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

Title: AHRQ Small Research Grant Program (R03)

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

Announcement Type
This is a reissue of PAR-01-040, which was previously released January 2, 2001.

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-06-448

Catalog of Federal Domestic Assistance Number(s)
93.226 (for all grants and cooperative agreements)

Key Dates
Release/Posted Date: June 7, 2006
Opening Date: June 24, 2006
Application Submission/Receipt Date(s): March 24, July 24, November 24 annually until March 24, 2007, then Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): within 3 months of submission
Earliest Anticipated Start Date(s): within 7 months of submission
Expiration Date: (Extended to May 8, 2010 per NOT-HS-10-006) Original Date: November 17, 2008 - (Old Expiration Date November 17, 2009 per NOT-HS-08-010)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) issued by AHRQ supports Small Research Grant (R03) applications. The R03 grant mechanism supports different types of health services research projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and, development of new research technology.

While grant awards are made to institutions rather than individuals, this FOA and its instructions are addressed to potentially interested individuals to inform them of this funding opportunity and facilitate the preparation of grant applications by the individuals who will actually assume the primary responsibility for the preparation of their organization’s application.

The applicant will be solely responsible for planning, directing, and executing the proposed project.

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 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Electronic Transmission of an Application to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ strives to achieve its mission by supporting research which directly relates to accomplishing one of the following broad-based goals:

The current priority areas of AHRQ include:

1) Translating Research into Practice and Policy

AHRQ's mission includes a significant commitment to translating research into practice and policy (TRIPP). Within this area, investigators conduct research and evaluation projects related to the translation of research findings into measurable improvements in quality, patient safety, healthcare outcomes and cost, use, and access. For example, AHRQ TRIPP-related research projects 1) test strategies for adoption, implementation, and routinization of evidence-based clinical and organizational interventions; 2) assess the degree to which interventions that have been proven successful in just a few health care settings or outside of health care are appropriate to other health care settings and the degree to which practices that worked well with one population fit other types of populations - especially racial and ethnic minorities, children, elderly, rural populations, and other priority populations; and, 3) identify successful past efforts to adopt, implement, and routinize evidence-based clinical and organizational interventions, and then take these "to scale" by replicating them across a number of organizations.

2) Patient Safety and Quality

One of the important elements in the AHRQ mission is to support the development of multi-disciplinary research teams in building the knowledge base on the scope and impact of medical errors, particularly for diverse care settings and populations, identify the root causes of threats to patient safety and effective system approaches to prevent the occurrence of errors, study the effectiveness of various interventions to capture information on medical errors, evaluate the implementation of information technology to reduce errors and increase efficiency, and disseminate and evaluate the outcomes of promising interventions in a variety of health care settings and across a variety of health care professions.

3) Patient-Centered Care

One critical set of issues facing public and private policymakers concerns the challenge of designing patient-centered processes to improve the quality and safety of care delivery. Patient-centered care is defined as health care that establishes a partnership among practitioners, patients and their families (when appropriate) to ensure that decisions respond to and respect patients' wants, needs and preferences and solicit patients' input on the education and support they need to make decisions and participate in their own care.

Essential dimensions of patient-centered care include but are not limited to: 1) accessible and customized information, communication, and education; 2) continuous collaboration, coordination and integration of care among providers, across conditions and settings; 3) shared decision-making of clinicians with patients and their families; 4) self-efficacy and self-management skills for patients; 5) patients' experience of care; 6) provider-patient partnership; and, 7) enhanced cultural competence of health care providers. AHRQ supports patient-centered care research focusing on the redesign and evaluation of new care processes that lead to greater patient empowerment, improved patient-provider interaction, easier navigation through healthcare systems, and improved access, quality, and outcomes. Specific strategies could include, but are not limited to, the value of a medical home, care coordination, medication therapy management, patient education and self-efficacy, and health professions education, for patients with multiple chronic illnesses and those who need for multiple risk-behavior interventions. Also, studies examining clinical and system approaches to reduce racial, ethnic and socioeconomic disparities in the care of sicker adults are encouraged.

4) Payment and Organization

One dilemma currently facing America is how to improve health care quality and access while costs continue to soar. There is now a recognition that a first fundamental step in dealing with this dilemma is through innovations in organization and payment structures. To understand the impact of changes in organizational structure and processes, new technologies, and management innovations, and to discover ways to create a less wasteful and higher-quality health system, AHRQ encourages research on system design and change as well as processes resulting in planned and unplanned change. Evaluation of innovations led by public and private sector leaders are of particular interest. For example, evaluation of innovations in prescription drug payments and cost-sharing, value-based purchasing, improving care processes within a health care organization, pay-for-performance incentives, state malpractice reforms, and response to Health Savings Accounts or consumer directed health options, are of interest.

Applicants are strongly encouraged to address health services research issues critical to AHRQ priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, and the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care.

Some examples of the types of projects that R03 research involves include the following:

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

Section II. Award Information

1. Mechanism(s) of Support

This Funding Opportunity Announcement (FOA) invites applications for small research (R03) projects. The individual researcher sponsored by each organizational awardee 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 be returned without review.

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 the AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

The budget limit on small project grant applications is $100,000 total costs (i.e., direct costs plus Facilities and Administrative (F&A) costs) for the entire project period. A project period of up to two years may be requested. Applications requesting more than $100,000 total costs or longer than 24 months of support will be returned to the applicant without review.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

For the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations and foreign institutions will be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

AHRQ does not require cost sharing for applications submitted in response to this Funding Opportunity Announcement.

3. Other-Special Eligibility Criteria

Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Resubmissions: Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Renewals: Applicants may not submit a renewal application.

Projects must be self-contained. They may be conceptually linked to future or past projects, but must contain all the elements of a stand-alone effort that can be reviewed and evaluated on its own for both scientific merit and budget.

The request may not be used to supplement currently supported projects, provide interim support for projects under review by the PHS, or obtain funding as a competing continuation of a small grant. Requests for support for thesis or dissertation research will not be considered under this small grant program. Applications to support dissertations should be submitted for consideration under the AHRQ Small Grant Program for Health Services Dissertation Research.

Section IV. Application and Submission Information

To download an Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site in accordance with the SF424(R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

A one-time registration is required for institutions/organizations at both:

Project Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organization/Institutional Registration in Grants.gov/Get Started

2) Organization/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the

"List of Grantee Organizations Registered in NIH eRA Commons.

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

NOTE: Both the PD/PI and Authorized Organization Representative/Signing Official (AOR/SO) need separate accounts in the Commons since both are authorized to view the application image. If you are the AOR/SO for your organization as well as PD/PI of the grant, you will need two separate accounts with different user names - one with AOR/SO authority and one with PD/PI authority. When an organization/institution is registered, an AOR/SO account is created. Log on to the account with the AOR/SO authority role and create another account with PD/PI authority.

Note that if a PD/PI is also an NIH or AHRQ peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take up to four weeks. Therefore, applicants should immediately check with their institutional/organizational official to determine whether their institution/organization is already registered in both Grants.gov and the Commons. AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the Attachment files may be useable for more than one FOA.

For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by AHRQ (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: June 24, 2006 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): March 24, July 24, November 24 annually until March 24, 2007, then Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): within 3 months of submission
Earliest Anticipated Start Date: within 7 months of submission

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Electronic Transmission of an Application to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

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, previously called Health Care Financing Administration (HCFA), 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 AHRQ's confidentiality 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 included in the DUA is the requirement that the 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 6 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 INQUIRIES.

To avoid double counting, applicants should not include the cost of the CMS data in the budget. Small research grant applicants should be aware that the costs of the grant, including the cost of CMS data, cannot exceed $100,000 total costs. In the event the total costs of the project plus the cost of CMS data is greater than $100,000, 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 $100,000.

4. Intergovernmental Review

This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html (See also Section VI.3. Reporting.)

6. Other Submission Requirements

AHRQ requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the NIH eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to one resubmission (formerly revisions/amendments") of a previously reviewed small grant application may be submitted. Resubmission receipt dates are the same as the receipt dates for new R03 applications.

Specific Instructions for Modular Grant applications.

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will be returned without review.

Application Characteristics

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Appendix: (New and Resubmission Applications)

Budget:

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS 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, which 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 also found at 42 USC 299. 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 are to 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.

HCUPS & 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 inpatient 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 databases include: the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states. More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, noninstitutionalized population. MEPS is comprised 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 MEPS is available at http://www.meps.ahrq.gov.

This does not preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

Not Applicable

Section V. Application Review Information

1. Criteria (Update): Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness. Merit Review Criteria are described in Section V.2 below.

2. Review and Selection Process

Review 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 be returned to the applicant without further consideration.

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

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.

The R03 small grant mechanism at AHRQ supports discrete, well-defined projects that realistically can be completed in two years. Because the research plan is restricted to 15 pages, an R03 grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers will evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: Does this study address an important scientific area in health services research? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of this study on the concepts, methods, technologies, treatments, services, or preventative interventions that drive health services research?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field of health services research? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support to carry out the project?

2.A. Additional Review Criteria:

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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 item 7 of the Research Plan component of the SF 424 (R&R).

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the

Budget: Does the proposed budget appear reasonable and is the requested period of support appropriate in relation to the proposed research? Is the percent effort listed for the PD/PI appropriate for the activities proposed? Is each budget category realistic and justified in terms of the project aims and methods?

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

Data Confidentiality

Pursuant to section 934(c) of the (PHS) Act (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 now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.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 RFA will also be obtained and managed in accordance with 42 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, for example, ordinarily will require either patient authorization of 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.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/.

The awardee 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 websites 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.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. 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; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended R03 applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate 7 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 NIH 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 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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NGA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See 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 beyond that the terms and conditions of the Public Health Service (PHS) Grants Policy Statement as part of the notice of grant award, found at http://grants.nih.gov/grants/policy/gps/index.html. For terms of the award, see http://grants.nih.gov/grants/policy/gps/5award.htm#terms, and see http://grants.nih.gov/grants/policy/gps/5award.htm#fund for the award and funding process.

As necessary, Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the Public Health Service (PHS) Grants Policy Statement, found at http://grants.nih.gov/grants/policy/gps/index.html.

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.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs. 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.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the FOA. Written and telephone inquiries concerning this FOA are encouraged.

Direct your questions regarding specific program matters to the AHRQ staff listed at: http://www.ahrq.gov/fund/staffcon.htm.

2. Peer Review Contacts:

Direct your questions about peer review matters to:

Kishena Wadhwani, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
301- 427-1556
E-mail address: [email protected]

3. Financial/Grants Management Contacts:

Direct your questions about financial or grant management matters to:

Michelle Burr
Office of Performance Accountability Resources and Technology
Division of Grants Management
301- 427-1451
[email protected]

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are to be 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 AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES).

Human Subjects Protection:

Federal regulations 45 CFR 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). Compliance with the Privacy Rule for those classified under the Rule as "covered entities". Decisions about applicability and implementation of the Privacy Rule reside with covered entities. 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 of a covered entity. 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 act 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, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption in FOIA. 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", 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 the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 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 or Health Systems Agency review. Awards are made under the authorization of Title IX of the Public Health Service Act (42 USC 299-299c-6), under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The PHS Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html.

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 PHS mission to protect and advance the physical and mental health of the American people.

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