Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ

Patient-Centered Outcomes Research Institute (PCORI)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Notice of Funding Opportunity (NOFO) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual NOFO.

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ),

Patient-Centered Outcomes Research Institute (PCORIhttp://www.pcori.org/)

Notice of Funding Opportunity Title

AHRQ and PCORI Learning Health System Embedded Scientist Training and Research Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

New

Funding Opportunity Announcement (NOFO) Number

RFA-HS-23-001

Companion Funding Opportunity

None

Assistance Listing Number(s)

 93.226 

Funding Opportunity Purpose

AHRQ and PCORI invite applications from qualified institutions to create Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Centers to support the professional development of scientists to conduct research that accelerates progress towards an integrated learning health system. To achieve this aim, the E-STaR Centers will build new models of LHS infrastructure that: strengthens institutional research training in CER and PCOR; enhances diversity in the LHS research workforce; strengthens partnerships with community partners and health system and other stakeholders; and conducts patient-centered clinical comparative effectiveness research projects to improve health system operations, quality, and health outcomes.

Applications will be funded under the P30 Research Program Projects and Centers grant mechanism, which supports Center Core grants intended to fund a multidisciplinary approach to shared resources and facilities for research and training by a number of investigators from different disciplines who focus on a common research problem. Programs are expected to prepare clinician and research scientists for independent research careers in PCOR/CER and equip them to advance the field through their training and scholarship as the next generation of Learning Health System Scientists and to support PCOR/CER and dissemination, implementation, and use of research findings.

Key Dates
Posted Date

December 23, 2022

Open Date (Earliest Submission Date)

December 28, 2022

Letter of Intent Due Date(s)

February 10, 2023.

Application Due Date(s)

March 24, 2023.

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

Generally, four months after receipt date

Advisory Council Review

Not Applicable. 

Earliest Start Date

Generally, four months after review date.

Expiration Date

March 25, 2023

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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 and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/NOFOguidance/index.html.

Applicants who propose the use of identifiable CMS data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data. 

When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    Part 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
    Purpose

    The Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI) seek applications for Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Centers (P30) grant to support institutions to train the next cadre of embedded Learning Health System (LHS) scientists who have the skills to conduct, apply, and implement patient-centered outcomes research (PCOR) a type of comparative clinical effectiveness research (CER). CER compares the effectiveness of two or more interventions or approaches to health care, examining their risks and benefits. PCOR compares two or more medical treatments, services, or health practices and addresses questions and outcomes important to patients and other healthcare stakeholders, through studies that engage, and generate evidence meaningful to, those who need this information to make health and healthcare decisions.  The goal of the Notice of Funding Opportunity (NOFO) is to train embedded health system scientists and to conduct PCOR/CER to improve health system operations, quality, and health outcomes. 42 U.S.C. 299b-37 authorizes AHRQ to establish a grant program that provides for the training of researchers in the methods used to conduct PCOR/CER and to support the agency's dissemination of comparative clinical effectiveness research findings. Consistent with 42 U.S.C. 299b-37(e), grants funded under this program will train clinical and research scientists to have the skills to support and lead efforts to apply PCOR/CER methods and conduct PCOR/CER in a LHS and to facilitate rapid implementation of evidence that will improve quality of care and patient outcomes.

    AHRQ defines a Learning Health System (LHS) as a health system in which internal data and experience are systematically integrated with external evidence, and that knowledge is put into practice (https://www.ahrq.gov/learning-health-systems/about.html). The goal of these systems is for patients to receive higher quality, safer, and more efficient care, and health care delivery organizations become better places to work. In a learning health system model, both institutional and clinical practice partners are actively engaged and participate in the generation, adoption, and application of evidence. A LHS scientist is an individual who is embedded within a health system and collaborates with its stakeholders to produce novel insights and evidence that can be rapidly implemented to improve the outcomes of individuals, populations, and health system performance.

    In 2018, AHRQ and PCORI funded 11 institutions to support the training of embedded researchers to conduct PCOR/CER within LHS, producing embedded LHS scientists. A core component of the LHS training programs was the implementation of AHRQ-developed core competencies (see https://www.ahrq.gov/learning-health-systems/building-workforce.html) for training PCOR/CER professionals to become LHS scientists.

    This AHRQ/PCORI P30 LHS E-STaR program NOFO builds on lessons learned from the AHRQ/PCORI LHS K12 Program (https://grants.nih.gov/grants/guide/rfa-files/RFA-HS-17-012.html) to support the professional development of scientists to conduct research that accelerates progress toward an integrated learning health system. Successful applicants to the AHRQ/PCORI P30 LHS E-STaR program NOFO will build new models of LHS infrastructure that: strengthen institutional research training in CER and PCOR; enhance diversity in the LHS research workforce; strengthen partnerships with community partners and health system and other stakeholders; and conduct PCOR/CER projects to improve health system operations, quality, and health outcomes.

    This funding opportunity is open to all eligible applicants.

    Program Objective

    AHRQ and PCORI invite applications from qualified institutions to create Learning Health System Embedded Scientist Training and Research (LHS E-STaR) Centers that support the professional development of scientists to conduct research that accelerates progress towards an integrated learning health system and build a critical and sustainable LHS research workforce. Grants will be funded under the P30 Research Program Projects and Centers grant mechanism, which supports Center Core grants that fund a multidisciplinary approach to shared resources and facilities for research and training by investigators from different disciplines who focus on a common research problem. Programs are expected to prepare clinician and research scientists for independent research careers in PCOR/CER and equip scientists to advance the field through their training and scholarship as the next generation of Learning Health System Scientists. In addition, the LHS E-STaR program supports PCOR/CER and the dissemination, implementation, and use of research findings.

    The NOFO objectives are to:

    • Prepare clinicians and research scientists for independent research careers and equip them to advance the field through their training and research as embedded Learning Health System Scientists.
    • Strengthen LHS Infrastructure by building partnerships between health systems, academic health centers, community partners, and other stakeholders.
    • Provide opportunities for clinicians and research scientists to conduct PCOR/CER and transition to PCORI, AHRQ, and other federally funded research grants.
    • Directly engage system, community and other stakeholder leaders with bidirectional opportunities for co-sponsorship within funded grants, such as data access, financial or in-kind support for LHS scientist training and/or compensation or in-kind support for community partners.
    • Address health system research priorities, including efforts to achieve health equity, enhance the diversity in the LHS research workforce, and accelerate progress towards an integrated learning health system.
    • Enhance diversity at all levels - from the kinds of research topics and projects to the regions in which it is conducted to the backgrounds of the people conducting it - contributes to excellence in research and training environments and strengthens the research enterprise. This NOFO is intended to support a diverse set of outstanding programs that will train a diverse cadre of embedded learning health system scientists.
    • Demonstrate value of LHS embedded training and research through program evaluation activities.
    Scope of the Program

    This program will establish LHS E-STaR Centers that focus on the application and mastery of the core LHS scientist competencies (see https://www.ahrq.gov/learning-health-systems/building-workforce.html) to support the professional development of scientists to conduct research that accelerates progress towards an integrated learning health system. The LHS E-Star Centers will build new models of LHS infrastructure that support and enhance existing institutional training and research infrastructure. This program will be structured to support training and PCOR/CER organized around shared resources and research infrastructure within each of the LHS E-STaR Centers. In this model, Centers will be able to use and pool knowledge of mentors to develop the didactic curriculum and learn from one another as they share their experiences in helping scientists to navigate their way through successful LHS projects. This approach will produce a cadre of LHS scientists, LHS mentors, and rapid learning projects that can accelerate advances in knowledge, health system performance, and patient outcomes.

    The benefit of supporting multiple institutions is that it broadens the pool of potential expertise beyond what is typically available at a single institution. Because the aim of the LHS model is to learn through rapid testing and iteration to ultimately scale research that engages health system, community partners, and others, the program will support learning among diverse sites and partners. This approach will contribute to more rapid growth in the number and diversity of individuals, as well as organizations, capable of successfully working at the interface of clinical operations, informatics and PCOR/CER.

    Applications to this NOFO from academic institutions must have a track record of excellence in training clinical and research scientists. Qualified, established training institutions must demonstrate a commitment to partner with healthcare delivery systems. Applications from healthcare delivery systems should have a track record of excellence in training researchers and conducting system-based research aimed at improving clinical treatment, health outcomes, quality, and/or health care delivery. Non-academic health systems may apply but would be expected to partner with an academic institution in providing formal, educational training needs. Both academic institution and system-based applicants must describe prior and planned collaborative relationships in their applications.

    Participating in PCORnet®, the National Patient-Centered Clinical Research Network, is not a requirement but use of PCORnet® is strongly encouraged as a resource to support LHS research.

    All applicants will be expected to recruit and train LHS scientists from beyond their own institution (for example, who are affiliated with other health systems or institutions, including PCORnet-participating sites), in order to provide experiential research opportunities for LHS scientists at a variety of institutions. To ensure a broad reach for didactic and experiential training applicants are encouraged to partner with diverse organizations such as safety net and community organizations and Federally Qualified Health Centers. All applicants must demonstrate mentoring support from all partners, including research and health care delivery operational leaders.

    Each application must:

    Have a focus on supporting the professional development of scientists to conduct embedded research that accelerates progress towards an integrated learning health system. New models of LHS infrastructure that support PCOR/CER should:

    • Demonstrate a plan for conducting PCOR/CER within health systems that can be rapidly implemented to improve quality of care and patient outcomes.
    • Demonstrate knowledge and strategy for involving and engaging patients, clinicians, community, and other stakeholders in research.
    • Integrate health equity into the LHS training program and research.

    Have a Training focus:

    • Use the AHRQ-sponsored LHS training competency domains or identify specific LHS competency domains or specific enhancements to those competencies the program will deploy, with justification.
    • Develop and implement a training program that includes both didactic and experiential learning and creates opportunities for embedded scholarship at the interface of research, informatics, clinical operations, and engagement within learning health systems.
    • Have a strong and high-quality infrastructure to support a combination of didactic and experiential training – including mentorship and learning opportunities provided within partner organizations. Partners may include safety net and community organizations and Federally Qualified Health Centers, academic, and learning health system settings allowing for the application and mastery of the knowledge and skills outlined across the LHS scientist core competencies. The entire program should be designed to rigorously monitor and provide a well-defined structure to ensure progress for all LHS scientists.
    • Develop a recruitment Plan to Enhance Diversity: The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies, and activities designed to recruit prospective scientists from diverse backgrounds, and propose metrics to assess the effectiveness of outreach activities.
    • Incorporate the PCORI Methodology Standards in the LHS training curriculum.

    Facilitate Collaboration:

    • Include research projects designed with LHS partners and stakeholders and conducted within a health system. Projects should focus on systematically engaging stakeholders, generating evidence, systematically adopting evidence and/or systematically applying evidence in order to expand the health system’s ability to support population health management and/or personalized health care.
    • Demonstrate evidence of institutional support (direct or in-kind) from health systems in which embedded scientists would conduct their research.

    Conduct Program Evaluation:

    • Conduct an evaluation with clear outcome metrics linked to improvements in health system performance.
    • Assess scientist research training outcomes including patient-centeredness of research, development of tools or policies, dissemination of research, and PCOR/CER outcomes.
    • Assess scientist training program outcomes including career advancement, attaining funding, publications, etc.  

    Applicants are encouraged to consider research activities that use PCORnet to conduct LHS research. Collaborating with PCORnet is one strategy to advance understanding and use of the nationally representative network, which can be used to conduct a range of study designs supporting learning health systems. PCORnet resources can facilitate collaboration between researchers, patient communities, clinicians, and health systems in research partnerships that leverage large volumes of health data while also ensuring that research focuses on the questions and outcomes that matter most to patients and those who care for them. For more information, applicants are encouraged to contact the PCORnet Front Door (https://pcornet.org/front-door/).

    Applicants must identify the career levels for which the proposed research education program is planned and describe the intended embedded scientists and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Embedded scientists to be supported by the program must be at the career level for which the planned program is intended and appointed for no more than three-year period.

    Organization

    Each LHS E-STaR Center should be organized around a series of core activities related to the Center's infrastructure-building and mentoring goals. The cores should be organized to provide intellectual leadership and innovation; facilitate and develop novel PCOR/CER strategies; conduct community-level engagement; stimulate incorporation of emerging technologies, methods, and scientific advances into research designs as appropriate; and provide mentoring for future leaders in LHS research from diverse backgrounds.

    Centers are expected to create a structure that integrates activities across the site’s Cores to support scientific and educational advancement. A minimum of three Cores is required: Each application must include an Administrative Core (AC), a Research Education Core (REC), and Research and Data Analysis Core (RDAC). The AC will provide leadership and governance for the LHS E-STaR Center and ensures that the program activities remain within the Center's scientific area of focus. The goal of the REC is to provide a mentoring mechanism leading to enduring careers in LHS research for LHS scientists. Individuals targeted for mentoring relationships may include clinician or research scientists. The RDAC will create, identify, catalogue, and disseminate scientific information produced by PCOR/CER projects conducted by the Center with a specific focus on AHRQ and PCORI priorities. Applicants should refer to Section IV.2 of this announcement for specific instructions on requirements for each of the Cores.

    Requirements of Required Cores

    Requirements: Administrative Core (Required Core)

    The Administrative Core (AC) will provide leadership for the LHS E-STaR Center, with a focus on training program administration. The LHS E-STaR Centers should have strong and experienced central leadership with an Administrative Core (AC) directed by the PD/PI(s). The PD/PI(s) should be recognized leaders in LHS embedded PCOR/CER and training and should be experienced in successfully mentoring investigators from diverse backgrounds and in supporting engagement with community and stakeholder partners in the context of LHS. The AC will coordinate proposed activities and maintain internal information flow. The AC is responsible for managing and coordinating interactions among the PD/PI(s), the core leaders, LHS scientists, mentors of pilot projects, other researchers at the applicant institution as well as partner institutions, stakeholders, other AHRQ/PCORI-funded programs, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located.

    Key responsibilities of the Administrative Core include:

    • Liaising with AHRQ/PCORI program staff, ensuring that program objectives and priorities, performance, challenges, and related information is communicated.
    • Creating mechanisms and procedures for ensuring interaction between the site’s Cores and partner institutions.
    • Creating mechanisms and procedures for ensuring regular and meaningful engagement between the site and community and stakeholder partners (for more information, see PCORI’s Building Effective Multi-Stakeholder Research Teams, and the section on Addressing Contextual Challenges to Engagement and Patient-Centered Outcomes Research: The Benefits of Multi-Stakeholder Engagement resource).
    • Ensuring that LHS scientists engage with colleagues at the primary and partner institutions, as well as community partners.
    • Developing approaches to ensure recruitment and retention of LHS scientists and the viability of mentoring and training relationships among affiliated institutions.
    • Facilitating communications, both internal and external.
    • Planning for LHS scientists’ research project development, including project solicitation, review and selection.
    • Coordinating LHS scientists’ participation in meetings and national conferences.
    • Designing and conducting program evaluation with clear outcome and impact metrics linked to improvements in health system performance, going beyond preparing manuscripts for publication.

    Requirements: Research Education Core (Required)

    The goal of the Research Education Core (REC) is to produce LHS embedded scientists and enhance diversity in the LHS workforce by: supporting PCOR/CER research projects for LHS scientists relevant to AHRQ/PCORI priorities; providing continuing mentoring activity for LHS Scientists to achieve research career training objectives; offering education in LHS research using AHRQ-sponsored LHS training competencies or specific enhancements to those competencies the program will deploy, with justification; and providing activities and resources to the LHS scientists throughout their training program affiliation. Individuals participating in mentoring relationships may include clinician or research scientists working in academic and health system or stakeholder partner organizations. It is the responsibility of the REC to assure successful mentoring of, and collaboration with, LHS scientists from diverse backgrounds.

    Required REC activities include:

    A strong and high-quality infrastructure to support a combination of didactic and experiential training – including mentorship and learning opportunities provided within both academic and LHS settings allowing for the application and mastery of the knowledge and skills outlined across the LHS scientist core competencies. The entire program should be designed to rigorously monitor and provide a well-defined structure that promotes the development of professional skills and research productivity for all embedded scientists.

    REC activities must be:

    • Be tailored to the LHS embedded scientists needs, using AHRQ-sponsored LHS training competency domains or specific enhancements to those competencies the program will deploy, with justification;
    • Include both didactic and experiential learning and embeds scientists at the interface of research, information, and clinical operations within learning health systems;
    • Conform to individual development plans;
    • Incorporate the PCORI Methodology Standards in the LHS training curriculum.

    RECs must promote PCOR/CER research that:

    • Incorporates mentorship for rapid cycle research in LHS;
    • Engages system, community, and stakeholder partners;
    • Leverages grant funding to secure partner funding, including funding from PCORI, AHRQ, other federal agencies, and health systems;
    • Uses emerging data and technology to support PCOR/CER, including PCORnet, Medicare and Medicaid data.

    Requirements:  Research and Data Analysis Core (Required Core)

    The Research and Data Analysis Core (RDAC) will create, identify, catalogue, and facilitate the dissemination, implementation, and use of scientific information produced by PCOR/CER projects conducted by the Center with a specific focus on AHRQ/PCORI priorities. RDAC personnel should have expertise in PCOR/CER methodology.

    Research cores will focus specifically on AHRQ/PCORI priorities, including:

    • Embedded LHS Patient-Centered Outcomes Research (PCOR), a type of comparative clinical effectiveness research (CER). PCOR compares two or more medical treatments, services, or health practices and addresses questions and outcomes important to patients and other healthcare stakeholders, through studies that generate evidence meaningful to those who need this information to make health and healthcare decisions.
    • Use of emerging data and technology to support PCOR/CER, including PCORnet, Medicare and Medicaid data.
    • Partnership with state Medicaid programs and other payers, community-based organizations, minority-serving institutions, diverse organizations such as safety net and community organizations, and Federally Qualified Health Centers.
    • Engagement of patients, communities, and other health care stakeholders as partners in research.
    • Facilitating research on priority topic areas, including:
    • Health equity
    • Healthcare disparities, including reducing both racial/ethnic and socio-economic gradient healthcare disparities in order to reduce healthcare and health disparities that are shared by all low-income, working populations. 
    • Primary care
    • Maternal health and maternal morbidity and mortality (MMM)
    • Intellectual and developmental disabilities (IDD)
    • Patient-centeredness and the science of patient and stakeholder engagement
    • Dissemination and Implementation approaches and tools.
    • PCOR/CER methods and application of PCORI Methodology Standards.
    • Facilitating dissemination, implementation, and use of research findings to improve health system operations, quality, and health outcomes.

      

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

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

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

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

    AHRQ intends to fund up to $10 million annually over five years to support approximately 10 awards, beginning in fiscal year 2023. Future year funding is contingent upon on the availability of funds.

    Award Budget

    Total annual costs (combined direct and indirect) for a project awarded under this NOFO will not exceed $1 million in any given year and $5 million for the entire project period.

    Funds may be used only for those expenses that are directly related to and necessary to the project and must be expended in compliance with the applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement

    Award Project Period

    The scope of the proposed project should determine the project period. The project period may not exceed five years.

    42 U.S.C. 299b-37 authorizes AHRQ to make these awards to support the agency's dissemination of comparative clinical effectiveness research findings and the training of researchers in the methods used to conduct such research. These awards will be funded together by PCORI under an agreement pursuant to 42 U.S.C. 299b-37(g).

    All applications submitted and AHRQ grants made in response to this NOFO are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

    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 AHRQ support as Public or Private Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)

    Federal Government

    • 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

    AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

    HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the recipient and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application.  There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities. 

    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 not allowed.

    Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as consortia or as subcontractors only. Applications submitted by foreign institutions will not be reviewed.

    Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible

    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.

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.  Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for AHRQ 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. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

    A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum full-time effort (i.e., at least 8 hours per week) in each given year of the project.

    2. Cost Sharing

    This NOFO does not require cost sharing.

    While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort.  An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project.  Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments.  Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

    3. Additional Information on Eligibility
    Number of Applications

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

    The AHRQ will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application.  This means that the AHRQ 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.

      

    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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:

    Division of Research and Education
    Office of Extramural Research, Education, and Priority Populations
    Agency for Healthcare Research and Quality
    Email: PCORtraining@ahrq.hhs.gov

    Pre-application Technical Assistance Webinar

    AHRQ will convene a technical assistance webinar to provide potential applicants with background information and respond to questions about the preparation of an application in response to this funding opportunity.

    The technical assistance webinar will take place on January 30, 2023 at 1:00PM to 2:00PM Eastern time. Attendees must register for this webinar by completing the registration form at https://cma.ahrq.gov/p30webinar. Registrants will receive log in information approximately 3 days before the webinar. The technical assistance webinar is open to any individual or organization. AHRQ encourages representatives from minority-serving institutions to participate in this webinar. Participation is not a prerequisite to submit an application.

    Participants are encouraged to submit questions via email prior to the technical assistance webinar. Please submit questions to trainingta@ahrq.hhs.gov by January 23, 2023, 5:00PM Eastern time. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the technical assistance webinar will be posted on the AHRQ web site.

    Page Limitations

    Available Components

    Research Strategy/Program Plan/Page Limits

    Overall

    6

    Admin Core (use for Administrative Core)

    6

    Res Ed Core (use for Research Education Core)

    12

    Res and Data Analysis Core (use for Research and Data Analysis Core)

    6

    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.

     

    Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

    The application should consist of the following components:

    • Overall: required
    • Administrative Core: required; maximum of 1
    • Research Education Core: required; maximum of 1
    • Research and Data Analysis Core: required; maximum of 1
    Overall Component

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

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Specific names provided for Other Attachments must be no more than 50 characters including spaces.

     

    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 (if applicable to this NOFO) for the entire application.

    The PD/PI should be a scientific leader experienced in LHS-embedded PCOR/CER, have a history of commitment to mentoring LHS scientists, and be able to coordinate, integrate, and provide guidance in the establishment of LHS embedded PCOR/CER training and research dissemination and implementation programs.

    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.

    AHRQ is not using the Modular Grant Application and Award Process. Applicants applying for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

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

    PHS 398 Research Plan (Overall)

    Introduction to Application: N/A.

    Specific Aims: Describe the aims of the overall Center and outline how the different cores will contribute to these aims.

    Research Strategy: All applications must address the significance, strategy, and innovation of the proposed LHS E-STaR approach.

    Significance. Focusing on the LHS E-STaR Center as a whole, address (i) the importance of the problem or critical barrier to progress the proposed LHS E-STaR Center addresses, (ii) how the proposed LHS E-STaR Center activities will enhance diversity and equity and improve scientific knowledge, technical capability, and/or practice (iii) how the concepts, methods, technologies, treatments, services, or preventive interventions will be changed if the proposed aims are achieved.

    Approach. Present the LHS E-STaR Center's overall strategy for supporting the professional development of scientists to conduct research that accelerates progress towards an integrated learning health system. The proposed strategy should build LHS infrastructure that serves to sustain research and training in its selected area of focus. Describe how the approach will accomplish the training, leadership, mentoring, engagement, research, dissemination, implementation, and use of research findings, equity, diversity, and evaluation functions expected of a LHS E-STaR Center. Describe how the LHS E-STaR Center will provide a supportive environment for investigators from diverse backgrounds, including groups underrepresented in science, who are supported through different awards. Describe how the different components of the LHS E-STaR Center will interact to help accomplish its aims, how the approaches of the Cores complement each other or are inter-dependent, and the mechanisms to be used in assessing progress toward the LHS E-STaR Center's goals. Where appropriate, provide timelines and organizational charts. Note the major LHS E-STaR Center Cores and other activities, referencing but not repeating appropriate subsequent sections of this application that contain more detail.

    Applicants should use this section to present preliminary data, prior experience, or evidence of preparatory activities for establishing a LHS E-STaR Center. Applicants should describe preliminary organizational work, experience with training and mentoring LHS embedded scientists, experience with and potential for developing new and exciting LHS embedded research, experience engaging health system and community stakeholders and specific plans for organization and implementation of the new program. Applicants should describe prior collaborations with health systems in training embedded scientist and conducting system-focused research.

    Innovation. Considering the LHS E-STaR Center as a whole, show how the proposed LHS E-STaR Center seeks to shift current research or practice paradigms within health systems to accelerate progress towards an integrated LHS. Describe the use of novel concepts, approaches, methodologies, or interventions proposed, and how these innovations will be applied to refine or improve training and infrastructure. 

     

    Letters of Support: Place institutional letters of support for the LHS E-STaR Center as a whole in this section.

    NOTE: Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

     

    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.

    Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO

     

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Overall)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

    PHS Assignment Request Form (Overall)

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

    Administrative Core

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

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

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

    Enter 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.

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

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

    List all performance sites that apply to the specific component.

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

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

    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum full-time effort (i.e., at least 8 hours per week) in each given year of the project.
    • The PD/PI(s) should be recognized leaders in the LHS research and experienced in successfully training and mentoring LHS scientists.
    • The PD/PI(s) should have demonstrated leadership and administrative skills. The Program Director/Principal Investigator of the proposed LHS E-STaR Center must also be the Administrative Core Leader; sufficient time should be devoted to the core to ensure that the aims are met and required functions are carried out efficiently. The PD/PI’s biographical sketch should present evidence of scientific expertise relevant to the themes of the LHS E-STaR Center and demonstrate the capacity for the leadership of a LHS E-STaR Center.
    • An Associate Director may be named who will be involved in the administrative and scientific efforts of the Center.
    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)

    Introduction to Application:

    Specific Aims: Clearly state how the Administrative Core (AC) will provide leadership for the LHS E-STaR Center and coordinate the proposed activities and maintain internal information flow. This includes managing and coordinating interaction among the PD/PI(s), the core leaders, LHS Scientists, mentors, other researchers at the applicant institution as well as outside institutions, stakeholder organizations, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located, as appropriate to the goals of the LHS E-STaR Center   

    Research Strategy:  Organize the Research Strategy into sections on: Significance and Approach.

    Significance: Explain the role of the Administrative core in the center as a whole and as a resource for other ongoing activities in the LHS E-STaR Center. 

    Approach: Describe how the center's administrative structure will:

    • Provide leadership on all program components:
    • Develop approaches to ensure recruitment and retention of LHS scientists and the viability of mentoring and training relationships among affiliated institutions.
    • Plan for PCOR/CER project solicitation, review and selection.
    • Coordinate LHS scientists’ participation in National conferences.
    • Design and conduct program evaluation with clear impact metrics linked to improvements in health system performance, in addition to preparing manuscripts for publication.
    • Create mechanisms and procedures for ensuring engagement between the site and community and stakeholder partners:
    • Describe goals of partnership to develop infrastructure and provide workforce development that achieves the LHS Core Competencies.
    • Define role of each partner.
    • Clarify level of partnership to date.
    • Define expectations for increased partnership over the course of the program, and key outputs.
    • If data exchange is anticipated, clarify whether key agreements (e.g., data use agreements) are in place.
    • Articulate goal/mission alignment with respect to activities of the LHS program (LHS Core Competencies; AHRQ and PCORI priorities).
    • Specify Budget – compensation or in-kind support such as partner contributing data, resources, or salary support.
    • Facilitate communications, both internal and external:
    • ·        Liaise with AHRQ/PCORI program staff, ensuring the program objectives and priorities, performance, challenges, and related information is communicated.
    • Create mechanisms and procedures for ensuring interaction between the site’s Cores and partner institutions.
    • Ensure that LHS scientists and pilot investigators interact with colleagues at the parent and partner institutions.

     

    Letters of Support:

    Each named partner on the proposal must provide a letter of support that is included as an appendix, including:

    • Description of goals indicating degree of alignment with organization mission/priorities with NOFO.
    • High level synopsis of partnership.
    • A review of project roles and defined contributions; expectations for increased partnership over the course of the program.
    • If data exchange is anticipated, clarify whether key agreements (e.g., data use agreements) are in place.
    • Confirm level of support and budget – compensation or in-kind.

    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. See section IV.7.

    Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

     

    Other Plan(s):

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

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    Research Education Core

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

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

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

    Complete only the following fields:

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

    Enter relevant component.

    Research & Related Other Project Information (Research Education Core)

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

    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.

    Facilities & Other Resources. Describe the educational environment, including the facilities, data, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically-related sources of support for research training and education following the format for Current and Pending Support.   

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

    List all performance sites that apply to the specific component.

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

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

    ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Program faculty who serve as mentors should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program mentors should also have a record of research training, including successful, former trainees who have established productive careers relevant to the AHRQ mission.
    • Researchers from diverse backgrounds, including groups underrepresented in science, persons with disabilities, and women are encouraged to participate as mentors.
    • Mentors must have research expertise and experience relevant to the proposed program. All proposed mentors must have a successful record of providing the type of career development and training activities required under this award, and have a successful record of engendering his or her trainees' research careers as evidenced by research productivity, their ability to obtain/participate in a continuing role in independent research, and their ability to work with health system stakeholders in a responsive fashion that has an impact on health care delivery.
    • Mentors must be committed to continue their involvement throughout the total period of the award.   
    Budget (Research Education 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.

    Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Salary support for LHS scientists should be included under Personnel. Any other costs associated with their support should be included in the appropriate budget categories (materials and supplies, travel, other expenses). 

    PHS 398 Research Plan (Research Education Core)

    Research Plan sections are: Introduction to Application, Specific Aims, Research Strategy, Progress Report Publication List, Multiple PD/PI Leadership Plan, Consortium/Contractual Arrangements, Letters of Support, and Appendix.

    Only include information that is different from application guide.

    The most commonly referenced Research Plan attachments are listed below for your convenience.

    Specific Aims:  Clearly state how the Research Education Component (REC) will provide a mentoring mechanism leading to enduring careers for LHS Scientists.

    Research Strategy:  The Research Strategy must include the following subsections:

    Proposed Research Education Program. Describe a strong and high-quality educational infrastructure to support a combination of didactic and experiential training – including mentorship and learning opportunities provided within both academic and learning health system settings allowing for the application and mastery of the knowledge and skills outlined across the LHS scientist core competencies. The entire program should be designed to rigorously monitor and provide a well-defined structure to ensure progress for all LHS scientists.

    Significance: Explain the role of the REC in the Center as a whole and as a mechanism for enhancing progress and diversity of the workforce in LHS.

    Approach: Describe how the REC will implement a plan to enhance training, professional development, and diversity in the professional research workforce in LHS, including recruiting a cadre of diverse LHS scientists. This plan should have the following components: supporting PCOR/CER research projects for LHS scientists relevant to AHRQ/PCORI priorities; providing Continuing Mentoring Activity for LHS scientists to achieve research career training objectives; offering education in LHS research using AHRQ-sponsored LHS training competencies or specific enhancements to those competencies the program will deploy, with justification; an outreach plan to recruit a diverse pool of LHS scientists, and providing activities and resources to support LHS scientists throughout their training program affiliation. Applications should articulate the activities and resources available to the scientists throughout their LHS E-STaR Center affiliation, both during and after training and research.

    Research Education Program Continuing Mentoring Activity (Required Activity): Each LHS E-STaR Center should specify strategies for mentoring LHS Scientists to enduring careers in PCOR/CER. The application should specify strategies for:

    • Identifying the LHS scientists’ training needs for which the proposed research education program is planned and describing the intended candidates and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. LHS scientists to be supported by the program must be at the career level for which the planned program is intended and supported for no more than three-year period.
    • Participating, in conjunction with the Administrative Core, in a semi-annual reporting procedure to track the success of its research project investigators;
    • Creating and maintaining a system for tracking its research study investigators through award of independent research funding.
    • Using AHRQ-sponsored LHS training competency domains or specific enhancements to those competencies the program will deploy, with justification tailored to the LHS embedded scientists needs.
    • Including both didactic and experiential learning and embeds LHS scientists at the interface of research, data and information systems, and clinical operations within learning health systems.
    • Incorporating the PCORI Methodology Standards in the LHS training curriculum.

    Program Mentors. Researchers from diverse backgrounds, groups underrepresented in science, persons with disabilities, and women are encouraged to participate as program mentors. Mentors should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

    Program Participants: Applications must describe the intended participants (LHS scientists), and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the training needs the proposed program will address.       

    Recruitment Plan to Enhance Diversity:

    Applications must include a description of plans to recruitment a diverse cadre of LHS scientists, including groups underrepresented in science. Applicants must include outreach strategies and activities designed to recruit prospective scientists from diverse backgrounds, and may wish to include data in support of past accomplishments.

    Applications lacking a diversity recruitment and retention plan will not be reviewed.

    Letters of Support: A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

    NOTE: Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

    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. See section IV.7.

    Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

    Appendix:

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

    Research and Data Analysis Core

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

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

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

    Complete only the following fields:

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

    Enter relevant component.

     

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

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

    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.

    Application guide states that Project Narrative is required.  However, it is only required for the Overall component.  If you would like the applicant to provide a project narrative for this component, update the above instructions accordingly. Specific names provided for Other Attachments must be no more than 50 characters including spaces.

    Facilities & Other Resources. Describe the educational environment, including the facilities, data, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically-related sources of support for research training and education following the format for Current and Pending Support.   

    Project /Performance Site Location(s) (Research and Data Analysis Core)

    List all performance sites that apply to the specific component.

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

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

    ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • Research and Data Analysis Core personnel should have expertise in PCOR/CER methodology, and/or unique expertise on the use of emerging data and technology to support PCOR/CER, including use of PCORnet, Medicare and Medicaid data. 
    Budget (Research and Data Analysis Core)

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

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

    Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

    Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support LHS scientists in the program.

    Research Project Budgets: Research project costs should be in the range of $100,000 total costs per year. Research projects may be awarded to embedded scientists outside of the home institution. Funds for the proposed research projects should be included under other expenses. Applicants are encouraged to include in-kind support for research projects, such as data access or other support, from health system partners.

    Future-year research projects must be submitted with the annual non-competing renewal applications.

    PHS 398 Research Plan (Research and Data Analysis Core)

    Research Plan sections are: Introduction to Application, Specific Aims, Research Strategy, Progress Report, Publication List, Multiple PD/PI Leadership Plan, Consortium/Contractual Arrangements, Letters of Support, and Appendix.

    Only include information that is different from application guide.

    Specific Aims:  Clearly state how the Research and Data Analysis Core (RDAC) will support the LHS E-STaR Center and LHS Scientists in conducting PCOR/CER and the dissemination, implementation, and use of PCOR/CER evidence in LHS.

    Research Strategy:  Organize the Research Strategy into sections on: Significance, Innovation and Approach.

    Significance: Explain the role of the RDAC in the center as a whole and as a mechanism for enhancing the rigor and impact of the work conducted in LHS. 

    Approach: Describe how the RDAC will implement a plan to create, identify, catalogue, and disseminate and implement, and promote use of scientific information produced by the Center with a specific focus on AHRQ/PCORI priorities. The application should describe how the RDAC will focus specifically on AHRQ/PCORI priorities, including:

    • PCOR and CER research.
    • Use of emerging data and technology to support use of PCOR/CER, including PCORnet, Medicare and Medicaid data.
    • Partnership with state Medicaid programs and other payers, community-based organizations, minority-serving institutions, diverse organizations such as safety net and community organizations and Federally Qualified Health Centers.
    • Priority topic areas for research projects, including
    • Health equity
    • Healthcare disparities
    • Primary care
    • Maternal health and maternal morbidity and mortality (MMM)
    • Intellectual and developmental disabilities (IDD)
    • Patient-centeredness and the science of patient and stakeholder engagement
    • Dissemination and implementation approaches and tools.
    • PCOR/CER methods and application of PCORI Methodology Standards.

    Letters of Support: Place letters of support for the RDAC in this section.

    NOTE: Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

    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. See section IV.7.

    Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

    Appendix:

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

    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.

    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

    For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

    These awards will not be made under expanded authorities; therefore, pre-award costs are not allowable without prior approval from AHRQ. 

    7. Other Submission Requirements and Information

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

                                                              

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

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

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see  https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

    Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.  

    Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this NOFO. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

     

     Priority Populations

    AHRQ is committed to the inclusion of priority populations in health services research. The overall portfolio of health services research that AHRQ conducts and supports shall include the populations specifically named in AHRQ’s authorizing legislation: inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care. 42 U.S.C. 299(c)(1). AHRQ also includes in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

    AHRQ will broadly implement this inclusion policy across the research that AHRQ supports and conducts so that the portfolio of research is inclusive of all populations. AHRQ intends that these populations be included in studies such that the research design explicitly allows conduct of valid analyses. The policy applies to all grant applications. Investigators should review the document entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-015.html. Applicants under this NOFO must consider and discuss including priority populations in research design as specified in this Notice.

    Public Access to AHRQ-Funded Scientific Publications

    Investigators should review the document titled ‘AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications’, which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher’s date of publication.

    AHRQ Data Management Plan Policy

    Investigators should review the document titled AHRQ Data Management Plan (DMP) Policy, which is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html). This policy requires applicants for AHRQ new/competing grants and research contracts to include a DMP for managing, storing and disseminating the primary data, samples, physical collections, and other supporting materials created or gathered in the course of research funded by AHRQ, or state why data management is not possible, as a component of their grant application or research contract proposal. 

    Plan for Sharing Research Data

    The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data should describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

    AHRQ and PCORI encourage openness in research and making research data available for purposes of replication and reproducibility. Recipients, upon the request of AHRQ, may be required to develop, maintain, and implement a data management and sharing plan that addresses the management, retention, and sharing of data collected in connection with research projects funded under this NOFO in a manner that is appropriate for the nature of any such research project and the types of research project data, and that is consistent with all applicable privacy, confidentiality, and other legal requirements. To the extent required by AHRQ or voluntarily developed by the Recipient, the data management and sharing plan must be acceptable to AHRQ. To the extent required by AHRQ or voluntarily developed by the Recipient, awardee institutions may designate the data repository (e.g., the Patient-Centered Outcomes Data Repository or a comparable data repository acceptable to AHRQ) at which the data will be deposited, and the time period for retention of the research data

    The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

    Data Confidentiality

    The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine-readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by recipient under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. 

    The recipient should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

    Sharing Research Resources:  Rights in Data

    Unless otherwise provided in grant awards, AHRQ recipients may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on recipients to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ requests that recipients notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date. 

    Regulations applicable to AHRQ recipients concerning intangible rights and copyright can be found at 45 CFR 75.322.

     
    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

    The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

    AHRQ's priority areas of focus are available

    at https://www.ahrq.gov/funding/policies/NOFOguidance/index.html.  Applications that are complete and responsive to the NOFO will be evaluated for scientific and technical merit by an appropriate objective group convened in accordance with standard AHRQ peer-review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this NOFO will not be reviewed.  Only the review criteria described below will be considered in the review process.

    Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, National Institutes of Health, and for responsiveness by AHRQ.

    Only the review criteria described below will be considered in the review process.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria - Overall

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

    Significance

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

    Investigator(s)

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

    Innovation

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

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project involves human subjects and/or AHRQ-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

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

    Environment

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

    Additional Review Criteria - Overall

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

    Does the project demonstrate a plan for supporting the professional development of embedded LHS scientists to conduct research that accelerates progress towards an integrated learning health system?

    Does the project demonstrate knowledge and an explicit strategy and partners for involving and engaging patients, clinicians, community, and other stakeholders in embedded research that accelerates progress towards an integrated learning health system?

    Does the project include a recruitment plan to enhance diversity, including outreach strategies and activities designed to recruit prospective scientists from diverse backgrounds?

    Does the project integrate research to achieve health equity into the LHS training program and health systems research?

    Does the project consider and discuss including priority populations in research design as specified in this Notice?

    Does the project use the AHRQ-sponsored LHS training competency domains or specific enhancements to those competencies the program will deploy, with justification?

    Does the project develop and implement a training program that includes both didactic and experiential learning and creates opportunities for embedded scholarship at the interface of research, informatics, clinical operations, and engagement within learning health systems?

    Does the project build or enhance a strong and high-quality infrastructure to support a combination of didactic and experiential training – including mentorship and learning opportunities provided within partner organizations including safety net and community organizations and Federally Qualified Health Centers, academic, and learning health system settings allowing for the application and mastery of the knowledge and skills outlined across the LHS scientist core competencies?

    Does the project incorporate the PCORI Methodology Standards in the LHS training curriculum?

    Does the project include research projects designed with LHS partners and stakeholders and conducted within a health system?

    Does the project focus on systematically engaging stakeholders, generating evidence, systematically adopting evidence and/or systematically applying evidence in order to expand the health system’s ability to support population health management and/or personalized health care?

    Does the project demonstrate evidence of institutional support (direct or in-kind) from health systems in which embedded scientists would conduct their research?

    Will the project conduct an evaluation with clear outcome metrics linked to improvements in health system performance?

    Does the project assess scientist research training outcomes including patient-centeredness of research, development of tools or policies, dissemination of research, PCOR/CER outcomes?

    Does the project assess scientist training program outcomes including career advancement, attaining funding, publications, etc.?  

    Additional Review Criteria - Cores

    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.

    Administrative Core

     How well do the organization and processes proposed for internal communication and synthesis of Core activities advance LHS E-STaR objectives?

    How well is time allocated to program management among senior staff?

    Is there an appropriate plan for evaluating the center's progress toward achieving its objectives?

    How well are the mechanisms and procedures created for ensuring interaction between the site’s Cores and partner institutions?

    How well are the mechanisms and procedures created for ensuring engagement between the site and community and stakeholder partners?   

    Research Education Core

     How well does the infrastructure support a combination of didactic and experiential training?

    Does the infrastructure include mentorship and learning opportunities provided within both academic and learning health system settings allowing for the application and mastery of the knowledge and skills outlined across the LHS scientist core competencies?

    Is the mentorship tailored to the LHS embedded scientists needs?

    Are there appropriate strategies for identifying the LHS scientists’ training needs for which the proposed research education program is planned?

    Are there appropriate descriptions of the intended LHS scientists and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program?

    Is there a description of plans to recruitment a diverse cadre of LHS scientists, including groups underrepresented in science. Are data included in support of past recruitment accomplishments?  

    Research and Data Analysis Core

     Is there an appropriate description of how the RDAC will implement a plan to create, identify, catalogue, and disseminate scientific information produced by the Center with a specific focus on AHRQ/PCORI priorities?

    Does the RDAC focus specifically on AHRQ/PCORI priorities?   

    Protections for Human Subjects

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

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

     

    Resubmissions

    N/A.

    Renewals

    N/A

    Revisions

    N/A

    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.

     The reviewers will comment on whether the Data Management Plan is reasonable.  

    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 that are complete and responsive to the NOFO will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this NOFO will not be reviewed.

    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.

    Applications will compete for available funds with all other recommended applications submitted in response to this NOFO.

    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.
    • Responsiveness to goals and objectives of the NOFO.
    • Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.
    • Approach to addressing health equity.
    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 HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html).

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, AHRQ Division of Grants Management staff will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b)”https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

    If all administrative and programmatic issues are resolved, 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 AHRQ grants management officer is the authorizing document and will be sent via email to the e-mail address designated by the recipient organization during the eRA Commons registration process.

    Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions.

    Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.  

    Any application awarded in response to this NOFO will be subject to the UEI, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at https://www.ahrq.gov/funding/grant-mgmt/index.html#terms.

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

    2. Administrative and National Policy Requirements

    All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards,” (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

    All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that recipients inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

    As necessary, additional Terms and Conditions will be incorporated into the NoA.

    If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions. AHRQ regulatory procedures that pertain to suspension and termination are specified in 45 CFR 75.371 through 75.375.

    There is a prohibition on certain telecommunications and video surveillance services or equipment that became effective on or after August 13, 2020.

    Should you successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which you agree, as a condition of receiving the grant, to administer your programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

    • For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

    • For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

    • HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html.

    • For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

    Contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at

    AHRQ: Health Literacy Universal Precautions Toolkit

    For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

    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), AHRQ awards will be subject to the Federal Recipient 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 AHRQ grants and cooperative agreements except fellowships.

    • Health Literacy – Below are available HHS resources.
    • HHS Health.gov: Health Literate Care Model
    3. Reporting

    When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually unless otherwise specified in the terms of award.

    For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the start date of the next budget period of the award.

    Evaluation

    In carrying out its stewardship of human resource-related programs, the AHRQ may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history including employment in a LHS leading effort in PCOR/CER to transform delivery of care, authorship of scientific publications, support from independent research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

    Program planning and performance reporting requirements:

    Recipient performance will be measured based on success in the following Program goals:

    Administrative Core

    • Number of LHS scientists recruited to participate in this program.
    • Number of program evaluation advancements completed.
    • Number of partnerships developed and/or partner engagement activities completed

    Research Education Core

    • Number of LHS scientists participated in this core.
    • Number of PCOR/CER studies conducted by LHS scientists as part of this core.
    • Number of mentors participating in this core
    • Number of mentor/scientist encounters

    Research and Data Analysis Core

    • Number of PCOR/CER projects conducted by LHS scientists.
    • Research project findings.
    • Number of partnerships developed and/or stakeholder engagement opportunities completed on research projects.

    Recipients are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

    Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html).  AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2023, the annual FFR is due 9/30/2023 (90 days after the end of the calendar quarter of 6/30/2023).

    A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends.  All final reports are due within 120 days of the project period end date.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/funding/grant-mgmt/index.html#Closeout.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable AHRQ 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 HHS Grants Policy Statement (http://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.

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

     

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

    Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

    Scientific/Research Contact(s)

    Division of Research and Education
    Office of Extramural Research, Education, and Priority Populations
    Agency for Healthcare Research and Quality
    Email: PCORtraining@ahrq.hhs.gov

    Peer Review Contact(s)

    Xavier Bogle, Ph.D.
    Division of Scientific Review
    Office of Extramural Research, Education, and Priority Populations
    Agency for Healthcare Research and Quality
    Email: DSR@ahrq.hhs.gov

    Financial/Grants Management Contact(s)

    Carol Kauffman
    Division of Grants Management
    Office of Management Services
    Agency for Healthcare Research and Quality
    Telephone: 301-427-1448
    Email: carol.kauffman@ahrq.hhs.gov

    Section VIII. Other Information

    Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.html.

    Authority and Regulations

    This program is described in the Assistance Listing Number(s) (formerly called the Catalog of Federal Domestic Assistance) at https://sam.gov/content/home and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

    Awards are made under the authority of 42 USC 299 et seq., and 42 U.S.C. 299b-37 authorizes AHRQ to make these awards to support the agency's dissemination of comparative clinical effectiveness research findings and the training of researchers in the methods used to conduct such research. These awards will be funded together by PCORI under an agreement pursuant to 42 U.S.C. 299b-37(g).

    These awards will be funded in accordance with 45 CFR Part 75 and other referenced applicable statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at https://www.ahrq.gov/funding/policies/hhspolicy/index.html.

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