FY26 Traumatic Brain Injury and Psychological Health Translational Research Award

Program Announcement for the Defense Health Agency

Traumatic Brain Injury and Psychological Health Research Program Translational Research Award

Funding Opportunity Number: HT942526TBIPHRPTRA

Pre-Application Due: July 13, 2026

Application Due: October 15, 2026

FY26 Traumatic Brain Injury and Psychological Health Translational 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 Translational 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

Appendix 3 Additional Focus Area Information

Appendix 4 Optimizing Research Impact Through Community Collaboration

FY26 Traumatic Brain Injury and Psychological Health Translational 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

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1. Basic Information About the Funding Opportunity

Summary: The Translational Research Award (TRA) intends to accelerate the conversion of scientific findings into impactful clinical applications. The TRA prioritizes innovative approaches over purely iterative or incremental research. Submissions focusing on minor modifications to existing standards without the intent or potential to significantly improve clinical care or patient outcomes do not meet the intent of the mechanism.

Distinctive Features: Basic research and clinical trials are prohibited. Preliminary data are required.

• For animal research, applications must describe the choice of model and its relevance to the human clinical condition.

• For research prospectively enrolling human subjects, the inclusion of community-based participatory research (CBPR) approaches is required.

• The Translational Research Award offers funding for two Research Levels. The applicant is responsible for selecting the Research Level based on the scope of the research.

○ Research Level 1: Supports the refinement of mature ideas and concepts into tangible and knowledge products positioned for further evaluation.

○ Research Level 2: Supports the rigorous evaluation of tangible and knowledge products in preparation for first-in-human studies or clinical trials.

• Early-Career Investigator Partnering Option (available for both Research Levels): This option accommodates two Principal Investigators (PIs), one of which is an Early-Career Investigator. If recommended for funding, each PI will receive a separate award.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $9.0M to fund approximately three TRA-Research Level 1 applications and three TRA-Research Level 2 applications, with total cost caps of $1.0M (Research Level 1) and $2.0M (Research Level 2). The maximum period of performance is 4 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), July 13, 2026

• Invitation to Submit an Application: August 27, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 15, 2026

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

• Peer Review: December 2026

• Programmatic Review: March 2027 Announcement Type: Initial Funding Opportunity Number: HT942526TBIPHRPTRA 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

Independent investigators affiliated with an eligible organization are eligible to be named PI, Initiating PI, or Partnering PI on the application, regardless of ethnicity, nationality or citizenship status. Individuals in mentored positions (e.g., postdoctoral fellows, clinical fellows) are not considered independent investigators.

Early-Career Investigator Partnering Option:

For applications that select the Early-Career Investigator Partnering Option, both PIs must be independent investigators, and the Early-Career Investigator must be within 10 years after completion of their terminal degree by the time of the application submission deadline (excluding time spent in residency or on family medical leave). Time spent as a postdoctoral fellow is included. Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application. For Early-Career Investigator Partnering Option applications, at least one of the named PIs must be an Early-Career Investigator.

Application limit: The same independent investigator may not be named as a PI, Initiating PI, or Partnering PI on more than four TRA applications.

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 General Application Instructions (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 Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP). 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 TBIPHRP in FY07 in response to the traumatic brain injuries (TBIs) sustained and psychological health issues experienced by our deployed forces in Iraq and Afghanistan. The TBIPHRP complements ongoing DOW efforts toward promoting a better standard of care for TBI and psychological health in the areas of prevention, detection, diagnosis, treatment and rehabilitation.

Appropriations for the TBIPHRP from FY07 through FY24 totaled $2.6 billion. The FY26 appropriation is $40.5 million (M).

The vision of the TBIPHRP is to optimize the prevention, assessment and treatment of psychological health conditions and/or TBIs. The program seeks to fund research that understands, prevents and treats psychological health conditions and/or traumatic brain injuries that accelerates solutions to improve the health, well-being and health care of Service Members, DOW beneficiaries, Veterans and the American public.

3.1. Award History

The TBIPHRP Translational Research Award mechanism was first offered in FY21. Since then, 293 Translational Research Award applications were received, and 50 were recommended for funding.

3.2. Intent of the Translational Research Award

The TRA supports research that accelerates the conversion of scientific findings into impactful clinical applications. The TRA prioritizes innovative approaches over purely iterative or incremental research. Research outcomes must clearly lead to the development of transformative health care products, technologies, or clinical practice guidelines.

Applications that focus on minor modifications to existing standards without the intent or potential to significantly improve clinical care or patient outcomes may not be competitive.

3.2.1. Focus Areas for the TRA

To meet the intent of the funding opportunity, applications must address at least one sub-area, (e.g., 1a, 1b, 2a, 2b) within one of the three FY26 TBIPHRP TRA focus areas listed below.

Bulleted items are provided in Appendix 3 to indicate additional context regarding programmatic intent but are not required to be specifically addressed by applications. Selection of the appropriate FY26 TBIPHRP TRA focus area is the responsibility of the applicant.

1. Understand: Research will address knowledge gaps in the epidemiology and etiology of psychological health conditions and/or TBI.

a. Understanding of risk, protective and biological factors, including sex as a biological variable, contributing to an individual’s vulnerability to, response to and long-term outcomes of psychological health conditions and/or TBI.

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b. Understanding psychological health factors or outcomes associated with sexual harassment and assault perpetration, victimization and barriers to reporting and response. Studies that ensure participant anonymity strongly encouraged.

2. Prevent and Assess: Research will address the prevention, screening, diagnosis or prognosis of psychological health conditions and/or TBI.

a. Identification and validation of biomarkers or other objective methods for assessment, diagnosis, prognosis or real-time monitoring of psychological health conditions and/or TBI, including subclinical presentations, and associated sequelae of these conditions.

Development of decision-making frameworks or tools that incorporate objective assessments and may consider long-term outcomes to inform return-to-activity/duty decisions are within scope.

b. Development and evaluation of approaches or tools to prevent or reduce risk of psychological health conditions and/or TBI.

c. Development and evaluation of crosscutting prevention approaches to address multiple adverse outcomes such as suicide, interpersonal violence including intimate partner and family violence, sexual assault, psychological health issues and/or TBI.

Crosscutting prevention approaches refer to strategies that enhance protective factors and reduce risk factors at multiple socio-ecological levels, e.g., individual, relationship and community.

d. Development and evaluation of solutions to support military and Family readiness and increase psychological resilience in individuals to the potential negative impacts of specific military and life stressors.

Military readiness refers to the ability of military forces to fight and meet the demands of national military strategy; Family readiness is the state of preparedness to effectively navigate the challenges of daily living experienced in the unique context of military service.

3. Treat: Research will address novel and repurposed interventions to improve the outcomes of psychological health conditions and/or TBI. Efforts that address treatment, rehabilitation and health services research are within scope.

a. Interventions that promote sustained functional recovery, including interventions administered acutely, during the post-acute phase or chronic phase of injury.

b. Development of postvention strategies to support individuals in workplace or community environments following a sexual assault, suicide event or other trauma.

Postvention refers to response activities that should be undertaken in the immediate aftermath of a suicide that has impacted the unit. Postvention has two purposes: to help suicide attempt survivors cope with their grief, and to prevent additional suicide.

c. Health services research to improve the adoption of evidence-based practices, access to care, or reduce barriers to care. Individual and systemic factors that influence access to or barriers to care as well as other factors that influence treatment engagement, follow-up care and improvement of long-term outcomes are applicable.

https://www.prevention.mil/Portals/130/Documents/PPoA_2.0.pdf https://apps.dtic.mil/sti/pdfs/ADA439918.pdf https://www.esd.whs.mil/Portals/54/documents/DD/issuances/dodi/134222p.pdf https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649016p.pdf?ver=2020-06-15-112615-427

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3.2.2. Key Elements for the TRA

Proposed research can align with TBI, psychological health, or a combination of both.

Non-Incremental Research: Research projects should leverage existing knowledge to accelerate ideas, strengthen evidence and move the field forward. Projects proposing incremental improvements to the existing body of knowledge and do not significantly propel the field do not meet the intent of this award mechanism.

Preliminary data: Applicants must provide sufficient preliminary data to support the rationale for the proposed research and associated endpoints.

Research Levels: The TBIPHRP TRA offers funding for two Research Levels (refer to Section 3.4, Funding Details). Applicants may choose only one Research Level per application. The applicant is responsible for selecting the Research Level that aligns with the scope of the proposed research. The Research Level selected should be based on the research scope and not on the amount of the budget. The following are generalized descriptions of the scope of the research appropriate for each Research Level:

• Research Level 1: Supports the refinement of mature ideas and concepts into tangible and knowledge products positioned for further evaluation.

• Research Level 2: Supports the rigorous evaluation of tangible and knowledge products in preparation for first-in-human studies or clinical trials.

Early-Career Investigator Partnering Option (available for both research levels): Both Research Levels include an option for more than one PI. 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. The intent is not to create a mentor-mentee arrangement. 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 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.

3.2.3. Other Important Considerations for the TRA

Hypothesis-Driven Research: Applications consisting solely or primarily of planning, engineering, manufacturing, or formulation activities, without a core scientific hypothesis and testing, may be administratively withdrawn.

Clinical trials are prohibited. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research.

Studies prospectively enrolling human subjects require a community-based participatory research (CBPR) approach. Applicants should propose research that directly addresses the psychological health conditions and TBI needs of people with lived experience, their families and care providers. These partnerships are key to maximizing research translational potential and impact. CBPR approaches can be documented in Attachment 11, CBPR Documentation.

Additional information can be found in Appendix 4.

Data Sharing Requirements for Traumatic Brain Injury or Psychological Health Human- Subjects Research: The CDMRP intends that information, data and research resources generated under this funding opportunity will be made available to the research community and 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=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes

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

FY26 Traumatic Brain Injury and Psychological Health Translational Research Award 9 the public at large. The information below outlines the mandatory data and sharing requirements for all prospective human-subjects research:

• Informed consent: Consent forms must allow for the submission of de-identified data to a repository. It is also strongly encouraged to include language for optional passive follow-up via electronic health records (EHR).

• Common Data Elements (CDEs): Use of CDEs relevant to the field of study (e.g., National Institute of Neurological Disorders and Stroke (NINDS) TBI CDEs, PhenX collections) is mandatory. Justification is required if CDEs are not used.

• Secondary Outcomes: Applicants are strongly encouraged to include secondary outcomes to address potential crosscutting impacts

• For studies prospectively enrolling 50 or more subjects, applications must share data in an appropriate repository based on the application’s research area. Recommended repositories are below:

○ National Institute of Mental Health (NIMH) Data Archive (NDA): The NDA houses, harmonizes and shares all human subjects data collected as part of NIMH-funded projects, with the goal of accelerating progress in mental health research. Applicants should use the NDA cost estimation tool to budget for manpower and associated costs.

○ Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System:

FITBIR is a central repository to promote collaboration, accelerate research and advance knowledge on the characterization, prevention, diagnosis and treatment of TBI.

Applicants should use the FITBIR cost estimation tool to budget for manpower and associated costs.

○ Additional National Institutes of Health (NIH)-supported Data Repositories can be found at https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html

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.

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, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

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. 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.

PIs 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://www.commondataelements.ninds.nih.gov/ https://www.commondataelements.ninds.nih.gov/ https://www.phenxtoolkit.org/index.php https://nda.nih.gov/ https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fs3.amazonaws.com%2Fnda.nih.gov%2FDocuments%2FNDA_Data_Submission_Cost_Estimation_Tool.xlsx&wdOrigin=BROWSELINK https://fitbir.nih.gov/ https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES:%7E:text=APPENDIX%2010.%0ADOW%20AND%20VA%20WEBSITES

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Classified research is prohibited. This includes classified research data within the application and/or proposing research of which the anticipated outcomes may be classified or deemed sensitive to national security concerns and may result in application withdrawal. This includes, but is not limited to, research involving directed energy (e.g., photonic, radio frequency, acoustic energy, other non-kinetic sources), Anomalous Health Incidents, Havana Syndrome and associated neurological syndromes/injuries. Refer to the GAI Appendix 7, Section C.

3.3. Funding Instrument

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

(31 USC 6304).

3.4. Funding Details

Period of Performance: The maximum period of performance is 4 years.

3.4.1. Application Submission With a Single PI

• For Research Level 1

○ Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.0M.

• For Research Level 2

○ Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $2.0M.

3.4.2. Application Submission With the Early-Career Investigator Partnering Option

• For Research Level 1

○ 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 $1.0M.

• For Research Level 2

○ 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 $2.0M.

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

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

3.4.3. 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 4 years.

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

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

Must be requested for:

• In Years 3 and 4, travel costs for the PI or Initiating PI and Partnering PI to present project information or disseminate project results at a DOW-sponsored meeting (e.g., Military Health System Research Symposium). For planning purposes, it should be assumed that the meeting will be held in the Central Florida Area.

May be requested for (not all-inclusive):

• Travel costs in support of multidisciplinary collaborations.

• Starting in Year 2, travel costs for the PI or Initiating PI and Partnering PI to present project information or disseminate project results at one scientific/technical meeting per year in addition to the required meetings described above. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 TBIPHRP TRA.

• Travel in support of multi-institutional collaborations.

• Research subject compensation and reimbursement for study-related out-of-pocket costs

(e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to enable participation). Note that clinical trials are prohibited.

• Costs associated with CBPR implementation.

• Costs associated with data and research resource sharing (i.e., making a large dataset available to the public or developing an important resource for the scientific community). If recommended for funding, the government reserves the right to reduce the data/resource sharing budget request during negotiations in order to maximize funding available for research. The TBIPHRP will not provide future TBIPHRP funds to preserve or share data/resources indefinitely.

Must not be requested for:

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

• Tuition.

• 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.

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

• Preproposal Narrative (two-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:

○ Focus Area: Describe how the proposed project is relevant to the selected sub-area(s) within one of the three FY26 TBIPHRP TRA Focus Areas.

○ Background and Rationale: State the ideas and reasoning on which the proposed work is based; include relevant preliminary data and literature citations.

○ Specific Aims and Study Design: Concisely state the hypothesis and specific aims.

Provide a brief overview of the study design. Identify and justify the requested Research Level. If prospective human subjects research is proposed, indicate how the study design is informed by the CBPR approach.

○ Research Team: Briefly state the qualifications and expected contributions of the PI(s) and key personnel to successfully complete the described research project. Note any DOW or VA collaborations.

○ Innovation, Impact and Relevance to Military Health: Describe how the proposed research is innovative and will lead to the development of transformative health care products, technologies, or clinical practice guidelines. Describe how research will generate non-incremental on a critical problem or question in psychological health and/or TBI research or patient care. Explain how the project is relevant to the health care needs of Service Members.

• 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:

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:%7E:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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FY26 Traumatic Brain Injury and Psychological Health Translational Research Award 13

○ 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).

○ Other Pre-Applications (two-page limit): If applicable, provide a list of all FY26 TRA pre-applications where the PI is also named as a PI, Initiating PI, Partnering PI, or collaborator. Each entry must include the CDMRP log number, the PI's role, the project title, the specific aims and a brief explanation of how each pre-application's research questions are distinct.

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

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications and previous work accomplished.

4.3. Full Application Components

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

Early-Career Investigator Partnering Option: The CDMRP requires separate full application package submissions for the Initiating PI and the 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 (12-page limit): Upload as

“ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background and Rationale: Describe in detail the scientific rationale for the study.

Provide a review and analysis of relevant literature, unpublished data, preliminary studies/data and/or preclinical data relevant to the proposed research.

Research including animal models are required to submit Attachment 7 Animal

Research Plan.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:%7E:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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

FY26 Traumatic Brain Injury and Psychological Health Translational Research Award 14

For studies prospectively enrolling human subjects, describe any CBPR/stakeholder engagement that was performed and how it helped to formulate the hypothesis/objective and research strategy. Full details of the CBPR approach can be provided in Attachment 11.

– Innovation: Describe the current scientific paradigm or clinical practice the research challenges. Clearly identify and describe the innovative component(s) in the proposed research. Justify why the research is necessary by describing why incremental/iterative improvements to current approaches and tools are insufficient to achieve the desired impact

– Specific Aims/Hypothesis: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in the proposed research and detail the specific aims that will address the hypothesis/research question. The aims should align with the associated tasks described in the Statement of Work (SOW); Attachment 5).

If the proposed research project is part of a larger study, present only those tasks that this FY26 TBIPHRP TRA would fund.

– Study Design: Outline the approach for executing non-incremental/iterative research and provide sufficient detail for evaluation of its appropriateness and feasibility. Describe how the proposed research aligns with at least one of the sub-area(s) within one of the three FY26 TBIPHRP TRA Focus Areas and is appropriate for the requested Research Level. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

Describe the study design, methods, models and outcomes and how they will address the specific aims and hypotheses.

If animals are to be used, briefly identify and describe the model to be utilized. Additional information regarding animal model relevance and experimental procedures will be provided in the Animal Research Plan (Attachment 7).

For studies performing retrospective or prospective human subject recruitment or observation, briefly describe the population(s) of interest and how access to the population(s) or dataset(s) will be achieved.

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. Note that CDMRP will not serve as the government sponsor or signatory on any access applications or agreements for DOW or VA patient populations, resources, or databases. 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. Full details on human subject recruitment will be required in the Study Population Recruitment and Safety Plan (Attachment 9).

If questionnaires or other research data collection instruments will be used, include a copy of them in Attachment 2: Supporting Documentation.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES

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FY26 Traumatic Brain Injury and Psychological Health Translational Research Award 15

Information describing the strategy for how sex will be considered as a biological variable will be requested in Attachment 2.

Address potential problem areas and pitfalls and provide alternative methods and approaches.

– Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Ensure sufficient information is provided to allow for a thorough evaluation of statistical calculations during review of the application.

Include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study. Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

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. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

○ 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.

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. Note that https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

FY26 Traumatic Brain Injury and Psychological Health Translational Research Award 16

CDMRP will not serve as the government sponsor or signatory on any access applications or agreements for DOW or VA patient populations, resources, or databases.

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. 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)1 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 NIH 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.

Questionnaires and Other Research Data Collection Instruments: Include a copy of the most recent version of questionnaires, data collection forms, rating scales, interview guides or other instruments. This should include any drafts that are currently in use or underdevelopment. This award may not be used to conduct clinical trials.

Quad Chart: Provide a Quad Chart for the proposed project. The format for the Quad Chart is available on the eBRAP “Funding Opportunities & Forms” web page.

○ 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.

1 NIH-supported Data Repositories can be found at https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html 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…