Full Text HL-93-01

COLLABORATIVE PROJECTS ON MINORITY HEALTH

NIH GUIDE, Volume 21, Number 39, October 30, 1992

RFA:  HL-93-01

P.T. 34, FF

Keywords: 
  Blood Diseases 
  Cardiovascular Diseases 
  Pulmonary Diseases 
  Diagnosis, Medical 
  Disease Prevention+ 

0785035

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  February 12, 1993
Application Receipt Date:  March 19, 1993

PURPOSE

The National Heart, Lung, and Blood Institute (NHLBI) invites the
concurrent submission of small groups of scientifically related
research grant applications (R01s) with a common theme related to
minority health issues and within the purview of the NHLBI.  The goal
of this program is to foster collaborative clinical research that
focuses on new and improved approaches for diagnosis, management, and
prevention of cardiovascular, lung, and blood diseases in minorities.
Applicants are expected to have demonstrated expertise in the
recruitment and retention of minority study participants.  This
solicitation is part of the NHLBI commitment to improve the health
status of the American population.

The special feature of this program is the concurrent submission of
research grant applications by investigators who wish to collaborate
on a common theme related to clinical research on minority health
issues, but do not require extensive shared physical resources or
core functions to conduct their research.  The common theme may be
one that spans the traditional boundaries of cardiovascular, lung,
and blood research (e.g., thromboembolic events), or it may deal with
a single disease or condition (e.g., asthma) from several points of
view.  Investigators may submit applications for small clinical
studies, including biobehavioral and prevention research.
Applications will be reviewed for scientific merit, relevance of
projects to the chosen theme, and overall proposed collaboration.
Special consideration will be given to applications from minority
investigators and institutions.

HEALTHY PEOPLE 2000

The PHS is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priorities.  This RFA, Collaborative Projects on
Minority Health, is related to the priority areas of cardiovascular,
lung, and blood diseases.  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 202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by for-profit or nonprofit
institutions, whether public or private, such as universities,
colleges, hospitals, and laboratories.

This RFA is intended to support individual research grants for
studies of minority human subjects.  Therefore, basic research
investigations and studies in non-minorities will not be responsive
to this RFA.  Large population-based studies, such as epidemiologic
surveys or clinical trials, will be considered unresponsive to this
announcement.  Awards will not be made to foreign institutions.

MECHANISM OF SUPPORT

The support mechanism for this program will be the traditional
individual research grant (R01).  Projects should include a
description of, and plans to address, the special needs for
recruitment and retention of research subjects.

In order to be responsive to this RFA, a minimum of three independent
investigators with related research objectives should submit
concurrent, collaborative, cross-referenced individual research grant
applications that address a common theme.  Each group of applications
must include a succinct description of the scientific relationship
among the group of R01s; plans for collaboration, interaction, and
communication among investigators in the group of applications; and
the individual responsible for organizing and maintaining effective
collaboration.  Individual investigators may request a small amount
of funds, not to exceed 15 percent of direct costs, (1) for the time
and effort contributed toward coordination of overall research and
(2) for that proportion of shared resources that is necessary for
their research.

Applicants are requested to furnish estimates of the time required to
achieve the objectives of the proposed research project.  Up to five
years of support may be requested.  It is anticipated that support
for the present program will begin in September 1993.  Administrative
adjustments in project period and/or amount of support may be
required at the time of the award.  At the end of the official award
period, renewal applications may be submitted for peer review and
competition for support through the regular grant process of the NIH.

Since a variety of approaches would represent valid responses to this
announcement, a range of costs is expected among individual grants
awarded.  However, a collaborative group must not exceed $1,000,000
total requested costs (direct + indirect) each year, and the average
total requested cost of applications within a group must not exceed
the average total cost of NHLBI R01 grants ($220,000).  Any equipment
requested must be especially justified.  Requests for expensive
pieces of equipment are not encouraged.  Collaborative arrangements
involving other institutions are encouraged and should be discussed
with the NHLBI program staff prior to submission of the applications.

All current policies and requirements that govern the research grant
programs of the NIH will apply to grants awarded in connection with
this RFA.

FUNDS AVAILABLE

Although the total costs for this program are estimated at
$5,000,000, award of grants pursuant to this RFA is contingent upon
receipt of funds for this purpose.  It is anticipated that four to
six collaborative groups (12-24 R01 awards) will be supported under
this program.  The number and specific amount to be awarded will
depend on the merit and scope of the applications received and on the
availability of funds.

RESEARCH OBJECTIVES

Background

The NHLBI supports a comprehensive program of research related to
diseases of the heart, blood vessels, lungs, and blood, as well as
the use and management of blood resources.  Although a number of
diseases that are particular concerns of the NHLBI constitute
significant causes of death for all Americans, they exact a
disproportionate toll from members of minority groups.  For example,
in 1989 the age-adjusted death rate for heart disease---the leading
cause of death in the United States---was 32 percent higher among
Black men than white men and 62 percent higher among Black women than
white women.  For heart failure, mortality rates among Blacks
exceeded those among whites by 48 percent for men and 72 percent for
women.  During the past decade, both morbidity and mortality from
asthma increased sharply, particularly among Blacks and Hispanics.
The reasons for these disparities are complex.  Health status is
influenced by a variety of factors such as physiology, culture,
behavior, environment, and socioeconomic status, whose interactions
and relative importance are poorly understood for the general
population and even less understood for the minority population.
Better knowledge of biological and other risk factors affecting
minority health will enhance understanding of disease etiology and
pathophysiology and lead to preventive educational and therapeutic
interventions applicable to special populations.

Studies in minority populations are needed to improve understanding
of variability in the clinical presentation, diagnosis, and
effectiveness of treatment of cardiovascular diseases.  Apparent
physiologic differences between whites and minorities have been
reported in a few studies, but their significance is uncertain.
Marked disparities in economic and educational status, cultural and
religious orientation, health insurance, and other factors that
affect access to medical care exist between minority and majority
populations, and it is certain that these factors influence disease
outcomes.  A recent report of racial disparities in utilization of
coronary artery bypass grafting among Medicare patients suggests that
therapeutic modalities may not always be available to minorities,
particularly Blacks.  Minorities have a high prevalence of
cardiovascular risk factors such as hypertension, diabetes, and
smoking.  Patterns of heart disease differ among population groups,
even when covariates of risk are taken into account.

Certain cardiovascular and pulmonary risk factors, including smoking,
obesity, low levels of physical activity, and diet, assume an
important role in the health of ethnic minorities.  For example,
although cigarette smoking has decreased over the last 25 years in
the overall U.S. population, this beneficial trend has not been
observed to the same extent among minorities.  Preliminary results
indicate that development of culturally valid and sensitive smoking
cessation programs may be an effective approach to this issue.
Obesity is a significant problem, especially among Black women and
certain tribes of American Indians.  A recent NHLBI conference
recommended that specific behavioral interventions be evaluated for
public health approaches to obesity prevention and treatment in
minorities.  Little is known about levels of physical activity in
various ethnic minority groups; however, data are currently being
collected in several NHLBI-sponsored epidemiologic studies.
Development of interventions to increase physical activity is an
important need.  Diet, a risk factor for obesity, diabetes, and
cardiovascular disease, plays a significant role in the poorer health
of ethnic minorities, particularly for those groups whose diets
traditionally have a high saturated fat content, such as American
Indians and Hispanics.

A number of pulmonary diseases disproportionately affect minorities,
including sarcoidosis, asthma, and infectious diseases such as AIDS
and tuberculosis.  Sarcoidosis appears more frequently and in a more
severe and chronic form in blacks than in whites, but the reasons for
this are unknown.  Improved strategies for prevention and treatment
of sarcoidosis in Blacks are urgently needed.  Asthma has a
strikingly higher prevalence among minorities, especially Blacks, but
few management protocols exist that are specifically targeted to
these populations.  With regard to AIDS, recent studies reveal
significant race-dependent shifts in the epidemiology of pulmonary
disease, as well as in the progression and clinical expression of
infections.  Although AIDS primarily affected homosexual/bisexual
white men during the early years of the epidemic, it now appears to
predominantly affect minority populations, including increasing
numbers of minority women, infants, and children.  The rate of
AIDS-associated tuberculosis is disproportionately high in Blacks and
Hispanics; new clinical strategies for controlling pulmonary disease
in minority AIDS patients are needed.

A number of unexplored questions exist in the area of blood diseases.
With respect to sickle cell disease, research is needed to develop
new pharmacologic agents to prevent or treat vaso-occlusive crisis,
to improve early identification and prevention in patients at high
risk of stroke, to address a range of clinical issues related to
osteonecrosis of the femoral head, and to elucidate the causes of
acute and chronic pulmonary complications.  It is well documented
that sickle cell anemia patients have an increased incidence of
stroke.  Although such patients are currently managed by transfusion
therapy, additional information on the role of the vascular
endothelium is vital to the development of safer and more effective
therapies.  Other important research needs in minorities relate to
the coagulation system for which little is known about the
fibrinolytic system and mechanisms, e.g., proteins C and S, that
normally protect against thromboembolic events.  Additional examples
of areas of need are studies to understand the development of
antiphospholipid antibodies in Black women and the contribution of
such antibodies to thromboembolic events and fetal loss, and research
to determine the role of lipoprotein (a) as an underlying cause of
vascular dysfunction.

In the area of transfusion medicine, approaches to encourage blood
and bone marrow donation by minority populations should be developed
to provide more closely matched blood, blood products, and marrow to
minority patients.  New methods are also needed to prevent and treat
alloimmunization following blood transfusion.

Other

The objective of the NHLBI Collaborative Projects on Minority Health
is to foster collaborative clinical research that focuses on new and
improved approaches for diagnosis, management, and prevention of
cardiovascular, lung, and blood diseases in minorities.

Examples of research that would be responsive to this RFA are given
below.  These research topics are intended to provide a perspective
on the scope of research that would meet the objective of this
program.  It is not required that all or any of them be included in a
particular group of applications.  Investigators are encouraged to
consider other topics relevant to this program.

o  Identification of factors responsible for variability in the
clinical presentation, diagnosis, and effectiveness of treatment of
cardiovascular diseases.

o  Investigation of approaches to reduce the prevalence of obesity,
identify mechanism(s) by which obesity alters blood pressure, and
enhance cardiopulmonary fitness, particularly among individuals at
high risk.

o  Development and evaluation of programs that incorporate strategies
for increasing compliance and for long-term maintenance of behavioral
changes.

o  Development of age-appropriate management strategies, including
methods of self-management, for the control of asthma.

o  Delineation of the etiologic and pathophysiologic factors that
contribute to the increased incidence, severity, and chronicity of
sarcoidosis, particularly for those individuals at high risk, and
development of rational intervention strategies for its treatment.

o  Development of refinement of approaches to prevent initiation of
smoking and to facilitate smoking cessation.

o  Elucidation of the mechanisms of expression and progression of
tuberculosis, characterization of the natural history of
HIV-associated pulmonary tuberculosis, and development of specific
treatment modalities.

o  Study of sickle cell disease, including development of therapies
to prevent osteonecrosis of the femoral head, pulmonary lesions that
cause the acute chest syndrome, strokes in young patients, and occult
progressive renal lesions.

o  Investigation of normal and abnormal coagulation; development of
noninvasive or minimally invasive technology to evaluate the
possibility of dysfunctional endothelium in sickle cell disease,
particularly in those individuals with stroke.

o  Development of methods and approaches to encourage blood and bone
marrow donation; development of preventive and therapeutic strategies
for alloimmunization.

o  Development of health education and prevention programs,
appropriate to particular groups, that will facilitate adoption of
optimal health behaviors.

SPECIAL REQUIREMENTS

Upon initiation of the program, annual meetings will be sponsored to
encourage an exchange of information and ideas among investigators
who participate in this program.  In the preparation of the budget
for the grant application, applicants must request travel funds for a
two-day meeting each year to be held in Bethesda, Maryland.
Applicants should also include a statement in their applications
indicating their willingness to participate in such meetings.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH
STUDY POPULATIONS

This RFA focuses on minorities.  NIH policy is that applicants for
NIH clinical research grants and cooperative agreements are required
to include women and minorities in study populations so that research
findings can be of benefit to all persons at risk of the disease,
disorder, or condition under study; special emphasis must be placed
on the need for inclusion of women and minorities in studies of
diseases, disorders and conditions which disproportionately affect
them.  This policy is intended to apply to males and females of all
ages.  If women or minorities are excluded or inadequately
represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale must be
provided.

The composition of a proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398 in
Sections 1-4 of the research plan AND summarized in Section 5, Human
Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
the NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans [including American Indians and Alaska Natives],
Asian/Pacific Islanders, Blacks, and Hispanics.)  The rationale for
studies on single minority population groups should be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders, or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Clinical studies in which human tissues cannot be identified
or linked to individuals are excluded.  However, every effort should
be made to include human tissues from women and racial/ethnic
minorities when it is important to apply the results of the study
broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants that do not comply with these policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 12, 1993, a
letter of intent that includes identification of any other
participating investigators and institutions, together with a
descriptive title.  The NHLBI requests such letters only for the
purpose of providing an indication of the number and scope of
applications to be received and, therefore, usually does not
acknowledge their receipt.  A letter of intent is not binding, and it
will not enter into the review of any application subsequently
submitted, nor is it a necessary requirement for application.  This
letter of intent is to be sent to:

Chief, Centers and Special Projects Review Section
Review Branch/Division of Extramural Affairs
National Heart, Lung, and Blood Institute, NIH
Westwood Building, Room 553
Bethesda, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  This form is available in the
applicant institution's office of sponsored research or business
office.  It can also be obtained from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, Westwood
Building, Room 449, Bethesda, MD 20892, telephone 301/496-7447.  In
preparing the application, it is important that the points identified
under REVIEW CONSIDERATIONS are fulfilled.  The new page limitation
requirements must be observed.  Two pages are allowed for Section 7
(consultants/collaborators) to describe the collaborative
arrangements in terms of the science and mechanisms for
collaboration.  Applicants may contact one of the program
administrators listed under INQUIRIES to seek clarification and
discuss any questions related to this announcement.

To identify the application as a response to this RFA, CHECK "YES" on
Item 2a of page 1 of the application and enter the title,
"Collaborative Projects (R01s) on Minority Health" and the RFA number
HL-93-01.

The RFA label included in the PHS 398 application must be affixed to
the bottom of the face page of the original completed applications.
Failure to use this label could result in delayed processing of the
applications.

The original and three signed photocopies of each R01 application
must be packaged together, making sure that the original application
with the RFA label attached is on top and sent to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892

An additional two copies of all R01 applications for a given
collaborative group must be sent in the same box to the Chief,
Centers and special Projects Review Section at the address listed
under LETTER OF INTENT.  It is important to send these two copies at
the same time as the original and three copies are sent to the
Division of Research Grants (DRG).  Otherwise the NHLBI cannot
guarantee that the application will be reviewed in competition for
this RFA.

Applications must be received by March 19, 1993.  An application not
received by this date will be considered ineligible.

REVIEW CONSIDERATIONS

Review Method

Upon receipt, applications will be reviewed by the DRG for
completeness.  Applications will be reviewed for their responsiveness
to the objective of this RFA by NHLBI staff.  If an application or
group of applications is judged incomplete or unresponsive, the
application will be returned.  If the application submitted in
response to this RFA is substantially similar to a grant application
already submitted to the NIH for review, but has not yet been
reviewed, the applicant will be asked to withdraw either the pending
application or the new one.  Simultaneous submission of identical
applications will not be allowed, nor will essentially identical
applications be reviewed by different review committees.  Therefore,
an application cannot be submitted in response to this RFA that is
essentially identical to one that has already been reviewed.  This
does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

Applications judged to be responsive will be reviewed for scientific
and technical merit by an initial review group that will be convened
by the Division of Extramural Affairs, NHLBI, solely to review these
applications.

This initial review will include a triage; the NHLBI will withdraw
from further consideration applications judged to be noncompetitive
and will promptly notify the principal investigator and the official
signing for the applicant organization.  Those applications judged to
be competitive will be further evaluated for scientific and technical
merit by usual peer review procedures.  Each application will receive
a priority score based upon review criteria listed below.  The second
level of review will be provided by the National Heart, Lung, and
Blood Advisory Council.

Review Criteria

Factors to be considered in the evaluation of each application will
be similar to those used in review of traditional research grant
applications and, in addition, will include overall proposed
collaboration.  Major factors to be considered in the evaluation of
applications will include:

o  Scientific merit of the proposed projects, including innovation,
originality, and feasibility of the approach; adequacy of the
experimental design and the plans for recruitment and retention of
research subjects.

o  Competence of the investigators to accomplish the proposed
research goals, their commitment, and the time they will devote to
the program.

o  Integration of the component R01s into a coherent enterprise with
adequate plans for collaboration, interaction, and communication of
information among participating investigators.

o  Adequacy of facilities for performance of the proposed research
including clinical facilities, proposed instrumentation and, when
needed, data management systems.

o  Appropriateness of the budget for the proposed project.

AWARD CRITERIA

It is anticipated that four to six collaborative groups (12-24 R01
awards) will be supported under this program.  The number and
specific amount to be awarded will depend on the merit and scope of
the applications received and on the availability of funds.  Special
consideration will be given to applications from minority
investigators and institutions.

INQUIRIES

Inquiries regarding this RFA may be directed to the following program
administrators:

Patrice Desvigne-Nickens, M.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Federal Building, Room 3C06
Bethesda, MD  20892
Telephone:  (301) 496-1081
FAX:  (301) 480-6282

Sri Ram, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Westwood Building, Room 6A11
Bethesda, MD  20892
Telephone:  (301) 496-0895
FAX:  (301) 496-9886

Carol H. Letendre, Ph.D.
Division of Blood Diseases and Blood Resources
National Heart, Lung, and Blood Institute
Federal Building, Room 516A
Bethesda, MD  20892
Telephone:  (301) 496-8966
FAX:  (301) 402-1622

Robin Hill, Ph.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Federal Building, Room 216
Bethesda, MD  20892
Telephone:  (301) 496-9380
FAX:  (301) 480-2435

For fiscal and administrative matters, contact:

Marie A. Willett
Grants Operation Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A12
Bethesda, MD  20892
Telephone:  (301) 496-7255
FAX:  (301) 402-1200

AUTHORITY AND REGULATIONS

These programs are described in the Catalog of Federal Domestic
Assistance Nos. 93.837, Heart and Vascular Diseases Research; 93.838,
Lung Diseases Research; and 93.839,  Blood Diseases and Resources
Research.  Awards will be made under the authority of the Public
Health Service (PHS) Act, Section 301 (42 USC 241) and administered
under PHS grants policies and Federal regulations, most specifically
42 CFR Part 52 and 45 CFR Part 74.  This program is not subject to
the intergovernmental review requirements of Executive Order 12372,
or to Health Systems Agency review.

.

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