AHRQ MINORITY RESEARCH INFRASTRUCTURE SUPPORT PROGRAM (M-RISP)

RELEASE DATE:  November 4, 2003

PA Number:  PAR-04-016  (See Notice NOT-HS-08-005)

EXPIRATION DATE:  February 2, 2007

Department of Health and Human Services (DHHS)

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

NOTE: THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS 
ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH.

CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER:   93.226

APPLICATION RECEIPT DATE:  February 1 (annually)

THIS PA CONTAINS THE FOLLOWING INFORMATION:

o   Purpose of the PA
o   Research Objectives
o   Mechanism(s) of Support
o   Eligible Institutions
o   Individuals Eligible to Become Principal Investigators
o   Special Requirements
o   Where to Send Inquiries
o   Submitting an Application
o   Supplementary Instructions
o   Peer Review Process
o   Review Criteria
o   Award Criteria
o   Required Federal Citations 

PURPOSE OF THIS PA


This program announcement (PA) supersedes PAR-01-001, dated October 12, 2000.
The Agency for Healthcare Research and Quality (AHRQ) has established the 
Minority Research Infrastructure Support Program (M-RISP) to increase the 
capacity of academic institutions predominantly or substantially serving 
minority racial and ethnic minority populations and the faculty at these 
institutions to conduct health services research that has the capacity for 
being disseminated, implemented and translated into practice and policy.  The 
intent of the research infrastructure program is to strengthen the research 
environments of minority institutions through grant support to develop and/or 
expand existing capacities for conducting research in health services.

To facilitate the goal of assisting minority institutions in increasing their 
capacity to conduct health services research, the M-RISP provides support for 
two types of primary activities:  (1) Institutional research development 
support, to strengthen the institutional infrastructure and enhance the 
capability of individual faculty members to undertake health services 
research; and (2) Individual investigator research project support, for 
developing research scientists to conduct small grant research activities 
that can lead to successful applications for funding under regular health 
services research grant mechanisms.

This Program Announcement (PA) expires three years from the release date 
shown above, unless reissued.

RESEARCH OBJECTIVES 

Background

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to 
improve the quality, safety, efficiency, and effectiveness of health care for 
all Americans.  AHRQ achieves its mission through health services research 
designed to (1) improve clinical practice, (2) improve the health care 
system’s ability to provide access to and deliver high quality, high-value 
health care, and (3) provide policymakers with the ability to assess the 
impact of system changes on outcomes, quality, access to, cost and use of 
health care services. 

A copy of AHRQ’s strategic plan is available at http://www.ahrq.gov (under 
the “About AHRQ” site).
                           
Through the M-RISP program, AHRQ seeks to expand the number of predominantly 
minority institutions and researchers with a demonstrable interest in racial 
and ethnic groups that have been shown to be underrepresented in health 
services research nationally.  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 must conduct health services research focused 
in one or more of the following areas:

o Translating Research Into Practice and Policy (TRIPP): Applicants are 
encouraged to conduct research and evaluation projects related to the 
translation of research findings into measurable improvements in quality, 
patient safety, health care 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 as well 
as those which take advantage of natural occurrences to study the impact of 
change.  Projects that have identified an existing or potential user base are 
encouraged.

o Patient Safety: One of the important elements in the AHRQ mission is to 
support the development of multidisciplinary research teams in building and 
implementing  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 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 as well as urban 
areas. Applicants are encouraged to review, “Building the Evidence to Promote 
Bioterrorism and Other Public Health Emergency Preparedness in Health Care 
Systems” at http://grants.nih.gov/grants/guide/pa-files/PAR-03-130.html.

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 work of 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 health care in inner-city and rural 
areas (including frontier areas); 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.  Further, the Agency supports the generation and dissemination of 
health services research to promote the equitable receipt of health care 
services for all Americans and eliminate health disparities among racial and 
ethnic minority populations.

o Faith-Based and Community Initiatives: The Department of Health and Human 
Services (DHHS) supports the President’s Faith-Based and Community 
Initiatives which were created to focus on improving human services for our 
country’s neediest populations.  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 health care research 
findings more effectively through faith-based and other community 
organizations.

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/), the National CAHPS 
Benchmarking Database (NCBD) 
(http://www.ahrq.gov/qual/cahpfact.htm#cahpsbenchmarking ) and other AHRQ 
sources.  Additional information is listed below in the AHRQ Data Section 
under Submitting an Application.

Information and announcements describing AHRQ research interests can be found 
at http://www.ahrq.gov (See “Funding Opportunities”). 

M-RISP provides support for two primary activities:

Institutional Research Development (Core)

M-RISP provides support to strengthen the institutional infrastructure so as 
to enhance the capability of individual faculty members to undertake health 
services research.  

Requests may be made for infrastructure enhancements such as support of 
collaborative linkages with senior scientists in other institutions, 
provision of resources for data management and statistical analyses, and 
laboratory development, including limited support for equipment.  For 
individual faculty development, support may be requested for activities such 
as enrolling in advanced seminars in scientific techniques, but not for 
participation in a formalized, structured, didactic training program which 
could lead to an advanced degree. 

Individual Investigator Research Projects

In addition to capacity development support, an M-RISP grant provides support 
for at least two initial or developmental research sub-projects from at least 
two or more faculty members who serve as Individual Investigators of these 
sub-projects.  The intent of this component of M-RISP is to support research 
activities that will lead to successful applications for funding under other 
AHRQ or other health services research grants programs.  Individual 
Investigator projects should be designed to take advantage of the 
infrastructure development being supported by the M-RISP program.

Application Characteristics

All applicants for new and competing continuation awards must include both 
short-term goals for the project and long-term plans that go beyond the 
duration of the requested project period.  Short-term goals should address 
planned accomplishments during the duration of the grant.  Long-term goals 
should address projected impact of the grant on the capacity of the 
institution and faculty to conduct health services research into the future 
and the impact of such research on health care delivery or policy at the 
local, State, regional, or national level.

Specifically, the research plan must (1) assess the current institutional and 
faculty capacity to conduct health services research; (2) identify unmet 
needs; and (3) describe activities that will be undertaken to develop and 
strengthen the institutional research infrastructure.  The plan should 
include both an institutional research development program and two or more 
individual investigator projects.  Up to three years of support can be 
requested by new applicants and up to five years for competitive renewals.

The application should contain the following:

Institutional Research Development Plan

o  Specific aims.

o  Summary of relevant ongoing health services research.

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

o  Design and procedures to be used to accomplish the specific aims of the 
research infrastructure development plan over the time period of the proposed 
project (3 years for new applications; up to 5 years for competitive renewal 
applications), including plans for administrative structure, recruitment and 
retention of persons skilled in health services research, staff training and 
mentoring, statistical and other consultation and data 
management, and collaboration with other institutions.

o  Description of equipment, space, and other facility resources available to 
support the development plan and extent to which enhancement of these 
resources is needed.

o Description of institutional financial or other in-kind support for the 
proposed minority health services research infrastructure development.

Applications for competitive renewal must describe the progress of prior 
supported individual investigators as well as the institution in terms of 
publications, recognition (e.g., publicity, honors and awards), ability to 
apply for and secure independent grant support, results of collaborations 
formed in terms of building the capacity of research at the institution and 
the formation of viable research partnerships, and the impact of research 
completed on local, State, regional or national health care delivery or 
policy.

The Institutional Research Development Plan section of the application is 
limited to 25 pages.

Individual Investigator Research Projects

o  Linkages to overall institutional capacity 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
o  Consultants and collaborators
o  Consortium/contractual arrangements
o  Detailed budgets for each project

The research plans for each Individual Investigator Research Project is 
limited to 10 pages (not including the list of references).

MECHANISM OF SUPPORT 

This PA will use the resource-related research projects mechanism (R24).  
This mechanism is used to support research projects that enhance capabilities 
to contribute to extramural research of the Public Health Service (PHS).  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.

AHRQ is not using the Modular Grant Application and Award Process.

Allowable Costs

Each application should include proposals and separate budgets and budget 
justifications related to both primary activities (Institutional Research 
Development (Core) Support and Individual Investigator Research Projects) and 
indicate how the infrastructure support will enhance the individual research 
projects.

AHRQ recognizes that different types of institutions will require different 
types of research infrastructure development activities and initiatives, 
depending upon particular needs and circumstances.  Accordingly, this 
announcement provides general rather than specific guidance as to the types 
of development activities appropriate under M-RISP.  Support may be requested 
for, but is not limited to, the following:

o  Salary support for persons engaged in the project proportional to the 
level of effort devoted to the project
o  Limited specialized research training for junior investigators related to 
enhancing capability to conduct research
o  Scientific and statistical consultation, including expenses incurred by a 
scientific advisory committee
o  Biostatistical and data management services
o  Research technicians and assistants
o  Research instruments
o  Small, project-specific equipment
o  Pilot and feasibility studies
o  Research subject costs
o  Data acquisition costs
o  Travel to scientific meetings

Applicants should refer to the PHS Grants Policy Statement at 
http://grants.nih.gov/grants/policy/gps/index.html for general information 
regarding allowable costs.

A new AHRQ M-RISP grant application must not exceed $500,000 in total costs 
per year including negotiated F&A.  The infrastructure Core component of new 
M-RISP grant applications must not exceed $100,000 per year, total costs.  
Individual Investigator projects for these applications must not exceed 
$100,000 per year, total costs.  Support can be requested for up to three 
years for new applications. 

Applications that exceed these budget ceilings will be returned without 
review.

A competing renewal AHRQ M-RISP grant application should not exceed $275,000 
in total costs per year including negotiated F&A.  The infrastructure Core 
component of competing renewal M-RISP grant applications should not exceed 
$75,000 per year, total costs.  Individual Investigator projects for these 
applications should not exceed $100,000 per year, total costs.  Support can 
be requested for up to five years for competing renewal applications.  
Competitive renewal applications require new individual investigators of sub-
projects.  Support for each proposed individual investigator research project 
cannot exceed three years. 

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

ELIGIBLE INSTITUTIONS 

You may submit an application if your institution has any of the following 
characteristics:

o  Non-profit organizations
o  Domestic organizations only
o  Public and private non-profit institutions, such as universities, and 
four-year colleges, conducting health services research
o  Tribes and Tribal organizations

For the purpose of this PA, 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 
section 501(c) 4 of the Internal Revenue Codes that engage in lobbying are 
not eligible.  

Partnerships between predominantly minority and other academic institutions 
that will result in strengthening predominantly minority institutions in 
their health services research capability are encouraged.

The applicant must indicate which of the following eligibility conditions 
apply to the institution and must furnish evidence to document eligibility:

o  An academic institution with at least 55 percent minority (African 
American, Hispanic, American Indian or Alaskan Native, Asian or Pacific 
Islander) student enrollment.

o  An institution with more than 30 percent minority student enrollment in 
each of the past three years that can provide evidence of efforts to recruit 
members of ethnic or racial minority groups into scientific careers.  

Additionally, the institution should show evidence of demonstrated commitment 
to minority faculty recruitment and development in expenditure of resources, 
as well as documented institutional need for support in its research 
development program.  Potential applicants who intend to apply under this 
eligibility criterion are advised to consult with AHRQ program staff (as 
listed under Inquiries) before submitting an application.

o  An Indian tribe may apply in conjunction with one or more institutions of 
higher learning that offer undergraduate and graduate degrees in health 
services research related fields.  Such applicants must have a recognized 
governing body and perform substantial governmental functions, or qualify as 
an Alaska Regional Corporation (ARC) as defined in the Alaska Native Claims 
Settlement Act (43 U.S.C. 1601 et seq.).

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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.

SPECIAL REQUIREMENTS

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 PA 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 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.

AHRQ expects grant recipients to keep the Agency informed of publications as 
well as the known uses and impact of their Agency-sponsored work.  Applicants 
are to agree to notify AHRQ immediately when a manuscript based on work 
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 the original and 2 
copies of an abstract, executive summary, and full report of the results in 
the format prescribed by AHRWQ no later tan 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 uses (WP5.1 or WP6.0 is 
preferable).

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA 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:
 
Shelley Benjamin, M.S.W.  
Health Science Administrator
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850            
Telephone:  (301) 427-1528
FAX: (301) 427-1562
Email: SBenjamin@AHRQ.gov
            
o   Direct your questions about peer review issues to:

Patricia Thompson, Ph.D.
Director, Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850            
Telephone:  (301) 427-1556
FAX: (301) 427-1561
Email: Pthompso@AHRQ.gov

o   Direct your questions about financial or grants management issues to:

George “Skip” Moyer
Grants Management Specialist
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1452
FAX: (301) 427-1462
E-mail Address: Smoyer@ahrq.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and form (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 the Federal grants or cooperative 
agreements.  The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site http://www.dunandbradstreet.com/.  The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form.  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 301-435-0714, Email: GrantsInfo@nih.gov.

The title and number of this PAR must be typed in line 2 of the face page of 
the application form and the YES box must be checked.

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.

SUPPLEMENTARY INSTRUCTIONS:

Applicants are encouraged to make use of AHRQ’S Healthcare Cost and 
Utilization Program (HCUP).  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 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 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.

This does not preclude the use of secondary data sources or primary data 
collection.
 
SENDING AN APPLICATION TO THE NIH and AHRQ:  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, labeled 
“Advanced Copy (s)” must also be sent to:

Shelley Benjamin, M.S.W.
Health Science Administrator
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
(301 427-1528
(301) 427-1562
E-mail Address: Sbenjamin@ahrq.gov

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
date described at the heading of this PA. 

The CSR and AHRQ will not accept any application in response to this PA 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 a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

Although there is no immediate acknowledgment of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

Applicants are encouraged to read all PHS Forms 398 instructions prior to 
preparing an application in response to this PA.  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 PA is also available on AHRQ’s Web site, http://www.AHRQ.gov, (see under 
Funding Opportunities).

Application Preparation (for Using CMS Data)  

Purchase of 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, especially 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 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 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.

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 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 2 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 (WordPerfect®, 
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.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness and 
responsiveness by the Agency referral officer, program staff, and grant 
management staff.  Incomplete and/or non-responsive applications or 
applications not following instructions given in this PA will be returned to 
the applicant without further consideration.  Applications that are complete 
and responsive to the PA 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 Undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed and assigned a priority score. 
o Receive a written critique.

REVIEW CRITERIA

In the written comments, reviewers will be asked to discuss aspects, see 
Special Review Criteria of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the pursuit of 
these goals.

General Review Criteria

The General review criteria for grant applications are: 

o consistency with the Agency’s mission and research priorities; 
o significance and originality from a scientific or technical viewpoint, 
adequacy of the methods(s) and proposed approaches; 
o availability of needed data or adequacy of the proposed plan to collect 
data required for the project; 
o adequacy and appropriateness of the plan for organizing and carrying out 
the project, qualifications and experience of the Principal Investigator and 
proposed staff; 
o 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; 
o the extent to which women, minorities, and if applicable children, are 
adequately represented in study populations; and 
o the adequacy of the proposed means of protecting human subjects, if 
applicable.

Special Review Criteria

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

o consistency with AHRQ’s research focus and mission.

o merit of the proposed short- and long-term research development goals to be 
achieved by the institution, which should be described in sufficient detail 
in the application, and the short- and long-term plans proposed to achieve 
the research development goals.

o evidence of strong commitment of the applicant institution to achieve the 
research development goals and to sustain those achievements.

o plans to sustain and grow the research program of the institution and 
investigators being developed during the duration of the grant and subsequent 
to the grant.

o probable long-term impact of the program on the research viability of the 
institution and research careers of the individual investigators being 
developed. 

o research qualifications and/or potential of existing and proposed personnel 
related to the M-RISP project.

o plans for dissemination and translation of research findings.

o anticipated impact of the proposed research for which infrastructure 
development support is requested from AHRQ.

o discussion of existing or potential users of the proposed research.

o justification and appropriateness of the requested budget and project 
goals, based on criteria delineated under Objectives and Scope.

o strength of the existing partnership 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
o Approach
o Investigators
o Environment
o Budget
 
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 FOR COMPETITIVE RENEWALS:  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. 

o past accomplishments, particularly those achieved during the first grant 
award period, relative to original proposed plans and future plans.

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 the proposed 
research projects and competing for significant public and/or private 
funding.

OTHER ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, each 
application will also be reviewed with respect to the following:

o 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.

o 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).

ADDITIONAL CONSIDERATIONS

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 PA 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 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/  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. 

Rights in Data 

AHRQ grantees may copyright unless otherwise provided in grant awards or seek 
patents 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 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). 

RECEIPT AND REVIEW SCHEDULE:

Application Receipt Date:  February 1 annually
Peer Review Date:  May annually
Earliest Anticipated Award Date:  September annually
Expiration Date:  October 2, 2007

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds
o  Programmatic priorities
o  Fit with existing M-RISP portfolio

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 and under FOIA, 5 USC 552(b), 
disclosure of identifiable data from a such study is exempted from disclosure 
under the exemption of material protected by statute, in this case AHRQ’s 
confidentiality statute, 42 U.S.C. 299c-3(c).  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 PA 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 other human subjects procedures given the potential for 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 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).  See in particular, 42 U.S.C. 299a-1.  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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