LIMITED COMPETITION FOR AHRQ BUILDING RESEARCH INFRASTRUCTURE AND CAPACITY 
PROGRAM: PHASE II

RELEASE DATE:  April 11, 2003

RFA: HS-03-004

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.226

LETTER OF INTENT RECEIPT DATE:  June 13, 2003 

APPLICATION RECEIPT DATE:  July 15, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION:

o   Purpose of the RFA
o   Research Objectives
o   Mechanism(s) of Support
o   Funds Available
o   Eligible Institutions
o   Individuals Eligible to Become Principal Investigators
o   Special Requirements
o   Where to Send Inquiries
o   Letter of Intent
o   Submitting an Application
o   Peer Review Process
o   Review Criteria
o   Receipt and Review Schedule
o   Award Criteria
o   Required Federal Citations 

PURPOSE OF THE RFA

This solicitation is the second phase of the Building Research 
Infrastructure and Capacity (BRIC) program initiated by the Agency for 
Healthcare Research and Quality (AHRQ) in 2001, and is limited to the 
current recipients of the initial BRIC planning grants.  The original 
BRIC concept was initiated in response to Congressional intent to 
broaden geographic distribution of health services research funding by 
enhancing the competitiveness for funding among institutions in states 
where the success rate for applications to AHRQ had historically been 
low.  

In Phase I, two-year planning grants (P20s) were awarded to six sites 
located in states which had not previously received significant health 
services research funding from AHRQ.  Importance in this new 
competitive solicitation will be placed on Phase I accomplishments and 
a demonstration of the need for continued support to further develop 
institutional research infrastructure.  Phase II will provide 
additional support for the refinement, expansion, and implementation of 
plans developed among grantees supported in Phase I, including 
resources for the conduct of pilot research projects. 

RESEARCH OBJECTIVES
 
Background

BRIC is designed to build, increase, strengthen, and sustain the health 
services research competitiveness of institutions and organizations 
within eligible states.  It is part of an integrated approach by AHRQ 
to develop and broaden the national infrastructure for conducting 
health services research.  Through this program, grantees will conduct 
health services research focused in one or more of the following areas:

o   Translating Research Into Practice (TRIP): 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 attention will be given to 
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.

o   Patient Safety: One of the important elements in the AHRQ mission 
is to support the development of multidisciplinary 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 
professionals.

o   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 systems 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 as well as urban areas.

o   Prevention: Applicants are encouraged to submit applications that 
relate to the Public Health Service's health promotion and disease 
prevention objectives as outlined in "Healthy People 2010". 
(http://www.health.gov/healthypeople).  Of particular interest would be 
those research projects investigating the appropriate use of clinical 
preventive services, such as screening tests, immunizations, and 
counseling, which are based on the U.S. Preventive Services Task Force 
(USPSTF).

o   Priority Populations/Health Disparities: AHRQ encourages 
applications that conduct and support research and evaluations and/or 
support demonstration projects with respect to the delivery of 
healthcare in inner-city and rural areas (including frontier areas); 
healthcare for priority populations, which include low income groups, 
minority groups, women, children, the elderly, and individuals with 
special healthcare needs, including individuals with disabilities and 
individuals who need chronic care or end-of-life healthcare.  Further, 
the Agency supports the generation and dissemination of health services 
research to promote the equitable receipt of healthcare services for 
all Americans and eliminate health disparities among racial and ethnic 
minority populations.

o   Faith-Based Initiatives: The Department of Health and Human 
Services (DHHS) supports the Presidents' Faith-Based and Community 
Initiatives which were created to focus on improving human services for 
our country's neediest populations.  As such, research is encouraged 
which uses faith-based and/or community organizations as subject 
recruitment sites and/or study implementation sites for health services 
research.  Also of interest are projects which develop and coordinate 
outreach efforts to disseminate health-related information or to 
translate or implement healthcare research findings more effectively 
through faith-based and other community organizations.

o   AHRQ Data: For research that is designed to use existing data, AHRQ 
encourages research applications that will use data from the Medical 
Expenditure Panel Survey (MEPS) (http://www.meps.ahrq.gov/), the 
Healthcare Cost and Utilization Projects (HCUP) 
(http://www.ahrq.gov/data/hcup/), and other AHRQ sources.  Additional 
information is listed below in the AHRQ Data Section under Submitting 
An Application.

Objectives and Scope

To facilitate the above goals, Phase II of the BRIC program will 
provide support for two types of primary activities:

Institutional Research Development Support:  Infrastructure development 
such as:

o   those involving collaborative linkages with senior scientists 
across multiple components of the applicant institution (e.g., schools, 
colleges, divisions, and departments) and/or in other institutions;
o   provision of resources for data management and statistical 
analyses, including data access or linkage and data dissemination 
systems;
o   developing the capacity of state administrative data for use in 
research projects and conducting state or community level analyses 
using AHRQ Quality Indicators (i.e., Prevention Quality Indicators, 
Inpatient Quality Indicators, or Patient Safety Indicators) applied to 
state inpatient administrative data;
o   Center development, including limited support for equipment and 
staff involved in the coordination of research activities across 
participating components; 
o   mentoring of junior faculty on research projects in which the 
latter play a major role.

For individual faculty development, support may be requested for 
activities such as enrolling in advanced seminars in scientific 
techniques, and for pilot work to serve as a basis for developing 
individual research projects.

Individual Investigator Research Projects -- BRIC funds may be 
requested for small-scale or pilot research projects.  These projects 
may support junior faculty members as Principal Investigators.  The 
intent of this component is to support research activities that will 
lead to publications; or that serve as pilot, developmental, or 
feasibility studies for future larger-scale projects; or that form the 
solid basis of a research application for funding under other research 
grant programs.  These projects should be designed to take advantage of 
the infrastructure development being supported by the program.  
Applicants are required to propose a minimum of one Individual 
Investigator Research Project but may propose a maximum of three.

Application Characteristics

An AHRQ BRIC application must present a plan that:  (1) describes past 
accomplishments based on the original BRIC grant, (2) assesses current 
institutional and faculty capacity to conduct health services research; 
and (3) describes activities that will be undertaken to develop and 
strengthen the institutional research infrastructure.  Support can be 
requested for Institutional Research Development Support AND an 
Individual Investigator Research Project(s) or for Individual 
Investigator Research Project(s) only.

All applications must provide:

o   A list of accomplishments, including output (e.g., description of 
what BRIC support has enabled the program to put in place that did not 
exist prior to the grant, how BRIC support has contributed to the 
development of a sustainable health services research program, examples 
of viable and long-lasting research linkages and collaborations that 
have been formed within and across institutional bounds) and outcome 
measures (e.g., research presentations, publications, development of 
grant applications, receipt of additional research funding).  

o   Identification of sources of health services research funding at 
the institution.  What funding sources, other than AHRQ, (including 
public and private) are available at the institution to conduct health 
services research?  What possible sources are being investigated for 
future funding in order to sustain research capacity?  What long-range 
funding goals and streams are anticipated to be tapped to maintain the 
viability of the research programs in the future?  How has BRIC 
increased the institution's probability of successfully competing for 
future AHRQ and other federal funding?  How are accomplishments and 
plans anticipated to prepare applicants to secure alternative support? 

o   A description of what applicants anticipate a successful research 
infrastructure will look like at their institutions after three and 
five years of AHRQ support, how they would measure success at different 
points in time, and what they anticipate this funding will allow them 
to do five and ten years after receipt of initial AHRQ funds.
  
With regard to specific future plans, the application should contain 
the following:

Institutional Research Development Plan

o   Specific aims.

o   Summary of Phase I proposed goals and accomplishments, highlighting 
achievements as well as problems encountered and how they were 
resolved.

o   Summary of recently completed, ongoing, and planned health services 
research at the site.

o   Assessment of institutional capacity to conduct state-of-the-art 
research on health services related issues and identification of gaps 
which Phase II is intended to fill.

o   Design and procedures to be used to accomplish the specific aims of 
the research infrastructure development plan over the proposed project 
period, including plans for administrative structure, recruitment and 
retention of persons skilled in health services research; staff 
training and mentoring; statistical and other data management 
consultation; and collaboration with other institutions or components 
of the applicant institution.

o   Description of institutional financial or in-kind commitment 
(office space, protected research time) to support the proposed health 
services research infrastructure development, including letters of 
support from administrative officials at the institution.

The Institutional Research Development Plan section of the application 
is limited to 15 pages.

Individual Investigator Research Projects should include:

o   Linkages to overall institutional research development plan
o   Specific aims
o   Background and significance
o   Progress report/preliminary studies
o   Literature review
o   Research plan, including experimental design and methods
o   Protection of human subjects, where applicable
o   Consultants and collaborators
o   Consortium/contractual arrangements
o   Detailed budgets for each project

Applicants must submit at least one Individual Investigator Research 
Project but not more than three.  The research plan for the Individual 
Investigator Research Projects are limited to 15 pages each (not 
including the list of references).

MECHANISM OF SUPPORT
 
This RFA will use the R24 award mechanism.  This mechanism is used to 
provide support for enhancing the capability to conduct innovative 
research which will significantly contribute to the mission and efforts 
of the Public Health Service (PHS).  As such, it is expected that the 
primary components of these projects will involve activities designed 
to foster the development of appropriate resources that support the 
implementation of research capabilities.  It is expected that proposed 
projects would eventually make a substantial contribution in the field 
of health services research.  

Each applicant will be solely responsible for planning, directing, and 
executing the proposed project.  The anticipated award date is 
September 2003.
 
AHRQ is not using the Modular Grant Application and Award Process. 
 
FUNDS AVAILABLE  

AHRQ intends to commit approximately $1 million in FY2003 to fund up to 
six competitive grants in response to this RFA.  It is anticipated that 
award size may vary based on request for Institutional Research 
Development Plan support and/or Individual Investigator Research 
Project(s).  Applicants must limit their request to a TOTAL cost of 
$200,000 per year for up to three years.  Up to $50,000 of this total 
can be budgeted for each individual research project. 

Applicants will not be required to match or share in project costs if 
an award is made.

This RFA is a one-time solicitation and there are no plans for it to be 
reissued.

Although this Program is provided for in the financial plans of AHRQ, 
awards pursuant to the RFA are contingent upon the availability of 
funds for this purpose.  Funding beyond the initial budget period 
(i.e., the second year of the planning grant) will depend upon progress 
made in the first year of the grant and the availability of funds.  

ELIGIBLE INSTITUTIONS
  
In 2001, AHRQ awarded six BRIC planning grants (P20s) under RFA-HS-01-
001.  Support was provided for planning activities related to the 
development of a health services research infrastructure within 
selected states which had not historically received significant health 
services research funding from the Agency.  This solicitation is a 
competitive continuation that extends these activities and only current 
recipients of the initial BRIC planning grants are eligible to apply.  
The purpose of these awards is to allow these grantees to build on 
their current work in progress and to conduct health services research 
projects.  Because the existing BRIC recipients possess the research 
objectives to enable them to build on the existing work and because 
continuity in the research is necessary, this will be a limited 
competition.  In addition, ongoing evaluation of the BRIC program 
requires a longer period of funding be in place for the current 
awardees in order to determine the appropriate structure for future 
Agency programs of a similar nature.  For-profit organizations may only 
participate in the grant projects as members of consortia or as 
subcontractors. 

SPECIAL REQUIREMENTS

Applicants should include projected expenses for traveling up to two 
members of the BRIC research team to an annual meeting of grantees and 
for attendance and presentation of research findings at least one 
meeting (subject to approval of AHRQ program staff), for each 
Investigator (or suitable team member) involved in a proposed research 
project. 

Data Privacy

All information about identifiable individuals or organizations 
obtained for the research purpose of carrying out a demonstration 
project supported pursuant to this RFA under AHRQ's statutory authority 
is protected by a Federal confidentiality statute, section 924 of the 
Public Health Service Act, 42 USC 229c-3(c).  Under this law, the only 
permissible disclosures of identifiable research information collected 
are those promised to, or agreed to by the subject individuals and 
organizations or those who supply the information to the researchers.  
There are substantial statutory penalties (up to $10,000) for improper 
use or disclosure of this information.  Thus, 42 USC 299C-3(c) provides 
a Federal statutory basis for resisting any Federal or state court 
order or subpoena to the extent that carrying out the order or subpoena 
would violate the protective restrictions of the statute.  Upon 
request, AHRQ will provide legal assistance in defending adherence to 
these statutory confidentiality protections with respect to 
identifiable data obtained in carrying out Agency research activities.

Note that identifiable data obtained by AHRQ-supported researchers is 
protected by this law when it is obtained to carry out AHRQ-supported 
research, but this law will not protect against access to this same 
information in medical records gathered and retained in their original 
clinical settings for other purposes.  If providers collect certain 
information solely for purposes of this research, it should be so 
marked and if necessary to protect its confidentiality, kept 
separately.  Note also that this law does not protect or restrict 
access or disclosures to aggregate and nonidentifiable statistical or 
data analysis and conclusions developed by the researchers that would 
not disclose information about any identifiable individuals or 
establishments.

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 patient-related 
health information.  These privacy regulations, developed pursuant to 
the Health Insurance Portability and Accountability Act of 1996 
(HIPAA), are effective and enforceable as of April 14, 2003.  These 
regulations serve to limit the disclosure of personally identifiable 
patient information and define when and how such information can be 
disclosed, for instance to researchers.  Thus, health care plans and 
providers subject to the HIPAA Privacy regulation will require either 
patient authorization of disclosures of identifiable information to be 
made to researchers who are not their health care providers or, waivers 
of such authorizations obtained from an IRB or Privacy Board (defined 
in the regulations) upon being satisfied that any identifiable health 
information will be appropriately safeguarded by the investigators.  
Additional information about the regulations and their implementation 
can be obtained from: http://www.aspe.hhs.gov/admnsimp/

In the Human Subjects section of the application, applicants must 
describe procedures for ensuring the confidentiality of information 
that could be used to identify human research subjects.  The 
description of the data protection 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.  
If the HIPAA privacy rules apply to data to be obtained, the 
application should indicate whether or not such data will be obtained 
pursuant to patient authorizations or with a waiver of authorizations 
from one or more IRBs or Privacy Boards.

The grantee 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 OBM 
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 for 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/handbook.pdf.

The application of these confidentiality and security standards to 
subcontractors and vendors should be addressed as necessary.

Priority Populations

The Agency's authorizing legislation (refer to 
http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency 
programs to populations of inner-city areas and rural areas (including 
frontier areas); 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.  Applications under this RFA should address 
attention to and potential benefits for these priority populations.  

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 Office of Health Care Information (OHCI) 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 OHCI 
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 OHCI 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 OHCI a brief plan describing how 
the product will be publicized.  An OHCI 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.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this RFA 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:

o   Direct your questions regarding programmatic issues, including 
information on the inclusion of women, minorities, and children in 
study populations to:

Kay Anderson, Ph.D.
Health Science Administrator
Office of Research Review, Education, and Policy
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400
Rockville, MD 20852
Telephone: (301) 594-6061
FAX: (301) 594-0154
E-mail Address: KAnderson@ahrq.gov

o   Direct your questions about peer review issues to:

Joan Hurley
Office of Research Review, Education, and Policy
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400
Rockville, MD 20852
Telephone: (301) 594-6075
FAX: (301) 594-0154
E-mail Address: JHurley@ahrq.gov

o   Direct your questions about AHRQ data sources to:

MEPS Household Component:
Nancy Krauss
Center for Cost and Financing Studies
Telephone: (301) 594-0846
E-mail Address: Nkrauss@ahrq.gov

MEPS Nursing Home Component:
Jeffrey Rhodes 
Center for Cost and Financing Studies
Telephone: (301) 594-0891
E-mail Address: Jrhodes@ahrq.gov

HCUP:
Kelly Carper
Telephone: (301) 594-3075
E-mail Address: Kcarper@ahrq.gov, hcupnis@ahrq.gov, hcupsid@ahrq.gov

Direct your questions about financial or grant management matters to:

George Moyer
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD 20852
Telephone: (301) 594-1842
FAX: (301) 594-3210
E-mail Address: SMoyer@ahrq.gov

LETTER OF INTENT

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

o   Descriptive title of the proposed research
o   Name, address, and telephone number of the Principal Investigator
o   Names of other key personnel
o   Participating institutions
o   Number and title of this RFA

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 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.
Health Science Administrator
Office of Research Review, Education, and Policy
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400
Rockville, MD 20852
Telephone: (301)594-6061
FAX: (301)594-0154
E-mail Address: KAnderson@ahrq.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and form (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

USING THE RFA LABEL 

The RFA label available in the PHS 398 (rev. 5/2001) application form 
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.

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 according to instructions provided in form PHS 398.  
Applications submitted in the Modular format will be returned without 
review.
 
SENDING AN APPLICATION TO THE NIH:  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
             (20817 for express/courier service)
 
At the time of submission, two  additional copies of the application, 
must also be sent to:

Kay Anderson, Ph.D.
Health Science Administrator
Office of Research Review, Education, and Policy
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 400
Rockville, MD 20852
Telephone: (301)594-6061
FAX: (301)594-0154
E-mail Address: KAnderson@ahrq.gov

APPLICATION PROCESSING: Applications must be received by the receipt 
dates listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.  
The CSR and AHRQ will not accept any application in response to this 
RFA that is essentially the same as one currently pending initial 
review unless the applicant withdraws the pending application.  The CSR 
and AHRQ will not accept any application that is essentially the same 
as one already reviewed.  This does not preclude the submission of 
substantial revisions of applications already reviewed, but such 
applications must include an Introduction addressing the previous 
critique.

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.  State and local government applicants 
may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and 
follow those requirements for copy submission.  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.

Given the nature of the Project and the speed with which successful 
applicants will need to begin work, the Agency has determined that IRB 
approval is required prior to peer review of all applications submitted 
in response to this RFA.  All investigators/applicants proposing 
research involving human subjects should pay particular attention to 
the instructions in the form PHS 398 regarding human subject 
involvement.  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)  and through AHRQ InstantFAX at (301) 594-
2800.  To use InstantFAX, you must call from a facsimile (FAX) machine 
with a telephone handset.  Follow the voice prompt to obtain a copy of 
the table of contents, which has the document order number (not the 
same as the PA number).  The RFA will be sent at the end of the 
ordering process.  AHRQ InstantFAX operates 24 hours a day, seven days 
a week.  For comments or problems concerning AHRQ InstantFax, please 
call (301) 594-6344.

Application Preparation (for Using CMS Data)  
 
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 Center for Medicare and Medicaid 
Services (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 299c3(c), the Privacy rules at 45 
CFR Part 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, for the sole 
purpose of assuring that data confidentiality is maintained, 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.  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, approving, and processing any 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.

AHRQ Data

AHRQ encourages research applications to use data from the Medical 
Expenditure Panel Survey (MEPS) (http://www.meps.ahrq.gov/), the 
Healthcare Cost and Utilization Project (HCUP) 
(http://www.ahrq.gov/data/hcup/), and other AHRQ sources.

MEPS is a rich data source that contains information on healthcare use, 
access, quality, and cost, as well as information on health insurance 
coverage for the civilian non-institutionalized population of the 
United States.  The foundation of the MEPS collection is information 
about the specific types of health services Americans use, how often 
they are used, how much they cost, and who pays.  MEPS contains 
information on quality of care from the consumer perspective (from 
CAHPS), on self-evaluations of health (including the SF-12 and 
EuroQual), and on quality of care measures for specific conditions such 
as diabetes, asthma, and hypertension.  MEPS includes information on 
the receipt of specific clinical preventive services as recommended by 
the U.S. Preventive Services Task Force for men, women, and children.

MEPS data have been fully released to the public for 1996 through 1999.  
Some data is available for 2000 and 2001.  Additional data items that 
have not been approved for release  to the public are available for 
research use at the CCFS data center.  The MEPS website 
(http://www.meps.ahrq.gov) has information on data availability, the data 
center, and abstracts of important research that has already been 
conducted using the MEPS.  These studies illustrate the breadth of 
possibilities for using the MEPS data.

The HCUP includes databases covering 1988-2000.  These all-payer 
databases were created through a Federal-State-industry partnership to 
build a multistate 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 from the Health Resources and 
Services Administration's Area Resource File and to hospital-level data 
from the annual Survey of the American Hospital Association.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness and 
responsiveness to the RFA.  Incomplete and/or non-responsive 
applications or those not following instructions given in this RFA will 
be returned to the applicant without further consideration.  
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.  

As part of the merit review, all applications will:

o   Receive a written critique
o   Undergo a process in which only those applications deemed to have 
the highest scientific merit will be discussed and assigned a priority 
score. 

REVIEW CRITERIA

General review criteria for grant applications are: consistency with 
the Agency's mission and research priorities; significance and 
originality from a scientific or technical viewpoint, adequacy of the 
methods(s) and proposed approaches; availability of needed data or 
adequacy of the proposed plan to collect data required for the project; 
adequacy and appropriateness of the plan for organizing and carrying 
out the project, qualifications and experience of the Principal 
Investigator and proposed staff; reasonableness of the proposed budget 
and the time frame for the project in relation to the work proposed; 
adequacy of the facilities and resources available to the applicant, 
the extent to which women, minorities, and if applicable children, are 
adequately represented in study populations; and the adequacy of the 
proposed means of protecting human subjects, if applicable.

Special Review Criteria

A major focus for the evaluation of an application will be the 
demonstration of the direct impact of past accomplishments and proposed 
plans on the achievement of short- and long-term health services 
research goals and securing additional support for the research program 
at each institution.  In addition, peer reviewers will assess the 
applicant's need for AHRQ support overall and specifically for the 
level requested, given the existing capacity at the institution.

Specifically, criteria for review of the overall application include 
the following:

o   consistency with AHRQ's research focus and mission

o   merit of the research development goals to be achieved by the 
institution and described in sufficient detail with the application and 
the plan proposed to achieve the research development goals

o   probable long-term impact of the program 

o   plans for dissemination efforts

o   past accomplishments, particularly those achieved in Phase I, 
relative to original proposed plans and future plans

o   probable impact of the proposed type of research for which 
infrastructure development support is requested from AHRQ

o   demonstration of the need for continued support, and the amount 
requested, to further develop the grantee's research infrastructure 
component in order to make the institution capable of successfully 
completing one or more of the proposed projects and competing for 
significant public and/or private funding in the conduct of health 
services research, given the overall health services research 
experience of the applicants and their institutions

o   research qualifications and/or potential of existing and proposed 
personnel related to the BRIC project

o   personnel and administrative strengths of the program

o   evidence of strong commitment of the applicant institution to 
achieve the research development goals and to sustain those 
achievements, preferably in the form of letters of commitment

o   plans to sustain the program after the period of grant support ends

o   justification and appropriateness of the requested budget and 
project goals, based on criteria delineated under Objectives and Scope
o   strength of the existing partnerships arrangements, both from the 
perspectives of assisting with the development of research 
infrastructures and contributing to the quality of the research 
proposed and produced
 
Criteria for review of each specific research project include:

o   Significance:  Does the study address an important problem that is 
relevant to the AHRQ mission? If the aims of the application are 
achieved, how do they advance scientific knowledge as outlined under 
Research Objectives?  Does the study adequately prepare the 
Investigator to conduct health services research and serve as an 
important step or component in the development of future grant 
applications?  Will the study likely result in publications?

o   Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed and appropriate to the aims of the 
project?  Are potential problem areas acknowledged and alternative 
approaches addressed?

o   Investigators:  Is the team appropriately trained and well-suited 
to carry out this work?  Is the proposed work appropriate to the 
experience level of the Principal Investigator and to that of other 
researchers (if any)?

o   Environment:  Does the scientific environment in which the work 
will be conducted contribute to the probability of success?  Do the 
proposed projects take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of  institutional support?  To what extent will the proposed 
research change/alter the environment, facilitate the institution's 
ability to conduct, expand, and improve health services research, 
and/or secure institutional support for and commitment to the conduct 
of health services research?

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

Additional Review Criteria:  In addition to the above criteria, each 
proposed research project of the application will be reviewed with 
respect to the following:

o   Protections:  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.

o   Inclusion: The adequacy of plans to address the need of both 
genders, all 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.)

DATA SHARING:

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 patient-related 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), are scheduled to be effective and enforceable in April 
2003. These regulations serve to limit the disclosure of personally 
identifiable patient information and define when and how such 
information can be disclosed. Thus, for example, health care plans and 
providers will require either patient authorization of disclosures of 
identifiable information to be made to researchers who are not their 
health care providers or waivers of such authorizations obtained from 
an IRB or Privacy Board (defined in the regulations) upon being 
satisfied that any identifiable health information will be 
appropriately safeguarded by the investigators. Additional information 
about the regulations and their implementation can be obtained from: 
http://www.aspe.hhs.gov/admnsimp/  
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. 

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, data bases, 
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 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 Health Care Information 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.access.gpo.gov/nara/cfr/index.html). 

Important legal rights and requirements applicable to AHRQ grantees are 
set out or references in AHRQ's grants regulation at 42 CFR Part 67, 
Subpart A (available in libraries and from the GPO's website 
http://www.access.gpo.gov/nara/cfr/index.html).

RECEIPT AND REVIEW SCHEDULE:

Letter of Intent Receipt Date:  June 13, 2003
Application Receipt Date:  July 15, 2003
Peer Review Date:  August 2003
Earliest Anticipated Start Date:  September 2003

AWARD CRITERIA:

All applications will equally compete for available funds.  The 
following will be considered in making funding decisions: 
quality/scientific merit of the proposed project as determined by peer 
review, how well the proposed research fits with AHRQ priorities and 
the overall Agency research portfolio, compatibility with other 
grantees with respect to cooperative activities, policy relevance, and 
types of populations included in the study.

In carrying out its stewardship of research programs, the AHRQ, at some 
point in the future, may begin requesting 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 (WP5.1 or WP6.0 is preferable).

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.

AHRQ Program staff may also provide additional information concerning 
these policies (see INQUIRIES).

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 action 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 
requirement for disclosure  under FOIA, 5 USC 552(b), disclosure of 
identifiable data from such study is exempted from FOIA 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. However, courts have generally not regarded a researcher's 
interest in "his" data as proprietary. NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 

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 think about how to structure informed consent statements and 
possibly human subjects procedures given the potential for any 
anticipated wider use of data collected under this award. 

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (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 the researcher and his/her institution. 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 on "Am 
I a covered entity?"  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-03-025.html.

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

The PHS strongly encourages all grant and contract recipients to 
provide a smoke-free workplace and promote the non-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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