

4.3. Full Application Components

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

4.3.1. Full Application Components for the 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 (18-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. Clearly demonstrate that there is sufficient scientific evidence to support the proposed research, including preliminary and/or published data. Cite relevant literature. Describe previous experience most pertinent to this project.

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− Hypothesis or Objectives: State the hypotheses or objectives to be tested in the proposed project.

− Specific Aims: Concisely explain the project’s specific aims. Describe only aims that the ERP RPA would fund.

− Focus Area: Describe how the work aligns to one of the FY26 ERP Focus Areas.

− Study Design and Feasibility: Describe the research strategy, methods and analyses, including appropriate controls, in sufficient detail for evaluation of its appropriateness and feasibility. Describe how the study is designed to achieve the project aims. Address potential problem areas, and present alternative methods and approaches. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

Indicate whether ongoing cohort studies or existing repositories will be leveraged in the study. If the research proposed is epidemiologic in nature, describe how the research will be conducted in accordance with the International League Against Epilepsy (ILAE) research guidelines for epidemiologic studies.

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 development and use of animal model(s) to study PTE. Include a rationale for the choice of animal model, injury method, and endpoints/outcome measures to be used. Full details will be required in the Animal Research Plan (Attachment 10). If an animal model will be employed, provide evidence that demonstrates the research team’s ability and capacity to execute the chosen model of TBI and record subsequent seizure activity.

If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the GAI, Appendix 4, for additional considerations.

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, including expertise within the fields of both TBI and epilepsy.

○ 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.

https://www.ncbi.nlm.nih.gov/pubmed/21899536 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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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.

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.

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

Provide an anticipated enrollment table(s) for the inclusion of women and minorities 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. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

○ 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.

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/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/Program.htm#:~:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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FY26 Epilepsy Research Partnership Award 14

Specific Aims: State the specific aims of the study.

Study Design: Describe the study design, including appropriate controls.

Impact: Briefly describe the short- or long-term impact of this study on PTE research, patient care and/or quality of life.

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.

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

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

– What are the likely contributions of the proposed research project to advancing PTE research, patient care and/or quality of life?

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

– What is the potential benefit of the proposed study and the anticipated outcomes 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.

– Federal Interagency Traumatic Brain Injury Research (FITBIR)-eligible research should also include the following subtasks:

▪ FITBIR investigator and study registration within the first 30 days of the award

▪ Sharing of draft data collection forms with FITBIR

▪ Annual FITBIR data submission

Each PI must submit an identical copy of a jointly created SOW. The specific contributions of the Initiating PI and each Partnering PI should be clearly noted for each task.

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”. This attachment should be written with a broad audience in mind, including readers without a background in science or medicine.

Address the impact of the proposed research on one or more of the FY26 ERP Focus Areas. Describe the short- and long-term impact of this study on PTE research, patient care and/or quality of life, including an assessment of the likelihood that a successful outcome of the proposed research project will increase understanding of PTE and associated comorbidities and/or lead to a practical application in individuals living with PTE. If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes. Indicate how the https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~: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:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Epilepsy Research Partnership Award 15 proposed research project is applicable to the health care needs and quality of life of Service Members, Veterans, and/or their Family members or care partners.

○ Attachment 7: Research Sharing Plan (two-page limit): Upload as “Sharing.pdf”.

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. If applicable, identify and describe the planned National Institute of Neurological Disorders and Stroke TBI and/or Epilepsy Common Data Elements (CDEs) to be used/collected.

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.

○ Attachment 8: Transition Plan (one-page limit): Upload as “Transition.pdf”.

Outline the project’s anticipated research outcome(s) (e.g., intervention, product, methodology, finding). 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 investigation (e.g., next-stage preclinical/clinical research, translational research, clinical trial) and engagement with end-users (e.g., patients, clinicians). Describe the steps that would need to be taken for the research outcome to impact patient care and outcomes. If applicable, discuss ownership rights/access to the intellectual property necessary for the development and/or commercialization of products or technologies supported with this award, including a plan for resolving intellectual and material property issues among participating organizations. If the intellectual property rights are not owned by the performer(s), describe the planned next steps necessary to make the product available to the PTE community.

○ Attachment 9: Partnership Statement (two-page limit): Upload as “Partnership.pdf”.

Describe the experience and background of the Initiating PI and Partnering PI(s).

Describe the contribution and time commitment of each PI toward the proposed research project. Explain how the investigators will utilize their distinct but complementary perspectives to synergistically address the proposed research question, including why the research goals would be unachievable through separate efforts. Outline plans for interactions between/among investigators, including communication, decision-making, allocation of resources, coordination of research progress and results, and sharing of https://www.commondataelements.ninds.nih.gov/Traumatic%20Brain%20Injury https://www.commondataelements.ninds.nih.gov/epilepsy#:~:text=The%20Epilepsy%20Common%20Data%20Elements,continue%20to%20evolve%20over%20time.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources

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Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Epilepsy Research Partnership Award 16 data. In addition, each Partnering PI should provide a letter of collaboration confirming their involvement in the proposed work as part of the application’s Supporting Documentation (Attachment 2).

○ Attachment 10: Animal Research Plan (three-page limit): Upload as “AnimalResPlan.pdf”. (Only applicable and required for applications proposing animal studies.)

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:

– Briefly 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 and injury model was chosen over other models, and how it is optimal for modeling PTE and addressing the study aims.

– Summarize the procedures to be conducted, including the method(s) for seizure detection. 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 for inclusion and exclusion of data, how outliers will be defined and handled, statistical methods for data analysis and identification of the primary endpoint(s).

○ Attachment 11: Community Collaboration Plan: Upload as “Collaboration.pdf”.

(Only applicable for applications utilizing a collaborative research approach that engages the PTE lived-experience community.)

– Community Collaboration Statement (three-page limit): If a partnership with the PTE lived-experience/consumer community will be utilized (e.g., PTE lived-experience consultation, partnership with a community-based organization), include the community partner’s name and describe the following, as applicable:

▪ The collaborative research approach that will be used (e.g., lived-experience consultation, partnership with community-based organization, community advisory board, co-researcher model), including a justification for the approach as well as when the approach will be used within the research project.

▪ Detail the community partner's contributions to the research process thus far, as well as the framework for capturing future input. Explain how this input will be meaningfully integrated to inform each phase of the research lifecycle, including needs assessment, planning, design, execution, analysis and dissemination.

https://arriveguidelines.org/arrive-guidelines

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FY26 Epilepsy Research Partnership Award 17

▪ The resource allocation and decision-making processes to be employed.

▪ Any training that will be provided to both scientific researchers and community members on collaborative research approaches, decision-making and equitable participation.

▪ Co-learning and capacity-building activities among all partners.

▪ The process measures to assess the effectiveness of the chosen collaborative research approach.

– Letters of Community Collaboration (two-page limit per letter is recommended): Provide a letter signed by each community partner (e.g.,…