Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: AHRQ is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate AHRQ/NIH's multi-project programs. See NOT-OD-13-075 and  NIH's Applying Electronically website for more information.

Part 1. Overview Information
Part 2. Full Text of 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

The progress cited in the patient safety literature during the past 15 years bears witness to the commitment, intellectual vigor, and skillful execution of many individuals and organizations in reducing harms to patients and creating safer health care environments. Well known to the patient safety community are the improved understanding and advances that have been made in infection control, medication safety, health information technology (IT), teamwork, patient safety culture, patient engagement, facilities design, clinical process redesign, simulation and training, and evidence-based tools.

As editorials in the patient safety literature have noted, no one is completely satisfied with the extent of progress. As fine as the achievements have been, they remain, for the most part, individual achievements and not the norm. Much of the progress has been on egregious and amenable threats to patient safety and has occurred at well-resourced and culturally receptive institutions. Further efforts are needed for improvements to be more widespread and better integrated into the fabric and structure of clinical work. The present FOA provides an opportunity to be more proactive, to envision the quality and safety of care that patients and providers would like to have, and to test innovative designs that have the potential to alter the status quo and shape a safer future rather than simply add a new patient safety practice on top the existing system.

Despite the eager endorsement about systems thinking by many health care advocates, there has been a scarcity of effort in actually incorporating systems principles, engaging the design and engineering disciplines in patient safety projects, and partnering with progressive sectors of the economy and other hazardous industries to realize new insights, and robust approaches. In 2005, the National Academy of Engineering and the Institute of Medicine drew from the combined talent in the engineering and health care communities to produce a consensus report and collection of papers entitled Building a Better Delivery System A New Engineering/Health Care Partnership. Despite the carefully crafted recommendations and thoughtful papers, its impact has been limited. In 2014, the President's Council of Advisors on Science and Technology (PCAST) issued a report calling for accelerated improvement in health care delivery and lower costs through systems engineering (Report to the President: Better Health Care and Lower Costs: Accelerating Improvements through Systems Engineering).

Safe and high quality health care depends on a number of system components and their interactions, aligned purposefully to achieve common safety and quality of care goals. Various socio-technical system models have been applied to health care, illustrating that changes to any of the components will have repercussions on other components in the system. In our open health care system, each system level subsumes lower systems and, in turn, gets subsumed by higher systems. While isolated safety gains have been made within system levels, it is recognized that broader patient safety advances likely will depend on the purposeful integration and alignment of subsystem components that interact across -- and up and down -- system levels.

In recognizing both the successes and limitations of patient safety efforts thus far, there remains a need to create opportunities for new ways of thinking and learning, and for fresh approaches that can be tested, revised and further developed when considered promising. As conceived in this FOA, learning laboratories are places and professional networks that allow multidisciplinary teams to identify closely related threats to patient safety, stretch professional boundaries, envision bold design innovations, and take advantage of brainstorming and rapid prototyping techniques that other leading-edge sectors of the economy employ. Further, opportunities are needed to refine promising design interventions by engaging in multiple develop-test-revise iterations as occur in systems engineering projects. The ultimate goal of the Learning Laboratories is to test the integrated system in simulated clinical settings or in the context of actual clinical settings. Applicants that focus upon significant related patient safety harms while simultaneously addressing frequent and high-cost care that occurs in under-resourced communities are also welcomed.

Applicants will identify and propose two to four closely related projects for which new and innovative approaches are needed. Given the intent of closely related efforts to have synergistic impacts, more than a singular patient safety issue or harm needs to be addressed. Greater improvements and system-wide effects are likely to be realized when two or more projects or subsystems are purposefully designed and integrated into a working system to enhance overall safety and quality for patients, providers, family members and other caregivers alike. Consider the opportunity to redesign and create a new emergency department or primary care office. What are the two or more projects that multidisciplinary teams could embark upon to address several patient harms? Foremost, the design of unit floor plans, patient rooms, storage areas, and equipment should be based on the activities and needs of patients, family members, and providers, rather than assuming the humans in the system simply will adapt to what is provided. In brief, competitive applications are likely to be those that tailor the design of facilities and workflow to the needs of people as they interact with devices, technology, and other physical features of the care environment.

While the areas of patient safety harms to focus upon are to be determined by the applicant, AHRQ foresees the need for a flexible and broadly defined methodology or approach that provides some rudimentary structure to the design and development projects to be undertaken. At a high level of abstraction, the following five phases provide a reasonable parallel or approximation to the successive phases that larger-scale design innovation and system engineering projects entail. In the interest of using terminology more familiar to the health care research community, the following terminology is used.

• Problem analysis
• Design
• Development
• Implementation
• Evaluation

Problem Analysis

Conduct problem analyses on two to four related areas of patient safety concern that the projects will address. Defining the problem thoroughly provides the foundation upon which all subsequent efforts are based. Yet, doing a problem analysis is where many projects start to fail from the outset. It is not uncommon that the wrong problem is solved, that the problem is defined in terms of a proposed solution, that the big picture or system perspective is missed, or that insufficient time and resources are given to the analyses, resulting in an insufficient understanding. It is important to identify all stakeholders who are directly or indirectly involved in the system. The problem analysis phase will likely entail repeated trips to the clinical setting where records, reports, risk assessments, and relevant documents can be reviewed, where clinical processes and procedures can be observed, where equipment and technology can be examined, and where front-line staff and unit leaders can be interviewed. Project teams need to learn about the needs of providers and preferences of patients and other social-technical factors (e.g., facility design features, equipment and technology, work processes and flow, and organizational, cultural, and contextual characteristics) that shape the clinical experience.

The problem analysis enables the team to set clear and specific goals that are based on patient harms and departures from quality care. Clear and specific goals are needed to bound and scope the problem, to inform metrics that will be used subsequently to verify system performance, and to give the team a purposeful sense of direction. In brief, the two to four areas of patient safety concern for which problem analyses are conducted provide the foundation for the two to four projects, which in turn, can be viewed as defining the two to four subsystems that will be developed, integrated, implemented and evaluated as an overall working system for enhancing patient safety.

Design

Create high level design for the two to four projects. Establishing design objectives is another early and critical phase of the projects to be undertaken. It is here that different stakeholders state their objectives or requirements for the system; in other words, what they need to accomplish with the new system as informed by the problem analysis, goals, and the necessary tasks performed in their own domains. In high level design, the idea is to take advantage of brainstorming sessions to generate ideas with impact. Be open to looking outside the orthodoxy of one's own discipline for new ideas. Make a serious effort to capture differing perspectives from other professions. Take advantage of the techniques that many leading design firms use such as brainstorming, living in the future, rapid prototyping, physical mock-ups, storyboarding or other methods to arrive at high level capabilities of the system. Engage in the exploratory develop-test-revise iterations of rapid prototypes to facilitate new design thinking. In addition to exploratory develop-test-revise iterations, design also includes development of a feasible evaluation plan or scheme that provides a way of determining which designs are likely to hold promise and deserving of subsequent development and which are not.

Create detailed designs in the two to four projects. Setting design objectives starts at a broad or relatively high level and then becomes more specific and detailed. Detailed design lends greater specificity to the high level capabilities in terms of mapping out the core and interdependent functions of the system along with inputs and expected outputs. Utilizing block and flow diagrams, computer models, prototype graphical user interfaces, and other tools, design teams lend greater specification to the allocation of functions to humans, hardware and software. Needs for standardization, interoperability, and redundancy within critical parameters are noted. End user needs and usability considerations should inform the design process. Plans for integrating the two to four projects or subsystems to achieve greater system-wide effects need to be formulated during this phase as well.

Development

Select the most promising patient safety designs for full scale development of the two to four projects. Specific development activities depend, in large measure, on the system under development. During this phase, a considerable amount of iterative testing and evaluation of subsystem components with representative users can be expected. The multidisciplinary team of clinicians, architects, designers, engineers, human factors specialists, and end users working together will help ensure not only that system requirements and design specifications are fulfilled, but human considerations in terms of cognitive, perceptual and physical capabilities of patients and providers also are taken into account. As the clinical processes, software and hardware components are created, acquired and tested, the interdependent subsystems undergo further formative testing with small groups of representative users for the purpose of improving their effectiveness and working relationships. At the same time, the selection of subsystems for development and integration has considerable impact on the very real constraints of time, resources and budget. While system development projects proceed in a phase-based forward moving direction, the repeated develop-test-revise iterations in conjunction with new insights and practical constraints may necessitate a two-steps forward, one-step backward progression where previous requirements and functions arrived at in the design phase may need redefinition. It is less costly in terms or resources encumbered to make changes at the earlier phases of design rather than proceed through development and then make the changes. Gaining a better understanding of the trade-offs and need for revision in some requirements and functions is part of the learning process; however, the end goal of the development phase is the integration of the closely related projects or subsystems into an overall working system.

Implementation

Implement overall system in simulated or clinical setting. Given completion of the development phase, the implementation phase affords the opportunity to evaluate the full and integrated complement of facility design features; equipment, tools and technology; new tasks, procedures and workflow patterns; provider personnel; patients and family members; and, organizational policy and contextual variables all functioning together. The implementation phase can be considered a full dress rehearsal to discover what is missing or has not been considered. What are the "bugs and glitches" that still need to be addressed? By using predefined metrics derived from earlier stated goals and evidence-based practices, the project team should be able to verify whether the integrated system is working as intended. Testing the integrated system in this fashion will reveal many important socio-technical factors that may have been unrecognized and neglected. Of concern are any system vulnerabilities or unintended consequences that may expose patients to new harms and that further the work burden of providers. Full-dress rehearsal testing continues until a point of diminishing returns is reached for discovering and correcting system vulnerabilities.

Evaluation

Develop an evaluation plan for the integrated system and conduct the evaluation. After the integrated system has undergone implementation testing and further improvement, it is installed in the actual clinical or simulated setting where its effectiveness can be more rigorously evaluated under realistic conditions. As will be relevant to the particular projects proposed, the plan needs to take into account the simulated or actual clinical sites utilized; the overall methodology; the extent and associated timelines of the evaluation; specific patient safety process and outcome measures to be captured; system performance metrics; safeguards for ensuring data reliability, confidentiality, and anonymity of subjects/units; any sampling and recruitment strategies; roles served by research, data collection, technical, and provider personnel; interface design, usability, and related human factors and work-systems issues identified; agreements reached with host site; equipment, tools, supplies to be utilized; organizational constraints; data analysis methods anticipated; and any travel or logistical needs identified. The conduct of the evaluation of the integrated system should be of sufficient scope and duration to enable a full and realistic assessment.

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 the Office of Management and Budget's (OMB's) "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards," (the "Uniform Grant Guidance") at 2 CFR part 200, et seq, the HHS Grants Policy Statement (see http://www.hhs.gov/asfr/ogapa/aboutog/grantsnet.html and http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

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;
• Units 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.

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 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.

Because the FOA is intended to improve healthcare delivery systems, organizational entities that are not health care provider organizations must have a provider organization that is actively engaged in the delivery of health care as a participating partner in the proposed project. For purposes of this FOA, a health care provider organization is defined as any organization engaged in the direct delivery of care to patients in any setting, including but not limited to, in-patient, out-patient or ambulatory centers, community health centers, emergency medical centers, laboratories, diagnostic centers, pharmacies, blood centers, long term care, and/or home care.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 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.
• 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.

Program Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account.  The PD/PI should work with the 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 NIH support.

Investigators must demonstrate knowledge of the patient safety domain and the ability to solicit and be open to new ideas from trans-disciplinary teams, and demonstrate leadership experience in the execution and integration of multiple projects to their successful completion.

A minimum of 15% effort in each given year of the project must be devoted to the Laboratory by the PD/PI. 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 the AHRQ will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
• In addition, AHRQ will accept submission:
• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid;

or

• Of an application with a changed grant activity code.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS 398 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.

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:

• Descriptive title of proposed activity
• Name, address, and telephone number of the PD/PI
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be emailed to:

Kerm Henriksen, Ph.D.
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Kerm Henriksen, Ph.D.
Agency for Healthcare Research and Quality
540 Gaither Road
Center for Quality Improvement and Patient Safety
Rockville, MD 20850
Telephone: 301-427-1331
Email: [email protected]

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

• Overall Core Component: 6 pages
• Administrative Core Component: 6 pages
• Project Core Component: 12 pages per project

Optional consideration: If there are additional core components within or across projects, applicants must complete a Research Strategy section for each (not to exceed six pages each) and submit separate detailed budgets and budget justifications.

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall Component
• Administrative Core Component
• Project Core Component
• Any additional cores

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Budget Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should 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 PHS 398 Application Guide. Applications submitted in the Modular format will not be reviewed.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:

The research team must identify specific aims for each proposed project.

Research Strategy:

Research Strategy: Applications must include problem analysis, design, development, implementation and evaluation as critical components of their proposed project. Applications must also explicitly address facility design, equipment, people (patients, family members, and providers), new procedures and workflow, and organizational contextual features in the approach. As appropriate, applications should involve an administrative and coordination function to ensure purposeful integration and overall system integrity for multiple projects or sub-systems.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Core or Project)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, (Core or Project)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Core or Project)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget and budget justification for Initial Budget Period (for Each Core or Project)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget and budget justification for each future year of support requested (for each Core or Project)

Use Form Page 4 for EACH future year detailed budget.

A core function that addresses the logistical, administrative and other related coordination for this grant must be represented in the most efficient manner possible. Any request for resources related to project coordination and management must be well justified.

Biographical Sketch (Each Core or Project)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Each Core or Project)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Each Core or Project)

All instructions in the PHS 398 Application Guide must be followed.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered "on-time" is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH's electronic system for grants administration.

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 not allowable without AHRQ prior approval.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email [email protected] 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 http://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.

The Learning Laboratory must have a statement of its purpose and mission that includes an on-going institutional commitment that satisfies all phases of the multiple system project.

The PD/PI of the Learning Laboratory must be identified and be responsible for the combined planning, technical, financial and administrative functions of the grant. A minimum of 15% effort in each given year of the project must be devoted to the Laboratory by the PD/PI, supported either through the grant or provided "in-kind." If "in-kind," a letter of support from an appropriate person in the institution is required.

A concise management plan needs to be provided that describes how the quality, timeliness, and within-budget performance of the projects will be ensured, but also procedures that will be followed for communicating, coordinating , and keeping members of the related patient safety projects well informed. Also describe outreach efforts for soliciting advice or feedback from expertise accessible from distributed networks.

Describe the facilities, spaces, environments, any specialized equipment or other forms of institutional support that will uniquely enable all phases of the proposed effort to be successfully realized.

Funds requested for equipment, hardware, and software must be clearly identified and well justified. In no case should these costs exceed 20% of the total project period budget.

Applicants should budget for two key members of the Laboratory to travel to Washington, DC each year to meet with AHRQ staff, other Laboratory members, and any invited guests for a full day meeting to inform participants of progress and accomplishments, discuss anticipated directions and approaches, and expand opportunities for further learning.

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 http://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.

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's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the Uniform Grant Guidance(available in libraries and on the website of the Office of the Federal Register at https://www.federalregister.gov/articles/2013/12/26/2013-30465/uniform-administrative-requirements-cost-principles-and-audit-requirements-for-federal-awards).

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 is highly innovative might come from an under-resourced scientific environment.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PI, collaborators, and other researchers appropriately trained and 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 leadership approach, governance and organizational structure appropriate for the project?

Does the investigative team include appropriate expertise (e.g., clinicians, architects, designers, engineers, human factors specialists, end users, and other appropriate personnel) to accomplish the proposed research objectives. Does the PD/PI have at least 15% minimum effort in each given year of the project?

Innovation

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?

Approach

Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are benchmarks for success presented?

Does the approach specifically describe the phases of problem analysis, design, development, implementation and evaluation? As appropriate, does the approach explicitly address: facility design, equipment, people (patients, family members, and providers), new procedures and workflow, and organizational contextual features?

Environment

Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Are the institutional support, equipment and other physical resources available to the investigators adequate for the projects proposed?

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

Protections for Human Subjects

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.

Degree of Responsiveness

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?

Inclusion of Priority Populations

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").

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable and whether the requested period of support is appropriate in relation to the proposed research.

Privacy and Security Protections for Patients

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

Not Applicable

Renewals

Not Applicable

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 initial merit review, all applications will:

- Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score

- Receive a written critique

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 portfolio priorities, as well as overall programmatic balance and geographic balance among applications submitted to this RFA and RFA-HS-14-005.

In order to assess progress in grant year 3, AHRQ will conduct a program review of the year 4 non-competing continuation applications funded under this FOA. Year 4 funding will be contingent on successfully demonstrating progress toward stated aims. Given sufficient and approved progress made in the first three years of the grant, awardees' plans for year 4 should focus on conducting an evaluation of the implemented and integrated system in the actual clinical or simulated setting where its effectiveness can be rigorously determined under realistic conditions.

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. 

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" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

Once all administrative and programmatic issues have been 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/fund/postawrd.htm#terms.

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, 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 final 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."

A standard term and condition of award will be included 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 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, grantees are required to submit the Research Performance Progress Report (RPPR) 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.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

Email: [email protected]

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

Kerm Henriksen, Ph.D.
Agency for Healthcare Research and Quality
Center for Quality Improvement and Patient Safety
Telephone: (301) 427-1331
Email address: [email protected]

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
Email address: [email protected]

Direct your questions regarding fiscal matters to:

Anna Caponiti
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1402
Email address: [email protected]

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 the OMB Uniform Grant Guidance 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.