Subject: RFA DK-9l-03 2/l/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 06 Feb 91 07:48 EST

Hi Paul,
   # 3 in the revised list.  Please post to the listserver as:
RFADK-91-03.910201
     Thanks.   Dottie
 ---------------------------- Text of forwarded message -----------------------
 
KIDNEY AND UROLOGY RESEARCH CENTERS
 
RFA AVAILABLE:  DK-91-03
 
P.T. 04; K.W. 0785095, 0785220, 0785055, 0785035, 0710030, 0745027, 0745070
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  March 15, 1991
Application Receipt Date:  July 16, 1991
 
The Division of Kidney, Urologic and Hematologic Diseases
(DKUHD) of the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) invites applications for
research center grants (P50) to be awarded in fiscal year
1992.  NIDDK anticipates the award of up to six competitive
center grants in Fiscal year 1992.
 
BACKGROUND
 
Kidney and urologic diseases account for substantial and
increasing morbidity and financial burden in the United
States.  They threaten the health, well-being, and longevity
of over 13 million Americans and accounted for an estimated
cost of at least $50 billion in 1990.  Although considerable
progress has been made in understanding the basic physiology
and patho-physiology of the renal and urologic
systems, there has been only limited progress in unraveling
the mechanisms of those disease processes that lead to
progressive deterioration in the function of these
systems.  Nevertheless, major progress has been made in the
management of their clinical consequences.  For example,
renal dialysis and transplantation are life-saving
procedures, and the clinical management of benign prostatic
hyperplasia has improved over the past several years.
Unfortunately, these scientific advances have not led to the
means to prevent or reverse these diseases, and their
incidence is steadily increasing.  The proposed
multidisciplinary research centers, the George M. O'Brien
Kidney and Urologic Diseases Research Centers, should
provide the necessary and appropriate expertise to
investigate topical areas of research related to the
pathogenesis of kidney and urologic diseases such as:
immunologically mediated diseases; diabetes mellitus and
other endocrine and metabolic disorders; primary renal
hypertension; genetic abnormalities; bladder physiology and
pathophysiology; developmental and obstructive disorders;
and nephrotoxins and toxic cell injury.
 
OBJECTIVES AND SCOPE
 
The emphases of this initiative are threefold:  (1) to
attract new scientific expertise into the study of the basic
mechanisms of kidney and urological diseases; (2) to
encourage interdisciplinary research; and (3) to extend
these basic investigations into areas that will provide the
basis for the development of innovative clinical and
epidemiologic studies of the causes, therapy, and prevention
of kidney and urologic diseases and disorders.  In
approaching the study of these disease processes, it is
anticipated that extensive collaboration will be required
between individuals in the clinical and basic sciences,
including cell biology, molecular biology, immunology,
genetics, epidemiology, biochemistry, physiology, and
pathology.  It is the expressed intent of the announcement
to attract into the study of kidney and urologic disorders
new investigators not currently active in this field and to
explore new basic areas that may have clinical research
applications.  Individual institutions with both basic and
clinical research capabilities are eligible to apply.
Interinstitutional collaborative research arrangements are
also appropriate and encouraged.
 
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.
 
MECHANISM OF SUPPORT
 
NIDDK expects to award up to six center grants (P50) in
Fiscal Year 1992 on a competitive basis.  The receipt of up to
six competing continuation applications from those centers
who are current awardees is anticipated.  These applications
will compete for awards along with other applications
received in response to this announcement.  Foreign
institutions are not eligible to apply.  The anticipated
awards are for five years and are contingent upon the
availability of appropriated funds.  The total amount of
available funds to support this program (including both
direct and indirect costs) is anticipated to be no more than
$4.2 million per year.  No applicant may request more than
$750,000 in total costs (both direct and indirect costs) in
the initial budget period followed by the use of a standard
escalation factor for subsequent budget periods.
 
Applications should include the following items:
 
A Table of Contents;
 
Rationale for the proposed Center and Statement of
Objectives;
 
Institutional Environment and Resources;
 
Organization and Administrative Structure of the Center;
 
Specific Managerial Responsibilities for the Center;
 
Travel funds in the proposed budget for an annual meeting of
Center Directors;
 
A description of the method for the replacement of the
Center Director (should the need arise);
 
A description of the procedure to be used for the
addition/deletion of cores and projects during the proposed
period of operation;
 
A description of the administrative relationship of the
Center to the Applicant Institution.
 
Competing Continuation (Renewal) Applications also should
include the following:
 
A brief summary of major accomplishments that can be
attributed to the Center;
 
Evidence that previous specific aims have been accomplished
and that new research goals complement the existing
expertise at the Center;
 
A list of projects and cores units that have been
discontinued, modified, or completed since the last
competitive review, identified by title and investigator
together with a brief rationale for the actions taken;
 
The justification for adding new projects or cores;
 
A combined list of publications, manuscripts, and abstracts
that have resulted from the Center grant;
 
A list of projects that have received funding from other
sources as a result of participation in the Center grant.
 
A list of projects and core units in the current Center
program, the amount of current funding for each, and the
requested funding for the first budget period of each
component that is requested for continuation in the Center
renewal application.  This information can be provided in
tabular form.
 
Consultation regarding this Request for Applications (RFA) and
suggested guidelines for preparation of applications may be
obtained from:
 
Dr. Ralph L. Bain
Kidney and Urology Research Centers Program Director
DKUHD/NIDDK
Federal Building, Room 102
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-8218
 
All potential applicants are strongly encouraged to consult
with the Program Director.
 
REVIEW PROCEDURES
 
Applications for an award of a research center grant will be
evaluated in a national competition by the NIH peer review
process. Applications will be reviewed initially by a
special review committee convened by the NIDDK and
subsequently by the National Diabetes and Digestive and
Kidney Diseases Advisory Council.
 
Applications are unlikely to be reviewed by a site visit
team; therefore, the written application should be complete
to facilitate review without a site visit.  Extensive
additional material submitted subsequent to the stated
receipt date will not be accepted.
 
If 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 so notify the
applicant and the institutional business official.  Those
applications judged to be both competitive and responsive to
the RFA will be further evaluated according to the review
criteria stated below.
 
The review criteria for individual research projects
include:
 
The scientific, technical, or medical significance and
originality of the proposed research;
 
The feasibility and adequacy of the experimental design;
 
The qualifications and research experience of the proposed
personnel;
 
The availability of resources necessary for the research;
 
The appropriateness of the budget and timetable in relation
to the scope of the proposed research;
 
The review criteria for scientific cores include:
 
The appropriateness and utility of the core to the proposed
Center; each core unit must provide facilities or services
to at least two research projects recommended for approval;
 
The quality of the proposed facilities or services including
administrative arrangements for utilizing the core;
 
The qualifications, experience, and commitment of the
personnel involved in the core;
 
The appropriateness of the budget.
 
The review criteria for the overall Center program include:
 
The scientific merit of the program as a whole;
 
The significance of the overall goals of the Center;
 
The cohesiveness and multidisciplinary scope of the Center
and the coordination and interrelationship of the projects
and cores to the common theme of the Center;
 
The leadership, scientific expertise, and commitment of the
proposed Center Director.
 
Additional criteria for competing continuation (renewal)
applications include:
 
Progress and achievements specific to the Center and
documentation that collaboration has occurred;
 
Evidence that the previous specific aims have been
accomplished and that the proposed research goals are
logical extensions of ongoing studies;
 
Previous performance and estimated use of the core(s);
 
Justification for adding new projects or cores or for
deleting components previously supported.
 
Administrative Considerations
 
For all Center applications, both new and competing
continuations, the review will assess:
 
The institutional environment for and resources available to
Center investigators;
 
The institutional commitment to the proposed Center;
 
The administrative leadership necessary to provide for the
quality control of supported projects in the Center, the
allocation of funds, and the ability to foster communication
and cooperation among Center investigators;
 
The appropriateness of the budget in relation to the
proposed activities of the Center;
 
The adequacy of addressing the protection of human subjects,
animal welfare, and biohazard issues.
 
METHOD OF APPLYING
 
Potential applicants are urged to submit a letter of intent
to the Program Director by March 15, 1991, regarding their
application.  The letter of intent is nonbinding and is not
a precondition for an award.  The letter of intent should
include the name(s) of the Principal Investigator(s),
principal collaborators, a descriptive title of the proposed
research center, and the organization(s) involved.
Applications must be submitted using PHS Form 398 (Rev.
10/88).  The RFA label contained in the application kit must
be affixed to the bottom of the face page of the original
copy of the application.  Failure to use this label could
result in delayed processing and review of the application.
Complete line 2 of the application face page by inserting the
title and number of this RFA and checking the YES box.
 
Mail the completed application (original and four copies)
to:
 
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD  20892**
 
Simultaneously submit two copies under separate cover to:
 
Review Branch, NIDDK
5333 Westbard Avenue
Westwood Building, Room 406
Bethesda, MD  20892
 
The special single receipt date for submissions in response
to this announcement is July 16, 1991, with earliest funding
August 1, 1992.
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849, Kidney, Urologic, and Hematologic
Diseases Research.  Awards will be made under the authority
of the Public Health Service Act, Title III, Section 301
(Public Law 78-410, as amended; 42 USC 241) and administered
under PHS grant policies and Federal Regulations 42 CFR Part
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.