HT942526VRPMCRA_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

Vision Research Program Mentored Clinical Research Award

Funding Opportunity Number: HT942526VRPMCRA

Pre-Application Due: August 25, 2026

Application Due: September 10, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Vision Mentored Clinical 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 Mentored Clinical Research Award;

provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

FY26 Vision Mentored Clinical Research Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

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

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

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

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

FY26 Vision Mentored Clinical Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Vision Research Program (VRP) Mentored Clinical Research Award (MCRA) supports patient-oriented vision injury research conducted by highly motivated military or civilian clinicians in training. The MCRA may be used to support a standalone study of high impact to vision injury care or the generation of clinical research data in preparation for a more expansive study. Research must align with at least one of the FY26 VRP Focus Areas. The MCRA may not be used to support preclinical research or clinical trials.

Distinctive Features:

• Key personnel must include an established clinician or Ph.D. clinical scientist, who will serve as Principal Investigator (PI) and a clinician in training (e.g., a fellow, resident, junior clinician, clinician in a Ph.D. program), who will conduct the proposed research under mentorship of the PI, with support from supporting personnel as appropriate.

• The clinician in training should have sufficient time remaining in their training program to complete the research proposed under the MCRA.

• Scored peer review criteria include Research Idea/Rationale, Research Strategy and Feasibility, Impact and Personnel.

• Programmatic review criteria include adherence to the intent of the MCRA, contribution to program portfolio, relative impact and relevance to military health.

• Applicants must submit documentation of Institutional Review Board (IRB)/Ethics Committee (EC) approval or exemption by January 1, 2027, in order for the MCRA application to be considered for funding.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $150,000 to fund approximately two MCRA applications with total cost caps of $75,000 per award. The maximum period of performance is 18 months. It is anticipated that awards made from this 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 25, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 10, 2026

• End of Application Verification Period: 5:00 p.m. ET, September 17, 2026

• Peer Review: November 2026

• Programmatic Review: January 2027 Announcement Type: Initial Funding Opportunity Number: HT942526VRPMCRA Assistance Listing Number: 12.420 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

FY26 Vision Mentored Clinical Research Award 5

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

Established clinicians or Ph.D. clinical scientists affiliated with an eligible organization are eligible to be named PI on the application, regardless of ethnicity, nationality or citizenship status.

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:%7E:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E: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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Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Vision Mentored Clinical Research Award 6

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 Vision Research Program (VRP). 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 VRP in 2009 to target the various causes, effects and treatment of visual injury resulting from exposures to the elements during combat operations and damage from explosive devices. Appropriations for the VRP from FY09 through FY24 totaled $204.95 million (M). The FY26 appropriation is $10M.

The goal of the VRP is to transform visual system trauma care for our Armed Forces and the nation. Visual system trauma includes both injury of the ocular system and vision dysfunction as a result of traumatic brain injury (TBI).

The FY26 VRP challenges the scientific community to design innovative research that will significantly advance understanding, prevention, diagnosis, mitigation and/or treatment of eye injury or visual dysfunction associated with military exposure.

3.1. Award History

The VRP MCRA mechanism was first offered in FY23. Since then, four MCRA applications were received, and two were recommended for funding.

3.2. Intent of the Mentored Clinical Research Award

The VRP MCRA supports patient-oriented vision injury research conducted by highly motivated military or civilian clinicians in training.

The MCRA may be used to support a standalone study of high impact to vision injury care or the generation of clinical research data in preparation for a more expansive study.

The MCRA can only be used to support clinical research. The MCRA may not be used to support preclinical research or clinical trials.

3.2.1. Focus Areas for the MCRA

To meet the intent of the funding opportunity, applications to the FY26 VRP MCRA must address research in one or more of the following focus areas:

• Understand and treat eye injury or visual dysfunction as related to military exposure

• Diagnose, stabilize and treat eye injuries in austere environments and prolonged care settings

• Restore visual function after military exposure-related vision loss or severe visual impairment

3.2.2. Key Elements for the MCRA

• In addition to the PI, key personnel must include a clinician in training (e.g., a fellow, resident, junior clinician, clinician in a Ph.D. program), designated as Mentee. The Mentee https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

FY26 Vision Mentored Clinical Research Award 7 will conduct the proposed research under guidance of the PI (the Mentor), with support from supporting personnel as appropriate.

• While additional junior scientists or clinicians may participate in the research, only one clinician in training may be designated as Mentee.

• The Mentee should have sufficient time remaining in their training program to complete the research proposed under the MCRA.

• A Letter of Support, signed by the Department Chair or appropriate organization official, and a Letter of Commitment, signed by the Mentee, should be submitted as part of Attachment 2: Supporting Documentation.

• Applicants must submit documentation of Institutional Review Board/Ethics Committee (IRB/EC) approval or exemption by January 1, 2027, in order for the MCRA application to be considered for funding. See Documentation of IRB/EC approval, exemption or application in Attachment 2: Supporting Documentation for instructions on the submission of required documents.

• Preliminary data are allowed but not required.

3.2.3. Other Important Considerations for the MCRA

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

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.

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 18 months.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $75,000. 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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

FY26 Vision Mentored Clinical Research Award 8

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 18 months.

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.

• Salary support for supportive personnel (e.g., research coordinator, research nurse, statistician, etc.).

• Costs for the Mentee to travel to one scientific/technical meeting during the period of performance to present project information or disseminate project results from the VRP

MCRA.

• 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).

Must not be requested for:

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

• Salary support for Mentor or Mentee

• Equipment over $10,000

• Costs typically covered as part of routine care

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

FY26 Vision Mentored Clinical Research Award 9

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

Pre-application submissions must include the following components.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted.

4.3. Full Application Components

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 (four-page limit): Upload as

“ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

− Research Idea/Rationale: Provide a sound scientific rationale for the proposed clinical research. Describe why it is needed and in which ways it can address the need(s). Clearly state the objective(s) to be reached and/or the hypothesis(es) to be tested. Present critical analysis of literature and, as available, preliminary data, to support the readiness of the objective(s), the soundness of the hypothesis(es) and the feasibility of the approach(es).

− Specific Aims: Describe the project’s specific aims.

− Research Strategy: Describe the experimental design, methods and analyses, including controls, in sufficient detail so that the appropriateness and feasibility of the research strategy can be fully evaluated. All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility https://ebrap.org/eBRAP/public/index.htm 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#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes 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#_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

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

FY26 Vision Mentored Clinical Research Award 10 and translational potential of clinical research, such as those described in the STROBE guidelines. As applicable, include measures to be taken to reduce bias and achieve reproducible and rigorous results to facilitate evaluation.

If proposing clinical research:

Describe the study population. Describe the rationale for the selection of subjects/samples/data. Explain how the selection is appropriate for addressing the study aims. Further details of research involving human subjects or human biological substances will be required in Attachment 7:

Human Subjects/Samples Acquisition and Safety Procedures, as applicable.

Clinical trials are not allowed.

Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial and ethnic group. If limiting inclusion of any group by sex, race or ethnicity, provide justification related to the scientific goals. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from IRB review) are exempt from this requirement. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity should be provided as part of Attachment 2:

Supporting Documentation.

Statistical Plan: Describe the statistical plan, including power analysis, and the rationale for the statistical methodology.

Address potential pitfalls and problem areas, and present alternative methods and approaches.

Explain how the research can be completed within the proposed period of performance.

Research involving 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 General Application Instructions, Appendix 4, for additional considerations.

○ 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 https://www.strobe-statement.org/ https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES 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 Vision Mentored Clinical Research Award 11 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.

Letter(s) of Support:

Provide a letter of support signed by the Department Chair or appropriate organization official. The letter should confirm:

The PI meets eligibility criteria.

The PI has the support and resources necessary for the proposed work.

The Mentee’s name, date the Mentee completed their terminal clinical degree and date the Mentee is estimated to complete their training program.

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 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.

Letter of Commitment: Provide a letter signed by the Mentee outlining qualifications and commitment to the proposed research. Describe past training, experience and expertise. Describe career goals and explain how the proposed project supports those goals. Describe the degree to which the Mentee participated in the development of the proposed project and application preparation. Confirm commitment to conducting and completing the project if funded.

Documentation of IRB/EC approval, exemption or application: Provide either a copy of IRB/EC determination letter or a copy of the submitted IRB/EC application, including a copy of the exempted/approved/submitted protocol. The protocol must cover the proposed research.

Applicants who submit a copy of IRB/EC application as part of Attachment 2 must submit a copy of IRB/EC approval/exemption letter to the CDMRP eBRAP Help Desk by January 1, 2027, in order for the MCRA application to be considered for funding.

Sex as a Biological Variable Strategy: 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.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf

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FY26 Vision Mentored Clinical Research Award 12

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

Do not submit a copy of the National Institutes of Health (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.

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

Write the technical abstract using the outline below. Programmatic Reviewers rely on the technical abstract for appropriate description of the project’s key aspects. Clarity and completeness within the space limits are highly important.

Research Idea/Rationale: Present the ideas and scientific rationale behind the proposed research.

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

Specific Aims: State the specific aims of the study.

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

Expected Outcome: Describe the expected outcome(s) of the proposed research.

Be as specific as possible.

○ 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 ideas and rationale for the proposed research. Why is it needed?

– Explain the objective(s) and study design of the proposed research. What questions will it answer, and how will it answer them?

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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FY26 Vision Mentored Clinical Research Award 13

– Explain the expected outcome. At the end of the project, what new knowledge or new capability will have been gained?

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

Refer to eBRAP for the Suggested SOW Format.

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

If conducting TBI-related research: The VRP requires that all TBI-related clinical research with at least 50 subjects funded by this program be shared through the jointly supported DOW-NIH Federal Interagency TBI Research Information System (FITBIR).

FITBIR-eligible research should 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

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”.

Describe the anticipated impact of the proposed research on vision injury research and/or patient care. Be as specific as possible. Write with a broad audience in mind, including readers without a background in science or medicine.

– Explain who will benefit from the proposed research and, if successful, how the proposed research will improve outcomes after vision injury for the target population.

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

○ Attachment 7: Human Subjects/Samples Acquisition and Safety Procedures (no page limit): Upload as “HumProc.pdf”.

Include the components listed below as applicable. Do not duplicate information from the Project Narrative.

– Study Population and Recruitment Process: Describe the study population, criteria for inclusion/exclusion and the methods that will be used for recruitment/accrual/retention of human subjects.

Demonstrate that the research team has access to the proposed study population. If applicable, discuss past efforts in recruiting human subjects from the target population for previous clinical studies. Address any potential barriers to accrual and plans for addressing unanticipated delays.

Enrollment Distribution: Provide anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity using the Public Health Service (PHS) Inclusion Enrollment Report. The enrollment table(s) should be appropriate to the objectives of the study.

Describe how the subject-to-group assignments process will be conducted (e.g., randomization, block randomization, stratified randomization, age-matched controls, alternating group or other procedures), if applicable.

Include a detailed description of and justification for the compensation plan if the human subjects will be compensated for participation in the study.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://fitbir.nih.gov/ https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Vision Mentored Clinical Research Award 14

For clinical studies proposing to recruit military or VA personnel, refer to the General Application Instructions, Appendix 4, for more information on recruitment process and considerations, payment and confidentiality. If a non-military non-VA population will be used for the proposed clinical study, explain how results obtained will be applicable to military or VA personnel.

– Informed Consent Process: Describe the plan for obtaining informed consent from human subjects. Include relevant draft process documents. Provide a draft, in English, of the Informed Consent Form.

– Screening Procedures: List and describe any evaluations that are required to determine eligibility/suitability for study participation and the diagnostic criteria for entry.

– Risks/Benefits Assessment: Identify all foreseeable study risks (physical, psychological, social, legal and other). Discuss the importance of the knowledge to be gained in relation to the risks to subjects. Clearly describe measures of risk management and plans for emergency response. Describe known and potential benefits, which may or may not be direct to subjects, in relation to risks.

Note: Payment and/or other compensation for participation are not considered benefits and must be addressed in Study Population and Recruitment Process.

– Human Samples: Describe the types and source(s) of specimens, records or data to be collected and evaluated. Include information about specimen storage (i.e., location, duration, special handling conditions). Describe the identifiers that will be associated with the human specimens and data and provide a list of who has access to subjects’ identities. Describe how individually identifiable private information will be protected.

○ Attachment 8: Researcher Development Plan (two-page limit): Upload as “ResearcherDev.pdf”. The individualized Research Development Plan should clearly describe a strategy for the Mentee to develop research expertise through conduction of the proposed project.

– Describe the PI’s background and experience in clinical research.

– Describe the PI’s track record in mentoring junior clinical researchers.

– Explain how the Mentee will develop research expertise through the proposed project. Describe the Mentee’s background, experience and role in the proposed project. Identify specific areas of growth.

– Provide details on the amount and types of planned interactions between the Mentee and the PI.

– Explain how the Researcher Development Plan is supported by the environment; this should include a description of ongoing vision injury research at the organization.

Include resources available and opportunities for the Mentee to interact with other vision injury researchers through collaborations, seminars, workshops and other interactions.

○ Attachment 9: Relevance to Military Health Statement (one-page limit): Upload as “Military.pdf”. Explain how the proposed research and the anticipated outcomes will benefit Service Members, Veterans and/or their Families. Discuss how the proposed research is applicable to operational performance, medical readiness and/or quality of life.

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 Vision Mentored Clinical Research Award 15

As applicable, include the elements below:

− If active-duty military, Veteran or military Family member population(s) will be used in the proposed research project, describe the population(s), the appropriateness of the population(s) for the proposed research and the feasibility of using the population. If a non-military population will be used for the proposed research project, explain how the population simulates the targeted population.

− If applicable, provide a description of how the knowledge, information, products or technologies gained from the research could be implemented in a dual-use capacity to both benefit the civilian population and address a military need.

− If the ultimate outcome of the research is intended to be applicable in the military operational environment (e.g., battlefield, Battalion Aid Stations, Forward Support Medical Battalions), identify any element(s) or special consideration(s) related to the intended applicability. Applicants may consult A Beginner’s Guide to Military Healthcare System for descriptions of the range of military operational environment and types of care provided.

○ Attachment 10: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 11: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

(c) Additional Application Materials:

The following are additional forms for application submission. Follow the instructions specific to the submission portal, as found within the GAI.

i. Research & Related Senior/Key Person Profile (Expanded)

○ Biographical Sketch

○ Current/Pending Support

Intragovernmental applicants must include their internally supported research and development programs.

ii. Research & Related Budget

iii. Project/Performance Site Location(s)

iv. Research & Related Subaward Budget Attachment(s) (if applicable, Grants.gov submissions only)

External Link to the GAI

Grants.gov xternal ink to the GAI eBRAP.org https://cdmrp.health.mil/vrp/pdf/A%20Beginner's%20Guide%20to%20Army%20Healthcare%20System.pdf https://cdmrp.health.mil/vrp/pdf/A%20Beginner's%20Guide%20to%20Army%20Healthcare%20System.pdf https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Required%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E: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.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=B.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget%20Form%2C%20if%20applicable%3A https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_IV:%7E:text=C.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:%7E:text=B.-,Additional%20Application%20Materials,-The%20following%20are

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FY26 Vision Mentored Clinical Research Award 16

4.4. Other Application Elements

If recommended for funding, a data management plan compliant with Section 3.c, Enclosure 3, DoD Instructions 3200.12 will be requested.

If recommended for funding, a Quad Chart will be requested. The format for the quad chart is available on the eBRAP “Funding Opportunities & Forms” web page.

The government reserves the right to request a revised budget, budget justification and/or additional information for applications recommended for funding.

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423 https://ebrap.org/eBRAP/public/Program.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:%7E:text=E.-,DOW%20Data%20Management%20Plan,-If%20recommended%20for

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FY26 Vision Mentored Clinical Research Award 17

5. Submission Requirements

5.1. Location of Application Package

Download the application package components for HT942526VRPMCRA from Grants.gov or eBRAP, depending on which submission portal will be used.

5.2. Unique Entity Identifier and System for Award Management

The applicant organization must be registered as an entity in the System for Award Management (SAM), SAM.gov, and receive confirmation of an “Active” status before submitting an application through Grants.gov. Organizations must include the unique entity identifier (UEI) generated by the SAM in applications to this funding opportunity and maintain an active registration in the SAM at all times during which it has an active Federal award or an application under consideration.

5.3. Submission Instructions

The CDMRP uses two portal systems to accept pre- and full application submissions. The workflow below shows which portal system to use for pre- and full application submissions, respectively.

Application Submission Workflow

5.3.1. Pre-Application Submission

All pre-application components must be submitted by the PI through eBRAP.

During the pre-application process, eBRAP assigns each submission a unique log number. This unique log number is required during the full application submission process. The eBRAP log number, application title and all information for the PI, Business Official(s), performing organization, and contracting organization must be consistent throughout the entire https://grants.gov/ https://ebrap.org/eBRAP/public/Program.htm https://www.sam.gov/content/home https://ebrap.org/ https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:%7E:text=Obtain%20Unique%20Entity%20Identifier%20from%20System%20for%20Award%20Management https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_PreApp_Submission:%7E:text=III.-,PRE%2DAPPLICATION%20SUBMISSION,-General%20information%20about

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

FY26 Vision Mentored Clinical Research Award 18 pre-application and full application submission process. Inconsistencies may delay application processing and limit or negate the ability to view, modify and verify the application in eBRAP.

Contact the eBRAP Help Desk if any changes need to be made.

5.3.2. Full Application Submission

Grants.gov Submissions: Full applications from extramural organizations must be submitted through the Grants.gov Workspace.

eBRAP Submissions: Only intramural DOW organizations may submit full applications through eBRAP.

5.3.3. Applicant Verification of Full Application Submission in eBRAP

Independent of the submission portal, once the full application is submitted, it is transmitted to and processed in eBRAP; the transmission to eBRAP may take up to 48 hours. At this stage, the PI and organizational representatives will receive an email from eBRAP instructing them to log in to eBRAP to review, modify and verify the full application submission.

The Project Narrative and Research & Related Budget Form cannot be changed after the application submission deadline. Other application components, including subaward budget(s) and subaward budget justification(s), may be changed until the application verification period ends. The full application cannot be modified once the application verification period ends.

5.4. Submission Dates and Times

The pre-application and full application submission process should be started early to avoid missing deadlines. Regardless of submission portal used, all pre- and full application components must be submitted by the deadlines stipulated in this program announcement.

There are no grace periods for deadlines; failure to meet submission deadlines will result in application rejection. The DHACA cannot make allowances/exceptions for submission problems encountered by the applicant.

Submission dates and times are specified in Section 1, Basic Information.

5.5. Intergovernmental Review

Not applicable for this funding opportunity.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E: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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E:text=IV.-,FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:%7E:text=V.-,FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Applicant_Verification_Grants_Submission:%7E:text=E.-,Applicant%20Verification%20of%20Grants.gov%20Submission%20in%20eBRAP,-Once%20the%20full

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FY26 Vision Mentored Clinical Research Award 19

6. Application Review Information

6.1. Application Compliance Review

Submitting applications that propose essentially the same research project to different funding opportunities within the same program and fiscal year is prohibited and will result in administrative…