Full Text DK-93-023


NIH Guide, Volume 22, Number 18, May 7, 1993

RFA:  DK-93-023

P.T. 34, FF

  Clinical Medicine, General 
  Disease Prevention+ 

National Institute of Diabetes and Digestive and Kidney Diseases
National Center for Nursing Research

Letter of Intent Receipt Date:  July 20, 1993
Application Receipt Date:  August 20, 1993


This Request for Applications (RFA) invites new and experienced
investigators to submit clinical research applications designed to
develop and validate intervention approaches for the amelioration or
prevention of diabetes mellitus and/or its complications among minority
populations, including African, Asian, and Hispanic Americans, Native
Hawaiians, and Pacific Islanders.  This RFA is a follow-up to the RFA
DK-91-09 "Research Planning Grant: Diabetes in Minority Populations."
However, respondents to this RFA are not restricted to those having
previously received a planning grant under the prior RFA.  Applications
are encouraged from any interested investigators regardless of their
prior record of grant support.

Although this RFA is designed to develop and validate interventions for
preventing diabetes mellitus and/or its complications, the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is
announcing another RFA (DK-93-007) specifically for clinical centers to
design and implement a full-scale, multi-center clinical trial to
evaluate the efficacy of interventions designed to delay or prevent
onset of NIDDM in individuals at increased risk for the disease.

The present RFA focuses on the specific minority populations as
indicated above.  An earlier RFA (DK-92- 17) was designed for studies
with Native Americans and Alaskan Natives.  While studies involving
these populations are not responsive to the present RFA, investigators
interested in working with these groups are advised to submit
applications through the normal NIH investigator-initiated review
process.  The NIDDK and the National Center for Nursing Research (NCNR)
seek to encourage research on all minority populations.


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Interventions in Diabetes Among Minority Populations, is specifically
targeted at diabetes mellitus and its complications as a major public
health problem.  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).


Applications may be submitted by domestic and foreign non-profit and
for-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of state and local governments
and eligible agencies of the Federal government.

Teams of applicants are encouraged that could include universities,
public health departments, voluntary organizations, and health clinics.
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 organization and any proposed consortium must have the staff
and facilities required for the proposed program. Applications from
minority individuals and women are encouraged.


Support of this program will be through the NIH research project grant
(R01) award.  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. Awards
will be administered under PHS grants policy as stated in the PHS
Grants Policy Statement.  This RFA is a one-time solicitation.  Future
unsolicited competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  The total requested project period
for applications submitted in response to this RFA may not exceed five
years.  A maximum of three years can be requested for foreign awards.
The earliest possible award date will be April 1, 1994.  Applicants
must limit their request to not more than $160,000 direct costs for the
initial budget period.  The average size of an award is expected to be
approximately $190,000.


For fiscal year 1994, $2.2 million will be committed to fund
applications submitted in response to this RFA.  The NIDDK and the NCNR
plan to support approximately 10 to 12 applications submitted in
response to this solicitation. However, this funding level is dependent
upon the receipt of a sufficient number of applications of high
scientific merit.  Although this program is provided for in the
financial plans of the NIDDK and the NCNR, the award of grants pursuant
to this RFA is contingent upon the availability of funds for this



Diabetes mellitus and its complications are major public health
problems in the United States today.  The National Institutes of Health
has encouraged research into the cause, cure and prevention of diabetes
and its related endocrine and metabolic disorders.  The Report of the
Secretary of Health and Human Services Task Force on Black and Minority
Health (1) identified non-insulin dependent diabetes mellitus (NIDDM)
and its complications as major public health problems in several
minority populations.  This task force cited diabetes as one of six
health problems responsible for excess mortality among United States
minority populations.

The rate of diabetes rises with age and reaches 15 to 20 percent among
those 65 years of age and older.  Rates in men and women are virtually
equal.  Until 1940, diabetes was less common in the African American
population than in the general population.  Today, the prevalence of
NIDDM is 60 percent higher in African Americans than in the caucasian
population.  Diabetes is the fourth leading cause of death from disease
in African American women and the seventh leading cause in African
American men.  Hispanic-Americans also suffer from diabetes to a degree
disproportionate to their representation in the United States
population as a whole.  In the United States, approximately half of the
people with NIDDM do not know they have the disease.  Among African,
Asian and Hispanic Americans, Native Hawaiians and Pacific Islanders,
as in other populations, the symptoms of NIDDM can be very subtle and
remain undetected for a long time.  When diagnosed, NIDDM is usually
treated with diet and exercise to control blood glucose levels.  Oral
hypoglycemic agents or insulin injections are employed if necessary.
A variety of other interventions are also employed to help prevent or
delay the chronic complications of diabetes that affect organs and
tissues throughout the body.

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 the Hispanic population than in the African
American population, and rates are higher in the African Americans than
in the Caucasians.  Most adults with diabetes in both Hispanic and
African American populations are overweight, and women are particularly
obese (20 percent or more above desirable weight).

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 are significant.

The NIDDK sponsored two National Conferences in 1988 and 1989 to
examine the problems of diabetes in African and Hispanic Americans and
to define issues and priority areas for programs to reduce the impact
of diabetes on these populations (2,3).

During fiscal year 1992, NIDDK awarded Collaborative Research Planning
Grants to support the development of collaborative research projects
that address critical questions related specifically to the etiology,
pathogenesis, diagnosis, treatment, cure and prevention of diabetes
mellitus and its complications in African, Asian and Hispanic
Americans, Native Hawaiians and Pacific Islanders.


The overall objective of this RFA is to stimulate original and
innovative studies directed at the elucidation of practical methods for
the reduction of the public health burden of diabetes in African, Asian
and Hispanic Americans, Pacific Islanders, and Native Hawaiians.
Applicants must demonstrate that their research teams have an
understanding of and are sensitive to the target populations.  Any
proposed intervention must be culturally relevant and acceptable.
Special consideration will be given to investigators with demonstrated
access, knowledge, and cultural sensitivity to Native Hawaiians,
Pacific Islanders and African, Asian and Hispanic Americans.

Examples of research topics relevant to this solicitation are listed
below, they should not be construed as required or limiting.
Responsive applications to this RFA include:

o  Development and validation of efficacious strategies for changing
health behaviors of people with or at high risk for diabetes, with
specific emphasis on high risk populations.

o  Development and validation of interventions designed to prevent
NIDDM or its major risk factors, such as obesity, on a community wide
basis for high risk populations.

o  Development and validation of interventions designed to prevent
NIDDM in targeted high risk subgroups (e.g., documented impaired
glucose tolerance, history of gestational diabetes, obese children or
young adults) within the population.

o  Development and validation of interventions designed to improve the
care of minority patients with NIDDM.

o  Development and validation of interventions designed to reduce or
prevent the long-term complications of diabetes among minority

o  Clinical studies of the physiologic effects of alternative
pharmacologic  and non-pharmacologic interventions for the treatment of
NIDDM in minority populations.


The research team, composed of the Principal Investigator and/or
collaborators, must include individual(s) who are experienced in
clinical 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/collaborators.

The applicant must demonstrate that the research team has an
understanding of and sensitivity to the target population.  Where
specific language or cultural barriers are important, the applicant
must provide a plan for addressing these barriers.



NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women in
study populations so that research findings can be of benefit to all
person at risk of the disease, disorder or condition under study;
special emphasis must 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 must be

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 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 (rev. 9/91) in
Item 4 (Research Design and Methods) of the Research Plan AND
summarized in Item 5, Human Subjects.  Applicants 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, African Americans
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 behavioral studies or 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 or 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

If the required information is not contained within the application,
the application will be returned without review.

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 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.


Prospective applicants are asked to submit a letter of intent by July
20, 1993.  The letter of intent should include a descriptive title of
the proposed research, the name and address of the Principal
Investigator, the names of key personnel, the participating
institutions, and the number and title of the RFA in response to which
the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows NIDDK staff to estimate the potential review workload and to
avoid possible conflict of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892
Telephone:  (301) 594-7515


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  The form is available from most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
(301) 594-7250.

The RFA label available in the PHS 398 must be affixed to the bottom of
the face page.  Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review.  In addition, the title of the RFA and
the number must be typed on line 2a of the face page on the application
form and check the yes box.

Submit a signed, original of the application, including the Checklist,
and three signed, exact photocopies, in one package to:

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

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by August 20, 1993.  If an application is
received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  However, it is allowable to submit the same
project as both an R01 and as a component project of a program project.
The DRG will not accept any application that is essentially the same as
one already reviewed.  This does not preclude the submission of
substantial revisions of applications previously reviewed.  Such
applications must not only include an introduction addressing the
previous critique but also be responsive to this RFA.


Upon receipt, applications will be initially reviewed by the Division
of Research Grants (DRG) for completeness. Incomplete applications will
be returned to the applicant without further consideration.  Evaluation
for responsiveness to the program requirements and criteria stated in
the RFA is an NIDDK staff function.  If the application is not
responsive to the RFA, NIDDK staff will contact the applicant to
determine whether it should be returned to the applicant, or whether it
should be held until the next regular receipt date and reviewed in
competition with all other applications.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.  If
the number of applications is large compared to the number of awards to
be made, a preliminary scientific peer review may be conducted and
applications withdrawn from further competition if they are not
competitive for the award. The NIDDK will notify the applicant and
institutional official of this action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group within the NIDDK
specifically convened for this RFA. Following this review, the
applications will be given a secondary review by the National Advisory
Councils unless not recommended for further consideration by the
initial review group.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.

o  scientific/technical merit criteria specific to the objectives of
the RFA;

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach,
methodology and staff, particularly but not exclusively in the area of
the proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  if an application involves activities that could have an adverse
effect upon humans, animals, or the environment, the adequacy of the
proposed-means for protecting against or minimizing such effects; and

o  for foreign applications, the uniqueness of research such that it
can only be performed outside of the United States.


Applications will compete for available funds with all other
recommended applications submitted in response to this RFA.  The
following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program balance among research areas of the announcement.

The anticipated date of award is April 1, 1994.


Written and telephone inquiries concerning this RFA are encouraged.
Inquires regarding programmatic issues may be directed to:

Charles A. Wells, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 622
Bethesda, MD  20892
Telephone:  (301) 594-7505

June R. Lunney, Ph.D., R.N.
Acute and Chronic Illness Branch
National Center for Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (301) 594-7397

Inquiries regarding fiscal matters may be directed to:

Mrs. Betty Bailey
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 594-7543

Sally A. Nichols
Grants Management Officer
National Center for Nursing Research
Westwood Building, Room 748
Bethesda, MD  208932
Telephone:  (301) 594-7498


Letter of Intent Receipt Date:  July 20, 1993
Application Receipt Date:       August 20, 1993
Initial Review:                 October/November 1993
Anticipated Date of Award:      April 1, 1994


This program is described in the Catalog of Federal Domestic Assistance
No 93.848.  Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99- 158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.


1.  United States Department of Health and Human Services.  Report of
the Secretary's Task Force on Black and Minority Health.  Vol. VII,
United States Government Printing Office, Washington, D.C., January

2.  Proceeding of the Symposium on Diabetes in African Americans:
Diabetes Care, Volume 13, No. 11, Supplement 4, November 1990.

3.  Proceeding of the Symposium on Diabetes in Blacks: Diabetes Care,
Volume 14, No. 17, Supplement 3, July 1991.


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