HT942526ARPCDA_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

Autism Research Program

Career Development Award

Funding Opportunity Number: HT942526ARPCDA

Pre-Application Due: July 27, 2026

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

FY26 Autism Career Development 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 Career Development 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 Career Development 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 Career Development Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Autism Research Program (ARP) Career Development Award supports early-career, independent investigators and/or the transition of established investigators from other research fields to conduct innovative, high-impact ideas or early-phase, proof-of-principle clinical trials with the potential to have a major impact on autism.

Distinctive Features: Applications are strongly encouraged to address one of the FY26 ARP Career Development Award Areas of Interest or provide justification that the proposed research addresses a critical problem, question, or need in autism.

FY26 Career Development Award submissions with a pilot clinical trial component are required to include community collaborations to optimize research impact. Applications are expected to name at least one community partner (e.g., an Autistic individual or caregiver, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $1.5 million (M) to fund approximately two Career Development Award applications with total cost caps of $0.75M 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 (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: HT942526ARPCDA

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 PI on the application, regardless of ethnicity, nationality or citizenship status.

• The investigator named by the organization as the PI on the application may select one of the following eligibility categories. These eligibility criteria are applicable as of the application submission deadline:

○ An independent investigator at or below the level of Assistant Professor or equivalent; or

○ An established independent investigator in an area other than autism at or above the level of Assistant Professor seeking to transition to a career in autism, thereby bringing their expertise to the field.

• In addition, the PI must:

○ Not have received a Career Development Award (or equivalent) previously from any program within the CDMRP or any other federal funding agency.

○ Not have received more than $250,000 in total direct costs for previous or concurrent autism research as a PI of one or more federally or privately funded, non-mentored, peer-reviewed grants.

○ Must hold a Ph.D., M.D., M.D./Ph.D., or equivalent at time of pre-application submission.

○ Not be a graduate student, postdoctoral fellow, or other “mentored” researcher.

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 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 $164.4M. 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 Career Development Award mechanism was first offered in FY21. Since then, 82 Career Development Award applications were received, and 16 were recommended for funding.

3.2. Intent of the Career Development Award

The Career Development Award (CDA) supports early-career, independent investigators and/or the transition of established investigators from other research fields to conduct innovative, high-impact ideas or early-phase, proof-of-principle clinical trials with the potential to have a major impact on autism.

3.2.1. Areas of Interest for the CDA

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 Career Development Award areas of interest:

• Assessment of novel therapeutics using valid preclinical models

• 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

• 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)

• Environmental risk factors

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

• Factors promoting success in key transitions of Autistic individuals over their lifespan

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• Improve diagnosis and access to services across the lifespan

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

• Long-term treatment outcomes from previous clinical trials for the core symptoms of autism or to alleviate co-occurring conditions

• Mechanistic studies focused on:

○ Heterogeneous clinical expression of autism

○ Underlying conditions co-occurring with autism (e.g., pain, sleep disturbances, gastrointestinal issues, inflammation, aggression, depression, anxiety, attention deficit and seizures)

○ Sex differences in autism (i.e., prevalence, biological mechanisms, phenotypic expression, core and comorbid syndrome expression and outcomes, developmental trajectories, diagnosis and treatment response)

• 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 CDA

• Impact: The proposed research is expected to make an important and original contribution to advancing the understanding of autism and ultimately lead to improved outcomes for Autistic individuals and their families/caregivers. The project’s impact on both autism research and autism care should be clearly articulated. A statistical plan is an important aspect of the FY26 ARP Career Development Award to demonstrate the significance of any research outcomes or findings.

• Preliminary Data: Although the proposed research must have direct relevance to autism, the required preliminary data, which may include unpublished results from the laboratory of the PI(s), research team, or collaborators named on the application, may be from outside the autism research field. Research should also be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.

• Personnel: The FY26 ARP seeks applications from investigators in the early stages of their autism career. The FY26 ARP Career Development Award is designed to support the continued development of promising independent investigators that are early in their faculty

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FY26 Autism Career Development Award 8 appointments or the transition of established investigators from other research fields into a career in the field of autism research. Applicants are strongly encouraged to strengthen their applications through collaboration with investigators experienced in autism research and/or possessing other relevant expertise as demonstrated by a record of funding and publications.

3.2.3. Other Important Considerations for the CDA

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

Clinical trials are allowed within this funding opportunity.

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

FY26 Career Development Award submissions with a pilot clinical trial component 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 Career Development Award are expected to name at least one community partner (e.g., an 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 11, Community Collaboration Plan).

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 $750,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://cdmrp.health.mil/#:~:text=Human%20Subject%20Research%20Resource 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.

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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FY26 Autism Career Development Award 9 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 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 investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the ARP Career Development Award.

• 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

Pre-application submissions must include the following components.

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

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

The Preproposal Narrative should include the following:

○ Principal Investigator: Describe the PI’s potential for a career at the forefront of autism research, including qualifications and achievements that make the PI an ideal candidate for this award. Describe the PI’s career goals as an autism researcher and how the proposed research experience will advance their career.

○ Research Idea: State the hypothesis to be tested or the objective(s) to be reached.

State the FY26 ARP Career Development Award Areas of Interest that will be addressed. If the proposed project does not address one of the Career Development Award areas of interest, provide justification that the proposed research addresses a critical problem, question, or need in autism. Detail the ideas and reasoning on which the proposed project is based. Concisely state the specific aims and provide a brief overview of the study design and details of the methods to be used. If the proposed research includes a clinical trial, briefly state the clinical intervention, subject population(s), and phase of the clinical trial.

○ Impact: Describe the potential impact, both short- and long-term, of this study on the outcomes of Autistic individuals, their families/caregivers, and/or the understanding of autism.

• 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 https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES 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

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FY26 Autism Career Development Award 11 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.

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 (page limits vary, as shown below): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Page Limit: Page limits vary:

▪ Projects without a clinical trial: Eight-page limit

▪ Projects with a clinical trial component: 15-page limit

Describe the proposed project in detail using one of the two outlines below, depending on whether or not a clinical trial is proposed. The inclusion of preliminary data relevant to the proposed project, but not necessarily derived from autism studies, is required.

Outline for projects without a clinical trial:

– Background: Present the scientific rationale behind the proposed research; include relevant literature citations. Describe and show the preliminary data to justify the rationale for the proposed project.

– Hypothesis(es) and/or Objective(s): State the hypotheses/study questions to be tested and overall objective(s) to be reached. Describe how the project addresses one or more of the FY26 ARP Career Development Award Areas of Interest or a critical problem or question in autism.

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

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#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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– Research Strategy: Describe the experimental design, methods, and analyses, with appropriate controls, in sufficient detail for assessment. Address potential limitations and present alternative methods and approaches. If animal studies are proposed, the applicant is required to submit an Animal Research Plan (Attachment 10). If human subjects or human biological samples will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples. Where relevant, describe the availability of and access to tissue, data, or human subjects.

– Statistical Plan: Clearly describe the statistical plan and the rationale for the statistical methodology as well as an appropriate power analysis. Describe in detail how the statistical plan is appropriate for the experimental methodology being used.

If applicable, describe how the human subject population is appropriate for the study and provide assurance that there is clear access to the designated population.

Inclusion of a biostatistician in the study team is encouraged.

– Principal Investigator: Describe the PI’s potential for a career at the forefront of autism research, including qualifications and achievements that make the PI an ideal candidate for this award. Describe the PI’s plan for continued development as an autism researcher and/or clinician (early-stage investigator) and/or the transition into a career in the field of autism research (established investigator) and how the proposed research experience will advance their career. Discuss the appropriateness of the level of effort of the PI for successful conduct of the proposed research.

Outline for projects with a clinical trial component:

Note: The Project Narrative is NOT the formal clinical trial protocol. Instead, all elements of the proposed clinical trial necessary for peer review must be described as indicated below.

– Background: Present the scientific rationale behind the proposed research and include relevant literature citations. Describe and show the preliminary data and/or laboratory and/or preclinical evidence to justify the rationale for the proposed project.

– Hypothesis(es) and/or Objective(s): State the hypotheses/study questions to be tested and overall objective(s) to be reached. Describe how the project addresses one or more of the FY26 ARP Career Development Award Areas of Interest or another critical problem or question in autism.

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

– Research Strategy: Describe the experimental design, methods, and analyses, including appropriate controls, in sufficient detail for assessment. Provide a well-developed, well-integrated research strategy that supports the translational feasibility and promise of the approach. Address potential problems and present alternatives.

– Clinical Strategy: Describe the following under separate subheadings:

▪ Type of clinical trial: Describe the type of clinical trial to be performed (e.g., prospective, randomized, controlled) and outline the proposed methodology in sufficient detail to show a clear course of action. Note whether the intervention is already in use.

▪ Challenges and alternative strategies: Describe potential challenges and alternative strategies where appropriate.

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▪ Scope of the trial: Outline the scope of the trial to be performed and the intervention to be tested.

▪ Study variables: Define the study variables; outline why they were chosen; and describe how they will be measured. Include a description of appropriate controls and the endpoints to be tested.

▪ Access to study population, recruitment plans, and inclusion/exclusion criteria: Indicate the access to the study population, recruitment plans, and inclusion/exclusion criteria. Describe how the human subject population is appropriate for the study and whether there is clear access to the designated population. Specify the number of human subjects to be enrolled. If multiple study sites are involved, state the approximate number to be enrolled at each site.

▪ Consent: Describe the informed consent process, including safeguards for vulnerable populations. If minors or other populations that cannot provide informed consent are included in the proposed clinical trial, describe the plan to obtain assent (agreement) from those with capacity to provide it, or a justification for a waiver of assent. Appendix 6 of the GAI contains additional considerations unique to DOW-sponsored research.

▪ Risks/Benefits Assessment:

❖ Foreseeable risks: Clearly identify all study risks, including potential safety concerns and adverse events. Address special precautions to be taken by the human subjects before, during, and after the study. If applicable, identify any potential risk to the study personnel.

❖ Risk management and emergency response: Appropriate to the study’s level of risk, describe how safety monitoring and reporting to the Institutional Review Board (IRB) and Regulatory Agency (if applicable) will be managed and conducted. Describe all safety measures to minimize and/or eliminate risks to human subjects and study personnel or to manage unpreventable risks. Discuss the overall plan for provision of emergency care or treatment for an adverse event for study-related injuries, including who will be responsible for the costs of such care.

❖ Potential benefits: Describe known and potential benefits of the study to the participants enrolled and others that may benefit. Articulate the importance of the knowledge to be gained as a result of the proposed research. Discuss why the potential risks are reasonable in relation to the anticipated benefits.

▪ Data Privacy and Reporting Plan: Explain the measures taken to protect the privacy of human subjects and maintain the confidentiality of study data.

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.

– Statistical Plan: Clearly describe the statistical plan and the rationale for the statistical methodology as well as an appropriate power analysis. Describe how the statistical plan is appropriate for the methodology being used. Describe how the human subject population is appropriate for the study and provide assurance that there is clear access to the designated population. Inclusion of a biostatistician in the study team is encouraged.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Research_Protections_Review_Reqs

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FY26 Autism Career Development Award 14

– Principal Investigator: Describe the PI’s potential for a career at the forefront of autism research, including qualifications and achievements that make the PI an ideal candidate for this award. Describe the PI’s plan for continued development as an autism researcher and/or clinician (early-stage investigator) and/or the transition into a career in the field of autism research (established investigator) and how the proposed research experience will advance their career. Discuss the appropriateness of the level of effort of the PI for successful conduct of the proposed research.

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 data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the GAI, Appendix 4, for additional considerations.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource 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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Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Autism Career Development Award 15

Sex as a Biological Variable (SABV) 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 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.

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

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

Do not submit a copy of the National Institutes of Health (NIH) Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

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

Write the technical abstract using the outline below. 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: Summarize how the proposed project is relevant to and will have an impact on the outcomes of Autistic individuals, their families/caregivers, and/or the 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 Autism Career Development Award 16 understanding of autism. Describe the impact on the specified population, if applicable.

Career Development: Describe how the award will provide the PI with the opportunity to effectively advance an independent career in autism research.

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.

– State the FY26 ARP Career Development Award Area(s) of Interest or another critical problem, question, or need in autism addressed by the project.

– Describe the ultimate applicability of the research.

▪ Who will it help and how will it help them?

▪ What are the potential clinical applications, benefits, and risks? If the research is too basic for clinical applicability, describe the interim outcomes expected and their applicability to the field.

▪ What is the projected time anticipated to achieve a clinically relevant outcome?

▪ What are the likely contributions of this study to advancing the field of autism research and ultimately leading to improved outcomes for Autistic individuals and the well-being of their families/caregivers?

– How is the project relevant to military Service Members, Veterans and their Families?

– Describe the PI’s career goals in autism research.

▪ How will the award advance the PI’s career in autism research?

▪ How do the research and career development plan support autism research in attaining these goals?

○ 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 either the Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work or Example: Assembling a Generic Statement of Work, whichever is most appropriate for the proposed effort. Include milestones for data or research resource(s) sharing.

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

Describe how the proposed research is relevant to autism now. Detail the anticipated outcome(s)/product(s) and/or improved understanding of autism that will be directly attributed to the results of the proposed research project (near-term impact). Explain the anticipated long-term impact from the proposed research project, including details on how this work will have a real-world impact on the autism community. If applicable, compare the anticipated outcomes from the proposed project to currently available autism information, products or treatments. If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format 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/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/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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Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Autism Career Development Award 17

If a clinical trial component is proposed, explain how the aims of the project will have a significant clinical impact on Autistic individuals. Describe how the long-term benefits for implementation of the intervention may impact patient care and/or quality of life.

Describe how well the project will translate promising, well-founded research findings into a larger clinical trial for a novel autism intervention.

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

Provide a letter, signed by the PI and the department chair, dean, or equivalent official, verifying that the eligibility requirements will be met by the application submission deadline. The letter should verify that the PI holds a Ph.D., M.D., M.D./Ph.D., or equivalent; that the PI is an independent investigator at or below the level of Assistant Professor, Instructor (or equivalent) or an established independent investigator in an area other than autism who is at or above the level of Assistant Professor and is seeking to transition to a career in autism, thereby bringing their expertise to the field; that the PI has not received more than $300,000 in total direct costs for previous or concurrent autism research as a PI of one or more federally or privately funded, non-mentored peer-reviewed grants; and that the PI has not received a Career Development Award previously from any program within the CDMRP (refer to Section 2.1.2, Principal Investigator for eligibility information).

Note: Graduate students, postdoctoral fellows, or other “mentored” researchers are not eligible for the FY26 Career Development Award.

○ Attachment 8: Research Outcomes Plan (one-page limit): Upload as “Outcomes.pdf”. Describe the anticipated research outcomes, including knowledge products, clinical products for development, etc. Describe the methods and strategies proposed to move the anticipated research outcomes to the next phase of development or clinical application after successful completion of the project. Detail the funding strategy to transition to the next level of investigation, development and/or commercialization (e.g., partners, applications for internal/external funding opportunities).

○ Attachment 9: Inclusion Enrollment Report (only applicable and required for applications proposing clinical research studies): Upload as “Enrollment.pdf”.

Provide an anticipated enrollment table(s) for the inclusion of women…