HT942526PRPEIRA_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

Parkinson’s Research Program Early Investigator Research Award

Funding Opportunity Number: HT942526PRPEIRA

Pre-Application Due: October 23, 2026

Application Due: November 6, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Parkinson’s Early Investigator 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 Early Investigator 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 Parkinson’s Early Investigator 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.

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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 Parkinson’s Early Investigator Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Parkinson’s Research Program (PRP) Early Investigator Research Award (EIRA) supports Parkinson’s disease (PD) research for investigators in the early stages of their careers. The FY26 EIRA offers two funding levels, which align to the research career stage of the Principal Investigator (PI). Funding Level 1 (for fellows) requires the investigator to receive guidance from a designated Mentor, whereas Funding Level 2 (for early-career independent investigators) does not. Proposed research must address at least one of the four FY26 PRP Focus Areas.

Distinctive Features:

• The Early Investigator is considered the PI of the application and must exhibit strong potential for and commitment to pursuing a career as an investigator at the forefront of PD research; however, the PI is not required to have previous PD research experience.

• Funding Level 1: Applications must include at least one Mentor appropriate to the proposed research project who has experience in PD research and mentoring, as demonstrated by a record of active funding, recent publications, and successful mentorship.

The selected Mentor(s) should also demonstrate a clear commitment to the development of the PI toward independence as a PD researcher. Preliminary data are encouraged but not required.

• Funding Level 2: Mentor not required. Preliminary data are required.

• Clinical trials are not allowed.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.2M to fund approximately seven Early Investigator Research Award applications with total cost caps of $0.3M for Funding Level 1 awards and $1.0M for Funding Level 2 awards. The maximum period of performance is 2 years. 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), October 23, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 6, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 13, 2026

• Confidential Letters of Recommendation Submission Deadline: 5:00 p.m. ET, November 13, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027 Announcement Type: Initial Funding Opportunity Number: HT942526PRPEIRA 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

FY26 Parkinson’s Early Investigator 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

Postdoctoral fellows, clinical fellows, or independent investigators within 10 years of advanced degree or residency training completion, or equivalent, who are affiliated with an eligible organization are eligible to be named PI on the application, regardless of ethnicity, nationality or citizenship status.

• Funding Level 1 applications are intended to support postdoctoral fellows, clinical fellows, or equivalent. Applications must include at least one mentor who has experience in PD research and mentoring as demonstrated by a record of active funding, recent publications, and successful mentorship.

• Funding Level 2 applications are intended to support early-career, independent investigators within 10 years of advanced degree or residency training completion, or equivalent. Applications do not require a mentor.

An investigator may be named on only one FY26 PRP EIRA application as the PI.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

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

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FY26 Parkinson’s Early Investigator 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 Parkinson’s Research Program (PRP). 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. In FY22, Congress transitioned the Neurotoxin Exposure Treatment Parkinson’s Program to PRP and broadened the research from neurotoxin exposure treatment Parkinson’s disease (PD) research to all types of PD research. Appropriations for the PRP from FY22 through FY24 totaled $48 million (M). The FY26 appropriation is $16M.

The vision of the PRP is to improve the health and lives of people with, or at risk for, Parkinson’s disease through innovative research that translates to clinically meaningful treatments.

The mission of the PRP is to support high impact research that intends to decrease risk, slow progression, or ease symptoms of Parkinson's disease to benefit Service Members and their Families, Veterans and the general public.

The PRP seeks to support research that is relevant to the health care needs of Service Members, Veterans, and their Families, and/or Family readiness of Service Members. As such, applications must demonstrate how the proposed research will decrease the burden of Parkinson’s disease on Service Members, their dependents, Veterans and other military beneficiaries (i.e., Family members of retirees). Inclusion of Service Members, Veterans, or other military beneficiary populations is not required, but the proposed research should be applicable towards and benefit those groups.

3.1. PRP Focus Areas

All applications must address at least one of the following FY26 PRP Focus Areas:

• Understanding how Parkinson’s disease biological and clinical heterogeneity impacts disease presentation, clinical course and therapeutic outcomes, from prodromal to late-stage Parkinson’s disease

• Development and characterization of in vitro model systems that approximate in vivo cellular and system complexity

• Biological mechanisms or biomarkers, such as clinical, fluid, imaging, tissue, and devices, of unmet medical needs that could lead to the development of treatments for PD. Applications can utilize laboratory models through to human participants. Examples of unmet medical needs of interest include, but are not limited to:

○ Non-motor symptoms:

– Autonomic

– Cognitive

– Fatigue

– Olfaction

– Pain

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FY26 Parkinson’s Early Investigator Research Award 7

– Psychiatric

– Sensory

– Sleep and circadian rhythm disruptions

○ Motor symptoms

– Dyskinesia

– Dystonia

– Gait and balance

– Tremor

• Interventions that address unmet medical needs of PD that include both clinical and preclinical models. Examples of interventions of interest include, but are not limited to:

○ Biological

○ Pharmacological

○ Non-pharmacological

○ Surgical

○ Non-surgical devices

○ Non-invasive central nervous system stimulation

3.2. Intent of the Early Investigator Research Award

To expand PD research capacity and address understudied PD research areas, the PRP Early Investigator Research Award (EIRA) supports PD research conducted by investigators in the early stages of their careers. The Early Investigator is considered the Principal Investigator (PI) of the application and must exhibit strong potential for, and commitment to, pursuing a career as an investigator at the forefront of PD research; however, the PI is not required to have previous PD research experience. The FY26 PRP EIRA offers two levels of funding, which align to the PI’s research career stage:

• Funding Level 1 applications are intended to support postdoctoral fellows, clinical fellows, or equivalent. Applications must include at least one mentor.

• Funding Level 2 applications are intended to support early-career, independent investigators within 10 years of advanced degree or residency training completion, or equivalent. Applications do not require a mentor.

3.2.1. Key Elements for the EIRA

All applications for the EIRA are to be written by the PI, with appropriate direction from the Mentor(s).

• Principal Investigator: The EIRA supports early-career investigators exploring innovative, high-impact ideas or new technologies applicable to PD research. The application should demonstrate the PI’s potential for, and commitment to, pursuing a career in treatment-related PD and/or patient care research. Funding Level 1 applications must include at least one Mentor, appropriate to the proposed research project, who has experience in PD research and mentoring as demonstrated by a record of active funding, recent publications, Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Parkinson’s Early Investigator Research Award 8 and successful mentorship. Funding Level 2 applications are not required to include a Mentor.

• Research Strategy and Feasibility: The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of the neurodegenerative effects of PD. Experimental strategies may be novel or may be based on strong rationale derived from previously published data, presented preliminary data, or literature review. The feasibility of the research design and methods should be well-defined, and a clear plan should be articulated as to how the proposed goals of the project can be achieved.

○ Preliminary data are encouraged for Funding Level 1 applications.

○ Preliminary data are required for Funding Level 2 applications.

Any unpublished preliminary data provided should originate from the PI, Mentor(s), or member(s) of the collaborating team. The preliminary data must support the feasibility of the study.

• Impact: The proposed research, if successful, should have an impact on an area of paramount importance to PD. The application must clearly and explicitly describe the potential short-term and long-term impacts of the proposed study and convey its level of significance. The research should benefit individuals with PD.

• Researcher Development Plan (Funding Level 1 Applications only): The application must outline an individualized Researcher Development Plan. The Researcher Development Plan should include a clearly articulated strategy for acquiring the necessary skills, competence, and expertise that will enable the PI to successfully complete the proposed research project and foster the PI’s development as an independent PD researcher. An environment appropriate to the proposed mentoring and research at the PI’s institution must be clearly described. Additional necessary resources and/or mentorship may be provided through collaboration(s) with other institutions. If the PI will be utilizing resources at another institution to successfully complete the proposed project, then the PI is strongly encouraged to designate a co-Mentor at the collaborating institution.

3.2.2. Other Important Considerations for the EIRA

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.

Clinical trials are not allowed within this funding opportunity; however, clinical research involving human subjects, secondary use of human data, and/or use of human anatomical substances is permitted.

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 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 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

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FY26 Parkinson’s Early Investigator Research Award 9 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 2 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $0.3M for Funding Level 1 awards and $1.0M for Funding Level 2 awards. 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 2 years.

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

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

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the PRP EIRA.

Must not be requested for:

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

• Clinical trial costs.

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FY26 Parkinson’s Early Investigator Research Award 10

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. Include the FY26 PRP Focus Area(s) under which the application will be submitted.

List of Individuals Providing Confidential Letters of Recommendation: Enter contact information for a minimum of two and maximum of three individuals (including the Mentor, if applicable) who will provide letters of recommendation. Each individual will receive an email generated from eBRAP containing specific instructions on how to upload their letter.

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 (Eight-page limit): Upload as

“ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below. The Project Narrative must be written by the PI. The Funding Level 1 Project Narrative should show evidence of appropriate direction from the Mentor(s).

– Principal Investigator: The PI should describe how their achievements (as reflected by academic performance, awards, honors, and/or previous publications and funding) indicate the potential for a successful career as a PD researcher. The PI should describe how their stated career goals demonstrate a strong personal commitment to pursuing an independent career as a leader in PD research. The PI 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#_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 Parkinson’s Early Investigator Research Award 11 should describe how their proposed level of effort, if not 100%, is appropriate for successful completion of the proposed work.

– Background: Present the ideas and reasoning behind the proposed research. The application must provide a sound scientific rationale to support the proposed project and its feasibility as established through the demonstration of logical reasoning and critical review and analysis of published literature; include relevant literature citations.

The presentation of preliminary and/or published data to support the proposed research project is required for Funding Level 2 applications. Any unpublished preliminary data provided should originate from the laboratory of the PI(s) or member(s) of the research team.

– Hypothesis or Objective: State the hypothesis to be tested or the objective to be reached. State concisely the new concept, theory, paradigm, and/or method that addresses an important problem in PD research and/or patient care.

– Specific Aims: Concisely explain the proposed research project’s specific aims to be funded by this application. If the proposed research project is part of a larger study, present only tasks that this award would fund.

– Research Strategy and Feasibility: Describe the experimental design, methods, and analyses, including appropriate controls, in sufficient detail for evaluation.

Clearly describe how data will be collected and analyzed in a manner that is consistent with the study objectives. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported. Describe availability of, access to, and quality control for all data and/or critical reagents, and/or cohorts, where relevant.

– If animal studies are proposed, describe how they will be conducted in accordance with the ARRIVE guidelines 2.0 to achieve reproducible and rigorous results, including the choice of model and the endpoint/outcomes to be measured.

– 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 11: 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, race 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 Institutional Review Board [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 11:

Human Subjects/Samples Acquisition and Safety Procedures.

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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes

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FY26 Parkinson’s Early Investigator Research Award 12 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.

– Statistical Analysis Plan: Describe the statistical model and data analysis plan with respect to the study objectives. Include a power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study. Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the U.S. Food and Drug Administration (FDA), if applicable.

– Address potential limitations and present alternative methods and approaches.

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

○ 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. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

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

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological 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#_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

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FY26 Parkinson’s Early Investigator Research Award 13 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.

Data and/or 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.

Intellectual and Material Property Plan (if applicable): Provide a plan for resolving intellectual and material property issues among participating organizations.

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

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

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

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

Specific Aims: State the specific aims of the study.

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

Impact: Briefly describe how the proposed research project will have short-term and/or long-term impact on PD research and/or patient care.

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

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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FY26 Parkinson’s Early Investigator Research Award 14

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

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

– Summarize the objectives and rationale for the proposed research.

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

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

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

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

Service Members, Veterans and/or their Families?

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

Refer to eBRAP for the Suggested SOW Format.

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

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

Articulate the pathway to making a clinical impact for individuals with, or at risk for, PD.

The impact statement 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.

Describe a practical vision for how the short- and long-term outcomes of the proposed research will support the PRP’s mission of supporting high impact research that intends to decrease risk, slow progression or ease symptoms of Parkinson's disease.

The short-term impact will be the anticipated outcome(s)/product(s) from the proposed research.

The long-term impact may be beyond the scope of the proposed research.

– Describe how the proposed research addresses at least one of the FY26 PRP Focus Areas.

– Explain briefly how the proposed research is relevant to the health care needs of Service Members, Veterans, their Families, and/or Family readiness of Service Members.

○ Attachment 7: Letter of Eligibility (one-page limit): Upload as “Eligibility.pdf”.

Provide a letter signed by the PI and the Department Chair, Dean, or equivalent official to verify that the eligibility requirements have been met. The letter should verify that the PI is currently a postdoctoral fellow, clinical fellow, and/or no more than 10 years from their advanced degree training or residency training completion, or equivalent, as of the application deadline (Refer to eligibility criteria).

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

– Describe the anticipated research outcomes, including knowledge products, clinical products for development, etc.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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

FY26 Parkinson’s Early Investigator Research Award 15

– Describe the methods and strategies proposed to move the anticipated research outcomes to the next phase of development or clinical application after successful completion of the project.

– Detail the funding strategy to transition to the next level of investigation, development, and/or commercialization (e.g., partners, internal/external funding opportunities to be applied for).

– Demonstrate that a plan for management of intellectual property is in place.

○ Attachment 9: Researcher Development Plan (only required for Funding Level 1 applications, two-page limit): Upload as “ResearcherDev.pdf”.

– Describe the plan to enable the PI to investigate a problem or question in PD research and acquire the necessary skills, competence, and expertise to successfully complete the proposed research project, and to effectively prepare him/her for a successful career as an independent PD researcher.

– Describe the background, funding, publications, and experience of the Mentor(s) in PD research. Explain how they will guide the PI throughout the period of performance in developing toward independence in PD research. Describe their track record in mentoring early-career investigators in PD research.

– Describe how the scientific environment at the primary institution and collaborating institution(s) are appropriate for the proposed research and career development activities, including professional interaction with established PD researchers.

– Do not reference or include members of the FY26 PRP Programmatic Panel.

○ Attachment 10: Animal Research Plan (only required for applications proposing animal studies, five-page limit): Upload as “AnimalResPlan.pdf”.

If the proposed study involves animals, a summary describing the animal research that will be conducted must be included in the application. Consult the ARRIVE guidelines

2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The Animal Research Plan may not be an exact replica of the protocol(s) submitted to the Institutional Animal Care and Use Committee (IACUC). The Animal Research Plan should address the following points to achieve reproducible and rigorous results for each proposed animal study:

− Briefly describe the research objective(s) of the animal study. Explain how and why the animal species, strain, and model(s) being used can address the scientific objectives and, where appropriate, the study’s relevance to human biology.

− Summarize the procedures to be conducted. Describe how the study will be controlled.

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

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

https://cdmrp.health.mil/prp/panels/PRP%20FY26%20Programmatic%20Panel%20List.pdf

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

FY26 Parkinson’s Early Investigator Research Award 16

− Describe how data will be handled, including rules for stopping data collection, criteria for inclusion and exclusion of data, how outliers will be defined and handled, statistical methods for data analysis, and identification of the primary endpoint(s).

○ Attachment 11: Human Subjects/Samples Acquisition and Safety Procedures (only required if clinical research is proposed, no page limit): Upload as “HumProc.pdf”.

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

− Describe the rationale for the proposed clinical research. Describe the endpoints to be measured and outline the proposed methodology in sufficient detail to show a clear course of action and justification. Outline what measures will be used to minimize bias, including blinding and randomization procedures. Describe any other measures taken to reduce bias. Include a description of controls, as appropriate.

Outline the timing and procedures planned during the follow-up period, as appropriate.

− If the proposed clinical research was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source of prior funding. Specifically, clearly articulate the portions of the clinical trial supported by this award.

– 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.

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.

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/Program.htm#:%7E:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report 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

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

FY26 Parkinson’s Early Investigator Research Award 17

– 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.

– Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Specify the approximate number of human subjects to be enrolled. Include a power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study and all proposed correlative studies. If a subpopulation of a recruited sample population will be used for analysis, complete a statistical analysis to ensure appropriate power can be achieved within the subpopulation study.

– Timeline: State how many months into the award the anticipated clinical research would be initiated, taking into account any needed regulatory approvals (IRB and DOD Office of Human Research Oversight [OHRO, previously Human Research…