and Human Services (HHS)
Department of Health and Human Services
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. |
Components of Participating Organizations |
None |
Funding Opportunity Title |
Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional) |
Activity Code |
R21/R33 Phased Innovation Award |
Announcement Type |
Reissue of PA-21-164 |
Related Notices |
August 27, 2024 - Notice of Change to Research Opportunity: Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional). See NOT-HS-24-021. May 13, 2024 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Improve Care Delivery, Access, Quality, Equity, and Health Outcomes for Older Adults. See NOT-HS-24-013.
April 8, 2024 - Notice of Intent to Publish a Funding Opportunity Announcement for Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional). See NOT-HS-24-011.
February 12, 2024 - AH Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2024. See 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 NOT-HS-24-042.
November 16, 2023 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Improve Healthcare for Persons Living with Disabilities. See Notice NOT-HS-24-004
May 8, 2023 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Advance Health and Healthcare Equity. See NOT-HS-23-013.
January 11, 2023 - AHRQ Announces Interest in Research on Climate Change and Healthcare. See Notice NOT-HS-23-006
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
May 26, 2020 -The Agency for Healthcare Research and Quality Data Management Plan Policy. See NOT-HS-20-011.
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) |
PA-24-266 |
Companion Notice of Funding Opportunity |
None |
Number of Applications |
|
Assistance Listing Number(s) |
93.226 |
Funding Opportunity Purpose |
This NOFO invites applications that propose research projects that test promising digital healthcare interventions used at the point of care and aimed at improving the quality of healthcare services delivery. This NOFO will use the Phased Innovation Award (R21/R33) mechanism to provide up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities. |
Posted Date |
July 19, 2024 |
Open Date (Earliest Submission Date) |
July 19, 2024 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply. The first application due date is October 16, 2024
All applications are due by 5:00 PM local time of the applicant organization.
Applicants are encouraged to apply early to allow adequate time to for them to make, by the due date, corrections to any errors found in the application during the submission process. |
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 the peer review date |
Expiration Date |
August 1, 2026 |
Due Dates for E.O. 12372 |
Not Applicable |
It is critical that applicants follow the Research (R) Instructions in How to Apply - 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 How to Apply - 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Notice of 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. Notice of Funding Opportunity Description
The mission of the Agency for Healthcare Research and Quality (AHRQ) is to produce evidence to make healthcare safer, higher quality, and more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure the evidence is understood and used (AHRQ Research Priorities and Compliance Guidance | Agency for Healthcare Research and Quality).
This Notice of Funding Opportunity (NOFO) invites applications for research projects that test promising digital healthcare interventions used at the point of care and aimed at improving the quality of healthcare services delivery. This NOFO will use the Phased Innovation Award (R21/R33) mechanism to provide up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO. Continuation from the R21 phase to the R33 phase will be determined by AHRQ staff based on progress achieved in the R21 phase and factors such as program priorities and availability of funds.
The digital healthcare ecosystem is rapidly evolving, and there is a need to build the evidence base on how digital healthcare innovations can be effectively, efficiently, and safely deployed at the point of care, which is considered any location where patient care is provided (e.g., hospital, primary and ambulatory care facilities, the bedside, home, long term care facilities, rehabilitation facilities or ambulance). The prolific emergence of new technological innovations used by multiple members of the healthcare team as well as caregivers in healthcare settings is transforming care delivery models and impacting care delivery and patient care experiences.
The use of evidence-based, technology-driven, point of care process solutions has the potential to revolutionize the way care is delivered. The use of these solutions can improve productivity, reduce errors, enhance safety, and increase opportunities for patient engagement and shared decision-making.
Artificial Intelligence (AI), Patient-Centered Digital Healthcare Technologies (PC-DHT), and Clinical Decision Support Systems (CDSS) are among the digital healthcare solutions that are being used to support efficient healthcare delivery, enhance patient engagement, advance the quality of care, and mitigate safety risks. For example, health-related AI applications are used to improve care processes and provide AI-based diagnostic and treatment recommendations (Alowais et al., 2023). PC-DHT such as mobile health applications, wearables, invisibles, and sensors are being used to improve care and patient experiences (Pyper, McKeown, Hartmann-Boyce, & Powell, 2023). PC-DHT is used to capture patient-generated data, provide timely health information to inform decisions, facilitate shared decision-making, and promote self-care activities. Digital CDSS tools are used to link clinicians with health knowledge to assist with clinical decision making at the point of care (Pinsky, 2024). Research is needed to understand how these technologies impact health outcomes and health equity, the delivery and quality of care, patient experiences, and healthcare disparities.
Health services research that explores the use of innovative patient-centric digital healthcare solutions to improve services at the point of care aligns with AHRQ's research priority to support healthcare professionals in providing whole-person care through healthcare system use of digital healthcare data (clinical, contextual, and patient-generated), knowledge (training, guidelines, decision support, and advanced analytics), and tools to support clinicians in providing better care.
The objective of this NOFO is to improve the quality of healthcare services delivery at the point of care through integration of digital healthcare solutions. This NOFO aims to support phased exploratory and developmental research projects that test promising digital healthcare interventions used at the point of care and intended to improve the quality of healthcare services delivery.
Research should be designed to test promising digital healthcare solutions that enable or facilitate technology-driven, point of care process solutions that use advanced analytics, patient-centered clinician and patient facing digital healthcare technologies, or clinical decision support systems to improve quality and health outcomes at the point of care. A theoretical framework should inform the research study and incorporate the use of care models when appropriate. The proposed digital healthcare solution should be accessed by a patient, provider, or other person providing healthcare during a care workflow.
Accordingly, this NOFO is focused on three research areas of interest. Examples of research projects responsive to this NOFO include but are not limited to:
Projects that will test innovative digital healthcare solutions that integrate the use of artificial intelligence (AI) (e.g., Natural Language Processing, Machine Learning) during the provision of healthcare services at the point of care. Such applications should assess and evaluate AI’s impact on practice workflow and quality of care.
Projects that apply machine learning against large health data sets to improve care delivery, equity, and quality at the point of care.
Projects that explore understanding how the use of patient-centered digital healthcare technologies (e.g., wearables, sensors, and mhealth solutions) impacts patient outcomes including functional status and well-being, experiences, and healthcare services delivery at the point of care. Such applications should assess and evaluate the technology implementation s impact on practice workflow and quality of care.
Of particular interest is (1) testing innovative digital healthcare technologies that facilitate information sharing and shared decision-making between patients and providers, and (2) evaluating the use of novel digital solutions for patients with multiple chronic conditions. This area of interest is intended to initiate research into how existing PC-DHTs can be integrated into care. Development of novel PC-DHTs, such as new sensors or wearables, is not allowed under this NOFO.
Projects that will test innovative digital clinical decision-making tools that incorporate the use of patient-generated data and patient-reported outcomes at the point of care.
Projects that evaluate a digital point of care solution that combines the use of natural language processing (NLP) with a decision support tool to turn unstructured clinical data into knowledge and facilitate the advancement of the knowledge into practice.
Enabling clinicians and health system decision makers to effectively and efficiently use standardized computable biomedical knowledge to support clinical decision making and shared care planning is also an interest area. Applications that explore digital healthcare innovations in support of this interest area are welcome.
It is acceptable for applicants to propose research that crosses the research categories of interest mentioned above. For example, an applicant may propose to study an innovation that integrates AI with a clinical decision support solution that incorporates patient-reported outcomes at the point of care.
This NOFO will use the Phased Innovation Award Mechanism (R21/R33) to provide up to 2 years of R21 support for initial developmental activities and up to an additional 3 years of R33 support for expanded activities.
Proposed projects must include both an R21 phase, with milestone-driven developmental activities, and an R33 phase with expanded activities that will build on the initial developmental phase to achieve the aims of the entire award.
Applications proposing only R21 or R33 activities alone will not be accepted.
Preliminary data are not required for this mechanism but may be included if available.
Three months prior to the end of the R21 phase, awardees will submit a package, endorsed by an authorized institutional official, that requests transition to the R33 phase. This package will include a progress report that describes progress made toward each of the initial applicant-defined milestones, and a clear description of whether the original R33 proposed aims will remain intact or be modified based on the results of the R21 phase. Materials will be reviewed by AHRQ program staff and then, if selected to continue into the R33 phase, the R21 grant will be transitioned to an R33 award.
Decisions on transitioning to the R33 phase will be based on successful completion of the original applicant-defined milestones, program priorities, and availability of funds. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO.
All projects must:
Fully describe the digital healthcare innovation and its evaluation:
Describe the digital healthcare intervention;
Describe the problem which the digital healthcare intervention is intended to address and its readiness for an exploratory/developmental research project;
Describe a unifying and testable hypothesis that transcends both R21 and R33 phases;
Describe how performance will be measured (expected standards, outcomes, baselines, indicators, etc);
Describe how the solution should be expected to reduce (or at least not exacerbate) disparities;
Evaluate the reliability, validity, and usability of the digital healthcare solution used at the point of care;
Describe how the digital healthcare intervention will be incorporated into the clinical workflow and will impact healthcare delivery;
Fully describe the context in which the innovation will be implemented:
Describe the healthcare practice setting(s) for the research;
Describe the patient population(s) impacted by the research;
Describe all users of the digital healthcare solution or system;
Describe an innovation adoption strategy, including:
Describe how technology modifications, systems, or tools will be designed from the outset to be easily adopted by other providers and teams in the organization and how the project will be designed to scale across the organization and beyond to other, similar organizations;
Clearly demonstrate how the resulting innovation can be sustained and adopted by other settings;
Develop an innovative and leading-edge dissemination strategy that will be implemented during the second phase of the grant;
Evaluate and report (as applicable):
Improvement in the quality of care and reduction in adverse events;
Improvement in patient experience and delivery of whole person-care;
Reduction in provider, patient, and caregiver burden;
Unintended patient safety events;
Impact on health inequities whether biases in care delivery and outcomes are exacerbated, maintained, or mitigated; and
Provide a detailed project timeline that shows major milestones.
Alowais, S. A., Alghamdi, S. S., Alsuhebany, N., Alqahtani, T., Alshaya, A. I., Almohareb, S. N., ... & Albekairy, A. M. (2023). Revolutionizing healthcare: the role of artificial intelligence in clinical practice. BMC medical education, 23(1), 689. doi: 10.1186/s12909-023-04698-z
Pyper, E., McKeown, S., Hartmann-Boyce, J., & Powell, J. (2023). Digital health technology for real-world clinical outcome measurement using patient-generated data: systematic scoping review. Journal of Medical Internet Research, 25, e46992. doi: 10.2196/46992
Guiding Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2812958
Multiple Chronic Conditions Electronic Care Plan project to improve interoperability of data for people living with MCCs; Include SMART on FHIR care planning applications, FHIR data standards, and value sets from common clinical terminologies.
Available on the Agency for Healthcare Research and Quality's (AHRQ) eCare Plan webpage. https://ecareplan.ahrq.gov/
See Section VIII. Other Information for award authorities and regulations.
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)
Need help determining whether you are doing a clinical trial? |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications.
Future year amounts will depend on annual appropriations. |
Award Budget |
In the R21 phase, the combined budget for total costs (direct and indirect) for the two-year period may not exceed $280,000. No more than $140,000 total costs may be budgeted in either year of the R21 phase.
In the R33 phase, the combined budget for total costs (direct and indirect) for the three-year period may not exceed $720,000. No more than $240,000 total costs may be budgeted in any given year.
Applications that exceed the total costs caps described above and applications that do not include budgets for both the R21 and R33 phases 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 OMB 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 duration of the entire R21/R33 award may not exceed 5 years. The R21 phase may not exceed 2 years of support. The R33 phase may not exceed 3 years of support. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO. Continuation from the R21 phase to the R33 phase will be determined by AHRQ staff based on progress achieved in the R21 phase and factors such as program priorities and availability of funds. |
These projects are being funded pursuant to 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.
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
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)
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.
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.
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.
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.
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. 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.
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.
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. 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.
An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-18-197).
Section IV. Application and Submission Information
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.
It is critical that applicants follow 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.
For this specific NOFO, the Research Strategy section is limited to 12 pages.
All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
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.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Research Strategy:
Approach:
Applicants should describe their approach to test promising digital healthcare interventions used at the point of care and aimed at improving quality of care and care delivery using advanced analytics, innovative patient-centered digital health technologies, or clinician decision support tools.
The Research Strategy must include details of both the R21 and R33 phases in the single Research Strategy attachment.
In describing this approach, applicants must address the following elements:
Describe the healthcare practice setting(s) and the point of care for the research;
Describe the patient population(s) impacted by the research;
Describe all users of the digital healthcare solution or system;
Describe how the solution should be expected to reduce (or at least not exacerbate) disparities;
Describe the digital healthcare intervention and the problem indicating its readiness for an exploratory/developmental research project; and
Describe how the digital healthcare intervention will be incorporated into the clinical workflow to meet the needs of and be adopted by users.
Evaluation:
Applicants are to describe their approach to test the innovative intervention(s) within the research strategy. Applicants should consider a wide range of scientific methods, including quantitative, qualitative, and other novel methods. The study design and analytical plan should be well-justified and consistent with the specific aims and study type. In describing this plan, applicants must also address the following elements:
Applicants must evaluate the reliability, validity, and usability of the digital healthcare solution used at the point of care.
Applicants must describe how the research will measure the following:
Improvement in the quality of care and reduction in adverse events;
Evaluate and report on unintended patient safety events.
Sustainability and Scalability:
Applicants are to describe how technology modifications, systems, or tools will be designed from the outset to be sustainable and easily adopted by other providers and teams in the organization and how the project will be designed to scale across the organization and beyond to other, similar organizations.
Milestones:
Grant applications must include a detailed project timeline that shows major milestones.
Include a specific section labeled "Milestones" within the research strategy. Milestones are intermediate goals which support the completion of specific aims. Applicants should convey milestones using a format of their choice, such as a Gantt chart, timeline, or table. Milestones should be clearly-described, feasible, well-developed, quantifiable, and scientifically justified to transition to the R33 phase. R21 and R33 milestones should be clearly differentiated as two separate projects. A discussion of the milestones relative to the progress of the R21 phase and the implications of successful completion of the milestones for the R33 phase should be included.
Dissemination:
Applicants are to describe their approach to disseminate research findings for both the R21 and R33 phases of the research grant within the research strategy in a specific section labeled "Dissemination." Applicants should consider applying innovative and leading edge dissemination strategies and methods that enhance the broader applicability, reproducibility, and scalability of the research findings.
Applicants must submit a dissemination plan that describes how the team will effectively communicate and disseminate research evidence and findings to diverse audiences.
Applicants should consider the following items when developing the dissemination plan:
Describe the target audiences, materials that will be developed, plans to disseminate evidence, and the strategy to evaluate the dissemination activities; and
Incorporate innovative and novel dissemination methods and strategies to communicate compelling stories, inform policy makers, and educate new audiences who may benefit from the knowledge.
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-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html for additional information on how to incorporate their data management plan into the resource sharing plan.
Appendix:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-18-126.
Project Administration:
Grant applications must fully address the administration of the project in a section titled "Project Administration" included as a required appendix. This is especially crucial for projects that require the coordination of multiple team members efforts across disciplines, institutions, and geographic regions.
When involving human subjects research, clinical research, and/or defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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.
All instructions in the How to Apply - Application Guide must be followed.
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
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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.
This initiative is not subject to intergovernmental review.
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.
Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to 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 How to Apply - 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, NIH and 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.
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 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.
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 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 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.
Section V. Application Review Information
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.
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.
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).
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?
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? Is a single PD/PI, or are the multiple PD(s)/PI(s) combined, devoting at least 20% minimum full-time effort (i.e. at least 8 hours per week) in each given year of the project?
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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in human subjects?
Is there a unifying and testable hypothesis that transcends both R21 and R33 phases? Does the application provide clear milestones for the R21 phase and related scientific goals for the R33 phase? Are those milestones conducive to accomplishing the study aims? Are the goals of the R33 phase based, in part, on findings collected during the R21 phase?
Does the approach focus on testing promising digital healthcare interventions that improve quality of care and healthcare delivery services at the point of care? Are the reliability, validity, and usability of the digital healthcare solution used at the point of care evaluated? Does the approach measure improvement in the quality of care, patient experience and/or reductions in adverse events? Is the intervention designed with sustainability and scalability in mind? Is the intervention designed to reduce (or at least not exacerbate) disparities? Is the dissemination plan well-described?
Does the project include a detailed project timeline? Is there an evaluation section included in the grant application and does the applicant adequately measure improvement in the quality of care and reduction in adverse events? Is there a dissemination plan that includes innovative approaches to disseminating evidence-based research findings to audiences that may benefit from the knowledge during each phase of the project?
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? Is the scientific and organizational environment strong enough to support completion of the project as described and according to the timeline?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
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.
Inclusion of Priority Populations
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.
Degree of Responsiveness
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?
Budget and Period of Support
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable
Not Applicable
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.
Not Applicable
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.
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.
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
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.
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.
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.
Successful applicants under this NOFO agree that, where award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipients are required to 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.
Successful applicants under this NOFO agree that, when award funding involves 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, recipients and subrecipients are required to 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.
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:
HHS Health.gov: Health Literate Care Model
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.
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
Program planning and performance reporting requirements
The overarching objective of this funding opportunity is to support research projects that test promising digital healthcare interventions aimed at improving the quality of healthcare services delivery at the point of care.
Recipient performance will be measured based on success in the following Program goals:
Reach: Who was reached by the project?
Performance measures: Number of practices, clinicians, and patients using the digital healthcare solution.
Timeline: reach target by year 2 for the R21 award and year 5 for the applications selected for expanded activities with the R33 award.
Process: How were interventions implemented?
Performance measures: Number and types of clinical/patient workflows (e.g., Medical, Nursing, Administrative, Allied Services, Patients) impacted by incorporating the digital healthcare intervention into practice.
Timeline: reach target by year 2 for the R21 award and year 5 for the applications selected for expanded activities with the R33 award.
Impact: Do health outcomes improve?
Performance measures: One or more quality of care and reduction of adverse events measures will be developed and described for the evaluation.
Timeline: reach target by year 2 for the R21 award and year 5 for the applications selected for expanded activities with the R33 award.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
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)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
grant resources)
Email: GrantsInfo@nih.gov (preferred
method of contact)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Stephanie R. Pitts, Ph.D.
Digital Healthcare Research Division
Center for Evidence and Practice Improvement
Telephone: 301-427-1505
Email: digitalhealthcareresearch@ahrq.hhs.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Boris Aponte, Ph.D.
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Telephone: 301-427-1396
Email: DSR@ahrq.hhs.gov
Brian Campbell
Office of Management Services
Grants Management
Telephone: 301-427-1266
Email: Brian.campbell@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 (https://www.ahrq.gov/funding/policies/hhspolicy.)
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 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 http://www.ahrq.gov/funding/policies/hhspolicy/index.html
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