Subject: RFADKNR-91-09.910208 2/8/91 NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 07 Feb 91 08:34 EST

Hello,
  Four of Six. Please post this one to the listserver as:
RFADKNR-91-09.910208.
  Thanks.  dottie
 ---------------------------- Text of forwarded message -----------------------
 
REQUEST FOR APPLICATIONS
 
RFA NUMBER:  DK-NR-91-09
 
RESEARCH PLANNING GRANT:  DIABETES IN MINORITY
POPULATIONS
 
P.T.
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Center for Nursing Research
 
Letter of Intent Receipt Date:  May 16, 1991
Application Receipt Date:  July 16, 1991
 
PURPOSE, SCOPE, AND OBJECTIVE
 
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) and the National Center for Nursing
Research (NCNR) invite applications for Research Planning Grants to
support the development of plans for research projects that
address critical questions related to the etiology,
pathogenesis, diagnosis, treatment, cure, and prevention of
diabetes mellitus and its complications in minority
populations, including Blacks, Native Hawaiians, Hispanics,
Pacific Islanders, and Asian Americans.  Comparisons among
these populations and the Caucasian population of the U.S.,
including ethnic/religious subsets, and with populations in
the country of origin would be welcome.  American Indians
and Alaskan Natives are not encouraged in this Request for Applications
(RFA), because a
similar initiative limited to these populations was
announced in the
NIH Guide for Grants and Contracts, Vol. 19, No. 40, November 9, 1990.
 
DISCIPLINES AND EXPERTISE
 
Research proposed in response to this RFA may involve basic,
clinical, behavioral, and epidemiologic studies.  Basic
research may be designed to elucidate biochemical
alterations responsible for increased suceptibility to
diabetes mellitus or to the complications of diabetes.
Clinical research may be oriented to the cellular, organ, or
human level and may include metabolic studies and
comparisons.  Behavioral studies, particularly those focused
on prevention of diabetes through weight control programs,
are encouraged.  Epidemiologic designs that might be
considered include observational and natural history
studies, case-control studies of racial/ethnic differences,
studies of migrant populations in the U.S. versus in their
country of origin, urban/rural comparisons, acculturation of
the minorities to the U.S. lifestyle and environment, and
longitudinal studies.  Issues of obesity, effects of aging on chronic
disease, and multiple chronic diseases (such as diabetes and
hypertension) are particularly encouraged.  Research
directed toward improving methodologies for population-based
studies of minority ethnic/racial groups is also
encouraged.  Innovative approaches that involve new inter-
disciplinary collaborations are particularly desirable.
Whenever possible, studies should make cost-effective use of
existing resources to help improve the health status of
these populations.
 
Accordingly, the applicant research team should include
individuals with the appropriate scientific, medical, and
sociocultural expertise to pursue the proposed research
project.  Special consideration should be given to including
team members with demonstrated access, knowledge, and
cultural sensitivity to the specified study population.
 
Although new research projects are desired, applicants are
urged to make cost-efficient use of current or recently
terminated studies that contain large components of
populations that are minorities in the U.S.  Examples of
studies that may have been conceived for reasons other than
for research on U.S. minorities or for studies on the
diseases listed above are the Barbados Eye Study, the
Trinidad St. James Study, Honolulu Heart Study, Puerto Rico
Heart Study, Bogalusa Heart Study, Evan County Study,
Tecumseh Study, Rochester Epidemiology Program, National
Survey of Black Americans, Lipid Research Clinics Program,
Meharry Cohort Study, Kaiser Permanente Twin Registry, Early
Treatment of Diabetic Retinopathy Study, Consolidated End
Stage Renal Disease Data System, and the various national
surveys of the National Center for Health Statistics (e.g., Health
and Nutrition Examination Surveys, Hispanic HANES, Health
Interview Survey, and others).
 
GENERAL BACKGROUND
 
The Report of the Secretary of Health and Human Services
Task Force on Black and Minority Health (1) identified
noninsulin-dependent diabetes (NIDDM) and its complications
as major public health problems in several minority
populations.  Until 1940, diabetes was less common in the
Black population than in the general population.  Today, the
prevalence of NIDDM is 33 percent higher in Blacks than in
the Caucasian population.  Diabetes is the third leading
cause of death from disease in Blacks.  Hispanic-Americans
suffer from diabetes to a degree disproportionate to their
representation in the U.S. population as a whole.  In all
populations, the rate of diagnosed diabetes rises with age
and plateaus at 9-10 percent among those 65 years of age and
older.  Rates in men and women are virtually equal.  Among
those 65 to 74 years of age and those 75 and older, the rate
has increased approximately 2.5-fold in the past 30 years.
In the United States, approximately half of the people with
NIDDM do not know they have the disease.
 
Obesity is a well-established risk factor for diabetes.  For
Hispanics, the rate of diabetes increases with each higher
level of percent desirable weight (PDW).  At obesity levels
of PDW over 100, rates of diabetes are higher in Hispanic
populations than in Black populations, and rates are higher
in Blacks than in Caucasians.  Most adults with diabetes in
both Hispanic and Black populations are overweight, and
women are particularly obese (20 percent or more above desirable
weight).  The prevalence of diabetes in the Black population
is about 50 percent higher than in non-Hispanic whites and
the occurrence in Hispanics is about double that of non-
Hispanic whites.
 
Obesity in children is a major concern.  One in five
American children is obese.  Younger children weigh more and
have more body fat than children the same age did 20 years
ago.  While the role of genes in predisposing people to
diabetes is important, almost all obesity studies have found
family influences significant.
 
MECHANISM OF SUPPORT
 
This RFA is a one-time solicitation by NIDDK and NCNR for
applications for Research Planning Grants (R21) to help
support the unique short-term needs of investigators
planning research studies related to diabetes in minority
populations.  It is anticipated that five to ten Research
Planning Grant awards will be made in response to this
solicitation, contingent on the receipt of meritorious
applications and the availability of appropriated
funds.  The award of these Research Planning Grants will be
followed within approximately one year by an RFA for
investigator-initiated research project grant applications
(RO1) related to this same program area.  This subsequent
RFA will provide the opportunity for investigators to
obtain support for periods up to five years for
meritorious research projects that address critical
questions related specifically to the etiology,
pathogenesis, diagnosis, treatment, cure, and prevention of
diabetes and its complications in minority populations.
 
PROVISIONS OF THE AWARD
 
Approved Research Planning Grant applications should request
no more than one year of funding for up to $25,000 direct
costs.  Examples of the allowed uses of these funds
include:  paying travel expenses of scientists, clinicians,
epidemiologists, and other essential personnel who will
assist in the preparation of the research plan; supporting
retrieval and analysis of extant data; supporting
preliminary studies to refine procedures, document
recruitment potential; paying for secretarial
assistance, telephone, postage, and office supplies.  In
addition, the study team should also have access to
individuals with appropriate expertise in statistics and
data management, and consultant fees may be paid for
biostatisticians and epidemiologists (but not generally for
other personnel).
 
SPECIAL REQUIREMENTS
 
A.  SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to
include minorities and women 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
should be placed on the need for inclusion of minorities and
women 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 should be provided.
 
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group.  In
addition, gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study.  This information should be
included in the form PHS 398 in Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors are urged to assess carefully the feasibility
of including the broadest possible representation of minority
groups.  However, 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
or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics).
 
The rationale for studies on single minority population groups
should be provided.
 
For the purpose of this policy, clinical research includes 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.  Basic research or 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.
 
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
 
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 or cooperative agreements that do not comply
with these policies.
 
B.  The research team, composed of the Principal
Investigator, Co-Investigator(s), and/or collaborators must
include individual(s) who are experienced in health science
research.  Involvement of individuals who have demonstrated
experience working with or delivering health services to
minority populations is highly desirable.  The application
should include a succinct discussion of previous relevant
investigational and health care activities.  Letters of
collaboration should be included for all proposed
consultants.
 
C.  The applicant must demonstrate that the research team
has an understanding of and is sensitive to the target
population.  Where specific language or cultural barriers
are important, the applicant must provide a plan for
addressing these barriers.
 
D.  NIH staff may take into account demographic and
geographic distribution of peer reviewed and approved
applications in the final selection process in order to
support the development of research projects involving an
appropriate distribution of populations of concern.
 
ELIGIBILITY REQUIREMENTS
 
Applicants may be non-profit or for-profit organizations,
including universities, public health departments, voluntary
organizations, or combinations thereof, both foreign and
domestic.  Among a team of applicants, one institution must
be proposed as the lead organization to serve as the Grantee
Institution and assume responsibility for the fiscal and
programmatic conduct of the project.  Other members of the
team should be proposed based on individual consortium
agreements (subcontracts) with those organizations.  The
Grantee Institution and any proposed consortium must have
the staff and facilities required for the proposed program.
 
REVIEW PROCEDURE
 
Applications must be received by July 16, 1991, and will be reviewed
initially by the Division of Research Grants (DRG) for
completeness.  Grants will be assigned to the relevant
participating Institute for possible funding.  Evaluation
for responsiveness to the program requirements and criteria
stated in the RFA will be conducted by NIH program staff.
Applications that are judged incomplete or non-responsive
will be returned.
 
Those applications judged to be responsive will be further
evaluated according to the review criteria stated below for
scientific and technical merit by an appropriate peer review
group convened by the Division of Extramural Activities,
NIDDK.  Subsequently, a second level of review will be
performed by staff of each participating Institute to
consider the special needs and priorities of that
Institute.  Applications recommended for approval will be
considered for funding beginning February 1, 1992.
 
REVIEW CRITERIA
 
Applicants are encouraged to submit and describe their own
ideas on how best to meet the objectives of this RFA.
Applications will be judged primarily on (1) the likelihood
that the new knowledge that may be gained will subsequently
help to reduce the burden of diabetes and its complications
on the health status of minority populations; (2) the
potential scientific and technical merit of the proposed
project, including the significance of the scientific
question(s), rationale, appropriateness of the proposed
planning process, consideration of appropriate ethical
issues, and availability of preliminary data; (3) the
potential to establish collaborations with groups and other
agencies involved in health care of the selected
populations; and (4) the qualifications and experience of
the proposed investigators.
 
Applicants are strongly encouraged to note these criteria
and to include sufficient information in their Research
Planning Grant Application so that these aspects of their
proposal can be adequately assessed.
 
The review group will also critically examine the requested
budget and will recommend an appropriate budget and period
of support for each approved application.
 
LETTER OF INTENT
 
Prospective applicants are requested to submit a letter of
intent by May 16, 1991, that includes a descriptive title of
the proposed research; the
name, telephone number and mailing address of the Principal
Investigator; the names of other key personnel; the name of
the applicant institution and other collaborating entities;
and the number and title of this RFA.
 
Although a letter of intent is not required, it allows NIDDK
Review Staff to estimate the potential review workload and
to avoid possible conflict of interest in selecting
reviewers.
 
This letter of intent must be sent to:
 
Dr. Robert D. Hammond
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases, NIH
Westwood Building, Room 406
Bethesda, MD  20892
 
INQUIRIES
 
The participating Institutes welcome inquiries from
potential applicants to clarify any issues or questions
regarding this RFA.  Inquiries should be directed to the following
NIDDK or NCNR program staff:
 
NIDDK
 
Dr. Lois F. Lipsett
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 620
Bethesda, MD  20892
Telephone:  (301) 496-7433
 
NCNR
 
Dr. Mary D. Lucas
National Center for Nursing Research
National Institutes of Health
Building 31, Room 5B03
Bethesda, MD  20892
Telephone:  (301) 496-0523
 
METHOD OF APPLYING
 
The regular research grant application form PHS 398 (revised
10/88) must be used.  This form is available from the Office
of Grants Inquiries, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 449, 5333
Westbard Avenue, Bethesda, Maryland 20892.
 
The RFA label available in the 10/88 revision of Application
Form 398 must be affixed to the bottom of the face page.
Failure to use this label could result in delayed processing
of your application such that it may not reach the review
committee in time for review.  In addition, the title of the
RFA and the number should be typed on line 2 of the face
page on the application form.
 
If the application submitted in response to this RFA is
substantially similar to a research 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.
 
Submit a signed, typewritten original of the application,
including the Checklist, and four (4) signed, exact
photocopies in one package to DRG at the address
below.  The photocopies must be clear and single sided.
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At time of submission, send two (2) additional copies of the
application to:
 
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases, NIH
Westwood Building, Room 406
Bethesda, MD  20892
 
Applications must be received by July 16, 1991.  If an
application is received after that date, it will be returned
to the applicant.
 
REFERENCES
 
1.   U.S. Department of Health and Human Services.  Report
of the Secretary's Task Force on Black and Minority
Health.  Vol. VII, U.S. Government Printing Office,
Washington, D.C., January 1986.