Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Artificial Intelligence and Technology Collaboratories for Aging Research (P30 – Clinical Trial Optional)  

Activity Code

P30 Center Core Grants

Announcement Type

New

Related Notices

July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128

August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137

Funding Opportunity Announcement (FOA) Number

RFA-AG-21-009

Companion Funding Opportunity

RFA-AG-21-018, R24 Resource-Related Research Projects – Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for the Artificial Intelligence and Technology Collaboratories (AITC) for Aging Research program. The AITC program will serve as a national resource to promote the development and implementation of artificial intelligence approaches and technology through demonstration projects to improve care and health outcomes for older Americans, including persons with dementia (PWD) and their caregivers.

Key Dates
Posted Date

March 12, 2020

Open Date (Earliest Submission Date)

September 1, 2020

Letter of Intent Due Date(s)

September 1, 2020

Application Due Date(s)

October 1, 2020. No late applications will be accepted for this funding opportunity announcement.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date

October 2, 2020

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the 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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.



  3. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. 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. Funding Opportunity Description

    The number of Americans aged 65 or older will grow to 95 million by 2060 and comprise nearly a quarter of the population; most will have multiple chronic conditions, and many will experience cognitive impairment and/or dementia. The combination of the projected growth of this population and the desire of many older Americans to live independently in their homes and communities makes it critical that the federal government proactively develop strategies, tools, and recommendations to enable them to live healthy, independent lives.

    Recognizing the needs of this looming population and the potential role for federal research and development, a Federal Task Force developed a report, “Emerging Technologies to Support an Aging Population,” which highlighted the following six areas for technology development that will require coordination across a wide range of disciplines and sectors of the economy: support with key activities of daily living, cognitive skills, communication and social connectivity, personal mobility, access to transportation, and access to healthcare. Research and development of artificial intelligence approaches was highlighted in a recently published report, "2016–2019 Progress Report: Advancing  Artificial Intelligence R&D," and technological solutions in these areas for use in homes and communities will require coordination across a wide range of disciplines.

    2. Specific Objectives of the Artificial Intelligence and Technology Collaboratories (AITC) for Aging Research Program

    The specific objectives of the AITC program are as follows: 1) serve as a national resource to promote the development and implementation of artificial intelligence approaches and technology through demonstration projects to improve care and health outcomes for older Americans, including persons with dementia (PWD) and their caregivers; 2) support pilot studies to develop and implement artificial intelligence approaches and technology across the country; 3) develop and disseminate technical and policy guidelines and best practices for effectively incorporating artificial intelligence approaches and technology for older Americans, in partnership with private industry, angel investors, venture capital firms, and healthcare systems; 4) work collaboratively with researchers across private industry, venture capital firms, the healthcare sector, and the NIA Office of Small Business Research to provide technical support for scaling up pilot studies; and 5) disseminate best practices for engaging stakeholders in research by (a) incorporating stakeholders into the research and development process and (b) conducting ethical research on how to incorporate artificial intelligence approaches and technology development in the special circumstances of individuals experiencing cognitive decline/impairment. 

    3. Organizational Structure

    The AITC program will build technology for older Americans, with a focus on technology to support PWD, as well as maintain a resource and knowledge base for technology in coordination with a designated Artificial Intelligence and Technology Coordinating Center (AITCC). Each Collaboratory will consist of in-house scientific and technological expertise and the clinical and industry partnerships necessary to facilitate the identification, application, and integration of artificial intelligence approaches and enabling technologies into devices that address the aging research priorities highlighted in this FOA. Specifically, each Collaboratory will be comprised of seven core components and one optional component:

    (A) Administrative Core

    (B) Stakeholder Engagement Core

    (C) Technology Identification and Training Core

    (D) Clinical Translation and Validation Core

    (E) Networking and Mentoring Core

    (F) Pilot Core (AD/ADRD Focus): Artificial Intelligence and Technology Development and Refinement

    (G) Pilot Core (Aging Focus): Artificial Intelligence and Technology Development and Refinement

    (H) Optional Core: Applicants have an option to propose one investigator-initiated Core designed to address AITC objectives not addressed in cores (A) through (G).   

    Applications will be deemed incomplete if they do not include an Administrative Core, Stakeholder Engagement Core, Technology Identification and Training Core, Clinical Translation and Validation Core, Networking and Mentoring Core, Pilot Core (AD/ADRD Focus), and Pilot Core (Aging Focus).

    Successful Collaboratory grant applications are required to cooperate and work with a Coordinating Center, to be funded via RFA-AG-21-018. This may require revision of aims and/or data and resource sharing statement in order to avoid overlap of activities with the Coordinating Center. It is recommended that each applicant provide detailed milestones for each Core for 5 years of proposed activities.

    A. Administrative Core

    This Core will provide administrative support for the Collaboratory. Suggested activities include, but are not limited to, the following:

    • Providing governance structure for the AITC;
    • Providing a public website for communication and sharing of the activities, events, and resources of the program; 
    • Hosting Artificial Intelligence and Technology Grand Rounds in conjunction with the AITCC;
    • Contributing content to the Living Textbook for Artificial Intelligence and Technology for Aging Research maintained by the AITCC;
    • Organizing and implementing an annual national competition for pilot projects (see two Pilot Cores), in conjunction with the AITCC, to include recommendations of meritorious pilot projects to NIA;
    • Providing organizational and logistical support for the activities of the AITC Cores;
    • Addressing overall artificial intelligence approaches and the technology refinement process by designing products that will address older Americans’ health needs, with attention to health disparities and access to and improvement of healthcare in rural areas across the United States;
    • Supporting standards and mechanisms to publicly share data, resources, and codes developed and utilized in AITC pilot projects; and
    • Organizing Collaboratory attendance at a one-day annual progress meeting with the External Advisory Panel (EAP) in Bethesda, MD, hosted by the AITCC, to highlight the progress of the Center.

    B. Stakeholder Engagement Core

    The Stakeholder Engagement Core (SEC) will be responsible for ensuring that the artificial intelligence approaches and technologies developed by the AITC will be maximally adoptable by and accessible to their end users by soliciting stakeholder input and involving key relevant parties throughout all phases of the development process. Stakeholders include, but are not limited to, older adults with and without Alzheimer’s disease and related dementias, family and other informal caregivers, physicians and other clinicians, and non-clinicians involved in the care of older adults.

    C. Technology Identification and Training Core

    The Technology Identification and Training Core will use evidence from the extant literature and stakeholder input to identify the technology needs of older Americans, as well as develop training activities for artificial intelligence and technology for scientists, engineers, clinicians and other medical professionals, patients, policy makers, and investors. Within this Core, applicants can propose assessments of clinical and user needs to inform artificial intelligence and technology design needs and further define and disseminate publicly available clinical needs information through the AITCC. This course can also offer training, such as intensive one- to two-week summer institutes courses and/or web-based courses on artificial intelligence and technology for developing technology tools for older Americans.

    D. Clinical Translation and Validation Core

    AITC are expected to validate prototypes and undertake rigorous feasibility testing for the artificial intelligence algorithms and technology devices in both clinical and “real-world” settings. Examples of settings include, but are not limited to, the integration of algorithms into clinical decision support tools and clinical workflow within low-resource settings and among the intended users and/or caregivers. An important characteristic of the AITC is, therefore, the ability to collaborate effectively with entities that possess the resources and expertise to commercialize the prototype devices developed through AITC activities. Support for clinical translation can also be in the form of sub-awards, tools, and/or other resources.

    E. Networking and Mentoring Core

    The Networking and Mentoring Core supports activities intended to advance the goals of the AITC by facilitating integration across studies, disciplines, and institutions to catalyze development of artificial intelligence approaches which can be incorporated into products or development of technologies to improve health. Networking includes all activities designed to bring together leading scientists, industrialists, venture capital firms, and the NIA Small Business Office, across disciplines and institutions, to develop an area or research infrastructure.

    F. Pilot Core (AD/ADRD Focus): Technology Development and Refinement

    This Core will support innovative AD/ADRD pilot projects within the scope of the AITC's overall aims. NIA expects the AITC to hold an annual competition after the award. Pilot projects should be designed to lead to the development of technology or integration of artificial intelligence with big data to improve the health and well-being of older Americans affected by AD/ADRD and/or their caregivers. The objectives of pilot projects can vary. For example, pilot studies can focus on such topics as the application of artificial intelligence to detect cognitive impairment or the development of an application to coordinate care.

    All pilot projects selected by the AITC must be within the scope of the AITC and require prior approval from NIA Program and Grants Management staff.

    Applicants should propose a consolidated or centralized IRB approach consistent with the NIH single IRB policy for multi-site research to facilitate both appropriate and timely study implementation.

    G. Pilot Core (Aging Focus): Technology Development and Refinement

    This Core will support innovative non-AD/ADRD pilot projects within the scope of the AITC's overall aims. NIA expects the AITC to hold one annual competition after the award. Pilot projects should be designed to lead to (or inform) the design of technology or integration of artificial intelligence with big data or technology to improve the health and well-being of older Americans. This set of pilot projects cannot focus on AD/ADRD research and/or their caregivers. For example, pilot studies can focus on innovative ways to collect data with sensors to predict multiple co-morbidities and design a system to intervene and improve health of older adults using data from electronic health records.

    All pilot projects selected by the AITC must be within the scope of the AITC and require prior approval from NIA Program and Grants Management Staff.

    Applicants should propose a consolidated or centralized IRB approach consistent with the NIH single IRB policy for multi-site research for trial oversight to facilitate both appropriate and timely study implementation.

    H. Optional Core

    Applicants have an option to propose one investigator-initiated Core that will benefit the overall AITC. The Optional Core must be relevant to the overall AITC.  

    4. Illustrative Topic Areas for the National Institute on Aging

    To achieve the objectives listed above, each AITC should promote a sustained research and infrastructure development program in one or more broad thematic areas. Research themes could include the following: 

    • Collection of data from sensors and application of artificial intelligence to enhance clinical trials and cohort studies;
    • Development and validation of clinical decision support tools that help physicians caring for older adult patients with multiple chronic conditions;
    • Tools for older adult patient self-management of multiple chronic conditions, including integrating artificial intelligence algorithms to improve healthcare delivery and decision making;
    • Validation and assessment of various methods for assessing and monitoring financial activity, including evaluating scam awareness;
    • Validation and assessment of appropriate user interfaces (e.g., on smart devices) to assist older Americans in financial decision making as they face cognitive decline;
    • Development of innovative monitoring technologies relevant to gerontology, including applications of artificial intelligence and machine learning, whose results would be suitable for inclusion in the electronic health records of older adults;
    • Integration of cognitive instruments and other digital biomarkers with electronic health records for early detection of cognitive decline or monitoring of outcomes at point-of-care;
    • Development of socially assistive robots to provide cognitive therapy, in-place monitoring, and/or assistance and care coordination for individuals with dementia and their caregivers;
    • Design and modification of technology by incorporating artificial intelligence applications into human factors problems/design associated with aging;
    • Development of applications that incorporate artificial intelligence approaches and behavioral economics principles to assist care providers, caregivers, or older individuals;
    • Development and modification of technology platforms to enable delivery of appropriate care for individuals with cognitive impairment and dementia, including management of common comorbid conditions; and
    • Design of technological platforms that identify early biomarkers for functional and cognitive changes and assess the impact of intervening health events on the quality of life, well-being, and health status of older Americans.

    All applicants, regardless of area of focus, need to clearly articulate how application of artificial intelligence and technology with the specific AITC will mitigate health disparities across the United States, including improving access and delivery of care in rural areas.

    5. Program Governance

    Cores will be established and will provide essential functions to the overall AITC. It is expected that the Cores will interact with each other and with the AITC Coordinating Center (AITCC). The AITCC will serve as a hub for the AITC program and will facilitate and coordinate trans-AITC activities. The AITCC will also provide overarching support and advice to AITCs in the following domains: (1) ethics; (2) the preparation of background instructions and submission templates to ensure compliance with laws and FDA regulations and facilitate approval of technology and products associated with artificial intelligence; (3) the preparation of background instructions and submission templates to assist AITC pilot investigators with reimbursement of technology through insurers; and (4) assistance to pilot investigators with scaling, dissemination, and commercialization of artificial intelligence and technology products derived from AITCs or other NIA-funded grants. Additionally, the Cores will provide a forum for discussing challenges and solutions across pilot projects; harmonized and standardized policies and processes will be vetted in these groups. 

    6. External Advisory Panel (EAP)

    An External Advisory Panel for the AITC program will be established, in conjunction with the AITC Coordinating Center, to review the progress of all components of the program and provide recommendations to the PD(s)/PI(s). Membership may include study investigators, representatives from relevant federal agencies (cannot include NIA or NIH representatives), and independent scientific experts in areas appropriate to the multidisciplinary content of the AITC. The EAP is expected to have 3-5 permanent members; however, membership may expand permanently or on an ad hoc basis as needed. The EAP will meet once a year to evaluate and comment on the progress of the AITC. The EAP will make recommendations, in writing, regarding progress of the AITC PD(s)/PI(s), including changes, if any, that would benefit the program.

    7. Responsiveness Criteria

    Applications on these topics will not be considered responsive and will not be reviewed:

    • Applications NOT focusing solely in the area/field of artificial intelligence and technology AND NOT addressing aging/cognitive decline/dementia
    • Applications not addressing health disparities, including health disparities in rural areas affecting older Americans
    • Applications without a consortium (e.g., technology companies, startups, venture capital firms, and angel investors)

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    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

    The National Institute on Aging (NIA) intends to commit $7 million in FY 2021 to fund 2 awards.

    Award Budget

    Application budgets are limited to $2.5 million in direct costs per year.

    Award Project Period

    The maximum project period is 5 years. 

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    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

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • 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

    Other

    • 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
    • Regional Organizations
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) 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  allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.

    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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
    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 FOA. See your administrative office for instructions if you plan 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 SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    Partha Bhattacharyya, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-3136
    Email: bhattacharyyap@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (use for Administrative Core)

    6

    Stakeholder Core (use for Stakeholder Engagement Core)

    6

    Tech ID Train Core (use for Technology Identification and Training Core Complex Component)

    6

    Clinical Trans Valid (use for Clinical Translation and Validation Core)

    6

    Network Core (use for Networking and Mentoring Core)

    6

    Pilot A Core (use for Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    6

    Pilot B Core (use for Pilot Core (Aging Focus): Technology Development and Refinement )

    6

    Optional Core

    6

    Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    The application should consist of the following components:

    • Overall: Required, 1
    • (A) Administrative Core: Required; maximum of 1
    • (B) Stakeholder Engagement Core: Required; maximum of 1
    • (C) Technology Identification and Training Core: Required; maximum of 1
    • (D) Clinical Translation and Validation Core: Required; maximum of 1
    • (E) Networking and Mentoring Core: Required; maximum of 1
    • (F) Pilot Core (AD/ADRD Focus): Technology Development and Refinement: Required; maximum of 1
    • (G) Pilot Core (Aging Focus): Technology Development and Refinement: Required; maximum of 1
    • Optional Core: Optional; maximum of 1
    Overall Component

    When preparing your application, use Component Type ‘Overall’.

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    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 & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    Applicants should describe their relevant experience and knowledge in the following areas to demonstrate the high level of expertise expected to conduct the required activities of the AITC program. The AITC Center Director is expected to have a technical (e.g., degree in computer science or engineering) or statistical (e.g., degree in applied mathematics or statistics) background and have worked collaboratively (e.g., demonstrated experience or a plan) with a team of geriatricians, neurologists, and other core leaders from different backgrounds. The proposed team and its structure should have a significant depth of experience. Such areas of expertise include:

    • Degree in computer science or engineering and relevant working experience in the artificial intelligence/technology industry;
    • Expertise in geriatrics, bioinformatics, and neurology;
    • Expertise in study coordination, data management, and statistics;
    • Knowledge of the regulatory requirements for artificial intelligence and technology;
    • Experience conducting prototype development studies of relevance to proposed areas of emphasis;
    • Familiarity with ethical issues related to older adults--specifically, age-related cognitive decline, AD/ADRD clinical research, clinical care, quality improvement, population health, surveillance--and their boundaries, and how the application of technology and artificial intelligence can improve health;
    • Demonstrated experience (when applicable for appropriate Core or administrative function) or a plan to collaborate with relevant AITC stakeholders, including older Americans not affected by dementia, persons with dementia (PWD) and their caregivers, venture capital firms, angel investors, research participants, researchers, practitioners, hospital and research informatics and technical personnel, and senior managers of healthcare and research organizations;Demonstrated knowledge of workflows and practices of technological innovation to improve healthcare delivery, adopted by industry or commercialized;
    • Knowledge and understanding of the strengths and weaknesses of artificial intelligence (e.g., current data models, algorithms, and approaches used by various studies and its implications) and technology (e.g., ethical issues with data collection via voice-activated sensors);
    • Project management experience in translating an idea to a product; and
    • Creativity and innovation (e.g., designing for adaptation of technology for older Americans) to solve technical and project challenges that respect and promote participation by all relevant communities.

    The activities of this award demand complex management and coordination, as many different entities will ultimately participate in the Collaboratory. Therefore, the PD(s)/PI(s) must commit and sustain 3 person-months of effort per year throughout the award to manage this complex Collaboratory. It is anticipated that a multi-PI structure may be proposed; in such structures, each PI should contribute a minimum of 3 person-months of effort. Multi-PD/PI leadership is highly encouraged. Core Directors will also need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding. Additionally, the applicant should provide evidence of how the planned collaboration will work among a team with potentially very different backgrounds.

    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.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. The applicant must include funds for AITC key personnel (e.g., PD(s)/PI(s) and Core Leaders) to attend an annual meeting in the Bethesda, MD area. Additionally, applicants should budget appropriately for administrative support for notetaking and travel services for the AITC External Advisory Panel.

    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)

    Specific Aims: Describe the specific aims for the proposed AITC. The AITC is charged with creating a dynamic infrastructure for supporting development of technology and artificial intelligence approaches to improve the health of older Americans (with AD/ADRD or without AD/ADRD) and their caregivers.

    Each AITC should promote a sustained research and infrastructure development program in one or more broad thematic areas which should be stated in the application and around which the goals, Specific Aims, and topic areas of the Collaboratory and of the Collaboratory Cores should be designed. All AITC applications must address the AD/ADRD and non-AD/ADRD research areas they will pursue in the Pilot Cores.

    Additionally, all applicants, regardless of area of focus, need to clearly articulate how application of artificial intelligence and technology with the specific AITC will mitigate health disparities across the United States, including improving access and delivery of care in rural areas. 

    Research Strategy: Applicants are expected to:

    • Develop a strategic vision for the AITC. Plan, coordinate, review, and manage the AITC's activities.
    • Address the overall objectives, long-term goals, and milestones of the AITC.
    • Propose plans to develop the consortium (technology companies, startups, venture capital firms, and angel investors), starting in the first year, and submit letter(s) of support (see Letters of Support) that demonstrate commitments from future collaborators and intentions to remain in the consortium in order to facilitate the success of pilot projects. Also propose plans to increase the consortium in future years.
    • Without duplicating information contained in the biosketches, address PD(s)/PI(s)' track record for the AITC's field of expertise and provide examples of successfully working in the artificial intelligence and technology development sector.
    • Without duplicating information contained in the biosketches, describe the experience of the proposed team members with respect to working in research consortia or other collaborative efforts to achieve a shared goal.
    • Include sustainability plans addressing post-award efforts. Sustainability may include letters of support from partnering institutions, as specified in the Letters of Support section below.
    • Describe how the AITC will engage nationally and work with other AITCs and the AITCC to stay abreast of emerging experience, regulations, and technical advances and to develop and design research approaches, methods, processes, policies, and tools used in this program. Successful Collaboratory grant applications are required to cooperate and work with a Coordinating Center to be funded via RFA-AG-21-018. This may require revision of the aims, data, and resource sharing statement in order to avoid overlap of activities with the Coordinating Center.
    • Describe how the AITC will collaborate with pilot project awardees.
    • Describe how the proposed approach will allow for rapid deployment of artificial intelligence approaches and technology into products that can improve older Americans' health.
    • Explain how the proposed activities will facilitate flexible, modular, and scalable policies, practices, and tools to enable broad collaboration and participation among artificial intelligence and technology researchers beyond academia.
    • Explain how the AITC will challenge and seek to impact the current artificial intelligence and technology research landscape and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools which can improve older American's health.
    • Explain how the AITC will address barriers with artificial intelligence approaches and technology development which can transcend from research exercise to practical application.
    • Explain how, if the aims of the AITC are achieved, clinical research and incorporation of artificial intelligence and technology will translate research into practice and integration with various stakeholders (patients, caregivers, healthcare delivery organizations, etc.
    • Specify how applications of artificial intelligence and technology within the AITC will mitigate health disparities across the United States, including improving access and delivery of care in rural areas.

    Cores will be established and will provide essential functions to the overall AITC. It is expected that the Cores will interact with each other and with the AITC Coordinating Center (AITCC). The AITCC will serve as a hub for the AITC program and will facilitate and coordinate trans-AITC activities. The AITCC will also provide overarching support and advice to AITCs in the following domains: (1) ethics; (2) the preparation of background instructions and submission templates to ensure compliance with laws and FDA regulations and facilitate approval of technology and products associated with artificial intelligence; (3) the preparation of background instructions and submission templates to assist AITC pilot investigators with reimbursement of technology through insurers; and (4) assistance to pilot investigators with scaling, dissemination, and commercialization of artificial intelligence and technology products derived from AITCs or other NIA-funded grants. Additionally, the Cores will provide a forum for discussing challenges and solutions across pilot projects; harmonized and standardized policies and processes will be vetted in these groups. 

    Letters of Support: At the time of application, the PD(s)/PI(s) must submit letter(s) of support that confirms planned collaboration between the applicant and relevant technology companies, startups, venture capital firms, and angel investors, as described in the proposed activities of the center. PD(s)/PI(s) must generate and sustain consortium partnerships in the future that will lead to the commercialization of pilots supported by the AITC.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    This FOA expects the sharing of resources with a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the AITC. It is imperative that the AITC is set up in a manner that will allow for such practice, in conjunction with the Coordinating Center. The AITC is expected to implement a Resources and Data Sharing Plan consistent with these program goals.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed

    PHS Assignment Request Form (Overall)

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Administrative Core

    When preparing your application, use Component Type ‘Admin Core.’

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative  Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative  Core)

    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) (Administrative Core)

    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 (Administrative  Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.     
    Budget (Administrative Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Administrative Core)

    Specific Aims: State the goals of the proposed Administrative Core concisely and summarize the expected outcome(s).

    Research Strategy: The objectives of this Core may include, but are not limited to, the following:

    • Administer a national pilot program which will support development and implementation of artificial intelligence approaches and technology.
    • Maintain and facilitate consortium partnerships with technology companies, startups, venture capital firms, and angel investors.
    • Coordinate activities and track outcomes of all Cores to meet requirements for reporting to the Coordinating Center that will be funded through RFA-AG-21-018.
    • Organize AITC attendance at a one-day annual progress meeting with the External Advisory Panel (EAP) in Bethesda, MD, hosted by the AITCC, to highlight the progress of the Collaboratory.

    A critical aspect of the Collaboratory’s administrative function is establishing and effectively managing a range of collaborations and partnerships. In the Administrative Plan, applicants should:

    • Describe the governance and organizational structure of the leadership team, communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. Multiple PD/PI applications will use the Multiple PD/PI Leadership Plan attachment to describe the governance and organizational structure of the leadership team and the research project, communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts; information from the Multiple PD/PI Leadership Plan may be referenced here but should not be duplicated.
    • Provide one or more examples of effective collaborations the PD(s)/PI(s) have established, including descriptions of the motivation for initiating the collaboration, the goals defined for the collaboration, and the outcomes achieved.
    • Delineate the roles and administrative, technical, and scientific responsibilities of the project staff as they relate to the various functions of the AITC.
    • Describe processes for problem solving, communication, and prioritization of work.
    • Include a plan for the integration of AITC activities to accomplish overall goals.
    • Describe operating procedures for ensuring responsiveness to members of the research community who wish to access the AITC and utilize AITC resources.

    Letters of Support: Only letters of support specific to "Administrative Core" should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications are expected to share resources generated from this Core through the Coordinating Center.

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed.

    Stakeholder Engagement Core

    When preparing your application, use Component Type ‘Stakeholder Core.’

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Stakeholder Engagement Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement ( Stakeholder Engagement Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Stakeholder Engagement Core)

    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) (Stakeholder Engagement Core)

    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 (Stakeholder Engagement Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.         

    Budget (Stakeholder Engagement Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Stakeholder Engagement Core)

    Specific Aims: State the goals of the proposed Stakeholder Engagement Core concisely and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the AITC/research field(s) involved (i.e., artificial intelligence and technology). List the specific objectives of the research proposed succinctly.   

    Research Strategy: Applicants should describe how they will meet the objectives of this Core which include, but are not limited to, the following:

    • Incorporate guidance from various stakeholders to inform development of technology supported through pilots. Stakeholders include, but are not limited to, older adults with and without Alzheimer’s disease and related dementias, family and other informal caregivers, physicians and other clinicians, and non-clinicians involved in the care of older adults. 
    • Establish partnerships with and solicit input from stakeholders through the methods most appropriate to the specific AITC. Methods must facilitate stakeholder involvement in technology design, development, refinement, implementation, and dissemination. Examples of such methods include establishing a stakeholder advisory board, conducting environmental scans and needs assessments, and holding town hall demonstrations, among others.

    Letters of Support: Only letters of support specific to ‘Stakeholder Engagement Core' should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All stakeholders input is expected to be shared in the form of reports to the AITC Coordinating Center.

    Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Stakeholder Engagement Core)

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed.

    Technology Identification and Training Core

    When preparing your application, use Component Type ‘Tech ID Train Core.’

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Technology Identification and Training Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Technology Identification and Training Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Technology Identification and Training Core)

    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) (Technology Identification and Training Core)

    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 (Technology Identification and Training Core  )

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.      

    Budget (Technology Identification and Training Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Technology Identification and Training Core)

    Specific Aims: State the goals of the proposed Technology Identification and Training Core concisely and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on identification of technology and training which can assist older Americans and their caregivers. List the specific objectives of the research proposed succinctly.    

    Research Strategy:

    Technology Identification

    State how technology needs for older Americans will be identified (e.g., from stakeholder input), including opportunities for the use of artificial intelligence methods to improve health and healthcare delivery.   

    User and Developer Training

    The training of physical scientists, computational scientists, and engineers (as well as researchers from other relevant disciplines, as appropriate) on clinical and process issues related to the development of artificial intelligence and technology is critical to accelerating the translation of enabling technologies into clinical use.

    • Propose specific and detailed plans to provide training opportunities to users and technology developers across various career levels, either through individual training opportunities, such as fellowships or sabbatical opportunities, or through workshops or other activities that target broader audiences.
    • Describe plans to educate relevant stakeholders (e.g. clinicians and other medical professionals, patients, policy makers, investors) on the development and potential impact of technologies.

    Clinical Needs and User Assessments

    Important aspects of training activities include guidance on the integration of clinical/user needs information into the device design process and the practical challenges associated with developing technologies for use in low-resource and decentralized settings, including lessons learned from go/no-go decisions made in the prototype development and testing efforts.

    • Demonstrate the ability to plan and execute assessments of clinical and user needs to inform the use of artificial intelligence algorithms and device design and to further define and disseminate publicly available clinical needs information.
    • Provide a summary of clinical and user needs from recent assessments, as well as a detailed plan for future assessments that extend beyond widely available information to capture specific details that can inform device design.
    • Provide a plan that demonstrates an understanding of rigorous methodologies for needs assessment as well as knowledge of and access to appropriate users and other stakeholders. Issues that should be evaluated in the needs assessment in the context of the intended diagnostic application, setting, and user include (but are not limited to) requirements for device performance (such as sensitivity and specificity), device robustness, and device usability.
    • Discuss the integration of clinical needs information into all aspects of Center function. The Center is expected to have appropriate staff with demonstrated expertise in performing needs assessments.

    Dissemination

    • The AITC is expected to broadly and effectively disseminate the results of clinical needs and user assessment and impact analysis activities in a way that will inform device design and accelerate development toward commercialization. Develop an outreach plan to educate and train technology and artificial intelligence developers on when and how to use artificial intelligence approaches/methods and technologies, quality control procedures, trouble shooting, and design of existing technologies to maximize the benefit of the technology for the end users such as older adults and their caregivers. Describe a plan to identify short-term user training needs upon the deployment of a technology and the long-term user training needs related to sustained use of technologies. Disseminate findings on user needs and lessons learned from AITC outreach through the AITCC, via conference presentation, webinar, publication, or other means.

    Letters of Support: Only letters of support specific to the ‘Technology Identification and Training Core' should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications are expected to share resources generated from this Core through the Coordinating Center.   

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Technology Identification and Training )

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed

    Clinical Translation and Validation Core

    When preparing your application, use Component Type ‘Clinical Trans Valid’.

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Clinical Translation and Validation Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Clinical Translation and Validation Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Clinical Translation and Validation Core)

    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) (Clinical Translation and Validation Core)

    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 (Clinical Translation and Validation Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.     

    Budget (Clinical Translation and Validation Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Clinical Translation and Validation Core)

    Specific Aims: Describe the specific aims to facilitate clinical validation of artificial intelligence and technology pilot projects.    

    Research Strategy: The Clinical Translation and Validation Core will primarily serve as a “clinical laboratory” for innovators to facilitate clinical validation of artificial intelligence approaches/methods or technologies. AITC pilots can be identified and selected to participate in the Clinical Translation and Validation Core to ensure success.

    AITCs are expected to validate prototypes and undertake rigorous feasibility testing for the artificial intelligence algorithms and technology devices in both clinical and “real-world” settings. Examples of settings include, but are not limited to, the integration of algorithms into clinical decision support tools and clinical workflow within low-resource settings and among the intended users and/or caregivers. An important characteristic of the AITC is, therefore, the ability to collaborate effectively with entities that possess the resources and expertise to commercialize the prototype devices developed through AITC activities. Support for clinical translation can also be in the form of sub-awards, tools, and/or other resources.

    The Research Strategy must include the following:

    • Description of clinical capacities within the Collaboratory (or partnership with healthcare providers) to validate artificial intelligence methods or technologies, such as the ability to test integration of technologies into clinical workflow, or validation of technologies through other means;
    • Strategy for identifying and selecting artificial intelligence approaches or technologies to be clinically validated in the Collaboratory or a partner (e.g., healthcare system), such as plans to solicit and review applications, evaluate project progression and outcome, and prioritize projects based on the Collaboratory’s resources and expertise;
    • Description of artificial intelligence approaches and technologies that can be validated in the Collaboratory at the onset of the award and successful examples, if any;
    • Description of existing connection and collaboration with the clinical research community, with supporting letters or other evidence demonstrating successful collaboration;
    • Strategy for matching promising technologies with ongoing or future clinical studies;
    • Plan to establish a searchable database with emerging artificial intelligence approaches or technologies to be validated in clinics and identify clinical researchers (and their clinical studies) and other stakeholders (such as health departments) interested in validating artificial intelligence algorithms or technologies in their clinics or other real-world settings; and
    • Description of how the technology will be used in the specific setting and how feasibility testing will occur to support and facilitate the implementation of the technology or artificial intelligence algorithms in the identified setting.

    Letters of Support: Only letters of support specific to 'Clinical Translation and Validation Core' should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications are expected to share resources generated from this Core through the Coordinating Center.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects. See https://nih-extramural-intranet.od.nih.gov/d/sites/default/files/PHSHumanSubjectsandClinicalTrialsInformationForm-Internal_Use_Only.pptx for more information.

    PHS Human Subjects and Clinical Trials Information (Clinical Translation and Validation Core)

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed.

    Networking and Mentoring Core

    When preparing your application, use Component Type ‘Network Core’.

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Networking and Mentoring Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Networking and Mentoring Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Networking and Mentoring Core)

    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) (Networking and Mentoring Core)

    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 (Networking and Mentoring Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.     

    Budget (Networking and Mentoring Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Networking and Mentoring Core)

    Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the activities proposed.

    Research Strategy: The objectives of this Core include, but are not limited to, the development of innovative research networks beyond the institution's boundaries on the topics listed in the ILLUSTRATIVE TOPIC AREAS section to enhance research not only at the institution, but more generally within the field, as well as in relation to other relevant disciplines.

    Applicants should propose activities to support the creation of innovative networks and bring unique resources together to advance science and mentor the next generation of technologists who will innovate for older Americans. Examples of network support activities include:

    • Meetings both large and small to develop program areas and interact on the development of artificial intelligence algorithms and technology.
    • Meetings on dissemination and outreach activities, conducted over the web to reach a wider audience.
    • Integration of stakeholders' feedback into networking in a lecture series or workshops.
    • Advanced seminars on artificial intelligence methodology geared to development of applications for older Americans.
    • Commissioned papers disseminated though the AITCC in AITC focus areas.
    • Special issue publications which highlight the application of artificial intelligence/development of technology which can improve health for older Americans.
    • Networking events with industry partners, angel investors, venture capital firms, and the NIA Small Business Research Office.
    • Networking events with funders, pilot awardees, and other AITCs.
    • In coordination with the AITCC and other AITCs, organizing (e.g., providing content and hosting activities) and supporting showcase meetings between artificial intelligence and technology experts across academia, industry, venture capital firms, pilot project awardees (including startups not funded by the AITC), and others (e.g., hospital systems, electronic health record vendors, etc.) to address updates to artificial intelligence and technology products for older adults. Meetings should be broadly accessible and disseminated through meeting summaries, live streams, and video recordings archived on the AITC or AITCC website.
    • Development of common research resources.
    • Activities that encourage and nurture the development of pilot awardees from underrepresented minorities; people with disabilities; and those from socially, culturally, economically, or educationally disadvantaged backgrounds.
    • Intensive one- to two-week summer institutes courses, or web-based courses of artificial intelligence and technology for developing technology tools for older Americans.

    Letters of Support: Only letters of support specific to the Networking and Mentoring Core should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications are expected to share resources generated from this Core through the Coordinating Center.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

    PHS Human Subjects and Clinical Trials Information (Networking and Mentoring Core)

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed.

    Pilot Core (AD/ADRD Focus): Technology Development and Refinement

    When preparing your application, use Component Type ‘Pilot A Core’.

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    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) (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    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 (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.     

    Budget (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    Budget forms appropriate for the specific component will be included in the application package.

    The AITC must hold an annual national competition to solicit pilot projects for a total of five years. The AITC must allocate $1,750,000 in total costs per year for five years exclusively for pilot projects, and the research budget for each pilot project may not exceed $200,000 in direct costs. Each pilot project is expected to last from six months to one year.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    Specific Aims: State the goals of the proposed Pilot Core (AD/ADRD Focus) concisely and summarize the expected outcome(s), including the impact that the results of the proposed activities will exert on the research field(s), as well as commercialization potential. Describe the methods to address selection, development/refinement, and management of pilot projects.

    Research Strategy: Applicants should include the following:

    • Succinct description of the types of pilot studies that the AITC may solicit within its scope. All pilot projects selected by the AITC must be within its scope.
    • Process for selecting and evaluating promising pilot projects with an AD/ADRD focus. All pilot projects selected by the AITC require prior approval from NIA Program and Grants Management Staff
    • Description of how new pilot projects will be solicited, peer reviewed, funded, and managed. Include a description of a national competition to invite AD/ADRD pilot applications, to be held on an annual basis.
    • Process for coordinating with the AITCC for management of pilot projects and tracking outcomes.

    Pilot projects should be designed to lead to the development of technology or integration of artificial intelligence with big data to improve the health and well-being of older Americans affected by AD/ADRD and/or their caregivers. The objectives of pilot projects can vary. For example, pilot studies can focus on such topics as the application of artificial intelligence to detect cognitive impairment or the development of an application to coordinate care.

    Applicants should propose a consolidated or centralized IRB approach consistent with the NIH single IRB policy for multi-site research to facilitate both appropriate and timely study implementation.

    Letters of Support: Only letters of support specific to ‘Pilot Core (AD/ADRD Focus)' should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications are expected to share resources generated from this Core through the Coordinating Center.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

    PHS Human Subjects and Clinical Trials Information (Pilot Core (AD/ADRD Focus): Technology Development and Refinement)

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed.

    Pilot Core (Aging Focus): Technology Development and Refinement

    When preparing your application, use Component Type ‘Pilot B Core’.

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Pilot Core (Aging Focus): Technology Development and Refinement)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Pilot Core (Aging Focus): Technology Development and Refinement)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Pilot Core (Aging Focus): Technology Development and Refinement)

    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) (Pilot Core (Aging Focus): Technology Development and Refinement)

    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 (Pilot Core (Aging Focus): Technology Development and Refinement)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.     

    Budget (Pilot Core (Aging Focus): Technology Development and Refinement)

    Budget forms appropriate for the specific component will be included in the application package.

    The AITC must hold an annual national competition to solicit pilot projects for a total of five years. The AITC must allocate $750,000 in total costs per year for five years exclusively for pilot projects, and the research budget for each pilot may not exceed $200,000 in direct costs. Each pilot project is expected to last from six months to one year.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Pilot Core (Aging Focus): Technology Development and Refinement)

    Specific Aims: State the goals of the proposed Pilot Core (Aging Focus) concisely and summarize the expected outcome(s), including the impact that the results of the proposed activities will exert on the research field(s), as well as any commercialization potential. Describe plans to address selection, development/refinement, and management of pilot projects.     

    Research Strategy: Applicants should include the following:

    • Succinct description of the types of pilot projects which the AITC may solicit within its scope. All pilot projects selected by the AITC must be within the scope of the AITC.
    • Process for selecting and evaluate promising pilot projects with a focus on aging. All pilot projects selected by the AITC require prior approval from NIA Program and Grants Management staff.
    • Description of how new pilot projects will be solicited, peer reviewed, funded, and managed. Include a description of a national competition to invite aging-focused pilot applications, to be held on an annual basis.
    • Process for coordinating with the AITCC for management of pilot projects and tracking outcomes.

    Pilot projects should be designed to lead to (or inform) the design technology or integration of artificial intelligence with big data or technology to improve the health and well-being of older Americans. This set of pilot projects cannot focus on AD/ADRD research and/or their caregivers. For example, pilot studies can focus on innovative ways to collect data with sensors to predict multiple co-morbidities and design a system to intervene using data from electronic health records.

    Applicants should propose a consolidated or centralized IRB approach consistent with the NIH single IRB policy for multi-site research for trial oversight to facilitate both appropriate and timely study implementation.

    Letters of Support: Only letters of support specific to ‘Pilot Core (Aging Focus)' should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications are expected to share resources generated from this Core through the Coordinating Center.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Pilot Core (Aging Focus): Technology Development and Refinement)

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed.

    Optional Core

    When preparing your application, use Component Type ‘Optional Core’.

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

    SF424 (R&R) Cover (Optional Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Optional Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Optional Core)

    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) (Optional Core)

    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 (Optional Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Core Directors will need to coordinate activities across multiple organizations and so must commit and sustain 1.5 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.     

    Budget (Optional Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Optional Core)

    Specific Aims: State the goals of the proposed Core concisely and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on AD/ADRD pragmatic trials/research field(s) involved. List the specific objectives of the research proposed succinctly and state how it will benefit the Collaboratory overall.     

    Research Strategy: This is an optional core which the PD(s)/PI(s) may propose. PD(s)/PI(s) should specify how this Optional Core will benefit the overall AITC and expected outcome(s), including the impact of the Core on the overall AITC.

    Letters of Support: Only letters of support specific to ‘Optional Core' should be attached to this section.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    All applications are expected to share resources generated from this Core through the Coordinating Center.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Optional Core)

    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 SF424 (R&R) 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, you must include 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.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    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 SF424 (R&R) Application Guide must be followed.

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Collaboratory to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Collaboratory proposed).

    Scored Review Criteria - Overall

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Collaboratory that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the Collaboratory address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the Collaboratory are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    Will the AITC serve as a national resource, provide national leadership, and engage multiple stakeholders to promote the development and implementation of artificial intelligence approaches and technology through demonstration projects to improve care and health outcomes for older Americans, including persons with dementia (PWD) and their caregivers? If the aims of the AITC are achieved, how will clinical research and incorporation of artificial intelligence and technology translate research into practice and integration with various stakeholders (patients, caregivers, healthcare delivery organizations, etc.)? How will successful completion of the aims change the capability, methods, and integration of artificial intelligence/technologies used to improve the health of older Americans?

    Will the proposed activities in this application bring together multiple stakeholders (e.g. clinicians and other medical professionals, patients, policy makers, investors) in order to facilitate translation? How well did the applicants specify how applications of artificial intelligence and technology within the specific AITC will mitigate health disparities across the United States, including improving access and delivery of care in rural areas?

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Collaboratory? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    Do the investigators have the appropriate expertise in computer science (artificial intelligence and technology), geriatrics, bioinformatics, and neurology? Do the personnel (specifically the PD(s)/PI(s)) have the appropriate breadth of expertise and experience, including but not limited to a degree in computer science or engineering and relevant work experience in the artificial intelligence/technology industry? How well do the qualifications of the investigators address the research goals of the AITC? Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the AITC? Have they demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of large, national-level inclusive networks or consortia? Are the investigators willing to collaborate with pilot project awardees to meet the goals and objectives of this program? How well does the application describe how the investigative team is up to date on the changing landscape of artificial intelligence and technology as it relates to improving American's health? Does the application provide evidence of how the planned collaboration will work among a team with potentially very different backgrounds?

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD(s)/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

    Does the application challenge and seek to impact the current artificial intelligence and technology research landscape and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools which can improve older American's health? Is a refinement, improvement, or new application of approaches, concepts, or tools proposed for translation of research into everyday practice which can improve older American's health? Does the application indicate creativity and flexibility in order to innovate on an ongoing basis, as the artificial intelligence and technology field is rapidly growing? Does the application address barriers with artificial intelligence approaches and technology development which can transcend from research exercise to practical application? 

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Collaboratory? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the Collaboratory involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    Will the proposed approach allow for rapid deployment of artificial intelligence approaches and technology into products that can improve older Americans' health? Will the proposed activities facilitate flexible, modular, and scalable policies, practices, and tools to enable broad collaboration and participation among artificial intelligence and technology researchers beyond academia?  

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable?

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    In addition, for applications proposing clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria - Overall

    As applicable for the Collaboratory proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Study Timeline

    Specific to applications proposing clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    When the proposed Collaboratory involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Nor Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

    As applicable for the Collaboratory proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    Qualitative Review Criteria – All Cores

    For all Cores, reviewers will provide adjectival descriptors based on the following criteria:

    Significance

    Administrative Core: Is the administrative foundation adequate to support the proposed activities and affiliated research projects? How well does the Core Leader demonstrate the capacity for leadership of the Collaboratory? How well does the proposed Collaboratory demonstrate appropriate organization and core management? Are the organizational plan and management structure adequate to support the Collaboratory? Are there adequate plans for administering pilot programs nationally?

    Stakeholder Engagement Core: Are older adults with and without AD/ADRD, family and other informal caregivers, physicians and other clinicians, and non-clinicians involved in the care of older adults integrated into the Core?

    Technology Identification and Training Core: Does the Core state how technology needs for older Americans will be identified? Will the proposed dissemination activities ensure the sustained use of the technologies and maximize the benefits for end users?

    Clinical Translation and Validation Core: Does the Core have the clinical capacity to validate artificial intelligences methods or technologies? How adequate is the strategy for identifying and selecting artificial intelligence approaches or technologies to be clinically validated in the Collaboratory? Are the proposed approaches for using the technology in specific settings and conducting feasibility testing to facilitate their implementation in the identified settings likely to be successful?

    Networking and Mentoring Core: Will successful completion of the Core's aims bring unique advantages or capabilities to the field? Does the application address how the proposed activities will have the potential to grow the field substantially through recruitment of new researchers, rather than sustaining only the original team?

    Pilot Core (AD/ADRD Focus): How well will the proposed approach for soliciting AD/ADRD pilot projects nationally (note that PD(s)/PI(s) are not permitted to propose pilot projects) contribute to the goals of the Collaboratory? How adequate are the plans for the Stakeholder Engagement Core, Technology Identification and Training Core, and Clinical Translation and Validation Core to inform the solicitation and selection of AD/ADRD pilots? How well will the proposed pilot projects and types of future pilot projects contribute to the goals of the Collaboratory? Are the pilot projects likely to lead to the development of larger research initiatives? To what extent is the Collaboratory having an impact on research beyond the institution's borders by supporting pilot projects led by outside investigators? 

    Pilot Core (Aging Focus): How well will the proposed approach for soliciting aging-focused pilot projects nationally (note that PD(s)/PI(s) are not permitted to propose pilot projects) contribute to the goals of the Collaboratory? How adequate are the plans for the Stakeholder Engagement Core, Technology Identification and Training Core, and Clinical Translation and Validation Core to inform the solicitation and selection of aging-focused pilots? How well will the proposed pilot projects and types of future pilot projects contribute to the goals of the Collaboratory? How will the pilot projects integrate with and contribute to the success of other Cores? Are the pilot projects likely to lead to the development of larger research initiatives? To what extent is the Collaboratory having an impact on research beyond the institution's borders by supporting pilot projects led by outside investigators? 

    Optional Core: How well does the Core contribute to the goals of the Collaboratory, as well as the national goals for incorporating technology and developing artificial intelligence approaches which can improve older Americans' health?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Collaboratory? Are potential problems, alternative strategies, and benchmarks for success presented? If the Core is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed?

    If any of the Collaboratory Cores involve human subjects and/or NIH-defined clinical research, are the plans to address:

    1) protection of human subjects from research risks, and

    2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? 

    Administrative Core: Are the procedures for internal communication and cooperation among the investigators and external stakeholders adequate? How well described and appropriate are the directions for future planning and optimal utilization of resources? How does the administrative structure facilitate team science and the integration of researchers outside of academia?  

    Stakeholder Engagement Core: How well does the Core incorporate guidance from various stakeholders to inform development of technology supported through pilots? How well suited are the proposed methods for obtaining stakeholder engagement?

    Technology Identification and Training Core: Are plans to provide training opportunities to users and technology developers across various career levels adequate and appropriate? How well described and adequate are the plans to provide training opportunities? Are the plans to educate relevant stakeholders on the development and potential impact of technologies adequate and appropriate? Does the Core provide adequate identification of technology and artificial intelligence approaches for meeting end users' needs and training for developers?

    Clinical Translation and Validation Core: Are the artificial intelligence approaches and technologies that can be validated in the Collaboratory well described? Do letters of support or other evidence provided adequately demonstrate successful collaborations with the clinical research community? Is the plan to establish a searchable database with emerging artificial intelligence approaches or technologies to be validated in clinics adequate and appropriate?

    Networking and Mentoring Core: Are the activities proposed likely to support the creation of innovative networks and bring unique resources together to advance science and mentor the next generation of technologists? Are the proposed network activities likely to serve the broader community of researchers beyond a single institution or set of institutions?

    Pilot Core (AD/ADRD Focus): How adequate are the plans for the Stakeholder Engagement Core, Technology Identification and Training Core, and Clinical Translation and Validation Core to inform the solicitation and selection of AD/ADRD pilots? Is the pilot project review process adequate to assess the scientific merit of pilots through national competition?   

    Pilot Core (Aging Focus): How adequate are the plans for the Stakeholder Engagement Core, Technology Identification and Training Core, and Clinical Translation and Validation Core to inform the solicitation and selection of aging-focused pilots? Is the pilot project review process adequate to assess the scientific merit of pilots through national competition?   

    Optional Core: Is the Core well-reasoned and likely to contribute significantly to the specific aims of the Collaboratory? How strong are the strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? How well does the Core augment or enhance the present capabilities of investigators using AITC resources?

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute on Aging in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging . The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.  
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

    Prior Approval of Pilot Projects

    Awardee-selected projects require prior approval by NIH prior to initiation. 

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.  

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Partha Bhattacharyya, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-3136
    Email: bhattacharyyap@mail.nih.gov

    Peer Review Contact(s)

    Ramesh Vemuri, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-9666
    Email: ramesh.vemuri@nih.gov

    Financial/Grants Management Contact(s)

    Nia Pree
    National Institute on Aging (NIA)
    Telephone: 301-827-6374
    Email: nia.pree@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.    

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