AI-Driven Assistive and Rehabilitation Technologies (P20 Clinical Trial Optional)

AI-Driven Assistive and Rehabilitation Technologies (P20 Clinical Trial Optional) is sponsored by U.S. Department of Health and Human Services; National Institutes of Health. This Notice of Funding Opportunity (NOFO) funds exploratory research on how AI influences learning and development in children with or at risk for Specific Learning Disabilities (SLDs), emphasizing innovation and community engagement.

RFA-HD-27-006: Novel Experiential Technologies Assisting Individual Learning (NExT AI) Hubs (P20 Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Funding Opportunity Title Novel Experiential Technologies Assisting Individual Learning (NExT AI) Hubs (P20 Clinical Trial Optional) Check for any recent Notices of NIH Policy Changes that may impact application requirements.

January 23, 2026 - NIH Pause on New Submissions to the NIH Human Embryonic Stem Cell Registry and Request for Information on Reducing Reliance on Human Embryonic Stem Cells in NIH-Supported Research. See Notice NOT-OD-26-031 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III.

3. Additional Information on Eligibility .

Assistance Listing Number(s) Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites exploratory grant applications, hereafter referred to as the Novel Experiential Technologies Assisting Individual learning Hubs or NExT AI Hubs (formerly Learning Disabilities Innovation Hubs), to address the impact of Artificial Intelligence (AI) technologies on developmental outcomes in children diagnosed with or at risk for developing a specific learning disability (SLD) impacting reading, writing, and mathematics.

NExT AI Hubs include a single Research Project and a Leadership Core that support the goals and aims of the Hub.

This NOFO seeks to serve as a catalyst to 1) speed the maturation of nascent/novel, high-impact, high-risk research that advances understanding of the role AI technology plays in supporting, improving, or limiting the learning, cognitive, and socio-emotional needs of children at risk for or diagnosed with SLDs, 2) build an evidence base for the SLD community to inform policy or practice, and 3) provide project-embedded, career-enhancing research and professional development opportunities to support the next generation of transdisciplinary SLD scientists.

This initiative provides opportunities to support planning and building a body of research and corresponding intellectual infrastructure to enable NExT AI investigators to compete for large research and program project opportunities in the future.

Funding Opportunity Goal(s) The Eunice Kennedy Shriver National Institute of Child Health and Human Development's mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Children and adolescents (defined here as birth through age 18) are increasingly exposed to and engaged with artificial intelligence (AI) technologies across both formal and informal learning environments. These technologies are often promoted as promising tools for supporting academic learning, cognitive growth, and socio-emotional development.

However, there remains limited scientific evidence regarding whether, how, and for whom AI technologies can be used effectively to support learning.

This Notice of Funding Opportunity (NOFO) invites applications for exploratory research grants, referred to as NExT AI Hubs, aimed at advancing understanding of how AI technologies influence learning, cognition, and socio-emotional development in children diagnosed with or at risk for specific learning disabilities (SLDs) in reading, writing, and/or mathematics.

For the purposes of this NOFO, AI is defined as technology that applies scientific and engineering principles to create intelligent systems capable of simulating aspects of human learning, reasoning, decision making, comprehension, and creativity. AI technologies are rapidly evolving and increasingly embedded in everyday contexts such as in homes, schools, and community settings.

Children may engage with these tools independently or in collaboration with teachers, caregivers, or peers. While AI technologies have the potential to support learning and development, they may also present risks or unintended challenges.

There is currently limited understanding of the conditions under which AI has beneficial or harmful effects, how individual differences (including co-occurring conditions) shape children's interactions with AI, and how different learning environments influence developmental outcomes over time.

Research Scope and Objectives This NOFO supports research examining how children with SLDs, or those at risk for developing SLDs, are exposed to and interact with existing and emerging AI technologies. The goal is to understand how these technologies function as part of the broader learning environment and how they may influence academic, cognitive, and socio-emotional development.

This NOFO does not support the development of new AI tools or technologies, nor does it prioritize evaluating the effectiveness of specific commercial products. Instead NICHD seeks to understand AI as a dynamic and evolving context in which learning occurs.

Areas of interest include: The ways children and their caregivers engage with AI technologies The knowledge, skills, and capacities required to use AI tools safely and effectively The features and affordances of AI technologies that may support or hinder learning and development Given the limited existing research base, applicants are encouraged to pursue exploratory and developmental research questions.

Investigators may draw on established evidence from other learning-support technologies to help contextualize findings related to AI. The program emphasizes innovation, tolerates higher levels of scientific risk, and encourages creative approaches to addressing complex public health challenges related to SLDs.

The NExT AI Hubs program is designed to stimulate new lines of inquiry and accelerate the development of a scientific foundation for understanding AI in the context of SLDs. These hubs will coordinate resources, foster transdisciplinary collaboration, and support the professional development of emerging researchers in this area. NExT AI Hubs are intended as time-limited, exploratory research initiatives.

Awards may be funded for up to four years and may be renewed once, for a total maximum of eight years. By the end of the funding period, investigators and research programs are expected to be positioned to transition to larger NIH center grants or independent investigator-initiated funding mechanisms..

Alignment with NICHD goals This NOFO aligns with NICHD's long-standing commitment to research on SLDs and children at risk for literacy and mathematics difficulties. It emphasizes under-studied, innovative topics and prioritizes populations with persistent learning challenges, including children with complex developmental profiles or co-occurring conditions such as ADHD or autism.

While the primary focus is on developmental SLDs, applications involving well-characterized pediatric patient populations with multiple disabilities or co-occurring conditions that affect impact learning are also appropriate. The NExT AI Hubs program complements the broader NICHD and NIH investments in SLD research and contributes to cross-programmatic efforts to support early career investigators and emerging scientific areas.

It also aligns with ongoing NICHD initiatives examining the impact of technology and digital media exposure on child and adolescent development. Career enhancement, training, and mentoring A central goal of this NOFO is to support the professional development of the next generation of transdisciplinary researchers.

Each NExT AI Hub is expected to provide project-embedded research opportunities, mentoring, and career development activities for early career investigators. Research and mentorship teams must include individuals with relevant expertise across the proposed project areas, with particular emphasis on AI technologies and their application in learning contexts.

For the purposes of this program, early career investigators may include: Post-baccalaureate trainees Postdoctoral scholars and clinical residents Newly independent researchers, including junior faculty, clinician-scientists, and early-stage industry researchers This NOFO strongly encourages the use of community-engaged research approaches, which involve meaningful, bidirectional partnerships between researchers and community partners.

Community engagement can enhance the relevance, quality, and impact of research by ensuring that study questions, methods, and outcomes, align with the needs and priorities of those most affected.

Community-engaged research strategies may include, but are not limited to: Establishing community advisory boards Collaboratively identifying research priorities with community partners Training community members as co-researchers Incorporating community feedback to interpret and validate findings Disseminating results to community audiences Using mixed methods to capture both quantitative outcomes and lived experiences Building long-term community capacity through the research process No single approach is required, and applicants may tailor engagement strategies to their specific research context.

Examples of Responsive Research Topics The following examples illustrate research topics that would be responsive to this NOFO. This list is not exhaustive, and applicants are encouraged to propose innovative, evidence-informed approaches.

Examine the potential benefits and risks of AI technology use for learning outcomes (e.g., reading, writing, and mathematics) in children with or at risk for SLDs Identifying neurobiological, psychological, or behavioral factors that influence how children with or at risk for SLDs experience AI-supported learning Determining the skills and competencies that children need to safely and effectively engage with AI technologies Investigating how contextual factors (e.g., home, school, and community environments) shape access to and outcomes of AI use Identifying features of AI technologies that support learning, cognition, and socio-emotional development Examples of AI Technologies of Interest For studies with children aged two years and younger, the focus should be on adults as the primary users of AI tools.

For studies with children aged three years and older, applications must justify the proposed balance of adult versus child interaction with the AI tool(s) as fitting the goals of the project and the developmental stage of the child. Applicants must also address potential concerns associated with AI use in the project's defined population and include plans to mitigate identified risks.

Relevant AI-based tools include, but are not limited to: AI chatbots that assist with homework, problem-solving, orwriting tasks AI-generated study supports such as summaries quizzes, or flashcards AI tools designed to increase engagement, motivation, or persistence Adaptive and personalized learning systems that provide feedback, hints, or alternative instructional approaches) AI tools that modify content formats (e.g., text-to-speech, visual, or video-based content) AI-powered educational games targeting cognitive or socio-emotional skills Non-Responsive Applications: Applications will be withdrawn without review if they fall outside the scope of this NOFO.

Non-responsive applications include those that: Do not substantially focus on children with or at risk for SLDs in reading, writing, or mathematics Primarily emphasize technology development or usability testing rather than developmental outcomes Focus on technology use by children under age two without involving caregivers as primary users Propose AI-based methods for identifying or diagnosing SLDs Focus exclusively on tools for teachers or caregivers without examining child outcomes Target adults (over age 18) as primary users, unless the adult is a teacher or caregiver supporting child development NICHD Data and Resource Sharing Expectations and Requirements: NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner.

The NIH Data Management and Sharing Policy ( NOT-OD-21-013 ) expects that scientific data will be accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (Plan).

The Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan ( NOT-OD-21-014) . The Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved Plan and any approved updates.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Information about DASH may be obtained at https://dash.

nichd. nih. gov/ .

For applications that aim to co-analyze already archived and shared data with data that have not yet been shared with the broader research community, applicants must describe their Plans for sharing such primary with the broad research community for example through DASH or another established repository.

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories.

For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy ( https://grants. nih. gov/grants/guide/notice-files/NOT-OD-14-124.

html ). Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NICHD intends to commit $1,600,000 in FY 2027 to fund up to 3 awards. Application budgets are limited to $390,000 in direct costs per year, but need to reflect the actual needs of the proposed project.

The maximum project period is 4 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks. All PD(s)/PI(s) must be registered with ORCID .

The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2- Definitions of Terms.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ) and where instructions in the How to Apply - Application Guide are directly related to the Grants.

gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Component Type for Submission Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application. When preparing the application, use Component Type 'Overall'.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted. SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Follow standard instructions. Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application. A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component. Specific Aims: Include Specific Aims for the NExT AI Hub project overall. Describe the short- and long-term objectives and goals of the proposed NExT AI Hub.

Include the objectives for the Research Project and the Leadership Core.

Research Strategy: The Research Strategy section of the Overall Component serves to 1) introduce the proposed NExT AI Hubs and its objectives, 2) identify the research goals addressed in the proposed Hub, 3) describe the project-embedded research, professional development, and learning opportunities for early career scholars to support their trajectories towards independent SLD research, 4) outline the planned community engagement activities, 5) describe the goals and planned activities for the Leadership Core and 6) importantly, illustrate the synergy between the research and leadership core activities.

This section is an opportunity to demonstrate fit and responsiveness with the NOFO and synergies between components of the Hub. To be responsive to this NOFO, applicants must: Demonstrate a primary focus on a population of learners at risk for SLDs or diagnosed with one or more SLDs and co-occurring condition(s).

Children who have already experienced formal learning opportunities are expected to either face or have already demonstrated significant and sustained learning challenges resistant to intervention.

When considering including children preschool-aged and younger, the applicant must directly address what factors (e.g., family history of SLD, prematurity, demonstrated language delay) increase the likelihood of developing significant difficulties in literacy and/or mathematics.

Describe for each population proposed the developmental epoch(s) under consideration and clearly enumerate the learning and broader cognitive and socio-emotional needs of the population(s) under consideration. Provide a strong justification for their choice of population and sample characteristics proposed.

Applicants need to explicitly describe and utilize innovative recruitment and/or methodological approaches to ensure adequate participant recruitment to increase the scientific rigor and reproducibility of the proposed research. Plan innovative (potentially high risk) research topics that inform the role that AI-based technologies play in supporting, improving, or limiting the learning experiences of the population(s) proposed.

Provide a strong rationale for the specific choice of technologies and clearly enumerate in the proposal whether the knowledge to be gained is anticipated to be general to technologies of the type(s) selected or specific to the technological choice.

Additionally, the applicant must propose research that is able to inform how the attributes of the learners may impact their ability to successfully utilize these technologies to support learning and broader cognitive and socio-emotional development. Provide a clear description and justification for the anticipated setting(s) where the technologies and learners would interact.

Please note clearly any distinctions between anticipated locations for the technology utilization versus where the project data was/will (e.g., extant or de novo data) be collected All applications should provide an overview of the major goals of the overall project, background information, and the overall importance of the research to the goals of the NOFO.

Explain the strategy for achieving the goals defined for the overall grant and how the single Research Project and single Leadership Core relate to that strategy.

Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research, how the combined resources create a synergistic, overall programmatic effort of integrated research. Describe how the project-embedded, research experiences, professional development and learning activities support the next generation of LD scholars.

Describe how the community engaged research activities increase relevance of the research to the partners who will use and benefit from the findings. Include any necessary tables, graphs, figures, diagrams and charts in this section.

Additionally, provide the following information as part of the research strategy: All applicants must discuss the philosophy, objectives, and potential impact of the proposed Research Project and Leadership Core on SLD research and describe how they would build on resources and expertise of the applicant institution (and collaborative institutions, if applicable).

Provide background on recent advances, limitations, and overall impact on research in domains of relevance to the application and more broadly to the field of learning disabilities research. Letters of Support: Please include only letters that reflect support for overall activities of the entire NExT AI Hub.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide . A Resource Sharing Plan is expected to be provided for the overall Center. Any resources to be developed under the individual core components must be included with the Resource Sharing Plan for the Overall Component.

Resources to be developed specifically under the Research Projects must be included with those components as indicated below. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data.

Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

The Data Management and Sharing (DMS) Plan must be provided in the Overall component. Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide ; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions: If you answered "Yes" to the question "Are Human Subjects Involved?"

on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

When preparing your application, use Component Type 'Research Project.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant's Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Research Project) Follow standard instructions. Research & Related Other Project Information (Research Project) Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?'

questions. Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project) List all performance sites that apply to the specific component. Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. Research & Related Senior/Key Person Profile