UNDERSTANDING AND ELIMINATING MINORITY HEALTH DISPARITIES
 
Release Date:  October 20, 1999

RFA:  HS-00-003
 
Agency for Health Care Policy and Research
 
Letter of Intent Receipt Date: December 22, 1999
Application Receipt Date: January 21, 2000

PURPOSE

The Agency for Health Care Policy and Research (AHCPR) invites applications 
for research program project grants to conduct research on racial and ethnic 
disparities in health that are amenable to improvements in health services.  
Projects funded under this Request for Applications (RFA) will build on 
previous research that has identified disparities in access to, and 
utilization, quality and outcomes of health care services and the excess 
burdens of illness and death for Blacks/African Americans, Hispanic Americans, 
American Indians, Alaska Natives, Asian Americans and Pacific Islanders 
compared to the United States non-minority population.  Projects funded by 
AHCPR will analyze causes and contributing factors for the inequalities that 
are related to the delivery and practice of health care, and identify and 
implement strategies to eliminate them.

AHCPR will support research to strengthen the science base for evaluating and 
implementing strategies to achieve the goals of the President’s Initiative to 
Eliminate Racial and Ethnic Disparities in Health: by the year 2010, eliminate 
differences in outcomes and health status for racial and ethnic minority 
populations in six clinical areas (infant mortality, cancer screening and 
management, cardiovascular disease, diabetes mellitus, HIV, and immunizations 
for both children and adults).  Although an incomplete understanding of 
disease processes as well as non-
medical determinants of health such as income and education contribute to some 
of the observed differences, provider, patient and organizational factors play 
a substantial role in the sub-optimal outcomes of these groups.   For further 
information, access the Initiative to Eliminate Racial and Ethnic Disparities 
in Health Web page at: http://raceandhealth.hhs.gov/.

Each research program project grant will support a broad, integrated, 
interdisciplinary, multi-
project health services research program—a center of excellence.  Such centers 
will bring together strong teams of experienced and new researchers focused on 
a central theme to share essential facilities, services, knowledge, and other 
resources in purchasing and developing data sources, developing new 
methodologies, performing analyses across supported projects and working with 
partners and communities to conduct research and translate research into 
practice.  Although the major goals of this RFA are to develop new knowledge 
and to accelerate the pace of improvements in health and health care for 
minority populations, applicants are also encouraged to design programs that 
will enable development of greater capacity for health services research 
undertaken by minority investigators and focused on racial and ethnic minority 
populations.  Building such capacity entails augmenting the skills and 
abilities of minority researchers and institutions, and non-minority 
researchers and institutions interested in studying racial and ethnic minority 
groups as well as developing sustainable and meaningful relationships with 
communities and community organizations.

HEALTHY PEOPLE 2000 

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2000," a PHS-led national 
activity for setting health improvement priorities for the United States.  
AHCPR encourages applicants to submit grant applications with relevance to the 
specific objectives of this initiative.  Potential applicants may obtain a 
copy of "Healthy People 2000" (Full Report:  Stock No.017-001-00474-0) or 
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1) through the 
Superintendent of Documents, Government Printing Office, Washington, DC 
20402-9325 (telephone 202-512-
1800) or at  http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS 

Applications may be submitted by domestic or foreign, public or private 
nonprofit organizations, including American Indian/Alaska Native 
organizations, universities, clinics, units of State, Tribal and local 
governments, and eligible agencies of the Federal government.  AHCPR, by 
statute, can make grants only to non-profit organizations, however, for-profit 
organizations may participate in grant projects as members of consortia or as 
subcontractors.  Organizations described in section 501(c)4 of the Internal 
Revenue Code that engage in lobbying are not eligible.

AHCPR encourages investigators who are women, members of minority groups and 
persons with disabilities to apply as Principal Investigators.  

MECHANISM OF SUPPORT 

This RFA will use the Research Program Project (P01) Grant mechanism.  AHCPR’s 
Guidelines for the Research Program Project Grant are available via the World 
Wide Web at http://www.ahcpr.gov/fund/guiderpg.htm.  The applicant will have 
sole responsibility for the planning, direction, and execution of the proposed 
project.  AHCPR will consider projects of up to 5 years.  The anticipated 
award date is September 1, 2000. 

The P01 mechanism is designed to support multiple, interacting discrete 
projects focused on a central theme, involving a number of independent 
investigators who share knowledge, data, and common resources.  A P01 must 
have a minimum of three and a maximum of eight discrete projects.  The degree 
to which the projects are related and the total budget of the program will 
influence the total number of projects.  Applicants are strongly encouraged to 
include cores.  A core is a separately budgeted component of a P01 that 
provides essential facilities or services to two or more of the proposed 
research projects.  For example, in addition to an administrative core, a P01 
may include a technical core to facilitate across-institution and across-
project sharing of resources in purchasing, developing and using data sources.  
Another potential core could be focused on dissemination and implementation of 
program findings.  A core may not count as one of the discrete research 
projects.  The Research Program Project may support projects that are 
performed at multiple sites but coordinated by a single Principal Investigator 
(PI) at the grantee institution.  An award will be made only to the PI"s 
institution.  Applicants are encouraged to coordinate most activities at other 
institutions through an administrative core located at the PI"s institution.

This RFA is a one-time solicitation.  AHCPR has not determined whether or how 
this solicitation will be continued beyond this present initiative. 

FUNDS AVAILABLE

AHCPR expects to award up to $4.35 million in total costs (direct costs plus 
facilities and administrative (F&A) costs) in fiscal year 2000 to support the 
first year of approximately two to four P01 grants under this RFA.  From the 
$4.35 million, the Agency will set-aside $850,000 for the study of clinical 
preventive services, $500,000 for the study of minority children and $500,000 
for the study of chronically-ill minority elderly.  The set-asides may be 
devoted to a single P01 or to a number of projects within one or more P01.  

Applicants for set-aside funds should explicitly note their intent to have a 
specific project considered for those funds.  For the purposes of this RFA, 
minority children and chronically-ill minority elderly are defined as members 
of ethnic or racial minority populations who are under 18 years of age, or 65 
years of age or older and under care for one or more medical conditions on an 
ongoing basis, respectively.  Clinical preventive services are defined as 
interventions such as screening tests, counseling, immunizations and 
chemoprophylaxis provided in clinical practice to prevent or detect specific 
conditions.

The actual number of applications funded is dependent on the number of high 
quality applications and their individual budget requirements, it is not the 
intent of AHCPR that the awards be equal in size.   The expected size of each 
award is $1-2 million in total costs.    

Although the financial plan of AHCPR provides for this program, awards 
pursuant to this RFA are contingent upon the availability of funds for this 
purpose.  Funding beyond the initial budget period will depend upon annual 
progress reviews by AHCPR and the availability of funds.

RESEARCH OBJECTIVES

Background

Disparities in health have been documented repeatedly over the last few 
decades across a broad range of medical conditions and for a wide range of 
ethnic and racial groups.  These differences have been noted in health 
outcomes such as quality of life and mortality, processes of care such as 
utilization rates of certain services, quality and appropriateness of care, 
and the prevalence of certain conditions or diseases.  The documentation of 
these wide-spread disparities has been an important contribution of outcomes 
and effectiveness research and health services research.  Nevertheless, these 
insights have infrequently led to significant improvements in racial and 
ethnic disparities, in part, because the causes of and contributing factors to 
these inequalities are inadequately understood.

Some of the most glaring differences in outcomes are highlighted by the 
President’s Initiative to Eliminate Racial and Ethnic Disparities in Health.  
In 1996, the infant mortality rate was nearly 2½ time greater for blacks than 
whites.  The incidence rate for cervical cancer is more than 5 times as high 
for Vietnamese women in the United States as for white women (47.3 vs. 8.7 
cases per 100,000 women).  And the prevalence of diabetes in Hispanics, Native 
Americans and Alaska Natives is approximately double that in whites.  In 
addition to infant mortality, cancer screening and management, and diabetes, 
the  President’s Initiative to Eliminate Racial and Ethnic Disparities in 
Health has targeted inequalities in cardiovascular disease, HIV infection and 
child and adult immunization for elimination by 2010 
(http://raceandhealth.hhs.gov/).

These disparities persist despite improvements in health for the Nation as a 
whole.  For example, mortality from ischemic heart disease decreased 20% for 
the overall population but only 13% for blacks between 1987 and 1995.  As 
minority populations continue to increase in size and proportion, the health 
of these groups will increasingly affect the health of the entire Nation.  
Also, lessons learned from understanding and eliminating disparities and 
improving the health care of under-served racial and ethnic groups will likely 
be applicable to the United States population as a whole.  Minority children 
and chronically-ill minority elderly are of particular interest because they 
may be especially vulnerable to a number of the causes of inequities and may 
be less able to safeguard their needs and interests adequately.

Similarly, greater attention to preventive care in minority populations has 
the potential for improving the health of the groups as well as improving our 
ability to prevent disease and disability for the Nation as a whole.  The 
improvements in mammography rates for low-income black women, for example, 
were noted to have implications for other racial and ethnic groups, including 
low-income white women, whose rates have not increased as much (Makuc, 1999).  
While substantial attention has been paid to problems with initial access for 
certain interventions with resulting improvements over the past decade, far 
less is known about the strength of the other necessary elements of an 
effective prevention program: quality of screening, timeliness of follow-up, 
appropriateness and effectiveness of interventions, quality of long-term 
management, and quality of communication between clinician and patient.

Etiologies for other disparities are also numerous yet inadequately 
understood.  They include differences in biology, environment, education, 
health literacy, socio-economics, access, health insurance, preferences, bias 
and interactions with the medical system.  Some argue that elimination of 
financial differences in access would profoundly reduce health disparities 
(Andrulis, 1998).  Nevertheless, disparities exist within health systems.  In 
a study of Medicare beneficiaries, providers gave less intensive treatment to 
blacks than to whites after controlling for other factors (Lee, 1997).  A 
study of black and white males treated for colorectal carcinoma in the 
Veterans Affairs system found that all-cause mortality was higher for blacks 
than whites despite an absence of difference in rates of surgery, chemotherapy 
and radiation, suggesting that underlying racial differences are associated 
with mortality (Dominitz, 1998).  A recent study of how physicians manage 
chest pain suggests that decision-making may be influenced by race and 
ethnicity after controlling for other factors (Schulman, 1999).    

Objectives and Scope

Research funded under this RFA is expected to expand the knowledge base that 
is necessary to achieve the goals of the President’s Initiative to Eliminate 
Racial and Ethnic Disparities in Health.  Specifically, the Initiative aims to 
eliminate differences in outcomes and health for racial and ethnic minority 
groups by the year 2010 for the following clinical areas: infant mortality, 
cancer screening and management, cardiovascular disease, diabetes mellitus, 
Human Immunodeficiency Virus, and childhood and adult immunization.  Although 
the study of health disparities for other clinical conditions will be 
considered under this funding program, the emphasis is on the six areas 
because of the potential to impact large numbers of people.  Also, the rapid 
elimination of health disparities is more likely in these areas because of the 
significant work that has already been done in understanding some of the 
underlying causes and in identifying strategies to diminish the inequities.  
This RFA will, however, focus on causes that are amenable to improvements in 
health services despite the fact that etiologies for the disparities are 
numerous and widely varied.  While inequalities have not been documented for 
many conditions and minority sub-groups, further documentation of disparities 
is not of interest under this solicitation unless it is specifically linked 
with efforts to understand underlying causes or to eliminate the disparities. 

The range of potential questions that could be addressed under this 
solicitation is broad.  In identifying underlying causes and contributing 
factors for the disparities, investigators may wish to address topics 
including patient, provider, organizational and modifiable, environmental 
factors.  Specific issues could include but are not limited to individual 
health practices and health literacy, access, preferences, clinical management 
and decision making, quality of care, financing and other economic 
considerations, and service delivery.  This RFA also addresses the 
identification and study of successful strategies to eliminate disparities 
which may be focused, again, on patients, providers, the organization of 
health care and the environment.  Examples of topics that would be of interest 
under this solicitation include but are not limited to:

Access

o  What are the racial and ethnic differences in the management of premature 
infants and what are the access-related causes for these differences?

Patient and Provider Characteristics

o  What patient and provider characteristics are associated with failure to 
receive recommended preventive screening, especially in delivery systems with 
organized internal strategies and, using this information, what interventions 
can be implemented to improve screening rates?
o  How can predictors of patient compliance such as understanding of their 
disease, trust in the medical system and financing of prescriptions be 
assessed and addressed in a high-volume practice setting? 

o  Are opinion leaders effective for improving the cost-effective management 
of hypertension for urban minority groups? 

Interventions

o  What clinical and systems-level strategies can be implemented to address 
the under-use of the pneumonia and influenza vaccines?

o  Can the opinion leader model for implementation be adapted for the care of 
minority populations and communities?

Organizational Strategies

o  Why have disparities in the quality of care for patients with HIV disease 
been eliminated for Latinos compared with whites but not for blacks (Shapiro, 
1999)?  What mutable provider and organizational characteristics are 
predictive for receiving recommended HIV treatment and how can health care 
systems apply this understanding? 

o  Are automated systems which generate reminders for both patients and 
providers effective for improving processes of care and glycemic control for 
minority patients with diabetes?

o  What are the strategies or tactics that have been successful for 
organizations that have diminished disparities in coronary artery disease and 
diabetes?
 
In order for the study of disparities to impact practices, policies and 
outcomes more effectively, research must advance from description and 
hypothesis generation to definitive studies, problem solving and 
implementation of findings.  In part, this will be accomplished by building 
upon existing linkages and developing new relationships between researchers 
and change agents.  These change agents could include: payers and policy 
makers, both public and private, provider groups including Community Health 
Centers, workplace and union-based clinics, and practice networks, 
professional organizations on the local as well as national level, community 
organizations such as religious and social groups, patient organizations such 
as those organized around diseases, and the media including print, television, 
radio, and the Internet.  Examples of change agents that have formed 
successful linkages with researchers include the Health Care Financing 
Administration’s Peer Review Organizations (PROs), which have been 
instrumental in implementing findings including the effectiveness of 
anticoagulation in the prevention of atrial fibrillation-associated strokes, 
the effectiveness of beta-blockers in elderly myocardial infarction survivors, 
and the importance of early administration of antibiotics in patients with 
community acquired pneumonia.  The PROs are potential partners for work under 
this solicitation, under their sixth scope of work, the PROs’ focus will 
include acute myocardial infarction, heart failure, stroke, diabetes and 
cancer screening.  Other examples of successful partnerships include: State 
Medicaid organizations which have worked to improve the management of otitis 
media in children, community health centers which have implemented programs to 
reduce intravenous drug use,  patient organizations which have sought to 
increase compliance with recommendations based on the Diabetes Control and 
Complications Trial, professional organizations which have issued guidelines 
and are collecting data on providers’ outcomes using newly developed measures, 
payers who profile providers using various quality indicators such as the 
appropriate use of corticosteroids in premature births, and local community 
groups which have improved rates of cancer screening and immunization.

These relationships should be utilized to identify needs and areas ripe for 
change and to implement new findings into practice rapidly (Tunis, 1999).  
Studies of efforts to improve practice have demonstrated that traditional 
approaches including distribution of educational material and lectures are 
generally ineffective while more active efforts such as academic detailing, 
and interactive educational meetings as well as combinations of interventions 
including those at an organizational level are effective (Bero, 1998).  
Studies that incorporate active approaches to dissemination and implementation 
are strongly encouraged.

This RFA will focus on health disparities in Alaskan Natives, American 
Indians, Asian Americans, Blacks/African Americans, Hispanic Americans, and 
Pacific Islanders.  Despite the heterogeneity of minority populations in the 
United States, AHCPR expects that the research findings from this RFA will be 
generalizable beyond the study communities.  Specifically, by focusing on 
attributes of the ethnic and racial groups, the underlying etiologies for the 
disparities and components and conditions of interventions to eliminate the 
disparities, the studies funded under this solicitation should produce 
findings that are widely applicable for minority as well as majority 
populations across the country.

While the focus of this RFA is on understanding and eliminating inequalities 
in health outcomes and care, we expect that this program will also enable the 
development of greater capacity for health services research by minority 
individuals and institutions and health services research focused on racial 
and ethnic minority groups.  Such a lack of capacity has been highlighted by 
the Association of American Medical Colleges (AAMC, 1997).  Strategies for 
developing greater capacity include linking less experienced individuals and 
teams with more experienced ones and developing formal and informal mentoring 
opportunities.  

This RFA is also expected to yield greater capacity in terms of forming new, 
and building upon existing, sustainable relationships between researchers, and 
communities and community organizations.  In participatory research, community 
involvement enhances the validity and reliability of findings by addressing 
the social, cultural and economic conditions of the community.  Such 
relationships are instrumental in identifying research needs and strategies, 
disseminating and implementing findings, and developing capacity for future 
health care planning (North American Primary Care Research Group, 1998).  
Successful partnerships have included those formed between academic medical 
centers and neighborhoods.  A number of federal programs developed under the 
President’s Initiative to Eliminate Racial and Ethnic Disparities in Health 
are also seeking to enhance community endeavors to improve health (e.g., the 
Centers for Disease Control and Prevention’s REACH 2010 Demonstration Projects 
and the National Heart, Lung, and Blood Institute’s Community-Based Action 
Centers for Enhanced Dissemination).

Research Methods

In general, methodological rigor should reflect the research question, 
potential consequences of misleading findings, and an assessment of the level 
of evidence necessary for influencing change agents.  For example, clinicians 
and policy makers were reluctant to embrace a risky therapy such as 
thrombolysis without a number of well-designed, randomized trials but have 
been more willing to extend the use of a more benign therapy such as beta-
blockers for elderly patients following heart attacks based on an 
observational study.  Applicants are encouraged to discuss the evidence needs 
with decision makers (Tunis, 1999).  Applications that include evidence of 
decision makers’ involvement with project design and implementation are 
strongly encouraged.

Applicants are also encouraged to submit applications across the continuum 
from descriptive to interventional studies, using both quantitative and 
qualitative methods, as appropriate.  The types of methodologies will be 
dictated by the specific research topic and the needs of decision-makers as 
well as the state of the science.  AHCPR recognizes that some areas have been 
studied in greater depth than others, allowing researchers to target their 
questions and interventions more effectively.  Qualitative methods are 
valuable for furthering our understanding of the causes of the inequalities, 
for identifying mutable predictive factors and for developing initiatives to 
eliminate the differences.  Sub-groups in which disparities have been 
diminished may be valuable sources of information.  Also, sub-group analyses 
may be valuable for investigation of interactions between race/ethnicity, 
gender, age and other factors.  For studies evaluating interventions to 
eliminate disparities, control groups are strongly encouraged to account for 
secular changes, as is measurement of costs and cost-effectiveness.  Because 
of the nature of the problem, expertise from multiple disciplines may be 
beneficial and is also encouraged.  Special attention may be necessary to 
address issues of cultural competency and community participation.  To the 
extent possible, applicants should submit proposals that build on available 
data, will generate early results, and are modest in terms of time, scale, and 
cost.  Existing data sources include those of AHCPR and HCFA.

Research Program Project Design

The P01 grant involves at least three and no more than eight inter-related 
individual projects bundled together under one program theme and involves a 
number of independent investigators from several disciplines or from several 
interests within one discipline.  Potential themes around which programs may 
be developed include a specific condition, a specific ethnic or racial 
minority group, or a cross-cutting issue such as health literacy.  This 
mechanism achieves an economy of effort and resources through the sharing of 
personnel, facilities, equipment, data and ideas.  The scope of this 
initiative and the capacity-building aspects of the P01 allows new 
investigators and institutions to be drawn in to work collaboratively with a 
team of researchers under the bundled projects.  Multiple applications focused 
around a similar theme from a single institution are discouraged, efforts 
should be made to consolidate the applications.  AHCPR encourages 
collaboration with researchers from minority institutions.
There are several features that distinguish program project grants from other 
assistance mechanisms.  Each project within a program project grant proposal 
is similar to the traditional research grant application in the sense that 
each is reviewed for scientific merit.  However, a component project is 
evaluated within the context of the special collaborative interrelationships 
and environment required for a program project.  A program project grant may 
contain one or more core component(s), each with a separate budget, for 
administrative or research support services that are required for and shared 
solely within this particular program project.  A core for dissemination and 
implementation may be an efficient use of resources.  There is no allowance 
for unspecified developmental research funds (seed money) in program project 
grants. 

Each P01 has three main types of leadership: the principal investigator, 
project leaders, and core directors.  The principal investigator is in charge 
of the entire P01 and sets the general over-
arching theme of all the projects in the P01.  Each individual project in the 
P01 is directed by a project leader.  In addition, individual projects in the 
P01 may share one or more ‘cores.’ Led by a core director, a core is a 
separately budgeted component of the P01 that provides essential facilities, 
administrative staff, or services for two or more of the P01’s individual 
projects.  The cores are to create synergies among the various projects, 
researchers, and institutions in the program.  For example, a technical core 
may be a separately budgeted facility that processes and analyzes data for 
several projects within the P01, allowing projects to link data sets and share 
variables.  For a detailed description of the design of the P01, please see 
AHCPR’s Guidelines for the Research Program Project Grant.

AHCPR Data 

AHCPR encourages research applications that will use, as is or in conjunction 
with other sources, data from the Medical Expenditure Panel Survey (MEPS), the 
Healthcare Cost and Utilization Project (HCUP), the HIV Cost and Services 
Utilization Study (HCSUS) and other AHCPR data.

MEPS is a nationally representative survey focused on the financing and 
utilization of medical care in the United States.  It is composed of four 
parts, the Household Component (HC), the Medical Provider Component (MPC), the 
Insurance Component (IC), and the Nursing Home Component (NHC), and is 
designed to yield comprehensive data that estimate the level and distribution 
of health care use and expenditures, monitor the dynamics of the health care 
delivery and insurance systems, and assess health care policy implications.  
It has been used to estimate the impact of changes in insurance coverage on 
different populations including racial and ethnic minority groups. 

HCUP is composed of two databases containing patient-level information for 
inpatient hospital stays for 1988-97.  The Nationwide Inpatient Sample (NIS) 
includes inpatient data from a national sample of about 900 hospitals while 
the State Inpatient Database (SID) covers inpatient care in community 
hospitals in 19 States that represent more than half of all U.S. hospital 
discharges.  The uniform data in HCUP make possible comparative studies of 
health care services and the use and cost of hospital care, including the 
effects of market forces on hospitals and the care they provide, variations in 
medical practice, the effectiveness of medical technology and treatments, and 
use of services by special populations.  The databases can be linked with 
other sources such as the Health Resources and Services Administration’s Area 
Resource File.

AHCPR, with supplemental funding from Health Resources and Services 
Administration, the National Institutes of Health and the Office of Minority 
Health in the Department of Health and Human Services, developed HCSUS to 
address a broad array of issues relevant to public policy formulation and to 
health services research regarding HIV.  The study interviewed a national 
probability sample of HIV-infected adults who were receiving ongoing or 
regular medical care in 1996.  Follow-up interviews and abstractions of data 
from patients" medical, pharmaceutical, and billing records were also 
conducted.  The sample was 49% white, 33% black, 15% Hispanic and 3% “other”.  
Public use tapes containing data from the baseline interviews will be 
available in the summer of 1999.  It is expected that all HCSUS data will be 
available for public use by the summer of 2000.

SPECIAL REQUIREMENTS

Data Privacy

Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a-
1(c)), information obtained in the course of any AHCPR-study that identifies 
an individual or entity must be treated as confidential in accordance with any 
promises made or implied regarding the use and purposes of the data 
collection.  Applicants must describe in the Human Subjects section of the 
application procedures for ensuring the confidentiality of such  identifying 
information.  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 safeguarded.

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 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://www.whitehouse.gov/OMB/circulars/a130/a130.html, 
http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf, 
http://csrc.nist.gov/publications/nistbul/csl96-10.txt,  and 
http://csrc.nist.gov/publications/nistbul/itl99-04.txt, respectively.     

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

Rights in Data

AHCPR grantees may copyright 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 AHCPR funds.  Such 
copyrights and patents are subject to a Federal government license to use and 
permit others to use these products and materials for AHCPR purposes.  In 
accordance with its legislative dissemination mandate, AHCPR purposes may 
include, subject to statutory confidentiality protections, making research 
materials, data bases, and algorithms available for verification or 
replication by other researchers, and subject to AHCPR budget constraints, 
final products maybe made available to the health care community and the 
public by AHCPR, or its agents, if such distribution would significantly 
increase access to a product and thereby produce public health benefits.  
Ordinarily, to accomplish distribution, AHCPR publicizes research findings but 
relies on grantees to publish in peer-reviewed journals and to market grant-
supported products.

Important legal rights and requirements applicable to AHCPR grantees are set 
out or referenced in the AHCPR’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).

INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS

It is the policy of AHCPR that women and members of minority groups be 
included in all AHCPR-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 
"NIH Guidelines on the Inclusion of Women and Minorities as Subjects in 
Clinical Research," which have been published in the Federal Register of March 
28, 1994 and in the NIH Guide for Grants and Contracts of March 18, 1994 .  To 
the extent possible, AHCPR requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the AHCPR 
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide 
Website http://grants.nih.gov/grants/guide/index.html.

AHCPR also encourages investigators to consider including children in study 
populations, as appropriate.  AHCPR announced in the NIH Guide of May 9, 1997, 
that it is developing a policy and implementation plan on the inclusion of 
children in health services research.  This Notice is available through the 
AHCPR Website http://www.ahcpr.gov (Funding Opportunities) and InstantFAX (see 
instructions under INQUIRIES).

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

LETTER OF INTENT

Prospective applicants are asked to submit, by December 22, 1999, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions, and the number and title 
of the RFA in response to which the application may be submitted.  

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 AHCPR staff to estimate the potential review workload and 
avoid conflict of interest in the review.  AHCPR will not provide responses to 
letters of intent.

The Letter of Intent is to be sent to Joanne Book (see address under 
INQUIRIES).

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  State and local government applicants may use PHS 
5161-1, Application for Federal Assistance (rev. 5/96), and follow those 
requirements for copy submission.  

Applications kits are available at most institutional offices of sponsored 
research.  They may also be obtained from the Division of Extramural Outreach 
and Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, E-mail: 
grantsInfo@nih.gov.

AHCPR applicants are encouraged to obtain application materials from the AHCPR 
Publications Clearinghouse  (see INQUIRIES).

In addition to the above, application procedures should conform to AHCPR’s 
Guidelines for the Research Program Project Grant.  Applications for a P01 
grant must include (1) an overall organizational plan, (2) an overarching 
research plan, and (3) detailed plans for the research projects.  For purposes 
of the page limitations of section 1 through 4 of the PHS 398 form, the P01 
organizational plan (including the administrative, technical, and other cores) 
and the overarching research plan should be considered one component with a 25 
page limit.  A maximum of 10 additional pages total may be used to describe 
the discrete research projects that the program project will undertake. 

The RFA label and line 2 of the application form PHS 398 (rev. 4/98) should 
both indicate RFA number.  The RFA label must be affixed to the bottom of the 
face page.  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 must also be typed on line 2 of the face 
page and the YES box must be marked.  The sample RFA label available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Applicants are encouraged to read all PHS Form 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.  

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:

Joanne Book, Program Analyst
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
6010 Executive Blvd., Suite 300
Rockville, MD  20852
Telephone:  (301) 594-4039 
FAX:  (301) 594-3211
E-mail Address: jbook@ahcpr.gov 

Applications must be received by January 21, 2000.  An application received 
after the deadline may be acceptable if it carries a legible proof-of-mailing 
date, assigned by the carrier, and the proof-of-mailing is not later than 1 
week prior to the deadline date.  If an application is received after that 
date, it will be returned to the applicant without review.  

Application Preparation (for Using HCFA 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 PHS 398) the specific 
files, time periods, and cohorts proposed for the research.  In consultation 
with the Health Care Financing Administration (HCFA), AHCPR will use this 
information to develop a cost estimate for borrowing the data.  This estimate 
will be included in the AHCPR estimated cost of the grant and may affect the 
fundability of the application.  To avoid double counting, applicants should 
not include the cost of the data in the budget.  

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 HCFA to protect the 
confidentiality of data in accordance with standards set out in OMB Circular 
A-130, Appendix III–Security of Federal Automated Information Systems.  The 
use of the data is restricted to the purposes and time period specified in the 
DUA.  At the end of this time period, the grantee is required to return the 
data to HCFA or certify that the data have been destroyed.  
Grantees must also comply with the confidentiality requirements of Section 
903(c) of the PHS Act.  See the Data Privacy Section for details on these 
requirements as well as references to Circular A-130 and its implementation 
guides from the National Institute of Standards and Technology.

In developing research plans, applicants should allow time for refining, 
approving, and processing their data requests.  Requests may take 6 months 
from the time they are submitted to complete.  Applications proposing to 
contact beneficiaries or their provider require the approval of the HCFA 
Administrator and may require meeting(s) with HCFA staff.

HCFA 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 HCFA data should be directed to the AHCPR program official 
listed under INQUIRIES.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness and 
responsiveness.  Incomplete applications and applications determined to be 
unresponsive to the 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 by AHCPR in accordance with the review criteria stated below.

As part of the merit review, all applications will receive a written critique, 
and also may undergo a process in which only those applications deemed to have 
the highest scientific merit will be discussed and assigned a priority score. 

General Review Criteria  

The goals of AHCPR-supported research are to enhance the outcomes, quality, 
and cost, use and access of our health care system.  The reviewers will 
comment on the following aspects of the application in their written critiques 
in order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  Each of these criteria will 
be addressed and considered by the reviewers in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have a 
major scientific impact and thus receive a high priority score.  For example, 
an investigator may propose to carry out important work that by its nature is 
not innovative but is essential to move a field forward. 

o  Significance.  Does this study address an important, common and/or costly 
problem? If the aims of the application are achieved, how will scientific 
knowledge be advanced?  What will be the effect of these studies on the 
concepts or methods that drive this field?  What will be the impact on care 
for racial and ethnic minorities?

o  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Are the proposed data sources appropriate and adequate?  Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics?

o  Innovation.  Does the project employ novel concepts, approaches or method?  
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

o  Investigator.  Is the investigator appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?  Is the project 
(or work plan) well organized?

o  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional support?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration, the adequacy of plans to include both genders, 
children, and minorities and their subgroups as appropriate for the scientific 
goals of the research and plans for the recruitment and retention of subjects, 
the provisions for the protection of human subjects, and the safety of the 
research environment.

Special Review Criteria  

In addition to the general criteria above, the reviewers will assess the 
application’s responsiveness to the RFA and other critical aspects including:

o  The extent to which the research will improve our understanding of the 
racial and ethnic differences in access, quality, outcomes or burden of 
disease and/or develop strategies to eliminate them with an emphasis on the 
latter.

o  The extent to which study results will be applicable to situations beyond 
that of the study and contribute to reduction or elimination of disparities 
across a range of environments and populations.

o  The existence or establishment of meaningful and sustainable linkages 
between researchers and change agents including practitioners, professional 
organizations, policy makers, legislators, payers, patient and community 
organizations and the media in order to accelerate the incorporation of 
findings into practice.  Letters of support or agreement to participate are 
strongly encouraged.  Also, financial commitments from organizations toward 
project involvement may demonstrate significant interest.
o  The existence or establishment of substantive and sustainable linkages of 
researchers with communities and community organizations and the participation 
of community members in appropriate stages of the project to ensure that 
patient needs and priorities are addressed.  A history of the relationship 
should be described.  Inclusion of community representatives on the Program 
Project Advisory Board is strongly encouraged as are letters of support that 
clearly describe expected involvement in the study (ies).

o  Understanding of and means to adjust for cultural differences and 
variations between research participants (including patients and providers) 
and researchers that may impact on their interactions and the validity, 
reliability and generalizability of the study itself.

o  Development of new infrastructure including talent, methods and data 
systems that will enhance our capacity to study minority populations.

Also, because a P01 is composed of a number of inter-related projects, grant 
applications will be reviewed for the merit of the individual research 
projects, the core components in the context and environment of the proposed 
program and the integrated nature of the program as a whole.  Applicants are 
strongly advised to review the evaluation criteria in the AHCPR Guidelines for 
the Research Program Project Grant before preparing their applications.

AWARD CRITERIA

The following will be considered in making funding decisions: 1) quality of 
the proposed project as determined by peer review, 2) availability of funds, 
3) portfolio balance with respect to the conditions, populations and 
strategies to understand and eliminate disparities addressed by the studies, 
4) fulfillment of set-aside funding targets and 5) potential for impact. 

INQUIRIES

Copies of the RFA and the PHS 398 grant application form are available from:

AHCPR Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD 20907-8547
Telephone 1-800-358-9295

The RFA is also available on AHCPR’s Web site, http://www.ahcpr.gov, and 
through AHCPR 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 RFA number).  The RFA will be sent at the end of 
the ordering process.  AHCPR InstantFAX operates 24 hours a day, 7 days a 
week.  For questions about this service, call AHCPR’s Division of 
Communications at (301) 594-6344.

AHCPR welcomes the opportunity to clarify any issues or questions from 
potential applicants.  Written and telephone inquiries concerning this RFA are 
encouraged.  Direct inquiries regarding programmatic issues, including 
information on the inclusion of women, minorities, and children in study 
populations to:

Joanne Book, Program Analyst
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
6010 Executive Blvd., Suite 300
Rockville, MD  20852
Telephone:  (301) 594-4039 
FAX:  (301) 594-3211
E-mail Address: jbook@ahcpr.gov 

For inquiries regarding AHCPR data sources:

Medical Expenditure Panel Survey
Nancy Krauss, M.S.
Center for Cost and Financing Studies
Agency for Health Care Policy and Research
2101 E. Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-0846
FAX: (301)594-2286
E-mail: nkrauss@ahcpr.gov

Healthcare Cost and Utilization Project
Anne Elixhauser, Ph.D.
Center for Organization and Delivery Studies
Agency for Health Care Policy and Research
2101 E. Jefferson Street, Suite 605
Rockville, MD 20852
Telephone: (301) 594-6815
FAX: (301)594-2314
E-mail: aelixhau@ahcpr.gov

HIV Cost and Service Utilization Study
Doris Lefkowitz, Ph.D.
Center for Cost and Financing Studies
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 500
Rockville, MD 20852
Phone: (301) 594-1077
FAX: (301)594-2286
E-mail: dlefkowi@ahcpr.gov

Direct inquiries regarding fiscal and eligibility matters to:

Joan Metcalfe
Grants Management Specialist
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone: (301) 594-1841
FAX: (301) 594-3210
Email: jmetcalf@ahcpr.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.226.  Awards are made under authorization of Title IX of the Public Health 
Service Act (42 USC 299-299c-6).  Awards are administered under the PHS Grants 
Policy Statement and Federal Regulations 42 CFR 67, Subpart A,  and 45 CFR 
Parts 74 and 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.

REFERENCES 

Association of American Medical Colleges (1997).  Draft Recommendations from 
the AAMC Meeting on Minority Health Services Research.  July, 1997.

Andrulis DP (1998).  Access to Care is the Centerpiece in the Elimination of 
Socioeconomic Disparities in Health.  Ann Intern Med,129:412-416.

Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA (1998).  
Closing the Gap between Research and Practice: an Overview of Systematic 
Reviews of Interventions to Promote the Implementation of Research Findings.  
BMJ,317:465-468.

Dominitz JA, Samsa GP, Landsman O, Provenzale D (1998).  Race, Treatment, and 
Survival among Colorectal Carcinoma Patients in an Equal-Access Medical 
System.  Cancer,82:2312-
2320.

Lee AJ, Gehlbach S, Homer DW, Reti M, Baker CS (1997).  Medicare Treatment 
Differences for Blacks and Whites.  Med Care,35:1173-1189.
Makuc DM, Breen N, Freid V (1999).  Low Income, Race, and the Use of 
Mammography.  Health Serv Res,34(1 Pt 2):229-239.

North American Primary Care Research Group (1998).  Responsible Research with 
Communities: Participatory Research in Primary Care.  A Policy Statement.  
November 6, 1998.

Schulman KA, Berlin JA, Harless W, Kerner JF, Sistrunk S, Gersh BJ, Dube R, 
Taleghani CK, Burke JE, Williams S, Eisenberg JM, Escarce JJ (1999).  The 
Effect of Race and Sex on Physicians" Recommendations for Cardiac 
Catheterization.  N Engl J Med,340:618-626.

Shapiro MF, Morton SC, McCaffrey DF, Senterfitt JW, Fleishman JA, Perlman JF, 
Athey LA, Keesey JW, Goldman DP, Berry SH, Bozzette SA (1999).  Variations in 
the Care of HIV-
Infected Adults in the United States: Results from the HIV Cost and Services 
Utilization Study.  JAMA,281(24):2305-2315.

Tunis S, Stryer D (1999).  The Outcomes of Outcomes Research at AHCPR.  AHCPR 
Pub. No. 99-R044.

U.S. Preventive Services Task Force.  Guide to Clinical Preventive Services 
(Second Edition).  U.S. Department of Health and Human Services.



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