Subject: NIH GUIDE - RFA DK-92-12 - V20(42) 11/08/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 11 Nov 91 15:46 EST

Dear Paul,
     Please post this to the NIH listserver:
     RFADK-92-12.911108
 ---------------------------- Text of forwarded message -----------------------
$$XID RFA DK9212 DK-92-12 P1O1 *****************************************
 
CLINICAL RESEARCH ON BENIGN PROSTATIC HYPERPLASIA AND CHRONIC
PROSTATITIS
 
RFA:  DK-92-12
 
P.T. 34; K.W. 0715105, 0785035, 0765033, 0745020
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date: December 1, 1991
Application Receipt Date: February 11, 1992
 
PURPOSE
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites new and experienced investigators to submit research
grant applications that will investigate the clinical aspects of two of
the major diseases of the prostate: benign prostatic hyperplasia (BPH)
and chronic prostatitis.  The purpose of this Request for Applications
(RFA) is to increase the knowledge of the clinical pathogenesis of
these diseases, investigate the interrelationship between these two
diseases, and explore new and unique techniques for early detection,
genetic predilection, and more accurate assessment of the growth and
severity of these diseases.
 
BACKGROUND
 
BPH is a major cause of morbidity in the adult male.  The diagnosis and
treatment of this disorder contributes significantly to health care
expenditures worldwide. Although the methods for treatment of BPH are
rapidly proliferating, surgical intervention still remains the most
effective therapy for obliteration of the enlarged portion of the
gland.  The following aspects of the disorder remain to be explored:
preventing the onset of hyperplastic growth, predicting who will
develop symptomatic BPH and at what rate established BPH will increase,
determining whether or not there are genetic and racial differences in
onset and growth, and determining whether or not systemic diseases such
as diabetes mellitus have any effect on the development of BPH.
 
Chronic abacterial prostatitis remains a clinical enigma. It affects
untold numbers of young and middle-aged adult men, resulting in
significant lost work hours, medical expenditures, significant anxiety,
marital discord, and excessive, futile therapeutic intervention.  There
have been very few studies that define its pathogenesis, natural
history, and interrelationship with the development of BPH, and any
racial and genetic differences in onset and pathology.
 
RESEARCH GOALS AND SCOPE
 
The overall goal of this request is to increase the amount of clinical
research on the pathology and pathogenesis of BPH and chronic
abacterial prostatitis.  Clinical research is defined, for the purposes
of this RFA, as research that involves human subjects and/or specimens
from human subjects. This does not exclude the use of non-human disease
models such as animal or cell/tissue cultures for comparison with human
clinical pathology.
 
An emphasis of this initiative is to foster collaboration between
clinical investigators in urology and investigators in the basic
sciences such as biochemistry, cell biology, embryology, endocrinology,
molecular biology and molecular genetics, pathology, and pharmacology.
 
Areas that might be investigated include, but are not limited to:
 
o  non-steroidal testicular factors involved in the pathogenesis of
BPH;
 
o  serum markers that can quantify the onset and progression of BPH;
 
o  growth hormones, interleukins, immunomodulators, in BPH;
 
o  diagnostic techniques that will predict the development of symptoms
in the asymptomatic male with BPH;
 
o  differences in the pathology and pathogenesis of BPH in diabetics
and non-diabetics;
 
o  cellular interactions between BPH tissue and tissue with chronic
prostatitis;
 
o  the role of urinary glycoproteins in the pathogenesis of chronic
prostatitis and BPH;
 
o  insights into the bladder dysfunction associated with BPH and with
chronic prostatitis;
 
o  seminal fluid markers of men with BPH and with chronic prostatitis;
 
o  racial differences in BPH and chronic prostatitis;
 
o  genetic and immune factors in individuals with chronic prostatitis;
 
o  urine factors in persons with chronic prostatitis and BPH.
 
Topics that are NOT INCLUDED IN THE SCOPE OF THIS RFA include all those
that solely examine treatment modalities and outcomes of treatment;
however, applications that include a therapeutic intervention as a
means to study the pathology or pathogenesis of a disease are an
acceptable area for investigation.
 
Research that utilizes malignant animal tumor models or cancer-derived
cell/tissue cultures as a model for studies on benign diseases will not
be funded through this RFA.
 
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,
Clinical Research on Benign Prostatic Hyperplasia and Chronic
Prostatitis, is related to the priority area of diabetes and chronic
diseases.  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).
 
UTILIZATION OF GENERAL CLINICAL RESEARCH CENTERS
 
Applicants from institutions that 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 must be included with the
application.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS
 
The NIH policy, as applied to this RFA, is that applicants for clinical
research grants will be required to include minorities 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 in
studies of diseases that disproportionately affect them.  This policy
is intended to apply to individuals of all ages.  If minorities are
excluded or inadequately represented in clinical research, particularly
in proposed population-based studies, a clear and compelling rationale
should be provided.
 
The composition of the proposed study population must be described in
terms of gender or ethnic group, together with a rationale for its
choice.  In addition, gender and racial or 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 on grant application form PHS 398 in Sections 2A-D of the
Research Plan AND summarized in Section 2E (Human Subjects).
 
Applicants are urged to carefully assess 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 or ethnic minority populations (i.e., Native Americans
(including American Indians or Alaskan Natives), Asian/Pacific
Islanders, Blacks, Hispanics).
 
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.
 
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 or 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 racial/ethnic
minorities when it is important to apply the results of the study
broadly, and this should be addresses by applicants.
 
If the required information is not contained within the application,
the application will be returned.
 
Peer reviewers will specifically address whether the research plan in
the application conforms to these policies.  If the representation of
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 a
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
that do not comply with these policies.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, for-profit and
non-profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, and eligible agencies of the Federal
Government.  Applications from minority individuals and from women are
especially encouraged.
 
MECHANISM OF SUPPORT
 
Support for this program will be through the traditional investigator-
initiated research grant (R01).  The regulations (Code of Federal
Regulation, Title 42, Part 52 and, as applicable to the State and local
governments, Title 45, Part 74) and policies that govern the research
programs of the National Institutes of Health will prevail.  Under this
funding mechanism, the applicants will plan, direct, and conduct the
research programs.  The project periods 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 for up to five years (renewable for subsequent
periods) subject to the availability of funds and progress achieved.
 
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 six to eight awards will be made.  This funding level is dependant
upon the receipt of a sufficient number of applications of high
scientific merit.  Although this program is provided for in the
financial plan of the NIDDK, the award of grants pursuant to this RFA
is contingent upon the availability of funds for this purpose.
Applicants must limit the budget requests to no more than $160,000 in
direct costs for the first year.
 
APPLICATION PROCEDURES
 
Applications must be submitted using form PHS-398 (rev. 10/88)
available in the business or grants offices of most academic or
research institutions and from the Office of Grants Inquiries, Division
of Research Grants, National Institutes of Health, Room 449, 5333
Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441.
 
TO ENSURE PROPER IDENTIFICATION AND PROCESSING OF THE APPLICATION, LINE
2 OF THE APPLICATION FRONT PAGE MUST STATE: "DK-92-12, CLINICAL
RESEARCH ON BPH AND PROSTATITIS".
 
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 your application such that it will not reach the review
committee in time for review.
 
Applications must be received by close of business on February 11,
1992.
 
The original and four copies of the application must be sent to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Two additional copies of the application must be sent
under separate cover to:
 
Robert Hammond, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 603
Bethesda, MD  20892
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by December 1, 1991, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the names
of key personnel, the participating institutions, and the number and
title of the RFA to which the applicant is responding.  Such letters
are requested for the purpose of obtaining an indication of the number
and scope of applications to be received.  The letter is not binding,
is not a requirement for submission, and does not enter into the review
of the application.  The letter of intent is to be sent to:
 
Robert Hammond, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 603
Bethesda, MD 20892
FAX:  (301) 402-1277
 
REVIEW PROCEDURES
 
Applications that are not responsive to the research goals and scope of
this RFA will be returned to the investigator.  If the number of
applications is large compared to the number of awards to be made, the
NIDDK may conduct a preliminary peer review to eliminate those
applications that are clearly not competitive.  Those applications will
be withdrawn from further review and the applicant and institutional
business office will be notified.  Responsive applications will first
be reviewed for scientific and technical merit by an Initial Review
Group convened by the Review Branch, Division of Extramural Program
Activities, NIDDK.  A secondary review for policy and program relevance
to the NIDDK mission will be made by the National Diabetes and
Digestive and Kidney Diseases Advisory Council.
 
SUMMARY OF IMPORTANT APPLICATION DEADLINES
 
Letter of Intent receipt date:  December 1, 1991
Application receipt date:       Close of business, February 11, 1992
Initial Review Group:           April 1992
Second Level Review:            May/June 1992
Earliest Funding Date:          July 1 1992
 
INQUIRIES
 
Additional information regarding any aspect of this RFA may be obtained
from:
 
Leroy M. Nyberg, Jr., Ph.D., M.D.
Director, Urology Program, DKUHD
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7133
FAX:  (301) 496-9721
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.849.  Awards will be made under the authority of the Public
Health Service Act, Title III, Section 301 and Section 431 (b) (Public
Law 78-410, as amended:  42 USC 241 and 42 USC 285c-5) and administered
under PHS grants policies and Federal Regulations 42 CFR Part 52 and
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.