Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions for this NOFO

• AITC Program: A collective consisting of individual P30 “Collaboratories” and a single U24 Coordinating Center. The program is comprised of the following types of Centers that operate independently, and in cooperation with all the other Centers:
  • AITC: P30 Center(s) that focus on implementation of AI and technology approaches for aging and AD/ADRD research. The Center(s) is/are funded through this NOFO, RFA-AG-26-006. Hereafter, the Centers will also be referred to as “Collaboratory(ies)” or "AITC(s)."
  • AITC Coordinating Center (AITCC): A center that provides leadership and coordination for the AITC program through a cooperative agreement with NIA. The AITCC is funded through RFA-AG-26-007, using the U24 (Resource-Related Research Projects – Cooperative Agreements) activity code. Hereafter, the AITC Coordinating Centers will also be referred to as “AITCC” or “Coordinating Center.”
  • AD/ADRD: ADRD include, but are not limited to, Frontotemporal dementia (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD), and Multiple Etiology Dementias (MED).

Background

This Notice of Funding Opportunity invites Center Core (P30) applications for the National Institute on Aging (NIA) Artificial Intelligence and Technology Collaboratories (AITC) Program. The AITC Program promotes the development and implementation of AI approaches and technology through research projects for aging and AD/ADRD research. AI and other emerging technologies have the potential to address pressing issues in aging and AD/ADRD. The AITC Program supports innovative cross-disciplinary collaborative teams, with investigators from academia, non-profit, and healthcare sectors across a wide range of disciplines working to advance priorities in aging and AD/ADRD research.Goals of the overall AITC Program are as follows:

1. Serve as a national resource to promote development and implementation of innovative AI and technology approaches to advance aging and AD/ADRD priorities;
2. Support nationwide research projects to develop and implement AI and technology approaches and respond rapidly to emerging priorities in the shifting AI and technology landscape; and
3. Collaborate with a wide range of stakeholders in addressing algorithmic fairness and how to incorporate AI and technology approaches in the special circumstances of individuals experiencing cognitive decline/impairment.

In achieving these goals, it is expected that the Collaboratories will interact with each other and with the AITCC. The AITCC will serve as a hub for the AITC Program and will facilitate and coordinate activities across Collaboratories. The AITCC will also facilitate a centralized program-wide Stakeholder Engagement Team to ensure that AI approaches and technologies developed by the Collaboratories will be maximally adoptable by and accessible to their end users by soliciting stakeholder input throughout all phases of the development cycle. 

Specific Objectives

The overarching objective of this NOFO and its companion NOFO, RFA-AG-26-007, are to provide a nimble infrastructure with resources to support collaborative opportunities for innovation in AI and technology approaches to advance aging and AD/ADRD research and improve the health and well-being of older adults, including those living with dementia and their caregivers.

To meet this objective, this NOFO invites applications for AITCs that:

1. Support innovative research projects to inform the design or application of AI and technology approaches relevant to NIA scientific priorities; and 
2. Develop infrastructure to enable broad collaboration and participation among investigators from academia, non-profit, and healthcare sectors across a wide range of disciplines.

To address ethical issues that are commonly raised about research in this area, all applications should propose strategies for addressing ethical challenges surrounding AI and technology development and implementation, and to employ, when possible, best practices established in the fields of aging and AD/ADRD.

Organizational Structure

Each Collaboratory will be comprised of two core components and one optional component: (A) Administrative Core; (B) Research Innovation Core; and (C) Investigator-Initiated Core (optional).

Applications will be considered incomplete if they do not include an Administrative Core and Research Innovation Core. Applicants have an option to propose one Investigator-initiated optional Core. Each Collaboratory must collaborate and engage in activities with the trans-AITC/AITCC Stakeholder Engagement Team led by the AITCC.

A. Administrative Core

This core will manage the overall vision and operations of the Collaboratory. Activities include, but are not limited to, the following:

• Providing a governance structure for the AITC.
• Providing a public website for communication and sharing of the activities, events, and resources of the program.
• Organizing and implementing an annual national competition for research projects, in conjunction with the AITCC, to include recommendations of meritorious research projects to NIA.
• Providing organizational and logistical support for the activities of the AITC Cores.
• Supporting standards and mechanisms to publicly share data, resources, and codes developed and utilized in AITC research projects.
• Collaborate with the AITCC to develop the theme, agenda, and logistics for an annual AITC Symposium to highlight progress of research project awardees. The AITCC will provide logistic and financial support for the annual AITC Symposium and the Collaboratories will engage with the AITCC in planning. 

B. Research Innovation Core

This core will support innovative research projects to inform the design or application of AI and technology approaches to advance aging and AD/ADRD research and improve the health and well-being of older adults, including those living with AD/ADRD and their caregivers. This core will collaborate with the AITCC to hold annual national competitions to fund and facilitate research projects consistent with the goals and scope of the AITC. Research projects can range in objectives, but must address topics related to aging and AD/ADRD. Each Collaboratory is expected to devote a minimum of 80% of its innovation budget toward AD/ADRD research projects. All research projects selected by the Collaboratory must be within the scope of the Collaboratory and require prior approval from NIA Program and Grants Management Staff.

Applicants should propose a consolidated or centralized institutional review board (IRB) approach consistent with the NIH single IRB policy and the revised Common Rule (rCR) cooperative research provision (45 CFR 46.114) for multi-site research for trial oversight to facilitate both appropriate and timely study implementation.

C. Investigator-Initiated Core (Optional)

Applicants have an option to propose one investigator-initiated optional core. This core is expected to serve the full AITC Program and should be beneficial to the research project awardees and applicants and may include focus areas such as study design, data science, technical support, ethics and privacy, or clinical translation. Successful applications may be required to revise aims of the Investigator-Initiated Core in order to avoid overlap of activities with other Collaboratories.

Illustrative Topic Areas

Each Collaboratory must promote a sustainable research and infrastructure development program in one or more thematic areas that have the potential to serve all NIA scientific interests. Illustrative topic areas for the Collaboratories may include the following:

• Resources to promote AI and machine learning (ML)-ready datasets.
• Design and modification of technology by incorporating AI applications into human factors problems/design associated with aging and AD/ADRD.
• Resources to promote integration of experimental and AI/ML approaches to better understand basic processes in the aging brain and AD/ADRD.
• Computational and informatics tools applied to the study of aging mechanisms.
• AI, ML, or health monitoring technologies in aging and AD/ADRD.
• AI-driven systems and computational biology.
• Imaging and image analysis.
• Clinical decision support tools using AI to enable personalized care for older adults with multiple chronic conditions.

Common Evaluation Metrics and Information Sharing

The continued success and sustainability of NIA’s AITC Program requires that Collaboratories demonstrate their value and impact in line with the program goals stated above. Collaboratories must cooperate and collaborate, under the purview of the AITCC, in sharing of AITC Program information and using common metrics and processes to inform future AITC Program evaluations by the NIA.

Common metrics and processes may include the following:

• Number and characteristics of research projects awarded each cycle;
• Representation of states and U.S. territories of applicants and awardees;
• Distribution of awardees across academia, industry, etc.;
• Number of research project awardees that go on to submit R01 or small business innovation research (SBIR) applications (or other outcomes of research project awards such as commercialization or business development);
• Distribution of project focus areas across NIA’s scientific portfolio;
• Innovation (e.g., are the research projects similar to the current NIA portfolio or do they stand out as different/innovative?);
• Number and nature of collaborations with other Collaboratories;
• Products resulting from collaborations with other Collaboratories;
• Number and nature of collaborations with other NIA or NIH funded projects;
• Products resulting from collaborations with other NIA or NIH funded projects;
• Number and nature of collaborations with organizations outside NIH; and
• Products resulting from collaborations with organizations outside NIH.

Collaboratories must cooperate and collaborate with the AITCC and the other Collaboratories in the development, utilization, and sharing of these metrics and processes. The AITC Program and its constituent parts will be evaluated by the Office of Planning, Analysis, and Evaluation at NIA on the extent to which they meet the overall goals of the program, and make recommendations regarding progress of the AITC Program, including changes, if any, that would benefit the program.

External Advisory Panel

An External Advisory Panel (EAP) for the AITC Program will be established, in conjunction with the AITCC, to review the progress of all components of the program and provide recommendations to the AITC and AITCC Project Directors and/or Principle Investigator (PD(s)/PI(s)).

• EAP Membership: 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 Collaboratory. The EAP is expected to have 5-7 permanent members; however, membership may expand permanently or on an ad hoc basis as needed. The AITCC is expected to propose suitable EAP members to NIA for final approval.
• EAP Meeting Logistics: The EAP will meet twice a year to evaluate and comment on the progress of the AITC Program. The meetings will alternate between virtual and in-person formats. The in-person meeting should be planned in conjunction with the annual AITC Symposium to be held at an NIA-approved federal or non-federal location.
• EAP Meeting Content: During the EAP meeting, AITC and AITCC PIs are expected to present annual accomplishments and future directions. The EAP will make recommendations, in writing, regarding progress of the AITC Program, including changes, if any, that would benefit the program.

Non-Responsive Criteria

The following types of applications will be considered non-responsive and will be withdrawn prior to review:

• Applications that do not propose a focus area in the field of AI and technology.
• Applications that do not address aging and AD/ADRD.
• Applications that do not address ethical issues in AI and technology development and implementation.
• Applications that do not identify a PD/PI with a degree in computer science, computational biology, or other field closely related to AI and technology

Clinical Research Operations Management System

NIA utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant and as described in NOT-AG-23-017. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website.

When applicable, all NIA grantees must ensure:

1. The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 §46.116, all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.” If using the NIA informed consent template please see Section 6: Statement of Confidentiality.

2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Local 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)

Federal Governments

• 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 Organizations/ International Collaborations

NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

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 per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- 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 How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

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

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

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 Locations (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 and Related Senior/Key Person Profile (Overall)

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

The Collaboratory Director is expected to have a technical (e.g., degree in computer science, engineering, or computational biology) or statistical (e.g., degree in applied mathematics or statistics) background and to have worked collaboratively (e.g., demonstrated experience or a plan) with a team of geriatricians, neurologists, neuroscientists, biologists, and other core leaders from different backgrounds. The proposed team must have the appropriate breadth of expertise, which may include, but is not limited to, the following:

• Degree in computer science, engineering, computational biology, or other similar fields, and/or relevant working experience in the AI/technology industry;
• Expertise in geriatrics, bioinformatics, computational biology, systems biology, biology of aging, and/or neurology and neuroscience;
• Expertise in study coordination, data management, and statistics;
• Experience conducting prototype development studies relevant to proposed areas of emphasis;
• 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 AI (e.g., current data models, algorithms, and approaches used by various studies and its implications) and emerging technologies;
• Project management experience in translating an idea to a product;
• Creativity and innovation (e.g., designing for adaptation of technology for older adults) 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. Therefore, the PD(s)/PI(s) must commit and sustain 3 person-months of effort per year throughout the award to manage the 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 must commit and sustain 3 person-months of effort to manage these cross-institutional and cross-organizational activities across all years of funding.

The Executive Director for the Collaboratory must contribute 9 person-months of effort across all years of funding.

The applicant must provide evidence of how the planned collaboration will work among a team with potentially very different scientific backgrounds. 

Note on Key Personnel: To avoid establishing conflicts of interest throughout the field, applicants are strongly encouraged to limit the number of key personnel. Except for those key personnel listed on the application, participation in Collaboratory activities, including presentation at workshops and conferences or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH. 

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 Collaboratory key personnel (e.g., PD(s)/PI(s) and Core Leaders) to attend an annual meeting in the Bethesda, MD area. 

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: 

• Describe the aims of the Collaboratory and outline how different core components will contribute to these aims.
• Each Collaboratory must promote a sustainable research and infrastructure development program in one or more 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 Collaboratory applications must address the general aging and AD/ADRD research areas they will pursue in the Research Innovation Core.
• It is recommended that each applicant provide detailed milestones for each core for 5 years of proposed activities.

Research Strategy:

Applicants must:

• Describe a strategic vision for the Collaboratory, addressing the overall objectives, long-term goals, and milestones of the Collaboratory.
• Describe how the proposed approach will advance AI and technology approaches to benefit AD/ADRD and general aging research and/or improve the health of older adults and persons living with AD/ADRD and their caregivers.
• Explain how the Collaboratory will employ principles of creativity and flexibility to facilitate innovation in the rapidly changing  AI and technology research landscape, including research implementation strategies, and use of  novel theoretical concepts, approaches or methodologies, or tools.
• Describe how different core components will interact to help accomplish the Collaboratory aims. Where appropriate, provide timelines and organizational charts.
• Describe how the Collaboratory will collaborate with research project recipients.
• Describe how the Collaboratory will uphold best practices for responsible use of AI and emerging technologies and address issues such as algorithmic fairness and improving access and delivery of care in rural areas.
• Describe plans to identify and address barriers to implementing AI and technology approaches.
• Explain how the proposed activities will facilitate flexible, modular, and scalable policies, practices, and tools to enable broad collaboration and participation among AI and technology researchers beyond academia.
• Describe how the Collaboratory will engage nationally and work with other Collaboratories and the AITCC to stay abreast of emerging experience, regulations, and technical advances to inform approaches, methods, processes, policies, and tools used in this program. Successful Collaboratory grant applications are required to cooperate and work with the AITCC to be funded via RFA-AG-26-007. (PLEASE NOTE: This may require revision of the aims, data, and resource sharing statement in order to avoid overlap of activities with the AITCC.)
• Describe how the Collaboratory will engage in activities with the AITC/AITCC-wide Stakeholder Engagement Team led by the AITCC. The objective of the AITCC-led Stakeholder Engagement Team is to ensure that AI approaches and technologies developed by the Collaboratories will be maximally adoptable by and accessible to their end users by soliciting stakeholder input throughout all phases of the development cycle.

Progress Report for Renewal Applications

Renewal applications must include descriptions of Collaboratory activities since the last competitive review. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits. 

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

Without duplicating information in the attachments to the PHS Human Subjects and Clinical Trials Information form, applications in response to this funding opportunity must provide further rationale supporting eligibility criteria and study population characteristics. Applicants should propose innovative and proactive recruitment strategies as applicable and justified by the scientific goals. Applicants should ensure that they address the populations appropriate and relevant to the proposed research and scientific goals. Recruitment and retention plans should demonstrate an understanding of the participant burden involved in research participation and strategies for minimizing this burden, as well as leveraging community partners and outreach efforts. The recruitment and retention plan must:

• Describe potential barriers to participation and plans to minimize these barriers.
• Describe a plan to leverage existing relationships with and/or conduct outreach to a broad range of community groups.

In addition, without duplicating information in the attachments to the Human Subjects and Clinical Trials Information form, applications in response to this funding opportunity must provide further rationale supporting eligibility criteria and study population characteristics that are representative of the population affected by the disease/condition as well as other populations relevant to the proposed research and scientific goals.

Where applicable, study teams should also demonstrate that they have critically evaluated whether eligibility criteria from an earlier phase trial should be carried forward into a later phase trial. Further rationale supporting eligibility criteria and study population must:

• Describe how the study results generalize to the wider patient population with this disease/condition.
• Explain how the rationale for selected eligibility criteria justifies the level of restriction in the study compared to clinical practice.

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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

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

All instructions in the How to Apply- 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 ‘Project 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.

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:

• Administering an annual national research project program which will support development and implementation of AI approaches and technology.
• Coordinating activities and tracking outcomes of cores to meet requirements for reporting to the AITCC that will be funded through RFA-AG-26-007.
• Supporting standards and mechanisms to publicly share data, resources, and codes developed and utilized in Collaboratory research projects.
• Collaborating with the AITCC to develop the theme, agenda, and logistics for an annual AITC Symposium to highlight progress of the AITC Program and research project recipients. 

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 must:

• Describe the governance and organizational structure of the Collaboratory 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 Collaboratory.
• Describe processes for problem-solving, communication, and prioritization of work.
• Include a plan for the integration of Collaboratory activities to accomplish overall goals.
• Describe operating procedures for ensuring responsiveness to members of the research community who wish to access and utilize Collaboratory resources.

Letters of Support: Only letters of support specific to "Admin 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 How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Research Innovation Core

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

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Innovation 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 (Research Innovation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Innovation 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) (Research Innovation 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 (Research Innovation Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.

Budget (Research Innovation Core)

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

Each Collaboratory must allocate $4,000,000 in total costs per year for five years exclusively for research projects. Each AITC must include AD/ADRD and general aging projects. The research project allocation must adhere to the following:

• At least 80% of Research Innovation Core funds must be allocated to AD/ADRD-related projects each year; no more than 20% of Research Innovation Core funds can be allocated to aging projects each year.
• Collaboratory-initiated research: Collaboratory PIs may conduct research as part of the Research Innovation Core. No more than $200,000 of Research Innovation Core funds may be allocated to support projects from the PI team each year and these projects must support the development of AITC infrastructure or resources (e.g., developing a large language model (LLM)-based search engine for AD/ADRD research). Collaboratory PIs are not required to conduct research as part of the Research Innovation Core.
• Annual national competition for research projects:
  • Each Collaboratory must participate in the annual national competition.
  • The budget for non-clinical trial research projects awarded through the annual competition may not exceed $200,000 in direct costs over two years. Each non-clinical trial research project is expected to last from six months to two years.
  • Collaboratories may award up to one fully-powered clinical trial per cycle but are not required to award any. Clinical trial budgets may not exceed $300,000 in direct costs over two years. As appropriate, proposed clinical trials should be conducted in accordance with the NIH Stage Model, to produce potent and implementable behavioral interventions that can be defined by their governing principles.
• Rapid-response innovation project: Collaboratories may award up to $200,000 of Research Innovation Core funds to fund one award outside of the annual national competition cycle through rapid-response solicitations for innovative research projects on topics of emerging importance.
• AD Innovation Award Competition: Each Collaboratory may independently hold an AD Innovation Award competition to solve pressing problems in AD/ADRD using novel applications of AI/technology. Collaboratory PIs must work with the AITCC to solicit AD Innovation Award applications. The AD Innovation Award may be a clinical trial but is not required to be a clinical trial. The budget for the AD Innovation Award may not exceed $500,000 in direct costs.

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 (Research Innovation Core)

Specific Aims: State the goals of the proposed Research Innovation Core concisely and summarize the expected outcome(s), including the impact that the results of the proposed activities will exert on the research field(s). Aims must include both general aging and AD/ADRD goals. Describe the methods to address selection, development/refinement, and management of research projects.

Research Strategy: The Research Innovation Core research strategy must:

• Provide a succinct description of the types of research studies that the Collaboratory may solicit within its scope. All research projects selected by the Collaboratory must be within its scope.
• If Collaboratory-initiated research is proposed, provide a description of the research and indicate how it will support development of center infrastructure or resources (e.g., developing an LLM-based search engine for AD/ADRD research).
• Describe the process for coordinating with the AITCC to facilitate the centralized solicitation and external review of research projects in the annual national competition.  
• Describe the process for selecting, and evaluating promising research projects with both general aging and AD/ADRD focus, including evaluation of data management and sharing (DMS) plans, in alignment with NIH DMS Policy. All research projects selected by the Collaboratory require prior approval from NIA Program and Grants Management Staff
• Describe how innovative and meritorious aging and AD/ADRD research projects will be funded and managed. Include a description of a national competition to invite research project applications, to be held on an annual basis.
• Describe the process for coordinating with the AITCC for management of research projects and tracking outcomes, including tracking compliance with DMS plans.

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 "RI 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 How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Innovation 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 How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Investigator-Initiated Core (Optional)

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

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Investigator-Initiated 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 (Investigator-Initiated Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Investigator-Initiated 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) (Investigator-Initiated 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 (Investigator-Initiated Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.

Budget (Investigator-Initiated 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 (Investigator-Initiated Core)

Specific Aims: State the goals of the proposed core concisely and summarize the expected outcome(s). Succinctly state how the proposed core will benefit the Collaboratory and AITC Program, including research project applicants and recipients.

Research Strategy: This is an optional core which the PD(s)/PI(s) may propose. PD(s)/PI(s) should specify how this Investigator-Initiated Core will benefit the overall Collaboratory and AITC Program and describe expected outcome(s). The Investigator Core Research Strategy must:

• Describe how the Investigator Core will augment or enhance the capabilities of the overall Collaboratory, including research project recipients, using collaborator resources.
• Describe potential challenges, alternative strategies, and benchmarks for success specific to the Investigor Core. 

Letters of Support: Only letters of support specific to "Investigator 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 How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Investigator-Initiated 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 How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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 How to Apply- 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 How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - 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 NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project proposed).

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 project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project 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 project 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?

Specific to this NOFO: 

How adequate are the plans to serve as a national resource, provide leadership in the field, and engage multiple stakeholders to promote the development and implementation of AI and technology approaches to address priorities in aging and AD/ADRD? To what extent does the applicant specify how AI and technology within the Collaboratory will advance aging and AD/ADRD research and translational priorities?

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 project? 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?

Specific to this NOFO: 

How adequate is the breadth of expertise and experience of the investigative team in computer science (AI and technology), computational biology, geriatrics, bioinformatics, and/or neurology? How well do the qualifications and experience of the investigators address the stated goals of the Collaboratory?  To what extent are the investigators willing to collaborate with research project recipients, other Collaboratories, and the AITCC to meet the goals and objectives of this program? How adequate are proposed plans for collaboration 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/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?

Specific to this NOFO: 

To what extent does the application challenge and seek to impact the current AI and technology research and implementation landscape using novel theoretical concepts, approaches or methodologies, or tools to advance aging and AD/ADRD research? To what extent does the application indicate creativity and flexibility needed for ongoing innovation in the rapidly changing fields of AI and technology? How well does the application identify and provide plans to address barriers to implementing AI and technology approaches?

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 project? Have the 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 project 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, 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?

Specific to this NOFO: 

To what extent will the proposed activities facilitate flexible, modular, and scalable policies, practices, and tools to enable broad collaboration and participation among AI and technology researchers beyond academia? To what extent does the proposed approach allow for implementation of AI and technology approaches towards advancing aging and AD/ADRD research and improving the health and well-being of older adults, including those living with AD/ADRD and their caregivers? How adequate are the proposed plans for engaging with the AITCC in stakeholder engagement activities? To what extent does the applicant specify how AI and technology within the Collaboratory will address algorithmic fairness and improving access and delivery of care in rural areas?

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, sex, 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 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 involving 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 project 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 involving 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 Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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.

Additional Review Criteria - Administrative Core

Approach

How adequate are the procedures for internal communication and cooperation among investigators and external stakeholders? To what extent does the proposed administrative structure facilitate team science and integration of researchers outside of academia?

Additional Review Criteria - Research Innovation Core

Significance

To what extent does the proposed scope of annual research project competition support innovative research and advance priorities in aging and AD/ADRD?

Approach

How adequate are the plans for soliciting innovative aging and AD/ADRD-focused research projects? To what extent does the application describe plans for coordinating with the AITCC to facilitate the centralized solicitation and external review of research projects in the annual national competition through national competitions?

Additional Review Criteria - Investigator-Initiated Core (Optional)

Significance

How well does the proposed Investigator-Initiated Core contribute to the goals of the AITC and mission of the overall AITC Program? To what extent will the proposed Investigator-Initiated Core serve as a resource to the entire AITC Program, including research project applicants and recipients?

Approach

How well does the proposed Investigator-Initiated Core augment or enhance the capabilities of investigators using AITC resources? To what extent does the application describe potential challenges, alternative strategies, and benchmarks for success?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policies and practices, 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 will receive a written critique.

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.

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

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient 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 Research Projects

Recipient-selected projects that involve require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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: https://www.era.nih.gov/need-help  (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

NIA

Email address for all inquiries: [email protected]

Rebecca Krupenevich, Ph.D.
Division of Behavioral and Social Research

Marcel Salive, MD, MPH
Division of Geriatrics and Clinical Gerontology

Leonid Tsap, Ph.D.
Division of Aging Biology

Amanda DiBattista, Ph.D.
Division of Neuroscience

Center for Scientific Review (CSR)
Email: [email protected]

Megan Hancock
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

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.

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 2 CFR Part 200.