Required Application Instructions

It is critical that applicants follow the instructions in 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 stated in this FOA 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

This initiative will fund a Patient-Centered Outcomes Research (PCOR) Clinical Decision Support (CDS) Learning Network ("PCOR CDS Learning Network"). The overall purpose of the PCOR CDS Learning Network is to engage stakeholders in the use of CDS to disseminate and to implement PCOR findings. By engaging stakeholders, the goal is to work towards CDS as a shareable, sustainable, and useful public resource.

Specifically, the PCOR CDS Learning Network will have the following primary objectives:

• Engage clinicians, patients, professional associations, health IT developers, and other stakeholders who can help promote the incorporation of PCOR findings into clinical practice through CDS;
• Identify barriers and facilitators to the use of CDS as a means to disseminate and to implement PCOR findings in clinical practice; and
• rovide consensus-based recommendations to the field of CDS developers, CDS implementers, and other stakeholders about CDS design and implementation best practices

Section 937(a) of the Public Health Service Act, which was added by the Affordable Care Act, requires AHRQ to broadly disseminate research findings published by the Patient Centered Outcomes Research Institute (PCORI) and other government-funded research relevant to comparative clinical effectiveness research.  AHRQ has specific requirements under Section 937 related to dissemination of PCOR findings and Clinical Decision Support (CDS).  Section 937(b) provides that AHRQ, in consultation with relevant medical and clinical associations, shall assist users of health IT focused on CDS to promote the timely incorporation of research findings disseminated under Section 937(a) into clinical practices and to promote the ease of use of such incorporation.  CDS is also referenced in Section 937(c), which requires AHRQ to establish a process for receiving feedback from physicians, providers, patients, vendors of health IT focused on CDS, and others, about the value of the information disseminated, and the assistance provided, under Section 937.

CDS provides patient-specific information and knowledge, enabled by health information technology (IT), to clinicians, patients, or other individuals to enhance health and health care (Mardon et al, 2014). CDS includes processes and mechanisms that aim to deliver the right information, to the right person, using the right format, in the right channel, and at the right time during workflow (often referred to as the "5 Rights" framework; Osheroff, 2009). Well-implemented, computerized CDS can improve health care processes (Lobach, 2012).

Incorporation of PCOR findings into clinical practice using computerized CDS builds on a complex array of activities. These activities include generation of scientific evidence (the PCOR itself), synthesis and review of the scientific evidence, development of evidence-based clinical practice guidelines, development and testing of CDS, improved clinical decision-making, and assessment of clinical performance using tools such as clinical quality measures. Further, much of the information that supports dissemination of best clinical practices appears in prose, narrative-based form. Transformation of evidence-based clinical practice guidelines into CDS, for example, involves a multi-step translation of guideline recommendations from their narrative form into semi-structured and semi-formal forms that are machine-interpretable (Mardon et al, 2014).

Semi-structured and semi-formal forms of CDS build upon health IT standards such as the Guideline Elements Model (Shiffman, 2000), Arden Syntax (see http://www.hl7.org/special/Committees/arden/index.cfm), and more recently, Health eDecisions. Further, efforts are currently underway to harmonize CDS standards with standards for electronic clinical quality measurement. Harmonized CDS and quality measurement standards would ideally make for more efficient and more consistently-implemented health IT designed to drive quality improvement (ONC, 2014). Information about efforts to harmonize and to build on health IT standards for CDS and for quality measurement can be found here:

• The Clinical Quality Framework (CQF) Initiative (http://wiki.siframework.org/Clinical+Quality+Framework+Initiative)
• US Health Information Knowledgebase (http://ushik.ahrq.gov)
• HealthIT.gov (http://healthit.gov/)
• The electronic Clinical Quality Improvement (eCQI) Resource Center (http://healthit.gov/ecqi-resource-center/)

The PCOR CDS Learning Network represents an integral component of AHRQ's PCOR CDS initiative, which as a whole will fulfill AHRQ's aims to increase the incorporation of PCOR findings in clinical practice through CDS. More information about AHRQ's PCOR CDS initiative can be found in the following notice: NOT-HS-15-010 .

The PCOR CDS Learning Network is intended to be a vibrant community of researchers and other stakeholders who are driving the field of CDS forward together. The field of CDS, as an area of scientific research, is evolving rapidly. The PCOR CDS Learning Network will be an agile partner that can identify the issues most important to the field, can bring together the most forward-thinking researchers and implementers, and can return those recommendations to the field with the highest chances of uptake. Additional information regarding the scope of each of the primary objectives follows:

1) Engage stakeholders who can help promote the incorporation of PCOR findings into clinical practice through CDS. Stakeholders would include but not be limited to:

• Medical and other clinical associations (e.g., professional societies)
• Clinicians (e.g., physicians, nurses, allied health professionals)
• Health care providers (e.g., hospitals, care delivery organizations)
• Patients and their families
• Vendors of health information technology, including those focused on CDS
• Federal and private health plans

Additional categories of stakeholders relevant to CDS and health IT, which in some cases may overlap with other categories, would include CDS developers (e.g., knowledge managers/translation professionals), CDS implementers (e.g., clinical information systems professionals), health IT management organizations or networks (e.g., regional extension centers, Health Center-Controlled Networks funded by the Health Resources and Services Administration), quality improvement organizations, and academic researchers devoted to CDS.

A successful PCOR CDS Learning Network will engage with and build upon ongoing efforts to harmonize Health Level 7 (HL7) standards for both CDS and for electronic clinical quality measurement. Information about these efforts can be found through the Clinical Quality Framework (CQF) Initiative (see http://wiki.siframework.org/Clinical+Quality+Framework+Initiative).

2) Identify barriers and facilitators to the use of CDS as a means to disseminate and to implement PCOR findings in clinical practice. Computerized CDS should be well-integrated into clinical workflow and represents one set of tools that a practice or organization may deploy to improve quality of care. A successful PCOR CDS Learning Network will identify the factors that can serve as barriers to or can promote CDS as a useful tool to improve care.

3) Provide consensus-based recommendations to the field of CDS developers, CDS implementers, and other stakeholders about CDS best practices. Given the large number of stakeholders that are relevant to the use of CDS as a means to incorporate PCOR findings in clinical practice, there will be a need to share perspectives and to learn from each other. A successful PCOR CDS Learning Network will provide a community for discussions to take place, will establish a process through which best practices for developing, implementing, and scaling CDS can be identified and recommended, and will provide a mechanism through which best practices can be disseminated with the highest chances of uptake among stakeholders. The PCOR CDS Learning Network must develop and maintain an online resource for sharing among stakeholders and for disseminating lessons learned to the public.

Lobach D, Sanders GD, Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian
L, Coeytaux R, Samsa G, Hasselblad V, Williams JW, Wing L, Musty M, Kendrick AS.
Enabling Health Care Decisionmaking Through Clinical Decision Support and Knowledge
Management. Evidence Report No. 203. (Prepared by the Duke Evidence-based Practice Center
under Contract No. 290-2007-10066-I.) AHRQ Publication No. 12-E001-EF. Rockville, MD:
Agency for Healthcare Research and Quality. April 2012. Available from http://www.effectivehealthcare.ahrq.gov/ehc/products/278/919/EvidenceReport203_Enabling-Health-Care-Decisionmaking_20120604.pdf

Mardon R, Mercincavage L, Johnson M, et al. Findings and Lessons From AHRQ’s Clinical Decision Support Demonstration Projects. (Prepared by Westat under Contract No. HHSA 290-2009-00023I). AHRQ Publication No. 14-0047-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2014.

Office of the National Coordinator for Health Information Technology (ONC), "Health IT Enabled Quality Improvement: A Vision for Better Health and Health Care", November 2014.

Osheroff JA, ed. Improving medication use and outcomes with clinical decision support: a step-by-step guide. Chicago, IL: HIMSS, 2009.

Shiffman RN, Karras BT, Agrawal A, Chen R, Marenco L, Nath S. GEM: a proposal for a more comprehensive guideline document model using XML. J Am Med Inform Assoc. 2000 Sep-Oct;7(5):488 498.

42 U.S.C. 299b-37 (a) - (c) authorizes AHRQ to make these awards to support the agency's dissemination of comparative clinical effectiveness research findings.

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.ahrq.gov/funding/policies/hhspolicy/index.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;
• For-profit private institution;
• 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)

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 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 Director/Principal Investigator (PD/PI)

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 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.

The PD/PI is required to devote a minimum of 20% annual full-time effort (i.e. at least 8 hours per week) in each year of the project.

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 Notice NOT-OD-14-074).

Applicants must download 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 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.

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 IC 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(s), address(es), and telephone number(s) 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 sent by email to:

Amy Lindinha
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Specific Aims is limited to 1 page
• Research Strategy section is limited to 12 pages
• Evaluation is limited to 2 pages
• Sustainability is limited to 2 pages

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. Research team members must describe their proposed role and why their experience and qualifications make them well-suited for this role in the Personal Statement section of their biographical sketch.  For proposed research team members for whom biographical sketches are not required, grant applications must describe in the Budget Justification their proposed role and why their experience and qualifications make them well-suited for this role .

Key personnel of the project team must collectively have expertise in the following areas:

• Clinical informatics
• Evidence-based clinical practice
• Convening and partnering with stakeholder organizations such as professional clinical associations, patient/consumer associations, and vendors of health information technology
• Patient-centered outcomes research
• System design
• Health IT standards
• Health communication

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:

Applicants should describe their approach to creating the PCOR CDS Learning Network and how the approach will lead to a vibrant, collaborative community for discussing and disseminating how PCOR findings can be incorporated into clinical practice through CDS. Applicants may wish to learn about the Electronic Data Methods (EDM) Forum as a similar community focused on the use of electronic health data for research and quality improvement (see http://www.edm-forum.org/home).

Research Strategy:

In describing the approach to meeting the primary objectives of the PCOR CDS Learning Network, applicants must address the following elements:

1) Engaging stakeholders who can help promote the incorporation of PCOR findings into clinical practice through CDS.

• How key stakeholders would be identified and engaged to participate in the PCOR CDS Learning Network. Applicants should propose key participating stakeholders (e.g., medical and other clinical associations, health care providers, patients/families, and vendors of health information technology focused on clinical decision support), and include letters of support from any key stakeholders who have been identified prior to application submission and have agreed to participate.
• How stakeholders would be convened (e.g., method[s], process, timeline, and logistics) to create meaningful, productive, and efficient interactions
• How different stakeholder perspectives can be recognized, integrated, and potentially reconciled with each other so that meaningful and actionable recommendations can be identified and taken up by all stakeholders
• How the PCOR CDS Learning Network will engage with and build upon ongoing efforts to harmonize Health Level 7 (HL7) standards for both CDS and for electronic clinical quality measurement. Information about these efforts can be found through the Clinical Quality Framework (CQF) Initiative (see http://wiki.siframework.org/Clinical+Quality+Framework+Initiative).

2) Identifying barriers and facilitators to the use of CDS as a means to disseminate and to implement PCOR findings in clinical practice.

• How key issues in the use of CDS as a means to disseminate and to implement PCOR findings in clinical practice will be identified
• How challenges (and solutions to those challenges) to the use of CDS will be identified
• How factors that can promote CDS as a useful tool to improve care will be identified

3) Providing consensus-based recommendations to the field of CDS developers, CDS implementers, and other stakeholders about CDS best practices.

• How findings from the PCOR CDS Learning Network will be synthesized into useful products for dissemination
• What specific vehicles/mechanisms will be used to disseminate products of the PCOR CDS Learning Network
• How dissemination activities will lead to greater uptake of PCOR findings in clinical practice. Applicants should consider working with eGEMS, the publication of the Electronic Data Methods (EDM) Forum (see eGEMS Web site here: http://repository.academyhealth.org/egems/) as a mechanism for disseminating generalizable lessons learned.
• How the PCOR CDS Learning Network will work collaboratively with other components of AHRQ's PCOR CDS initiative

Evaluation:

Applicants should address how the PCOR CDS Learning Network will evaluate its impact on the use of PCOR findings in clinical practice. Note that the successful applicant must be prepared to also collaborate with an external evaluator (e.g., a contractor or another grantee) tasked with evaluating AHRQ's overall PCOR CDS initiative.

Sustainability:

Applicants should describe their approach for how the PCOR CDS Learning Network may be sustained beyond the project period.

Letters of Support:

Applicants should include letters of support from stakeholder organizations (e.g., professional medical societies, patient/family representative organizations, provider organizations) who have agreed to participate in and collaborate as part of the PCOR CDS Learning Network.

Letters of support, recommendation or endorsement should NOT be included from any entity or individual who is not directly participating in the PCOR CDS Learning Network. These types of letters may impede the review and/or selection process.

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

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

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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, the electronic system for grants administration. eRA Commons 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late and may not be accepted.

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 not allowable without AHRQ prior approval.

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.

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 by the Center for Scientific Review, NIH, and for responsiveness by AHRQ. Applications that are incomplete, non-compliant, or non-responsive will not be peer 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.

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 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 [email protected] at least four to six weeks in advance of the journal’s expected publication date. 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).

The PD/PI is required to devote a minimum of 20% annual full-time effort (i.e. at least 8 hours per week) in each year of the project

The PD/PI will be expected to meet with AHRQ program staff by teleconference on at least a monthly basis at mutually agreeable times.

The PCOR CDS Learning Network will be expected to collaborate with other grantees and/or contractors taking part in AHRQ's overall PCOR CDS initiative, including an external evaluator of the entire AHRQ PCOR CDS initiative.

Applicants should anticipate that some dissemination activities will be conducted in cooperation with AHRQ contractors responsible for monitoring project progress and/or updating content on the Health IT Web site, http://healthit.ahrq.gov. Awardees are required to cooperate fully with AHRQ staff and contractors in promoting their work and findings. Activities that the awardee may engage in with AHRQ contractors for the duration of the grant may include:

• Reviewing a project description or profile that a contractor develops for publication on the Health IT Web site and providing timely feedback;
• Providing brief, high-level quarterly updates on the progress of the grant; and
• Sharing information on any grant outputs (e.g., publications, survey instruments) for inclusion in AHRQ output repositories, as appropriate, so that the contractor(s) can update the project profile on an annual basis.

The PCOR CDS Learning Network will be expected to develop and maintain an online resource (e.g., website with appropriate functionality) that would allow participating stakeholders to participate in group discussions and to provide feedback. The online resource will also be used to publicly disseminate findings and lessons learned from the PCOR CDS Learning Network as appropriate.

Applicants should budget for one in-person, annual meeting to convene the PCOR CDS Learning Network and stakeholders in the Washington, D.C. area in each year of the grant. The PD/PI must attend these meetings.

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, are currently required to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). PRA review and approval is required in cooperative agreements if AHRQ has significant input or control over the data collection activity. Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least six months from date of initial submission to AHRQ to receive clearances ,and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until grantees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

Grantees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information

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 by its nature is not innovative may be essential to advance a field.

• Will this project lead to sustained change in clinical practice as a result of the community it develops, its engagement of stakeholder organizations, and its dissemination activities?
• Are the proposed participating stakeholder organizations likely to have significant influence and wide impact on the uptake of PCOR findings in clinical practice through CDS?
• Will the approach to engaging stakeholders and identifying barriers and facilitators to effective CDS implementation lead to meaningful and actionable recommendations for all stakeholders?
• Will this project build upon ongoing efforts to harmonize Health Level 7 (HL7) standards for both CDS and for electronic clinical quality measurement?

• Is the work proposed appropriate to the experience level of the PD/PI and other researchers?
• Are the leadership approach, governance, and organizational structure appropriate for the project?
• Does the project team include the required areas of expertise, including:
  • Clinical informatics;
  • Evidence-based clinical practice;
  • Convening and partnering with stakeholder organizations such as professional clinical associations, patient/consumer associations, and vendors of health information technology;
  • Patient-centered outcome research;
  • System design;
  • Health IT standards; and
  • Health communication?
• Is the PD/PI devoting a minimum of 20% annual effort in each year of the project?

• Does the project represent an innovative community of stakeholders?
• Are the methods proposed to synthesize the discussions innovative?
• Are the methods proposed to disseminate generalizable lessons learned and recommendations to the field innovative?

• Will the approach lead to meaningful, productive, and efficient interactions among stakeholders?
• Will factors that can promote CDS as a useful tool to improve care, including challenges and solutions to those challenges, be identified?
• Will findings be synthesized into useful products for dissemination, and are the dissemination activities likely to lead to greater uptake of PCOR findings in clinical practice?
• Is the proposed self-evaluation appropriate, and will it assess the PCOR CDS Learning Network's impact on the use of PCOR findings in clinical practice?
• Are potential problems and alternative strategies presented?

• Does the applicant have the capability to successfully convene the wide range and number of stakeholders related to PCOR and CDS?
• Are the collaborative arrangements with the proposed stakeholder participants adequate?
• Is the applicant committed to working collaboratively with other components of AHRQ's PCOR CDS initiative?
• Are the institutional support, equipment and other physical resources available to the investigators adequate for the project 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.

• Is the scope of the approach based on disseminating and implementing PCOR findings (as opposed to findings from other types of research)?
• Is the sustainability plan adequate? Is it realistic?

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.

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 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. 

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). 

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/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 referenced 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.

Cooperative Agreement Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the award statement and will be provided to the grant recipient at the time of award.

Terms and Conditions of Cooperative Agreement Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines: DHHS grant administration regulations at 45 CFR Parts 75, and other DHHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering the cooperative agreements under this FOA.

The administrative and funding instrument used for this program is the cooperative agreement. A cooperative agreement is an "assistance" mechanism (rather than an "acquisition mechanism), in which substantial AHRQ programmatic involvement with the grantees is anticipated during the performance of the activities. Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the grant recipient and the PD/PI for the project as a whole, although specific tasks and activities may be shared between the grantee and AHRQ as described in this subsection of the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by AHRQ.

Program Director/Principal Investigator (PD/PI) Rights and Responsibilities
The grant recipient and PD/PI will be responsible for complying with all the terms and conditions of the Notice of Award. The PD/PI will provide oversight of the PCOR CDS Learning Network. The PD/PI may be asked to serve on work groups that will be convened as part of AHRQ's overall PCOR CDS initiative. The PD/PI will be expected to meet with AHRQ program staff by teleconference on at least a monthly basis at mutually agreeable times.

In addition to the annual progress report, the grantee is required to submit quarterly progress reports to AHRQ. Instructions on reporting requirements will be provided with the grant award.]

AHRQ Responsibilities
AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

[Through the Program Official (PO) or his/her designee, AHRQ will be substantially involved in the following areas:

• Attending learning network meetings and helping to set meeting agendas
• Helping to identify the CDS issues that will be addressed and discussed by the learning network. The learning network is just one component of AHRQ’s larger PCOR CDS initiative. As those other components build, test, disseminate, and/or evaluate CDS, AHRQ expects to generate ideas for discussion that would be well-suited for the learning network.
• Helping to identify stakeholder perspectives to be included in the learning network.
• Informing the learning network of relevant and ongoing efforts to incorporate health IT standards into CDS

The PO will be as informative as possible in terms of facilitating collaboration between the PCOR CDS Forum and other components of AHRQ's PCOR CDS initiative that have yet to be awarded or implemented.

Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Collaborative Responsibilities

The grantee should be prepared to collaborate with an external entity (e.g., another grant or contract) tasked with evaluating AHRQ's PCOR CDS initiative as a whole.

In addition to the annual progress report, the grantee is required to submit quarterly progress reports to AHRQ. The reports will cover but not necessarily be limited to a summary of the activities of the PCOR CDS Learning Network, synthesis of stakeholder discussions, description of how discussions are being translated into disseminated products, and discussion of how the ongoing work of the PCOR CDS Learning Network could be improved. Further instructions on the format and requirements for quarterly reports will be provided after award.

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.

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 date of the 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 4/30/2016, the annual FFR is due 9/30/2016 (90 days after the end of the calendar quarter of 6/30/2016).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required once 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: http://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 CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Direct your questions about general FOA issues, including information on the inclusion of priority populations to [email protected]. 

For reasons of equity and consistency, all scientific/research (program related) inquiries pertaining to general FOA issues must be submitted, and will only be answered, via email. A compilation of frequently asked questions and answers will be posted at: http://www.ahrq.gov/funding/fund-opps/index.html.

Amy Lindinha
Division of Health Information Technology
Center for Evidence and Practice Improvement (CEPI)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Email: [[email protected]

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

Nghia Vo
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1191
Email: [email protected]

Direct your questions regarding fiscal matters to:

Kathryn Carr
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1025
Email: [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. This award is made pursuant to AHRQ's authority to support the dissemination of comparative clinical effectiveness research findings, 42 U.S.C. 299b-37(a) -(c), in accordance with the statutory requirements generally applicable to research supported under Title IX of the Public Health Service Act, 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.