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

NIA AD/ADRD Health Care Systems Research Collaboratory (U54 Clinical Trial Required)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-19-009

Companion Funding Opportunity

PAR-18-585, R61/R33 Exploratory/Developmental Phased Award

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

93.866

Funding Opportunity Purpose

The purpose of this FOA is to solicit applications for the AD/ADRD Health Care Systems Research Collaboratory ("Collaboratory", henceforth) to improve care for persons with dementia (PWD) and their caregivers through health systems. Health and long-term systems for this FOA are defined broadly and include organizations providing care across settings to include primary and specialty outpatient care, acute inpatient care, skilled nursing and other rehabilitation facilities, residential long-term care, and home and community-based services. Organizations may be traditional health care systems (e.g., health maintenance organizations, or HMOs), health insurance companies, managed care plans, home health care providers, memory clinics, nursing homes, assisted living facilities, outpatient clinics, federally-designated health centers, hospitals, and other providers of acute and long-term care. The Collaboratory will: 1) serve as a national resource to promote development of pragmatic trials and demonstration projects to improve care and health outcomes for PWD and their caregivers; 2) support pilot pragmatic trials within the Collaboratory; 3) develop and disseminate technical and policy guidelines and best practices for effectively conducting AD/ADRD research studies in partnership with health care systems; 4) work collaboratively with researchers to provide technical support for scaling up pilot studies; and 5) disseminate best practices for engaging stakeholders, conducting ethical research in the special circumstances of dementia care, and involving long-term and acute-care providers.

Key Dates
Posted Date

June 25, 2018

Open Date (Earliest Submission Date)

August 6, 2018

Letter of Intent Due Date(s)

August 6, 2018

Application Due Date(s)

September 6, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity Announcement.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2018

Advisory Council Review

January 2019

Earliest Start Date

April 2019

Expiration Date

September 7, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

  3. Table of Contents

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

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    1. Background

    There is an urgent need to improve care for persons with dementia (PWD) and their caregivers within the context of health and long-term care systems. Lack of continuity of care is associated with higher rates of hospitalization, emergency department visits, unnecessary testing, and health care spending. Late diagnoses of dementia and lack of coordination among providers and care settings can lead to inappropriate care, premature institutionalization, and burdensome transitions in late-stage dementia. Poor-quality and inappropriate care can mean a worse quality of life for PWD and their caregivers. Changes in the content and organization of care might improve the quality of life for PWD, relieve the burden for caregivers, improve care transitions, and enhance care overall. Small studies have provided some evidence that improvements are possible. However, there is a need for studies in real-world settings and at scales adequate to provide evidence for benefit across multiple health care settings and across different health systems.

    The aim of this FOA is to support a center for collaborative research within and among health and long-term care systems to encourage pragmatic trials of innovative dementia care. Specifically, for this FOA, health and long-term care systems are defined broadly and include organizations providing care across settings to include primary and specialty outpatient care; acute inpatient care; skilled nursing and other rehabilitation facilities; residential long-term care; and home and community-based services. Organizations may be traditional health care systems (e.g., HMOs), primary care clinics, health insurance companies, managed care plans, home health care providers, memory clinics, nursing homes, assisted living facilities, outpatient clinics, federally designated health centers, hospitals, and other providers of acute and long-term care.

    2. Specific Objectives of the Collaboratory

    The specific objectives of the Collaboratory are: 1) serve as a national resource to promote development of pragmatic trials and demonstration projects to improve care and health outcomes for PWD and their caregivers; 2) support pilot pragmatic trials within the Collaboratory; 3) develop and disseminate technical and policy guidelines and best practices for effectively conducting AD/ADRD research studies in partnership with health care systems; 4) work collaboratively with researchers to provide technical support for scaling up pilot studies; and 5) disseminate best practices for engaging stakeholders in research, conducting ethical research in the special circumstances of dementia care, and involving long-term and acute-care providers.

    The Collaboratory will build investigator capacity, support Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) pragmatic trial design, and maintain the resource and knowledge base for AD/ADRD pragmatic trials through the following features:

    • Administrative coordination;
    • Data, Electronic Health Records (EHRs), and health care systems interactions;
    • Collection and use of Clinical Outcome Assessments (COAs), including patient-reported outcomes (PROs), caregiver-reported outcomes (CRO), observer-reported outcomes (ObsROs), performance outcomes (PerfOs), and clinician-reported outcomes (ClinROs);
    • Robust stakeholder engagement in Collaboratory governance and in research;
    • Biostatistics and pragmatic trial study design;
    • Pilot projects;
    • Participant recruitment, ethics, and regulation;
    • Evidence synthesis and systematic review; and
    • Dissemination and implementation, including training and education.

    3. Organizational Structure

    The Collaboratory will use in-house and external scientific expertise (see Section I.4. for "Experience and Knowledge") and have a Consortium Agreement Requirement with health and long-term care systems (see Section VI.2. for Cooperative Agreement Terms and Conditions of Award) to facilitate core functions. At minimum, the Collaboratory will be comprised of seven core components which will incorporate the features highlighted in Section I.3: (A) Administrative Core; (B) Technical/Data Core; (C) Regulation & Ethics Core; (D) Design/Statistical Core; (E) Pilot Studies Core; (F) Patient & Caregiver Reported Outcomes (PCRO) Core; and (G) Dissemination & Implementation Core. There are (H&I) Optional Cores as well. Applicants are encouraged to address the features described in Section I.2 in the seven Cores, but also have an option to propose two investigator-initiated Cores relevant to AD/ADRD research. Examples of contents of each of the Cores are highlighted below, but are not limited to the following:

    A. Administrative Core:

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

    • Providing governance structure for the Collaboratory;
    • Providing a public website for communication and sharing of activities, events, and resources of the program (see "NIH Health Care Research Systems Research Collaboratory"); 
    • Hosting a Living Textbook for conducting AD/ADRD Pragmatic Trials;
    • Hosting AD/ADRD Pragmatic Trials Grand Rounds;
    • Collaborating and offering input for pragmatic trials during the planning phase of projects;
    • Holding a semi-annual national competition for AD/ADRD pilot pragmatic trials and recommending funding of such trials to NIA (individual pilot trials may not exceed $200,000 in direct costs);
    • Providing organizational and logistical support for the activities of the Collaboratory Cores, Project Scientist(s), Steering Committee, and Collaboratory External Advisory Panel (EAP);
    • Holding annual research meetings in Bethesda, MD for AD/ADRD pragmatic trials starting in Year 3;
    • Addressing data interoperability between health systems and between EHR vendors;
    • Supporting standards and mechanisms to publicly share data, resources, and codes developed and utilized in AD/ADRD pragmatic trial projects supported by both the NIA and the Collaboratory; and
    • Organizing and supporting two face-to-face meetings of the Collaboratory Cores and Steering Committee in the vicinity of Bethesda, MD for approximately 1.5 days in the first year, annual meetings of similar length in following years, and preparing meeting summaries.

    B. Technical/Data Core:

    This Core will facilitate guidance for health systems and electronic health record (EHR) vendors to standardize data structures that capture relevant health outcomes for research on the health of PWD and their caregivers. This may include incorporating recommendations from the Patient & Caregiver Reported Outcomes Core, described below. This core may compile and disseminate methods for using EHRs to:

    • Identify potential study participants;
    • Assess the impact of various eligibility criteria on cohort size;
    • Support real-time or near real-time recruitment to expedite study enrollment;
    • Automate extraction of demographic and clinical information for reporting and analysis;
    • Provide real-time support to guide protocol-based management of trial participants;
    • Track patients and improve follow-up;
    • Automate clinician notifications to collect trial-specific metrics and outcomes; and
    • Automate outcome ascertainment occurring over months or years.

    This Core may also establish a remote enclave for sharing sensitive administrative data (e.g., EHRs, private claims records, state registry data) among Collaboratory investigators (i.e., those conducting pilot pragmatic trials) and other NIA-funded AD/ADRD pragmatic trials. Furthermore, it may work with international health systems to standardize EHRs to enable cross-national AD/ADRD research. The inclusion of EHR vendors and/or researchers addressing data interoperability to permit cross-organization collaboration is also encouraged.   

    C. Regulation & Ethics Core:

    This Core will develop ethics guidelines for conducting pragmatic trials to provide a national resource for the research community. This Core will also develop methods and share best practices for compliance with the various regulatory structures affecting long-term care as well as acute and post-acute care.

    D. Design/Statistical Core:

    This Core will facilitate and provide design and analysis support for AD/ADRD pilot pragmatic trials. This Core may also develop an AD/ADRD Living Textbook and other guidance documents for conducting pragmatic trials within health care systems. Also, this Core may work with the Technical/Data Core that manages the remote data enclave in order to conduct analyses and replication studies. Concurrently, this Core may conduct statistical analyses of measures and instruments developed in the PCRO Core.

    E. Pilot Studies Core:

    This Core will support innovative research projects, which may not exceed $200,000 per project (direct cost), for up to $2,500,000 per year (total cost) starting in Year 2. In Year 1, the NIA expects the Collaboratory to hold one annual competition, and the research project budget may not exceed $200,000 per pilot project and up to $1,250,000 (total cost). Pilot projects should be designed to lead to (or inform) the design of larger-scale pragmatic trials. The objectives of the pilot projects are to generate preliminary data for larger research efforts on AD/ADRD relevant pragmatic trials and demonstration projects within health systems. Multi-year pilot projects are not encouraged and will require review and approval by the NIA. The NIA encourages a national competition to invite AD/ADRD pilot applications to be held on a semi-annual basis, with peer review.

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

    F. Patient & Caregiver Reported Outcomes (PCRO) Core

    This Core will develop patient and caregiver-reported outcome measures and instruments relevant to AD/ADRD research that can be captured in EHRs for use in the Technical/Data Core. Additionally, this Core may provide guidance for the creation of efficient, high-quality data collection systems for such measures compatible with EHRs and registries.

    G. Dissemination & Implementation Core

    This Core will identify from the scientific literature evidence-based AD/ADRD pragmatic trials and disseminate findings across health systems and among researchers. This Core can also assist with implementation activities across health systems. There are limited numbers of pragmatic trials currently funded by the NIA; as such this Core can be limited in scope in the initial years, but it is expected to grow overtime and play a crucial role in dissemination and implementation as many more AD/ADRD pragmatic trials pilot projects are supported by the Collaboratory.

    H. Optional Core

    Applicants have an option to propose two investigator-initiated Cores which will benefit the overall Collaboratory. Core H must be relevant to AD/ADRD research.

    I. Optional Core

    Applicants have an option to propose two investigator-initiated Cores which will benefit the overall Collaboratory. Core I must be relevant to AD/ADRD research.

    4. Experience and Knowledge

    Collaboratory staff are expected to have significant experience and knowledge in the following areas. The proposed team and its structure should have depth of experience. Such areas of expertise include:

    • Knowledge of the regulatory requirements for conducting AD/ADRD research with the use of health care data for AD/ADRD research, and experience conducting AD/ADRD research that complies with applicable regulations;
    • Conducting multi-site research studies with participation by multiple health care delivery organizations that focus on AD/ADRD;
    • Extracting information from electronic health records (EHRs) and relevant clinical systems for research, and experience with three or more health care systems is preferred;
    • Familiarity with ethical issues related to AD/ADRD clinical research, clinical care, quality improvement, population health, surveillance, and their boundaries;
    • Working collaboratively with others including persons with dementia (PWD), research participants, researchers, practitioners, hospital and research informatics and technical personnel, and senior managers of health care and research organizations;
    • Knowledge of workflows and practices of health care systems and their practitioners;
    • Workflows and practices of research teams, and experience in design and implementation of randomized studies should be highlighted;
    • Knowledge and understanding of the strengths and weaknesses of current data models, algorithms, and approaches used by various networks and studies to define clinical phenotypes, extract information, define endpoints, and discover errors in data from health care systems;
    • Project management experience in taking a research question from idea through implementation to completion;
    • Study design and statistical expertise—particularly in pragmatic trials—as well as novel study designs and methods;
    • Using creativity and innovation to solve technical and project challenges that respect and promote participation by all relevant communities; and
    • Reusable and sustainable models for incorporating COAs in health care EHRs and research study management tools, including electronic transfer of information from devices such as home blood pressure monitors.

    It is expected that the Collaboratory will engage nationally with others working in similar areas to stay abreast of emerging experience, regulations, and technical advances that impact the ability for research to be conducted in health care settings. This could include other NIH-funded AD/ADRD projects, but also other federally and privately funded efforts, such as projects funded by the Center for Medicare and Medicaid Innovation (CMMI) and/or private foundations.

    The Collaboratory will be responsible for facilitating harmonization and sharing of tools and approaches among AD/ADRD pragmatic trials in this collaborative program. Applicants must be willing to cooperate with pragmatic trials teams supported in the companion FOAs and with the NIH in the development and design of research approaches, methods, processes, policies, and tools used in this program. Applicants should have documented prior experience of working collaboratively in research consortia and other collaborative projects to accomplish shared goals.

    5. AD/ADRD Research Collaboratory Program Governance

    The award funded under this FOA will be a cooperative agreement (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH, pilot grantees and awardees under the Companion FOA (PAR-18-585) will be required to accomplish the goals of this program.

    Cores will be established and will provide essential functions to the overall Collaboratory. It is expected that the Cores will interact with each other. Additionally, the Cores will provide a forum for discussing challenges and solutions across projects; harmonized and standardized policies and processes will be vetted in these groups. Individual Cores are expected to be established in the following areas, at a minimum: Administrative, Technical/Data, Regulation & Ethics, Design/Statistical, Pilot Studies, Patient & Caregiver Reported Outcomes, and Dissemination & Implementation. In addition, the PD/PI can propose two additional Cores.

    A. Collaboratory Steering Committee

    A Collaboratory Steering Committee will be established to address issues that span across all projects, provide input towards the policies and processes of the Collaboratory, and assist in dissemination of policies and processes that enable research in partnership with health care systems, their patients, and practitioners. The Steering Committee will be composed of a representative from NIA-funded pragmatic trials, PDs/PIs of the Collaboratory, three representatives from the Cores, Project Lead of pilot projects funded through the Collaboratory, three external members which PDs/PIs will appoint with consultation with NIA, and the NIA Projects Scientist(s). Representation from NIA-funded pragmatic trials and pilot projects may not exceed more than two members total. All members are expected to participate actively in all Steering Committee activities. The combined vote of NIH/NIA membership may never exceed 40 percent. It is recommended that PDs/PIs not name the three external members in the application.

    B. AD/ADRD Research Collaboratory Program External Advisory Panel (EAP)

    An External Advisory Panel for the AD/ADRD Research Collaboratory program will be established to review the progress of all components of the program and provide recommendations to the steering committee. The steering committee will appoint members of the EAP. Membership may include, study investigators, representatives from relevant federal agencies, and independent scientific experts in areas appropriate to the multidisciplinary content of the Collaboratory. The EAP is expected to have 6-8 permanent members; however, membership may expand permanently or on an ad hoc basis as needed. The EAP will meet twice a year, for one in person meeting and one telephone conference. During the first year, the EAP will meet in person twice. At least once a year, there will be a joint meeting with the Steering Committee to allow members of both the EAP and the Steering Committee to interact directly. Twice a year the EAP will make recommendations, in writing, regarding progress of the program to the steering committee and to PD/PI, including changes, if any, that would benefit the program. At the end of Year 3, the EAP will provide recommendations for the continuation or termination of the program, including possible models for sustainability, if continuation is recommended. 

    It is recommended that the project be supported by detailed milestones for 5 years.

    The applicant must include funds for the Collaboratory PD/PI and key personnel to attend two, one-and-a-half-day Collaboratory program meetings in the first year and an annual meeting in subsequent years in the Bethesda, MD area. Additionally, applicants should budget appropriately for secretarial support for notetaking and travel services for the Collaboratory Steering Committee and External Advisory Panel.

    6. Collaboratory Center Director and Core Leaders Required Level of Effort

    The activities on this award demand complex management and coordination as many different entities will ultimately participate in the Collaboratory. Therefore, Program Director(s)/Principal Investigator(s) must commit and sustain sufficient effort throughout the award to manage this complex entity. Core directors will also need to coordinate activities across multiple organizations and so must also commit and sustain sufficient effort to manage these cross-institutional and cross-organizational activities.

    Consortium Agreement Requirement: Applications that lack a consortium agreement at the time of submission will be considered incomplete and will not be reviewed. The consortium agreement should bring together multiple health systems in the first year who will be willing to participate in AD/ADRD Pragmatic Trials or demonstration projects to improve care for PWD and their caregivers. The application must contain letters of support indicating institutions willing to join the Collaboratory (if funded by NIA in the first year) from at least four health systems (i.e., HMOs), at least two nursing home systems (minimum of over 100 nursing home per system/chain), and at least two hospital systems. Starting in Year 2, the application must show plans, and demonstrate the ability (letter of support from future collaborators indicating their willingness to participate in the Collaboratory), to bring in additional partners (health care systems (e.g., HMOs), health insurance companies (e.g., managed care plans), home health care providers, memory loss clinics, units, nursing homes, assisted living facilities, outpatient clinics, memory clinics, federally designated health centers, and hospitals). It is expected that by the end of Year 3 the awardee will have health care systems (e.g., HMOs), health insurance companies, managed care plans, home health care providers, memory clinics, nursing homes, assisted living facilities, outpatient clinics, federally designated health centers, hospitals, and other providers of acute and long-term care participating in the Collaboratory and contributing to pilot projects in multiple health systems.

    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.

    Clinical Trial?

    Required: Only accepting applications that propose clinical trial(s).

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    NIH intends to fund an estimate of 1 award, corresponding to a total of $6 million for fiscal year 2019; $12 million for fiscal year 2020; $12 million for fiscal year 2021; $12 million for fiscal year 2022; and $12 million for fiscal year 2023.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project.   

    Award Project Period

    The maximum project period is 5 years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

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

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

    Use of Multiple PDs/PIs is encouraged to ensure personnel from across disciplines and organizations are included as appropriate to the proposed structure of the Collaboratory.   

    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.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    A button to access the online ASSIST system 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.

    Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

    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.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    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

    Component Types Available in ASSIST

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (use for Administrative Core)

    6

    Technical Data (use for Technical/Data Core)

    6

    Regulation Ethics (use for Regulation & Ethics Core)

    6

    Design Statistical (use for Design/Statistical Core)

    6

    Pilot Studies (use for Pilot Studies Core)

    6

    PCRO (use for Patient & Caregiver Reported Outcomes Core) 

    6

    DI (use for Dissemination & Implementation Core)

    6

    Optional Core 1

    6

    Optional Core 2

    6

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

    Instructions for the Submission of Multi-Component Applications

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

    The application should consist of the following components:

    • Overall: Required
    • Administrative Core: Required; maximum of 1
    • Technical/Data Core: Required; maximum of 1
    • Regulation & Ethics Core: Required; maximum of 1
    • Design/Statistical Core: Required; maximum of 1
    • Pilot Studies Core: Required; maximum of 1
    • Patient & Caregiver Reported Outcomes (PCRO) Core: Required; maximum of 1
    • Dissemination & Implementation Core: Required; maximum of 1
    • Optional Core 1: Optional; maximum of 1
    • Optional Core 2: Optional; maximum of 1
    Overall Component

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

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

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

    Research & Related Senior/Key Person Profile (Overall)

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

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

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

    PHS 398 Research Plan (Overall)

    Specific Aims:  Describe the specific aims for the proposed AD/ADRD Research Collaboratory.  The Collaboratory is expected to be charged with creating a dynamic infrastructure for supporting AD/ADRD pragmatic trials with multiple health systems which will facilitate translation into clinical application for improving care delivery and health for PWD and their caregivers.  

    Research Strategy: Applicants are expected to:

    • ·    Address overall objectives, long-term goals, and milestones of the Collaboratory;
    • ·    The PD/PI must propose plans starting in year 2 and must submit letter(s) of support (see Letters of Support) that demonstrates future collaborations (by bringing in additional partners (health and long-term care systems (e.g., HMOs), health insurance companies, managed care plans, home health care providers, memory clinics, nursing homes, assisted living facilities, outpatient clinics, federally designated health centers, hospitals, other providers of acute and long-term care) and maintain the Collaboratory Consortium.
    • ·    Address their track record for the respective field of expertise of the Center and provide examples of successfully working with health systems;
    • ·    Describe the experience of the proposed team members with respect to working in research consortia or other collaborative efforts to achieve a shared goal.
    • ·    Include sustainability plans addressing post award efforts. Sustainability may include letters of support from partnering institutions/health systems as specified in the Letter of Support Section Below.
    • ·    Describe how the Collaboratory will engage nationally with others working in similar areas to stay abreast of emerging experience, regulations, and technical advances that impact the ability for research to be conducted in health care settings. This could include other NIH-funded AD/ADRD projects, but also other federally and privately funded efforts, such as projects funded by the Center for Medicare and Medicaid Innovation (CMMI) and/or private foundations.

    It is recommended that the grantee articulate and provide detailed milestones for 5 years.

    Letters of Support: At the time of application, the PD/PI must submit letter(s) of support that demonstrates collaboration  with at least 4 HMOs, at least 2 nursing home systems (minimum of over 100 nursing home per system/chain), and at least 2 hospital systems. The letter(s) of support must indicate institutions are willing to Join the Collaboratory if funded by the NIA in the first year.  Additionally, the PD/PI must submit letter(s) of support indicating willingness to engage with other NIH-funded AD/ADRD projects and with other federally and privately funded efforts, such as projects funded by the Center for Medicare and Medicaid Innovation (CMMI) and/or private foundations.

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

    This FOA expects the sharing of resources with a broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program. It is imperative that the Collaboratory is set up in such a manner that will allow for such practice. Additionally, the Collaboratory encourages sharing study data from pilot projects in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the Collaboratory is expected to implement a Resources and Data Sharing Plan consistent with these program goals.

    Additionally, this Collaboratory FOA encourages sharing software and codes that are developed or modified to accomplish the aims of this Program. This may include, but is not limited to: software, tools, code sets for extraction, or definition of data from EHRs, clinical systems, and other health care data systems; implementation of new workflows for research studies; analytic and analysis programs; and tools for incorporating patient input. The goals of software sharing under this program include: 1) broad availability to biomedical researchers, health care delivery organizations, research institutions, and government health care systems and researchers; 2) terms that permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages; and 3) terms of software availability that include the ability for individuals outside the applicant institution and its collaborating organizations to modify the source code, sharing modifications with others. While software development is not the primary goal of this Program, it is expected that software or sets of code may be developed under this Collaboratory, whether for pilot projects or pragmatic trials. Thus, grantees and their sub-contractors are expected to implement software sharing plans consistent with the goals of this Program.

    Appendix:

    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 NIH-defined human subjects research, clinical research, and/or 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

    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 in ASSIST, use Component Type ‘Admin Core .’

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

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

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

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

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

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

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

    List all performance sites that apply to the specific component.

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

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

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

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

    PHS 398 Research Plan (Administrative Core)

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

    Research Strategy:  

    The objectives of this Core may include, but are not limited to:

    • ·    Providing 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 Center structure;
    • ·    Describing 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.
    • ·    Delineating the roles and administrative, technical, and scientific responsibilities for the project staff as they relate to the various functions of the Collaboratory;
    • ·    Including a plan for the integration of Collaboratory's activities to accomplish overall goals; and
    • ·    Describing operating procedures for ensuring responsiveness to members of the research community who wish to access the Collaboratory and utilize Collaboratory resources.

    A critical aspect of the Center's administrative function is establishing and effectively managing a range of collaborations and partnerships. In the Administrative Plan:

    • ·    Provide one or more examples of effective collaborations the PD/PI has established, including descriptions of the motivation for initiating the collaboration, the goals defined for the collaboration, and the outcomes achieved; and 
    • ·    Describe processes for problem-solving, communication, and prioritization of work.

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

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

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

    Appendix:

    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 (Core or Project Name)

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    Technical/Data Core

    When preparing your application in ASSIST, use Component Type ‘Technical Data.’

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

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

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Technical/Data Core)

    Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

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

    Project /Performance Site Location(s) (Technical/Data Core)

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Technical/Data Core)

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

    Budget (Technical/Data Core)

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

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

    PHS 398 Research Plan (Technical/Data Core)

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

    Research Strategy:

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

    • ·    Producing guidance for health systems and EHR vendors to standardize data structures to capture relevant health outcomes for research on the health of PWD and their caregivers; and
    • ·    Potentially establishing a remote enclave for sharing sensitive administrative data (e.g., EHRs, private claims records, state registry data) among Collaboratory investigators (i.e., those conducting pilot pragmatic trials) and other NIA-funded AD/ADRD pragmatic trials.

    Letters of Support: Only letters of support specific to ‘Technical/Data Core" should be attached to this section.

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

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

    Appendix:

    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 Instructions.   

    PHS Human Subjects and Clinical Trials Information (Technical/Data Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    Regulation & Ethics Core

    When preparing your application in ASSIST, use Component Type ‘Regulation Ethics’

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

    SF424 (R&R) Cover (Regulation & 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 (Regulation & Ethics Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Regulation & 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) (Regulation & 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 (Regulation & Ethics Core)

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

    Budget (Regulation & 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 (Regulation & Ethics Core)

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

    Research Strategy:

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

    • ·    Developing guidelines for human subject protection, with special attention to concerns (e.g., informed consent) raised when conducting research on unique or vulnerable populations, such as individuals with dementia; and
    • ·    Providing resources on developed guidelines, as well as regulations relevant to conducting pragmatic trials research.

    Letters of Support: Only letters of support specific to ‘Regulation & Ethics Core " should be attached to this section

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

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

    Appendix:

    Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Regulation & Ethics Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    Design/Statistical Core

    When preparing your application in ASSIST, use Component Type ‘Design Statistical.’

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

    SF424 (R&R) Cover (Design/Statistical 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 (Design/Statistical Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Design/Statistical 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) (Design/Statistical 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 (Design/Statistical Core)

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

    Budget (Design/Statistical 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 (Design/Statistical Core)

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

    Research Strategy:

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

    • ·    Supporting analyses and replication studies of public, administrative, and/or restricted data sets;
    • ·    Providing resources on existing literature regarding AD/ADRD pragmatic trials and interventions;
    • ·    Developing an AD/ADRD Living Textbook containing guidance documents to conduct pragmatic trials; and
    • ·    Potentially providing support for statistical analyses of pilot projects funded through the Collaboratory and NIA funded AD/ADRD pragmatic trials.

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

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

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

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Design/Statistical Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    Pilot Studies Core

    When preparing your application in ASSIST, use Component Type ‘Pilot Studies’.

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

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

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Pilot 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) (Pilot 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 (Pilot Studies Core)

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

    Budget (Pilot Studies Core)

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

    In Year 1, the NIA expects the Collaboratory to hold one annual competition, and the research project budget may not exceed $200,000 per pilot project (direct cost) and, across all projects, $1,250,000 (total cost).

    Starting in Year 2, this Core can support innovative research projects, which may not exceed $200,000 per project (direct costs), and, across all projects, $2,500,000 per year (total cost).

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

    PHS 398 Research Plan (Pilot Studies Core)

    Specific Aims: State the goals of the proposed Pilot Studies Core concisely and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on AD/ADRD pragmatic trials/research field(s) involved. Describe the specific aims to address selection, development/refinement and management of pilot projects.

    Research Strategy:

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

    • ·    Selecting and evaluate promising pilot projects which should be designed to lead to (or to inform) the design of larger-scale AD/ADRD pragmatic trials; and
    • ·    Detailing a plan for the process for which new projects will be solicited, reviewed, funded and managed must be provided.

    Letters of Support: Only letters of support specific to ‘Pilot Studies Core" should be attached to this section

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

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

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Pilot Studies Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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, with the following additional instructions:

    Section 3 - Protection and Monitoring Plans

    3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

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

    Delayed Onset Study

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

    Patient & Caregiver Reported Outcomes (PCRO) Core

    When preparing your application in ASSIST, use Component Type ‘PCRO’.

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

    SF424 (R&R) Cover (Patient & Caregiver Reported Outcomes (PCRO) 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 (Patient & Caregiver Reported Outcomes (PCRO) Core )

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Patient & Caregiver Reported Outcomes (PCRO) 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) (Patient & Caregiver Reported Outcomes (PCRO) 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 (Patient & Caregiver Reported Outcomes (PCRO) Core)

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

    Budget (Patient & Caregiver Reported Outcomes (PCRO) 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 (Patient & Caregiver Reported Outcomes (PCRO) Core)

    Specific Aims: State the goals of the proposed PCRO Core concisely and summarize the expected outcome(s), including the impact of developing measures, instruments, and systems for patient and caregiver reported outcomes data, where results of the proposed research will exert on AD/ADRD pragmatic trials/research field(s) involved. List the specific objectives of the research proposed succinctly.

    Research Strategy:

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

    • ·    Developing novel outcome measures and instruments that can be integrated into EHRs.
    • ·    Providing guidance (e.g., overcoming technological and operational challenges) to health care systems to develop and implement PCRO data collection systems.

    Letters of Support: Only letters of support specific to ‘Patient & Caregiver Reported Outcomes Core’ should be attached to this section.

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

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

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information (Patient & Caregiver Reported Outcomes (PCRO) Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    Dissemination & Implementation Core

    When preparing your application in ASSIST, use Component Type ‘DI’.

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

    SF424 (R&R) Cover (Dissemination & Implementation 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 (Dissemination & Implementation Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Dissemination & Implementation 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) (Dissemination & Implementation 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 (Dissemination & Implementation Core)

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

    Budget (Dissemination & Implementation 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 (Dissemination & Implementation Core)

    Specific Aims: State the goals of the proposed Dissemination and Implementation Core concisely and summarize the expected outcome(s). These should include disseminating and implementing scientific findings across health care systems, and impacting how much the results of the proposed research influence AD/ADRD pragmatic trials/research field(s). List the specific objectives of the research proposed succinctly.

    Research Strategy:

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

    • ·    Assisting health care systems with implementation of pragmatic trials;
    • ·    Developing an outreach plan for disseminating research findings to participating health care systems, the scientific community, the federal government, and the public. Such dissemination might include briefings, training seminars, working paper series, and research briefs, and newsletters; and
    • ·    Developing a strategy for scaling up dissemination and implementation activities to accommodate future growth in the number of pragmatic trials across health care systems

    Letters of Support: Only letters of support specific to ‘Dissemination and Implementation Core" should be attached to this section.

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

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

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Dissemination & Implementation Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    Optional Core 1

    When preparing your application in ASSIST, use Component Type ‘Optional Core 1’.

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

    SF424 (R&R) Cover (Optional Core 1)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Optional Core 1)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Optional Core 1)

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

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

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

    Project /Performance Site Location(s) (Optional Core 1)

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Optional Core 1)

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

    Budget (Optional Core 1)

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

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

    PHS 398 Research Plan (Optional Core 1)

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

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

    Letters of Support: Only letters of support specific to ‘Optional Core 1" should be attached to this section.

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

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

    Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Optional Core 1)

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    Optional Core 2

    When preparing your application in ASSIST, use Component Type ‘Optional Core 2’.

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

    SF424 (R&R) Cover (Optional Core 2)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Optional Core 2)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Optional Core 2)

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

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

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

    Project /Performance Site Location(s) (Optional Core 2)

    List all performance sites that apply to the specific component.

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

    Research & Related Senior/Key Person Profile (Optional Core 2)

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

    Budget (Optional Core 2)

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

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

    PHS 398 Research Plan (Optional Core 2)

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

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

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

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

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

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Optional Core 2)

    When involving NIH-defined human subjects research, clinical research, and/or 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

    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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 Collaboratory to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Collaboratory proposed).

    Scored Review Criteria - Overall

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

    Significance

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

    Specific to this FOA:

    Will the AD/ADRD Research Collaboratory provide national leadership and engage multiple stakeholders in advancing policies and practices that enhance the broad participation of researchers and health care systems in research to improve care for patients with Dementia and their caregivers? If the aims of the Collaboratory 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 PWD and their caregivers?

    Will the proposed activities in this application bring together health and long-term care facilities in a Collaboratory research setting to conduct pragmatic clinical trials?

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

    Investigator(s)

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

    Specific to this FOA:

    Do the personnel have the appropriate breadth of expertise and experience, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, 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? Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the project? 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 Pilot Project awardees, and NIA-funded AD/ADRD pragmatic trials to meet the goals and objectives of this program?  How well does the application describe how the investigative team is up to date on the changing landscape of health care systems research and participant protection regulations?

    Does the application provide evidence of how the planned collaboration will work among a team with potentially very different backgrounds?

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

    Innovation

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

    Specific to this FOA:

    Does the application challenge and take into account current AD/ADRD research or clinical practice paradigms,  , and enlarge participation in clinical research by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools? Does the application challenge and seek to impact current AD/ADRD 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 AD/ADRD pragmatic trials? Does the application include mechanisms for leveraging novel collaboration and communication strategies for AD/ADRD pragmatic trials researchers? 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 Collaboratory? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the Collaboratory involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?   

    Will the proposed approach allow for rapid deployment of Collaboratory and collaborative tools to enable speedy AD/ADRD pilot trials?  Is the plan for administrative support across the Collaboratory program facilitative of the proposed plan for support of the Pragmatic Trials which were not initially supported by the Collaboratory (e.g., pilots) and will it add to the productivity of the program? 

    Does the application adequately address the following, if applicable

    Study Design

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

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

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

    Data Management and Statistical Analysis

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

    Environment

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

    Specific to this FOA:

    Will the proposed activities facilitate flexible, modular, and scalable policies, practices, algorithms, protocols, and tools to enable broad collaboration and participation among AD/ADRD researchers? Will the proposed approach allow efficient management upkeep of a public website?

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

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

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

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

    Additional Review Criteria

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

    Study Timeline

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

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

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six 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 six 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 Children 

    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 children 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).

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources

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

    Budget and Period of Support

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

    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:

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

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

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

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

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

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

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

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

    Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

    Prior Approval of Pilot Projects

    Awardee-selected projects 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: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

    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 other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, NIH will support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award 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 awardees for the project, although specific tasks and activities may be shared among the awardees and NIH as defined below.

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

    • Determining approaches, designing, and setting project milestones and implementing the project plan for the Collaboratory;
    • Cooperating in sharing knowledge and experience with various tools and approaches utilized in conducting research in health care settings, including their strengths and weaknesses;
    • Cooperating in sharing issues related to data quality, data management, data biases and errors, query quality and sampling challenges, and pitfalls in utilization of health care data for research;
    • Cooperating with each pilot projects and pragmatic trials (demonstration project) awardees in the development and testing of implementation plans;
    • Collaborating with other awardees in harmonizing and sharing of tools, methods, and approaches within and between interventions;
    • Cooperating with others in sharing of study designs, methods, protocols, tools, and strategies;
    • Participating in group activities, including program-wide Work Group(s) and Steering Committee meetings;
    • Facilitating comparability across pragmatic trial projects wherever possible;
    • Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating work group meetings, committee meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution;
    • Cooperating with other awardees in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources;
    • Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance;
    • Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination;
    • Sharing resources, data, and software as appropriate and consistent with achieving the goals of the Collaboratory program and approved plans;
    • Planning and hosting the face to face meetings of the Work Groups, Steering Committee, and any subcommittees;
    • Planning for and hosting the Collaboratory program EAP meetings;
    • Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined under “NIH Responsibilities”;
    • The PD(s)/PI(s) will consider the advice of the EAP regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement(s). EAP advice is not binding on the Principal Investigator(s) who retains primary responsibility for scientific direction and implementation. 
    • Submitting periodic progress reports, including materials for the mid-project review at end of Year 3, in a standard format, as agreed upon by the Steering Committee, PDs/PIs, and the NIH; and
    • Retaining custody and having primary rights to the data and software at the awardee institution developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and goals of this program. All research, data (it is expected the Collaboratory will have a Data Sharing plan which will protect human subjects), and resources generated are expected to have broad availability through a public-facing website in order to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program

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

    • NIA/NIH Project Scientist(s) will work with the PI and the Steering Committee to ensure that the objectives of the program are being met. The dominant role and prime responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and NIA/NIH Project Scientist(s);
    • NIA/NIH Project Scientist(s) will provide technical assistance, advice, and coordination; however, the role of NIH staff will be to facilitate and not to direct activities. It is anticipated that decisions in all activities will be reached by consensus of the program and NIH staff will be given the opportunity to offer input to this process;
    • NIA/NIH Project Scientist(s) serves as the contact point for addressing the program objectives with the awardee;
    • NIA/NIH Project Scientists(s) will serve as liaison between the Steering Committee and NIH External Advisory Panel (EAP);
    • Additional NIA/NIH staff (e.g., additional projects scientists) may participate in all work groups, implementation teams, and committees, including the Steering Committee, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program;
    • NIH staff may serve as resources for, or interface with, other ongoing NIH activities that may be relevant to the activities in the HSC Research Collaboratory to avoid duplication and facilitate collaboration and communication in overlapping areas;
    • NIA/NIH staff may assist in development, design, and coordination of activities and projects;
    • NIA/NIH staff may attend Collaboratory program EAP meetings and receiving a copy of the recommendations; and
    • An agency program official(s) will be responsible for the normal scientific (project scientist) and programmatic stewardship (program officer) of the award and will be named in the award notice.

    Areas of Joint Responsibility include:

    • A plan for the structure of the Steering Committee will be determined by the PD(s)/PI(s) and will be approved by the NIH Program Official at the time of the award.  A plan for the structure of the External Advisory Panel (EAP) will be determined by the Steering Committee and will be approved by the NIH Program Official within six months of the award.
    • A Collaboratory Steering Committee will be established to address issues that span across all projects, provide input towards the policies and processes of the Collaboratory, and assist in dissemination of policies and processes that enable research in partnership with health care systems, their patients, and practitioners. The Steering Committee will be composed of a representative from NIA-funded pragmatic trials, PDs/PIs of the Collaboratory, three representatives from the Cores, PDs/PIs of pilot projects funded through the Collaboratory, three external members which PDs/PIs will appoint with consultation with NIA, and the NIA Projects Scientist(s).  Representative from NIA funded pragmatic trials and pilot projects may not exceed more than 2 members total. All members are expected to participate actively in all Steering Committee activities. The combined vote of NIH/NIA membership may never exceed 40 percent.
    • Awardee(s) agree to have an External Advisory Panel (EAP).  An EAP for the Collaboratory program will be established to review the progress of all components of the program and provide recommendations to the awardee.  The steering committee will appoint members of the EAP.  The NIH/NIA expects EAP members will meet with the Collaboratory Steering Committee to review the progress on all components of the Program and provide recommendations to the awardee.    
    • Collaboratory Core Work Groups will be established as the core collaborative activity of this program. The Work Groups will provide a forum for discussion of challenges and solutions across projects; harmonized and standardized policies and processes will be vetted in these groups. Work Groups are expected to be established in the following areas, at a minimum: Technical/Data, Regulation & Ethics, Design/Statistical, Pilot Studies, Patient & Caregiver Reported Outcomes, Dissemination and Implementation. Work Groups will be open to participation by individuals from all NIA-funded pilot projects and pragmatic trials (demonstration projects), Collaboratory staff, and NIA staff.  NIA staff may or may not be involved in all workgroup activities;
    • Establishment and adherence by each pilot project team and NIA-funded pragmatic trial team, Collaboratory, and NIH staff to a written plan of engagement with timelines to ensure delineation of roles and timely delivery of the tested implementation plan;
    • Pilot project grantees and pragmatic trials grantees will work with the Collaboratory and the NIH, through all phase of their projects, including the implementation and close out phase, to assure all resources, materials, protocols, data, best practices, and lessons learned, as well as software or sets of code, are disseminated broadly through the Collaboratory; and
    • All awardees and the NIH will cooperate to ensure the timely and broad dissemination of all Collaboratory program endorsed policies and practices and lessons learned in the program to inform researchers and health care systems engaged in research in health care settings.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and 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 awardee. This special dispute resolution procedure does not alter the awardee'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.

    Additional Terms for Termination:

    Dispute resolution will not be applicable if an awardee is unable to maintain the Consortium of health systems (as specified in Part 2, Section I of this FOA) to participate in demonstration projects (e.g., pilots) through the Collaboratory; the cooperative agreement may be terminated by the NIH/NIA. That is, the awardee institution and the NIH/NIA will not engage in dispute resolution.

    3. Reporting

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

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

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

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

    Scientific/Research Contact(s)

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

    Peer Review Contact(s)

    Ramesh Vemuri, Ph.D.

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

    Financial/Grants Management Contact(s)

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

    Section VIII. Other Information

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

    Authority and Regulations

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

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