It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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. 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section 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

Research Objectives

The Agency for Healthcare Research and Quality (AHRQ) announces the availability of grants to develop, test, and evaluate the impact of various simulation approaches for the purpose of improving the safe delivery of health care. As a training technique, simulation in health care uses a variety of approaches mannequins, task trainers, virtual reality, in situ scenarios, hybrid configurations, and standardized patients to expose individuals and teams to realistic clinical challenges. A distinguishing feature of simulation is that it allows participants to experience, in real- or near real-time, the consequences of their decisions and actions as they learn new skills and address system anomalies in an environment that does not put patients at risk. Simulation also can be used as a test-bed to identify failure modes and other areas of concern in new clinical processes, procedures, and technologies that might threaten patient safety. Another use of simulation is as a vehicle to help establish performance competency benchmarks of interest to credentialing and certification initiatives. AHRQ is seeking applications that address a variety of clinical settings. Yet other investigators have used computerized modeling as a way of representing a system that is infeasible to study directly for the purpose of forecasting the effect of changes under different conditions. The projects funded under this funding opportunity announcement (FOA) will inform providers, health educators, payers, policy makers, AHRQ, patients, and the public about the effective use of simulation in improving patient safety.

Applicant institutions are required to describe the simulation, including the expected impact on patient safety outcomes; provide a project design and methodology plan that covers development, test and evaluation activities; specify the simulation methods, equipment, and resources that will be utilized; outline how the simulation will be implemented in the proposed health care setting; describe the metrics to be used to indicate acceptable performance; provide a data analysis and evaluation plan, and address the projected dissemination, adoption, and sustainability issues associated with the particular simulation approach used.

AHRQ encourages a variety of simulation projects from across the health care spectrum which impact diverse patient populations, including priority populations, provider groups, and clinical settings. Priority populations include: low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. Diverse settings of care and venues for simulation might include, but are not limited to, hospitals, ambulatory surgery centers, primary care clinics, medical centers, schools of nursing, universities, community colleges, health care provider organizations, health systems, health professional associations, and quality and safety improvement organizations. Projects presented for consideration under this FOA should comply with the Agency’s policy regarding the inclusion of priority populations (see AHRQ Notice https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html, as well as further information below in the special requirements section of this FOA.

AHRQ’s Role in Patient Safety

In its release of To Err is Human: Building a Safer Health System in November 1999, the Institute of

Medicine (IOM) estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors. The IOM report quickly elevated awareness of patient safety. One of the major take-home messages was that preventable adverse events arise from problems inherent in a complex and fragmented health care system that providers inherit. Although the United States provides some of the best health care in the world, it isn t evenly distributed throughout the nation, and the number of patients that are harmed as a result of the process of health care is unacceptably high. The report called for systematic change in health care practice, and cited safety improvements made in other hazardous industries through the use of error reporting systems, information technology, human factors considerations, process redesign, simulation and teamwork, and cultures of open communication and learning.

AHRQ was subsequently directed to lead a national effort to improve patient safety through appropriately targeted research. The initial patient safety grants focused on reporting systems, clinical informatics, the working conditions of providers, Centers of Excellence for multiple, programmatic projects, Developing Centers for new researchers, and education and dissemination efforts. Since these early beginnings, patient safety has continued to be a major research portfolio area of AHRQ. A fuller and more detailed account of other patient safety initiatives and activities can be found on AHRQ’s Web site at http://www.ahrq.gov/professionals/quality-patient-safety/index.html.

Simulation Overview

While simulation in health care can be traced to the 1960s with Resusci-Anne used for cardiopulmonary resuscitation (CPR) training, it was not until the late 1980s that pioneering research efforts started to take hold in anesthesiology with the development of simulation systems that trained participants in clinical management and teamwork.

Traditionally, the education of providers has focused on knowledge acquisition rather than the acquisition of defined levels of acceptable clinical performance. At the same time, it is recognized that many health care procedures are potentially dangerous and very difficult to teach and learn. A troubling paradox of health care delivery is that today's patients can be harmed in the training of tomorrow's practitioners. The apprenticeship expression of "see one, do one, teach one" has been reframed as "see one, do many with simulation, teach one" by adopters of simulation techniques. It is increasingly recognized that the education and training of providers is a life-long process, especially as new technology and less invasive procedures make their way into clinical practice. It is reasonable to expect that simulation's benefits accrue not only to inexperienced and vulnerable health care workers at the start of their careers, but also to experienced practitioners learning new procedures and technologies.

In addition to their promising potential of reducing risk to patients, simulations are valued for their ability to create conditions that optimize learning. Limited performance repertoires of novices and practitioners learning new procedures can be expanded with a graduated crawl-walk-run approach. Intricate elements of a difficult procedure can be selectively rehearsed again and again. Simulations can be programmed to provide training on patient complications and equipment malfunctions that occur infrequently in practice, but that require decisive action and skilled performance when they do occur. Simulations enable a complex mosaic of multiple skills cognitive, perceptual-motor, and affective to be simultaneously exercised. When fluid team performance is the goal, simulations provide a venue for technical skills, decision-making, communication and leadership skills to be exercised together.

In contrast to training-based applications, simulations also can serve as evaluation and usability test-beds to work out the unanticipated wrinkles of new emerging technologies and design features of facilities. Changes to the clinical workflow and potential threats to patient safety can be identified as new point-of-care systems and design features are modeled and tested in a simulated environment.

Within the past decade, there has been a progressively increasing interest in a broad array of simulation applications to health care. Advances in medical simulation technology, a progressive lowering of associated costs, a national focus on patient safety, greater recognition of the performance-based component of clinical competency, shortening of hours for residents thereby reducing exposure to less common procedures, and a greater willingness to incorporate lessons learned from other high-risk industries are a few of the factors that help to account for this heightened interest. Other indicators of the heightened interest can be found in the impressive growth of simulation centers in medical and nursing schools, and the Society for Simulation in Healthcare with its own journal and well-attended annual conferences.

AHRQ-Funded Simulation Grants

In fiscal years 2006 and 2007 AHRQ awarded approximately $10 million to advance knowledge of how simulation can improve patient safety across diverse health care disciplines, settings and populations. The grants were 2-year cooperative agreements and covered a diverse range of simulated clinical applications. Representative of the diversity were simulations that focused on central venous catheter insertion, diagnosis of melanoma, obstetric emergency response drills, pediatric airway management, rapid response teams, acute coronary syndrome management in rural settings, patient care hand-offs, virtual reality team training, and disclosure of medical error. In 2008, AHRQ, along with other organizations, supported an academic emergency medicine (AEM) consensus conference that was organized to help define a national research agenda for maximizing effective use of simulation across undergraduate, graduate, and continuous medical education. (Another supported AEM conference is scheduled for 2017.) In 2011, AHRQ funded 11 more multi-year demonstration grants to evaluate the use and effectiveness of various simulation approaches in another set of diverse care settings (e.g., cardiac surgery, pathology diagnosis, recognition of sepsis, pediatric resuscitation, leadership and emergency team performance, usability testing of rapid-prototype infusion pump designs, measuring characteristics of laparoscopic skill, and using simulation for teaching femoral arterial access). In 2011, 2014, and 2016, AHRQ updated and released new multi-year FOAs, entitled Advances in Patient Safety through Simulation Research, as its continuing funding vehicle for simulation research.

To make the same advances in health care with simulation that other hazardous industries have made will take a continuing programmatic effort. A vast number of research challenges remain that need to be addressed for simulation in healthcare to reach its full potential. The current FOA is an effort to support projects that will respond to these challenges on a steady and on-going basis. Provided below is a partial list of research challenges, questions, and issues to stimulate thinking and ideas about potential projects. It by no means exhausts the range of simulation issues that are of interest to AHRQ; thus, applications addressing relevant simulation and patient safety challenges not stated below are also welcomed.

Individual Performance

What are the acceptable levels of individual performance for particular tasks, procedures, or processes within provider groups? How are these levels established? Can graduated levels of performance competency and proficiency be established?

What does skill acquisition look like in terms of rate of acquiring the skill and level of performance achieved? How much variation among trainees is there with respect to rate of skill acquisition and performance levels achieved? Does simulation help to reduce the variation?

What does skilled performance look like as fixed periods of time elapse in the absence of deliberate practice? Are certain dimensions of skilled performance more subject to skill decay than others?

How much simulation retraining is needed to restore decayed performance to an earlier established level? For intricate, risky procedures, can simulated performance criteria be established to assess readiness for performing such procedures on actual patients?

Team Performance

What are the core team skills or competencies of key provider groups that can be enhanced with simulation and that are closely linked to patient safety? Are additional team skills and competencies required for addressing the needs of patients with disabilities or less commonly encountered health care issues?

Are there distinguishing differences between ad hoc teams versus fixed teams with respect to team performance levels achieved and retained? What is the impact on patient safety?

How can simulations be used to enhance resiliency and the adaptive capacity of teams and clinical units in responding to the unexpected in different care settings? In what ways is patient safety enhanced?

Given the fluid, dynamic and distributed nature of clinical work with its multiple fixed and ad hoc agents, can patient safety be enhanced by using simulations to foster a shared mental model? How does one demonstrate the operation of a shared mental model and its connection to patient safety?

System Performance

Can simulations incorporating systems engineering principles be used to help health care entities achieve greater improvements and system-wide effects by addressing interdependent patient safety concerns? Can scenarios be created that exercise a continuity of safety across the transitions of the patient care experience?

What are the patient safety challenges that cannot be addressed directly in the actual clinical setting for which modeling techniques might be appropriate for exploring outcomes under different conditions? What can be learned about unexpected system-demands that might occur in disaster response operations and sudden patient surges?

How can simulations be used as evaluation or usability test-beds for medical devices, new technology, new protocols, and facility design features to assess patient safety as well as broader scale system impacts?

Are there promising applications of simulation to new frontiers of patient safety such as the cognitive and system challenges associated with diagnostic work and its improvement?

Measurement and Methodological Issues

Are there agreed-upon nomenclatures, taxonomies, and metrics for the tasks, skills, and procedures that make up different provider specialty areas to guide and aggregate research findings?

What are the metrics and designs for demonstrating positive transfer to training to the clinical setting? Are the metrics and designs sensitive to negative transfer of training as well?

What methodological approaches are most appropriate for optimizing the advantages and unique features of part-task trainers, mannequin-based simulation, virtual reality, in situ techniques, standardized patients, crises resource management, modeling, serious gaming, usability testing, and hybrid forms of simulation?

How can use of multiple processes, outcomes, and other measures best triangulate the linkages among simulation performance, clinical performance, and patient safety outcomes?

Educational and Training Issues

How does one optimize the total learning experience and not just the simulation experience? How does simulation get integrated with other components of the educational curriculum? What principles from the psychology of learning, instructional systems design, mastery learning, cognitive work analysis, blended learning, and adult learning theory can be put to good use?

Is it possible to assign and run educational scenarios on mobile devices, computer- or web-based trainers, part-task trainers, and simulators in an integrated or step-wise approach to achieve greater educational efficiencies and effectiveness?

Are there educational strategies that can be used to solidify and further reinforce what has been learned during and after the debriefing to promote new and continued learning?

What types of performance records need to be kept on individuals or teams to track performance levels achieved and for appropriate assignment to more advanced levels of training and simulation? Can the learning experience be managed more effectively?

Accreditation and Certification

How can simulation be used reliably by entities responsible for accreditation of clinical programs and certification of specialists to ensure that standards, knowledge, and skills are maintained at acceptable levels of quality and safety? Are the benefits, risks, and limitations understood?

What assessment methods and criterion levels of performance are most appropriate for the different clinical specialty areas?

How can simulation be used to help ensure that residents (or other health care providers) in training are exposed to a necessary and sufficient number/diversity of clinical challenges during their rotations (or training periods)?

How can simulation be used to help ensure that veteran practitioners learning new procedures and technologies are qualified in their use and do not put patients at increased risk?

Devices and Information Technology

As medical devices, computer networks, and people have become increasingly interconnected, what role can simulation serve in addressing not only the individual components, but the needs of an integrated care delivery system?

How can simulation serve as a testing ground for bringing clinical engineers, IT specialists, and providers together to identify device and IT vulnerabilities and establish work-system processes for mitigating risk?

Can simulation be used to address the obstacles and patient safety harms associated with the design, operation, and maintenance of alarms, patient monitors, infusion pumps, connectors, endoscopes, and dialysis equipment? Can it help improve user-device interface concerns and interoperability issues with other components in the information network?

How can simulation help inform designers and developers of new health IT about the capabilities and limitations of users, the nature of the tasks to be performed, and the impact of the physical and social environment where devices and technology are employed?

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

These projects are authorized by 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 FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , 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.

1. Eligible Applicants

Eligible Organizations

You may submit an application(s) if your institution/organization is a (an):

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Unit of local or State government;
• Eligible agency of the Federal government.
• Indian/Native American Tribal Government (Federally recognized)
• Indian/Native American Tribal Government (Other than Federally recognized);
• Indian/Native American Tribally Designated Organization.

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Non-Profit Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 health care 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 grantee 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 to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

The PD/PI must have an eRA Commons account. The PD/PI should work with his/her 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, he/she 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/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

Only one PD/PI may be designated on the application.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. This means that AHRQ will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

A letter of intent is not required for this funding opportunity.

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 FOA.

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, with the following additional instructions:

Budget Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants 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 that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions:

1. The applicant organization or a partner organization must be a health care provider organization or an affiliate of a health care provider organization and serve a significant role in achieving project aims.

2. The application should provide supporting evidence as to how the particular simulation method potentially impacts the safe delivery of health care.

3. The application must identify the issues addressed by the simulation, the setting of care where the simulation will be conducted, the health professional groups involved in the simulation, and the anticipated patient population impacted by the simulation.

4. The application must describe in succinct but sufficient detail the patient safety problem to be addressed by the proposed simulation. This could include the relevant literature with respect to the problem area, as well as anticipated benefits, limitations, conceptual frameworks, scientific, clinical or performance-based significance, and underlying assumptions or boundary conditions of the proposed research.

5. The application must provide clear articulation of the research objectives, the methodology or research design that will be enable the research objectives to be realized, and any associated practical considerations. Where appropriate, the application should include specification of outcome measures, process measures, and formative measures for pilot testing, implementation, adoption, and sustainability. Measures that would be of interest to decision- and policy-makers (e.g., return on investment, cost effectiveness) also should be considered. This section should specify the sampling strategy that identifies the target audience to be sampled, the type of sampling, sample sizes, and any priority populations, conditions, or characteristics that will help inform the reviewers. The design should include milestones and proposed timelines covering all major phases of the project.

6. The application should describe the functions that the simulation performs and major system components that will enable realization of the functions. Where appropriate, the application should describe the clinical, physiological, behavioral, cognitive, visual, auditory, tactile or otherwise unique features that are important. Since simulations often make unique demands on the parent organization, the application should describe the full complement of support requirements for effective and efficient deployment of the simulation, such as space and facilities; computer and technical support; specialized equipment; maintenance; and instructors, schedulers, researchers and training development personnel. It is assumed that the applicant institution has sufficient facilities and simulation equipment for the proposed research and that this will preclude the need for acquisition of major equipment or supply items. Applicant institutions may request no more than 15% of total Federal grant funds for purchasing equipment, hardware, or software in any given year of the project.

7. As appropriate, the applicant is encouraged to formulate an implementation plan which includes the necessary steps, preparations, permissions, approvals, and rehearsals for conducting the simulation. Consider including information on scenario generation, pilot-testing, scheduling of participants, assignment of participants to groups in accordance with the research design, preparation of materials, orientation of participants, briefing and de-briefing procedures, data collection procedures and instruments, training of personnel and data collectors, and any specialized device, mannequin, or ancillary equipment requirements. The plan should describe quality control procedures for ensuring that all components function well together in achieving a smooth implementation of the simulation.

8. As appropriate, the applicant is encouraged to describe how the data are to be collected, coded, stored, and analyzed in terms of descriptive or inferential methods. Any potential limitations, concerns, or anticipated contingency planning with respect to data collection procedures also should be noted.

9. As appropriate, the applicant is encouraged to describe how the project potentially could be integrated into the mainstream clinical environment. Also applicants should consider discussing what can be learned about necessary resource requirements for effective and efficient deployment of the simulation, as well as its longer term sustainability.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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 Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Pre-award costs are allowable. A grantee 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 grantee 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 grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee'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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number 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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH and for responsiveness by AHRQ. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. 42 USC 299(c). Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html. Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

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 may wish to 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.

Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications which is available at (https://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.

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. 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 grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee 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, 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.

Unless otherwise provided in grant awards, AHRQ grantees 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 grantees to publish research results in peer-reviewed journals and to market grant-supported products.

AHRQ requests that grantees notify the Office of Communications and Knowledge Transfer (OCKT) 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 grantees concerning intangible rights and copyright can be found at 45 CFR 75.322.

Applicants are required to follow our Post Submission Application Materials policy.

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:

• Improve health care quality by accelerating implementation of patient-centered outcomes research (PCOR).
• Make health care safer.
• Increase accessibility by evaluating Affordable Care Act (ACA) coverage expansions.
• Improve health care affordability, efficiency, and cost transparency.

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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer 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 FOA will not be reviewed. Only the review criteria described below will be considered in the review process.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD/PI, collaborators, and other researchers well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project?

Is the project original and innovative? For example: Does the project challenge current research or seek to shift clinical practice paradigms; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

Environment

Will the scientific environment contribute to the potential success of the research? Do the proposed studies benefit from unique features of the scientific environment such as equipment, suitable physical facilities, availability of subject populations, or other useful collaborative arrangements?

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

For research that involves human subjects but does not involve one of the six 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 six 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.

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

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements ).

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. The committee will evaluate whether there is an effective and efficient use of project resources, including whether the request for equipment, hardware, or software exceeds 15% of total project costs in any given year of the project.

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not applicable.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group , in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will 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 FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance.

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.

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

If the application is under consideration for funding, AHRQ 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).

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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. See also Section IV.5., Funding Restrictions.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/funding/grant-mgmt/index.html.

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.

A standard term and condition of award will be included in the Notice of Award (NOA) that states: in any grant-related activity in which family, marital, or household consideration are, by statute or regulation, relevant for purposes of determining beneficiary eligibility or participation, grantees must treat same-sex spouses, marriages, and households on the same terms as opposite-sex spouses, marriages, and households, respectively. By same-sex spouses, HHS means individuals of the same sex who have entered into marriages that are valid in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By same-sex marriages, HHS means marriages between two individuals validly entered into in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By marriage, HHS does not mean registered domestic partnerships, civil unions or similar formal relationships recognized under the law of the jurisdiction of celebration as something other than a marriage.

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 grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award. Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Progress reports are due 3 months before the anniversary of the award. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. If applicable, detailed instructions on additional reporting requirements will be provided with the grant award.

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 (http://www.ahrq.gov/fund/hhspolicy.htm). 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 4/30/2015, the annual FFR is due 9/30/2015 (90 days after the end of the calendar quarter of 6/30/2015).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm) for additional information on this reporting requirement.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Email: support@grants.gov

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Kerm Henriksen, PhD
Agency for Healthcare Research and Quality
Center for Quality Improvement and Patient Safety
Telephone: (301) 427-1331
E-mail: Kerm.Henriksen@ahrq.hhs.gov

David Rodrick, PhD
Agency for Healthcare Research and Quality
Center for Quality Improvement and Patient Safety
Telephone: (301) 427-1876
E-mail: David.Rodrick@ahrq.hhs.gov

Direct your questions about peer review issues of grant application made in response to this FOA to:

Andrew Louden
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1183
E-mail: Andrew.Louden@ahrq.hhs.gov

Direct your questions regarding fiscal matters to:

Steven Young
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1458
E-mail: Steven.Young@ahrq.hhs.gov

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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ 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/fund/hhspolicy.htm.