Building Research Infrastructure and Capacity (BRIC) Program

RFA Number:  RFA-HS-05-010 

Part I Overview Information

Department of Health and Human Services (DHHS)

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

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

Announcement Type: New

Catalog of Federal Domestic Assistance Number(s): 93.226

Key Dates
Release Date :August 30, 2004
Letters Of Intent Receipt Date(s):  October 10, 2004
Application Receipt Dates(s):   January 18, 2005 
Peer Review Date(s):   April 2005
Earliest Anticipated Start Date:  August 2005
Additional Information To Be Available Date (Url Activation Date):  NA
Expiration Date:  January 19, 2005

Due Dates for E.O. 12372 :   Not Applicable

Executive Summary

The Building Research Infrastructure and Capacity (BRIC) program is a merit-based, peer-reviewed program in response to Congressional intent to broaden geographic distribution of health services research funding among institutions located in states in which the aggregate success rate for applications to the AHRQ has historically been low.  This RFA will use the Exploratory Grant (P20) award mechanism.  AHRQ intends to commit approximately $1 million in FY 2005 to fund four to six new grants in response to this RFA.

Applications may be submitted only by institutions within BRIC-eligible states.  BRIC-eligible states include all states which have received less than $3 million dollars in AHRQ support over the past five years (FY1999-FY2003).  These states include Alaska, Arkansas, Delaware, Hawaii, Idaho, Kentucky, Louisiana, Maine, Montana, Nebraska, Nevada, North Dakota, Oklahoma, South Dakota, West Virginia, and Wyoming.  In addition, institutions in the Commonwealth of Puerto Rico and the Virgin Islands are also eligible.  Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.  The application must include a proposed institutional plan for the development of a health services research infrastructure and one proposed research project.

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001).  The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.

Telecommunications for the disabled:  TTY 301-451-5936

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
    3. Other - Special Eligibility Criteria

Section IV. Application and Submission and Instructions
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Time
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      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. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

Section VI. Award Administration Information
    1.  Award Notices
    2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award   
    3. Award Criteria
    4. 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

The Agency for Healthcare Research and Quality (AHRQ) announces the Building Research Infrastructure and Capacity (BRIC) Program.  BRIC is a merit-based, peer-reviewed program originally initiated in 2001 in response to Congressional intent to broaden geographic distribution of health services research funding by enhancing the competitiveness for research funding among institutions located in states in which the aggregate success rate for applications to the AHRQ has historically been low.  Primary goals of BRIC are to (1) enhance the competitiveness of research institutions and organizations in the BRIC-eligible states (see below) for AHRQ-funded grants and  (2) increase the probability of long-term growth of AHRQ-competitive funding to investigators at institutions from these eligible states.  This Request for Application (RFA) describes a two-year planning and development effort to plan, develop, and begin the implementation of a viable and sustainable health services research program in institutions within states which have received less than $3 million dollars in AHRQ support over the past five years (FY1999-FY2003).

1.   Research Objectives
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of healthcare for all Americans.  The research sponsored and conducted by the Agency provides information that enables better decisions about health care.  General research goals of AHRQ include:

1. Supporting improvements in health outcomes;
2. Strengthening health care quality measurement and improvement; and

3.   Identifying strategies to improve access, foster appropriate use, and reduce unnecessary expenditures related to healthcare.

4.  Medical Errors/Patient Safety:  One of the important elements in the AHRQ mission is to support the development of multidisiciplinary 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; and disseminate and evaluate the outcomes of promising interventions in a variety of health care settings and across a variety of health care professions.
5.  Translating Research into Practice and Policy (TRIPP):  Applicants are encouraged to conduct innovative and rigorous 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.  Particular interest lies in research that can bridge the chasm between promising prototypes and generalizable knowledge that can be applied in multiple settings and lead to systematic improvement on a large scale.  Some of these topics are described in the following program announcement: Translating Research into Practice, Joint Program Announcement, http://grants.nih.gov/grants/guide/pa-files/PA-02-066.html.
6.   Bioterrorism:  Applicants are encouraged to submit applications that investigate and evaluate promising practices and strategies being developed and implemented at the State, local, and health system level to promote health system readiness in response to bioterrorism.  Also of interest is the application of available methods and tools that can be of assistance in developing systems capacity and enhancing readiness in rural and urban areas. http://grants1.nih.gov/grants/guide/pa-files/PAR-03-130.html
7.   Prevention:  Applicants are encouraged to submit applications that relate to the Public Health Services’ Health Promotion and Disease Prevention objectives as outlined in “Healthy People 2010”. (http://www.health.gov/healthypeople). 

Information and announcements describing AHRQ’s general research areas of interest are available at http://www.ahrq.gov  (see Funding Opportunities).  For a description of recent research topics of interest to the Agency, applicants are encouraged to review the following research solicitations:

Applicants are further encouraged to address health services research issues critical to 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 healthcare needs, including those with disabilities and those who need chronic or end-of-life healthcare.  More information can be obtained from the following web address:  http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html

AHRQ acknowledges that due to variability among potential applicants, the size and scope of the BRIC program will depend in large part upon the current size and extent of the health services research environment of applicant institutions and organizations.  It is recommended that in order to achieve maximum impact of the available funds, applicants propose innovative research activities that will stimulate sustainable improvements in the capacities of institutions and organization in eligible states to compete successfully for AHRQ funds and to enhance their research competitiveness in future years.

Examples of types of activities may include:

The application must include a proposed institutional plan for the development of a health services research infrastructure and one proposed research project.  These proposals must provide sufficient information to allow the peer reviewers to assess it in terms of the Review Criteria stated below.

The institutional infrastructure plan of the BRIC application should include:

The institutional research development plan section of the application is limited to 25 pages.

The following should be addressed within the research project proposal:

The research project plan is limited to an additional 10 pages (not including the Literature Cited section).

It is anticipated that by the end of the two-year award period, the grantee should be positioned to submit a successful application(s) for funding to build on the work originating from this BRIC grant.  Such funding could be from other Federal, State, or local agencies, and/or from private foundations.  The grantee should also be in the final stages of manuscript and/or professional presentation preparation, highlighting their BRIC-related accomplishments.  Topics for these might include “lessons learned,” how to develop and/or build a health services research infrastructure, pilot study methodologies/results, research findings, faculty development strategies, research infrastructure trajectories, etc.  The grantee should also be able to demonstrate the growth and institutionalization of health services research within his/her organization, through such means as citing administrative acknowledgement and support of activities,  growth in partnerships or areas of research foci across components of the institution in which the grant is housed or with additional institutions, the impact the grant has had on the grantee, the institution, and/or the local area or state as related to health care policy or improvements in the delivery of healthcare. 

Section II. Award Information

1.  Mechanism(s) of Support

This funding opportunity will use the Exploratory Grant (P20) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.   This RFA is a one-time solicitation and will be reviewed according to the Review Criteria described below.  The anticipated award date is August 2005.

AHRQ is not using the Modular Grant Application and Award Process.  Applications submitted in modular format will be returned without review.

No supplemental funds will be awarded.

The total project period for an application submitted in response to the RFA may not exceed two years.  It is anticipated that after successful completion of these exploratory grants, grant recipients will be in a position to compete for subsequent multi-year funds which AHRQ may offer, contingent upon funding availability, through a separate solicitation to be released in Fiscal Year 2007.

2.  Funds Available

AHRQ intends to commit approximately $1 million in FY 2005 to fund four to six new grants in response to this RFA.  An applicant may request a project period of up to two years and a total budget not to exceed $250,000 per year.  Those applications requesting more than $250,000 will be returned without review.

Because the nature and scope of the proposed research will vary by application, it is anticipated the size of each award will also vary.  Although the Agency’s financial plans  provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.  At this time, it is not known if this RFA will be reissued. 

In general, the direct costs listed in the PHS Grants Policy Statement as allowable for research grants are also allowable for the BRIC program.  Funds requested for the BRIC program may be used to support the following:

Direct costs NOT allowable:

Support provided through the BRIC award may not replace existing state, institutional or Federal research support, but can be used to replace such support which has expired.

Section III. Eligibility Information

1.  Eligible Applicants
1.A.   Eligible Institutions

Applications may be submitted only by institutions within BRIC-eligible states.  BRIC-eligible states include all states which have received less than $3 million dollars in AHRQ support over the past five years (FY1999-FY2003).  These states include Alaska, Arkansas, Delaware, Hawaii, Idaho, Kentucky, Louisiana, Maine, Montana, Nebraska, Nevada, North Dakota, Oklahoma, South Dakota, West Virginia, and Wyoming.  In addition, institutions in the Commonwealth of Puerto Rico and the Virgin Islands are also eligible.

Collaborative and cooperative programs between or among institutions within and outside of BRIC-eligible states are allowed and encouraged.  The applicant institution must perform a substantive role in the conduct of the planned research project activities and may not serve primarily as a conduit for the transmission of funds to another party or multiple parties.  Institutions in eligible states which currently possess a BRIC grant from AHRQ are not eligible to apply as the prime grantee, but may be involved in a partnership with another institution within the same state, which serves as the prime applicant organization.

You may submit an application if your institution is from the above mentioned states and has any of the following characteristics:

For the purpose of this RFA, AHRQ will make grants only to non-profit organizations.  For-profit organizations may participate in projects as members of consortia or as subcontractors. Organizations described in sections 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 their 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 for AHRQ programs. 

2.   Cost Sharing

AHRQ does not require cost sharing for applications submitted in response to this RFA.

3. Other-Special Eligibility Criteria

Section IV. Application Submission Instructions

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. 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 PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (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.dunandbradstreet.com/The D&B number should be entered on line 11 of the face page of the PHS 398 form.
See also Subsection VI.2. for additional information.

To ensure equity among applicants, however, applicants using the Form PHS 398 must observe page number and font size requirements specified in the form.

3.  Submission Dates and Time
3.A.   Receipt, Review and Anticipated Start Dates
Letters Of Intent Receipt Date(s):  October 10, 2004
Application Receipt Dates(s):   January 18, 2005
Peer Review Date(s):   April 2005
Earliest Anticipated Start Date:  August 2005

3.A.1.   Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Kay Anderson, Ph.D.
OEREP/DRE
Agency for Healthcare Research and Quality
540 Gaither Road, Room 2109
Rockville, MD  20850                 
Telephone:  (301) 427-1555
FAX: (301) 427-1562
Email: KAnderson@AHRQ.gov

3.B.  Sending an Application to the NIH

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

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

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


Kay Anderson, Ph.D.

OEREP/DRE
Agency for Healthcare Research and Quality
540 Gaither Road, Room 2109
Rockville, MD  20850                 
Telephone:  (301) 427-1555
FAX: (301) 427-1562
Email: KAnderson@AHRQ.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing
Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.
 
The NIH & AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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.

Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA.  The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned.  It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without 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).

The RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, (see under Funding Opportunities).

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 NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria)

6.  Other Submission Requirements

o   Priority Populations

The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and 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.  To implement this directive, 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 RFA should address the requirements of including priority populations as specified in the Notice. 

o   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 and/or contractors are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature.  Grantees and contractors 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.  Contact with the media will take place in close coordination with OCKT and the press offices of the grantee’s or contractor’s institutions.  In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors 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.

o   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 develops and maintains a family of health care databases, related software tools, support services, and products whose information resources are grounded in a Federal, State, and Industry Partnership.  The multi-state HCUP databasesbring 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 discharge-level health care data.  HCUP includes the largest collection of longitudinal hospital care data in the United States, with all-payer, discharge-level information beginning in 1988. These databases enable research on a broad range of health policy issues, including cost and quality of health services, medical practice patterns, access to health care programs, and outcome of treatment at the national, State, and local market levels.

The HCUP includes databases covering 1988-1997, with 1998 and 1999 data available in 2001. These all-payer databases were created through a Federal- State-industry partnership to build a multi-State healthcare data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample of about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 states. Other HCUP databases contain ambulatory surgery data from nine states. These databases can be directly linked to county-level data form the Health Resources and Services Administration’s Area Resource File and to hospital-level data from the Annual Survey of the American Hospital Association.   More information on HCUP can be found at http://www.ahrq.gov.

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, noninstitutionalized population.  MEPS comprises 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.

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

o  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 statue, 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.

o   Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, the 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.

To receive an award, applicants must agree to submit an original and two copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period.  The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (Word Perfect, or Word, or ASCII format).

The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess applicants’ potential for responsible stewardship of awarded funds.

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.  Applications submitted in the Modular format will be returned without review.

Section V. Application Review Information

1.   Criteria
Not Applicable

2.  Review and Selection Process
Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA.  Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration.  An appropriate peer review group convened in accordance with standard AHRQ peer review procedures will evaluate applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures.

3.   Merit Review Criteria

As part of the merit review, all applications will:

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.  The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. 

The application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high 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 forward.

Significance/Impact: Does your study address an important problem from a scientific and/or translational (i.e., is the work proposed or subsequent efforts stemming from it likely to be relevant to the delivery of clinical care, operations of healthcare delivery systems, or local, regional or national policy) perspective? If the aims of the application are achieved, how do they advance scientific knowledge or how usable are they to decision makers or consumers?  What will be the effect of these studies on the concepts or methods that drive this field?

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

Innovation:  Does the project employ novel concepts, approaches or methods? Are the aims original and innovative?  Does your project challenge existing paradigms or develop new methodologies or technologies?

Investigator: Is the investigator appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to the experience level as the principal investigator and other researchers (if any)?

Environment:  Does the environment in which your work will be done contribute to the probability of success?  Does the work take advantage of unique features of the environment or employ useful collaborative arrangements?  Is there evidence of institutional support?

Inclusion of Priority Populations: Does the applicant adequately address the priority population policy of AHRQ, found in http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html.  For a list of frequently asked questions and answers with regard to the implementation of this policy, please see http://www.ahrq.gov/fund/ppopfaq.htm

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

3.A.  Additional Review Criteria:

In addition to the above criteria, your application will also be reviewed with respect to the following:

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

Protection:  The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application.

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project.  Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Agency policies and Requirements, below.)-

3.B.    Additional Review Considerations

Not Applicable

3.C.   Sharing Research Data

Data Confidentiality

Pursuant to section 924(c) of the Public Health Service 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 the 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 managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of protected health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) became mandatory for covered entities on April 14, 2003.  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, for example, health care plans, 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) satisfied that any identifiable health information will be appropriately safeguarded by the investigators. The HHS 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 those 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.

3.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 Federal government 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 these issuances 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).

Section VI. Award Administration Information


1.   Award Notices

Not Applicable

2.   Administrative and National Policy Requirements

Not Applicable

2. A.   Cooperative Agreement Terms and Conditions of Award

Not Applicable

 3. Award Criteria

The following will be considered in making funding decisions:

4.   Reporting

Not Applicable

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:

Direct your questions about scientific/research issues, including information on the inclusion of women, minorities, and children, and other priority populations in the study to:

Kay Anderson, Ph.D.
OEREP/DRE
Agency for Healthcare Research and Quality
540 Gaither Road, Room 2109
Rockville, MD  20850        
          Telephone:  (301) 427-1555
FAX: (301) 427-1562
Email: KAnderson@AHRQ.gov

2.   Peer Review Contacts:

Direct your questions about peer review issues to:
Scott Andres, Ph.D. 
OEREP/DSR 
Agency for Healthcare 
Research and Quality 
540 Gaither Road, Room 2103 
Rockville, MD  20850                 
Telephone:  (301) 427-1546
FAX: (301) 427-1562
Email: SAndres@AHRQ.gov

3.   Financial or Grants Management Contacts:

Direct your questions about financial or grants management matters to:

Marc Pitts
OPART/GM
Agency for Healthcare Research and Quality
540 Gaither Road, Room 4202
Rockville, MD  20850                 
Telephone:  (301) 427-1704
FAX: (301) 427-1462
Email: MPitts@AHRQ.gov

Section VIII. Other Information

Required Federal Citations

Inclusion of Women, Minorities, and Children in Research Study Populations:  It is the policy of AHRQ that women and members of minority groups 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 with respect to the health of the subjects or the purpose of the research. 

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).

AHRQ also encourages investigators to consider including children in study populations, as appropriate.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some 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 is not subject to this disclosure requirement.  Furthermore, even if a Federal regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." 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 constituted trade secrets or commercial information collected. 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 RFA 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002.  This 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). Mandatory compliance with the Privacy Rule (for those classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). 

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.

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/, Number 93.226.  Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999).  Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. 

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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