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
Understanding the Supply of Professional Dementia Care Providers and Their Decisions (U54 Clinical Trial Not Allowed)
Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type
New
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-AG-23-018
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to develop a national survey of professional Alzheimer’s disease (AD) and AD-related dementias (ADRD) care providers and link consented survey respondents (providers and institutional representatives) to administrative data (e.g., electronic health records, claims, payroll, and other institutional and state-level data).

The goal of the new resource is to expand research on the AD/ADRD care workforce, including the supply of skilled labor, and provide a deeper insight into how professional care providers and institutions provide care for persons living with AD/ADRD. The survey will oversample individuals from populations understudied in AD/ADRD research who serve in various professional caregiving roles (e.g., physicians, licensed practical nurses (LPNs), social workers, etc.) and institutions serving predominately underserved populations. This will allow for the examination of how the characteristics of professional care providers, and the institutions employing them, lead to variations in care provided to persons living with AD/ADRD. It may also facilitate the identification of modifiable behaviors, at both an organization and an individual level, that can improve overall health care delivery and eliminate AD/ADRD disparities.

Key Dates

Posted Date
September 02, 2022
Open Date (Earliest Submission Date)
January 03, 2023
Letter of Intent Due Date(s)

January 3, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
February 03, 2023 Not Applicable Not Applicable June 2023 August 2023 December 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
February 04, 2023
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

Key Definitions for This Funding Opportunity Announcement (FOA)

Underserved populations: Groups identified as “Priority Populations” in the National Institute on Aging’s (NIA) Health Disparities Framework and/or other groups known to experience barriers to accessing needed health care services or to have inadequate health care coverage. This includes people living with dementia (PLWD) served by paid providers and/or institutions in rural areas and individuals experiencing language barriers. A full description of Priority Populations can be found on NIA's Health Disparities Framework webpage.

Medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities, and individuals in adult day care centers or other professional care settings that serve individuals living with Alzheimer's disease (AD) and AD-related dementias (AD/ADRD).

Henceforth, the terms "AD/ADRD" and "dementia" will be used interchangeably.

Background

The number of people diagnosed with dementia is expected to triple in the next 30 years. With few promising therapies in the pipeline, there is a pressing need to understand how dementia care is supplied by various professional providers and institutions, the burden it can have on the health care system, and its effects on PLWD and their caregivers. A great deal of research focuses on demand factors for dementia care, such as how PLWD are cared for in different settings (e.g., nursing homes and hospitals) and how PLWD choose their Medicare advantage plans, primarily using administrative data from the Centers for Medicare and Medicaid Services (CMS). However, what is missing from this literature is how care is supplied to PLWD and what decisions are made by providers and institutions that lead to wide variations in care for PLWD. PLWD receive care from an array of paid care providers that include neurologists, geriatricians, psychiatrists, nurses, occupational therapists, social workers, certified nursing assistants (CNAs), and home health aides. Across these care providers, there are differences in training requirements, compensation, and payment models for services provided, as well as variations in market conditions by region. Together, these factors shape the composition of the dementia care workforce: size, expertise, tenure, roles, and care quality and access for PLWD.

Purpose and Research Objectives

This FOA invites applications to develop a national survey of professional dementia care providers and link consented survey respondents (providers and institutional representatives) to administrative data (e.g., electronic health records, claims, payroll, and other institutional and state-level data). The integration of the supply side survey with administrative data can provide deeper insights into: how professional care providers and institutions provide care for persons living with AD/ADRD; how the characteristics of professional care providers, and the characteristics and decisions of the institutions employing them, lead to care variation among PLWD in the United States; and what behaviors could be modified, at both an organization and an individual level, to improve overall health care delivery and eliminate AD/ADRD disparities. This FOA encourages research on dementia care provision to individuals in populations that are underserved or vulnerable due to medical, geographic, and social factors.

The survey will be administered online, on an annual basis, to health care providers and their institutional representatives nationwide. The survey will seek to measure how PLWD are cared for by a wide range of professional providers, the interactions between professional care providers and institutions, and how provider/institution interactions impact the care provided to PLWD across institutional settings.

The survey will encompass multi-dimensional measures—including items related to training, compensation, payment models, care practices, and other procedures, as well as vignettes—and will be linked to administrative data (e.g., claims, electronic health records (EHR), payroll, and other relevant institutional and state-level data) to provide insight on costs, intensity of care provided, guideline-concordant care received by PLWD, and quality of care experienced by PLWD.

To address multiple AD+ADRD Research Implementation Milestones—specifically Milestone 13.J, which relates to expanding research on the care workforce and supply of skilled labor; Milestone 1.H, which relates to enabling better access to EHR data and providing support for their integration with other data; and Milestone 13.K, which calls for the expansion of research leading to understanding of effectiveness and impacts of non-residential and residential care of PLWD—the national study should be designed to track changes in the following:

  1. The mix of skilled labor in the health care system
  2. The care provided to PLWD as a result of changes in health care-related programs, such as Medicare and Medicaid, and/or health care-related policies/guidance
  3. State, provider, and institutional characteristics that affect care for PLWD

The study should enable exploration of how professional care provider groups and institutions will meet future needs by addressing barriers to entry, interactions among providers, challenges of retention, challenges of recruiting workers from varied backgrounds, causes and effects of turnover, and the impact of the aging physician workforce on care provided for PLWD.

Oversampling Requirement

Large samples of care providers serving older populations are required in order to understand how the paid medical care and caregiving workforce serving PLWD affects care. In order to support research on important sub-populations of providers, the proposed study must include oversamples of the following groups:

  • Providers (e.g., primary care physicians, neurologists, geriatricians and psychiatrists)
  • Other health care workers (e.g., social workers, registered nurses, licensed practical nurses (LPNs), and CNAs
  • Health care facilities (e.g., nursing homes and adult daycare facilities) in geographic locations with a high concentration of older Americans

Organizational Structure

This FOA will support a cooperative agreement that engages scientific expertise at the primary institution as well as external to the primary institution and has the flexibility to draw, as needed, on external scientific expertise to achieve the core functions of this FOA. At minimum, the cooperative agreement  must include the following components: (1) Administrative Core; (2) Screening and Survey Instrument Development Core; (3) Administrative Data Transfer Masking, Access, and Ethics Core; (4) Data collection, Linkages, Cleaning and Sharing Core; and (5) Research Studies Core. Examples of contents of each component are highlighted below.

Administrative Core

This component will provide administrative support for the cooperative agreement. Suggested activities under this component include, but are not limited to, the following:

  • Providing governance for the cooperative agreement.
  • Providing a public website for communication and sharing of activities, events, and resources of the program.
  • Hosting a training session, Grand Rounds, and other activities facilitating and highlighting use of data.
  • Collaborating and providing input and support across all core activities.
  • Providing input to NIA staff regarding the necessary expertise for members of a Data Monitoring Board (DMB). The DMB is intended to provide recommendations by third-party subject matter experts on the study activities to NIA and to the Project Director(s)/Principal Investigator(s) (PDs/PIs). Applications should not recommend specific individuals to be members of the DMB.
  • Providing organizational and logistical support for the activities of the components, Program Officer(s), Project Scientist(s), and the DMB.
  • Supporting standards and mechanisms to publicly share data, resources, and codes developed and utilized under this FOA.
  • Contributing to the development of agendas and materials for DMB meetings in concert with the NIA Program Official and an NIA-designated contractor. The contractor will provide support for facilitating the meetings (e.g., organizing space, travel, invitations, honoraria, etc.). The PI will work with NIA program staff and contractors to organize and support two meetings of the cooperative agreement core team and the DMB in the first year and annual meetings in following years. NIA will make appointments of DMB members, execute a charter for the DMB, prepare meeting summaries, and host the meetings. The meetings will be held virtually or in person. In-person meetings will be located in the vicinity of Bethesda, MD. The meetings are expected to last approximately 1.5 days. The applicant institution should cover the travel costs of DMB members.
  • Planning and implementing annual research meetings in Bethesda, MD starting in Year 3 with input from the NIA Program Official.
  • Addressing data interoperability between instrument development, consent and administrative data linkages from the health facilities.
  • Facilitating, creating, and supporting the development and execution of ALL material transfer agreements within 30 days of NIA notice.

Screening and Survey Instrument Development Core

This component will facilitate and optimize screening, using data from CMS, professional societies, and health care associations, to lower cost for data collection and develop the survey instruments. Activities under this component include, but are not limited to, the following:

  • Developing a sampling strategy to produce a nationally representative sample of providers with required oversamples that limits bias from selection based on screening/sampling approaches.
  • Developing relationships with organizations.
  • Optimizing survey responses. This component will operationalize monetary and behavioral incentives to maximize survey responses. Specifically, this component is encouraged to utilize incentives (e.g., it will take a neurologist 30 min to complete the survey, so they will be paid $250 to facilitate data collection with the neurologist; or an institution (e.g., nursing home) will need to provide access to their administrative data and time and/or incentives for facility administrators and care providers (e.g., LPN, CNA) to complete the survey instrument.
  • Supporting the development of instruments for the survey to cover various health care providers and institutions providing care for PLWD. Beyond the development of instruments, this component will hold annual competitions among researchers and other stakeholders for pilot development of survey instruments and/or seek ideas of incorporating and testing administrative data when viable.
  • Advising on longitudinal versus cross-sectional development of the survey (e.g., selection of sub-groups of professional providers or institutions for annual follow up).
  • Incorporating feedback from the DMB and playing a key role in the selection, and assessing the appropriateness of collecting, longitudinal versus cross-sectional data across providers and institutions on an annual basis.

Administrative Data Transfer, Masking, Access, and Ethics Core

This component will focus on executing agreements with institutions and building a pipeline (e.g., application programming interface (API)), or other digital means to transfer administrative data to the Data Collection, Linkages, Cleaning and Sharing Core so that it can be linked to survey instruments. In order to safeguard the privacy of survey participants and institutions, it is imperative that this component play a crucial role in masking data (when necessary), consider privacy preserving linkages when appropriate, review data requests for restricted data, set up the governance structure of data with institutions (e.g., organizing Data Review Board meetings), facilitate requests for restricted data use within 30 days of request, and provide ethical guidance for data collection and integration for the overall infrastructure. Activities under this component include, but are not limited to, the following:

  • Executing institutional agreements.
  • Supporting administrative data transfers.
  • Harmonizing and data cleaning activities associated with administrative data sets.
  • Providing data masking services.
  • Providing support for restricted data review in a timely manner.
  • Providing ethical guidance.

Data Collection, Linkages, Cleaning and Sharing Core

This component will support a competitive process that will enable the selection of an organization to support data collection. To minimize cost and maximize data collection and sample size, NIA requires the cooperative agreement institution to utilize a competitive process to select an entity that will:

  • Support data collection (i.e., internet survey);
  • Link the survey data to administrative data (e.g., EHR and claims); and,
  • Create user friendly data sets (see resource sharing plan) and enable access to public use file and restricted data through cloud interface. This FOA encourages the application to explore use of Health and Aging Data Enclave as appropriate for data sharing.

Research Studies Core

This component will support innovative research projects that will be required to use the data generated from this FOA. Individual projects may not exceed $100,000 in direct costs per project. Up to $800,000 per year in total costs may be budgeted for this purpose, starting in Year 1 and in subsequent years. Research projects must be designed to address NIA AD/ADRD Research milestones. Multi-year research projects are not encouraged and need prior approval by the NIA program official before solicitation. NIA requires a national competition to invite AD/ADRD research applications to be held on a annual or semi-annual basis, with peer review. All projects will require review and approval by the NIA Program Official.

Applicants must propose a consolidated or centralized Institutional Review Board (IRB) approach consistent with the National Institutes of Health's (NIH) single IRB policy for multi-site research for study oversight to facilitate both appropriate and timely study implementation.

Resources for Applicants

Non-Responsiveness Criteria

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

  • Applications that do not propose a sampling strategy for a national survey
  • Applications that do not survey providers and institutions which provide services to underserved and vulnerable older adults, as defined in this FOA

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?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIA intends to commit $16,200,000 in FY 2023 to fund 1 award.

Award Budget

Application budgets are limited to $16,200,000 in total costs each year.

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 not eligible to apply.

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

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

Required Registrations

Applicant organizations

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

  • 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.

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 IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

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

Page Limitations

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 12 Required 1 1
Administrative Core Admin Core 6 Required 1 1
Screening and Survey Instrument Development Core Core 6 Required 1 1
Administrative Data Transfer Masking Access and Ethics Core Core 6 Required 1 1
Data Collection Linkages Cleaning and Sharing Core Core 6 Required 1 1
Research Studies Core Core 6 Required 1 1

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
  • Screening and Survey Instrument Development Core: required
  • Administrative Data Transfer, Masking, Access, and Ethics Core: required
  • Data Collection, Linkages, Cleaning and Sharing Core: required
  • Research Studies Core: 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.

Personnel must have the appropriate breadth of expertise and experience to develop and administer an electronic survey that queries providers and to then link respondents to administrative data. This includes, but is not limited to, experience with the following:

  • Survey methodology and data extraction across clinical settings
  • Ethical issues related to research and care boundaries
  • Design, conduct, and analysis of research studies
  • Collaborative research with a variety of stakeholders and background in AD/ADRD research

With regard to the proposed leadership for the project, the PD/PI(s) and key personnel should have the expertise, experience, and ability to organize, manage and implement the proposed survey as well as adequate expertise in study coordination, data management, and statistics.

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)

I.

Specific Aims: Describe the aims of the overall center and outline how the different core components will contribute to these aims.

Research Strategy: Focusing on the center as a whole, applicants should comprehensively describe how they will accomplish the following goals of this FOA: (1) to develop and support an internet survey that queries health care providers and their institutions to understand how PLWD are cared for by a wide range of professional providers and to link the survey to administrative data sources; (2) to examine interactions between professional care providers; and (3) to examine how providers' interactions impact care provided to PLWD across institutional settings.

Applicants must describe how the center will provide national leadership and engage multiple stakeholders in advancing survey methodology for providers and institutions. In addition, applicants must detail how, if the aims of the center are achieved, clinical research, translation of research into practice, and participation by health care delivery organizations in research will be improved as well as lead to change in the capability, methods, and technologies used in addressing research important to affect health improvement for PLWD.

Applicants must describe how the project will challenge and take into account current AD/ADRD research, or clinical practice paradigms, and increase participation of paid dementia care providers and institutions by utilizing novel theoretical concepts, approaches, methodologies, or tools for the survey. Applicants must describe how the project will challenge and seek to impact current data management and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools. Applicants must indicate whether a refinement, improvement, or new application of approaches, concepts, or tools are proposed for the survey. Applicants must describe the mechanisms for leveraging novel collaboration and communication strategies for the survey as well as indicate how the project will ensure creativity and flexibility to innovate on an ongoing basis. Applicants must describe the innovative elements, as appropriate, that enhance the project’s sensitivity, potential for information, or potential to advance scientific knowledge or clinical practice.

Applicants must present the overall strategy for developing a national survey of professional dementia care providers and institutions and linking respondents (i.e., providers and institutions) that consent to administrative data. Describe how the different components of the center will interact to help accomplish its aims, how the approaches of the core components complement each other or are interdependent, and the mechanisms to be used in assessing progress toward the Center's goals. Where appropriate, provide timelines and organizational charts. Provide preliminary data in support of the sampling strategy. Describe the planned analyses and statistical approach and survey methodology in relation to the proposed study design.

Applicants should address the capability and ability to conduct the survey at the proposed site(s) or centers and describe plans to add or drop enrollment sites, as needed, due to lack of recruitment.

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

Applicants must describe the proposed leadership approach, staffing, governance and organizational structure. The PD/PIs must have demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia.

Applicants must describe how the investigators will collaborate with the Research Project awardees. Applicants must describe how the investigative team is up to date on the changing landscape of survey methodology research and participant protection regulations.

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

For a multicenter study, the organizational structure must be described and the application should identify a core of potential center investigators and staffing for a coordinating center.

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.

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 Resource Sharing Plans, including (1) a Data Sharing Plan; (2) a plan for  Sharing Model Organisms; and (3) a Genomic Data Sharing Plan (GDS).
  • This FOA REQUIRES the sharing of ALL resources with a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program.
  • It is imperative that the data collection and permission/consents are set up in such a manner with respondents and institutions that will allow broad use of data and resource sharing.
  • This FOA encourages sharing software and codes that are developed or modified to accomplish the aims of this program
  • This FOA requires adoption of Findable, Accessible, Interoperable, and Re-usable(FAIR) data principles when addressing each application component and encourages PD/PIs to consider obtaining a Core Trust Seal by the third year of the award.
  • Applications must address the following items:
    • Indicate the repository/consortium/enclave where they will place the data or other resource or have a clear plan and capacity to share from their own site(s). Working with an external repository or through a consortium can be advantageous for many investigators.
    • Describe any transformations to the data (e.g., application of algorithms, tools) that will be applied to the data in preparing them to be shared.
    • Describe and justify the timetable to release the data or other resource. Generally, the data and referenced resource from a publication should be made available by the on-line publication date unless NIH policy specifies an earlier date. Investigators should justify exceptions to that timing.
    • Identify any restrictions on sharing and justify them. Restrictions might include, for example, no commercial use of the data or resource, only qualified users may access the material, or, no attempt to reveal personal or private information may be made. Investigators may also set different levels of access, for example, for expert users and novice users.
    • Describe how all materials (e.g., sampling frame, instruments, and all resources generated from this FOA) will be transferred to a new entity at the end of the project period to enable long-term follow up with survey respondents and institutional representatives.
    • For studies involving human participants, describe how the investigators will mitigate deidentification risk with the data, whether that procedure is one following HIPAA, IRB, or other Institutional guidance, and generally how they will secure the personal and private information of the participants; this includes a condition on the end-user certifying that no attempts to identify participants from the de-identified data will be made.
    • To ensure that qualified users will have easy access to the data, describe either (1) how the investigators will curate the data or other resource, what documentation they will provide (“metadata”) and the format in which it will be provided, and whether any data or resource will be held back, or (2) how the investigators will work with the identified repository/consortium/enclave to prepare the data or resource and documentation.
    • Address considerations of privacy-preserving linkages and how such keys will be transferred to various parties (e.g., consortium members, researchers) preserving PII for future follow-up.
    • Address timely (i.e., within 30 days of NIA notice) execution of the material transfer agreement within and across the consortia, and with third parties if directed by NIA. The material transfer agreement includes, but is not limited to, transfer of data, sampling frame, and all data and resources generated by the cooperative agreement.
    • Describe the risk to respondent confidentiality and how it will be mitigated.
    • Explain how the complete collection of metadata (data about the data) will be provided.
    • Explain how the complete variable metadata (variable and value labels) will be provided either directly in the data file(s) or in supporting syntax file(s).
    • Explain how documentation (e.g., codebook, questionnaire, and user guide) will be provided and how the data will be made searchable.
    • Describe the process for ensuring that variable names for lontigudinal data are consistent across waves or follow a consistent pattern across waves so it is clear to secondary data users that those data were collected and measured at each time point (for instance, T1_health_status, T2_health_status, etc.).a
    • If applicable, specify how data will be provided via tiered access (e.g., public use file versus data access via enclave) based on identification risk.
    • Present milestones for various releases of data resulting from this FOA.
    • Present a plan to review restricted data within seven business days of a data user's request.

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 ‘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.
  • Describe expertise in establishing and effectively managing a range of collaborations and partnerships, including one or more examples of effective collaborations the PD/PI has established with descriptions of the motivation for initiating the collaboration, the goals defined for the collaboration, and the outcomes achieved.

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.

The budget should include funds to organize and support meetings, and prepare meeting summaries, for the cooperative agreement core team and the DMB. The meetings will be face-to-face or virtual. The location of the meeting will be in the vicinity of Bethesda, MD, and each meeting is expected to last approximately 1.5 days. In the first year, two meetings will be held, following by annual meetings of similar length in the remaining years.

The budget should also include funds to convene annual research meetings in Bethesda, MD starting in Year 3.

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 center 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 bring unique advantages or capabilities to the center.

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

  • Present a plan for the integration of multiple activities to accomplish overall goals.
  • Explain how information about the center will be disseminated, including a public website for communication and sharing of activities, events, and resources of the program.
  • Describe activities the Core will conduct to facilitate and highlight use of data, including training sessions, Grand Rounds, and others.
  • Describe how the Administrative Core will collaborate with other cores and offer input and support across the center.
  • Explain how the Core will provide organizational and logistical support for center activities as well as for Program officer(s), Project Scientist(s), and the DMB.
  • Describe how the Core will support standards and mechanisms to publicly share data, resources, and codes developed and utilized in this cooperative agreement.
  • Explain how the Core will address data interoperability between instrument development, consent, and administrative data linkages from the health facilities.
  • Describe how the Core will facilitate, create and support development and execution of ALL material transfer agreement within 30 days of NIA notice.
  • Present an administrative plan appropriate for effective management of a complex collaborative structure. Multiple PD/PI applications will use the Multiple PD/PI Leadership Plan to address effective management of a complex structure.
  • Describe the governance and organizational structure of the leadership team, communication plans and processes for making decisions on scientific direction, and procedures for resolving conflicts. Multiple PD/PI applications will use the Multiple PD/PI Leadership Plan attachment to describe the governance and organizational structure of the leadership team and the research project, communication plans and processes for making decisions on scientific direction, and procedures for resolving conflicts; information from the Multiple PD/PI Leadership Plan may be referenced here but should not be duplicated.
  • Delineate the roles and administrative, technical, and scientific responsibilities for the project staff as they relate to the various functions of data collection.
  • Describe processes for problem-solving, communication, and prioritization of work.

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.

 

Screening and Survey Instrument Development Core

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

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

SF424 (R&R) Cover (Screening and Survey Instrument Development 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 (Screening and Survey Instrument Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Screening and Survey Instrument Development 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) (Screening and Survey Instrument Development 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 (Screening and Survey Instrument Development Core)

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

Budget (Screening and Survey Instrument Development 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 (Screening and Survey Instrument Development Core)

Specific Aims: Identify general objectives planned for the Screening and Survey Instrument Development Core along with the main benchmarks that would indicate the accomplishment of these objectives. Describe how the Core will facilitate and optimize screening and develop the survey instruments.

Research Strategy: The core should facilitate and optimize screening when possible using data from CMS and professional societies in order to lower cost for data collection, develop user friendly data, and facilitate and ensure data is widely available in a timely manner. In addition, this core should develop survey instruments to cover various health care providers and institutions providing care for PLWD.

Applications must address the following:

  • Explain the overall vision of the Screening and Survey Instrument Development Core and how this meets the project objectives;
  • Describe plans to optimize screening to lower cost of the survey;
  • Present the approach to developing relationships with organizations;
  • Explain the strategy for optimizing survey response, including use of monetary and behavioral incentives to maximize survey response. Specifically, this core is encouraged to utilize financial incentives;
  • Describe plans to support development of instruments for the survey to cover various health care providers and institutions providing care for PLWD;
  • Describe plans to hold annual competitions among researchers and other stakeholders for pilot development of survey instruments and/or seek ideas of incorporating and testing administrative data when viable; and
  • Describe plans to incorporate feedback from the DMB and facilitate decisions on the selection of appropriate methods (i.e., longitudinal or cross-sectional) to collect different types of data across providers and institutions on an annual basis.

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 (Screening and Survey Instrument Development 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 Informationform 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.

 

Administrative Data Transfer, Masking, Access, and Ethics Core

When preparing your application, use Component Type ‘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 Data Transfer, Masking, Access, and Ethics 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 Data Transfer, Masking, Access, and Ethics Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Data Transfer, Masking, Access, and Ethics 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 Data Transfer, Masking, Access, and Ethics 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 Data Transfer, Masking, Access, and Ethics Core)

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

Budget (Administrative Data Transfer, Masking, Access, and Ethics 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 Data Transfer, Masking, Access, and Ethics Core)

Specific Aims: Identify general objectives planned for the Administrative Data Transfer, Masking, Access, and Ethics Core along with the main benchmarks that would indicate the accomplishment of these objectives. . Describe how the Core will transfer administrative data to the Data Collection, Linkages, Cleaning and Sharing Core, safeguard privacy of participants and institutions, facilitate requests for data use, and provide ethical guidance for the center.

Research Strategy: This core will focus on transferring administrative data to the Data Collection, Linkages, Cleaning and Sharing Core; masking data and otherwise preserving privacy of participants and institutions; facilitating requests for data use; and providing ethical guidance to the entire center.

Applications must address the following:

  • Explain the overall vision of the Administrative Data Transfer, Masking, Access, and Ethics Core and how this meets the project objectives;
  • Describe plans for executing data use agreements with institutions and building a pipeline (e.g., applicational programming interface (API)) or other digital means to transfer administrative data to the Data Collection, Linkages, Cleaning and Sharing Core, so that it can be linked to survey instruments;
  • Explain how the Core will support administrative data transfer;
  • Provide a strategy for setting up the governance structure of data with institutions (e.g., organizing DRB meetings);
  • Describe plans to harmonize and clean data from administrative data sets;
  • Describe plans to mask data and otherwise preserve privacy of individuals and institutions when linking data;
  • Present a strategy for facilitating requests for restricted data use and reviewing those requests in a timely manner; and
  • Describe how the Core will provide ethical guidance for data collection and integration for the overall infrastructure.

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 Data Transfer, Masking, Access, and Ethics 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 Informationform 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 Collection, Linkages, Cleaning and Sharing Core

When preparing your application, use Component Type ‘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 Collection, Linkages, Cleaning and Sharing 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 Collection, Linkages, Cleaning and Sharing Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Collection, Linkages, Cleaning and Sharing 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 Collection, Linkages, Cleaning and Sharing 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 Collection, Linkages, Cleaning and Sharing Core)

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

Budget (Data Collection, Linkages, Cleaning and Sharing 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 Collection, Linkages, Cleaning and Sharing Core)

Specific Aims: Identify general objectives planned for the Data Collection, Linkages, Cleaning and Sharing Core along with the main benchmarks that would indicate the accomplishment of these objectives. Describe how the Core will support data collection for the center.

Research Strategy: This core will facilitate data collection, linking data to administrative data (e.g., EHR and claims), and enabling access to public use files and restricted data through a cloud interface. To minimize cost and maximize data collection and sample size, NIA requires the prime cooperative agreement institution to utilize a competitive process to select an entity to conduct these activities.

Applications must describe the approach for a competitive process to select an organization to:

  • Support data collection (i.e., the internet survey);
  • Link the survey data to administrative data (e.g., EHR and claims); and
  • Create user friendly data sets (see resource sharing plan) and enable access to public use file and restricted data through cloud interface. The FOA encourages the application to explore use of the Health and Aging Data Enclave as appropriate for data sharing.
  • Release all data products in a timely manner.

PDs/PIs are encouraged to provide a timeline for the proposed survey and when public and restricted data will become available for research use.

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 Collection, Linkages, Cleaning and Sharing 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 Informationform 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.

 

Research Studies Core

When preparing your application, use Component Type 'Core.’

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

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Studies Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Studies Core)

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

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

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

Project /Performance Site Location(s) (Research Studies Core)

List all performance sites that apply to the specific component.

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

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

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

Budget (Research Studies 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 (Research Studies Core)

Specific Aims: Identify general objectives planned for the Research Studies along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: This Core will support innovative research projects that will be required to use the data generated from this cooperative agreement. Research projects may not exceed $100,000 in direct costs per project and $800,000 in total costs per year starting in Year 1.

Applications must address the following:

  • Describe how research projects will be solicited and reviewed and the process for selecting meritorious projects via national competition;
  • Describe how the Core will manage making awards to support research projects;
  • Present a plan for ensuring that research projects are designed to lead to, or inform, NIA AD/ADRD Research milestones.
  • Propose a consolidated or centralized IRB approach consistent with the NIH single IRB policy for multi-site research for study oversight to facilitate both appropriate and timely study implementation.

Multi-year research projects are not encouraged and will require review and approval by NIA prior to solicitation. NIA requires a national competition to invite AD/ADRD research studies applications to be held on a annual or semi-annual basis, with peer review which will address NIA AD/ADRD milestones.

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 (Research Studies 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 Informationform or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 and responsiveness by NIA, 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.

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?

Questions Specific to this FOA

Will the center provide national leadership and engage multiple stakeholders in advancing survey methodology for provider and institutions? If the aims of the Center are achieved, how will clinical research, translation of research into practice, and participation by health care delivery organizations in research be improved? How will successful completion of the aims change the capability, methods, and technologies used in addressing research important to effect health improvement for PLWD?

Will the proposed activities in this application allow surveys of dementia care providers and institutions?

Is the sampling strategy well supported by preliminary data?

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?

Questions Specific to this FOA

Do the personnel have the appropriate breadth of expertise and experience, including but not limited to, experience with survey methodology and data extraction across clinical settings, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of research studies, experience in collaborative research with a variety of stakeholders and background in AD/ADRD research? Have they demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia? Are the investigators willing to collaborate with the Research Project awardees? How well does the application describe how the investigative team is up to date on the changing landscape of survey methodology research and participant protection regulations?

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 survey? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter study, 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?

Questions Specific to this FOA

Does the application challenge and take into account current AD/ADRD research or clinical practice paradigms and increase participation of paid dementia care providers and institutions by utilizing novel theoretical concepts, approaches, methodologies, or tools for this survey? Does the application challenge and seek to impact current data management and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools? Is a refinement, improvement, or new application of approaches, concepts, or tools proposed for the survey? Does the application include mechanisms for leveraging novel collaboration and communication strategies for the survey? Does the application indicate creativity and flexibility to innovate on an ongoing basis?

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?

Questions Specific to this FOA

How well-described is the overall strategy for developing a national survey of professional dementia care providers and linking respondents (providers and institutions) that consent to administrative data? Does the application detail how the different components of the center will interact to help accomplish its aims, how the approaches of the core components complement each other or are interdependent, and the mechanisms to be used in assessing progress toward the Center's goals? Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the project? Does the application provide evidence of how the planned collaboration will work among a team with potentially very different backgrounds?

Are planned statistical and survey methodology along with sampling strategy appropriate for the proposed study design?

How reasonable are the following Resource Sharing Plans: (1) DataSharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS)? How adequate are the plans for resource sharing, including a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication of software and codes? Do the application’s plans for resource sharing adhere toFAIR data principles with regard to the repository/consortium/enclave where they will place the data or other resource, any transformations to the data (e.g., application of algorithms, tools) that will be applied to the data in preparing them to be shared, the timetable to release the data or other resource, restrictions on sharing and justifications for those restrictions, and methods for ensuring all materials (e.g., sampling frame, instruments, and all resources generated from this cooperative agreement) will be transferred to a new entity to enable long-term follow up with survey respondents and institutional representatives?

For studies involving human participants, how well does the application describe plans to mitigate deidentification risk with the data, whether that procedure is one following HIPAA, IRB, or other Institutional guidance, and generally how the project will secure the personal and private information of the participants? Are plans well-described for either (1) how the investigators will curate the data or other resource, the documentation they will provide (“metadata”) and the format in which it will be provided, and how, if applicable, any data or resource will be held back, or (2) how the investigators will work with the identified repository/consortium/enclave to prepare the data or resource and documentation to allow easy access to qualified users? Does the application include considerations of privacy-preserving linkages and how such keys will be transferred to various parties (e.g., consortium members, researchers) preserving PII for future follow up? Does the application address timely (i.e., within 30 days on NIA notice) execution of the materials transfer agreement within and across consortia, and with third parties if directed by NIA?

How well does the application address the following items?

  • The risk to respondent confidentiality and how it will be mitigated
  • Provison of a complete collection of metadata (data about the data)
  • Provision of complete variable metadata (variable and value labels) directly in the data file(s) or by providing supporting syntax file(s)
  • Provision of documentation (e.g., codebook, questionnaire, user guide) and facilitation of the searchability of data
  • For longitudinal data, the process for ensuring that variable names are consistent across waves or follow a consistent pattern across waves so it is clear to secondary data users that those data were collected and measured at each time point (for instance, T1_health_status, T2_health_status, etc.)
  • Specification ofhow data will be provided via tiered access (e.g., public use file versus data access via enclave) based on identification risk, if applicable
  • Presentation of milestones for various releases of data resulting from this FOA
  • Presentation of a plan to review restricted data within seven business day of data user’s request

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?

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?

Questions Specific to this FOA

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll survey respondents; (2) adhere to the survey 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.

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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

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

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?

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?

How well-described is the investigative team’s expertise in establishing and effectively managing a range of collaborations and partnerships?

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?

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?

Does the application present a plan for the integration of multiple activities to accomplish overall goals? Is the plan to disseminate information about the center adequate? Is the administrative plan appropriate for effective management of a complex collaborative structure? How well-described are the governance and organizational structure of the leadership team, communication plans and processes for making decisions on scientific direction, and procedures for resolving conflicts? Are the roles and administrative, technical, and scientific responsibilities for the project staff as they relate to the various functions of data collection clearly delineated? How well-described are the processes for problem-solving, communication, and prioritization of work?

How well-described are the activities the Core will conduct to facilitate and highlight use of data, including training sessions, Grand Rounds, and others for utilizing the survey data? How well-described is the plan for the Administrative Core to collaborate with other cores and offer input and support across the center? Is the plan for the Core to provide organizational and logistical support for center activities as well as for Program officer(s), Project Scientist(s), and Data Monitoring Board (DMB) logical and appropriate? How well-described is the plan for the Core to support standards and mechanisms to publicly share data, resources, and codes developed and utilized in this cooperative agreement? Does the application explain how the Core will address data interoperability between instrument development, consent, and administrative data linkages from the health facilities? How well-described is the plan for the Core to facilitate, create and support development and execution of ALL material transfer agreement within 30 days of NIA notice?

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?

Additional Review Criteria - Administrative 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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Administrative 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

Not Applicable

Select Agent Research

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

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 - Screening and Survey Instrument Development 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

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?

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?

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?

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?

Reviewers will evaluate the overall vision of the Screening and Survey Instrument Development Core and how this meets the project objectives. How well-described are plans to optimize screening? Is the approach to developing relationships with organizations likely to lead to success? Does the application explain the strategy for optimizing survey response, including use of monetary and behavioral incentives to maximize survey response? How well-described are plans to support development of instruments for the survey to cover various health care providers and institutions providing care for PLWD? How well-described are plans to hold annual competitions among researchers and other stakeholders for pilot development of survey instruments and/or seek ideas of incorporating and testing administrative data when viable? How well-described are plans to incorporate feedback from the DMB and facilitate decisions on the selection of appropriate methods (i.e., longitudinal or cross-sectional) to collect different types of data across providers and institutions on an annual basis?

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?

Additional Review Criteria - Screening and Survey Instrument Development 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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Screening and Survey Instrument Development 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

Not Applicable

Select Agent Research

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

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 Data Transfer, Masking, Access, and Ethics 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

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?

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?

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?

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?

Reviewers will evaluate the overall vision of the Administrative Data Transfer, Masking, Access, and Ethics Core and how this meets the project objectives. How well-described are plans for executing data use agreements with institutions and building a pipeline or other digital means to transfer administrative data to the Data Collection, Linkages, Cleaning and Sharing Core? Does the application adequately address how the Core will support “big data” transfer? Is the strategy for setting up the governance structure of data with institutions (e.g., organizing DRB meetings) appropriate? How well-described are plans to harmonize and clean data from administrative data sets? How well-described are plans to mask data and otherwise preserve privacy of individuals and institutions when linking data? Is the strategy for facilitating requests for restricted data use and reviewing those requests in a timely manner sound? How well-described are plans for the Core to provide ethical guidance for data collection and integration with the overall infrastructure?

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?

Additional Review Criteria - Administrative Data Transfer, Masking, Access, and Ethics 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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Administrative Data Transfer, Masking, Access, and Ethics 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

Not Applicable

Select Agent Research

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

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 - Data Collection, Linkages, Cleaning and Sharing 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

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?

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?

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?

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?

How well-described is the approach for a competitive process to select an organization to support data collection (i.e., the internet survey); link the survey data to administrative data (e.g., EHR and claims); and, and create user friendly data sets (see resource sharing plan) and enable access to public use files and restricted data through cloud interface? Is the approach well-developed and likely to lead to success?

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?

Additional Review Criteria - Data Collection, Linkages, Cleaning and Sharing 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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Data Collection, Linkages, Cleaning and Sharing 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

Not Applicable

Select Agent Research

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

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 - Research Studies 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

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?

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?

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?

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?

How well-described are plans for research projects to be solicited and reviewed and the process for selecting meritorious projects via national competition? Is the process likely to be successful and result in the selection of projects that will move the field forward? How well-described are the plans for the Core to manage making awards to support research projects? Does the application present a plan for ensuring that research projects are designed to lead to (or inform) NIA AD/ADRD Research milestones? Does the application propose a consolidated or centralized IRB approach consistent with the NIH single IRB policy for multi-site research for study oversight to facilitate both appropriate and timely study implementation?

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?

Additional Review Criteria - Research Studies 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 Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Research Studies 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

Not Applicable

Select Agent Research

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

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

For this FOA, 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.

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

Prior Approval of Research Studies

Recipient-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: 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.

The PI(s) will have the primary responsibility for the design and details of the study/studies funded under this FOA, and will retain primary responsibility for performance of the activities, including analyzing and publishing results, negotiating required Restricted Use Agreements with institutions as required, and maintaining ownership over data collected. The recipient(s) agree(s) to accept assistance from the designated NIH/NIA Program Official and Project Scientist in aspects of the scientific and technical management of the study/studies and in coordinating with other Federal agencies. The PD/PI agrees to execute materials transfer agreement within 30 day of NIA notice.

After award, the PD/PI(s) will work with the Data Monitoring Board (DMB), which includes experts in the scientific community who are not connected with the study/studies except in this capacity, to advise the PD/PI(s) and NIA on the overall scientific and financial management of the study/studies.

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

A NIH/NIA Project Scientist from NIA's Division of Behavioral and Social Research (BSR) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH/NIA Project Scientist will assist in the following areas: refining study objectives, methodologies, and survey instruments; exploring the use of alternative sampling frames; developing record linkages with administrative files; initiating and maintaining collaborative relationships with relevant federal agencies and other groups; and analyzing and publishing the results of the study.

Additionally, an agency Program Official from BSR will be responsible for the normal scientific and programmatic stewardship of the award(s). The NIA Program Official will approve all major stages of the study/studies and all new major additions/changes to content and methods. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIA Program Official for any replacements of key personnel or other changes in subcontracts.

In order to ensure that the study achieves NIA assistance objectives under the cooperative agreement, NIA will establish and appoint members to a DMB comprised of NIA staff, study investigators, representatives from relevant federal agencies, and independent scientific experts in areas appropriate to the multidisciplinary content areas of the survey. The NIA will appoint DMB members whose purpose is to provide expert independent advice to the NIA and PI(s) on the successful implementation of the study/studies. Experts, including, but not limited to, the Principal Investigator(s), co-Investigators, NIA staff, and invited independent experts, will make presentations to the DMB on scientific and administrative issues regarding the development and implementation of study aims. The NIA Program Official and the PIs may request the DMB’s advice on specific issues. The NIA Program Official and the investigators will consider the recommendations of the DMB regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement(s). The DMB will report to the NIA and it will communicate specific advice to the NIA regarding funding priorities via executive sessions of DMB meetings. The DMB will also, where appropriate, provide advice and recommendations to therPI(s); this advice is not binding on the PI(s) who retain primary responsibility for scientific direction and implementation. New DMB Chair and members will be appointed by NIA when necessary.

Areas of Joint Responsibility include:

  • None; all responsibilities are divided between recipients and NIH staff as described above.

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.

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

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

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

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
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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