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, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.

Components of Participating Organizations

Agency for Healthcare Research and Quality

Center for Outcomes and Evidence)

Funding Opportunity Title

The Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Research Network (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices

  • April 30, 2013 - See Notice NOT-HS-13-007. Notice of Cancellation of this FOA.

Funding Opportunity Announcement (FOA) Number

RFA-HS-13-009

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.226 

Funding Opportunity Purpose

This funding opportunity announcement (FOA) solicits Research Program Cooperative Agreement (U19) applications from organizations that propose a Research Center in outcomes and effectiveness research and focus in one of two programmatic themes:  patients served by (1) Medicare; or (2) State Medicaid and/or Children’s Health Insurance (CHIP) programs. 

This FOA is intended to support (a) one to two comprehensive primary research studies that are designed to produce objective scientific evidence for informing evidence-based decision-making by Medicare, State Medicaid, and/or CHIP patients; (b) a dissemination project that transfers knowledge from a Center’s primary research studies to appropriate stakeholders; (c) Center infrastructure including research data, personnel, pilot research studies, learning forums on research methods, multicenter collaborations, and a stakeholder technical expert panel; and (d) each Centers’ shared responsibility in program governance and scientific oversight through active participation in a multicenter consortia focused on either Medicare or on State Medicaid/CHIP.  Interventional or observational research studies that assess the quality, effectiveness, or safety of preventive, diagnostic, therapeutic, behavioral, health information technology, or health systems interventions on patient health outcomes will be considered under this FOA.

Key Dates
Posted Date

April 17, 2013

Letter of Intent Due Date(s)

May 15, 2013

Application Due Date(s)

May 31, 2013

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

(Now Expired April 30, 2013 per NOT-HS-13-007), Originally June 1, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH/AHRQ are committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and are currently investigating solutions that will accommodate NIH/AHRQ’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) broadly solicits Research Program Cooperative Agreement (U19) applications to become a Center in the “Developing Evidence to Inform Decisions about Effectiveness” (DEcIDE) Research Network Program.  DEcIDE Centers will conduct one to two primary research studies and implement related projects directed at improving healthcare outcomes for Medicare, State Medicaid, and/or CHIP patients.  For this initiative, research must focus on examining the outcomes of health care interventions or services, including studying the effectiveness, quality, safety, and the use of health information technology.

The primary purposes of each DEcIDE Center are to:

1a)  conduct one to two well-controlled, protocol-directed investigations on specific problems that one or more stakeholders have previously identified or endorsed as critically important to informing decisions about the effectiveness of healthcare interventions or services in either Medicare or State Medicaid, and/or Children’s Health Insurance (CHIP) patients; and

1b)  analyze decision processes and study practical approaches for improving patient outcomes through the effective dissemination of a Center’s primary research findings to either Medicare, or State Medicaid, and/or CHIP stakeholders.

Based on the subject area of the primary research investigation(s) and dissemination project, each DEcIDE Center will also be expected to:

2a)  establish and operate a Stakeholder Technical Expert Panel for consultation on a Center’s research program and to directly facilitate dissemination of a Center’s primary research results to key decision makers;

2b)  expand data capacity and conduct pilot studies on research databases that are created by a Center with appropriate input from a Center's Stakeholder Technical Expert Panel;

2c)  contribute to learning forums for local and external research trainees or post-doctoral scientists to acquire knowledge about research methodologies, methodological standards, and advanced statistical techniques used in a Center’s research investigations; and

2d)  support program collaborations, operations, communications, and governance through participation with other DEcIDE Centers in one of two or three multicenter consortia that is focused on either Medicare or State Medicaid/CHIP and peer-led by an Executive Committee.

Background

Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), 42 U.S.C. 299b-7, authorizes AHRQ to conduct and support research designed to improve the quality, effectiveness, and efficiency of Medicare, State Medicaid, and the Children's Health Insurance Program (CHIP).  See also 42 U.S.C. 299a(a)(1).  AHRQ established the Effective Health Care (EHC) Program  to implement Section 1013 in 2005.  The essential goals of the EHC Program are to develop valid scientific evidence about the effectiveness of different treatments and appropriate clinical approaches to difficult health problems and make it accessible to decision makers.  Achieving these key goals encompasses reviewing, synthesizing, generating, and disseminating scientific evidence.  

A component of AHRQ’s EHC program that is dedicated to the generation of new scientific evidence through research is the DEcIDE Network.  The Network currently involves eleven research centers whose support from AHRQ will end in September 2013.  Citations of DEcIDE Network publications and information about the EHC Program are available at http://effectivehealthcare.ahrq.gov/

This FOA is open to any eligible organization; it is not limited to current DEcIDE Centers nor does it exclude these Centers if eligible under the terms of this FOA.  Research data and infrastructure created for other research initiatives, such as ARRA grants and contracts, may also be incorporated, re-developed, or expanded as an approach to implementation of a proposed DEcIDE Center under this FOA.  For this FOA, the definition of outcomes and effectiveness research is the conduct of research examining the benefits and/or harms of health care interventions and strategies designed to prevent, diagnose, treat and monitor health conditions, or to improve the delivery of care.  Proposed studies may focus on the effectiveness, quality, and safety outcomes of health care interventions as well as the effects of health information technology on patient health outcomes.

Research Objectives and Scope

DEcIDE CENTER STRUCTURE

Applicants to this FOA will propose a DEcIDE Center that examines the outcomes and/or effectiveness of one or more health care interventions relevant to (1) Medicare or (2) State Medicaid and/or CHIP patients.  These two programmatic thematic areas will be used to organize all funded Centers into one or more multicenter DEcIDE Consortia, which will be led by an Executive Committee.  Each Center will conduct one to two primary research investigations that serve as the central foundation for developing a Center’s infrastructure, collaborations, and other major activities.  Research may include other patient populations outside of Medicare, Medicaid, or CHIP but study findings must also be directly relevant to patients in one of these federally supported programs.  The structure of each Center will include an Administrative Core, a Research and Data Core, and a Dissemination Core.

Each Center will be composed of a minimum of one comprehensive research study on an outcomes and effectiveness topic and one related project on the dissemination of a Center’s research results, each of which is organized around an infrastructure that supports additional analyses of research databases, regular consultations with stakeholders, and external collaborations with other DEcIDE Centers through Consortium participation.  Executive Committees of DEcIDE Consortia will make decisions about program governance, operations, and the scientific review of DEcIDE products.  It is expected that as a result of this structure, Centers will be better equipped to compete for future research funding from AHRQ and other funders, and will be better able to produce high quality research for evidence-based decision making in Medicare and/or Medicaid/CHIP.  AHRQ intends to publish future FOAs describing research or dissemination studies that will be limited to funded DEcIDE Centers because of the cohesive infrastructure required to respond to these opportunities if funds become available.

Within its chosen thematic area of Medicare or Medicaid/CHIP and based on the primary research study or studies, applicants must also propose one, two, or three areas of research concentration that represent the main identity of a Center’s research program and its primary functional contributions to the science within a Consortium.  Areas of concentration may be self-defined by the applicant but the concentrations must be justified as relevant to outcomes and effectiveness research for Medicare or Medicaid/CHIP beneficiaries.

Examples of potential areas of general concentration include, but are not limited to, the following categories: (A) recognized clinical areas (e.g., obstetrics and gynecology, pediatric pulmonology, radiology); (B) research methodologies (e.g., patient registries, decision analysis, patient-reported outcome measurement); (C) subpopulations (e.g., low income elderly, people living with disabilities, racial or ethnic minorities); (D) health communication technology; or (E) health care systems and/or care coordination.  Applicants do not need concentrations in all five categories and may assert multiple concentrations in a single category.

DEcIDE CENTER COMPONENTS

Each Center is required to have an infrastructure that is comprised of a minimum of three core units: (1) an Administrative Core, (2) a Research and Data Core, supporting one to two primary research studies and supplemental analytic activities, and (3) a Dissemination Core for the dissemination project.  Although not required, it is recommended that approximately 60 to 70 percent of a Center's resources be dedicated to the Research and Data Core, with approximately 15 to 20 percent devoted to each of the Administrative and Dissemination Cores.

Administrative Core

Each Center must include an Administrative Core, under which all Center activities will be managed, coordinated, and supervised.  In addition, the Administrative Core will support a Stakeholder Technical Expert Panel, participation in a multicenter DEcIDE Consortium and its affiliated Executive Committee, communications, and logistics for required meetings.  The Administrative Core, at a minimum, will contain one Center Director and a Center Coordinator.  The Center Director must be the Program Director/Principal Investigator (PD/PI) for the application.  Multiple PD/PI's are not allowed.  In general, the PD/PI will be the lead investigator on a primary research study of the Center.  The Center Coordinator will be an experienced project manager who tracks all milestones, publications, dissemination tools, and other products produced by a Center. 

Stakeholder Technical Expert Panel.  Each Center will establish and operate a Stakeholder Technical Expert Panel (STEP) through their Administrative Core.  This panel will be composed of approximately 6 to 12 stakeholders representing diverse patient, clinician, and policy maker perspectives pertinent to a Center’s primary research project.  The principal purposes of the STEP are to a) consult on a Center’s primary research study or studies; b) provide input and feedback on the dissemination project; c) engage respective Medicare, Medicaid and/or CHIP programs in the Center's activities; and d) identify research questions for future research.  The Administrative Core will work with the STEP to identify and prioritize relevant research topics.  Of the topics that are identified by the STEP, each Center is encouraged to publish these topics each year.

Each Center will host an annual in-person meeting of the STEP in the Washington, DC area on a date that is coordinated each year with its Consortium’s Executive Committee.  Each Center may also host regularly scheduled teleconference calls with its STEP.

Consortium Objectives and Operations.  Based on a Center’s thematic area and primary research project, it will collaborate with other DEcIDE Centers through participating in a DEcIDE Consortium that is focused on improving patient-centered, evidence-based decision making in either Medicare or Medicaid/CHIP.  Centers share responsibilities for Consortium leadership, operations, communications, and meeting logistics through equal participation on an Executive Committee.  Funded Centers will be grouped into Consortia in the first two months of the award according to the Center's thematic focus (i.e., research in Medicare or Medicaid/CHIP) by AHRQ in consultation with each grantee.  The main objectives of the Consortia are to share knowledge across each of the DEcIDE Centers on their primary research studies, methodologies, dissemination projects, and stakeholder engagement initiatives; coordinate work to maximize the impact of the program; and pursue additional research and funding based on collective expertise of all constituent Centers.  These objectives will be operationalized mainly through electronic communication using a secure web portal provided by AHRQ, document sharing, quarterly teleconferences, a public website, and an annual meeting that is held in conjunction with each  Consortia's annual STEP meeting in the Washington, DC area.

Administrative Core Support for Executive Committee.  Each Center Director and one member of each Center's STEP who is designated in the application will serve on the respective Consortium Executive Committee for either Medicare or Medicaid/CHIP.  Each Executive Committee will also include two non-voting members who are AHRQ-appointed federal employees.  At least one of the two federal employees will be employed by AHRQ.  The Executive Committee is primarily responsible for setting the scientific agenda for a Consortium, which will be based on the primary research topics of its constituent Centers and input from each STEP.  The Committee exercises its responsibility by creating manuscript review procedures and publication policies, managing conflicts of interest, reviewing dissemination products, providing general scientific oversight of research, resolving conflict, coordinating website information, and supporting collegiality across all members of a Consortium.  Executive Committees will host annual in-person meetings as part of annual Consortia meetings and may host monthly meetings by teleconference.

Research and Data Core

Each Center will have a Research and Data Core that consists of personnel with the appropriate clinical or scientific background and experience in research methodologies to serve as investigators on a Center's research projects.  Centers may also include students and trainees in the Core; particularly those interested in research but who are supported through other sources like AHRQ or NIH training grants, other funders, or by public or private-sector employers.  Each Center in this initiative will provide or develop new data resources necessary to conduct high quality research studies. 

Primary Research Project.  Each Center must conduct one to two well-controlled, protocol-directed research investigations.  The study or studies shall be the foundation for operationalizing a Center’s activities and associated infrastructure within the DEcIDE Network.  Well-designed research is integral to a Center’s success, and must be clearly described in the application.  Primary research questions and associated analytic plans are to be developed by each Center with input from stakeholder partners as part of the application submission.  The primary research may prospectively collect new data, use existing health data, or use both approaches as appropriate for the investigation.  For transparency and reproducibility of these primary research studies, successful applicants will subsequently make the full study protocol(s) or comprehensive analytic plan(s) readily accessible to the public during the post-award period through a Consortium's website in a format prescribed by the respective Executive Committee based on published standards for protocol development (e.g., see http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&mode=&productid=1166&ehc=bluead).

A Center’s primary research project should be designed to produce valid research findings that can be used along with other high quality evidence to inform the healthcare decisions of patients, families, providers, policy makers, and/or communities served by Medicare or State Medicaid/CHIP.  Furthermore, the project must consist of original research that substantially adds to the existing scientific evidence base.  Primary analyses should be completed in less than 42 months from the initiation of the grant award so a Center also has time to publish in peer-reviewed scientific journals and actively participate in dissemination of study results. 

Each Center’s primary research project must address critical questions that at least two representative stakeholder partners or stakeholder organizations have pre-identified or endorsed as a high priority because current scientific evidence is deemed insufficient to support stakeholders’ actions or is inadequate to inform patient decisions about the health outcomes that can be expected from specific health care interventions or services.  Stakeholder groups broadly include patients, providers, payers, purchasers, administrators, policymakers, consumer organizations, community groups, professional societies, State Medicaid Medical Directors and regional Medicare Carriers.  Emphasis in selecting research problems should be placed on both the priority of the topic for stakeholders and the feasibility of the proposed analysis to provide results that are capable of informing the decisions or actions of patients, clinicians, and/or policy makers in a meaningful way.  Studies including patient populations that are traditionally underrepresented in clinical trials or in other forms of research are strongly encouraged.  Likewise, research questions relevant to patient health outcomes for rare and neglected diseases are also supported under this FOA.  

Pilot Research Studies.  In addition to the primary research study or studies, each Center's Research and Data Core must complete at least one pilot study each year for a minimum of three years starting in the first or second year of the grant.  In general, pilot studies should be innovative and exploratory on topics related to one of a Center’s areas of concentration, or a methodological topic, and produce research reports of publishable quality.  The Research and Data Core will make regular reports to the STEP on these studies and may solicit feedback from stakeholders to appropriately guide the pilot research.  As part of the application, applicants shall describe their approach to conducting the pilot research and provide details of the pilot studies that can be derived from their primary research project and research databases. Since pilot studies are generally based on a Center's primary research project and the  existing research databases, budgets for these projects should be a relatively small proportion of the overall annual budget.  It is recommended that a minimum of 3 percent and no more than 30 percent of an annual budget is used for conducting pilot studies.  Costs of pilot studies or analysis should mainly be for time and effort of existing personnel, particularly researchers in the Data and Research Core.  Accordingly, the Research and Data Core may include personnel and other resources to conduct these studies. In addition, 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 for pilot studies or supplemental analyses.  

Methods Training.  Each Center will be responsible for coordinating with AHRQ training programs in research methodologies and the AHRQ Electronic Data Methods (EDM) Forum to annually produce at least two methods learning forums (e.g., 60-minute teleconferences, webinars, or standard lectures) on research methodologies, methodological standards, or advanced statistical techniques used in a Center’s research investigations.  These learning forums will be open to local and external research trainees or post-doctoral scientists at a Center and be available to other AHRQ grantees such as other DEcIDE Centers.  However, applicants may limit access through registration or other means in order to manage and control costs associated with this training.

Dissemination Core

The Dissemination Core must consist of personnel with the appropriate scientific background and technical experience in methodologies to plan, implement, and evaluate the dissemination project.  The Dissemination Core will make regular reports to the STEP and receive feedback on the dissemination project.

Dissemination Project.  Centers will conduct a dissemination project that may be implemented concurrently and in conjunction with the primary research project of the Center.  The purpose of this dissemination project is to analyze decision processes and study practical approaches for the effective dissemination of a Center’s primary research findings in appropriate forums specifically for Medicare, State Medicaid, or CHIP stakeholders.  Each Center will first work with representatives from one or more stakeholder groups to understand their needs for research findings; and then develop dissemination tools that meet those needs.  Tools are broadly defined as dissemination methods that are designed to appropriately apply research findings to practice, convey research findings (and study limitations) to clinicians and/or patients, or communicate study results to end users.  Once the tools are developed a Center will evaluate their effectiveness and make the tools freely accessible to the public. 

Tools should be designed to facilitate the appropriate use of a Center’s primary research results into evidence-based decision making.  Therefore, a Center may collect baseline information, develop prototypes, and conduct pilot tests with partners during the initial years of the award as part of this project in order to better design the final dissemination tools that a Center will deploy.

Dissemination tools may be created in different formats based on the needs of the relevant stakeholders.  These tools are encouraged to be innovative, but also applicable in a variety of settings where health care decisions for Medicare, State Medicaid, and/or CHIP programs are made.  Parsimonious, sustainable, and scalable approaches to tool development and dissemination are strongly encouraged over complex tactics that may be difficult to replicate or costly to maintain.

Milestones and Staging.  It is recommended that the dissemination project be incrementally staged with milestones produced annually to discuss with the STEP.  Staging will allow Center investigators and stakeholder representatives to work together to study decision processes and plan for the dissemination of the Center’s primary research findings based upon what is learned at each stage.  While dissemination milestones will vary depending upon the nature of the research and needs of stakeholders, one potential way of staging the dissemination project is as follows: (A) analyze targeted stakeholders’ informational needs, decision making processes, and communication networks for using results from research studies; (B) develop dissemination tools and forums that are compatible with stakeholder needs and are based on the results of the Center’s primary research project; (C) deploy the new dissemination tools; (D) evaluate the tools’ effectiveness for improving knowledge, understanding or appropriate application of research findings to decisions or patient outcomes; and (E) provide free public access to the final tools.   

Specific Areas of Research Interest

It is recommended, but not required, that applicants work directly with stakeholder partners and organizations in advance of submitting the application to clearly articulate the research problems for which stakeholders seek new scientific evidence.  Research must be designed to produce findings that are relevant to important decisions facing Medicare or Medicaid/CHIP patients but research findings do not need to be limited or unique to these populations.  Other stakeholder perspectives and patient populations may be incorporated into the research to strengthen the validity and/or generalizability of the study findings.  Given state and regional variations in the implementation of the Medicare and Medicaid/CHIP programs, applications are not required to address problems that affect multiple States or multiple Medicare regions.  Among the resources that may be used to identify important gaps in the evidence base, and facilitate discussions with stakeholders, include knowledge gaps identified by a) systematic reviews, b) prior research, and c) AHRQ future research needs report series (see http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayProduct&productID=521).  Interventional or observational research studies that assess the quality, effectiveness, or safety of preventive, diagnostic, therapeutic, behavioral, health information technology, or health systems interventions on patient health outcomes will be considered under this FOA.

Section II. Award Information
Funding Instrument

Cooperative Agreement.

Application Types Allowed

New

The OER Glossary and the PHS 398 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.

AHRQ intends to commit an estimated total of $2,000,000 in FY 2013 to fund approximately 4 awards.

AHRQ expects to award a minimum of one application under each programmatic theme area assuming high quality, competitive applications are received for each area.  The programmatic theme areas are Medicare and Medicaid/CHIP..

Award Budget

The total (direct + indirect) costs for a project awarded under this FOA may not exceed either $500,000 per year or $2,500,000 for the entire project period.

Award Project Period

The scope of the project should determine the project period.  The maximum length of a cooperative agreement funded under this FOA is 5 years.

These projects are being funded pursuant to 42 U.S.C. 299b-7 and pursuant to 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and  http://dhhs.gov/asfr/ogapa/grantinformation/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): 

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.

Foreign Institutions

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

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

The Program Director/Principal Investigator (PD/PI) must also work with his/her institutional officials to register with the eRA Commons or ensure the existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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. 

It is expected that PD/PI will commit substantial time to oversight of the Center and activities (a minimum of 10% annual effort).   

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

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 any application that is essentially the same as one already reviewed within the   past thirty-seven months (as described in http://www.ahrq.gov/funding/grants/policies/hhspolicy.html

And the NIH Grants Policy Statement), except for submission:

  Section IV. Application and Submission Information

1. Address to Request Application Package

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

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Scott R. Smith, PhD
Email: Scott.Smith@ahrq.hhs.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide must be followed with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited to 30 pages.  Page limits for individual components of the Research Strategy are as follows:

Application Submission

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

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

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

Scott R. Smith, Ph.D.
Agency for Healthcare Research & Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301-427-1511
Email: Scott.Smith@ahrq.hhs.gov

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application.  Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.  All applications must be submitted on Form PHS 398.  The multi-project grant application must be assembled and paginated as one complete document.  Instructions for the Overall Component are presented first, followed by instructions for Research Projects, followed by instructions for Cores.  All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

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

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

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

Provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program.

Key Personnel (Overall): Under "Key Personnel", list the Program Director/Principal Investigator of the multi-project application, followed by the Core Leaders of the component research project(s) and cores, other key personnel, and then other significant contributors.

Table of Contents (Overall)

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

Bearing in mind that the application will be scientifically reviewed based on the primary research study or studies, the dissemination project, and the three cores, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component listed below. 

A page reference should be included for the detailed budget for each project and each core.  Further, each project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader.  The page location of a COMPOSITE BUDGET should be indicated in the Table of Contents.

Detailed Budget for Initial Budget Period (Overall)

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

Budget for Entire Proposed Period of Support (Overall)

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

Using the suggested format presented below, prepare a composite budget for all proposed years of support.  (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE:  Consolidated Total Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Medicaid study

179,032

186,193

193,641

120,252

0

679,118

Project 2. Medicaid dissemination

20,887

24,766

35,807

37,239

74,597

193,296

Administrative Core

59,439

45,653

45,655

59,189

61,557

271,493

Research & Data Core

28,645

29,791

30,983

91,976

98,474

279,869

Dissemination Core

9,190

17,951

10,443

10,861

87,521

135,966

Total Direct Costs (including third party indirect costs)

297,193

304,354

316,529

319,517

322,149

1,559,742

Total Indirect Costs (@55%)

163,456

167,395

174,091

175,734

177,182

857,858

Total Costs

460,649

471,749

490,620

495,251

499,331

2,417,600


Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. 

Detailed budgets are required within the descriptions of each project and core (see below). 

Detailed budgets and budget justifications for each year of support are required within the descriptions of each project and core.  The budget justifications must clearly explain and detail any budget fluctuations in future years.  Please use Form Pages 4 (for each year of support for each project) and 5 of PHS Form 398 for each individual project.

STEP and Consortium Annual Meetings

In the application, budget requests must include travel costs for attendance of the PD/PI and relevant staff at an annual, two day meeting that will involve the Center's STEP in Day 1 and the a consortium meeting in Day 2.  It is recommended that staff travel is limited to one to a maximum of three people.  Centers may also budget for the travel of the STEP members to attend the meeting in person.

In addition, budget requests must include travel costs for attendance of the PD/PI and relevant staff to attend an annual one day meeting of the Steering Committee.

All meetings will convene yearly in the Rockville, Maryland or Washington, DC area.  Meetings will be organized by the respective Executive Committee with assistance from AHRQ.

Biographical Sketch (Overall)

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

Resources (Overall)

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

Research Plan (Overall)

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

Specific Aims: 

List in priority order, the broad, long-range objectives and goals of the proposed DEcIDE Center.  Concisely and realistically describe how the proposed Center will contribute to evidence based decision-making in Medicare, Medicaid, or CHIP.

Research Strategy:

The narrative section summarizes the overall research and dissemination plans for the multi-project application and explains how the proposed Center satisfies the purpose and all objectives of this FOA as delineated in Section I.  Applications responding to this FOA must describe the central theme of the proposed Program and explain how the proposed primary research study or studies and dissemination project are synergistic and fit under the overarching Program theme.  This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program - by giving a statement of the general problem area and by laying out a broad strategy for addressing the problems.  Summarize the special features in the environment and/or resources that make this application strong or unique.

For all pilot projects, describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials, if applicable.

Primary Research Project

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

A minimum of one primary research study is required.

For each primary research study (or studies), include:

Face Page (Primary Research Project)

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

The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application.  Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about the primary research study.  This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

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

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

Table of Contents (Primary Research Project)

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

Detailed Budget for Initial Budget Period (Primary Research Project)

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

Budget for Entire Proposed Period of Support (Primary Research Project)

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

Biographical Sketch (Primary Research Project)

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

Resources (Primary Research Project)

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

Research Plan (Primary Research Project)

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

Summarize the objectives of the project, the problem it addresses, the participants, data source(s), relevance to Medicare/Medicaid/CHIP, key measures, outcomes, study design, description of data, major study limitations, and date for completion.

Specific Aims: List, in priority order, the broad objectives and goals of the proposed project.  Concisely and realistically describe the key research questions, hypothesis or hypotheses to be tested.  In addition, state the primary research project's relationship to the Program’s goals and how it relates to other projects or cores.  When possible, it is recommended to write research questions using the PICTOS framework or a variation thereof (see Richardson WS, Wilson MC, Nishikawa J, et al. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995 Nov-Dec;123(3):A12-3).  Questions that use the PICTOS typology include the following six components: the population(s), intervention(s), comparator(s), outcome(s), timeframe for assessing outcomes, and setting of interest.   

Research Strategy: Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.

For all Research Projects (within the Research Strategy page limit), describe the research design conceptual procedures, and analyses to be used to accomplish the specific aims or investigate the key questions of a primary research study.  Explain input received from stakeholder partners as part of the application submission or cite relevant publications describing stakeholder priorities.  Clearly describe the major study variables, the methods of assessment (i.e., measurement), and the data that will be analyzed.  Establish that the data and study design are appropriate to sufficiently address the research questions and stakeholders' evidentiary needs.  Describe all statistical methods including those to control for confounding.  If applicable, describe methods for subgroup analyses and sensitivity analyses.

Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts or approaches for the proposed study.  Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.  As part of this section, provide a tentative sequence or timetable for the project.  Describe how the research strategy is informed by an understanding of the public health issues in Medicare, Medicaid, or CHIP.  Describe anticipated barriers and propose research and/or strategies to overcome these barriers.  

Dissemination Project

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

Face Page (Dissemination Project)

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

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

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

Table of Contents (Dissemination Project)

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

Detailed Budget for Initial Budget Period (Dissemination Project)

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

Budget for Entire Proposed Period of Support (Dissemination Project)

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

Biographical Sketch (Dissemination Project)

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

Resources (Dissemination Project)

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

Research Plan (Dissemination Project)

Specific Aims:  List, in priority order, the broad objectives and goals of the dissemination project.  Concisely and realistically describe plans to analyze decision processes and study approaches for the effective dissemination of a Center’s primary research findings to Medicare, State Medicaid, or CHIP stakeholders.  Identify important project milestones, how the project will be staged, and how stakeholders will provide input.

Research Strategy: For all pilot projects, describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials, if applicable.

Administrative, Research, and Dissemination Cores

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

Each Center must include Administrative, Research and Data, and Dissemination Core.

For each individual Core, include:

Face Page (Core or Project)

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

The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application.  Instead, use the 398 continuation page to create a "Cover Page" containing selected data about each individual core.  This Cover Page will demarcate each core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):

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

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

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the objectives.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors. The PD/PI must be the director of the Administrative Core and must commit at least 0.6 person months effort per year to these responsibilities. An Administrative Core Associate should be a research administrator responsible for the daily administration and fiscal management of the Center. It is recommended that the Administrative Core Associate devote a level of effort ranging from 3 to 6 person months per year to the execution of the administrative details of the Center projects and to managing the day-to-day operations within the Center. Any additional Administrative Core personnel must be clearly justified.

Table of Contents (Cores)

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

Detailed Budget for Initial Budget Period (Cores)

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

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

Requests for funds to support required travel may be included here.

Budget for Entire Proposed Period of Support (Cores)

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

Biographical Sketch (Cores)

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

Resources (Cores)

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

Provide information on resources available for each core.  Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)  

Research Plan (Cores)

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

Specific Aims (Cores)

List in priority order, the broad, long-range objectives and goals of the proposed Administrative, Research, and Dissemination Cores. In addition, state each core’s relationship to the Program’s goals and how it relates to the individual Research Project(s) or other aspects of in the application.

Research Strategy for Admin Core (required)

The Administrative Core must include a Management Plan that identifies and discusses: the Administrative Core structure; the roles of Administrative Core personnel; the composition and duties of the Stakeholder Technical Expert Panel; the facilitation of communications throughout the Center and with AHRQ staff; and assurance that all research activities are carried out in compliance with all federal and AHRQ regulations. The plan should specifically address continual evaluation of research and development progress, communications, group meetings and teleconferences, presentation and publication of data, resource and model sharing, the identification and proposed resolution of problems and engagement of the AHRQ Staff as appropriate.  A description of how subcontracts will be managed should be provided and should include how communications such as periodic meetings and conference calls will be organized, managed and documented.  The plan must include a Core budget and should identify how research-related travel will be managed.  The plan must also explain procedures for consultations and meetings with the STEP on the research and dissemination activities of the Center.

Research Strategy for Research and Data Core

Use this section to describe how the proposed Research Core activities will contribute to meeting the Center's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.  In addition, this section should indicate the relevance of the core to the primary theme of the application.

As part of the application, applicants shall briefly describe a minimum of three pilot research studies that generally can be derived from the Center's primary research databases.  The descriptions should include background, objectives, and research methods.  It is recommended that no more than one page is used to describe each pilot study.

Research Strategy for Dissemination Core

Use this section to describe how the proposed Dissemination Core activities will contribute to meeting the Center's goals and objectives.  In addition, this section should indicate the relevance of the core to the primary theme of the application.

Appendix for the Entire Application

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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, which can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Pre-award costs are not allowable without AHRQ prior approval.

6. Other Submission Requirements and Information

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

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.  Applications that are incomplete and/or nonresponsive 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 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.

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 by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521).  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/.

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

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 at 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.

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 (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources:  Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.     

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 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. 

AHRQ is providing this support for Research Center grants to foster innovative, synergistic, and targeted research studies that will expand the evidence base on patient health outcomes associated with preventive, diagnostic, therapeutic, behavioral, or health systems interventions.  The central objectives are to conduct new research studies aimed at critical research questions of importance to Medicare, State Medicaid, and/or CHIP stakeholders, disseminate research findings, and advance research methods for strengthening the validity of findings from research studies.

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. 

As part of the initial merit review, all applications will:

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 - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

Scored Review Criteria - Overall

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

Significance

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

 Has a research need for the Center been clearly identified by at least two stakeholders?  Will the proposed Center's research clearly address the identified need?  Will the proposed research be applicable (although not necessarily exclusively) to Medicare, Medicaid, and/or CHIP beneficiaries?  Will dissemination of the research results be effective to the targeted audiences? 

Investigator(s)

Are the PD/PI, collaborators, and other researchers appropriately trained to lead the Center? 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 (if applicable)? Is the leadership approach, governance and organizational structure appropriate for the project?  Does the research team provide expertise not only for the primary research project(s), but also for stakeholder engagement and dissemination of evidence?  Does the research team have the flexibility and capacity to do additional analyses as identified by the Stakeholder Technical Expert Panel? 

Innovation

Is the project original and innovative? For example: Does the project challenge current research or seek to shift clinical practice paradigms; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?  Does the application offer a novel mechanism for translating research into practice, for example, ways to penetrate difficult-to-reach audiences and populations and thereby inform decision making?

Approach

Are the conceptual or clinical framework, overall strategy, design and methodology, and analyses adequately developed, well-reasoned, and appropriate to accomplish the aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?      

Additional Review Criteria - Overall

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.

Do Administrative Core personnel have the background and requisite expertise to appropriately administer the proposed Center and fulfill the objectives of the DEcIDE Network Program?  Does the proposed approach and composition of the Stakeholder Technical Expert Panel provide a collaborative environment that provides appropriate consultation to researchers while maintaining the scientific integrity of all projects?  Is the Administrative Core configured to actively collaborate with other DEcIDE Centers through participation and support of a Consortium and affiliated Executive Committee?  Has the applicant adequately planned for their roles and responsibilities in Executive Committee participation?  Will the Research and Data Core adequately support the primary research project?  Will innovative pilot projects be implemented through the Research and Data Core and appropriate interactions with the Stakeholder Expert Panel?  Are researchers and other methodologists adequately trained on research methodologies, methodological standards, and advanced statistical techniques to teach methods to others as part of a DEcIDE methods learning forum?  Does the dissemination core personnel have the appropriate scientific background and technical experience to plan, implement, and evaluate the dissemination project?  Is the proposed dissemination project appropriate for the primary research study?  Would the dissemination project effectively disseminate the primary research findings?  Will stakeholders representing the Medicare, Medicaid and CHIP programs be engaged in the Center?  Are milestones for incrementally staging the dissemination project clearly described and achievable in the proposed grant timeline?

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 Human Subjects Protection and Inclusion Guidelines.

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? [NOTE: Information may be added here]

Inclusion of Priority Populations 

Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  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. [NOTE: Information may be added here]

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention. (Note: use this as appropriate)

Resubmissions

Not Applicable

Renewals

Not Applicable.

Additional Review Considerations - Overall

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:

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:

 NOTE: bullets above may be modified as appropriate

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

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, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

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

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

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

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

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/grants/policies/hhspolicy.html), and the terms and conditions set forth in the notice of grant award.  

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

Cooperative Agreement Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the Notice of Award and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines:  DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable for State and local Governments), 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 grantee is anticipated during the performance of the activities.  Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipient's 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 grantee and with 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.

2. A.1. Principal Investigator Rights and Responsibilities

The Center Coordinator will have the primary responsibility for:

2. A.2. AHRQ Responsibilities
AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The role of the AHRQ Program Official in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the grantee.  The AHRQ Program Official will work closely with the grantee and other Center member scientists to facilitate collaborations and to leverage the resources available to the Center.

The AHRQ Program Official will monitor the progress of the Center, help coordinate research approaches among all Centers funded through the FOA, and provide consultation on research projects or approaches as warranted. The AHRQ Program Official will support and facilitate this process but will not direct it.

In addition, AHRQ (in consultation with each grantee) will establish approximately two multicenter consortia and affiliated Executive Committees to comprise the DEcIDE Network based on the research plans in the final selection of meritorious applications.

The AHRQ DEcIDE Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award.  

2.A.3. Collaborative Responsibilities

In this section, areas of joint responsibility, including membership, duties, voting, etc., are described.   

Executive Committee for Medicare and Medicaid/CHIP Consortia

The Center will work with AHRQ's Office of Communication and Knowledge Transfer (OCKT )and the AHRQ program official in product dissemination, including the development of marketing plans, launch and press release activities, and media outreach and partnership development, with a focus on the first 30 days following publication or product release. OCKT staff and the AHRQ Program Official will work in consultation with the parent institution of the DEcIDE Research Center to determine the extent of outreach and target audiences for each publication or product. As part of this effort, OCKT will translate key messages for the intended audience.  A summary of these outreach efforts will be provided to the DEcIDE Research Center and each Consortia’s Executive Committee on an ongoing basis as determined by the characteristics of the specific research result or product.  OCKT also will work with the DEcIDE Research Center and each Consortia’s Executive Committee to track the impact of publications and products. Other Federal Agencies (e.g., FDA, CMS) and private or public stakeholders involved in therapeutics may also participate in dissemination and translation activities for specific publications or products. 

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions.  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 PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ will provide the timetable for these progress reports.  In addition to the annual progress report, recipients are required to submit quarterly progress reports to AHRQ. Detailed instructions on 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 (see 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 will be 90 days after the end of the calendar quarter in which the budget period ends.  Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter.  For example, if the budget period ends 4/30/2014, the annual FFR is due 9/30/2014 (90 days after the end of the calendar quarter of 6/30/2014).

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.

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Direct your questions about general FOA issues, including information on the inclusion of priority populations to DEcIDE3FOA@ahrq.hhs.gov:

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/fund/grantix.htm.

Agency for Healthcare Research and Quality
Center for Outcomes and Evidence
E-mail address: DEcIDE3FOA@ahrq.hhs.gov

Peer Review Contact(s)

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

Andrew Louden, Ph.D.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1183
Fax: (301) 427-1562
E-mail address: Andrew.Louden@ahrq.hhs.gov  

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

GMI@ahrq.hhs.gov
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality

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. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.


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