This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Autism Research Program

Clinical Trial Award

Funding Opportunity Number: HT942526ARPCTA

Pre-Application Due: July 27, 2026

Application Due: October 22, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Autism Clinical Trial 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 Clinical Trial 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 Autism Clinical Trial 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 Autism Clinical Trial Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Autism Research Program (ARP) Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of autism. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

Distinctive Features: Applications are strongly encouraged to address one of the FY26 ARP Clinical Trial Award Areas of Interest.

Partnering Principal Investigator (PI) Option for Early-Career Investigator: The FY26 Clinical Trial Award mechanism is offering a higher level of funding for applications that propose to partner an experienced PI (i.e., Initiating PI) with an Early-Career Investigator (i.e., Partnering PI) wishing to pursue a career in autism clinical trial research.

FY26 Clinical Trial Award submissions are required to include community collaborations to optimize research impact. Research teams are therefore required to establish and utilize effective and equitable collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research. Applications to the FY26 ARP Clinical Trial Award are expected to name at least one community partner (e.g., Autistic individual or caregiver, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings (see Attachment 12, Community Collaboration Plan).

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $3.25 million (M) to fund approximately one Clinical Trial Award with a total cost cap of $1.50M and one Clinical Trial Award - Partnering PI Option for Early Career Investigator application with a total cost cap of $1.75M. The maximum period of performance is 4 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 (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 27, 2026

• Invitation to Submit an Application: August 28, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 22, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 27, 2026

• Peer Review: December 2026

• Programmatic Review: February 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526ARPCTA

Assistance Listing Number: 12.420

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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named as PI on the application, regardless of ethnicity, nationality or citizenship status

For application submissions under the Single Principal Investigator Option: Investigators must be at or above the level of Assistant Professor (or equivalent) to be named by the organization as the PI on the application.

Industry titles may not be analogous to a faculty hierarchy in academia. For industry, investigators at or above an independent scientist level may be named by the organization as the PI on the application.

For application submissions under the Partnering PI Option for Early-Career Investigator:

• The Initiating PI (Mentor) named by the organization as the PI on the application must be at or above the level of Assistant Professor (or equivalent).

• By the full application submission date, the Partnering PI (Early-Career Investigator) must:

○ Be in a current postdoctoral training position or have completed postdoctoral training.

○ Be no more than seven years from the receipt of a terminal degree (excluding time spent in residency or on family medical leave). Lapses in research time or appointments as denoted in the biographical sketch may be articulated in the application.

• The Partnering PI (Early-Career Investigator) must contribute at least 50% effort for the proposed research that would be supported by this award.

It is not required that the Partnering PI (Early-Career Investigator) and the Initiating PI (Mentor) be located at the same institution.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the General Application Guidelines (GAI) for additional recipient qualification requirements.

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Autism Research Program (ARP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the ARP in 2007 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the ARP from FY07 through FY24 totaled $164.4 M. The FY26 appropriation is $8.0M.

The ARP’s vision is to improve the lives of individuals with autism and their families, now and in their future.

Research funded by the FY26 ARP should be responsive to the needs of people with autism, their families and/or caregivers. Researchers are therefore encouraged to establish and utilize effective collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research.

3.1. Award History

The ARP Clinical Trial Award mechanism was first offered in FY09. Since then, 189 Clinical Trial Award applications were received, and 32 were recommended for funding.

3.2. Intent of the Clinical Trial Award

The ARP Clinical Trial Award supports the rapid execution and analysis of clinical trials with the potential to have a significant impact on the treatment or management of autism. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs, biologics or medical devices), clinical guidance and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (i.e., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

3.2.1. Areas of Interest for the CTA

To meet the intent of the funding opportunity the ARP encourages applications that address critical needs of the autism community in one or more of the FY26 ARP Clinical Trial Award Areas of Interest:

• Create tools and strategies to increase the speed of the dissemination/implementation of evidence-based practices and interventions in community-based settings

• Determinates of diagnosis, treatment efficacy and service delivery

• Factors impacting quality of life for current and former military families

• Health care provider-focused training or tools to improve health care delivery for Autistic individuals across the lifespan and the continuum of care (i.e., primary care, urgent/emergent care and disaster relief)

• Improve diagnosis and access to services across the lifespan

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FY26 Autism Clinical Trial Award 7

• Interventions to support Autistic individuals and their families, including key transitions into adulthood and across their lifespan

• Mental health issues (such as grief, masking, suicide risk, trauma, etc.) or disorders in Autistic individuals

• Non-pharmacological therapies for the core symptoms of autism or to alleviate co-occurring conditions (including pain, sleeping, eating)

• Pharmacological, genetic, and other biological treatments for the core symptoms of autism or to alleviate co-occurring conditions

• (New for FY26) Physical health, mental health, and related quality-of-life issues in aging Autistic adults

• (New for FY26) Sexual health, sexual education, and reproductive health for Autistic individuals

• Uncovering new advances using a strength-based model

• Understanding heterogeneity in treatment response, including identification of psychosocial or biological factors that (1) impact treatment outcomes or (2) can be used to prospectively identify treatments that are most likely to benefit particular subgroups of individuals

3.2.2. Key Elements for the CTA

Partnering PI Option for Early-Career Investigator: The FY26 Clinical Trial Award mechanism includes an option for a higher level of funding for applications that propose to partner an experienced PI (i.e., Initiating PI) with an Early-Career Investigator (i.e., Partnering PI) wishing to pursue a career in autism clinical trial research. The Initiating PI on the Clinical Trial Award must mentor the Early-Career Investigator (Partnering PI) to promote their career development in clinical trial research. The Early-Career Investigator must meet specific eligibility criteria as described in Section 2. Eligibility Information. The Initiating PI will be responsible for the majority of the administrative tasks associated with application submission. The Initiating and Partnering PIs each have different submission requirements, as described in Section 5.3, Submission Instructions; however, both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. 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.

When developing applications to the ARP Clinical Trial Award mechanism, the ARP strongly encourages applicants to provide sufficient evidence to demonstrate the following key considerations.

• Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency.

• Impact: The proposed intervention(s) to be tested should offer significant potential impact for Autistic individuals.

• Preliminary Data Are Required: Inclusion of preliminary data relevant to the proposed clinical trial is required.

• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The

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FY26 Autism Clinical Trial Award 8 application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, sex, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

• Intervention Availability: The application should demonstrate the documented availability of and access to the drug/compound, device and/or other materials needed, as appropriate, for the proposed duration of the study.

• Personnel and Environment: The application should demonstrate the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of U.S. Food and Drug Administration (FDA) processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local IRB of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities

• Statistical Analysis and Data Analysis: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data.

• The application should include a transition plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the FY26 ARP Clinical Trial Award.

3.2.3. Other Important Considerations for the CTA

Funding from this award mechanism must support a clinical trial. Preclinical research is not supported in this funding opportunity.

FY26 Clinical Trial Award submissions are required to include community collaborations to optimize research impact (see Attachment 12, Community Collaboration Plan).

Applicants seeking funding for research that does not meet the definition of a clinical trial should consider other FY26 ARP funding opportunities that may be more appropriate for such research.

An informational resource for preparing an application, the Human Subject Research Resource, is available on the CDMRP website.

The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency. Unless otherwise noted, for the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any equivalent international Regulatory Agency.

If an Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or equivalent, is required, a regulatory application must be submitted to the relevant Regulatory Agency by the Clinical Trial Award application submission deadline. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial.

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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 4 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.5M for a Single PI and $1.75M for the Partnering PI Option for Early-Career Investigator. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

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

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.

Any application that requests the higher level of funding and that does not include a collaborative PI will have its budget reduced as appropriate.

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

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Travel between collaborating organizations.

• Costs for two investigators to travel to two scientific/technical meetings per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the ARP Clinical Trial Award.

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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost

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• Research subject compensation and reimbursement for trial-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to enable participation).

Must not be requested for:

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

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4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

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

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

• Preproposal Narrative (three-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Research Idea: Concisely state the project’s objective and specific aims. State the FY26 ARP Clinical Trial Award Area(s) of Interest to be studied. If the proposed clinical trial does not address a Clinical Trial Award area of interest, provide justification that the proposed clinical trial addresses another important problem with respect to Autistic individuals. Briefly describe the proposed project and the population(s) that will be enrolled in the study. Briefly describe the preliminary data and rationale including literature references supporting the proposed clinical trial. Identify the population, access to the population, recruitment goals, including a brief description of the statistical plan.

State how this project meets the vision of the ARP.

○ Intervention: Describe the intervention to be tested, the outcome measures, participant inclusion and exclusion criteria, and how it is applicable to the study population.

Describe the feasibility in utilizing the intervention, any potential risks, and how the potential benefits outweigh the risks of the intervention to be tested.

○ Clinical Impact: Describe the potential impact of this study on the outcomes of Autistic individuals and, if applicable, their families/caregivers.

○ Personnel: State how the background, clinical trial experience, and autism expertise of the clinical team are appropriate to accomplish the proposed trial (e.g., statistical expertise, expertise in autism research and clinical studies).

○ Partnering PI Option for Early-Career Investigator (if applicable): Describe how the Initiating PI (Mentor) is positioned to provide the Partnering PI (Early-Career Investigator) with mentorship toward a successful career in autism clinical trial research.

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Briefly describe the researcher development plan and how it will contribute to fostering the Partnering PI’s career development as an autism clinical trial researcher.

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

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

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

4.3. Full Application Components

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

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

4.3.1. Full Application Components for the PI or Initiating PI

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

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

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

(b) Attachments:

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

○ Attachment 1: Project Narrative (20-page limit): Upload as “ProjectNarrative.pdf”.

○ The page limit of the Project Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs (uniform resource locators) that provide additional information that expands the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the application.

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The Project Narrative is NOT the formal clinical trial protocol. Instead, all essential elements of the proposed clinical trial necessary for scientific review must be included as directed in Attachment 1 (the Project Narrative) and Attachments 6-10 described below. Failure to submit these attachments as part of the application package will result in rejection of the entire application.

Describe the proposed project in detail using the outline below. It should be clear from this description that the proposed study meets the definition of a clinical trial.

– Background: Describe in detail the scientific rationale for the study. Provide a review and analysis of the available literature and completed/ongoing studies relevant to the proposed clinical trial.

▪ Describe the preliminary studies and/or preclinical data that support the proposed clinical trial.

▪ Summarize key preclinical pharmacological findings, dosage studies, and other clinical studies (if applicable) that examine the safety and stability (as appropriate) of the intervention.

▪ Provide a summary of other relevant ongoing, planned, or completed clinical trials and describe how the proposed study differs.

If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source(s) of prior funding. Identify the specific portions of the study that will be supported with funds from this award.

– Objectives, Specific Aims and Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in the proposed clinical trial and detail the specific aims that will address the hypothesis/research question.

– Study Design: Describe the proposed clinical trial in sufficient detail to evaluate its appropriateness and feasibility, relating to both the scientific success of the study and setting reasonable expectations for what study participants will experience.

▪ Describe the type of study to be performed. Outline the proposed clinical trial methodology and study variables in sufficient detail to demonstrate a clear course of action and justification. Describe the interaction with the human subject, including the study intervention that they will experience, and include the dose and administration route. Provide sufficient detail in chronological order for a person uninvolved in the study to understand what the study participant will experience. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ Provide a schedule (e.g., flowchart or diagram) of study intervention(s), evaluation(s), and follow-up procedures, including, if applicable, the biospecimen that will be collected along with the collection schedule and amount. Describe measures to ensure consistency of dosing (e.g., active ingredients for nutritional supplements, rehabilitation interventions). Define each arm/study group of the proposed trial, if applicable, and describe how group assignment will occur.

Include a description of controls, as appropriate. Specify the approximate number of study participants to be enrolled. Indicate whether subjects, clinicians, data analysts, and/or others will be blinded during the study. Describe any other measures to be taken to reduce bias.

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

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

FY26 Autism Clinical Trial Award 14

▪ Define all endpoints/outcome measures relevant to the objectives of the study, explain why they were chosen, and describe how, when, and where they will be measured. Include all evaluations that will be made for study purposes. If questionnaires or other research data collection instruments will be used, include a copy of them within Attachment 6: Intervention. Describe the reliability and validity of the selected endpoint/outcome measure and evaluation, along with the applicable quality standards. Explain how the results of evaluations and/or data collection instruments will be used to meet the objectives of the study (or to monitor safety of human subjects).

▪ Briefly describe the study population and the inclusion and exclusion criteria that will be used to meet the needs of the proposed clinical trial. Additional details should be provided in Attachment 7: Study Population Recruitment and Safety Plan.

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

▪ Include a complete power analysis to demonstrate that the proposed clinical trial’s anticipated sample size is appropriate to meet the objectives of the study.

Describe all clinical and statistical justifications and assumptions that support the sample size calculations. Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

Pitfalls and Mitigation Strategy: Describe potential challenges and discuss alternative methods/approaches that may be employed to overcome them.

○ 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

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

FY26 Autism Clinical Trial Award 15

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 for the duration of the proposed clinical trial. 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.

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 trial participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed clinical trial 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.

Commercial Entity Letters of Commitment (if applicable): If the proposed study involves use of a commercially produced investigational drug, device, or biologic, provide a letter of commitment from the commercial entity indicating the availability of the product for the duration of the proposed clinical trial, support for the proposed phase of research, and support for the indication to be tested.

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

The following supporting documents are required only for application submissions under the Partnering PI Option for Early-Career Investigator:

Early-Career Investigator Statement (one page recommended):

The Early-Career Investigator Statement is expected to be written by the Partnering PI (Early-Career Investigator) while also showing evidence of appropriate direction from the Initiating PI, who will serve as the Mentor for this project.

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

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

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

FY26 Autism Clinical Trial Award 16

▪ The Early-Career Investigator should describe their accomplishments (i.e., academic performance, awards, honors, and/or previous publications and funding) and how they are indicative of potential for a successful, productive, independent career in autism clinical trial research.

▪ The Early-Career Investigator should describe their career goals and how the proposed research project and mentored research experience will promote their career development in autism clinical trial research. The Early-Career Investigator should discuss their career/research plans after the completion of this award.

– Researcher Development Plan (if applicable) (two pages recommended):

The Researcher Development Plan is expected to be written by the Initiating PI (Mentor) and articulate the following:

▪ Clearly describe and outline the individualized Researcher Development Plan, including proposed training (e.g., coursework, mentorship) to support the development of the Early-Career Investigator’s clinical trial research skills.

▪ Highlight the unique features of this plan as it pertains specifically to autism clinical trial research.

▪ Clearly articulate a strategy for the Early-Career Investigator to develop the necessary skills, competence, and expertise to pursue a promising career in autism clinical trial research.

▪ Describe the Initiating PI’s experience in autism clinical trial research and mentoring, as demonstrated by a record of active funding, recent publications, and successful mentorship.

▪ Describe how the Initiating PI is positioned to mentor the Early-Career Investigator toward a successful career in autism clinical trial research.

▪ Describe how the Researcher Development Plan is supported by the research environment, including a description of ongoing autism research at the institution(s). Include information on collaborations with other investigators.

▪ Describe the Early-Career Investigator’s role in the proposed research project.

– Partnering PI Option for Early-Career Investigator Letter of Eligibility (if applicable) (one-page limit): Use the Clinical Trial Award Early-Career Investigator Eligibility Statement Template (available for download on the Full Announcement page in Grants.gov and under Funding Opportunities and Forms in eBRAP) signed by the Department Chair, Dean, or equivalent official to verify that the eligibility requirements will be met at the application submission deadline.

Transcripts (if applicable) (no page limit): Include a copy of the Early-Career Investigator’s transcripts from all graduate institutions attended. All foreign-language transcripts must be accompanied by a certified English translation. The government reserves the right to request official transcripts during award negotiations. Diplomas are not acceptable in lieu of academic transcripts. If an institution does not provide academic transcripts (i.e., a record of courses completed, grades and credit hours earned, and indication of completion of degree), complete and include the Academic Statement (available for download on the “Full Announcement” page in Grants.gov) in place of the transcript.

https://grants.gov/

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

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

FY26 Autism Clinical Trial Award 17

○ 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 ideas and rationale behind the proposed clinical trial.

– Hypothesis/Objective(s): State the objective of the proposed clinical trial and the hypothesis/research question to be addressed.

– Specific Aims: State the specific aims of the study.

– Study Design: Briefly describe the study design, including appropriate controls.

– Clinical Impact: Briefly describe how the proposed clinical trial will have a significant impact on the research field and/or treatment or management of autism.

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

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

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

Summarize the objectives and rationale for the proposed clinical trial.

Describe the intervention(s).

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

What are the expected clinical applications, and potential risks of the anticipated outcomes?

Describe the ultimate applicability and impact of the proposed study and the anticipated outcomes to advancing research, patient care and/or quality of life?

State which FY26 ARP Clinical Trial Award Area(s) of Interest will be addressed in the study or provide justification that the trial addresses another important problem or critical issue with respect to Autistic individuals

Describe the potential benefit of the proposed study and the anticipated outcomes to Service Members, Veterans and/or their Families.

○ Attachment 5: Statement of Work (four-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 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 the Partnering PI should be clearly noted for each task.

○ Attachment 6: Intervention (no page limit): Upload as “Intervention.pdf”. The Intervention attachment should include the components listed below.

Description of…