Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ

NOTE: The policies, guidelines, terms, and conditions stated in this Notice of Funding Opportunity (NOFO) may differ from those used by the NIH. Where this 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 & QUALITY (AHRQ)

None

Funding Opportunity Title
Disseminating PCOR Evidence for Long COVID Care into Practice Through Up-to-Date Clinical Decision Support
Activity Code

R18 Research Demonstration and Disseminations Projects

Announcement Type
New
Related Notices
  • February 12, 2024 - Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2024. See Notice NOT-HS-24-007.
  • December 21, 2023 - Reminder of eRA Commons ID Requirement for All Personnel on the R&R Senior/Key Person Profile Form. See Notice NOT-OD-24-042.
  • May 11, 2022 - Competitive Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Enhance Workforce Diversity in Health Services Research. See PA-22-175
  • October 5, 2016 - AHRQ Policy Guidance Regarding Inflationary Increases (aka, cost-of-living adjustments, or COLAs) beginning in Fiscal Year 2017. See NOT-HS-17-001.
Funding Opportunity Number (FON)
RFA-HS-25-001
Companion Funding Opportunity
None
Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.226
Funding Opportunity Purpose

The purpose of this is NOFO is to disseminate patient-centered outcomes (PCOR) evidence for Long COVID care into clinical practice through clinical decision support (CDS) that is consistently updated as best practices and new evidence emerge.

Key Dates

Posted Date
January 10, 2025
Open Date (Earliest Submission Date)
January 10, 2025
Letter of Intent Due Date(s)

30 days prior to the application due date.

Application Due Date(s)

The application due date is April 10, 2025.

 All applications are due by 5:00 PM local time of applicant organization. 

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after the receipt date.

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after the peer review date.

Expiration Date
April 11, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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.

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The goal of this NOFO is to disseminate and implement patient-centered outcomes research (PCOR) evidence for Long COVID care into practice through up-to-date clinical decision support (CDS). Because Long COVID is a clinical area where research evidence is rapidly evolving, funded applications will demonstrate how healthcare organizations can consistently update their clinical decision support (CDS) systems for Long COVID care to reflect emerging evidence. It is envisioned that research results will help other healthcare systems design similar processes for Long COVID and other post-infectious illnesses where the evidence and treatment are rapidly evolving.

Background

AHRQ has a rich history of investing in CDS to bridge the gap between research findings and their application in clinical settings. With the reauthorization of the Patient-Centered Outcomes Research Trust Fund (PCOR TF) in 2019, AHRQ has continued to fund its multi-component initiative aimed at advancing PCOR evidence into practice through CDS and to make CDS more shareable, interoperable, and publicly available. CDS can take many forms, such as order sets, recommendations about needed care like screening tests, dashboards that can provide summary information, and alerts that need attention from care team members. CDS is developed to implement current medical knowledge and clinical practice guidelines to provide the right information, to the right people, in the right formats, through the right channels, at the right times, in the clinical workflow.1 Various sources, such as clinical practice guidelines, peer-reviewed literature, and local best practices, form the basis for these CDS tools, which provide a means to advance new medical knowledge into clinical practice more quickly and effectively. Therefore, the ability to quickly update these CDS tools is an important component of providing new knowledge to clinical providers, especially when that knowledge is rapidly updated.

Other initiatives in the public and private sectors with similar goals have also gained momentum. For example, efforts such as Adapting Clinical Guidelines for the Digital Age by the Centers for Disease Control and Prevention (CDC) has sponsored several projects to advance the computability of clinical practice guidelines and the interoperability of CDS, such as through its work with Health Level 7 (HL7). In 2017, the National Academy of Medicine introduced thirteen key priorities in their publication "Optimizing Strategies for Clinical Decision Support". One of these priorities was the establishment of an investment program for CDS research.

One area that requires further exploration is how healthcare systems can transform the latest research findings into new or updated CDS more efficiently. Developing, maintaining, and updating CDS often depends on lengthy and labor-intensive processes, which can be particularly problematic in clinical domains where evidence and best practices are evolving quickly. Many facets may impact CDS implementation including obtaining the necessary approvals, governance requirements, authoring the updates to the CDS, clinical considerations and review, and technical considerations, as well as the necessary resources to deploy and test the update.

Each of these areas may have their own sub-processes to implement updates to the CDS based on new evidence. For example, (1) clinical committees may need to review and approve new clinical practice pathways, (2) administrative or departmental leadership may need to approve funding or address staff changes related to clinical workflows, and (3) Information Technology leadership and staff will need to review changes and dedicate resources to test and deploy the CDS implementation. Each of these processes may occur in different departments within the healthcare organization, which necessitates additional processes for communicating and monitoring approvals and implementation as a whole.

The COVID-19 pandemic underscored the necessity for streamlined administrative and knowledge management practices. Once an organization has made the determination that evidence has changed and their organization’s practices need to be updated accordingly, updated CDS tools with the latest evidence for improved patient care is important to ensuring that the best evidence can get to practice effectively. This need has evolved to include diagnosing and managing Long COVID, as research into the biology and treatment of post-infectious conditions produces new evidence. The complex, multi-system nature of Long COVID, relative lack of evidence for diagnosis and treatment, and the massive federal investment in new research make it an ideal context for developing more advanced, timely CDS that can quickly incorporate new evidence to inform care decisions.2

With complicated treatment approaches like Long COVID, a more comprehensive understanding of the framework supporting CDS infrastructure that can deliver updated best practices – which can include local platforms and protocols --is crucial to fostering agility in these systems and ensuring swift updates aligned with emerging evidence. The concept of updating CDS to incorporate the latest knowledge aligns closely with frameworks that describe learning health systems. When health evidence is rapidly changing, the ongoing evaluation of CDS performance is essential. Using the learning health system framework would employ internal data and experience that is then systematically integrated with external evidence, analyzed for impact, and then iteratively improved. Applicants may use this framework, or a similar framework, which could provide a broad, systems view for their evaluation and that reflects a culture of adaptation.

Additionally, the AHRQ-developed Analytic Framework for Action (AFA),3 is based on early understanding of learning health systems and provides a useful framework for understanding and organizing the cyclic nature of providing maintenance and updates required for keeping CDS up to date. The AFA cycle involves prioritizing what evidence-based practice should be considered, updating the CDS tools, testing and deploying the updated CDS, and validating CDS performance and impact. Other considerations, such as governance, marketplace, and legal factors can influence any or all the phases. This framework includes a focus on what is important to patients and families throughout the cycle and has been advanced further by ongoing work in the CDS Innovation Collaborative.

The process to support and sustain CDS can be complex, requiring the implementation of new versions of the software to stay current with practice guidelines. The symptoms and recommended practice standards related to Long COVID are revised often and not on a predictable schedule, which requires multiple CDS updates. Therefore, combining the emerging work on Long COVID with improving the processes to update production CDS systems will provide multiple opportunities to apply these lessons learned across the healthcare system.

For CDS to improve care it needs to support person-centered care for people living with Long COVID who often have multisystem involvement and multiple underlying chronic conditions. Providing care requires considering the impact of evidence-based recommendations on the overall care of the patient. Therefore, the CDS should support person-centered, whole person care.

Objectives and Scope

The objective of this NOFO is to disseminate and implement patient-centered outcomes research (PCOR) evidence for Long COVID care into practice through up-to-date clinical decision support (CDS). More investigation is required to learn how healthcare systems can update and maintain CDS in rapidly changing clinical domains. Funded applications will demonstrate how healthcare systems can update and maintain their CDS systems to reflect the latest evidence-based care for Long COVID.

To meet this objective, proposals must:

  • Describe the evidence for Long COVID care that forms the basis for their CDS and the plan(s) for identifying new evidence to be incorporated into the CDS.
  • Describe the processes for how the CDS will be updated as new evidence is identified and how those processes – technical, clinical, and administrative – will be studied.
  • Describe how the proposed work will reduce implementation cycle times for updated Long COVID CDS, including a description of the process improvement framework to be used and the rationale for using the chosen framework.
  • Describe the relevance and use of standards, such as:
    • Health Level 7 International, Clinical Practice Guideline on Fast Healthcare Interoperability Resource (HL7 CPG-on-FHIR) standard and implementation guide (https://confluence.hl7.org/display/CDS/CPGonFHIR).
    • Clinical Quality Language (CQL).
    • Long COVID value sets,4 or similar sets of codes based on standardized terminologies.
  • Include a plan for evaluating and monitoring how well the updated CDS processes are valued by the intended stakeholders who would be using these CDS tools
    • To support person-centered whole person care, patients should also be considered as stakeholders in this evaluation and monitoring plan
  • Consider equity and bias in the development and modification of the CDS tools.
  • Describe how safety net providers will be included in the development process so that these tools may potentially be usable in other healthcare environments.
  • Describe how the project fits within one of the four main elements of the AHRQ PCORTF Strategic Framework (https://www.ahrq.gov/pcor/strategic-framework/index.html), including how the research is conducted through a health equity lens.
  • Include a detailed project timeline that shows major milestones.
  • Include a plan of how the project will disseminate lessons learned and contribute to the community of CDS developers and implementers.

Examples of highly responsive topics include, but are not limited to:

  • Innovative use of visualization tools or dashboards to monitor the improvement cycle.
  • Enhancing the processes that examine how evolving evidence for Long COVID will be collected and locally validated.
  • Changes to the CDS software design that would allow new recommendations to the symptoms and conditions that define Long COVID to be updated using a simple approach.
  • Changes to the IT implementation workflow that would reduce the cycle time required to update the CDS for Long COVID.
  • Processes for data collection and analysis, related to change approval, resources needed, and development that would improve the quality, efficiency, and timeliness of this process.
  • Improving the training processes used to educate clinical staff on the use of the updated Long COVID CDS.

Definitions

Clinical Decision Support (CDS): provides timely information to help inform decisions about patient care. CDS is patient-specific and can take many forms, such as order sets, recommendations about needed care, summary information, and alerts. CDS is a set of technology-based tools that delivers the right information to the right people using the right channels and formats at the right times.1

Health information technology (health IT): technology used to acquire, analyze, or deliver information required for CDS design, deployment, and evaluation. Examples include electronic health records (EHRs), health information exchanges, clinician and patient-facing apps, dashboards, and middleware.

Implementation cycle: For updating CDS in a health system, an implementation cycle is the full cycle of multiple business functions in the organization that leads to deployment in live, operational settings. This includes, but is not limited to, identifying new clinical recommendations, request, and approval processes for developing and updating CDS, deciding upon and allocating IT resources, testing updated CDS, training of staff, and deploying the updated software. Depending on the organization, there may be other requirements for change approval for the updated CDS.

Long COVID: an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing, and remitting, or progressive disease state that affects one or more organ systems.5-7

Patient-Centered Outcomes Research (PCOR): is comparative clinical effectiveness research of the impact on health outcomes of two or more preventive, diagnostic, treatment, or healthcare delivery approaches. PCOR produces not only clinical findings (e.g., thiazide diuretics are an effective first-line therapy for hypertension), but also evidence about the effectiveness of how healthcare is delivered. There are multiple sources of PCOR findings, including but not limited to those listed below:

AHRQ Effective Health Care Program (http://www.effectivehealthcare.ahrq.gov/)

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

U.S. Preventive Services Task Force (http://www.uspreventiveservicestaskforce.org/)

Community Preventive Services Task Force (https://www.thecommunityguide.org/)

References:

1. Osheroff JA e. Improving medication use and outcomes with clinical decision support: a step-by-step guide. Chicago, IL: HIMSS, 2009.

2. Pfaff ER, Girvin AT, Bennett TD, et al. Identifying who has long COVID in the USA: a machine learning approach using N3C data. Lancet Digit Health 2022;4(7):e532-e41.

3. Marcial LH, Richardson JE, Lasater B, et al. The Imperative for Patient-Centered Clinical Decision Support. EGEMS (Wash DC) 2018;6(1):12.

4. COVID-19 Value Sets.  2023. https://vsac.nlm.nih.gov/valueset/2.16.840.1.113762.1.4.1223.22/expansion/20200409. Accessed July.

5. CDC. Long COVID Definition https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html. Accessed June 2024.

6. National Academies of Sciences E, and Medicine. A Long COVID Definition: A Chronic Systemic Disease State with Profound Consequences. Washington, DC: The National Academies Press, 2024.

7. Thaweethai T, Jolley SE, Karlson EW, et al. Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection. JAMA 2023;329(22):1934-46.

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

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance 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 How to Apply - 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).

Funds Available and Anticipated Number of Awards

AHRQ plans to invest up to $6 million over 2 years to support six awards. Future year funding is contingent upon the availability of funds for each year of support.

Award Budget

The total costs (direct and indirect costs) awarded to a grant under this NOFO will not exceed $500,000 in any given year and $1 million for the entire project period. An application with a budget that exceeds $500,000 total costs in any given year will not be reviewed. Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with 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 2 years.

42 U.S.C. 299b-37(b) authorizes AHRQ to make these awards to assist users of health information technology focused on clinical decision support to promote the timely incorporation of government-funded PCOR research findings into clinical practice and to promote the ease of use of such incorporation. 

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; https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), the HHS Grants Policy Statement (see https://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:

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

Nonprofits Other Than Institutions of Higher Education

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

Local Governments

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

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

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 Organizations

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

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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 How to Apply - Application Guide.

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. 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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 AHRQ 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:

Roland Gamache
Agency for Healthcare Research and Quality
Email:[email protected] 
 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

Budget Component: Special Instructions for AHRQ applications

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. 

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • Specific Aims section is limited to 1 page.
  • Research Strategy section, including tables, graphs, figures, diagrams, charts, the dissemination plan, and the timeline is limited to 12 pages.

All projects must:

Describe their approach to demonstrate how healthcare systems can deliver the latest evidence-based care for Long COVID through CDS. Specifically, applicants must address the following elements:

  • Describe the evidence for Long COVID care that forms the basis for their CDS and the plan(s) for identifying new evidence.
  • Describe the processes for how the CDS will be updated as new evidence is identified and how those processes – technical, clinical, and administrative – will be studied.
  • Describe how the proposed work will reduce implementation cycle time for updated Long COVID CDS, including a description of the process improvement framework to be used and the rationale for using the chosen framework.
  • Describe the relevance and use of standards, such as:
    • Health Level 7 International, Clinical Practice Guideline on Fast Healthcare Interoperability Resource (HL7 CPG-on-FHIR) standard and implementation guide (https://confluence.hl7.org/display/CDS/CPGonFHIR).
    • Clinical Quality Language (CQL).
    • Long COVID value sets,4 or similar sets of codes based on standardized terminologies Include a plan for evaluating and monitoring how well the updated CDS processes are valued by the intended stakeholders who would be using these CDS tools.
    • To support person-centered whole person care, patients should also be considered as stakeholders in this evaluation and monitoring plan.
  • Consider equity and bias in the development and modification of the CDS tools.
  • Describe how safety net providers will be included in the development process so that these tools may potentially be usable in other healthcare environments.
  • Describe how the project fits within one of the main elements of the AHRQ PCORTF Strategic Framework (https://www.ahrq.gov/pcor/strategic-framework/index.html), including how the research is conducted through a health equity lens.
  • Include a detailed project timeline that shows major milestones.
  • Include a plan of how the project will disseminate lessons learned and contribute to the community of CDS developers and implementers.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide, with the following modification:

  • Submission of a data management plan is required. AHRQ applicants are reminded to refer to NOT-HS-25-010: The Agency for Healthcare Research and Quality Data Management and Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-25-010.html for additional information on how to incorporate their data management plan into the resource sharing plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed.

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.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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.

Pre-award costs are allowable. A recipient may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the recipient must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the recipient to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the recipient's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile formFailure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ. See Section III of this NOFO for information on registration requirements.

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. 

The applicant should pay particular attention to the SF424 (R&R) application guide instructions https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

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

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.

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.

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 Policy for Public Access to AHRQ-Funded Scientific Publications’, which is available at (NOT-HS-25-011: AHRQ Policy for Public Access to AHRQ-Funded Scientific Publications). 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 and Sharing Policy, which is available at (NOT-HS-25-010: Agency for Healthcare Research and Quality (AHRQ) Data Management and Sharing Policy). 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.

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-18-012Confidentiality 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 NOFO 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 [email protected] 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.

Section V. Application Review Information

1. Criteria

The mission of AHRQ is to produce evidence to make healthcare 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. 

AHRQ's priority areas of focus are detailed here: https://www.ahrq.gov/funding/policies/nofoguidance/index.html.

As part of this mission, applications are submitted to AHRQ to support health services research which are evaluated for scientific and technical merit through the AHRQ peer review system.

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.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

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

Overall Impact

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

Scored Review Criteria

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

 

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

  • To what extent will the project disseminate and implement Long COVID care best practices into care through CDS?
  • To what extent will the project increase our knowledge about updating and maintaining CDS to reflect current, evidence-based care?
  • To what extent will the project increase our knowledge about the use of CDS-related standards to reduce the time and effort required to implement CDS updates?
  • Will the new or updated processes make CDS updates more efficient?
  • Does the proposal describe a reasonable approach to determine the usability of the CDS in a real-world setting? (Do the clinicians and patients find the CDS useful?)
  • Will the new processes be scalable to other healthcare systems and settings, particularly to underserved settings?

In addition, for applications involving clinical trials

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

 

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

  • Developing, testing, and evaluating Long COVID clinical updates and the synthesis of Long COVID evidence that has been discovered since the previous update to the CDS Long COVID tools.
  • Health IT support and expertise for CDS implementation.
  • Project management, communication, and collaboration skills.
  • Experience with the use of health informatics standards such as clinical quality. language (CQL), HL7 standards, public value sets, and the use of SMART on FHIR resources. 

In addition, for applications involving clinical trials

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

 

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

  • To what extent will the project include innovative methods that reduce the healthcare system burden of updating CDS for Long COVID?
  • Will new or enhanced frameworks be developed that provide an improved understanding of methods to update CDS artifacts?
  • To what extent will the project provide methodologies to update CDS that are FAIR (Findable, Accessible, Interoperable, and Re-usable)?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

 

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

  • To what extent will the project include innovative methods that reduce the healthcare system burden of updating CDS for Long COVID?
  • Will new or enhanced frameworks be developed that provide an improved understanding of methods to update CDS artifacts?
  • To what extent will the project provide methodologies to update CDS that are FAIR (Findable, Accessible, Interoperable, and Re-usable)?

If the project involves human subjects and/orclinical 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?

 

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?

  • Will the proposed organizational structure provide and support the clinical, IT, standards, operations, and informatics expertise needed for the success of the project?
  • If the application indicates partnering organizations, is there a history of successfully working together?
  • Is there evidence of institutional commitment and support from all proposed departments, divisions, and/or organizations?
  • Will the scientific environment in which the work will be done contribute to the probability of success?
  • Does the healthcare system provide care for a sample size for the Long COVID patient population to conduct the proposed research?

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria

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

 

Specific to applications involving clinical trials

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

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

 

If the project involves human subjects and/or clinical research, are there 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?

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.

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.

 

Peer reviewers will assess the adequacy of plans to address the needs of AHRQ priority populations.

Peer reviewers must include their assessment of the proposed inclusion plan for priority populations in evaluating the overall scientific and technical merit of the application and assigning the impact score.

In evaluating the overall impact of the application, the review groups will:

  • Evaluate the application for the presence or absence of the inclusion plan based on the proposed research objectives.
  • Evaluate the adequacy of the proposed plan for the inclusion of priority populations.
  • Evaluate the proposed justification for the exclusion of priority populations when a requirement for inclusion is described as inappropriate with respect to the purpose of the research.
  • Evaluate the plans for outreach and recruitment of study participants, including priority populations, where appropriate.
  • Evaluate the proposed plan for study design, execution, and outcome assessments so that study results will be relevant to one or more priority populations, where appropriate.
  • Assess the plan as being “acceptable” or “unacceptable” with regard to the appropriateness of the inclusion or exclusion of priority populations in the proposed research.
 

Reviewers will assess how well the application addresses the purpose and objectives of this NOFO. How responsive is the application to the special eligibility criteria, including the project requirements, noted in the NOFO? 

 

The committee will evaluate whether the proposed budget is reasonable, and whether the requested period of support is appropriate in relation to the proposed research.

 

Not Applicable

 

Not Applicable

 

Not Applicable

Additional Review Considerations

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

Resource Sharing Plans

        Not Applicable

     Data Management Plan

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

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.

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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.

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 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.

Where award funding involves: Implementing, acquiring, or upgrading health IT for activities by any funded entity use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act- Use health IT certified under the ONC Health IT Certification Program, if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
  2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data.

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 41 U.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. 

If you receive an award, HHS may terminate it if any of the conditions in 2 CFR 200.340(a)(1)-(4) are met. No other termination conditions apply. 

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

If you receive an award, you must follow all applicable nondiscrimination laws. You agree to this when

you register in SAM.gov. You must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website. 

Health Literacy 

Below are available HHS resources:

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. 

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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.

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 the threshold. See the 2 CFR Part 170 (https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-170) 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.

Recipient performance will be measured based on success in achieving project aims.

The overarching objectives of these projects should be addressed through program and performance reporting including progress with respect to:

  • Reach: Who or what groups were reached by this project?
  • Performance measures: Number of CDS iterations implemented, reduction in process time for the iterative implementation, and patient and provider satisfaction with the CDS
  • Impact: Barriers to CDS updates identified and reduced, dissemination of the information, ability of resource-constrained healthcare facilities to implement these tools to update their CDS more easily

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: [email protected]

Scientific/Research Contact(s)

C. Jean Hsieh, PhD, 
Scientific Review Officer 
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Email: [email protected]  
 

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Anna Caponiti
Office of Management Services
Division of Grants Management
Agency for Healthcare Research and Quality
Telephone: 301-427-1402
Email: [email protected] 
 

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 (https://www.ahrq.gov/funding/policies/hhspolicy/index.html).

Authority and Regulations

This program is described in the Assistance Listings (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 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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