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
Screening for Cognitive Impairment: Decision-Making (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AG-23-007
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites research to develop, validate, and disseminate measurement tools that could be used to screen for deficits related to decision-making, planning, and other important higher order functional outcomes in older adults. In particular, we are interested in instruments that can track changes in decision-making capacity that could be useful in the context of future screening for cognitive impairment and the development of interventions targeting functional outcomes in persons living with cognitive impairment and/or quality of life outcomes of their care partners/caregivers. The goal of this FOA is to support a research network whose goals would be to review and assess the dimensions of higher cognitive abilities and functional capacities already believed to support higher order planning and decision-making; to develop valid and reliable measures of those abilities; and to provide support for pilot efforts during the instrument development and validation in a racially, ethnically, geographically, and diagnostically diverse set of participants, as well as a set of enduring resources. Enduring resources include the measurement instruments, documentation, and normative data that will enable other, future projects to incorporate the new measurements into studies.

Key Dates

Posted Date
February 23, 2022
Open Date (Earliest Submission Date)
June 11, 2022
Letter of Intent Due Date(s)

June 11, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 11, 2022 Not Applicable Not Applicable October 2022 January 2023 April 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
July 12, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This U24 Cooperative Agreement Funding Opportunity Announcement (FOA) will support a Research Network (hereafter Network) for the creation of new, or the identification of existing, measurement instruments assessing decision-making capacity in the context of screening for cognitive impairment generally, or assessing decision-making capacity specifically. The Network will also support the validation and dissemination of these instruments. The Network will accomplish its goals via four main activities:

  1. Reviewing and assessing dimensions of higher cognitive abilities already believed to support higher order planning and decision making;
  2. Identifying and developing new measures of those abilities that can be made available under an open source license allowing no-cost use by researchers or clinicians;
  3. Assessing the reliability and validity of the developed measures in older adults, including persons living with cognitive impairment (PLWCI) or persons living with dementia (PLWD), and members of NIH-defined Health Disparity Populations; and
  4. Providing resources that will allow other projects supported independently of this FOA to incorporate the new instruments into studies of screening efficacy, interventions to enhance daily high level functional outcomes, and research seeking to improve clinical management of PLWCI and/or ease the burden of caregiving.

The activities by which these goals will be attained will include support of piloting efforts as well as larger scale projects using network-developed or optimized assays and the facilitation of continued dialogue and interdisciplinary collaboration among  basic researchers in decision-making, cognitive aging, clinical scientists, population scientists, epidemiologists, biostatisticians, and others whose expertise will enhance the success of the development effort. Network members are also expected to consult with PLWCI, PLWD, and their care partners/caregivers, as well as personnel supplying primary care in order to enhance the acceptability and feasibility of using these new measurement tools in clinical contexts.

Background

In early 2020, the United States Preventive Services Task Force (USPSTF) released a continued “I Statement” summarizing their analysis of the benefits and costs of screening for cognitive impairment in older adults (also published as USPSTF, 2020 JAMA). The taskforce concluded that “more research is needed to make a recommendation for or against screening.” The fact that the evidence for or against screening is still considered inconclusive, despite a decade of investigator-initiated research on the topic (spurred in part by the inclusion in the Affordable Care Act of the “detection of any cognitive impairment” in the Medicare Annual Wellness Visit), suggests that a more programmatic approach will be required, and that some previous assumptions about the costs and benefits of screening may need to be revisited. Overall, the USPSTF concluded that “more research is needed on the effect of screening and early detection of cognitive impairment ( MCI and mild to moderate dementia) on important patient, caregiver, and societal outcomes, including decision-making, advance planning, and caregiver outcomes” (emphasis ours). It remains important to determine whether, in the absence of any effective treatment, there is a “potential preventable burden” for older adults or their families, and to demonstrate that the benefits of screening would compensate for any potential harms. Demonstrating that screening either does or does not provide net benefits will ultimately require additional well-designed and ,eventually, well-powered trials that have clear, specific, and routinely used outcome measures. In this context, the USPSTF notes that the field would benefit greatly from “more consistent definitions and reporting of outcomes to allow comparisons across trials, especially from trials with longer-term follow-up.”

The National Institute on Aging (NIA) currently supports a large and growing research portfolio, both in the development of caregiving and dementia care interventions, as well as the society-level burden of dementia, with relatively less work being done on individual level outcomes forPLWCI or PLWD. This FOA seeks to fill this research gap by supporting the further development and validation of measurement tools that could be used to screen for deficits related to decision-making, planning, and other important higher order, everyday functional outcomes and assess change in these constructs that could be useful in the context of future intervention development. The need for improved instruments to measure decision-making is also implicit in the requirements for the Medicare Cognitive Assessment & Care Plan Services visit (CPT 99483) where one required element is specifically to “Conduct a functional assessment of Basic and Instrumental Activities of Daily Living, including decision-making capacity.” Currently, although the importance of decision-making is clear to clinicians, patients, and family members alike, current measurement instruments are either very lengthy or else focused on specific domains (e.g., financial decision-making) and are not known to be sensitive to change in capacity, nor have they been shown to yield valid outcomes in health disparity populations.

The target population for this FOA is PLWCI, as well as those who are at high risk for cognitive impairment generally or deficits in decision-making capacity specifically. Within the defined space of higher-level cognitive abilities tightly related to medical, advanced care, financial, and everyday decision-making by PLWCI, the ability of research to provide useful evidence in either observational or interventional studies relies heavily on the quality and consistency of the outcome measures used. Because these abilities have been notably understudied, the Screening for Cognitive Impairment: Decision-Making project will focus on the development of a taxonomy of higher-level skills that support autonomy in daily life, as well as a more detailed mapping between those skills and daily life activities. This work will then support the design and/or validation of reliable and valid instruments to measure those skills. Future work can then ascertain which of these skills are most amenable to intervention whether by training or by the design of supports that can be used in the home and the community and then to design and/or test the efficacy and effectiveness of those interventions, which could provide concrete evidence of the value of screening. In the long run, it is hoped that measurement at the level of higher order cognitive skills and interventions targeting those skills would also improve the outcomes of care partners/caregivers of PLWCI or PLWD, by providing a better understanding of their specific strengths and weaknesses. In short, this initiative seeks to capitalize on our increasing ability to detect even subtle cognitive decline to identify individuals who could benefit from the training or support of the cognitive skills that best predict independence and autonomy and potentially reduce financial, medical, and clinical management crises as well as caregiving challenges.

Scope

For the reasons stated above, this FOA focuses on the identification and development of measures of higher order cognitive abilities and decision-making capacity to support both the improvement of screening for cognitive impairment and the improvement of measurement of these constructs as outcomes in interventions. To give an example of the latter, the specifics of an intervention to improve planning could be very different for a person who now has greater amnestic issues and needs supports for producing and recalling next steps compared to a person whose memory is perhaps less poor but whose ability to appropriately sequence activities or follow a routine is more impaired. Other psychological dimensions that can have a large effect on the quality of decisions include the accuracy of the PLWCI to detect indications that another is honest or trustworthy (a key component of susceptibility to scams) or the ability to appreciate the likely outcome of an action.

Although none of these more specific abilities, except possibly memory deficits, are tested in the usual cognitive screens, some or all of them may be impacted relatively early in the clinical course of an individual developing cognitive impairment. Indeed, we have an increasing understanding that survey items querying the general ability of an older adult to manage medications or money are more likely to signal future cognitive impairment than many others. Moreover, the independence of a PLWCI is more likely to depend on the quality of decisions and the feasibility of near-term plans than it is on the ability to remember phone numbers or lists of words or skills more tightly connected to the more basic cognitive abilities more routinely included in screens. Indeed, given recent progress in research already supported by NIA in developing more sensitive cognitive screening methods, we could envision opportunities to intervene at even earlier stages and teach skills that would directly enhance the current level of decision-making quality or provide supports to establish safeguards against fraud, or facilitate programs to establish power-of-attorney relationships. Any of these options has the potential to extend the interval during which independence could be maintained, even as more basic cognitive abilities become more impacted.

Although the details of how best to implement the goals of the network are left up to the applicants, the funds available for this FOA increase over the lifetime of the project in recognition of the fact that implementation, validation, and dissemination efforts are likely to require more resources as the development effort continues. In any event, applications should describe how it will achieve each of the four activities required of the network:

Required Activity 1: Review and assess the dimensions of higher cognitive abilities supporting higher order planning and decision making necessary for independent functioning

The application must describe how any systematic review will be accomplished, how information from outside the network will be requested and obtained, and what statistical or meta-analytical techniques will be used to derive constructs relevant to abilities supporting higher order planning and decision making. The application should also describe a plan for making the materials and code required to perform this assessment and review available to outside researchers.

Required Activity 2: Identify existing and develop new measures of decision-making capacity that can be used to detect cognitive impairment in PLWCI

The application must describe how the results of the review activities described in the first required activity, as well as possible feedback given during the development process for this required activity, will be used to identify existing and create new measurement instruments, and how the preliminary testing of these measures will be accomplished before clearing these measures for broader deployment and the assessment of measurement reliability and validity in Required Activity 3. Note that applicants may choose to interleave Required Activities 2 and 3 if they can describe the process by which the quality of the measurement scales/items will be therefore refined. In order to ensure the broadest adoption of the developed instruments, every effort must be made to minimize or,preferably, eliminate the use of items, tests, or scales that depend on intellectual property (IP) of network members or others unless such IP rights are explicitly waived for their use in the instruments under development.

Required Activity 3: Assess the reliability and validity of the developed measures

The application must describe how the reliability and validity of the developed measures, including sensitivity to change, will be determined in populations that span the entire range of decision-making capacity from the normal to the seriously impaired. Additionally, applications must describe how NIH-designated health disparities populations will be included in these assessments. Futher, in addition to determining reliability and validity, investigators must describe any efforts to establish the acceptability and feasibility of using the proposed instruments in cognitively normal individuals as well as PLWCI.

Required Activity 4: Support the adoption of developed instruments into ongoing research

Applications must describe any other activities that will enhance the adoption of instruments developed into ongoing or future observational or clinical trial projects. In some situations, activities described under Required Activity 3 may also be relevant to this dissemination activity. Investigators must develop a website that will be public-facing and hyperlinked to Network-developed resources and reports, as well as any other sites that contain Network-relevant materials (e.g., code hosted on GitHub, datasets hosted by other established repositories). Investigators are also required to describe a plan for the sustainability of Network-developed resources, including a plan for preserving any code base supporting online or on personal/mobile device collection of data. Other activities may include, but are not limited to, support for pilot projects; the creation of publicly available library of measures; and the publication of norms.

Clinical Research Operations Management System: The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of a CROMS data templates as specified.

Non-responsiveness Criteria

Applications that do not describe how the proposed network will be able to complete each of the four required activities described above under Scope will be deemed unresponsive and will not be reviewed.

Additionally, applications that do not propose to assess reliability and validity of proposed measures in cognitively normal as well as cognitively impaired individuals will be deemed unresponsive and will not be reviewed.

Frequently Asked Questions

Responses to Frequently Asked Questions about this FOA will be posted here: https://www.nia.nih.gov/research/dbsr/behavioral-and-social-research-funding-opportunities-and-applicant-resources.

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

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

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

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIA intends to commit $1,280,000 in FY 2023 to fund 1 award. Future year awards will depend on NIA appropriations, but NIA also intends to commit $1,760,000 in FY 2024; $2,048,000 in FY 2025; $2,816,000 in FY 2026; and $2,816,000 in FY 2027.

Award Budget

Application budgets are limited to $1,280,000 in total costs for FY 2023; $1,760,000 in total costs for FY 2024; $2,048,000 in total costs for FY 2025; $2,816,000 in total costs for FY 2026; and $2,816,000 in total costs for FY 2027. Application budgets 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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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

Non-domestic (non-U.S.) components of U.S. Organizations are 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are 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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Jonathan W. King, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: NIAScreeningDMFOA@nih.gov

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: The application must describe the plan to review and assess the dimensions of higher cognitive abilities supporting higher order planning and decision-making. The application must describe how any systematic review will be accomplished, how information from outside the network will be requested and obtained, and what statistical or meta-analytical techniques will be used to derive constructs relevant to abilities supporting higher order planning and decision-making.

The application must describe how the results of the review activities described in the first required activity, as well as possible feedback given during the development process for this required activity, will be used to identify existing and create new measurement instruments. The application must also describe the plan to use the results of the review activities, and possible feedback given during the development process, to create new measurement instruments and/or describe the process by which the quality of the measurement scales/items will be therefore refined. In order to ensure the broadest adoption of the developed instruments, discuss how every effort has been made to minimize or, preferably, eliminate the use of items, tests, or scales that depend on intellectual property (IP) of network members or others, unless such IP rights are explicitly waived for their use in the instruments under development.

The application must describe how the reliability and validity of the developed measures will be determined in populations that span the entire range of decision-making capacity, from the normal to the seriously impaired, and how sensitivity to change will be evaluated. Applications must also describe how NIH-designated health disparity y populations will be included in these assessments in order to establish their validity in these populations. Further, in addition to determining reliability and validity, investigators must also describe any efforts to establish the acceptability and feasibility of using the proposed instruments in cognitively normal individuals as well as PLWCI.

Applications must describe any other activities in the outyears that will enhance the adoption of instruments developed into ongoing or future observational or clinical trial projects. In some situations, activities described as assessing the reliability and validity of the developed measures may also be relevant to this dissemination activity. Investigators are also required to describe the process of constructing the Network website, as well as any other means by which their newly developed measures can be made available in relevant measures repositories and systems for the collection of data online or via personal/mobile devices. Such activities may include support for both pilot and more substantial validation/norming efforts. Applications proposing to support projects requiring new subcontracts should describe their process for solicitation and review of pilots.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. This Data Sharing Plan must include plans for sharing any code(s) used to generate scores from raw data, and any code(s) used to obtain raw data from participants who respond to any of the new measurement instruments using a personal or mobile device or a website used to collect data and specify what open source licenses will be employed to achieve these goals.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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.

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) must include their eRA Commons ID in the Credential fieldof 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. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number 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 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

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

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.

 

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?

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?

 

 

 

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?

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?

 

 

 

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?

 

 

 

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?

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?

Specific to this FOA:

How well does the application describe the plan to review and assess the dimensions of higher cognitive abilities supporting higher order planning and decision making? Are the activities and techniques proposed likely to successfully derive constructs relevant to abilities supporting higher order planning and decision making? Is the Data Sharing plan for making the materials and code required to perform the assessment and review available to outside researchers adequate?

How well does the application describe the plan to use the results of the review activities and possible feedback given during the development process to identify existing and create new measurement instruments? Is the process for ensuring quality of measurement scales/items before broader deployment and the assessment of measurement reliability and validity adequate? Are the investigators' efforts adequate to minimize or, preferably, eliminate the use of items, tests, or scales that depend on intellectual property (IP) of network members or others unless such IP rights are explicitly waived for their use in the instruments under development?

Are the proposed methods for determining reliability, validity, feasibility, and acceptability appropriate and inclusive of populations that span the entire range of decision-making capacity from the normal to the seriously impaired? Is the plan for including NIH-designated health disparity populations in these assessments adequate? Are efforts to establish the acceptability and feasibility of using the proposed instruments in cognitively normal individuals as well as PLWCI well-described? Are the activities proposed to enhance the adoption of instruments into ongoing or future observational or clinical trial projects and to make newly developed measures available in relevant measures repositories and systems for the collection of data online or via personal/mobile devices likely to yield broader uptake?

 

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

In addition, for applications involving clinical trials

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

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

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

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

 

 

 

 

 

Additional Review Criteria

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.

 

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)?

 

 

 

 

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.

 

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.

 

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

 

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.

 

Not Applicable

 

Not Applicable

 

Not Applicable

Additional Review Considerations

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.

 

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.

 

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).

 

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).

 

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.

 

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 the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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: Recipient 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: General and 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 identify, 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 and 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.

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:

  • Developing objectives, approaches, and goals for network infrastructure development, including all 4 required components.
  • Designating investigators to serve as members on a Network Steering Committee and other subcommittees with NIH staff, as appropriate.
  • Complying with Federal regulatory requirements, including but not limited to those relating to humansubjectsprotections.
  • Attending quarterly (or as needed) virtual Network Steering Committee meetings.
  • Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices of NIH. Agreeing to accept close coordination, cooperation, and management of the project with NIA Staff. The PD/PI(s) will be expected to maintain close communications with the NIA Project Scientist(s) and, where appropriate, the Program Officer. The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
  • Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIA of the results and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
  • Overseeing the overall budget, activities, and performance of the cooperative agreement.
  • Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.
  • 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.

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

  • NIA Project Scientists

    • One or more NIA Project Scientists will participate as a member of the resource development network and assist the PD/PI(s) in identification of relevant NIA/NIH-funded researchers and longitudinal studies for potential involvement in Network activities. The NIA Project Scientist will serve as liaison to other NIA components to promote collaborations. The NIA project scientist will also facilitate involvement of representatives from other NIH institutes, as appropriate, in Network activities.
    • The NIA Project Scientist(s) will work with the PD(s)/Pl(s) and participate in the Network Steering Committee to ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientist(s).
    • NIA will assign a Program Officer(s) who will be responsible for retaining overall programmatic responsibility for theaward andwill clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
    • NIA may designate additional staff to provide advice to the recipient on specific scientific and/or administrative issues to optimize the conduct of network activities.
    • NIA will serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
    • NIA staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
    • NIA staff (Project Scientist(s)) will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the network objectives.
       
  • NIA Program Official

    • Additionally, an NIA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Officer will make recommendations for continued funding basedon:a) overall networks progress; b) cooperation in carrying out the research; and/or c) maintenance of a high quality of research in alignment with the goals of this RFA.

Areas of Joint Responsibility include:

The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientist(s).

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 75.113 and 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 75 and 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)

Jonathan W. King, Ph.D.
Division of Behavioral and Social Research (DBSR)
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: NIAScreeningDMFOA@nih.gov

Nina Silverberg, Ph.D.
Division of Neuroscience (DN)
National Institute on Aging (NIA)
Telephone: 301-496-9530
Email: nina.silverberg@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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