Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy; if this is the case, page limits are indicated within the individual FOA. AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at http://www.ahrq.gov/funding/policies/foaguidance/index.html

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)

Funding Opportunity Title

Scaling Established Clinical Decision Support to Facilitate the Dissemination and Implementation of Patient-Centered Outcomes Research Findings (R18)

Activity Code

R18 Research Demonstration and Disseminations Projects

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

PA-16-283

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.226 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites R18 grant applications for research projects to scale and spread existing clinical decision support (CDS) to facilitate the dissemination and implementation of findings from Patient-Centered Outcomes Research (PCOR) into clinical practice.  The purposes of this FOA are to extend the implementation ("scale") and evaluation of well-established and effective CDS beyond the initial clinical setting or institution in which the CDS was originally developed and implemented, thereby extending the impact on clinical practice.

Key Dates

 

Posted Date

May 23, 2016

Open Date (Earliest Submission Date)

August 25, 2016

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

 Not Applicable.

Scientific Merit Review

 Generally, four months after receipt date.

Advisory Council Review

 Not applicable

Earliest Start Date

Generally, four months after peer review date.

Expiration Date

New Date March 20, 2017 per issuance of NOT-HS-17-009. (Original Expiration Date: January 26, 2018)

Due Dates for E.O. 12372

Not Applicable

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 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.


Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) invites R18 grant applications for research projects to scale and spread existing clinical decision support (CDS) to facilitate the dissemination and implementation of findings from Patient-Centered Outcomes Research (PCOR) into clinical practice.  The purposes of this FOA are to extend the implementation ("scale") and evaluation of well-established and effective CDS beyond the initial clinical setting or institution in which the CDS was originally developed and implemented, thereby extending the impact on clinical practice. 

Background

AHRQ has specific requirements under Section 937 of the Public Health Service Act related to the dissemination of PCOR findings and CDS.  Section 937(a), 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. 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 information technology (IT) focused on CDS, and others, about the value of the information disseminated, and the assistance provided, under Section 937.

PCOR is comparative clinical effectiveness research of the impact on health outcomes of two or more preventive, diagnostic, treatment, or health care delivery approaches. This definition is based on section 6301(a) of the Patient Protection and Affordable Care Act of 2010. PCOR produces not only clinical findings (e.g., diuretics are superior to angiotensin-converting enzyme inhibitors and biologic agents in the management of patients with Crohn's disease), but also evidence about the effectiveness of health care delivery. Examples of PCOR findings can be found in, but are not limited to, the following places:

CDS provides patient-specific information and knowledge, enabled by health 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, electronic CDS can improve health care processes (Lobach, 2012).

Incorporation of PCOR findings into clinical practice using 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 (http://wiki.siframework.org/).  

Efforts are currently underway to harmonize CDS standards with standards for electronic clinical quality measures (eCQMs). 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). Common CDS and eCQM standards for metadata, a data model (e.g., Quality Improvement and Clinical Knowledge or QUICK), and an expression language (e.g., Clinical Quality Language or CQL) are being developed through Health Level 7 (HL7) and the Clinical Quality Framework (CQF) Initiative (http://cqframework.info). 

Objectives and Scope

In 2016, AHRQ funded the PCOR CDS Learning Network (Research Triangle Institute) to create a community of stakeholders working towards disseminating and implementing PCOR findings through CDS in clinical practice. AHRQ strongly encourages successful applicants to collaborate with the PCOR CDS Learning Network grantee as a stakeholder group, which aims to provide valuable insight and lessons for CDS implementation.  Additional information about the PCOR CDS Learning Network can be found here: https://healthit.ahrq.gov/ahrq-funded-projects/patient-centered-outcomes-research-clinical-decision-support-learning-network.

Developing CDS involves translating evidence-based recommendations (e.g., clinical practice guidelines) into health IT-enabled tools and interventions adapted to local clinical environments. Best practices for how to share CDS beyond the initial clinical environment in which it was successfully implemented are needed. For the purposes of this FOA, well-established CDS is defined as already designed, validated, developed, tested, deployed, evaluated, and effective CDS.  This FOA intends to support projects that extend the implementation of well-established, electronically implemented CDS beyond the initial clinical setting or institution to disseminate and implement PCOR findings. As a result, AHRQ seeks to fund a spectrum of CDS projects that focus on increasing scale and impact and that span settings, institutions, health IT systems, clinical conditions, geographic areas, and priority populations.

This FOA focuses on scaling well-established, effective CDS to additional sites and on demonstrating its positive effect. For the purposes of this FOA, additional sites are defined as sites outside the department that originally developed the CDS, as new types of settings (e.g., inpatient vs. outpatient), or as new systems (e.g., CDS on one electronic health record (EHR) vs. another EHR).

Examples of scaling projects to disseminate and implement PCOR findings relevant to this FOA include, but are not limited to, the following:

  • Demonstrating successful implementation of existing CDS beyond the initial clinical setting, clinical department, institution, or health system;
  • Demonstrating successful implementation of existing CDS and use by clinicians using different EHR systems;
  • Demonstrating successful implementation of existing CDS in under-resourced settings where Medicaid and priority populations receive care;  
  • Extending existing CDS to diverse and new users or clinical sites, including under-resourced settings through interoperable health information exchange;
  • Extending existing CDS to integrate primary care and behavioral or mental health services across systems of care;
  • Extending existing CDS to integrate multiple recommendations of the U.S. Preventive Services Task Force that are A, B, or C grades and allow for integration of multiple preventive services simultaneously at the point of care.

All proposed projects must:

  • Incorporate at least one government-funded PCOR finding or study (e.g., PCORI, AHRQ Effective Health Care Program, U.S. Preventive Services Task Force, or AHRQ National Guideline Clearinghouse™) into the CDS and provide appropriate citations; 
  • Extend ("scale") well-established and effective CDS that is based on at least one government-funded PCOR finding(s) beyond the initial clinical setting or institution to disseminate and implement PCOR findings;
  • Incorporate the "5 Rights" framework of delivering the right information, to the right person(s), using the right format, in the right channel, and at the right time during workflow (Osheroff, 2009);
  • Have a quantifiable impact of the scaling effort in terms of an increased number of clinicians who would use the CDS and an increased number of diverse patients who would benefit from care facilitated by use of the CDS;
  • Describe the scaling effort, including scaling methodology, evaluation of the scaling effort, and evaluation of the actual impact on outcomes among Medicaid and AHRQ's priority populations specified under the AHRQ Act of 1999 (e.g., workload impact, efficiency, CDS usage, care processes, adherence to guidelines, patient safety, patient outcomes, healthcare services utilization and efficiencies, costs, unintended consequences);
  • Evaluate the reliability, validity, and usability of the CDS among diverse populations;
  • Be prepared to collaborate with other components of AHRQ's PCOR CDS initiative, such as contractors tasked with creating a repository of CDS, developing tools for CDS authoring and sharing, and developing CDS based on PCOR findings.  Additional information about other components of the PCOR CDS initiative can be found here (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-15-010.html); and

Applicants are strongly encouraged to:

  • Incorporate health IT standards that harmonize CDS and quality measurement (e.g., those that have been piloted through the CQF Initiative);
  • Partner with a stakeholder organization to deliver CDS to target audiences, including professional organizations that focus on racial or ethnic minority health issues; thus leading to more widely used CDS and greater uptake of PCOR findings in clinical practice for diverse populations (e.g., CDS delivered to a professional society's membership);
  • Collaborate with the AHRQ PCOR CDS Learning Network in order to share lessons learned and best practices and to take advantage of the PCOR CDS Learning Network's community of stakeholders and dissemination mechanisms.

References

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.

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.

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

 

Funding Instrument

Grant

Application Types Allowed

New

Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

Award Budget

The total costs (direct and indirect) for a project awarded under this FOA will not exceed $500,000 in any given year or $1 million for the entire project period. 

Award Project Period

 The project period may not exceed 2 years.

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 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html and  http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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

Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;

  • Unit of local or State government;
  • Eligible agency of the Federal government.
  • Indian/Native American Tribal Government (Federally recognized)
  • Indian/Native American Tribal Government (Other than Federally recognized);
  • Indian/Native American Tribally Designated Organization.

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Because the purpose of this program is to improve 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.

Foreign Institutions

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.

Required Registrations

Applicant Organizations

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

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

Program Directors/Principal Investigators (PD/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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

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.

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

2. Cost Sharing

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. 

3. Additional Information on Eligibility
Number of Applications

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

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

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

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

2. Content and Form of Application Submission

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.

Letter of Intent

Not applicable.

Page Limitations

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 section is limited to 1 page,
  • Research Strategy section is limited to 12 pages, and
  • Evaluation Strategy section is limited to 2 pages.
Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Software, Hardware, and/or Equipment Purchases: Combined purchases for software, hardware, or any other equipment needed to conduct the project are expected to be less than 20% of the total costs of the project over the duration of the project.  These purchases may include modest incremental software development to enable implementation of existing health IT in a new setting or to improve health IT functionality.  If funds for such purchases are in excess of 20% of overall total direct costs budgeted for the duration of the project, an explicit justification must be included.

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.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 must describe the following elements:

Research Strategy:

Applicants should describe their approach to extending well-established, effective CDS to additional sites and on demonstrating its positive effect.

Additional sites are defined as:

  • Sites outside the department that originally developed the CDS, or
  • New types of settings (e.g., inpatient vs. outpatient), or
  • New systems (e.g., CDS on one EHR vs. another EHR).

In describing this approach, applicants must address the following elements:

  • At least one government-funded PCOR finding or study (e.g., PCORI, AHRQ Effective Health Care Program, U.S. Preventive Services Task Force, or AHRQ National Guideline Clearinghouse™) on which the proposed CDS is based with relevant citation(s).
  • The existing, established CDS, including its initial development, implementation, validation, evaluation, and demonstration of its impact on outcomes to date.
  • How the CDS will be extended within the project period of 2 years, including time for refinement, testing, evaluation, and additional phases where necessary.
  • How the approach considers the following design factors: current information needs and related processes; user needs, goals, and motivations; the environments and context in which the health IT application or system will be used; the need for training and testing; and impact on workflow and workload, efficiency, economic, and health or clinical outcomes.
  • The sustainability of the approach beyond the project period.
  • Any partnership(s) with stakeholder organization(s), including professional organizations that focus on racial or ethnic minority health issues; their role in this specific project, and how the partnership(s) will lead to more widely used CDS and to greater uptake of PCOR finding(s) in clinical practice.  For example, applicants may wish to partner with a professional clinical association to scale the CDS and to make it available for use by the association's members.  Partnerships are encouraged.

Evaluation:

Applicants should describe their approach to evaluating the extension of well-established, effective CDS to additional sites. In describing this approach, applicants must address the following elements:

  • The metrics to be applied in order to assess the extent to which PCOR finding(s) have been incorporated into clinical practice as implementation of well-established and effective CDS beyond the initial clinical setting or institution in which the CDS was originally developed and implemented.
  • The study design and methods to evaluate the impact of CDS on outcomes.
  • Contextual and implementation factors associated with the CDS.
  • How barriers and facilitators to the scaling effort will be identified.
  • Examples of measures to evaluate the scaling effort include, but are not limited to the following:
  • Workload impact, efficiency (e.g., time to complete work tasks);
  • CDS usage (e.g., additional patients impacted, additional target users, additional sites, rate of alert firing, alert overrides, feedback from users);
  • Care processes, adherence to guidelines (e.g., adherence to clinical guidelines; time to ordering of important medications);
  • Patient safety (e.g., error reports, adverse events, transfers to ICU, death, medication prescribing errors);
  • Patient outcomes (e.g., disease management related to adoption of guidelines (e.g., blood pressure control, lipid levels, H1ac levels, hospital lengths of stay, re-hospitalizations);
  • Healthcare services utilization and efficiencies (e.g., reductions in unnecessary or inappropriate laboratory test orders);
  • Costs (e.g., resource management, provider medication, and laboratory test costs); and
  • Unintended consequences (e.g., alert fatigue, overrides of serious alerts, and adverse events due to CDS).

Privacy and Security Protections in the Development and Implementation of Health IT Systems:

  • From its earliest investments in health IT research activities, AHRQ has emphasized the importance of the privacy and security of personal health information to engender individual trust in the use of health IT applications and systems.  Without this trust in a health IT application or system, patients and other users (e.g., clinicians, caregivers) will not use it fully, and as a result, system data may be inaccurate or incomplete.  As a result, the potential for quality and safety improvement from investments in health IT will be lost.  More importantly, assuring privacy and security are values patients and clinicians should expect and receive from the health care system.
  • Keeping health information in electronic format introduces new risks, real and perceived, to the privacy and security of health information.  New concerns arise, such as who has access to and use of electronic data, how electronic data are stored and kept secure, patient access to an accounting of certain health information disclosures, patient consent requirements for sharing information electronically, the ability of patients to decline participation in electronic data collection, patient access to audit trails or logs, and informing patients of any security breaches.
  • Stakeholder groups have promulgated policies in order to assure patient awareness of, comfort with, and participation in, electronic data collection, use, and disclosure.  While privacy and security solutions are not intended to be the focus of projects under this announcement, health IT interventions should be designed to incorporate emerging privacy and security principles that may be applicable (see http://www.healthit.gov/sites/default/files/GovernanceFrameworkTrustedEHIE_Final.pdf and http://www.healthit.gov/sites/default/files/nationwide-ps-framework-5.pdf)
  • Distinct from a Plan for Protection of Human Subjects, grant applications must contain a Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems.  Near the end of the Research Strategy, applicants must insert the header, “Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems.”  In this section the applicant must identify if it is necessary to have a Privacy and Security Protections Plan in place to conduct the research project.  If it is not necessary, a justification must be provided.  If a plan is required, the Research Strategy section of the grant application must contain a concise summary of the planned resources and processes to be used to address privacy and security issues in the design, implementation, and/or use of the health IT intervention.
  • A full description of the plan for Privacy and Security Protections must be included in Appendix A, unless a justification for not needing a plan has been included in the grant application.  The appendix must describe how, in the design, implementation, and/or use of the health IT intervention, privacy and security concerns related to the exchange of personal health information will be identified and addressed.  The appendix should describe the resources and processes the applicant will use to assure that these privacy and security concerns are being met throughout the project period.  These could include the inclusion of participating patients in periodic reviews in order to solicit their input and consultation with knowledgeable professionals over the course of the project, as well as a description of any existing privacy or security practices and technology consistent with those policies that will be incorporated into the project and reviewed for compliance on a regular basis.
  • The adequacy of the Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems will be assessed by the peer review panel.  AHRQ reserves the right to request clarification on the Plan for Privacy and Security Protections prior to funding.

Project Administration:

  • Grant applications must fully address the administration of the project.  This is especially crucial for teams necessitating the coordination of multiple team members’ efforts across disciplines, institutions, and geographic regions. 
  • Grant applications must include a detailed project timeline.

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 proposed project.

Letters of support, recommendation, or endorsement should NOT be included from any entity or individual who is not directly participating in the proposed project. 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.

If a "Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems," is required as described under PHS 398 Research Plan Research Strategy instructions above, a full description of the Privacy and Security Protections must be included in Appendix A.

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

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

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. 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.

The applicant should pay particular attention to the SF424 (R&R) application guide instructions concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

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

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

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks

Priority Populations

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data 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.

 
Data Confidentiality

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.

 
Sharing Research Resources:  Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. 

AHRQ requests that grantees notify the Office of Communications and Knowledge Transfer (OCKT) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date. 

Regulations applicable to AHRQ grantees concerning intangible rights and copyright can be found at 45 CFR 75.322.

Other Special Requirements

AHRQ Contractors:

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;
  • Sharing information on any grant outputs (e.g., publications, survey instruments) for inclusion in AHRQ output repositories, as appropriate, and so that the contractor(s) can update the project profile on an annual basis; and
  • Assisting in disseminating project-specific CDS findings and/or CDS authoring lessons; informing the stakeholder engagement process; and/or supplying other relevant and reasonable content as requested to aid in the dissemination of PCOR findings through CDS.

AHRQ PCOR CDS Learning Network:

AHRQ grantees funded under this FOA are strongly encouraged to:

  • Collaborate and interact with the PCOR Learning Network;
  • Participate in meetings with the PCOR Learning Network as requested;
  • Provide approaches to scale and evaluate well-established, effective CDS that incorporates PCOR findings to additional CDS;
  • Provide updates on the progress of the grant;
  • Share information, lessons learned, and best practices regarding scaling well-established, effective CDS to additional sites and on demonstrating its positive effect.
Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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.

Overall Impact

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.

Scored Review Criteria

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.

Significance
  • Is the CDS based on at least one government-funded PCOR finding or PCOR study (e.g., PCORI, AHRQ Effective Health Care Program, U.S. Preventive Services Task Force, or AHRQ National Guideline Clearinghouse™) and are citation(s) provided?
  • Will extending the existing, established CDS potentially increase the uptake of PCOR findings in clinical practice?
  • Will the proposed approach to extending the existing, established CDS based on PCOR findings likely have a significant and wide impact leading to more widely used CDS and greater uptake of PCOR findings in clinical practice as demonstrated by the proposed evaluation plan?  
  • Are there any partnership(s) with stakeholder organization(s) and if so, will  their level of involvement likely have significant and wide impact leading to more widely used CDS and greater uptake of the PCOR findings in clinical practice?
Investigator(s)
  • Are the PD/PI, collaborators, and other researchers well suited to the project?
  • 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?
  • Is the PD/PI devoting a minimum of 20% annual full-time effort in each year of this project (i.e., at least 8 hours per week)?
  • Are letters of support included for collaborating stakeholder organizations?
Innovation
  • Is the project original and innovative?
  • Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?
  • Are the methods sustainable and shareable?
  • Are unique partnerships presented that could create a broader impact of CDS in clinical practice?
Approach
  • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
  • Does the approach build on the "5 Rights" framework of delivering the right information, to the right person(s), using the right format, in the right channel, and at the right time during workflow (Osheroff, 2009)?
  • Will this project build upon ongoing efforts to harmonize and to build on health IT standards (e.g., HL7) for CDS and for electronic clinical quality measurement?
  • Are the plans to scale the existing CDS to additional settings, sites, or systems likely to be successful? Are they realistic?
  • Are the plans for data collection/analysis, CDS refinement, CDS testing, and evaluation scientifically sound?
  • Are the proposed metrics for evaluating impact appropriate?
  • Is the approach realistic to be completed and demonstrate impact within the proposed timeframe?
  • Does the approach adequately discuss scalability and sustainability of the CDS?
  • Is the project management plan adequately developed?
  • Does the approach address a meaningful plan to interact and collaborate with the AHRQ PCOR CDS Learning Network?
  • Does the approach include any partnership(s) with stakeholder organization(s) , and if so, will the partnership(s) lead to more widely used CDS and to greater uptake of PCOR finding(s) in clinical practice?
  • Are potential problems and alternative strategies presented?
Environment
  • Will the scientific environment in which the work will be done contribute to the probability of success?
  • If the application indicates partnering organizations, is there a history of successfully working together?
  • Is there evidence of institutional commitment and support from all proposed organizations?
  • Will the proposed organizational structure support scaling the CDS to new settings, sites, or systems that are different from where the CDS is currently implemented and being used?
  • Are the institutional support, equipment, and other resources available to the investigators adequate for the project proposed?
Additional Review Criteria

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.

Evaluation

Is a section entitled “Evaluation” included in the Research Strategy section of the grant application?  Has the applicant adequately described the evaluation plan for the proposed study? Has the grant application adequately described the study design and methods to evaluate CDS impact on outcomes? Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the proposed study? Has the grant application adequately described the metrics to be applied in order to assess the extent to which PCOR finding(s) have been incorporated into clinical practice as implementation of well-established and effective CDS beyond the initial clinical setting or institution in which the CDS was originally developed and implemented? Have contextual and implementation factors associated with the CDS been discussed? Has the grant application adequately considered how barriers and facilitators to the scaling effort will be identified?

Privacy and Security Protections in the Development and Implementation of Health IT Systems

Is a section entitled “Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems” included in the Research Strategy section of the grant application?  Has the applicant identified if it is necessary to have a Privacy and Security Protections Plan in place to conduct the research project?  If the applicant states such a plan is not necessary, is adequate justification provided?  If a plan is necessary, has the applicant adequately described the privacy and security policies and features of the health IT application or system being designed, implemented, or used in the proposed study? Has the grant application adequately described the process for identifying and addressing privacy and security issues related to the exchange of personal health information and encouraging the involvement of patients to the extent appropriate?  Has the grant application adequately considered patient access to an accounting of certain health information disclosures, patient consent process for sharing information electronically, ability for patients to decline participation in electronic data collection, patient access to audit trails or logs, and patient notification of security breaches?

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?

Does the approach use PCOR findings as the basis for the CDS?

Does the approach focus on extending well-established, effective CDS beyond the initial clinical setting?

Does the approach focus on the impact of scaling the CDS beyond the initial clinical setting?]

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.

Is the budget allocation for purchase of health IT hardware, software, and support appropriate and well-justified? 

Is the budget allocation for purchase of health IT software, hardware, and support less than 20% of the total costs of the project over the duration of the project?  If not, is appropriate justification provided for exceeding the 20% limit on these costs?

Resubmissions

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

Renewals

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 Not applicable.  

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects.  For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NOA are at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5., “Funding Restrictions.”

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards,” (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of  Award.

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

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm).  AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends.  For example, if the budget period ends 4/30/2015, the annual FFR is due 9/30/2015 (90 days after the end of the calendar quarter of 6/30/2015).

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

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

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

Tiffani J. Bright, Ph.D.
Agency for Healthcare Research and Quality
Division of Health Information Technology
Center for Evidence and Practice Improvement (CEPI)
E-mail:  PCORClinicalDecisionSupport@ahrq.hhs.gov

Peer Review Contact(s)

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

Boris Aponte, MPH, Ph.D.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1396
E-mail:  Boris.Aponte@AHRQ.hhs.gov

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Carol Kauffman
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1448
E-mail: Carol.Kauffman@ahrq.hhs.gov

Section VIII. Other Information

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.

Authority and Regulations

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, 45 CFR Part 75, and other referenced applicable statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

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