CENTERS OF EXCELLENCE IN PEDIATRIC NEPHROLOGY
Release Date: February 12, 2001
RFA: RFA-DK-01-016 (This RFA has been reissued, see RFA-DK-06-011)
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: May 11, 2001
Application Receipt Date: June 22, 2001
PURPOSE
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), NIH, invites grant applications for Specialized Centers of
Research (P50) in pediatric nephrology. The purpose of the research
center is to attract a partnership of interdisciplinary research among
investigators with scientific expertise who will use complementary and
integrated approaches into the study of kidney diseases endemic to the
pediatric population. In approaching the study of these disease
processes it is anticipated that extensive collaboration will be required
among individuals in the clinical and basic sciences, including cell
biology, molecular biology, immunology, virology, genetics, epidemiology,
biochemistry, physiology and pathology. Studies designed to foster and
extend the development of new approaches into the causes, early
diagnoses, improved treatment, and where possible, prevention of these
diseases and disorders are appropriate.
The emphases for this program are several-fold (1) to continue to
attract new scientific expertise into the study of the basic mechanisms
of kidney diseases and disorders among infants, children, and
adolescents, (2) to encourage multidisciplinary research focused on the
causes of these diseases, 3) to explore new basic areas that may have
clinical research application and 4) to design *Developmental Research
(DR)/Pilot and Feasibility (P&F) studies of two years duration, which
are anticipated will lead to new and innovative approaches to study
kidney disease amongst the pediatric population, and the eventual
submission of competitive investigator-initiated R01 research grant
applications.
Individual institutions with research capabilities relating to diseases
of the kidney in the pediatric population are eligible to apply.
Inter-institutional collaborative research arrangements are also
appropriate and encouraged. Coordination for such arrangements must be
evident and clearly meaningful and appropriate for the research
proposed.
Support of this program will be through the NIH Specialized Center
(P50) 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. The total requested project
period for an application submitted in response to this RFA must not
exceed five years. The earliest anticipated award date is April 1,
2002.
*Generally DR/P&F proposals are expected to have little preliminary
data and are reviewed based on the development of hypotheses and
supporting literature.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS-led national activity for setting priority areas. This Request for
Applications (RFA), CENTERS OF EXCELLENCE IN PEDIATRIC NEPHROLOGY is
related to the priority area of Maternal, Infant and Child Health,
Chronic Kidney Disease, Diabetes, Disability and Secondary Conditions
and Educational and Community-Based Programs. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and nonprofit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government. Foreign institutions are
not eligible for P50 grants. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as
principal investigators.
To be considered eligible, applicant organizations must have: (1) a
statement of institutional commitment that addresses how the
institution will incorporate the Centers of Excellence in Pediatric
Nephrology high within its institutional priorities, (2) a qualified
principal investigator who is a scientific leader in the field, (3)
independent investigators who are successful in obtaining peer-reviewed
research support (R01, P01, U01, or equivalent) who together
collectively represent experience in both laboratory and clinical
research, and utilize a balance and diversity of research approaches,
4) research subprojects, representing a balance and diversity of
research approaches, (5) developmental/pilot & feasibility programs,
and (6) appropriate shared resources to support the proposed research
of the Centers of Excellence in Pediatric Nephrology. Although an
application must be submitted by a single applicant institution,
subcontracted collaborative scientific arrangements with scientists
from other institutions may be included if these arrangements are
clearly delineated, and formally and officially confirmed by signed
statements from the responsible officials of each institution.
However, a full institutional commitment must come from the applicant
institution.
Criteria for designating an investigator as a center grant participant
should be defined. Subsets of participants based on degree of
participation or other measures are acceptable. Each center is
encouraged to develop guidelines for center participation by
investigators.
Support will not be provided for applications with research activities
focused exclusively on basic research, or clinical research or trials,
or epidemiological research.
NIDDK program staff listed under INQUIRIES should be consulted if there
are questions regarding any of the above eligibility requirements for
exclusion.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) Specialized
Center (P50) award mechanism. This mechanism supports the full range
of research and development from basic to clinical and intervention
studies. The spectrum of activities comprises a multidisciplinary
approach on a specific kidney disease process or biomedical problem.
These grants differ from traditional program project (P01) grants in
that they are more complex and flexible in terms of the activities that
can be supported. In addition to support for multidisciplinary
research subprojects, support is also provided for pilot research
projects, specialized resources, and shared core facilities.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant. The total
project period for an application submitted in response to this RFA may
not exceed five (5) years. Awards will be administered under NIH
grants policy as stated in the NIH Grants Policy Statement.
Applicants from institutions which have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research. In such a case, a letter of agreement from either the GCRC
program director or principal investigator should be included with the
application.
This RFA is a one-time solicitation. The anticipated award date is
April 1, 2002.
FUNDS AVAILABLE
The NIDDK intends to fund two (2) new and/or competing continuation
center grants in response to this RFA. Two competing continuation
applications are anticipated in response to this RFA. Both new and
renewal applicants may request a project period of up to five (5) years
and a budget for up to $700,000 direct costs per year (not to exceed
$3.5 million for five years). However, the direct cost cap can be
exceeded with the inclusion of Facilities and Administrative (F&A)
Costs (previously referred to as “indirect costs”) for consortia
subcontracts to other participating institutions. The budgets of these
consortia subcontracts may also include the regular cost-of-living
increases (currently 3% per year). For renewal applications, budgets
requested for research subprojects and core facilities are limited to
20% budget growth over the most recent non-competing budget. Both new
and renewal applications must include budgets of at least $120,000
annually for Developmental Research/Pilot and Feasibility (P&F)
projects. Because the nature and scope of the research proposed may
vary, it is anticipated that the size of each award will also vary.
Although the financial plans of the NIDDK provide support for this
program, awards pursuant to this RFA are contingent upon the
availability of funds in FY 2002 and the receipt of a sufficient number
of applications of outstanding scientific and technical merit. At this
time, it is not known if this RFA will be reissued.
RESEARCH OBJECTIVES
Background
Kidney disease is a major cause of illness and death in infants,
children and adolescents, who make up approximately 25 percent of the
United States population. Of this population, both incident and
prevalent rates have increased moderately since 1990, with rates
continuing to be highest in 15-19 age group, with particularly high
rates -- three times those of Caucasian Americans -- in African
American children of both genders. It is estimated that 14,000 have
kidney disease, 5,000 have kidney failure and are on dialysis or have a
kidney transplant, of these about 60 percent are 12 years of age or
younger. As a consequence the financial cost to the American taxpayer
is enormous.
Developmental disorders of the kidney account for about one-third of
all childhood cases. Investigators are beginning to perform molecular
and genetic analyses to link specific gene products to normal kidney
growth and development and human kidney diseases. For example in
congenital nephritic syndrome, a glomerular disease characterized by
massive amounts of protein in urine and progressive renal failure in
infants, researchers have recently identified mutations in glomerular
protein called nephrin. This disorder often progresses so that
dialysis or renal transplantation is often required during infancy.
Other disorders in the very young patient include renal dysplasia(s)
and hypoplasia(s), cystic malformations, PKD, tubulointerstitial
diseases and congenital structural abnormalities i.e., obstructive
uropathy, vesicoureteral reflux and the resulting reflux nephropathy.
Older children often develop end-stage renal failure from conditions
such as immune complex disease, hereditary nephropathy, focal segmental
glomerulosclerosis, IgA nephropathy, and the hemolytic uremic syndrome.
The basic cellular and molecular mechanisms of the majority of these
disorders are poorly understood. Progression often occurs even when
the primary disease process has been thought to be adequately treated
and the disorder appears to have become inactive. Several diseases
that lead to chronic renal disease and end-stage renal disease (ESRD)
in adults often have their origin in childhood, a notable example is
diabetes and hypertension. Up to one third of children who develop
Type 1 (insulin-dependent) diabetes will develop ESRD in their twenties
or thirties. Strategies to prevent kidney disease ideally should begin
in childhood or late adolescence, and therefore, a great need exists to
better understand the pathogenesis of these conditions, with the
ultimate aim of prevention of complications and/or the development of
improved therapies. In kidney disease, children face special growth
and developmental challenges and strategies to address this are another
urgent need.
Representative, but not all-inclusive areas of research appropriate for
investigation include:
(1) studies of renal disorders of genetic and congenital origin that
may lead to progressive loss of renal function or cause severe
metabolic imbalances in children, including hyperoxaluria, and which
include the use of gene targeting and transgenic technologies in
addressing Bartter’s, Gitelman’s and Liddle’s syndromes during
development, and congenital nephrogenic diabetes insipidus,
(2) further identification and study of genes and gene mutations and
molecular events involved in renal and urogenital morphogenesis and
differentiation,
(3) studies of events involved in cellular signaling in renal
morphogenesis in health and disease, including the definition of events
involved in cellular communication and mechanisms by which growing
cells influence and are influenced by extracellular matrix,
(4) immune-mediated disorders, including such diseases as post-
infectious glomerulonephritis, human immunodeficiency virus (HIV),
immunoglobulin A (IgA) nephropathy, Goodpasture’s syndrome, and
Wegner’s granulomatosis,
(5) studies to understand the molecular mechanisms underlying the renal
hypertension in infants and children,
(6) studies addressing the short and long-term effects of
anti-hypertensive agents in infants and children,
(7) identification of risk factors and predisposing factors
contributing to renal disease progression in infants and children,
(8) studies addressing the etiology, pathophysiology, and treatment
strategies for end-stage renal disease in infants and young children,
including determinants of abnormal growth and development, the
development of animal models to quantitate the contribution of
selective variables in growth retardation in chronic renal failure, the
effects of exogenous recombinant hormones, and the role of uremia in
protein synthesis in young growing infants,
9) cellular and molecular studies underlying the development and
progression of glomerulonephritis in children, including the molecular
changes affecting the glomeruli, alterations of the basement membrane,
mechanisms leading to proteinuria, and the biochemistry of the nephron
during pathological states.
Other
The Specialized Center (P50) must be an identifiable unit within a
single university medical center or within a consortium of cooperating
institutions with a university affiliation. The overall goal of a P50
Center is to bring together, in a cooperative, multidisciplinary and
integrative manner, basic science and clinical investigators to enrich
the effectiveness of research into causes, treatment and cure of kidney
disease in infants, children and adolescents.
Interrelated, basic research subprojects, each with high scientific merit
and clear research objectives have provided the traditional framework of
the Centers of Excellence in Pediatric Nephrology program. In the
aggregate, the subprojects should continue to be directed to the
development of fundamental knowledge leading to the understanding of
childhood kidney disease processes and the design of curative or
preventive strategies. However, a new dimension to the centers program
is the requirement to include Research Development/Pilot and
Feasibility (P&F) project(s) as integral components of the centers
concept (described below). Core facilities that will benefit the
overall centers program are likely components of a center (described
below).
SPECIAL REQUIREMENTS
Other then the customary requests for support of research subprojects
and cores (e.g., administrative, animal, etc.), the following new
program should be included in the submissions for this RFA for Centers
of Excellence in Pediatric Nephrology.
Developmental Research (DR)/Pilot & Feasibility (P&F) Projects
A DR/P&F program may be included which will provide modest support for
innovative initiatives with the potential to advance progress in
understanding cellular and molecular mechanisms that cause kidney
diseases of the pediatric population. This program is directed toward
both new and established investigators who wish to explore the
feasibility of a novel approach to a problem in this area. Investigators
eligible for DR/P&F funding fall into three general categories: (1) new
investigators without current or past NIH support as a principal
investigator, and whose current or previous support from other sources
has been modest, (2) established investigators with limited previous work
on the kidney who wish to apply their expertise to a problem in this
area, and (3) established renal investigators who propose testing
innovative ideas that represent a clear departure from their ongoing
research directions. It is anticipated that the majority of the
recipients of DR/P&F funding will be from the first category.
Each DR/P&F study award is intended to provide a modest amount of
support, not to exceed $60,000 per year direct costs, for duration not to
exceed two years, which will allow an investigator the opportunity to
develop sufficient preliminary data to provide the basis for an
application for independent research support. DR/P&F study support is
not intended for large projects by established investigators, which
otherwise would be submitted as separate research grant applications.
DR/P&F funds also are not intended to support or supplement ongoing
funded research of an investigator.
Each DR/P&F study proposal should state clearly the justification for
eligibility of the investigator under one of the above three criteria. A
proposed DR/P&F study should present a testable hypothesis and clearly
delineate the question being asked, detail the procedures to be followed,
and discuss how the data will be analyzed. The DR/P&F studies should be
submitted for review generally in the format of NIH research project
applications (R01), but with a 15-page limitation.
Within this structure, it is imperative for each applicant institution
to establish a mechanism to oversee the ongoing use of funds for the
proposed DR/P&F program. This mechanism must include the use of
appropriate consultants (described below) for review from the
scientific community external to the center. These same consultants
may, if desired, review and assess other activities of the center and
may constitute the external advisory group to the center. The projects
selected to receive these funds are to be described by the Director in
the DR/P&F section of the application.
Enrichment and Educational Program
The center proposal may budget for and provide limited support for an
enrichment program, whose description and budget may be included within
the administrative core. It may provide support for visiting scientists,
seminars, and research forums. Limited travel support is allowable for
center investigators to travel to present scientific findings, learn new
laboratory techniques, develop new collaborations, or engage in
scientific information exchange. In all cases, the enrichment program
should further the overall aims and objectives of the center as well as
of the scientific cores.
Annual Kidney Center Workshop
Centers of Excellence in Pediatric Nephrology investigators may be
expected to participate in an annual workshop organized by the DKUHD-
NIDDK to share positive and negative results with other kidney research
centers (O’Brien Kidney and PKD), share materials, assess progress,
identify new research opportunities, and establish interactions and
research priorities and collaborations that will maximize the impact of
the research on reducing incidence and mortality, and improving
survival. Travel funds for the Principal Investigator and selected
center investigators and collaborators may be budgeted for this
purpose.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups
and their sub-populations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable, and b) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS.
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific or ethical reasons
not to include them. This policy applies to all initial (Type 1)
applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the “NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects” that was published
in the NIH Guide for Grants and Contracts, March 6, 1998, and is
available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained
within specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no
obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit, by May 11, 2001 a letter of
intent that includes a descriptive title of the proposed research, the
name, address, and telephone number of the Principal Investigator, the
identities of other key personnel and 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 a subsequent application, the information
that it contains allows NIDDK staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 655 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8885
FAX: (301) 480-3505
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants. These forms are available at most
institutional offices of sponsored research and may be obtained from
the Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone 301-710-0267, email: GrantsInfo@nih.gov.
The RFA label available in the PHS 398 (rev. 4/98) application form
must be affixed to the bottom of the face page of the application.
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 RFA title and number must be typed on line 2
of the face page of the application form and the YES box must be
marked.
The sample RFA label available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf format.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At time of submission, two additional copies of the application must be
sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 655 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Applications must be received by the application receipt date listed in
the heading of the RFA. If an application is received after that date,
it will be returned to the applicant without review. Supplemental
documents containing significant revision or additions will not be
accepted, unless the Scientific Review Administrator notifies
applicants.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR 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, but such applications must include an introduction addressing
the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIDDK. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDDK in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will receive a written critique and undergo a process in
which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review
by the National Diabetes and Digestive and Kidney Diseases Advisory
Council.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of the application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and
considered in assigning the overall score, weighting them as
appropriate for each application. Note that the application does not
need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Do these studies address an important problem? If
the aims of the application are achieved, how will scientific knowledge
be advanced? What will be the effect of these studies on the concepts
or methods that drive this field?
(2) Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
(4) Investigator: Are the investigators appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
(5) Environment: Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will
also be evaluated.
o the reasonableness of the proposed budget and duration to the
proposed research.
o the adequacy of the proposed protection of humans, animals, or the
environment, to the extent that they may be adversely affected by the
project proposed in the application.
o the adequacy of the proposed plan to share data.
Schedule
Letter of Intent Receipt Date: May 11, 2001
Application Receipt Date: June 22, 2001
Peer Review Date: October-November 2001
Council Review: February 13-14, 2002
Earliest Anticipated Start Date: April 1, 2002
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of the application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and
considered in assigning the overall score, weighting them as
appropriate for each application. Note that the application does not
need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Specific criteria to be used in the evaluation of grant applications
are listed below.
a. Individual Research Subprojects:
Within the Centers of Excellence in Pediatric Nephrology concept of
research to be performed, reviewers will evaluate each research
subproject using the five criteria listed below. Each criterion will
be addressed and considered by the reviewers in assigning the overall
score project merit:
a.1. Significance: The importance of the research objective to
pediatric kidney disease and its likelihood of completion within the
subproject period. Do these studies address an important problem? If
the aims of the application are achieved, how will scientific knowledge
be advanced? What will be the effect of these studies on the concepts
or methods that drive this field?
a.2. Approach: The adequacy of the experimental design and methods to
achieve the research objectives. Are the conceptual framework, design,
methods, and analyses adequately developed, well integrated, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics?
a.3. Innovation: Originality and novelty of the experimental design
as it relates to the proposed research. Does the project employ novel
concepts, approaches or methods? Are the aims original and innovative?
Does the subproject challenge existing paradigms or develop new
methodologies or technologies?
a.4. Investigators: The qualifications of the investigators to
conduct the proposed subproject research and the appropriateness of the
time commitments of each investigator to the conduct of the subproject.
Are the investigators appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
a.5. Environment: The scientific environment in which the
investigations will be done, and the unique features, if any, of the
environment to support the proposed work. Does the scientific
environment in which the work will be done contribute to the
probability of success? Do the proposed experiments take advantage of
unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional
support?
The initial review group will also examine: the appropriateness of
proposed subproject research budget and duration, the adequacy of plans
to include both genders and minorities and their subgroups, and
children as appropriate for the scientific goals of the research and
plans for the recruitment and retention of subjects, the provisions for
the protection of human and animal subjects, and the safety of the
research environment.
b. Shared Resources (Cores)
b.1. adequacy of the proposed plan to maintain appropriate cores and
potential for the distribution of reagents, tissues, transgenic animals
within and outside the Centers of Excellence in Pediatric Nephrology,
b.2. degree to which plans indicate that shared resources effectively
and efficiently support (or will support) the subproject and P&F
research of the Centers of Excellence in Pediatric Nephrology in a
manner that cannot be supported through available national resources,
b.3. adequacy of the justification for each specialized resource
relative to its essential need for the conduct of Centers of Excellence
in Pediatric Nephrology subproject research or pilot projects,
b.4. adequacy of qualifications and performance (if applicable) of
managers of resources,
b.5. appropriateness of the requested budgets to conduct each resource
operation.
c. Developmental Research Program/Pilot & Feasibility Projects
c.1. adequacy of the process and/or track record for attracting new
ideas for pilot studies within and outside of the Centers of Excellence
in Pediatric Nephrology institution.
c.2. adequacy of the proposed process and/or track record for
continuously reviewing and funding a spectrum of pilot projects (e.g.,
research, technology development, resources) for their quality and
importance to research that will have an impact on human renal disease.
c.3. general quality of the pilot projects provided by the Centers of
Excellence in Pediatric Nephrology to demonstrate the effectiveness of
the process of including pilot projects,
c.4. established mechanism within the institution to solicit DR/P&F
proposals and to oversee the use of funds for the proposed DR/P&F
program. This mechanism must include the use of appropriate consultants
for review from the scientific community external to the center.
c.5. appropriateness of the budget relative to the needs and
demonstrated capabilities of the Centers of Excellence in Pediatric
Nephrology.
d. Overall Program Organization and Capability:
d.1. scientific qualifications and involvement of the Centers of
Excellence in Pediatric Nephrology Principal Investigator, as well as
his/her demonstrated scientific and administrative leadership
capabilities, adequacy of the time commitment of the Principal
Investigator,
d.2. adequacy of the planning and evaluation process to include:
determining research productivity of existing projects and resources,
discontinuing activities of low productivity, initiating new activities
in response to important research opportunities, establishing
collaborations, and the use of external advisors,
d.3. adequacy of access to patients and populations for conducting
current and projected therapeutic, prevention, detection and control
research,
d.4. degree to which the organization and leadership of the Centers of
Excellence in Pediatric Nephrology promote and facilitate scientific
interactions between subprojects, pilot projects, etc., and effective
use of the Centers of Excellence in Pediatric Nephrology infrastructure
(e.g., shared resources) in the conduct of research,
d.5. effectiveness of and/or plans for promoting interdisciplinary
scientific interaction,
d.6. adequacy of tangible institutional commitments that will enable
and facilitate the research objectives of the Centers of Excellence in
Pediatric Nephrology (e.g., special facilities, recruitments,
discretionary resources such as dollars and space),
d.7. Interactions with Other Centers of Excellence in Pediatric
Nephrology
e. Interactions with other Centers of Excellence in Pediatric
Nephrology
e.1. adequacy of plans (new application) or progress (competing
renewal applications) to promote and maintain communication and
integration of scientific projects of mutual interest with other
Centers of Excellence in Pediatric Nephrology,
e.2. willingness to interact with other Centers of Excellence in
Pediatric Nephrology and with the NIDDK in sharing information, in
assessing scientific progress, in identifying new research
opportunities and in establishing scientific priorities.
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o Adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will
also be evaluated
o The adequacy of the proposed protection of humans, animals, or the
environment, to the extent that they may be adversely affected by the
subproject and P&F proposed research in the application.
o The adequacy of the proposed plan to share data.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit as determined by peer review,
o Availability of funds,
o Programmatic priorities.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
M. James Scherbenske, Ph.D.,
Renal Physiology/Cell Biology and
Kidney Centers and SBIR Program Director
DKUHD/NIDDK
6707 Democracy Blvd, Room 613
Bethesda, MD 20892-5458
Telephone: (301) 594-7719
FAX: (301)480-3510
E-mail: js255f@nih.gov
Direct inquiries regarding fiscal matters to:
Mrs. Mary K. Rosenberg
Grants Management Branch
DEA-NIDDK, NIH
6707 Democracy Blvd, Room 638
Bethesda, MD 20892
Telephone: (301) 594-8891
FAX: (301) 480-3504
E-Mail: RosenbergM@extra.niddk.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.849. Awards are 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 NIH grants
policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education, library,
day care, health care or early childhood development services are
provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.