Subject: NIH GUIDE - RFA DK-92-07 - V20(41) 11/01/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 04 Nov 91 14:53 EST

Hi Paul,
    # 5 from the ll/l/9l NIH Guide.  Please post to the NIH Listserver
as:
   RFADK-92-07.911101
                     Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DK9207 DK-92-07 P1O1 *****************************************
 
BASIC AND CLINICAL STUDIES ON THE MORBIDITY AND MORTALITY OF THE
END-STAGE RENAL DISEASE PATIENT
 
RFA:  DK-92-07
 
P.T. 34; K.W. 0755015, 0785095, 0785165, 0745025, 0745065
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  December 11, 1991
Application Receipt Date:  January 23, 1992
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) announces a Request for Applications (RFA) on the above
subject.  The mechanism of support will be limited to the
investigator-initiated research grant (R01) funding mechanism.
 
BACKGROUND
 
Most organ systems are affected by the development of renal failure
and the uremic state.  The treatment regimen for these patients
consists of either a dialysis modality or a renal allograft.  The
annual mortality rate of the dialysis patient population in the
United States is approximately 20%, almost double that reported by
European countries and Japan.  This high mortality rate underscores
the need for research on the causes of morbidity and mortality in the
ESRD population.  Similarly, the renal transplant failure rate is
nearly 50% at five years.  In fact, one of the major causes of renal
failure for patients entering the dialysis program is transplant
failure.  The scope and magnitude of the problem as reported in the
United States Renal Data System (USRDS) and the National Kidney and
Urologic Diseases Advisory Board Report point out the need for more
basic and clinical research related to morbidity and mortality of the
ESRD patient population.
 
Although some understanding of the causes of renal disease has been
gained in the past few years, little insight into the different
pathogenetic mechanisms leading to progression of renal disease has
occurred.  Nor has much insight been gained in developing means to
prevent or curtail progression of renal disease after the initial
insult has occurred.
 
It is the objective of this RFA to stimulate research activity on:
1) the causes of ESRD; 2) ways to decrease the rate with which
chronic renal failure progresses to end-stage renal disease; 3)
enhanced quality and effectiveness of dialysis and transplantation;
and 4) reducing to a minimum the short- and long-term complications
associated with these therapies.  Understanding the mechanisms
involved in dialysis-related morbidity and mortality, particularly
are also paramount in achieving the objectives of this initiative.
 
RESEARCH GOALS AND SCOPE
 
This special grant program will support fundamental, clinical and
applied research.  An additional emphasis of this initiative,
however, is to foster extensive collaboration among individuals in
the basic sciences, including biochemistry, cell biology, embryology,
endocrinology, molecular biology, genetics, epidemiology, nutrition,
pathology, pharmacology, renal physiology and pathophysiology.  It is
the intent of this solicitation to engage investigators with diverse
research interests but who wish to apply their technologies and
expertise in elucidating and extending the current understanding of
the renal mechanisms, including cardiovascular, immunological,
metabolic, and endocrinologic, that may be affected in ESRD.  To that
end, the following are some suggested topics that might be addressed
to achieve the objectives of this solicitation:
 
Cardiovascular Influences
 
o  The effects on cell and organ function that result from the acute
fluid and electrolyte shifts induced by dialysis treatment; organ
specificity of these changes in the volume and composition of the
body fluids, and laboratory indicators which might have clinical
utility in the management of dialysis patients; and the rate and type
of change in body fluid exchange which improve the health of these
patients.
 
Vascular Access
 
o  Development of new access concepts, materials and designs; tissue
reactions to new biomaterials.
 
o  Studies of the roles of coagulation, fibrinolytic, complement and
other mediator systems.
 
Hormonal and Metabolic Influences
 
o  Studies to assess the quantitative impact of various hormones,
especially insulin, on protein and amino acid metabolism in chronic
renal failure.
 
o  Develop a means to measure in humans and/or animal model(s) the
metabolic consequences of ESRD and dialysis.
 
Infection and Immunity Problems
 
o  Studies directed to elucidating the role of cytokines, including
TNF and IL-1 in the morbid and mortal events in the uremic state.
 
o  Fundamental studies of immune dysfunction in uremia. For example,
agonist-signal-effector relationship and how uremia and its therapy
affects these abnormalities.
 
Nutritional Influences
 
o  In vivo studies assessing whole body protein turnover (synthesis
and breakdown) and of regional aspects of protein and amino acid
metabolism (e.g., muscle, liver, intestine).
 
o  Studies to better define optimal nutrition interventional
approaches for patients on dialysis, which will delineate the optimal
combination of nutrients, including total protein, protein quality,
calories and minerals.
 
Epidemiologic Studies
 
o  Studies addressing the role of nutritional factors in the
pathogenesis of infections, and the influence of biomaterials on
infection rates in the dialysis population.
 
o  Studies to define the prevalence and risk factors for the various
types of heart disease, including concentric hypertrophy, eccentric
hypertrophy, dilated cardiomyopathy, atherosclerotic ischemic heart
disease, non-atherosclerotic ischemic heart disease, carditis,
pericarditis, stroke, peripheral vascular disease, arrhythmia and
sudden death, in the ESRD population.
 
The above are examples only and be viewed as all inclusive.
 
ELIGIBILITY
 
Research grant applications may be submitted by foreign and domestic,
non-profit and profit-making, organizations and institutions, State
and local governments and their agencies, and eligible agencies of
the Federal Government.  Applications from women and minorities are
encouraged.
 
MECHANISM OF SUPPORT
 
Applications may be submitted for the traditional,
investigator-initiated research project grant (R01). Under this
mechanism, applicants will plan, direct, and conduct the research
programs.  The project period during which the research will be
conducted must adequately reflect the time required to accomplish the
stated goals and be consistent with the policy for grant support.
Support will be provided up to five years (renewable for subsequent
periods) subject to the availability of funds and progress achieved.
 
REVIEW PROCEDURES AND CRITERIA
 
Review Procedures
 
Upon receipt, applications will initially be reviewed by the Division
of Research Grants (DRG) for completeness. Incomplete applications
will be returned to the applicant without further consideration.
Applications will then be reviewed by program staff for their
responsiveness to the objectives of this RFA.  If an application is
considered unresponsive, the applicant will be contacted and given an
opportunity to withdraw the application or have it considered as an
unsolicited grant application to the NIH.  If the application
submitted in response to this RFA is substantially similar to a 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.
 
Review Procedures
 
Applications in response to this RFA will be reviewed in accordance
with the NIH peer review procedures. Applications will first be
reviewed for scientific and technical merit by an Initial Review
Group that will be convened by the Review Branch, Division of
Extramural Activities, NIDDK.  This group will be composed primarily
of non-Federal scientific consultants.  The applications will then be
reviewed by the National Diabetes and Digestive and Kidney Disease
Advisory Council.  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 notify
the applicant and institutional business official.
 
Review Criteria
 
Review criteria include the extent of relevance and/or contribution
of the proposed research to the overall goals and objectives of the
RFA; the novelty, originality, and feasibility of the approach; the
training, experience, and research competence of the investigator(s);
the adequacy of the experimental design; the suitability of the
facilities; and the appropriateness of the requested budget to the
work proposed.
 
HEALTHY PEOPLE 2000
 
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,
Basic and Clinical Studies on the Morbidity and Mortality of the End-
stage Renal Disease Patient, is related to the priority area of
diabetes and chronic disabling conditions.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).
 
SPECIAL INSTRUCTIONS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH policy is that applicants for 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, together with a rationale
for its choice.  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 questions(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.
 
FUNDS AVAILABLE
 
For FY 1992, $1.5 million in total costs per year will be committed
to fund applications submitted in response to this RFA.  It is
anticipated that eight to ten awards will be made.  However, this
funding level is dependent upon the receipt of a sufficient number of
applications of high scientific merit.  The total project period for
applications submitted in response to this RFA may not exceed five
years.  In order to help meet NIDDK goals for managing the costs of
biomedical research, applicants must limit their requests to not more
than $160,000 in direct costs for the first year.  Although this
program is provided for in the financial plans of NIDDK, the award of
grants pursuant to the RFA is contingent upon the availability of
funds for this purpose.  The earliest award date will likely be July
1, 1992.
 
METHOD OF APPLYING
 
Letter of Intent
Prospective applicants are encouraged to submit an optional letter of
intent that includes the title of the proposed project and
identification of all participating institutions.  Such letters are
requested only for the purpose of obtaining an indication of the
number and scope of applications to be received.  A letter of intent
is not binding, is not a requirement of submission, and it will not
enter into the review of the application subsequently submitted.
This letter is to be received no later than December 11, 1991, and is
to be sent to:
 
Robert D. Hammond, Ph.D.
Chief, Review Branch, Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 406
Bethesda, MD  20816
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the 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 must be included
with the application.
 
The RFA label (found in the 10/88 revision of application form PHS
398) 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 of the application such that it will not reach the
review committee in time for review.
 
Applications must be submitted using form PHS 398 (rev. 10/88),
"Application for Public Health Service Grant", available in the
business or grants office of most academic or research institutions
and from the Office of Grants Inquiries, Division of Research Grants,
National Institutes of Health, 5333 Westbard Avenue, Room 449
Bethesda, MD  20892, telephone: 301/496-7441.  In order to ensure
proper identification of the application, line 2 of the application
form should state "DK-92-07, Morbidity and Mortality of End Stage
Renal Disease" and check the "YES" box.
 
Timetable
 
A letter of intent is requested by December 11, 1991.
Applications must be received by C.O.B. January 23, 1992.
Applications not received by this date will be returned
to the applicants.
 
APPLICATION        INITIAL       COUNCIL      EARLIEST
RECEIPT            REVIEW        REVIEW       START DATE
 
Jan. 23, 1992    March 1992    June 1992   July 1, 1992
 
Send the original and four copies of the application to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING
IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE
ADDRESS FOR THE WESTWOOD BUILDING IS:
 
5333 Westbard Avenue
Bethesda, MD  20816
 
To expedite the review, send two copies of the application to:
 
Robert D. Hammond, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 406
Bethesda, MD  20816
 
INQUIRIES
 
M. James Scherbenske, Ph.D.
Program Director, Renal Physiology/Cell Biology
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-04A
Bethesda, MD  20892
Telephone:  (301) 496-7458
 
For fiscal and administrative matters, contact:
 
Mrs. Helen Y.S. Ling
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 639
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849.  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
CRF Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.