Examining the Impact of Artificial Intelligence (AI) on Healthcare Safety (R18) is sponsored by Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services. This Notice of Funding Opportunity (NOFO) intends to support healthcare safety by determining whether and how certain breakthrough uses of AI systems can affect patient safety, and how AI systems can be safely implemented and used.

Expired PA-24-261: Examining the Impact of Artificial Intelligence (AI) on Healthcare Safety (R18) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Health and Human Services Part 1. Overview Information Participating Organization(s) Agency for Healthcare Research and Quality ( AHRQ ) NOTE: The policies, guidelines, terms, and conditions stated in this Notice of Funding Opportunity (NOFO) may differ from those used by the NIH.

Where this NOFO provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO.

Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual NOFO of Participating Organizations Funding Opportunity Title Examining the Impact of Artificial Intelligence (AI) on Healthcare Safety (R18) Demonstration and Dissemination Project March 17, 2026 - Notice of Early Expiration of PA-24-261-- Examining the Impact of Artificial Intelligence (AI) on Healthcare Safety (R18)..

See Notice NOT-HS-26-009 March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 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. 12, 2024 - AHRQ Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2024.

See 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 8, 2023 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Advance Health and Healthcare Equity. See NOT-HS-23-013.

11, 2023 - AHRQ Announces Interest in Research on Climate Change and Healthcare. See Notice NOT-HS-23-006 6, 2023 - Salary Limitation on AHRQ FY2023 Grants, Cooperative Agreements, and Contracts. See NOT-HS-23-005 .

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 . 11, 2022 - Competitive Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Enhance Workforce Diversity in Health Services Research.

See PA-22-175 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) Companion Notice of F unding Additional Information on Eligibility .

Assistance Listing Number(s) F unding 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 Open Date (Earliest Submission Date) Letter of Intent Due Date (s) dates apply. The first application due date is September 25, 2024.

All applications are due by 5:00 PM local time of the applicant 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) Generally, four months after the receipt date. Generally, four months after the peer review date.

New Date March 17, 2026 per issuance of NOT-HS-26-009 . (Original Expiration Date: May 26, 2027) 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 . the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. do not comply with these instructions may be delayed or not accepted for 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. Use the NIH ASSIST system to prepare, submit and track your application online.

Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Workspace to prepare and submit your application and eRA Commons to track your application. Part 1. Overview Information Part 2.

Full Text of the Announcement I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement 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 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 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? 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 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 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 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 Research to determine how AI can be implemented to mitigate and not exacerbate inequities in care, particularly in the area of patient safety 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 Intelligence Risk Management Framework Describe how AI hazards, harms, benefits, and process improvements will be identified, harms prevented or mitigated, and processes implemented Evaluate and report (as applicable): Improvement in the safety and effectiveness of care and reduction Improvement in patient and/or clinician experience; Reduction in provider burden; and Unintended adverse clinician impact or patient safety events and mitigating actions taken.

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 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 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 Transformational Effort on Patient Safety. Report to the President.

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. Resources, if applicable: 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 Plan webpage. https://ecareplan.

ahrq. gov/ See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed Optional: Accepting applications that either propose or do not propose clinical trial(s) 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 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.

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 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 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.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 Non-domestic (non-U.S.) components of U.S. Organizations are not eligible 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 Award Management (SAM) Applicants must complete and maintain an active 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. 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. 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. 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. Applicants must have an active SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

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

Eligible Individuals (Pro gram Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

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. Information on Eligibility 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 A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. It is critical that applicants follow the Research (R) Instructions 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 of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in Apply Application Guide and should be used for preparing an application All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application All instructions in the SF424 (R&R) Application Guide 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 PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 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 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 Improvement in patient and/or clinician experience; Reduction in provider burden; Unintended adverse clinician impact or patient safety events and mitigating actions taken.

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. Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following 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 Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide 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 . PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3. Unique Entity Identifier and System for Award See Part 1.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next 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. are responsible for viewing their application before the due