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 NFO 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.
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The mission of the Agency for Healthcare Research and Quality (AHRQ) is to produce evidence to make health care safer, higher quality, and more accessible, equitable, and affordable.
AHRQ achieves this mission by working within the U.S. Department of Health and Human Services and with other partners to make sure the evidence is understood and used.
AHRQ’s Role in Diagnostic Patient Safety
In 2015, the National Academies of Sciences, Engineering, and Medicine (NASEM) defined diagnostic error as the failure to (a) establish an accurate and timely explanation of the patient's health problem(s) or (b) communicate that explanation to the patient.
The progress to decrease diagnostic error has been slow. Researchers have reported that random error (also known as an error in precision), ranges from 10-50% depending on medical subspecialty, error detection methods, and other factors. Random errors may be detected through secondary review processes when there is a disagreement about a diagnosis. Diagnostic errors occur in all settings of care, contribute to at least 10% of patient deaths per year, and are the primary reason for medical liability claims. In the ambulatory setting diagnostic errors affect at least 12 million residents of the United States per year.
The high level of error arises from largely unchecked process variance, a lack of clearly defined standard reference diagnoses, and low levels of diagnostician agreement, resulting in imprecision. Diagnosticians practice under uncertainty and need sufficient knowledge and skill in assessing disease presentations, history-taking, mechanisms of disease, laboratory testing, radiologic testing, evaluation, causation, quality improvement, forecasting, and critical thinking to make a diagnosis or judgment. The making of a diagnosis is one of the most challenging tasks in medicine.
Ambulatory care encompasses a vast array of diagnostic services, which include primary care, physical medicine and rehabilitation, urgent care, emergency medicine, obstetrics and gynecology, mental health care, wilderness medicine, telemedicine, dental care, and dermatopathology to name but a few. The growth in ambulatory diagnostic services represents a large shift from hospital-based diagnosis, which was the mainstay in the early to late 20th century.
Although the majority of all diagnostic care occurs in the ambulatory environment, the focus of diagnostic safety research largely has been in hospital-based settings, such as internal medicine, anesthesiology, and other hospital services. Despite the ubiquity of ambulatory care services, there has been little rigorous study of diagnostic safety in many of the branches of ambulatory care. Ambulatory care, such as primary care and emergency medicine, are heterogenous in terms of patient populations, organizational structure, information technology systems, and other factors, which likely affect diagnostic safety.
Another important area of diagnostic safety research is understanding risk factors, such as age, race/ethnicity, and sex, that may impede a person from receiving an accurate and timely diagnosis. There are many reasons for diagnostic inequities-- lack of access to medical care, ingrained biases, and the fact that many diagnostic tests were only developed and conducted on white populations, to name a few. Accurate diagnosis is particularly challenging in older adults due to multiple factors including differences in disease presentation (e.g., hyperthyroidism presenting as weight loss alone), presence of multiple pre-existing conditions to which to attribute symptoms and signs of a new condition, common undifferentiated symptoms such as fatigue that have multiple causes, age-related differences in normal values for laboratory tests, presence of hearing loss that can impede communication, and agism. Thoroughly understanding the extent to which diagnostic inequities occur in the ambulatory setting and their root causes is the first step in designing interventions to prevent them from happening.
Over the years, AHRQ has funded R01 grants focused on diagnostic safety. The R01 grants funded to date that focused on the ambulatory setting were highly successful in producing data to understand ambulatory care patient safety, the timeliness of diagnostic care, improvement in patient-provider communications, and diagnostician understanding of adverse events and diagnostic uncertainty. The current Notice of Funding Opportunity (NOFO) highlights AHRQ's continued interest in the investigation of diagnostic safety in the ambulatory care setting.
Funding Opportunity Purpose
The purpose of this R01 NOFO is to invite proposals focused on Understanding and Improving Diagnostic Safety in Ambulatory Care: Incidence and Contributing Factors. These settings include emergency medicine, primary care, urgent care, mental health, obstetrics and gynecology, physical medicine and rehabilitation, and oncology, and connected ambulatory systems such as the cancer pathway, which involves numerous subspecialities. R01 applications are generally focused on hypothesis driven research, rather than demonstrating the effectiveness of a result or a method. A hypothesis is a tentative explanation that can be tested by further investigation. Thus, an R01 application hypothesis may be "patients who have a blinded second opinion prior to getting a diagnosis will have fewer diagnostic errors than patients who have a diagnosis without a second opinion."
As there has been little study of diagnostic safety in many areas of ambulatory care, researchers are encouraged first to investigate the incidence and contributory factors of diagnostic error. These observational findings then may be used to design and perform hypothesis testing involving patient safety interventions based in these environments.
The purpose of this funding announcement is to invite proposals focused on understanding and improving diagnostic safety in the heterogenous ambulatory care environment. AHRQ is interested in learning the strengths and weaknesses within and across the array of ambulatory care diagnostic services and in providing support designed to develop, test, and evaluate such activities.
Funding Opportunity Description
Over 860 million ambulatory visits occur annually in the United States (2.7 visits per person per year). Approximately half of these visits involve a primary care physician. The majority of visits involve a diagnostician making a new diagnosis and/or monitoring previously made diagnoses. A diagnosis is a judgment of the disease or condition in a patient. A diagnosis generally concludes the diagnostic process, which includes a number of process steps such as history-taking, physical examination, ordering of ancillary laboratory and/or radiologic studies, and critical thinking. The making of an accurate and precise diagnosis is one of the most challenging components of medicine.
The study of the field of diagnostic safety entails understanding the science of error. Practitioners recognize two types of diagnostic error. The first type is bias, which is the systematic tendency for a diagnosis to deviate from the actual or true diagnosis. The absence of bias is accuracy. The second type is random error, which is scattered observer deviation from the actual diagnosis. This type of error also is referred to as noise or the lack of repeatability. The absence of random error is precision. The goal of a diagnostician is to make a diagnosis that is as close to the true value as possible and for other diagnosticians to agree on the diagnosis.
Specific Objectives of the NOFO
This NOFO requests applications from research institutions and their investigators to conduct Health Services Research Projects (R01) in response to the objectives identified below. A separate program (R18) announcement is available to investigators whose research interests are related to evaluating strategies to reduce and eliminate diagnostic errors.
1) Assess the complexity and incidence of diagnostic error and its associated costs and harms.
2) Assess the contributing factors that are associated with or cause diagnostic error and the knowledge needed to facilitate diagnostic improvement. Such contributing factors may include how race and ethnicity impact diagnosis.
In "Improving Diagnosis in Health Care," NASEM described six topic areas of research for decreasing diagnostic error. These topic areas are:
AHRQ encourages researchers to consider these and other areas of research. AHRQ also encourages applications that seek to understand disparities in diagnosis, particularly why some populations are more likely to suffer diagnostic errors. Examples of four potential areas of research are below. These are just examples. AHRQ is interested in receiving applications related to the other two areas listed directly above (Patient and Family Engagement and the Diagnostic Process and External Environment) but not mentioned below.
Topic 1. Identification, Analysis, and Reduction of Diagnostic Errors. NASEM highlighted the importance of understanding variance in the diagnostic testing process. Wennberg et al pioneered the studies of unwanted healthcare variance and physician diagnostic uncertainty. As diagnoses are judgments under uncertainty, studies are needed to assess the relationship of diagnostician uncertainty and unwarranted variance. Diagnostic errors arise from the variance of the testing process. Variance is a summary of all the positive, neutral, and negative differences in the diagnostic process steps. The main “buckets” of variance arise from the patient, the diagnostician, and the diagnostic process itself. Examples of subject (patient) variance include level of disease progression, secondary diseases and conditions, age, gender, and communication skills. Any changes in people, structures, environment, and methods also change the level of variance that affects diagnostic performance. For this example, an application could test the hypothesis that the use of variance analysis-based physical examination checklists in emergency medicine practices improves the quality of physical examination and decreases diagnostic error compared to usual practice.
Topic 2. Health Care Professional Education and Training. The National Academy of Science, Engineering, and medicine (NASEM) indicated the need to assess diagnostic performance in education and training at all professional levels (medical students, residents, fellows, and practicing diagnosticians) and to consider issues related to measurement for accountability. Medical educators differ considerably on the best methods to teach novices and experts in making or improving a diagnosis and on the environments that facilitate programmatic success. For example, some educators favor using methods based on acquiring specific competencies and other educators focus on improving individual components of diagnostician practice, such as critical thinking. In making a diagnosis, NASEM described a classic hypothetico-deductivist model, which is a specific critical thinking logic model based on hypothesis and verification. Some diagnosticians use different critical thinking logic models, such as abductive reasoning, or other models such as the Socratic method, the Paul-Elder Critical Thinking Framework, Beyer’s Evaluative Thinking Model, The Writing-Critical Thinking Connect, Benjamin Bloom’s Taxonomy of Educational Objectives, Divergent Thinking, Edward de Bono’s Lateral Thinking or Six Thinking Hats methods. For this example, an application could test the hypothesis that the use of a new educational critical thinking logic model in ambulatory care decreases diagnostic error compared to textbook self-study.
Topic 3. Health Information System. In the field of diagnostics, Nobel prize winner Kahneman contends that noise (random error) is an invisible problem and frequently overlooked. In day-to-day practice, many diagnosticians may not realize that a colleague might disagree with their diagnosis. Yet, in controlled secondary review studies, the level of disagreement may be as high as 10%-50%. Diagnosticians occasionally are in a situation where they learn that a colleague disagrees with their diagnosis, but this is often an isolated case. Larger scale comparison of blinded diagnoses is rare. Diagnoses often are “noisy” and the noise is unrecognized by the diagnostician. Kahneman suggests that one method to lower disagreement frequency is by creating “noise-free” diagnostic algorithms, which generally perform better than solitary diagnosticians in making a diagnosis. These algorithms often have been developed in information technology systems. Ideally, structured task diagnostician input also is included to further augment noise reduction. Other approaches to lowering noise involve using multiple raters. For this example, an application could test the hypothesis that improving diagnostic precision in geriatric medicine using teams of geriatric medicine physicians using consensus making activities improve diagnostic precision compared to solitary geriatric physicians.
Topic 4. Work System Improvements. NASEM noted the importance for more research exploring teamwork, culture, and leadership to improve diagnostic safety. Teamwork and resiliency research from other disciplines, such as the airline industry, have led to adoptions in healthcare resulting in safer work. The recent development of TeamSTEPPS® for Diagnostic Error has the capability of transforming the diagnostic process with the inclusion of additional team members, aside from the patient and solo diagnostician. These members include nurses, patient advocates, subspecialist clinicians, engineers, family members, and quality improvement specialists. The development of TeamSTEPPS for Diagnostic Error model provides researchers the opportunity to understand the strengths and weaknesses in different diagnostic team structures, processes, and roles that could decrease diagnostic error. For this example, an application could test the hypothesis that TeamSTEPPS for Diagnostic Error Process with dyad Advanced Practice Registered Nurse (APRN) - Physician Teams improves diagnostic accuracy compared to solitary physician practice.
Concurrently, AHRQ has put forth an R18 NOFO to invite proposals focused on research in demonstration and dissemination. In diagnostic safety, a demonstration project may be conducted to show: 1) the effectiveness of an existing or new process, such as requiring a second opinion on all new patients prior to finalizing a diagnosis (i.e., method demonstration) or 2) the effectiveness of an application, such as a new computer algorithm to improve diagnostic accuracy (i.e., result demonstration). Dissemination is the targeted distribution of information and materials about an evidence-based intervention to a specific clinical practice or public health audience. Dissemination is most effective when it starts early, galvanizes support, uses champions and brokers, considers contextual factors, is timely, relevant, and accessible, and understands the stakeholders and processes. This AHRQ R01 NOFO supports projects that mitigate risks, errors, and harms through the design, implementation and evaluation of patient safety strategies and the adaptation, refinement, and sustainment of those strategies. Additional examples can be found in the R18 NOFO.
See Section VIII. Other Information for award authorities and regulations.
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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 Institutions) are not eligible to apply.
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 possible.
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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for AHRQ support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.
Ambulatory care settings are highly diverse in provider types, services, and patient populations, which has changed the scope of clinical practice. Ambulatory care now includes mobile care, retail clinics, urgent care, free-standing emergency departments, high tech centers, the internet, computers, smart phones and convenient care. Providers in these practices have different expectations, skills sets, and knowledge bases regarding diagnostic safety, compared to hospital-based providers. Applicants are encouraged to put in place a team with unique investigator skills outside of traditional hospital medical fields that will contribute to the research in diagnostic safety.
This NOFO does not require cost sharing.
While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The AHRQ will not accept duplicate or highly overlapping applications under review at the same time per 22.214.171.124 Submission of Resubmission Application. This means that the AHRQ will not accept:
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 SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be emailed to:
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) 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:
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:
One of the following 2 bullets can be added to the text box above. DO NOT USE BOTH BULLETS. For R13 or U13 FOAs, Resource Sharing Plans are never applicable. Use the second bullet
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 Plane Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.htm) for additional information on how to incorporate their data management plan into the resource sharing plan. l
Only limited Appendix materials are allowed. 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.
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. AHRQ and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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.
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.
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.
The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine-readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by recipient under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.
The recipient should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Sharing Research Resources: Rights in Data
Unless otherwise provided in grant awards, AHRQ recipients may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on recipients to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that recipients notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date.
Regulations applicable to AHRQ recipients concerning intangible rights and copyright can be found at 45 CFR 75.322.
The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.
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? Did the application describe what diagnostic error studies have been performed in ambulatory settings and what makes this study unique? Did the application seek to understand disparities in diagnosis, particularly why some populations are more likely to suffer diagnostic errors?
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 PI team have unique investigator skills outside of traditional medical fields that will contribute to the research program?
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 application include innovative methods to detect and prevent diagnostic errors? Does the application include innovative methods that reduce disparities in diagnosis, particularly in AHRQ priority populations?
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 vertebrate animals or human subjects? Does the application state how inequities in diagnosis will be addressed? Are patient safety improvement methods being proposed and are they appropriate for the stated research aims?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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? Does the application identify how they will recruit ambulatory care populations so that populations that experience health disparities are included?
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.
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:
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.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Resource Sharing Plans
Reviewers will comment on whether the Data Sharing 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:
Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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. Section IV.6. Funding Restrictions. Section IV.6. Funding Restrictions. 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 OMB's Uniform Grant Guidance, HHS’s “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards,” (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75, and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.
All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that recipients inform their employees in writing of employee whistleblower rights and protections under 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.
AHRQ regulatory procedures that pertain to suspension and termination are specified in 45 CFR 75.371 through 75.375.
There is a prohibition on certain telecommunications and video surveillance services or equipment that became effective on or after August 13, 2020.
Should you successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which you agree, as a condition of receiving the grant, to administer your programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.
Contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at
Health Literacy – Below are available HHS resources.
For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Recipient Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all AHRQ grants and cooperative agreements except fellowships
Cooperative Agreement Terms and Conditions of Award
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually unless otherwise specified in the terms of award.
For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the start date of the next budget period of the award.
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 NIH 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 NIH Grants Policy Statement 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 the following Program goals:
Fidelity: Execution of the study design as planned or as modified with approval of AHRQ– includes addressing each aim of the study.
Timeliness: Timely submission of required reports to AHRQ:
Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.
Applicants must budget for up to two key members of the research team to travel to Washington, DC each year to meet with AHRQ staff, other diagnostic safety grantees, and any invited guests for a 1.5 day meeting to inform participants of progress and accomplishments, discuss anticipated directions and approaches, and expand opportunities for further learning.
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
Division of General Patient Safety
Center for Quality Improvement and Patient Safety
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Robyn Sagatov, PhD, MHS, RDN
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
AHRQ Division of Grants Management
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.
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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