Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
More Monitoring of Cognitive Change, Continued (M3C3) (U2C Clinical Trial Optional)
Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type
New
Related Notices

RFA-AG-18-012 - Mobile Monitoring of Cognitive Change (U2C)

Funding Opportunity Announcement (FOA) Number
RFA-AG-23-021
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to expand the content, design, and implementation of research infrastructure funded under RFA-AG-18-012, “Mobile Monitoring of Cognitive Change (U2C),” collectively known as the Mobile Toolbox (MTB) Project, by addressing the need to (1) add assessments on mobile devices of non-cognitive socioemotional psychological functions, health states, and contextual factors that may modify cognitive performance; and (2) enable widespread dissemination and support for use of the tools developed for monitoring of age, state, context, or health condition-related changes in cognitive and non-cognitive abilities on mobile devices. The expanded MTB efforts must include the development, or support for development, of applications on the two leading smartphone platforms, the Android and iOS smartphone platforms, and the validation of new tests and items to be used on the platforms by age groups ranging from 20 to 85. Goals of this expanded platform are to support data collection efforts from participants enrolled in the project awarded through this FOA, as well as other studies funded by the National Institutes of Health (NIH), through fiscal year 2027, and to enable the widespread sharing of both the collected data and the test instruments. Thus, research supported through this FOA will continue the development of the MTB platform as described above, with expanded content, wider dissemination, and the ability to add study-specific measures, as well as leverage a shared data processing backend. Additionally, supported research will aim to bring to maturity a model for future cost recovery, via standardized subcontracting terms, conditions, and costs, that will allow the platform to remain continuously updated and available for widespread use as the easiest means for researchers to collect real-time, real-world, and temporally extended data most relevant to the early detection and study of Alzheimer’s disease (AD) and AD-related dementias (ADRD).

Key Dates

Posted Date
July 11, 2022
Open Date (Earliest Submission Date)
September 18, 2022
Letter of Intent Due Date(s)

September 20, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 20, 2022 October 20, 2022 Not Applicable February 2023 May 2023 July 2023

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 Funding Opportunity Announcement.

Expiration Date
October 21, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.



  3. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The pathological processes related to Alzheimer’s disease (AD) and AD-related dementias (ADRD) may begin in midlife, if not before, which increases the need for precise and reliable measurements of even subtle neuropsychological changes in midlife. To be most useful, these measures should be easy to obtain in real-world settings at multiple points across time. In response to this need, the National Institute on Aging (NIA) released Funding Opportunity Announcement (FOA) RFA-AG-18-012, “Mobile Monitoring of Cognitive Change (U2C),” which has supported the development and validation of the Mobile Toolbox (MTB). The MTB involves two closely collaborating cooperative agreements designed to create tools that expand the range of contexts and frequencies for cognitive assessments, resulting in more accurate estimates of cognitive variability and vulnerability. Such tools include ultra-brief cognitive tests suitable for ecological momentary assessment and burst measurement designs that, over an extended period, allow for the detection of very subtle cognitive changes, as well as mobile application (app) versions of the NIH Toolbox for Assessment of Behavioral and Neurological Function® (NIH Toolbox) that can serve as replacements for traditional neuropsychological tests.

The MTB is designed to allow the detection of very subtle cognitive changes and afford expanded opportunities to compute cognitive trajectories. In addition, platforms developed under the MTB may allow investigators to measure intra-individual cognitive variability, which is increasingly recognized as a potential sign of future cognitive decline. Together, these tools could expand the range of contexts in which, and frequency with which, aspects of cognition can be assessed, potentially resulting in more accurate estimates and earlier detection of cognitive vulnerability.

To date, the MTB Project has combined complementary approaches to the development of research infrastructure that enables mobile phone-based monitoring of cognitive abilities and of cognitive changes associated with age, state, context, and health conditions. These efforts include the development of apps on the two leading smartphone platforms, Android and iOS, allowing validation of tests and items in age groups ranging from 20 to 85 years of age, along with further norming of validated mobile measures against non-mobile gold standard neuropsychological measures in nationally representative U.S. population samples. The MTB is on track to make a limited release of finished apps in 2022, while population norms are being generated, followed by general researcher availability by 2023.

Except for measures specifically dependent on language, the tasks under development have been designed to be as culture-independent as possible, andthe MTB will have versions of the instruments in both English and Spanish upon release. Moreover, prior work has demonstrated that the NIH Toolbox, which is the source of the non-ecological momentary assessments (EMA) based measures in the Mobile Toolbox, is readily translatable into other languages and usable in a wide variety of settings.

Measures involving AD/ADRD biomarkers, either neuroimaging or fluid-based, are invasive and costly when considered for the purpose of repeated measures to allow for early detection. Additionally, AD/ADRD biomarker measures fail to provide information about functional outcomes, either in terms of cognition specifically or activities of daily living more broadly. Dementia screenings can detect moderate to severe impairment, and neuropsychological tests can detect milder levels of impairment; however, validated tests for assessing subtle behavioral changes at earlier points in the trajectory of AD/ADRD-related decline are not yet available. Therefore, the original MTB project, and this expansion FOA, centers on the development of tools for the early detection of psychological and behavioral changes that may presage a transition to Mild Cognitive Impairment (MCI) or differentiate specific types of AD/ADRD (e.g., frontotemporal dementia (FTD)).

One challenge of measuring subtle, albeit meaningful, psychological or behavioral change is that change itself is multi-timescale, meaning it occurs and can be measured over short or long timespans. Additionally, change is multi-directional, meaning that on any given occasion, performance may be better or worse for a variety of reasons (e.g., stress, fatigue, inflammation, brain changes, social activity, etc.). Measurement error and other confounds (e.g., practice, test/retest, etc.) further complicate the earliest detection of interpretable and meaningful subtle changes. Addressing these challenges is a major goal of the MTB project, and is in line with milestone 9.H of the AD+ADRD Research Implementation Milestones. The 9.H milestone is to, "Launch research programs to develop and validate sensitive neuropsychological and behavioral assessment measures to detect and track the earliest clinical manifestations of AD and AD-related dementias."

Purpose

This FOA invites applications to expand the content, design, and implementation of research infrastructure funded under RFA-AG-18-012, also known as the MTB Project, by addressing the need to (1) add assessments on mobile devices of non-cognitive socioemotional psychological functions, health states, and contextual factors that may modify cognitive performance; and (2) enable widespread dissemination and support for use of the tools developed for monitoring of age, state, context, or health condition-related changes in cognitive and non-cognitive abilities on mobile devices. The expanded MTB efforts must include the development, or support for development, of applications on the two leading smartphone platforms, the Android and iOS platforms, and the validation of new tests and items to be used on the platforms by age groups ranging from 20 to 85. Goals of this expanded platform are to support data collection efforts from participants enrolled in the project awarded through this FOA, as well as other studies funded by the National Institutes of Health (NIH) through fiscal year 2027, and to enable the widespread sharing of both the collected data and the test instruments. Thus, research supported through this FOA will continue the development of the MTB platform as described above, with expanded content, wider dissemination, and the ability to add study-specific measures, as well as leverage a shared data processing backend. Additionally, supported research will aim to bring to maturity a model for future cost recovery, via standardized subcontracting terms, conditions, and costs, that will allow the platform to remain continuously updated and available for widespread use as the easiest means for researchers to collect real-time, real-world, temporally extended data most relevant to the early detection and study of AD/ADRD.

Research Objectives

With the original MTB project nearing completion, and a greater interest in remote assessment due to the COVID-19 pandemic, this FOA is intended to support efforts to expand the content supported by the MTB, and to promote the wide dissemination, utilization, and further enhancements of the apps and infrastructure developed under this project to date. Specifically, this FOA invites proposals to enhance existing infrastructure to support measurement of other “non-cognitive” neuropsychological variables relating to socioemotional skills and capacities, such as affect, self-regulation, motivation, social states, personality-related processes, decision-making abilities, stress experiences, and stress reactivity. There is increasing interest in the extent to which early psychological and functional changes in these psychological functions may be harbingers of cognitive decline, MCI, and AD/ADRD.

A truly comprehensive platform must include assessment of contextual variables that influence the affective, social, cognitive, and functional changes associated with AD/ADRD. For example, additional measures of environmental stressors may provide critical information about stress reactivity or self-regulation in the moment and its concurrent impact on cognition. NIH has supported multiple networks that offer opportunities for collaboration and input on mobile measures to be developed. Examples of such opportunities include, but are not limited to, the following:

Additionally, NIH has supported various workshops and expert meetings that are germane to this initiative. For example, the recent expert meeting on “Non-pharmacological Approaches to the Early Prevention of AD/ADRD” identified a number of potential non-cognitive targets for intervention and for which measures of subtle cognitive, and non-cognitive, changes are critical.

To address research questions about how both cognitive and non-cognitive psychological functions are shaped by context, applications must propose the development of functionality to enable the addition of mobile phone-based ultra-brief surveys to capture critical information about acute and/or chronic exposures, such as daily hassles, caregiving stressors, health challenges, health behaviors, discrimination, and health systems interactions.

Applications must also propose to develop functionality that would allow linkages to the physiological data obtainable through passive sensors on mobile devices or attachable biosensors (e.g., location, gait speed, heart rate variability, skin conductance) to capture information about health states. With infrastructure designed to handle data intensive monitoring and/or machine learning-based analyses, such information could shed light on factors influencing cognition across time at the individual level. Moreover, analyses of aggregate data from large numbers of individuals could address important clinical questions, such as whether certain medications are associated with changes in cognitive status in a dose and/or time-dependent manner.

As is the case with all mobile research apps, one important design/implementation challenge to be met by this expansion of the MTB is how best to encourage or incentivize persistent use of the app(s), especially in studies that will need to be “active” for an extended period of time. It is expected that the MTB will develop and implement best practices for adherence derived from other platforms, while also informing the development of app adherence strategies given the broad array of use cases that are anticipated. The recent NIH-NASEM workshop on the “Experimental Medicine Approach in Primary Prevention” is relevant to this point. Additional information about this approach is available on NIA's Science of Behavior Change's webpage.

An additional opportunity could be provided by the potential inclusion of the MTB in large longitudinal studies of AD/ADRD. For example, the MTB could provide a very large cognitive dataset that could be used for genome-wide analyses of very refined phenotypes related to AD/ADRD throughout the lifespan.

The ultimate mobile platform developed under this FOA will need to be flexible in adapting to specific research needs; this flexibility will be enhanced through the use of well-documented Application Programming Interfaces (APIs) on which the MTB is based that allow other investigators to use the platform to develop and deploy instruments for their own studies as well as for use by others. To date, the MTB has followed both the FAIR and TRUST data principles, and it is required that applications describe explicit plans to incorporate these principles so that all code developed in support of the project will be available under an Open Source license. These principles are vital for carrying over into future efforts and must be followed in future work as outlined in this FOA. Additionally, applications must describe plans for future cost-recovery efforts to sustain continued development/ refinement of the platform.

Resources for Applicants

  • NIA's webpage for information regarding the Cost-Effective Early Detection of Cognitive Decline workshop – An NIA-sponsored workshop held in October 2017 that examined the science for cost-effective early detection of cognitive decline, using both passive and active approaches, and identified research gaps and opportunities in this area. Invited speakers included researchers and experts from academia, nonprofit organizations, and industry.
  • NIA's webpage for information regarding NIA's Division of Behavioral and Social Research's (BSR) Research Networks – BSR currently supports 17 interdisciplinary research networks that provide infrastructure for advancing the development of high priority areas of behavioral and social research relevant to aging. These networks are intended to serve the broader community of behavioral and social researchers engaged in aging-relevant research in several scientific areas.
  • NIA's webpage for information regarding Data Sharing Resources for Researchers – There are a variety of data sharing policies, considerations, resources, and guidance available to support researchers in safely and efficiently sharing data from their studies. NIA also provides data resources to the Alzheimer’s and the broader aging research community.
  • Download a summary report of the Applying Digital Technology for Early Diagnosis and Monitoring of Alzheimer’s Disease and Related Dementias workshop – An NIA-sponsored workshop held in April 2019 that brought together participants from academic research and medical centers, industry, and the federal government to examine the potential of digital technologies in combination with powerful computational tools to detect subtle changes in cognitive, behavioral, sensory, and motor functions that may signal the gradual onset of AD/ADRD.

Non-Responsiveness Criteria

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

  • Applications that do not build on prior work already completed in the MTB project funded under RFA-AG-18-012.
  • Applications that do not include plans for assessing adherence and adherence strategies given the broad array of use cases that are anticipated.
  • Applications lacking explicit plans for developing and validating mobile measures of “non-cognitive” socioemotional psychological functions.
  • Applications lacking explicit plans for developing and validating mobile assessments for some effects of ‘exposures’ and functionality.
  • Applications lacking explicit plans for linkage with physiological data obtainable through passive sensors on mobile devices or attachable biosensors to capture information about health states.

Frequently Asked Questions

Responses to frequently asked questions about this FOA will be posted here.

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

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

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

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIA intends to commit $4,800,000 in fiscal year 2023 to fund 1 award.

Award Budget

Application budgets are limited to $4,800,000 in total costs per year and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • 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 full SAM and Grants.gov registrations; 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Dana Jeffrey Plude, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: Dana.Plude@nih.gov

Page Limitations

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

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 6 Required 1 1
Admin Core Admin Core 6 Required 1 1
Data and Statistical Analysis Core Data Core 12 Required 1 1
Technical Core Technical Core 6 Required 1 1
Extension and Dissemination Core ED Core 6 Required 1 1
Projects Project 12 Required 1 2

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required
  • Data and Statistical Analysis Core: required
  • Technical Core: required
  • Extension and Dissemination Core: required
  • Projects: required

Overall Component

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

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site 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 FOA) for the entire application.

The investigative team should demonstrate sufficient software and hardware expertise to support use of and modifications to the current platform.

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.

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

PHS 398 Research Plan (Overall)

Specific Aims: Comprehensively address the goals of this FOA, which are to design and implement research infrastructure that will enable assessments on mobile devices of non-cognitive socioemotional psychological functions, health states, and contextual factors that may modify cognitive performance, as well as enable widespread dissemination and support for use of the tools..

Research Strategy: Applicants must describe the overall structure of their proposed solution to the infrastructure problem; their proposed development strategy for the required backend software system and for app development on the iOS and Android systems; the process for consideration, evaluation, and determination of new measurement instruments that may be added or changed within the project; any novel approaches they will use to capture relevant information; unique advantages or capabilities of the research resource; and how the overall system will leverage free and open tools for software development and the establishment of APIs, or, if proprietary systems are used, a justification for the use of these non-sharable components. Note that the project may require modification of existing instruments or creation of new ones appropriate to the target groups in this initiative, but should not propose creation of intellectual property that cannot be freely shared with the research community or the general public. The resource should allow accessibility of measurement tools and data by researchers. Applicants must describe how their plan will increase uptake of the resource for use in research and clinical settings. In the Overall section, applicants should address how the various cores will be coordinated in order to establish the research resource. Applications must describe explicit plans for incorporation of FAIR and TRUST data principles, and for ensuring that all code developed in support of the project will be available under an Open Source license. Applications should describe design plans for future cost-recovery to sustain continued development/ refinement of the platform.

Applicants must also describe the resources available in the scientific environment to support electronic information handling, as well as commitments of facilities, infrastructure, and other resources to allow for the full-scale operation.

Focusing on the project as a whole, applicants must describe (i) the importance of the problem and barriers to progress in the study of life course cognitive change; (ii) how the resource to be developed in the proposed project will improve scientific knowledge, assessment capability, and/or clinical practice; and (iii) how assessment and monitoring of cognitive ability across the lifespan will be changed if the proposed aims are achieved.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application. Only letters relevant to the entire application should be submitted in this component. Letters specific to a core or project should be submitted in the relevant component.

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

  • All applications, regardless of the amount of direct costs requested for any one year, must address Resource Sharing Plans, including (1) a Data Sharing Plan; (2) Sharing Model Organisms; and (3) a Genomic Data Sharing Plan (GDS). The plans must provide details for what will be shared (including apps, code, instruments, and other resources), how it will be organized to enhance the user experience, and any limitations/restrictions on access to resources and data produced by the project. The data sharing plan must ensure maximum availability to the research community beyond the study team (accounting for human subjects considerations).

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Applications should describe the experience and training of the investigative team in managing mobile measurement research and in coordinating collaborative research. If the Center is multi-PD/PI, explain how the investigators have complementary and integrated expertise and skills; and how their leadership approach, governance, plans for conflict resolution, and organizational structure are appropriate for the Core. If necessary, describe the team’s experience overseeing selection and management of subawards

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: Identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives. Describe how the proposed Core addresses the needs of the research projects that it will coordinate and how the scope of activities proposed for the Core is appropriate to meet those needs. Explain how successful completion of the aims brings unique advantages or capabilities to the research projects.

Research Strategy: The Administrative Core will provide overall administrative and organizational oversight and management of the Cores and Projects. As part of this section, applicants must address the following:

  • Explain how the Core will establish and implement the basic governance, operational, and policy structures, including setting up committees and coordinating their execution;
  • Explain how the Core will interface with the other Cores and support the work of the Project, including facilitating novel multidisciplinary and interdisciplinary strategies;
  • Explain how Core staff will lead the proposed program and interact with any other program and organizational components within and outside the institution;
  • Describe an appropriate plan for work-flow and a well-established timeline;
  • Describe internal evaluations, self-assessment processes, and progress reporting activities that have the ability to assess and anticipate both researcher and participant needs;
  • Describe meeting support for annual Steering Committee meetings and monthly teleconferences, and subcommittees as necessary;
  • Describe the support for the External Scientific Panel (ESP) to attend annual Steering Committee meetings and disseminate feedback to all cores and projects;
  • Describe the Core's ability to prioritize and incorporate improvements into operations and software that enhance its utility for research;
  • Describe the process for addressing any readily anticipatable challenges/obstacles and alternative strategies to surmount potential obstacles; and
  • Describe a strategy for providing communication channels (e.g., email, social media, or web-based content such as frequently asked questions, and other appropriate mechanisms).

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

 

Data and Statistical Analysis Core

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

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

SF424 (R&R) Cover (Data and Statistical Analysis 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 (Data and Statistical Analysis Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data and Statistical Analysis 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) (Data and Statistical Analysis 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 (Data and Statistical Analysis Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Data and Statistical Analysis 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 (Data and Statistical Analysis Core)

 

Specific Aims: Identify general objectives planned for the development and functioning of the Data and Statistical Analysis Core. Objectives should target plans for development of psychometric properties for the test instruments proposed in the Project (Measurement Battery) below, data interoperability, data access and security, and privacy, along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: The Core should develop a central data and software resource for integrating and facilitating access, analysis, and dissemination of data for the purposes of determining the measurement properties of the instruments in the defined groups. Information regarding the dissemination of data and instruments should be presented in the Extension and Dissemination Core.

Applications must describe the following:

  • The overall vision of the Data and Statistical Analysis Core and how this meets the project objectives;
  • Overall approach to developing and utilizing the appropriate expertise from the measurement science and assessment technology communities;
  • The proposed process for creating a central data repository with the capability to store/aggregate all primary and processed data;
  • Plans for statistical and psychometric oversight and input;
  • Plans for integration and analysis of data obtainable from mobile devices (e.g., cognitive tests, "non-cognitive” neuropsychological variables, other psychological measures, information on activity or movement, and physiological sensors) on the same subjects to achieve development of a valid research resource;
  • Plans to prioritize and incorporate improvements into operations and software that enhance its utility for research;
  • Plans to establish a data-submission pipeline, quality-control metrics, and provenance checking required to deposit data for analysis;
  • Plans to combine and analyze various formats of data, including previously collected machine-readable data on the participants in the study;
  • The ability to store and report participant data to the researchers via a secure system compliant with applicable federal data-security standards;
  • The ability to test additional instruments for possible inclusion into the research resource;
  • Specific processes and methods for integration of data generated by outside sources; and
  • The ability to perform quality control to ensure that any new measures meet relevant standards.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Data and Statistical Analysis Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

 

Technical Core

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

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

SF424 (R&R) Cover (Technical 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 (Technical Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Technical 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 (Technical Core)

 

Specific Aims: Identify general objectives planned for the development and functioning of the Technical Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: Describe the technologies to be initially deployed, the capacity to address system standards and upgrades, and the incorporation of any new measures into the proposed measurement system platform. Applications must describe the following:

  • The overall approach and methods for utilizing existing smartphone development platform(s) and technologies in the context of the project goals;
  • The process for monitoring the hardware and software technology in the context of the project;
  • The ability to create programming and database structures for receipt, storage, management, and analysis of the collected data;
  • Software maintenance and upgrades as well as security and backup processes;
  • How the Core will build upon and coordinate the use of existing standards, specifications, and resources where possible to meet requirements;
  • How the Core will facilitate novel multidisciplinary and interdisciplinary research strategies;
  • How Core staff will lead the proposed program and interact with any other program and organizational components within and outside the institution;
  • Basic technical support for use of smartphone apps;
  • The ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.;
  • The ability to ensure appropriate translation of any proposed or additional instruments into foreign languages (e.g., Spanish);
  • The ability to ensure data security and maintain confidentiality of personally identifiable information at the highest level; and
  • Server maintenance, software maintenance and upgrades, security, backup processes, and a data recovery plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Technical Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

 

Extension and Dissemination Core

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

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

SF424 (R&R) Cover (Extension and Dissemination 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 (Extension and Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Extension and Dissemination 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) (Extension and Dissemination 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 (Extension and Dissemination Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Extension and Dissemination 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 (Extension and Dissemination Core)

 

Specific Aims: Identify general objectives planned for: 1) the sharing of participant data according to user-definable search criteria as well as code used to implement specific tests/instruments as appropriate and consistent with achieving the goals of the program; and 2) the ability to accommodate and implement new specific tests/instruments from researchers that have been approved by the Steering Committee and have been implemented according to the application program interfaces (APIs) required by the platform.

Research Strategy: Describe how new tests/instruments implemented according to published platform APIs and approved by the Steering Committee could be integrated into the platform. Applications must describe the following:

  • The overall approach to ensuring data that has been appropriately consented for sharing can be de-identified for public use;
  • The overall approach to developing tools and APIs for finding and accessing de-identified data, and documentation for how to convert data and sharable metadata to interoperable formats (e.g., JSON, YAML);
  • How the Core's strategy will lead to the ultimate financial stability of the program, including future cost recovery ;
  • The process for updating tools and APIs used for dissemination to track evolving best practices and monitoring the hardware and software technology in the context of the project;
  • The process for updating tools and APIs used for the implementation and integration of new tests/instruments into the resource;
  • The approach and methods for inclusion of any nominated new measures for inclusion in the app;
  • The process for performing software maintenance and upgrades, and security and backup processes;
  • How the Core will build upon and coordinate the use of existing standards, specifications, and resources where possible to meet requirements;
  • How the Core will facilitate novel multidisciplinary and interdisciplinary research strategies;
  • How Core staff will lead the proposed program and interact with any other program and organizational components within and outside the institution;
  • How basic technical support for users attempting to find, access, or reuse data will be provided;
  • How basic technical support for researchers attempting to implement new tests/instruments according the published APIs will be provided.
  • The strategy for providing communication channels (e.g., email, social media, or web-based content such as frequently asked questions, and other appropriate mechanisms); and
  • The ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Extension and Dissemination Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

 

Project

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

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

SF424 (R&R) Cover (Project)

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 (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

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

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

  • 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 (Project)

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 (Project)

 

Specific Aims: Specify a set of aims for a project that designs, tests, and implements a collection of cognitive tests and assessments of non-cognitive socioemotional psychological functions, health states, and contextual factors that may modify cognitive performance that can be administered via smartphone and that will enable the monitoring of cognitive abilities and age- or condition-related changes in cognitive abilities on mobile devices, making use of the infrastructure implemented as described in the preceding Cores.

Research Strategy: Applicants should describe the scientific rationale and process for the selection of cognitive domains to be tested and justification for how the tests proposed for implementation and validation will measure the chosen constructs and, simultaneously, are appropriate for use on smartphones. The plans for collection of data and validation of the measures in populations ranging in age from 20 to 85, as well as the process for norming the tests chosen against “gold standard” measures should also be described.

Applicants must describe how the central objectives of the Project will be accomplished, including the following aspects:  

  • How the resultant measurement tools will better serve the biomedical research enterprise by facilitating detection of disease at earlier stages, allowing tracking of change in performance over time, and providing a resource for uniform data collection;
  • How the Project will use the Cores for its functions;
  • How the resources and environment prioritize and incorporate improvements into operations and software that enhances its utility for research;
  • How the Project will facilitate novel outcome assessment strategies;
  • Justification of the sample size, selection of participants, and how participants are stratified;
  • Plans for recruitment of participants, including plans to enroll individuals across the entire age range;
  • Procedures for measurement administration, data collection, and transfer to central repository for analysis;
  • Plans for recruiting and retaining participants from minority health and NIH-designated populations that experience health disparities.
    ;
  • Procedures for “evergreening” the platform by introducing new tasks/tests that can be cross-validated with participants; and
  • How the proposed activities will successfully collect data to validate the NIH Toolbox measures in designated groups.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at Ramesh.Vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a 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?

RFA-Specific Questions:

How well does the application describe (i) the importance of the problem and barriers to progress in the study of life course cognitive change; (ii) how the resource to be expanded in the proposed project will improve scientific knowledge, assessment capability, and/or clinical practice; and (iii) how assessment and monitoring of cognitive ability across the lifespan will be changed if the proposed aims are achieved?

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?

RFA-Specific Questions:

How well-suited is the investigative team’s software and hardware expertise to support use of and modifications to the current platform?

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?

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

RFA-Specific Questions:

How well-described is the overall structure of the proposed solution to the infrastructure problem; the proposed development strategy for the required backend software system and for app development on the iOS and Android systems; the process for consideration, evaluation and determination of new measurement instruments that may be added or changed within the project; any novel approaches the project will use to capture relevant information; unique advantages or capabilities of the research resource; and how the overall system will leverage free and open tools for software development and the establishment of APIs, or, if proprietary systems are used, a justification for the use of these non-sharable components?

Are the proposed activities likely to increase uptake of the resource for use in research and clinical settings?

How adequate is the plan for coordinating the cores to establish the research resource?

How well-described are the plans for incorporation of FAIR and TRUST data principles and for ensuring that all code developed in support of the project will be available under an Open Source license?

Are the design plans for future cost-recovery likely to sustain continued development/ refinement of the platform?

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). How adequate are the applicant's plans to share, organize, and store resources and data (including apps, code, instruments, and other resources)? 

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

RFA-Specific Questions

Are the resources available in the scientific environment sufficient to support electronic information handling? Are commitments of facilities, infrastructure, and other resources likely to allow for the full-scale operation?

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 Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

Scored Review Criteria - Administrative Core

Significance

Does the proposed Core address the needs of the research project that it will coordinate? Is the scope of activities proposed for the Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research project?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing mobile measurement research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Core? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research projects the Core will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research project the Core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the project, 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 operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the project? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

RFA-Specific Questions

How well-developed are the plans for establishing and implementing the basic governance, operational, and policy structures, including setting up committees and coordinating their execution? Are the plans for how the Core will interface with the other Cores and support the work of the Project well-described? Are the plans for how Core staff will lead the proposed program and interact with any other program and organizational components within and outside the institution well-described?

How well-described are internal evaluations, self-assessment processes, and progress reporting activities that have the ability to assess and anticipate both researcher and participant needs? Are the plans for meeting support for annual Steering Committee meetings, monthly teleconferences, and subcommittees adequate? Are the plans for support for the External Scientific Panel (ESP) to attend annual Steering Committee meetings and disseminate feedback to all cores and projects adequate?

How well-described is the Core’s ability to prioritize and incorporate improvements into operations and software that enhance its utility for research? How well-described is the process for addressing any readily anticipatable challenges/obstacles and alternative strategies to surmount potential obstacles? How well-described is the strategy for providing communication channels (e.g., email, social media, or web-based content such as frequently asked questions, and other appropriate mechanisms)?

Environment

Will the institutional environment in which the Core will operate contribute to the probability of success in facilitating the research project it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Core proposed? Will the Core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Considerations - Administrative Core

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.

Scored Review Criteria - Data and Statistical Analysis Core

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

RFA-Specific Question

Is the overall vision of the Data and Statistical Analysis Core well-articulated and is the vision likely to meet the project objectives?

Investigators

Innovation

Approach

 

RFA-Specific Questions

Is the overall approach to developing and utilizing the appropriate expertise from the measurement science and assessment technology communities well-described? Is the proposed process for creating a central data repository with the capability to store/aggregate all primary and processed data sufficient? How well-articulated are the plans for statistical and psychometric oversight and input? How well-articulated are the plans for integration and analysis of data obtainable from mobile devices (e.g., cognitive tests, non-cognitive” neuropsychological variables, other psychological measures, information on activity or movement, physiological sensors) on the same subjects to achieve development of a valid research resource? Are the plans to prioritize and incorporate improvements into operations and software likely to enhance its utility for research? Are the plans to establish a data-submission pipeline, quality-control metrics and provenance checking required to deposit data for analysis adequate? Are the plans to combine and analyze various formats of data, including previously collected machine-readable data on the participants in the study appropriate? Will the project be able to store and report participant data to the researchers via a secure system compliant with applicable federal data-security standards? Will the project be able to test additional instruments for possible inclusion into the research resource? Are the proposed processes and methods for integration of data generated by outside sources adequate? Is the project’s ability to perform quality control to ensure that any new measures meet relevant standards well-documented?

Environment

Additional Review Criteria - Data and Statistical Analysis Core

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Renewals

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

Additional Review Considerations - Data and Statistical Analysis Core

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

Scored Review Criteria - Technical Core

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

Investigators

?

Innovation

?

Approach

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

RFA-Specific Questions

How well-described are the technologies to be initially deployed, the capacity to address system standards and upgrades, and the incorporation of any new measures into the proposed measurement system platform? Is the overall approach and methods for utilizing existing smartphone development platform(s) and technologies in the context of the project goals adequate? How well-developed is the process for monitoring the hardware and software technology in the context of the project? Does the application adequately document the Core’s ability to create programming and database structures for receipt, storage, management and analysis of the collected data and to conduct software maintenance and upgrades, and security and backup processes? Are plans to build upon and coordinate the use of existing standards, specifications, and resources where possible to meet requirements well-articulated? How well does the application describe how the Core will facilitate novel multidisciplinary and interdisciplinary research strategies and ow Core staff will lead the proposed program and interact with any other program and organizational components within and outside the institution? How well-described are the plans for basic technical support for use of smartphone apps and for referrals to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.? Does the application document the ability to ensure appropriate translation of any proposed or additional instruments into foreign languages (e.g., Spanish)? How adequate are the plans to ensure data security and maintain confidentiality of personally identifiable information at the highest level? How well-described are the plans for of server maintenance, software maintenance and upgrades, security, backup processes, and data recovery?

Environment

?

Additional Review Criteria - Technical Core

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of thecategories 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 theGuidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Renewals

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

Additional Review Considerations - Technical Core

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

Scored Review Criteria - Extension and Dissemination Core

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

Investigators

Innovation

Approach

?

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

RFA-Specific Questions

How well does the application describe plans for integrating new tests/instruments implemented according to published platform APIs and approved by the Steering Committee into the platform? Is the overall approach to ensuring data that has been appropriately consented for sharing can be de-identified for public use adequate? Is the overall approach for developing tools and APIs for finding and accessing de-identified data, and documentation for how to convert data and sharable metadata to interoperable formats (e.g., JSON, YAML) adequate? How likely is the Core’s strategy to lead to the ultimate financial stability of the program? How well-described are the processes for updating tools and APIs used for dissemination to track evolving best practices; monitoring the hardware and software technology in the context of the project; and the implementation and integration of new tests/instruments into the resource? Are the approach and methods for inclusion of any nominated new measures for inclusion in the app sound? How adequate is the process for performing software maintenance and upgrades, and security and backup processes? Does the application sufficiently describe how the Core will build upon and coordinate the use of existing standards, specifications, and resources where possible to meet requirements; how the Core will facilitate novel multidisciplinary and interdisciplinary research strategies; and how Core staff will lead the proposed program and interact with any other program and organizational components within and outside the institution? How well-described are the plans for providing basic technical support for users attempting to find, access, or reuse data and for researchers attempting to implement new tests/instruments using the published APIs? Are the strategies for providing communication channels (e.g., email, social media, or web-based content such as frequently asked questions, and other appropriate mechanisms) well-articulated? How well-described is the ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.?

Environment

?

Additional Review Criteria - Extension and Dissemination Core

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Renewals

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

Additional Review Considerations - Extension and Dissemination Core

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

Scored Review Criteria - Project

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

Investigators

?

Innovation

Approach

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

Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

RFA-Specific Questions

How well-described is the scientific rationale and process for the selection of specific domains to be tested (including non-cognitive socioemotional psychological functions, health states, and contextual factors that may modify cognitive performance) and the justification for how the tests proposed for implementation and validation will measure the chosen constructs and (simultaneously) are appropriate for use on smartphones? How well-described are the plans for collection of data and validation of the measures in populations ranging in age from 20 to 85 as well as the process for norming the tests chosen against “gold standard” measures? Are the resultant measurement tools likely to better serve the biomedical research enterprise by facilitating detection of disease at earlier stages, allowing tracking of change in performance over time, and providing a resource for uniform data collection? How well-articulated are the plans for how the Project will use the Cores for its functions and how the resources and environment prioritize and incorporate improvements into operations and software that enhances its utility for research? Does the Project adequately explain how it will facilitate novel outcome assessment strategies? Is the justification of the sample size, selection of participants, and how participants are stratified logical and appropriate? How well-developed are the plans for recruitment of participants, including plans to enroll individuals across the entire age range and for recruiting and retaining participants from minority health and NIH-designated populations that experience health disparities? How adequate are the procedures for measurement administration, data collection, and transfer to central repository for analysis? How adequate are the procedures for “evergreening” the platform by introducing new tasks/tests that can be cross-validated with participants?

Environment

?

Additional Review Criteria - Project

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Renewals

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

Additional Review Considerations - Project

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications 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 FOA.

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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).

 

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • In general, and as noted in the body of the funding opportunity announcement, it is expected that instruments/tests made available through this platform will be made freely available under an open source license to be agreed upon by members of the Steering Committee. In some limited situations (e.g., related to projects that need to validate instruments against existing ones), the platform may need to incorporate tests/instruments that have different or more restrictive licensing agreements. In these cases, awardees will be responsible for relevant intellectual property oversight.

The PD(s)/PI(s) assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of research conducted with or through the grant in accordance with terms and conditions of the award.

  • Defining objectives and approaches for the award and its components, in collaboration with the Steering Committee (do not list the names of committee members);
  • Overseeing the planning and conducting of all scientific, organizational, and administrative activities;
  • Promoting and coordinating scientific collaborations across sites (if multiple sites are involved) and projects (when directed by the Steering Committee);
  • Overseeing the adherence to the approved plans for timely sharing of resources and data consistent with achieving the goals of the program;
  • Participating as voting member(s) in the activities of the Steering Committee and interacting with any sub-committee(s);
  • Accepting and implementing all scientific, organizational, administrative, and policy recommendations approved by the Steering Committee to the extent consistent with applicable grant regulations;
  • Organizing and participating in the periodic Steering Committee Meetings and other activities of the project as relevant;
  • Cooperating in the program evaluation process and interacting with NIH representatives coordinating this process;
  • Overseeing the timely preparation and submission to the NIH of annual progress reports and other information as needed;
  • Conducting periodic self-evaluation of the resource; and
  • Being prepared for possible administrative site visits by NIH staff members.
  • The grant will be subject to external evaluation (coordinated by the NIH) by an External Scientific Panel. The investigators will be expected to participate in such evaluations.

Intellectual Property Consideration

  • Ensuring the ability to maintain, manage, modify, and distribute data by securing appropriate permissions from other parties involved;
  • Developing criteria for making decisions to include outcome measures and various technology as needed to address intellectual property constraints while ensuring minimal burden to users of these instruments;
  • Notifying users of the existence of third party ownership or reach-through, as appropriate;
  • Ensuring that infrastructure, items, and instruments developed with NIH grant support are made available to users in a manner consistent with NIH sharing policies (seehttp://sharing.nih.gov/), including the NIH research systems policy and the NIH data sharing policy as applicable;
  • Ensuring that agreements with any party, including users, do not unreasonably limit access by other parties to the infrastructure developed through this cooperative agreement and/or items or instruments; and
  • Establishing appropriate agreements between/among stakeholders for the appropriate sharing of data and appropriate protection of intellectual property, consistent with achieving the goals of the program.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

One or more designated NIH Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Additional NIH scientific staff members with relevant expertise may also become substantially involved in grant activities as Projects Scientists or Coordinators

The NIH Project Scientist(s) and other substantially involved NIH program staff members will assist with the grant by:

  • Monitoring the operations of the components and activities;
  • Making recommendations to the Steering Committee on strategic directions and improvements to the components and activities;
  • If appropriate, collaborating scientifically on research projects involving the investigators;
  • Serving as a liaison to facilitate and/or coordinate interactions between the investigators and other entities that may be mutually beneficial;
  • Using the NIH channels to disseminate knowledge about the resource to the scientific community;
  • Facilitate contacts between the awardee(s) and outside researchers interested in potential collaborations and/or the use of the resource; and
  • Coordinating an external evaluation of the research program.

NIH staff members who are substantially involved in the scientific activities (e.g., publications) of the grant will not attend peer review meetings of renewal and/or supplemental applications.

  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Steering Committee. The Steering Committee will serve as the main governing board for the research resource development. The Steering Committee will consist of the following voting members:

  • PD(s)/PI(s), one of whom is expected to chair the Steering Committee;
  • Three to five other PD(s)/PIs and/or senior scientific staff from the grant, with at least one representative from each core; and
  • Up to four NIH scientific staff, including the primary NIH project scientist and possibly additional NIH staff who have domain-relevant expertise in either mobile monitoring, measurement development, or cognitive aging in order to facilitate those aspects of the project.

NOTE: Each voting member noted above will have one vote (including those individuals who may have multiple responsibilities).

All NIH representatives will collectively have no more than one third of the total votes.

Additional individuals may be added to the Steering Committee as non-voting members by a decision of the existing voting members. These additional non-voting members may include, for example, other NIH Program Staff members, and/or Program Staff members from other Federal Agencies (e.g., U.S. Food and Drug Administration).

The Steering Committee will meet once per year in person and monthly via phone conference. Applicants should budget for in-person meetings to occur in the Washington, D.C. metropolitan area.

The Steering Committee will have primary responsibility for:

  • Overseeing the overall functioning of the award;
  • Establishing advisory committees and subcommittees, as needed;
  • Reviewing strategic goals for its evolution as a research resource (in consultation with Scientific Consulting Panel, see below);
  • Ensuring goals for sustainability are prioritized;
  • Evaluating proposals from other NIH grantees to augment the tests/instruments available on the platform, as noted in the Extension and Dissemination Core description;
  • Ensuring that the award takes advantage of existing NIH resources and programs; and
  • Ensuring that award meets the missions/needs of funding agency, to the extent possible.

The Steering Committee will also form subcommittees as appropriate and necessary, each with a specific functional area of oversight as defined in the application.

External Scientific Panel. An External Scientific Panel (ESP) consisting of 6-8 individual will operate as an independent group that will advise the Steering Committee and providing technical expertise to the entire project. The ESP will comprise scientific experts not affiliated with the grantee institution(s) and may include scientists from academic and other research institutions as well as from NIH, clinicians and clinical staff, and relevant stakeholders. Members of the ESP will be selected by NIH, in consultation with the Steering Committee. The ESP will attend the annual in-person Steering Committee Meeting and may attend other Steering Committee meetings on an as-needed basis. The ESP will be charged with the following activities:

  • Reviewing the overall progress and making appropriate recommendations to strengthen activities in certain areas once per year;
  • Participating in the annual Steering Committee Meeting;
  • Providing additional consultations to the Steering Committee and investigators as needed (responding to inquiries via e-mail and/or telephone); and
  • Providing linkages to investigators not funded by the grant but conducting, or interested in conducting, related research.

Because members of the ESP will be appointed by NIH following the award, potential members should NOT be named in the application as this will limit the potential pool of reviewers unnecessarily.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Dana Jeffrey Plude, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: dana.plude@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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