HT942526PRPIIRA_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

Investigator-Initiated Research Award

Funding Opportunity Number: HT942526PRPIIRA

Pre-Application Due: October 23, 2026

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

FY26 Parkinson’s Investigator-Initiated Research Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Investigator-Initiated Research Award; provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

FY26 Parkinson’s Investigator-Initiated Research Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

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

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

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

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

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

FY26 Parkinson’s Investigator-Initiated Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Parkinson’s Research Program (PRP) Investigator- Initiated Research Award (IIRA) supports highly rigorous, multidisciplinary, high-impact research projects that have the potential to make an important contribution to Parkinson’s disease research. Research must address at least one of the four FY26 PRP Focus Areas.

Distinctive Features:

• Partnering Principal Investigator (PI) Option: Allows for more than one PI. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI(s) will be identified as Partnering PI(s), with a maximum of two Partnering PIs.

• Preliminary data are required.

• Clinical trials are allowed.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $10M to fund approximately five Investigator-Initiated Research Award applications with total cost caps of $2M per award. The maximum period of performance is 3 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

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526PRPIIRA

Assistance Listing Number: 12.420

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

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FY26 Parkinson’s Investigator-Initiated 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

Independent investigators at all academic levels, or equivalent, affiliated with an eligible organization are eligible to be named PI, Initiating PI, or Partnering PI on the application, regardless of ethnicity, nationality or citizenship status.

Each investigator may be named to no more than two PRP IIRA applications as either the Initiating PI or Partnering PI.

The PRP IIRA requires that the Initiating PI dedicate at least 15% of their full-time professional effort to each IIRA during the award period.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

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

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

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the 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

To meet the intent of the funding opportunity, 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

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– Pain

– 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:

○ Biologicals

○ Pharmacological

○ Non-pharmacological

○ Surgical

○ Non-surgical devices

○ Non-invasive central nervous system stimulation

3.2. Intent of the Investigator-Initiated Research Award

The PRP Investigator-Initiated Research Award (IIRA) supports highly rigorous, multidisciplinary, high-impact research projects that have the potential to make an important contribution to Parkinson’s research. This award mechanism supports the full spectrum of research from basic science through clinical trials.

3.2.1. Key Elements for the IIRA

• 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 to support feasibility are required. Any unpublished preliminary data provided should originate from the laboratory of the PI or member(s) of the research team.

The preliminary data must support the feasibility of the study.

Clinical trials may be supported by this award mechanism and require the submission of Attachment 11, Clinical Trial Strategy.

• 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.

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

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• Principal Investigator and Research Team: The PRP seeks applications from investigators working across a broad spectrum of disciplines including, but not limited to, basic science, engineering, bioinformatics, population science, translational research, and clinical research. The application should demonstrate that the research team’s background is appropriate to successfully achieve the proposed specific aims and advance the PD field.

The PRP IIRA requires that the Initiating PI dedicate at least 15% of their full-time professional effort to this award during the award period.

• Partnering PI Option: The IIRA includes an option for more than one PI. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI(s) will be identified as a Partnering PI(s). All PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section 5.3, Submission Instructions.

3.2.2. Other Important Considerations for the IIRA

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, clinical research involving human subjects, secondary use of human data, and/or use of human anatomical substances are allowed within this funding opportunity.

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

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

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 3 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $2M.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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FY26 Parkinson’s Investigator-Initiated Research Award 9

For Partnering PI Option (PPIO) applications, the combined total costs (partnering and initiating direct and indirect costs) budgeted for the entire period of performance in the applications of the Initiating PI and each Partnering PI should not exceed $2M.

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.

For PPIO applications, a separate award will be made to each PI’s organization.

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

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

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

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

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

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one PI 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 IIRA.

Must not be requested for:

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

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FY26 Parkinson’s Investigator-Initiated 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

The Initiating PI must submit the following pre-application components.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted. Include the FY26 PRP Focus Area(s) under which the application will be submitted.

4.3. Full Application Components

Partnering PI Option: The CDMRP requires separate full application package submissions for the Initiating PI and each Partnering PI, even if the PIs are located within the same organization.

The application submission process for each Partnering PI uses an abbreviated full application package.

4.3.1. Full Application Components for the PI or Initiating PI

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

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

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

(b) Attachments:

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

○ Attachment 1: Project Narrative (12-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background: 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 data to support the proposed research project https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~: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:~: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:~: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:~: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 Investigator-Initiated Research Award 11 is required. Any preliminary data provided should originate from the laboratory of the PI(s) or a member(s) of the research team.

– Hypothesis or Objective: State the hypothesis to be tested or the objective to be reached. State concisely the 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 aims 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, 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 or clinical trial:

▪ 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.

▪ If funds for clinical research are requested, further details of research involving human subjects or human biological substances will be required in Attachment 10: Human Subjects/Samples Acquisition and Safety Procedures, as applicable.

▪ If funds for a clinical trial are requested, further details regarding the Clinical Trial Strategy must be described in Attachment 11: Clinical Trial Strategy.

Only those proposed studies measuring safety, effectiveness, and/or efficacy of an intervention are considered clinical trials and should submit a Clinical Strategy Statement.

▪ 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 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 10:

Human Subjects/Samples Acquisition and Safety Procedures and/or Attachment 11: Clinical Trial Strategy, as applicable.

▪ If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

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FY26 Parkinson’s Investigator-Initiated Research Award 12 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 analysis plan for the resulting outcomes. If applicable, include a complete power analysis to demonstrate 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. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

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

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~: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:~: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:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Parkinson’s Investigator-Initiated 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#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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FY26 Parkinson’s Investigator-Initiated 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 or Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work. Include milestones for data or research resource(s) sharing.

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

○ 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: Research Team Statement (one-page limit): Upload as “Team.pdf”.

Discuss the qualifications of the research team and each individual’s specific contributions to the project, including how the appropriate expertise is incorporated to address the research question and enable the success of the proposed project.

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

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FY26 Parkinson’s Investigator-Initiated Research Award 15

Discuss how the PI’s and other key personnel’s experience, expertise, and record of accomplishment demonstrate their ability to successfully complete the proposed research project.

Explain how the levels of effort by the PI and other key personnel are appropriate to ensuring success of the proposed research project. Clearly state if the PI is not receiving salary from the award but providing the required 15% dedication of full-time professional effort.

Describe plans for communication, decision-making, allocation of resources, coordination of research progress and results, and sharing of data among key personnel and organizations participating in the project. For multi-institutional studies, provide an organizational chart that identifies key members of the study team and provides an outline of the governing structure.

For applications proposing a clinical trial, describe the composition of the clinical trial team. Provide details on how the team (including investigators, study coordinator, biostatistician) possesses the appropriate expertise in PD and in conducting clinical trials.

Partnering PI Option (if applicable):

− Describe how the partners’ combined experience will better address the research question and explain why the work should be done together rather than through separate efforts.

○ Attachment 8: Post-Award Transition Plan (three-page limit): Upload as “Transition.pdf”. Describe/discuss the methods and strategies proposed to move the anticipated research outcome (e.g., intervention, product, methodology, finding) to the next phase of development (e.g., clinical trials, commercialization, and/or delivery to the civilian or military market) after successful completion of the award. Applicants are encouraged to work with their organization’s Technology Transfer Office (or equivalent) to develop the transition plan. Applicants are encouraged to explore developing relationships with industry and/or other funding agencies to facilitate moving the product into the next phase of development. The Post-Award Transition Plan should include the components listed below:

– The project’s anticipated research outcomes, including knowledge products, clinical products for development, etc.

– A description of the necessary next logical steps to advance the research outcome to clinical implementation.

– A timeline with defined milestones and deliverables describing the expected post-award progress of the research outcome. This timeline should include the necessary next steps to move the research outcome to the next phase of development and eventual clinical implementation.

– A description of collaborations and other resources that are in place or will be established to execute the next steps to advance the research outcome to the next phase of development and eventual clinical implementation (e.g., clinical partners, commercial partners, manufacturing partners, clinical practice guideline development/execution committees, training providers/resources).

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FY26 Parkinson’s Investigator-Initiated Research Award 16

– Details of the funding strategy to transition to the next level of investigation, development, and/or commercialization. This may include commercial sponsorship, venture capital, federal or non-federal funding opportunities, etc.

– An assessment of the opportunities available and potential barriers that would impact the progress of commercializing and/or translating the research outcome into clinical practice.

o Attachment 9: 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.

− 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 10: 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.

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

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FY26 Parkinson’s Investigator-Initiated Research Award 17

– 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.

– 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.