PARTNERSHIP PROGRAMS TO REDUCE CARDIOVASCULAR DISPARITIES
 
RELEASE DATE:  September 15, 2003
 
RFA Number:  RFA-HL-04-002

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

National Institutes of Health (NIH)
 (http://www.nih.gov/)
 
COMPONENTS OF PARTICIPATING ORGANIZATIONS:

National Heart, Lung and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.837   

LETTER OF INTENT RECEIPT DATE:  January 22, 2004
APPLICATION RECEIPT DATE:  February 19, 2004
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The purpose of this initiative is to promote and expedite research that improves 
cardiovascular disease (CVD) outcomes in racial and ethnic minorities.  This 
objective will be accomplished by funding up to seven collaborative partnerships 
(i.e., Partnerships Program to Reduce Cardiovascular Health Disparities) between 
research-intensive medical centers (RIMCs) that have a track record of NIH-
supported research and patient care; and minority healthcare serving systems 
(MSSs) that lack a strong research program.  Each Partnership Program will: a) 
design and carry out multiple interdisciplinary research projects that 
investigate complex biological, behavioral and societal factors that contribute 
to CVD health disparities and facilitate clinical research within the MSS to 
improve CVD outcomes and reduce health disparities, and b) provide reciprocal 
educational and skills development programs to develop investigators able to 
conduct research aimed to reduce cardiovascular disparities and thereby enhance 
research opportunities, enrich cultural sensitivity and cardiovascular research 
capabilities at both institutions.

For the purpose of this solicitation, minority serving systems (MSSs) may 
include graduate or medical schools with more than 50% enrollment of minority 
students (African American, Hispanic, Native Americans, Alaskan Natives, Native 
Hawaiians, Pacific Islanders) or non-academic medical centers, community 
hospitals, community health centers or private practices serving minority 
communities and which lack a robust research program.  Research-intensive 
medical centers (RIMCs) are universities, medical schools or medical centers 
with documented accomplishments in research.  Research intensive medical 
institutions that serve a significant number of minorities are considered RIMCs, 
not MSSs for the purpose of this solicitation.

Applicants must indicate whether they are applying as an RIMC or MSS and provide 
documentation of their strengths in support of their eligibility claim.  Because 
this program seeks to establish new partners, a single institution should not 
apply as both the RIMC and MSS for a Partnership Program unless there are 
special circumstances, such as a large umbrella health system that includes 
multiple facilities that operate independently.

RESEARCH OBJECTIVES

Nature of the Research Problem

While there has been great progress in reducing CVD morbidity and mortality in 
the U.S. over the past 40 years, some minority groups have not shared fully in 
this progress and continue to have lower life expectancy and higher CVD 
morbidity.  On average, minorities have less access to medical care, receive 
less aggressive care and fewer diagnostic and therapeutic cardiac procedures, 
and adhere poorly to prescribed medical regimens.  Thus, research to reduce 
health disparities by improving CVD outcomes in minorities offers potential for 
a substantial positive public heath impact.  Academic medical centers and 
institutions capable of carrying out such research, however, often lack access 
to and the trust of minority patients.  Minority patients often receive 
fragmented care because they lack access to regular medical care, present to 
emergency departments rather than primary care physicians for complications of 
an advanced chronic CVD condition, and are less likely to follow medical 
regimens.  Minority communities often harbor distrust of clinical research.  
Minority patients report greater satisfaction when receiving care from minority 
providers and are reluctant to receive treatment outside their MSS.

Background

In general, minorities have high rates of hypertension, elevated cholesterol, 
cigarette smoking, obesity, metabolic syndrome, and diabetes, as well as other 
behavioral, environmental, and occupational risk factors for cardiovascular 
diseases, such as sleep problems - all elements that contribute to excess CVD 
morbidity and mortality.  The causes of minority health disparities are complex 
and incompletely understood.  Although evidence of genetic, biologic, and 
environmental factors is well documented, poor outcomes are also attributed to 
under-treatment.  Such under-treatment may be due to limited access to health 
care or, in some cases, break-down of the medical system, or failure of the 
physician and/or patient to allow for optimal health care, even when access is 
not impaired.  The complex interactions of behavior, socio-economic status 
(SES), culture, and ethnicity are important predictors of health outcomes and 
sources of health disparities.  Despite efforts to elucidate genetic and 
environmental risk factors and to promote cardiovascular health in high-risk 
populations, trends in CVD outcomes suggest that CVD health disparities continue 
to widen.

Scientific Knowledge to be Achieved through Research Supported by the Program

This program is intended to promote a coordinated, comprehensive, 
interdisciplinary, and focused research effort to improve cardiovascular health 
outcomes in minority populations.  The program will accomplish this goal by 
establishing meaningful partnerships between a RIMC (which will provide research 
experience and expertise) and a MSS (which will provide access to patients and 
established close community interactions).  The MSS and RIMC must be full 
partners who together will provide a fertile environment for studying how to 
optimize prevention, diagnosis and treatment of CVD in minority populations and 
individuals.  Each partnership will minimize medical access barriers through 
community participation and fostering of collaboration between researchers and 
community health providers to develop effective strategies to overcome 
impediments to the prevention and treatment of CVD.  It is expected that 
patients eligible for clinical studies in the partnerships program will be 
recruited, treated and followed in the MSS with minimal disruption of 
established practice relationships.  The RIMC would insure rigorous standards of 
scientific investigation, analysis and dissemination of findings. 

Scope of Research and Educational Objectives

This RFA is designed to stimulate MSSs and RIMCs to generate partnerships to: 1) 
conduct collaborative research on the causes and resolution of disproportionate 
burden of cardiovascular disease in U.S. minority populations, and 2) provide 
culturally sensitive, reciprocal educational and skills development programs 
that will serve to enhance and enrich the research potential and cardiovascular 
disease management capabilities at the collaborating organizations. 

Each Partnership Program will design and carry out an integrated research 
program to improve a cardiovascular health outcome relevant to the MSS and its 
community.  Multiple projects may address gaps in our understanding of how CVD 
outcome is influenced by clinical presentation and manifestations; differences 
in behavior, education, cultural and economic environment; and differing 
responses to treatment.  Measurements selected to monitor CVD outcome of 
interest must be meaningful to the local, health care practice, and research 
communities in terms of demonstrating improvement over the period of the 
program.  

Partnerships are expected to encourage recruitment of new investigators with 
interests in reducing health disparities.  Interdisciplinary teams may include 
behavioral and social scientists in addition to basic and clinical 
investigators.  

Types of Research and Experimental Approaches

The two applications, one from the MSS and one from the RIMC, that form a 
Partnership Program should include an identical "Research Plan" that covers in 
no more than 40 pages (Section A through D) four aims and two educational aims. 
(See "Special Requirements").  A wide range of research areas (e.g. 
pathophysiologic mechanisms, pharmacology, clinical trials, complementary 
medicine, and patient and health care provider education) would be responsive to 
this RFA directed at understanding and reducing cardiovascular disparities.  It 
is expected that each project will include or derive methods to reduce 
cardiovascular disparities.  A few topics illustrative of these areas are 
provided below.  These are only examples and applicants are encouraged to 
propose others. 
         
A.  Examples of Research Topics

o Intervention projects that will prevent, decrease, or eliminate cardiovascular 
disparities. 

o Intervention projects that will improve cardiovascular outcomes in minorities.

o Investigations to elucidate pathophysiologic mechanisms that result in 
differing clinical symptoms, response to diagnostic evaluation, and/or 
intervention.

o Investigations to elucidate the contributions, roles, and mechanisms of risk 
factors in cardiovascular disparities.

o Investigations to provide new strategies to enhance delivery of medical care, 
such as improving patient, physician, or medical system adherence.

o Investigations to elucidate and resolve the effect of various factors of 
health care seeking behavior on cardiovascular health disparities. 

o Studies which focus on community environment as a resource to eliminate 
disparities.

o Studies to identify and validate suitable measures of outcomes to monitor 
improvement in health care that are practical and compelling to community, 
practice and research communities.

B.  Education and Skills Development

A second goal of this RFA is to educate and promote career development of new 
investigators capable of conducting research to reduce cardiovascular health 
disparities.  The proposed program should encourage reciprocal educational 
programs between the MSS and the RIMC to enhance research capabilities and 
enrich the sensitivity to minority cardiovascular research projects and 
interventions at both institutions.  The educational activities within a 
Partnership Program should include educational programs in cardiovascular care 
in high risk populations as well as the conduct of research.  

The educational project must represent a true collaboration between partner 
organizations.  For example, proposed training or skills development might 
provide graduate students in the MSS with the opportunity to fulfill research 
requirements in the RIMC with mentoring by RIMC investigators.  Clinical 
research training and skills development proposed for RIMC students could 
include rotations at the MSS that focus on dealing with cross-cultural factors 
and reducing cardiovascular health disparities.
 
Successful activities should lead to more extensive educational projects that 
may ultimately lead to competitive applications for NIH training grants. The 
educational aim(s) in each application should include the following elements: 

o Designation of key personnel who will lead the educational activities at each 
institution in the Partnership Program and description of the organizational 
structure and management to insure collaboration.

o Plans for a training core to accomplish the cross-institution training 
objectives of the RFA that is comprised of courses, seminars, mentoring projects 
or other training methods.

o Plans for training students, investigators and other personnel on issues and 
problems associated with cardiovascular disparities in minority populations.

o Plans by the MSS to stimulate research programs in the RIMC that focus on 
reducing cardiovascular disparities and provide education for the Partnership 
Program researchers and staff in cultural sensitivity and methods to promote 
community participation in research. 

o Plans by the RIMC to help the MSS build its resources, research capacity, and 
skills to conduct clinical research.  This should include seminars or mentoring 
for administrative personnel as well as researchers and include issues related 
to research grant development and administration with grant awarding agencies 
such as NIH.

o Plans to sustain the partnership and help investigators at the MSS and the 
RIMC generate collaborative investigator-initiated research proposals and 
continue reciprocal training opportunities.  

o Plans of the partnership to foster career development programs that expand the 
scientific cadre of investigators dedicated to research on cardiovascular health 
and disease in minority populations.
                   
Program Organization 

Partnership programs must include established academic investigators and primary 
care and cardiovascular medicine health providers that will work as a team to 
develop an integrated research program focused on a significant contributory 
factor(s) to poor cardiovascular health outcomes in one or more minority 
populations.  Projects may address multiple areas such as pathophysiology, 
pharmacology, genetics or genomics, behavioral or social science, patient 
education, and alternative methods to focus on reducing or eliminating health 
disparities.  Each component partner is required to include an education and 
skills development aim to expand the number of investigators dedicated to 
research aimed at improving CVD outcomes in high risk minority populations.  
Partnerships are permitted to request support for a core or shared resources 
including administrative staff.
                      
A successful Partnership Program will recognize the separate but, complementary 
strengths of each component partner.  It is anticipated that the goal of 
reducing health disparities is facilitated by the effective collaboration of the 
MSS and RIMC and resulting Partnership Program organization, management and 
operation.  Each Partnership Program will include two or more projects that 
relate to a clearly defined, unified central theme.  Each partner institution 
will be responsible for at least two research aims and one educational aim 
within the research projects.  Because the factors contributing to health 
disparities are complex, proposed programs may include multiple requisite 
disciplines.  The central theme should be clearly developed in the introduction 
and indicate the rationale of how the multidisciplinary projects are related and 
will uniquely meet the goals of the five year program.  The relationship of each 
project to the central theme must be described and each project should have 
clearly defined hypotheses and aims.  Projects should be patient-oriented and 
include at least one intervention project to reduce cardiovascular health 
disparities which can be completed in a five-year project period.  Each 
Partnership Program may request core facilities for administration, community 
participation, and education.

An important element of the Partnership Program is the community involvement.  
Community participation is expected to improve awareness, understanding and 
knowledge of specific projects and to promote acceptance of the overall goals of 
the Partnership Program by the target population.  It is also expected that an 
open dialogue with representative community leaders will facilitate 
identification and resolution of obstacles to conducting clinical 
investigation(s).  Ultimately research objectives and methods should be mutually 
understood and accepted by the research team and the target population.  
Community acceptance will enhance subject recruitment and interest in the 
successful completion and results of the Partnership Program.  Description of 
community involvement and how it will enhance the Partnership Program should be 
fully developed.

Example of a Partnership Program

One example of a partnership would be the collaboration of an urban research 
hospital center with MEDICAID-supported managed care facilities.  In such a 
partnership, investigators might develop a program around the theme of excess 
morbidity and mortality in African-Americans with coronary artery disease.  
Separate interventions to improve outcomes following acute myocardial infarction 
might include 1) aggressive revascularization versus usual care, or 2) protocol-
guided aspirin, beta-blocker, ACE inhibition versus usual community care in-
hospital and with follow-up.  Outcome measures might include the proportion of 
patients that reach target treatment goals.  Studies that address 1) adherence 
to medical regimens in patients with multiple risk factors, 2) impaired 
endothelial function in African-Americans and 3) patient recognition of acute 
myocardial infarction symptoms, are examples of related projects.  Examples of 
other possible topics that would benefit from this coordinated approach include: 
a) obesity-related cardiovascular diseases in Hispanics; or b) hypertension-
related end-organ disease in African Americans. 

Minimum Requirements for Partnership Program Application

Each partnership should include the following:

o Minority healthcare serving system 

o Research-intensive medical center in close proximity to the minority 
healthcare serving system.

o Interdisciplinary investigation of the complex biological, behavioral and 
societal factors contributing to higher CVD morbidity and mortality in 
minorities.

o Collaborative research conducted in each of the partnership components (RIMC 
and MSS).

o Community participation for improving community understanding and interest in 
the successful completion of program and for recruiting and retaining minority 
patients.

o Education and skills development of new investigators focusing on reduction of 
CVD health disparities.

o Identification and development of objective endpoints to gauge the 
effectiveness of each interventional project conducted.

MECHANISM OF SUPPORT

This RFA will use NIH U01 award mechanism(s). The NIH (U01) is a cooperative 
agreement award mechanism in which the Principal Investigator retains the 
primary responsibility and dominant role for planning, directing, and executing 
the proposed project, with NIH staff being substantially involved as a partner 
with the Principal Investigator, as described under the section "Cooperative 
Agreement Terms and Conditions of Award".  This RFA is a one-time solicitation.  
Future unsolicited, competing-continuation applications based on this project 
will compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures. The anticipated award date 
is September 30, 2004. 

This RFA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
https://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.  Otherwise follow the 
instructions for non-modular research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm 

The total project period for an application submitted in response to this RFA 
may not exceed 5 years.  Applications from each collaborating organization that 
form a partnership should clearly identify the institutions constituting the 
Partnership Program and the investigators in each institution who will serve 
respectively as the Principal Investigator and Co-principal Investigator(s) of 
each grant.  The two applications, one from the MSS and the other from the RIMC, 
will be treated as a single program for review purposes and receive a single 
score based on the strengths and weaknesses of the two component applications.  
Although they will receive separate grant awards, if successful, they will be 
treated as a single entity (i.e., a Partnership Program for Reducing 
Cardiovascular Disparities) in post award monitoring, for submission of progress 
reports and other RFA-related activities. 

FUNDS AVAILABLE
 
The NHLBI intends to commit approximately $6.0 million in FY 2004 to fund 5 to 7 
new partnership programs in response to this RFA.  An applicant (one component 
of the Partnership Program) may request a project period of up to 5 years and a 
budget of up to $600,000 total costs per year. A maximum of $75,000 may be 
budgeted for educational and career development activities in each application.  
Travel funds for a roundtrip to Bethesda for at least two individuals from each 
partner institution should be included for program-related travel for each year 
of the grant period.  Funds for core facilities and expenses for administration, 
community participation and training may also be requested.  Because the nature 
and scope of the proposed research will vary from application to application, it 
is anticipated that the size and duration of each award will also vary.  
Although the financial plans of the NHLBI provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.  At this time, 
it is not known if this RFA will be reissued.
 
ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your organization is a domestic 
institution and has any of the following characteristics: 
   
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and 
laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Faith-based or community-based organizations 
 
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.  Individuals from underrepresented racial and ethnic groups as well 
as individuals with disabilities are encouraged to apply.   
 
SPECIAL REQUIREMENTS 

(Please see SUPPLEMENTARY INSTRUCTIONS too)
Applications may be submitted by institutions that meet the definitions for MSSs 
and RIMCs provided in the RFA.  Applications will be accepted only from MSSs and 
RIMCs that enter into bilateral agreements and establish themselves as a 
Partnership Program for Reducing Cardiovascular Health Disparities.  Separate 
applications are to be submitted by each partner in the Partnership Program, but 
the applications will provide the same Research Plan (i.e., identical parts A to 
D of Form PHS 398-Rev. 5/01).  The common Research Plan, which has 40 page 
limit, must have at least six specific aims (four research-specific aims plus 
two training-specific aims), with each institution serving as the lead 
performance site for at least two research-specific aims and one training-
specific aim.  It is expected that the research and training program at one 
component of the Partnership Program will complement the program at the other, 
be performed as a collaborative effort and that the Principal Investigator from 
one component of the Partnership Program will name investigators from the second 
component as collaborating investigators.  Each of the two applications should 
identify the component institutions of the Partnership program, delineate the 
research and educational activities to be performed at each of the components, 
and explain how these activities complement each other.  Although the Research/
Education Plan section of the applications from each institution will be 
identical, the applications will have different Face Pages, Budgets, 
Biographical Sketches, and Other Support and Resource pages.  Because of the 
expected complementary and interrelated nature of this common research effort, 
the separate applications from each Partnership Program for Reducing 
Cardiovascular Disparities will be considered and reviewed as a single program, 
and assigned the same priority score by the Scientific Review Group.  However, 
a successful Partnership Program will receive two separate awards, one to the 
MSS and the one to the RIMC. 
 
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award statement 
and provided to the Principal Investigator as well as the institutional official 
at the time of the award.  These special Terms of Award are in addition to and 
not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant 
Administrative Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS and 
NIH Grant administration policy statements. 

1.  Awardee Rights and Responsibilities  
 
Awardees have primary authorities and responsibilities to define objectives and 
approaches, to plan and conduct the research activities, and to analyze and 
publish results, interpretations and conclusions of their studies. 
 
Awardees will retain custody of and have primary rights to the data developed 
under these awards, subject to Government rights of access consistent with 
current HHS, PHS, and NIH policies.

Awardees, two from the MSS and two from the RIMC, should attend an annual 
meeting at Bethesda, Maryland for the purpose of discussing progress and 
exchanging ideas.

2.   NHLBI Staff Responsibilities  

The dominant role and prime responsibility for the Center activities reside with 
the awardees for the project as a whole, although specific tasks and activities 
in carrying out the programs will be shared among the awardees and the NHLBI 
Project Scientist. The Program Administrator may serve as the NHLBI Project 
Scientist.
 
The Program Administrator will be an Extramural official with responsibility for 
normal program stewardship and administration of the award.  The NHLBI reserves 
the right to terminate or curtail the study (or an individual award) for lack of 
scientific progress, failure to adhere to policies of the NHLBI under the U01 
mechanism, or failure of the partnerships to evolve within the intent and 
purpose of this initiative.  The NHLBI Project Scientist's scientific-
programmatic involvement during the conduct of this activity is expected to be 
above and beyond that normally exercised in the administration of a traditional 
R01 research grant.  The expanded programmatic involvement will provide 
technical assistance, support, coordination, and momentum to help accomplish the 
goal of creating effective research partnerships and will include:

o working with individual investigators and partners to facilitate 
collaborations, including coordinating regularly scheduled conference calls with 
principal investigators to discuss progress and approaches to address any 
problems;
  
o assisting the partnership efforts by facilitating access to fiscal and 
intellectual resources provided by NHLBI, NIH, and federal funding agencies;

o providing assistance in reviewing and commenting on all major transitional 
changes of an individual partner's activities prior to implementation to assure 
consistency with the goals of the RFA;

o coordinating activities with other ongoing studies supported by NHLBI to avoid 
duplication of efforts and encourage sharing and collaboration in the 
development of new interventions to reduce cardiovascular health disparities;

o linking the approaches developed from these partnerships to other Partnership 
Programs funded by the RFA to ensure that information is shared and utilized on 
the widest basis possible;

o helping re-direct program efforts within the peer reviewed scope of work, 
including modifying projects/programs when they are not making sufficient or 
timely progress; and

o organizing an annual meeting of the RFA participants.

3.  Arbitration 
 
Any disagreement that may arise on scientific/programmatic matters (within the 
scope of the award); between award recipients and the NHLBI may be brought to 
arbitration.  An arbitration panel will be composed of four members: one 
selected by each of the individual awardees in the Partnership Program, a third 
member selected by NHLBI, and the fourth member to be selected by the three 
previously selected members.  This special arbitration procedure in no way 
affects the awardee's right to appeal an adverse action that is otherwise 
appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D 
and HHS regulation at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Patrice Desvigne-Nickens, M.D.
Division of Heart and Vascular Diseases 
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Suite 9044, MSC 7956
Bethesda, MD  20892-7940
Bethesda, MD 20817 (for express/courier service)
Telephone:  (301) 435-0515
Fax:  (301) 480-1336
Email:  DesvignP@NHLBI.NIH.GOV

o Direct your questions about peer review issues to:

Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD  20892-7924
Bethesda, MD 20817 (for express/courier service)
Telephone:  (301) 435-0270
FAX:  (301) 480-0730
Email:  ClarkA@nhlbi.nih.gov

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

David Reiter
Grants Management
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive 
Room 7156, MSC 7926
Bethesda, MD 20892-7926 
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0166
FAX: (301) 480-3310
Email: Reiterd@nhlbi.nih.gov
 
LETTER OF INTENT
 
Prospective applicants from each partnership programmed are asked to submit a 
joint letter of intent that includes the following information:

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

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows NHLBI staff to estimate the potential review workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to Dr. Anne Clark at the address 
listed under WHERE TO SEND INQUIRIES.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal 
Identifier when applying for Federal grants or cooperative agreements. The DUNS 
number can be obtained by calling (866) 705-5711 or through the web site at 
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 document is 
available at https://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS: Each component institution within a proposed 
Partnership Program for Reducing Cardiovascular Health Disparities should submit 
a separate application with a cover letter that clearly delineates the proposed 
partnership and includes a letter of commitment to the Partnership Program that 
describes the bilateral agreement (See "Special Requirements"). 

Although each component submits a separate application, each application will 
provide the same "Research Plan" (identical parts A to D of the PHS 398 form).  
The "Research Plan" will cover both the research and educational aims (see 
"Special Requirements") and must be limited to 40 pages.  The research section 
of the plan should include, for each of the 4 proposed research aims, a specific 
description of the research approach proposed to address the aim, including the 
goals, background and significance, preliminary studies, and research design and 
methods. The "Research Plan" should also include an explanation of how the four 
aims relate to and complement each other, and a timeline that describes how the 
four aims will be addressed over the five year grant period. The educational 
section of the plan should include the elements described in the "Education and 
Skills Development" section of this RFA. 

Description of community participation in the Partnership Program is required.  
Community awareness, understanding, and commitment to the goals of the program 
are likely to favorably influence participant recruitment and retention.  
Outreach activities may include but are not limited to: establishing 
relationships with traditional or non-traditional (regarding health) community 
leaders, employing established or new methods to identify and trouble shoot 
community concerns and obstacles to conducting the Partnership Program, 
inclusion of community representatives in the Partnership Program, and 
disseminating educational and informational materials.  Evidence or plans for 
establishing ties with the target community during planning, performance and 
dissemination of program should be detailed under discussion of the environment.

Since the application must include an intervention project, plans for data 
safety monitoring, including establishment of and independent data and safety 
monitoring board must be included.  Applicants should describe the 
organizational structures and procedures they will employ to ensure the safety 
of participants and the validity and integrity of the data; for a statement of 
issues and concerns, see "NIH Policy for Data and Safety Monitoring," NIH guide 
to Grants and Contracts, Release Date: June 10, 1998,
https://grants.nih.gov/grants/guide/notice-files/not98-084.html.  
At the time of the award, applicants should be prepared to make adjustments to 
their procedures based upon NHLBI policy.  

Travel funds for a two-day meeting each year, most likely to be held in 
Bethesda, Maryland, must be included in the budget calculation. The Principal 
Investigators at the MSSs and RIMCs must include a statement indicating their 
willingness to participate in these meetings.  Applicants are encouraged to 
contact the program officials listed under INQUIRIES for further information.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked. The RFA label is also available at: 
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the 
application, including the Checklist, and three signed, photocopies, in one 
package to:
 
Center For Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application plus all 
five collated sets of appendix material must be sent to 
Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES.
  
APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application 
is received after that date, it will be returned to the applicant without 
review. 

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

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, it 
is to be prepared as a NEW application.  That is, the application for the RFA 
must not include an Introduction describing the changes and improvements made, 
and the text must not be marked to indicate the changes from the previous 
unfunded version of the application. 

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NHLBI. Incomplete applications will not be reviewed.  

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 
the NHLBI in accordance with the review criteria stated below.  Because of their 
interrelatedness, the applications from each component institution comprising a 
Partnership Program will be reviewed as a single program and assigned the same 
priority score.  As part of the initial merit review, all applications will:

o Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will 
be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Heart Lung and Blood Advisory 
Council or Board. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In the 
written comments, reviewers will be asked to evaluate the following aspects of 
the application in order to judge the likelihood that the proposed research will 
have a substantial impact on the pursuit of these goals. The scientific review 
group will address and consider each of these criteria in assigning the 
application's overall score, weighting them as appropriate for each application.

o Research plans
o Educational plans
o Collaboration 
o Innovation
o Investigators
o Environment and institutional commitment including community participation

The application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

RESEARCH PLANS: Do the proposed research projects address important problems? If 
the aims of the application are achieved, would care and clinical outcomes of 
minority patients be improved? Are the conceptual framework, design, methods, 
and analyses adequately developed, well-integrated, and appropriate to the aims 
of the project? Do preliminary data support feasibility and proposed endpoints 
and sample sizes? Do the applicants acknowledge potential problem areas and 
consider alternative tactics?  

EDUCATIONAL PLANS: Is the organizational structure of training activities well 
planned?  Are the content and breadth of proposed courses, seminars, and 
mentorships appropriate for career development of the investigators/staff?  Are 
the educational aims of each partner complementary to one another such that the 
research potential and cardiovascular disease management skills of the trainees 
at both institutions will be enriched to reduce health disparities? 

COLLABORATION:  What is the quality of the collaborations envisioned within each 
member institution and between the two partnering institutions?  Are the aims at 
the two partnering institutions complementary?  Is there evidence that MSS and 
RIMC have jointly planned projects?  Is there evidence of community involvement 
and acceptance of the proposed research?

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

INVESTIGATORS: Are the investigators from both members of the partnership 
appropriately trained and well suited to carry out this work?  Are the levels of 
effort of the investigators sufficient for successful functioning of the 
Partnership Program?

ENVIRONMENT: Do the scientific environments in which the work will be done 
contribute to the probability of success?  Do the proposed studies take 
advantage of available resources?  Does the Partnership Program have access to 
minority populations willing to participate in clinical research projects?  Is 
there evidence of institutional support?  Is the proposed community 
participation appropriate for recruiting and retaining study participants?

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section on 
Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from genders, all racial and ethnic groups (and subgroups), 
and children as appropriate for the scientific goals of the research.  Plans for 
the recruitment and retention of subjects will also be evaluated. (See Inclusion 
Criteria in the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.  

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct costs 
in any year of the proposed research must include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, reviewers 
will not factor the proposed data sharing plan into the determination of 
scientific merit or priority score. See 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html 
for guidance. 

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: January 22, 2004
Application Receipt Date: February 19, 2004
Peer Review Date: June/July, 2004
Council Review: September 2-3, 2004
Earliest Anticipated Start Date: September 30, 2004

AWARD CRITERIA

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

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against these 
risks, the potential benefits of the research to the subjects and others, and 
the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding 
studies (phase I); efficacy studies (phase II); efficacy, effectiveness and 
comparative trials (phase III).  The establishment of data and safety monitoring 
boards (DSMBs) is required for multi-site clinical trials involving 
interventions that entail potential risk to the participants.   (NIH Policy for 
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or more 
in direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
https://grants.nih.gov/grants/policy/data_sharing  
Investigators should seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and Federal 
laws and regulations, including the Privacy Rule. Reviewers will consider the 
data sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the 
NIH that women and members of minority groups and their sub-populations must be 
included in all NIH-supported clinical research projects unless a clear and 
compelling justification is provided indicating that inclusion is inappropriate 
with respect to the health of the subjects or the purpose of the research. This 
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public 
Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on 
October 9, 2001 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) all 
applications or proposals and/or protocols must provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable; and b) investigators 
must report annual accrual and progress in conducting analyses, as appropriate, 
by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The 
NIH maintains a policy that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them. This 
policy applies to all initial (Type 1) applications submitted for receipt dates 
after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
https://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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.  It is 
important for applicants to understand the basic scope of this amendment.  NIH 
has provided guidance at 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a description 
of the 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 
Privacy Rule, including a complete Regulation Text and a set of decision tools 
on "Am I a covered entity?"  Information on the impact of the HIPAA Privacy Rule 
on NIH processes involving the review, funding, and progress monitoring of 
grants, cooperative agreements, and research contracts can be found at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for 
NIH funding must be self-contained within specified page limitations. Unless 
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not 
be used to provide information necessary to the review because reviewers are 
under no obligation to view the Internet sites.  Furthermore, we caution 
reviewers that their anonymity may be compromised when they directly access an 
Internet site.

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 priority areas. This RFA is related to 
one or more of the priority areas. Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople.  
It is also supportive of the President's new Healthier US Initiative and the 
DHHS Secretary's Prevention Initiative, Steps to a Healthier US which can be 
accessed at http://www.healthierus.gov/steps/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92).  All awards are 
subject to the terms and conditions, cost principles, and other considerations 
described in the NIH Grants Policy Statement.  The NIH Grants Policy Statement 
can be found at https://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the PHS 
mission to protect and advance the physical and mental health of the American 
people.

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