Subject: RFA from NIH GUIDE - Vol. 19, No. 40, November 9, 1990 - RFA DK-
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 08 Nov 90 08:29 EST

Hello Again,
   Another one to post to the NIH Listserver.  Please post as:
      RFADK-91-01.110990
      Thanks.      Dottie
 
COLLABORATIVE RESEARCH PLANNING GRANT - DIABETES
IN AMERICAN INDIANS AND ALASKA NATIVES
 
RFA NUMBER:  DK-91-01
 
P.T. 34, FE; K.W. 0715075, 0755030, 0765033, 0745070, 0745027
 
National Institute of Diabetes and Digestive and Kidney
Diseases
 
Letter of Intent Receipt Date:  December 15, 1990
Application Receipt Date:  February 15, 1991
 
PURPOSE, SCOPE AND OBJECTIVE
 
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) and the Indian Health Service (IHS) have
initiated a joint program on Diabetes in American Indians
and Alaska Natives to help improve the health status of
these populations.  In this Request for Applications (RFA),
NIDDK invites applications
for Collaborative Research Planning Grants to support the
development of plans for 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
American Indians and Alaska Natives.
 
DISCIPLINES AND EXPERTISE
 
Collaborative research studies proposed in response to this
RFA may involve basic biomedical research, clinical
research, behavioral research, education research, clinical
trials, and epidemiologic research.  Accordingly, the
applicant research team should include individuals with the
appropriate scientific, medical, and sociocultural expertise
to pursue the proposed research project.  In this regard,
special consideration should be given to including team
members with demonstrated access, knowledge, and cultural
sensitivity to the specified study population.
 
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, including American Indians.  Diabetes and its
complications have become an increasingly important health
problem for certain American Indian populations.  Rates of
NIDDM are often 2-5 times higher among American Indians than
among other populations in the U.S.  The incidence of
diabetes in the Pima Indians of Arizona is 19 times greater
than in Caucasians in Rochester, Minnesota, and the
difference continues to increase with time.  With respect to
complications, diabetic end-stage renal disease (ESRD) is
more than five times more common in American Indians than in
the U.S. White population.  Heart disease is the leading
cause of death in the Indian community and diabetes is a
major risk factor. Currently 4.1 percent of all births at
IHS facilities are complicated by diabetes.  In addition,
mortality associated with diabetes in American Indians is
almost three times greater than for the U.S. as a whole.
 
In the United States, approximately half of the people with
NIDDM do not know they have the disease, and 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 is also employed to help prevent or
delay the chronic complications of diabetes that affect
organs and tissues throughout the body.
 
SCIENTIFIC BACKGROUND
 
The NIDDK and IHS cosponsored a conference entitled Diabetes
in American Indians and Alaska Natives to review the state
of the art of science and to assess related progress, needs,
and opportunities for future research.  Although the precise
reasons for the disproportionate prevalence, morbidity, and
mortality associated with NIDDM in American Indians and
Alaska Natives are still unknown, the results of research
studies suggest that the fundamental disease process
involved is essentially the same in both American Indian and
Caucasian populations.  American Indians may differ,
however, in the nature and level of risk factors--genetic,
metabolic, and environmental--for NIDDM.  For instance, 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.
 
Americans Indians have undergone rapid cultural changes
during this century, with many changes having taken place
during the last 40 to 50 years.  Currently, the amount of
cultural and genetic admixture of American Indians with the
remaining U.S. population varies substantially.  Far more
integration has occurred in some areas and some native
populations than in others (2).  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 population.  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.  Therefore, it is important to
recognize that generalization 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 only 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.
 
MECHANISM OF SUPPORT
 
This RFA is a one-time solicitation by NIDDK for
applications for Collaborative Research Planning Grants
(R21) to help support the unique short-term needs of
investigators planning research studies related to diabetes
in American Indians and Alaska Natives.  It is anticipated
that five to ten Collaborative Research Planning Grant
Awards will be made in response to this solicitation,
contingent on the receipt of meritorious applications and
the actual availability of appropriated funds.  The award of
these Collaborative 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
establish 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 American Indians and
Alaska Natives.
 
PROVISIONS OF THE AWARD
 
Approved Collaborative 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, tribal representatives, and
other essential personnel who will assist in the preparation
of the collaborative research plan; supporting retrieval and
analysis of extant data; supporting preliminary studies to
refine procedures, document recruitment potential, etc;
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).  Applicants should also
budget funds for the Principal Investigator and up to two
co-investigators to attend a two-day workshop in Phoenix,
Arizona, in November/December 1991.  At that time,
recipients of Collaborative Research Planning Grants will be
invited to present their preliminary research proposals and
to participate with NIDDK and IHS staff in discussions
regarding specific problems, needs, and opportunities
related to both research and health care delivery.
 
SPECIAL REQUIREMENTS
 
A.  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
American Indian 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.
 
B.  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.  The applicant must also document
that all affected tribes have been consulted.  Letters must
be provided from the tribal leadership to document that they
have agreed to participate in the proposed research planning
process.
 
C.  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 and linguistic groups.
 
ELIGIBILITY REQUIREMENTS
 
Applicants may be non-profit or for-profit organizations.
Teams of applicants are encouraged which could include
universities, public health departments, 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, etc., 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.
 
REVIEW PROCEDURE
 
Applications received by February 15, 1991, will be reviewed
initially 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 will be conducted by NIDDK program staff.
Applications that are judged non-responsive will also 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, in consultation with the Indian Health Service
Research Program.  Subsequently, a second level of review
will be performed by staff of the National Institute of
Diabetes and Digestive and Kidney Diseases to consider the
special needs and priorities of the Institute.  Applications
recommended for approval will be considered for funding
beginning July 1, 1991.
 
REVIEW CRITERIA
 
Applicants are encouraged to submit and describe their own
ideas on how best to meet the objective 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 American Indians and Alaska Natives;
(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 agreement of a suitable American Indian population to
participate in planning the proposed study, and potential to
establish collaboration with the tribal 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 Collaborative
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.
 
Applicants are reminded of the NIH policy regarding the
inclusion of women in clinical research.  For
further information, consult the NIH Guide for Grants and
Contracts, August 24, 1990, (Vol. 19, No. 31, pp. 18-19).
 
LETTER OF INTENT
 
Prospective applicants are requested to submit a letter of
intent by December 15, 1990, 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 should 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
 
NIDDK welcomes inquiries from potential applicants to
clarify any issues or questions regarding this RFA.  Such
inquiries should be directed to the following NIDDK Program
Staff:
 
Dr. Robert E. Silverman
Chief, Diabetes Programs Branch
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney
Diseases, NIH
Westwood Building, Room 626
Bethesda, MD  20892
Telephone:  (301) 496-7888
 
     or
 
Dr. Joan T. Harmon
Executive Director, Diabetes Research Program
Diabetes Program Branch
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney
Diseases, NIH
Westwood Building, Room 622
Bethesda, MD  20892
Telephone:  (301) 496-7731
 
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, Room 449, Westwood Building, 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.
 
Submit a signed, typewritten original of the application,
including the Checklist, and four (4) signed, exact
photocopies, in one package to the DRG at the address below.
The photocopies must be clear and on single sides.
 
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
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 February 15, 1991.  If an
application is received after that date, it will be returned
to the applicant.
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.
 
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.
 
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.