Full Text DK-92-17


NIH GUIDE, Volume 21, Number 34, September 25, 1992

RFA:  DK-92-17

P.T. 34, FA, FE


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  November 12, 1992
Application Receipt Date:  December 8, 1992


This Request for Applications (RFA) invites new and experienced
investigators to submit clinical research applications designed to
develop and validate intervention approaches to the amelioration or
prevention of diabetes mellitus and/or its complications among American
Indians and Alaska Natives.  This RFA is a follow-up to the RFA
(DK-91-01) Collaborative Research Planning Grant-Diabetes in American
Indians and Alaska Natives.  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.


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,
Diabetes Mellitus in Native Americans and Alaska Natives, 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
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, which could include universities, public health
departments, Indian Health Service (IHS) hospitals, voluntary
organizations, health clinics, and Federally recognized Indian tribe or
tribal organizations as defined in P.L. 93-638 and amended by P.L.
100-472, or combinations thereof.  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


The support mechanism for this research will be the individual research
grant (R01) and the First Independent Research Support and Transition
(FIRST) Award (R29).  This is a one time solicitation.  Subsequent
unsolicited competing continuation applications will compete with all
investigator-initiated applications and will be reviewed according to
customary peer review procedures.  This RFA will provide the
opportunity for investigators to establish support for periods up to
five years for meritorious research projects designed to develop and
validate intervention approaches to the amelioration or prevention of
diabetes mellitus and/or its complications among American Indians and
Alaska Natives.

Foreign institutions are not eligible for FIRST awards.


The National Institute of Diabetes and Digestive and Kidney Disorders
(NIDDK) plans to support approximately eight to ten applications
submitted in response to this solicitation and $2 million total costs
(direct and indirect costs) for this program have been included in the
financial plans for fiscal year 1993.  The number of awards to be made
is dependent upon receipt of a sufficient number of applications of
high scientific merit and upon availability of funds.  In order to help
meet NIDDK goals for managing the costs of biomedical research,
applicants must limit their request to not more than $160,000 direct
costs for the initial budget period, and normal biomedical inflation
increments in future years will be allowed.  Although this program is
provided for in the financial plans of the NIDDK, the award of grants
pursuant to this RFA is also contingent upon the availability of funds
for this purpose.



Diabetes mellitus and its complications are major public health
problems in the United States today.  The National Institutes of Health
(NIH) has encouraged research into the cause, cure, and prevention of
diabetes and its related endocrinologic and metabolic disorders.  The
Report of the Secretary of Health and Human Services Task Force on
Blacks and Minority Health (1) identified non-insulin dependent
diabetes mellitus (NIDDM) and its complications as major public health
problems in several minority populations. In the U.S., the rates of
NIDDM are often two to five times higher among American Indians than
among the general U.S. population.  For example, population based
surveys have shown that the incidence of diabetes in the Pima Indians
of Arizona is 19 times greater than in Caucasians of Rochester,
Minnesota, and the difference continues to increase with time.  A
partial explanation of this disproportionate occurrence may be related
to obesity.  It is well established that obesity is a major risk factor
for NIDDM, and certain Indian populations have a much higher prevalence
of obesity than the majority of the U.S. population.  With respect to
diabetes associated complications, diabetic end-stage renal disease
(ESRD) is five times more common in American Indians than in the U.S.
Caucasian population.  Diabetes is a major risk factor for heart
disease, the leading cause of death in the American Indian community.
In aggregate, rates of mortality associated with diabetes in American
Indians are almost three times greater than for the U.S. as a whole.
In addition, currently 4.1 percent of all births at IHS facilities are
complicated by diabetes.

In the U.S., approximately half of the people with NIDDM do not know
they have the disease; however, the proportion of American Indians and
Alaska Natives with unrecognized NIDDM is unknown.  Among American
Indians and Alaska Natives, 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.

American Indians have undergone rapid cultural changes during this
century, with many changes having taken place during the last 40 to 50
years.  These changes may account for part of the apparent tribal and
geographic variation in reported diabetes rates.  A frequently
overlooked but potentially important distinction is the interplay of
the genetic, cultural, and historical heterogeneity of the American
Indian populations.  Tribal groups now living within U.S. borders
originated from several distinct migrations from Asia into North
America over a 40,000-year period.  Distinct subgroups of American
Indians of different origin can be identified by cultural descriptions,
linguistic analyses, and determination of genetic markers (3).

Multiple factors may contribute to current levels of risk for diabetes
in American Indians.  Variations may exist among tribal groups,
secondary to genetic admixture, to both the degree and duration of
acculturation and to attained socioeconomic status.  It is important to
recognize that generalizations about risk factors for diabetes and its
complications in American Indians may be inappropriate and that extant
data may only be valid in groups with similar origins and history.
Many studies have been conducted on individual tribes and have never
been repeated; therefore, data on temporal trends in diabetes
incidence, prevalence, and morbidity in American Indians and Alaska
Natives are limited.

The NIDDK and the IHS co-sponsored a conference, entitled "Diabetes in
American Indians and Alaska Natives," to review the state of the
science and to assess related progress, needs, and opportunities for
future research.  During fiscal year 1991, the 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 Native
Americans and Alaska Natives.

Research Goals and Scope

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 Native
American and Alaska Native populations.  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 American Indians and Alaska Natives.

Examples of possible research topics relevant to this RFA include, but
are not limited to:

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

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 patients with NIDDM.

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

o  Clinical studies of the physiologic effects of alternative
pharmacologic  and non-pharmacologic interventions for the treatment of


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 Alaska Native
or American Indian populations is highly desirable.  The application
should include a succinct discussion of previous relevant
investigational and health care activities.  Letters of collaboration
must be included for all proposed consultants.

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.  Letters must be
provided from the tribal leadership to document that they have agreed
to participate in the proposed research.



NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements are required to include
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 must be placed on the need for inclusion of
women in studies of diseases, disorder and conditions which
disproportionately affect them.  This policy is intended to apply to
males and females of all ages.  If women 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.  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.  Since evidence exists of
geographic variation in diabetes rates and risk-factor levels among
American Indians and Alaska Natives, NIDDK 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 from different geographic locations.


Prospective applicants are asked to submit, by November 12, 1992, a
letter of intent that includes 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 to which the applicant is responding.  Such letters
are requested for the purpose of obtaining an indication of the number
and scope of applications to be received.  The letter is not binding,
is not a requirement for submission, and does not enter into the review
of the application.

The letter of intent is to be sent to:

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


The research grant application form PHS 398 (rev. 9/91) is to be used.
This 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, Westwood Building, Room 449,
5333 Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441.

The RFA label available in the form PHS 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 number and title
of the RFA must be typed on line 2a of the face page on the application

Applications must be received by December 8, 1992.

The original and three copies of the application must be sent to:

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

Two additional copies of the application must be sent under separate
cover to:

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

If an 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

FIRST Award applications must include at least three sealed letters of
reference attached to the face page of the original application.  FIRST
Award applications submitted without the required number of reference
letters will be considered incomplete and be returned to the applicant
without review.


Applications that are not responsive to the research goals and scope of
this RFA will be returned to the investigator.  If the number of
applications is large compared to the number of awards to be made, the
NIDDK may conduct a preliminary scientific peer review (triage) to
eliminate those applications that are clearly not competitive.  Those
applications will be withdrawn from further review and the applicant
and institutional business office will be notified.  Responsive
applications received in response to this RFA will first be reviewed
for scientific and technical merit by an Initial Review Group convened
by the Review Branch, Division of Extramural Program Activities, NIDDK.
A secondary review for policy and program relevance to the NIDDK
mission will be made by the National Diabetes and Digestive and Kidney
Diseases Advisory Council.


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

o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Programmatic balance among the applications competing


Written and telephone inquires concerning this RFA are encouraged.  The
opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Charles A. Wells, Ph.D.
Diabetes Research Program Director
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) 402-2599

Direct inquiries regarding fiscal matters to:

Betty E. Bailey
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Disorders
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467


This program is described in the Catalog of Federal Domestic Assistance
No 93.847, Diabetes Endocrinology and Metabolism Research.  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.  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.

2.  U.S. Department of Health, Education, and Welfare. Indian Health
Trends and Services.  U.S. Government Printing Office.  Washington,
D.C. 1978.  HSA 78-12009.

3.  Williams RC, Steinberg AG, Gershowitz H, Bennett PH, Knowler WC,
Pettitt DJ, Butler W, Baird R, Dowda-Rea L, Burch TA.  GM allotypes in
American Indians:  evidence for three distinct migrations across the
Bering land bridge. Am J Phys Anthropology 1985, 66:9-19.


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