Part I Overview Information 


Department of Health and Human Services

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP), (http://www.ahrq.gov)

Title:   AHRQ Research Infrastructure Program: Phase II Limited Competition (R24)  

Note:  The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
This Funding Opportunity Announcement (FOA) is a new RFA.

Request For Applications (RFA) Number: RFA-HS-09-001 

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: February 19, 2009
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Dates(s): April 21, 2009
Peer Review Date(s): Approximately July, 2009
Earliest Anticipated Start Date: Approximately September, 2009
Additional Information To Be Available Date:  Not applicable
Expiration Date:  April 22, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) is the second phase of a Research Infrastructure Program initiated in 2006, and thus it is limited to the recipients of those initial planning grants. This FOA will use the R24 award mechanism, a grant mechanism used to fund resource-related research projects by supporting the enhancement of the institution’s capability to conduct innovative research.  It is expected that the primary components of these projects will involve activities designed to foster the development of institutional research capabilities.

Purpose. This FOA is the second phase of a research infrastructure program for grantees that were awarded planning grants (P20s) under RFA-HS-05-010 in 2006 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-05-010.html).  Under this original program, five grants were funded for planning activities related to the development of health services research infrastructure within selected states that historically had received limited health services research funding from AHRQ.  This FOA is a competitive continuation that extends these activities.  Only the original five grantees supported under the above referenced RFA are eligible to apply in response to this FOA.  The purpose of this second phase is to allow these grantees to build on their achievements from the original P20 grant, to refine, expand, and implement the plans developed during the first phase, and to conduct two to three health services research projects.  At least one of these projects must be a primary, as opposed to a pilot, research project.  It is believed that this additional funding will ensure that the health services research infrastructure is sufficiently developed to allow for sustainability by the end of the funding.

Because these funded recipients have conducted the initial planning and development activities to enable them to build on the existing work, and because continuity in the research is necessary, this will be a limited competition. 

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to AHRQ
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1.  Research Objectives

This FOA is the second phase of the Research Infrastructure Program initiated under the RFA HS-05-010.  Under the Phase I of the program, five, two-year planning grants were awarded.  These grants focused on the development of institutional research infrastructure in states that had limited health services research funding from AHRQ.  The second phase of the program is designed to implement and strengthen existing infrastructure.  Thus, the competition for Phase II is limited to the original five grantees supported under RFA-HS-05-010.  Applicants must propose activities focusing on building research capacity in their institutions.  In addition, each applicant must also propose at least two, and up to three, health services research projects.  Importance in this new competitive solicitation will be placed on Phase I accomplishments, justification for continued infrastructure support, and research projects focused on AHRQ Portfolio priorities.

To facilitate the above goals, Phase II of this program will include: 

1)  Research Infrastructure Development Support

Development support includes, but is not limited to, the following types of activities:

2)  Individual Investigator Research Projects 

Applications must include a request for support for a minimum of two, but not more than three, research projects.  At least one project must be active in all years of support and must be a primary research project. The others may be pilot projects. This requirement for a minimum of one primary project may be met either by a single project for the full duration of the award, or by several projects running sequentially, as long as at least one primary project is active each year. The expectation is that this support, in concert with the institutional infrastructure enhancement, will eventually enable the individual research project directors to become competitive in sponsored research programs. Securing other support for research projects under the infrastructure grant umbrella such as from the university, foundations, or other mechanisms is encouraged.  

Primary research projects refer to research studies that have well-specified specific aims, hypotheses, methods, and data analysis plans; however, they are not expected to provide the level of detailed description characteristic of R01 applications.  Pilot projects refer to research studies that seek to establish the feasibility or merit of a particular area of inquiry. They are expected to yield findings that address, for example, confirmation of the significance of the research, feasibility of the methods, and refinement/delineation of hypotheses. Convincing justification of the potential significance of the research should be made although methods and hypotheses may be in their early formative stages.  Research projects must be clearly identified in the application as either primary or pilot projects.

The PI may serve as the lead investigator (also called the research project director) on only one research project.  Junior faculty may serve as Project Directors on individual pilot or primary projects which should at a minimum involve such faculty and/or students.  The research should be designed to take advantage of the specific methodological and substantive thrust(s) of the infrastructure development being supported by the program.  The intent of this component is to support research activities that will:

Research projects must focus on one or more of the following current Portfolio research priority areas at AHRQ:

Value:  The Value portfolio focuses on the development, dissemination, and translation of rigorous evidence that can be used by public and private policymakers, by health system and community leaders, and by managers of healthcare organizations.  The main emphasis is placed on the reduction of unnecessary healthcare costs (waste), while maintaining or improving healthcare quality.  Thus, the intent is to increase value and efficiency in the organization, delivery, and financing of health care for all Americans.  In conducting such research, qualitative and mixed-methods research, as well as quantitative methods, are encouraged.

AHRQ is also interested in supporting research that will provide appropriately generalizable findings about the consequences of value-driven experimentation for health care quality and costs, including how such issues relate to AHRQ priority populations.  This also includes encouraging experimentation and the spread of promising strategies for reducing waste and improving value.  Thus, AHRQ seeks to both facilitate and quickly learn from this rich body of “natural experiments,” focusing on:  changes in the organization of health care (e.g., alliances and mergers, regionalization of trauma or other services, use of physician assistants); payment (e.g., tiering, no payment for hospital‑acquired conditions); insurance and benefits redesign (e.g., value‑based benefits design, coverage expansions); healthcare delivery redesigns (e.g., open scheduling;  redesigning emergency room throughputs, lean redesigns); and cultural competency and literacy programs.

Health Information Technology:  Health information technology (health IT) is broadly defined as the use of information and communication technology in health care to support the delivery of patient or population care, or to support patient self-management.  Health IT can support patient care-related activities such as order communications, results reporting, care planning and clinical or health documentation.

Health IT-related portfolio projects of interest to AHRQ include three AHRQ priority areas.  These are:

Comparative Effectiveness: AHRQ is interested in projects that examine comparative effectiveness of different clinical treatments and services, as authorized in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) Section 1013.  The focus is on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system.

Projects can have either a clinical or methodological emphasis, but must focus tightly on the study and/or the use of comparative effectiveness research.  For projects with a methodological emphasis, the goals should be to advance study designs and methods to fill specific knowledge gaps and to enhance the consistency, applicability, and generalizability of the comparative effectiveness studies.  For projects with a clinical emphasis, the goals should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions.  For studies in which randomized controlled trails may not be feasible or timely, or would raise ethical concerns that are difficult to address, novel or alternative study designs may be proposed.  Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders (e.g., policy-makers, providers, and patients) to insure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study.  Research projects should also be organized around a set of priority conditions of importance to the Medicare, Medicaid, and SCHIP programs as mandated by the MMA section 1013.  The current list of conditions includes:

Prevention/Care ManagementAHRQ is interested in supporting two broad strategic goals:  prevention research and care management research. The first goal focuses on preventive services.   Projects awarded in this portfolio area should complement the work of the U.S. Preventive Services Task Force in terms of advancing methods for assessing the benefits and harms of preventive services, and improving the implementation of evidence-based recommendations on preventive services.  AHRQ is interested in funding areas that have not traditionally been the focus of prior funding initiatives, such as:

Examples of projects that would be considered under this portfolio area include, but are not limited to, research on: 

A second area of interest is based on the Care Model (Wagner 1998; Barr, et. al.; 2002).  AHRQ is interested in supporting projects that aim to improve primary care and clinical outcomes through health care redesign, clinical-community linkages, self management support, and care coordination.  Less emphasis is placed on research related to specific conditions, but rather AHRQ seeks to support projects focused on system redesign in ambulatory care, the results of which would be generalizable across health conditions.  Examples of such projects under this area include, but are not limited to, research on the effectiveness, efficiency, and/or implementation of:

Generally, AHRQ is interested in research that involves non-traditional ambulatory health care sites that serve the uninsured, Medicaid, and other vulnerable populations.  Vulnerable populations, as defined by the IOM in 2002, include the uninsured, low-income, under-insured, Medicaid beneficiaries, minority population, immigrant populations and geographically or economically disadvantaged communities.

Patient SafetyPatient safety research initiatives can be considered to occur in three different stages:

The area of patient safety will support research projects seeking to create new knowledge by identifying the risks and hazards encountered by patients as a result of health care.  Proposals in this area may investigate important topics such as the impact of human performance and working conditions on patient safety.  Examples of other topics of interest include the role consumers can play and how they can contribute to protecting patient safety, organizational characteristics and the structure of care delivery organizations.  Additional factors that relate to patient safety such as diagnostic error, communication and teamwork, and the challenges inherent in transitions of care and handoffs between health care providers.

AHRQ encourages an interdisciplinary approach to research that is related to Patient Safety, so that the perspectives not only from the field of health care services but also from the social and behavioral sciences (such as organizational psychology), education, industrial engineering, human factors, and others are incorporated in such a way so that they contribute meaningfully to research plans. 

Additionally, AHRQ supports the inclusion of approaches that address risks and hazards across various dimensions of patient characteristics and priority populations (e.g., the elderly, children, individuals with low health literacy, patients with multiple chronic conditions) settings of care (hospital, long-term care, ambulatory, home health care), and health-related conditions.

Innovations and Emerging IssuesInnovations projects seek to identify and support researchers and institutions with ideas that have the potential for high impact.  These ideas will be novel and span a diverse (and perhaps non-traditional) array of disciplines.  AHRQ anticipates that such projects will foster and nurture ideas that have the potential to lead to highly innovative solutions that may lead to significant advances in healthcare practice, organization, delivery, and management.  Research and activities supported under as innovations will reflect ideas substantially different from those already being pursued elsewhere. These projects will fund transformative research focused on transforming existing conditions and solving pressing healthcare problems.  The main focus is problem solving in order to accelerate improvement in healthcare. 

Research areas of interest include, but are not limited to: 

Innovations for financing and organizing healthcare and related systems to improve quality (including safety, timeliness, effectiveness, efficiency, equity, patient-centeredness) for individuals with complex healthcare needs (e.g., children with special healthcare needs, people with disabilities, frail elderly people).   Studies of other countries or systems’ approaches to financing and organization may be studied for possible adaptation to the United States.  The innovation proposed must be one that can be implemented either nationally or in a representative region of the U.S.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the AHRQ Resource-Related Research Projects Grants (R24) award mechanism and is a one-time solicitation.  The individual researcher sponsored by each applicant organization will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

AHRQ intends to commit up to $1.5 million annually, beginning in FY 2009, to fund three to five grants in response to this FoA.  Applications may be up to three years in duration with a budget supported by AHRQ not to exceed $500,000 per year in total costs to the government.  Applications with project periods that exceed three years or budgets that exceed $500,000 total costs in any given year will not be reviewed. The infrastructure component cannot exceed half of the total cost or $150,000 total costs, whichever is less. 

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

In 2006, AHRQ awarded five research infrastructure planning (P20) grants under RFA-HS-05-010.  Support was provided for planning activities related to the development of a health services research infrastructure in institutions located within selected states which had not historically received significant health services research funding from the Agency.  This announcement is a competitive continuation that extends these activities and only the grantees funded under the above referenced FOA are eligible to apply.  The purpose of these awards is to allow these grantees to build on their achievements from the original P20 grant, to refine, expand, and implement the plans developed during the first phase, and to conduct two to three health services research projects.  Because these funded recipients have conducted the initial planning and development activities to enable them to build on the existing work and because continuity in the research is necessary, this will be a limited competition.  For-profit or foreign organizations may only participate in the grant projects as members of consortia or as subcontractors.

1.B. Eligible Individuals

It is anticipated that the PI from the original infrastructure grants will be the PI for this limited competition FOA.  If this is not the case, it is expected that the applicant PI will be from the same institution/organization and have extensive knowledge of the original infrastructure grant, as well as a background in health services research.  It is also expected the PI will devote at least 20 percent of his or her effort annually to the proposed project in order to insure its success.  Less than 20 percent effort by the PI must be well justified.  Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for AHRQ support.

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

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.

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA. 

Renewal applications are not permitted in response to this FOA

Applicants may submit only one application in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A below for details. 

3.A. Receipt, Review and Anticipated Start Dates
Application Receipt Date: April 21, 2009
Peer Review Date(s): approximately July, 2009 
Earliest Anticipated Start Date(s): approximately September, 2009 

3.A.1. Letter of Intent

Not applicable.

3.A.2. Technical Assistance

Not applicable.

3.B. Sending an Application to AHRQ/NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, one additional copy of the application and any appendix material must be sent to:

Kay Anderson, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1555          
FAX: (301) 427-1562
Email: Kay.Anderson@ahrq.hhs.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review, unless the applicant withdraws the pending 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research.  In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data.  This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Privacy rules at 45 CFR Parts 160 and 164, if applicable; and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements, the DUA will include the requirement that the data user agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget.  In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap. 

4. Intergovernmental Review

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. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

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.

6. Other Submission Requirements and Information

Applications must include projected expenses for traveling each primary investigator on a research project, as well as the PI of the grant (if different from the primary investigators of the individual research projects), to attend and present research findings at the AHRQ annual conference, held normally in September in the Washington, D.C. area.  Applications must also include a composite budget page and separate budget pages and justifications for the infrastructure component and for each proposed research project.

Research Plan Requirements

Each application must include the following two components:

1)  Research Infrastructure Development Plan.  This component is limited to 25 pages (not including budget pages, letters, or biosketches), and it should include:

Plans may also include the establishment of an External Advisory Board to help guide the program, including development and mentoring activities in support of the research projects.  Such a panel may consist of three to five external individuals with relevant expertise in health services research to aid in the development of health services research capacity.  If an External Advisory Board is included, applications should contain a biographical sketch and a letter of commitment from each proposed advisory panel member (these do not count toward the 25 page limit).

2)  Individual Investigator Research Projects. 

Applicants must propose at least two, but not more than three, research projects.  At least one project must be a primary research project.  Primary research projects must not exceed 10 pages in length for each project described. Pilot projects must not exceed five pages in length for each project described. 

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to 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.  This authority is found at 42 USC 299(c).  To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see 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.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature.  Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff.  The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers.  This is critical when outreach to the general and trade press is involved.  Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions.  In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized.  An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs.  Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS).  HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership.  HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data.  HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place.  HCUP include two nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids’ Inpatient Database (KID), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD).  More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population.  MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC).  The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample.  The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees.  More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants’ use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

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.

Section V. Application Review Information


1. Criteria

Administrative Criteria:  Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria are described below.  The review criteria described below will be considered in the review process.

2. Review and Selection Process

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:

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed plans will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field and/or institution forward.

Significance:  Given the goals of the research infrastructure development program, does the main theme of the application address an area of health services research of priority to AHRQ?  Given the current capacity of the institution, if the aims of the overall plan are achieved, will there be a significant impact on the institution’s capacity for engaging in and sustaining health services research activities that are relevant at the local, state or national level?  How will the proposed plan prepare faculty and students to advance the field of inquiry proposed in the application in significant ways, and/or to develop useful research products/services that can be used in policy or health care delivery?

Regarding the individual research projects, do the projects address important problems?  If the aims of the application are achieved, how will scientific knowledge, health care delivery policy or practice, or clinical practice be advanced?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Do the studies adequately prepare the investigators to conduct health services research and serve as an important step or component in the development of future grant applications?  Is it likely that the study will result in publications, presentations, policy or health care delivery briefs?  Are there adequate plans for dissemination?

Approach:  To what extent has the original planning grant made progress in research capacity building, both in terms of infrastructure development and in the advancement of faculty and/or student careers, based on the original goals and the length of time that the program has been implemented?  Does the application demonstrate need for the grant and does it logically build on the planning activities.

In the context of infrastructure development efforts, how will the overall program be evaluated, both from a formative and a summative perspective?  Is career development assistance provided as needed to faculty and students in areas such as scientific writing and publication, research design and analyses, substantive seminars; participation in meetings and conferences; mentoring; and research opportunities and support?  Are any proposed plans for faculty and student development feasible given the institution’s current capacity, and will these plans contribute to capacity building goals?

What is the quality of the design in the individual research projects?  Does the applicant address both the benefits and the limitations of the research projects?  Are the projects firmly grounded in the current literature?  How will the research projects contribute to the field?  If pilot in nature, do the research projects seek to establish feasibility, or the merit of a particular area of inquiry?  What is the appropriateness of the approach in the research projects?  Are there available resources and support for the investigators leading the research projects?  Do the research projects provide adequate opportunities for faculty and student mentoring and development?

Innovation:  Given that the focus of this effort is the development of research infrastructure, does the applicant approach institutional capacity building in ways that are creative?  Does the applicant propose to establish collaborations that can potentially lead to new discoveries?  If relevant, does the applicant explore new approaches to attracting faculty, staff, and students to health services research? Will the implementation plans stimulate innovative or policy/practice relevant questions?  Do the research experiences provide faculty and students with opportunities to explore gaps in our understanding of the research problems or priorities addressed? 

Are the proposed research projects original and innovative?  For example, do the projects challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Do the projects develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators:  Given that the PI/PD is critical to the sustainability of research efforts at the institution, how well does the PI/PD demonstrate commitment to health services research and to faculty and student development?  Are there clear indicators of institutional support (i.e., release time, letters from university leadership, courses already taught), and evident availability to lead the effort and mentor faculty and students?  How adequate is the letter of institutional commitment, and does it address protected time for faculty to engage in health services research, and research mentoring; opportunities to recruit and retain quality faculty and students; and opportunities for career development for faculty, as needed?  How well can the PI/PD provide direction and leadership in the research proposed?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?  What is the quality of the available resources at the institution, including equipment and research space, and how is it linked to capacity development plans?  To what extent will the proposed research change/alter the environment, facilitate the institutions’ ability to conduct, expand, and improve health services research, and/or secure institutional support for commitment to the conduct of health services research?  Are research administration, collaborative arrangements, and data management and analysis support adequate?  What is the current faculty and student interest in health services research and professional development activities?  What is the probable long-term impact of the program?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Degree of responsiveness:  How well does the application address 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?

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research

Inclusion: 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,” and inclusion criteria included in section VIII of Required Federal Citations, below.)

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Privacy and Security Protections for Patients:  The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Applications submitted in response to this funding opportunity 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:

2.B. Additional Review Considerations

Not applicable.

2.C. Resource Sharing Plan(s)   

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data.  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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

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 National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. 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

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes.  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).

3. Anticipated Announcement and Award Dates

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

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.

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 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). 

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization.  Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official.  The NOA signed by the grants management officer is the authorizing document.

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.”

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, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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

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 a through f as described in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 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.  Annual impact statements, described above, must also be included in these annual reports.  AHRQ will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

A final Progress Report and Financial Status Report are required when an award ends.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contacts:

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

Kay Anderson, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1555
Fax: (301) 427-1562
E-mail address: Kay.Anderson@ahrq.hhs.gov

2. Peer Review Contacts:

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

Ali Azadegan, D.V.M., Ph.D
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1869
Fax: (301) 427-1562
E-mail address: Ali.Azadegan@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to: 

Al Deal
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1806
Fax: (301) 427-1447
E-mail address: Al.Deal@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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 are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html.  AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
 
Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances.   Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement.  Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption” in FOIA, 5 USC 552(b)(3).  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for example, if it constitutes trade secrets or commercial information.  NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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. 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/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.


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