Subject: (Copy) RFA DK-91-05
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 27 Dec 90 13:51 EST

Hi Paul,
   The last of the day for posting to the NIH Listserver.  Please post
as:
   RFADK-91-05.901228
       Thanks.
              Dottie
 ---------------------------- Text of forwarded message -----------------------
 
REQUEST FOR APPLICATIONS
 
RFA:  DK-91-05
 
DIABETES INTERDISCIPLINARY RESEARCH PROGRAM
 
P.T. 34; K.W. 0715075, 0710030, 1002019, 0710070, 1002004, 1002008
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  March 15, 1991
 
Application Receipt Date:  May 17, 1991
 
INTRODUCTION
 
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) and the Juvenile Diabetes Foundation
International (JDFI) invite investigator-initiated program
project grant applications that incorporate an
interdisciplinary research approach to the etiology and
pathogenesis of insulin-dependent diabetes mellitus (IDDM)
or to the genetic susceptibility for the long-term
complications of diabetes.  This solicitation is intended to
stimulate the application of advances in basic molecular
biology, genetics, immunology, cell biology, and biophysics
to the study of IDDM and its complications.
 
Applications will be submitted to the NIH and will be
reviewed by NIH according to the usual NIH peer review
procedures.  Applications judged meritorious but not funded
by the NIH may be considered by the JDFI for possible
funding.  Applicants wishing to have their application
considered by the JDFI must authorize the NIDDK to provide a
copy of their letter of intent, application, and NIH-
prepared summary statement of the initial review to the
JDFI.
 
GENERAL BACKGROUND
 
In 1987, the National Diabetes Advisory Board (NDAB) formulated a
National Long-Range Plan to Combat Diabetes.  A
number of significant recommendations were made by the NDAB
in this plan.  One of these was to establish Diabetes
Interdisciplinary Research Programs (DIRPs) to be supported
by NIDDK.  The DIRPs would promote the integration of new
research methodologies into diabetes research.  As a result
of establishing these programs, young as well as established
scientists with research commitments to diabetes would be given
the opportunity to immerse themselves in new technologies at
the cutting edge of modern science.
 
In order to implement this recommendation, the NIDDK
convened three colloquia on "Genetics and Diabetes," "Gene
Regulation and Cellular Signaling in Diabetes" and
"Immunology and Diabetes Mellitus" during 1988.  The
discussions and presentations focused on interdisciplinary
dialogue between investigators in new and rapidly evolving
areas of biomedical research (i.e., molecular biology and
immunology) and biomedical research areas related to
diabetes.
 
The NIDDK is coordinating efforts with the JDFI to implement
DIRPs in areas of research that appear particularly relevant
to the cure, prevention, and improved treatment of IDDM.
Toward this end, the JDFI has recently embarked on a major
long-term capital fund raising campaign targeted at
establishing programs of excellence in diabetes research.
 
SCIENTIFIC BACKGROUND
 
It has been established that IDDM is an autoimmune disease
with major genetic influences.  Much has been learned about
the nature of the immunologic process involved but many
questions remain.  Informative animal models of IDDM (i.e.,
BB/W rat and NOD mouse) continue to be a central focus of
research.  Specific genes in the HLA locus have been
associated with IDDM, but the molecular or genetic roles of
these genes or closely linked genes in the diabetic process
have not been clearly defined.
 
There is a great deal of epidemiologic, clinical, and
physiologic information on the long-term microvascular,
macrovascular, and neurologic complications of diabetes.
There are biochemical theories of causation that have
prompted research during the last decade as well.  At this
time, however, the molecular pathophysiology of diabetic
complications is still unclear.  Despite the epidemiologic
and clinical evidence of genetic factors in the development
of complications, very little is known about the identity or
function of specific genes in these processes.
 
Recent breakthroughs in basic biomedical research have
revolutionized our ability to study complex diseases such as
diabetes.  Limited but highly successful application of the
new capabilities of molecular biology, genetics, immunology,
cell biology, and biophysics to diabetes research has been
evident.  Importantly, the increased utilization of these
technologies and approaches promise an improved
understanding and enhanced development of potential
preventative and therapeutic strategies.
 
OBJECTIVE AND SCOPE
 
It is the intention of the NIDDK and JDFI to further
stimulate the integration of the most current basic
biomedical research approaches into diabetes-related
research.  It is expected that this will be accomplished by
bringing to the diabetes arena those who are skilled in
these approaches by the support of meritorious, synergistic,
multidisciplinary research program project applications.
Proposals should include the involvement of both basic and
applied scientists in collaborative endeavors.  Research
proposals should be in the broad areas of IDDM or molecular
and genetic aspects of complications of the disease.
Relevant topics listed below are examples and should not be
construed as required or limiting.
 
o  Identification and functional characterization of genes
for IDDM or IDDM susceptibility
 
o  Identification of initial instigating events or factors
in the development of IDDM
 
o  Molecular mechanisms of beta cell destruction in IDDM
 
o  Genetic regulation of beta cell differentiation and its
role in diabetes
 
o  Identification and characterization of targets for the
autoimmune process in IDDM
 
o  Genetic manipulation of beta cells or surrogate cells to
replace physiologic insulin secretion capacity that has been
destroyed in IDDM
 
o  Immunoalteration of beta cells or the immune response in
an attempt to prevent or ameliorate autoimmune destruction
of beta cells
 
o  Molecular mechanisms of rejection of grafted tissue and
other causes of transplanted pancreas or islet failure
 
o  Identification and characterization of genes influencing
the development of long-term diabetic complications
 
o  Molecular mechanisms responsible for tissue destruction
or dysfunction in the long-term complications of diabetes
 
o  Interventions in basic molecular or cellular processes to
prevent or halt the progression of long-term complications
of diabetes.
 
MECHANISM OF SUPPORT
 
The mechanism of support will be the program project grant
award (PO1).  A program project grant is for the support of a
broadly-based multidisciplinary or multifaceted research
program that has a specific major objective or central
theme.  The award may support research components and core
functions.  Collectively, these components should
demonstrate essential elements of unity and interdependence
and result in a greater contribution to program goals than if each
activity were pursued individually.
 
The NIDDK plans to make one or two awards in FY 1992
contingent on the receipt of highly meritorious applications
in response to this solicitation.  The JDFI plans to make
two to four awards.  With respect to post-award
administration, the current policies and requirements that
govern the research grant programs of the NIH or the JDFI
will prevail depending on the funding source. Applicants
should note that grants funded by the JDFI will be subject
to the indirect cost policy of JDFI.
 
Although this solicitation is included in the funding plans
for Fiscal Year 1992 for NIDDK, the award of grants pursuant
to this RFA is contingent upon the receipt of appropriated
funds for this purpose.  The duration of proposed projects
may be up to five years.  Projects may be extended through
competing continuation applications.  A monetary cap on
applications specific to this RFA has been set by the NIDDK.
A program project application may request up to $3.75 million
in direct costs over a 5-year period.
$5 million in total costs).
 
Upon initiation of this program, the NIDDK and the JDFI plan
to sponsor periodic meetings to encourage exchange of
information among investigators, to foster collaborative
efforts between program grantees, and to identify resources
that would enhance the productivity of several grantees.
For this purpose, requests for travel funds for
a two-day meeting each year, probably to be held in
Bethesda, Maryland, should be included in the budget section
of the application.  Applicants should also include a
statement in their applications indicating their willingness
to participate in such meetings and to cooperate with other
researchers at other diabetes interdisciplinary research
program sites.
 
REVIEW PROCEDURES AND CRITERIA
 
In the event that the number of applications is large
compared to the number of awards to be made, the NIH may
conduct a preliminary scientific peer review to eliminate
those applications that are clearly not competitive.  The
NIH will administratively withdraw from competition those
applications judged to be noncompetitive and notify the
applicant and institutional business official.
 
Those applications judged to be both competitive and
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.  It is not anticipated that
site visits will be part of the review process; therefore,
each proposal should be complete in itself and should be
prepared as if no visit is expected.  Following the IRG
review, the applications will be reviewed by the National
Diabetes and Digestive and Kidney Diseases Advisory Council.
 
The criteria for review of applications will be those used
regularly for the review of program project grant
applications by the NIDDK.  These criteria concern the
scientific and technical merit, originality, and feasibility
of the constituent individual research projects; the utility
and quality of the proposed core facilities; the
cohesiveness, synergy, significance, and overall scientific
and technical merit of the entire program project; and the
qualifications, experience, and commitment of the
participating personnel.  A complete and detailed
description of these criteria is contained in the
publication entitled "NIDDK Program Project Grants:
Administrative Guidelines" that is available by request as
discussed below.
 
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.
 
METHOD OF APPLYING
 
Applicants should request a copy of the publication entitled
"NIDDK Program Project Grants:  Administrative Guidelines."
These guidelines contain important additional information on
the format of applications and review criteria.  Prospective
applicants may obtain these guidelines from:
 
Dr. Robert D. Hammond
Chief, Review Branch
Division of Extramural Activities
NIDDK, NIH
Westwood Building, Room 406
Bethesda, MD  20892
 
Letter of Intent:
 
Potential applicants are strongly encouraged to submit a
letter of intent.  The letter of intent need only include 1)
names of the Principal Investigator/program director and
principal collaborators, 2) descriptive title of the
potential application, and 3) identification of the
organization(s) involved.  The letter of intent should be sent to
the Chief, Review Branch, NIDDK at the address noted above.
 
Letter of Authorization:
 
Applicants must submit a brief letter to the NIDDK
indicating whether or not they wish their applications to be
considered for funding by the JDFI.  While applicants may
request that their applications be considered only by the
NIDDK and not by the JDFI, it is necessary that the record
indicate the applicant's consideration of this opportunity.
For those applicants who wish to have the JDFI consider
their application, all materials relating to the application
will be promptly forwarded to that organization by NIDDK,
and the summary statements for such applications will be
shared with the JDFI at the time of their availability.  The
NIDDK will provide no information to the JDFI nor any other
non-governmental agency related to proposals from applicants
who request that the JDFI not consider their application.
Letters of authorization should be prepared by the Principal
Investigator and co-signed by the offfical signing for the
applicant organization.  This letter may be combined with
Letters of Intent or may be submitted as cover letters
accompanying applications.
 
In all cases, the NIDDK will make its funding decisions
prior to those of the JDFI.
 
Format for Application:
 
Applications should be submitted on the PHS 398
(rev. 10/88 or 9/89) application form available at most
institutional business offices or from the Division  of
Research Grants, NIH, (301) 496-7441.  On item 2 of the face
page of the application, applicants should enter:  RFA:
Diabetes Interdisciplinary Research Programs and the RFA
number, DK-91-05.  The RFA label available in the current
revision of Application Form 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 to the
extent that it may not reach the review committee in time
for review.
 
Application Procedure:
 
Applications must be received by May 17, 1991, the original
and four copies of the application should be sent or
delivered to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Two additional copies of the application should be sent to:
 
Review Branch
National Institute of Diabetes and Digestive and Kidney
Diseases
Westwood Building, Room 406
Bethesda, MD  20892
 
Timetable:
 
A letter of intent should be submitted no later than
March 15, 1991.  Applications must be received by May 17,
1991.  Any applications received after this date will be
considered ineligible for this special solicitation.
 
APPLICATION                                     EARLIEST
RECEIPT DATE  INITIAL REVIEW  COUNCIL REVIEW   START DATE
May 17, 1991   Sept. - Oct.    Jan. - Feb.    April 1, 1992
 
INQUIRIES
 
Inquiries regarding this announcement should be addressed
to:
 
Joan T. Harmon, Ph.D.
Executive Director, Diabetes Research Program
Diabetes Programs Branch
NIDDK, DDEM
Westwood Building, Room 622
Telephone:  (301) 496-7731