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. 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 |
None |
Funding Opportunity Title |
Examining the Impact of Artificial Intelligence (AI) on Healthcare Safety (R18) |
Activity Code |
R18 Research Demonstration and Dissemination Project |
Announcement Type |
New |
Related Notices |
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.
February 12, 2024 - AHRQ Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2024. See Notice NOT-HS-24-007.
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
January 6, 2023 - Salary Limitation on AHRQ FY2023 Grants, Cooperative Agreements, and Contracts. See NOT-HS-23-005.
December 21, 2023 - Reminder of eRA Commons ID Requirement for All Personnel on the R&R Senior/Key Person Profile Form. See Notice NOT-HS-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) |
PA-24-261 |
Companion Notice of Funding Opportunity |
None |
Number of Applications |
|
Assistance Listing Number(s) |
93.226 |
Funding Opportunity Purpose |
The purpose of this NOFO is to invite grant applications that support healthcare safety by determining (1) whether and how certain breakthrough uses of Artificial Intelligence (AI) systems can affect patient safety; and (2) how AI systems can be safely implemented and used. AI has the potential to improve the safety, effectiveness, efficiency, accessibility, and affordability of healthcare. However, as with most technologies, this potential must be balanced by identifying and mitigating potential risks for patient harm and user burden. |
Key Dates
Posted Date |
July 15, 2024 |
Open Date (Earliest Submission Date) |
July 15, 2024 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply. The first application due date is September 25, 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 make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Generally, four months after the receipt date. |
Advisory Council Review |
Not Applicable |
Earliest Start Date |
|
Expiration Date |
May 26, 2027 |
Due Dates for E.O. 12372 |
Not Applicable |
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.
Table of Contents
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).
For the purposes of this NOFO, AI is defined as the capacity of a software application to perform operations and tasks analogous to learning and decision making in humans, including the capability to abstract perceptions of real and virtual environments into models through automated analysis, use model inference to formulate options for information or action, and generate new content in response to a prompt.
AI has the potential to improve the safety, effectiveness, efficiency, accessibility, and affordability of healthcare. However, as with most technologies, this potential must be balanced by identifying and mitigating possible risks for patient harm and user burden. AI is not a technology to ignore its use is gaining momentum and researchers need to conduct the work to validate its value in real clinical settings.
In 2017 AHRQ, together with the Office of the National Coordinator for Health Information Technology and the Robert Wood Johnson Foundation, published a study by JASON ("JASON (advisory group)," n.d.) on how AI might shape the future of health and healthcare delivery. One of the questions posed in the study was whether AI use was a fad which would wane without making an impact on health and healthcare delivery. JASON’s overarching observation was that this time is different since the following societal forces will now enable AI-based approaches to advance in healthcare: 1) societal frustration with the cost and quality of our healthcare, 2) ubiquity of networked smart devices in our society, and 3) U.S. public acclimation to technology-enabled conveniences such as online shopping with home delivery. Fast forward to 2024, add burgeoning clinician burnout (Willard-Grace et al., 2019) combined with a growing shortage of clinicians (Zhang et al., 2020) to the 2017 list of societal forces, and AI is off and running with advances like generative AI that healthcare systems and providers are currently exploring to improve healthcare delivery. In this context, researchers need to determine if these AI advances are positively affecting the provision of safe care.
As the nation’s lead patient safety agency, AHRQ funds research that provides critical evidence about the use of technology to improve patient safety and the safe implementation and use of technology. This NOFO is focused on two priority areas:
(1) One focus of this NOFO is to understand whether and how newer or what might be considered breakthrough uses of AI can affect patient safety. For the purposes of this NOFO an AI breakthrough is a significant advance, development, or achievement that removes a hazard or a barrier to progress in healthcare processes; it may also enable new healthcare processes. This includes leading edge, innovative or novel AI approaches which have not yet been rigorously evaluated.
Examples of AI approaches that have precipitated what this NOFO refers to as "breakthrough" AI systems include large language models (LLMs) and generative AI that can quickly answer patient (Ayers et al., 2023) and clinician questions or create clinical documentation. Such AI systems present potential breakthrough solutions for alleviating clinician burden and burnout and allowing clinicians more time to deliver patient care. Given the association between clinician burden and adverse impacts on patient care (Nijor et al., 2022), these AI systems may also represent a breakthrough for patient safety.
However, more research is needed to solidify the connection between such AI systems purported to reduce clinician burden and their actual value in practice. Do such systems actually speed up the clinical documentation process or improve clinical documentation? Do such systems provide responses to inbox queries more quickly and with acceptable accuracy if so, do we see a commensurate decrease in clinician pajama time, or time spent completing work beyond normal working hours (Saag et al., 2019)? Research is also needed to understand whether these systems can lead to new patient safety concerns and unintended clinician burdens.
Also, AI breakthrough uses beyond clinician burden reduction may warrant exploration. AHRQ would be interested in research determining the patient safety implications of such breakthroughs. For example, are there breakthrough uses of AI that might address the declining clinician population in rural areas? If so, how does this affect patient safety?
(2) The second focus of this NOFO is to examine the safe implementation and use of AI systems, where AI systems means software applications that operate in whole or in part using AI. As noted in the 2023 report "A Transformational Effort on Patient Safety" produced by the President’s Council of Advisors on Science and Technology, AI has the potential to address patient safety challenges when it’s carefully honed, integrated, and leveraged in healthcare environments (President s Council of Advisors on Science and Technology, 2023, p. 26). For the purposes of this NOFO and this focus area, AHRQ is only interested in AI systems that have previously been shown to be efficacious in healthcare settings.
Selecting and managing medications, improving diagnostic accuracy, shortening time to diagnosis, monitoring patient conditions, as well as predicting treatment effectiveness based on individual characteristics are areas where AI can and has been shown to assist in improving patient safety. A 2020 systematic review concluded that AI-enabled decision support systems can improve error detection and patient stratification (Choudhury & Asan, 2020). However, we need evidence-based practices aimed at honing, integrating, and leveraging (i.e., implementing and using) AI systems that support the aforementioned opportunities for AI to address patient safety challenges. There is a need to understand how users can best interact with AI systems and carefully monitor a system's use and performance post-implementation. Areas to examine may include but not be limited to workflow integration, usability, human-computer teaming, and governance for monitoring safe use of AI systems post implementation.
As noted above, this NOFO is focused on two research areas of interest: (1) whether and how certain breakthrough uses of AI systems can affect patient safety and (2) how AI systems can be safely implemented and used.
It is acceptable for applicants to propose research that crosses these research categories of interest. For example, an applicant may propose to study how a breakthrough AI system can positively affect patient safety when it's implemented or used in a certain manner.
This NOFO is not intended to support the development of new AI systems, instead it focuses on assessing the impact, both positive and negative, of actual AI deployments in healthcare delivery systems and how that impact can be affected by implementation and use strategies.
Examples of applied research projects responsive to this NOFO include but are not limited to those described below. Mixed methods research projects are encouraged where applicable.
Research to demonstrate the clinician time saved through implementation of AI systems to reduce documentation or inbox burdens
Research to determine if AI systems to reduce documentation or inbox burdens create new patient safety issues and, if so, how might they be mitigated or eliminated
Research to determine how best to integrate AI systems that alleviate clinician burden into clinician workflows
Research to determine how to safely implement and use an LLM- based system, which has been shown to expedite accurate responses to patient or clinician queries
Research to determine how best to ensure the usability of AI systems that address patient safety challenges
Research to develop an evaluation tool or approach to assess the safe implementation of AI systems
Research to determine how best to integrate AI systems into clinician workflows to maximize their effect on enhancing patient safety and identifying and mitigating patient safety hazards.
Research to determine how to enhance clinician-AI teaming to improve patient safety
Research to determine how AI can be implemented to mitigate and not exacerbate inequities in care, particularly in the area of patient safety
All projects must:
Describe the healthcare practice setting(s) for the research: outpatient, inpatient, emergency department, ambulatory surgery center, post-acute care settings, home, etc.;
Describe the patient population(s) impacted by the research;
Describe how the research considers the guidance released by the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) in its Artificial Intelligence Risk Management Framework
Describe how AI hazards, harms, benefits, and process improvements will be identified, harms prevented or mitigated, and processes implemented and/or improved;
Evaluate and report (as applicable):
Improvement in the safety and effectiveness of care and reduction in adverse events;
Improvement in patient and/or clinician experience;
Reduction in provider burden; and
Unintended adverse clinician impact or patient safety events and mitigating actions taken.
Special requirements and information
Grantees awarded through this NOFO will have external collaboration with each other via two virtual meetings to address learning and dissemination. PD/PI and any key personnel are encouraged to participate in the learning and dissemination meetings.
Key personnel on the research team must include individuals having expertise in AI or the implementation of AI systems as well as expertise in patient safety, quality assurance, or human factors engineering.
JASON (advisory group) (n.d.). In Wikipedia. https://en.wikipedia.org/wiki/JASON_(advisory_group)
Willard-Grace, R., Knox, M., Huang, B., Hammer, H., Kivlahan, C., & Grumbach, K. (2019). Burnout and health care workforce turnover. The Annals of Family Medicine, 17(1), 36-41. https://doi.org/10.1370/afm.2338
Zhang, X., Lin, D., Pforsich, H., & Lin, V. W. (2020). Physician workforce in the United States of America: forecasting nationwide shortages. Human resources for health, 18(1), 1-9. https://doi.org/10.1186/s12960-020-0448-3
Ayers, J.W., Poliak, A., Dredze, M., Leas, E.C., Zhu, Z., Kelley, J.B., Faix, D.J., Goodman, A.M., Longhurst, C.A., Hogarth, M., Smith, D.M. (2023). Comparing Physician and Artificial Intelligence Chatbot Responses to Patient Questions Posted to a Public Social Media Forum. JAMA Intern Med., 183(6):589-596. doi:10.1001/jamainternmed.2023.1838.
Nijor, S., Rallis, G., Lad, N., & Gokcen, E. (2022). Patient safety issues from information overload in electronic medical records. Journal of Patient Safety, 18(6), e999. doi:10.1097/PTS.0000000000001002.
Saag, H.S., Shah, K., Jones, S.A., Testa, P.A., Horwitz, L.I. (2019). Pajama Time: Working After Work in the Electronic Health Record. J Gen Intern Med., 34(9):1695-1696. doi: 10.1007/s11606-019-05055-x.
President’s Council of Advisors on Science and Technology. (2023 September). A Transformational Effort on Patient Safety. Report to the President. Available from: https://www.whitehouse.gov/wp-content/uploads/2023/09/PCAST_Patient-Safety-Report_Sept2023.pdf
Choudhury, A. & Asan, O. (2020). Role of Artificial Intelligence in Patient Safety Outcomes: Systematic Literature Review. JMIR Med Inform., 8(7), e18599. doi: 10.2196/18599.
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; Includes 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 support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. |
Clinical Trial? |
Optional: Accepting applications that either propose or do not propose clinical trial(s)
Need help determining whether you are doing a clinical trial? |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications.
Future year funding is contingent upon the availability of funds for each year of support.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. |
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.
Application budgets should reflect actual needs of the proposed project, within the total costs cap.
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. |
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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.
System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
o Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.
A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum full-time effort (i.e., at least 8 hours per week) in each given year of the project.
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.
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
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 Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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 SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
All projects must:
Describe the healthcare practice setting(s) for the research: outpatient, inpatient, emergency department, ambulatory surgery center, post-acute care settings, home, etc.;
Describe the patient population(s) impacted by the research;
Describe how the research considers the guidance released by the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) in its Artificial Intelligence Risk Management Framework;
Describe how AI hazards, harms, benefits, and process improvements will be identified, harms prevented or mitigated, and processes implemented and/or improved;
Evaluate and report (as applicable):
Improvement in the safety and effectiveness of care and reduction in adverse events;
Improvement in patient and/or clinician experience;
Reduction in provider burden;
Unintended adverse clinician impact or patient safety events and mitigating actions taken.
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
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.
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 SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed. 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 SF424 (R&R) 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.
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 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 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 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
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.
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.
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? Will knowledge gained from the project facilitate responsible and safe AI implementation in a healthcare setting?
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? Does the research team have expertise in AI or the implementation of AI systems? Does the research team have patient safety, quality assurance, or human factors engineering expertise?
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? Does the proposed project represent a unique approach to either (a) evaluating the effectiveness and safety of AI system breakthroughs or (b) creating safe and effective methods for the implementation and ongoing use of AI systems? Will it provide a significant advance, development or achievement that removes a hazard or barrier to progress in healthcare processes? Does it address a breakthrough AI approach which has not yet been rigorously evaluated?
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?
Does the project focus on the implementation of AI systems within a healthcare setting? Does the investigator apply mixed methods approaches, if applicable, to assessing patient safety or clinician burden in their project design?
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?
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.
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.
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.
Renewals
Not Applicable
Revisions
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.
Data Management Plan
The reviewers will comment on whether the Data Management Plan is reasonable.
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.
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.
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.
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.
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.
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 was reached by this project?
Performance measures: Number or variety of organizations, practices, facilities, healthcare workers, and/or patients reached by the implementation.
Timeline: reach target by year 2.
Process: What AI hazards, advantages or impact on healthcare processes were evaluated, implemented or improved as a result of this project?
Performance measures: number, types, or magnitude of hazards, advantages and/or healthcare processes evaluated, implemented, or improved.
Timeline: reach target by year 2.
Impact: Were AI hazards, advantages and impact on healthcare processes mitigated, enhanced or otherwise managed as represented by process measures?
Performance measures: Impact of AI on select healthcare process or outcome measures.
Timeline: report on impact target by year 2.
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)
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
Agency for Healthcare Research and Quality
Telephone: 301-427-1505
Email: DigitalHealthcareResearch@ahrq.hhs.gov
Hamid Jalal, MD, MHSA
Patient Safety
Agency for Healthcare Research and Quality
Telephone: 301-427-1033
Email: Hamid.Jalal@ahrq.hhs.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Email: DSR@ahrq.hhs.gov
Brian Campbell
Office of Management Services
Division of Grants Management
Agency for Healthcare Research and Quality
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/index.html
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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