Full Text DK-95-007

BASIC AND EPIDEMIOLOGIC RESEARCH RELATED TO DISORDERS OF THE URINARY
BLADDER

NIH GUIDE, Volume 24, Number 12, March 31, 1995

RFA:  DK-95-007

P.T. 34

Keywords: 
  Epidemiology 
  Urogenital System 
  Etiology 
  Pathophysiology 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Date:  June 13, 1995
Application Receipt Date:  August 10, 1995

PURPOSE

The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD),
of the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), solicits grant applications for support of basic
research studies focused on the pathophysiology of normal and
abnormal urinary bladder function in females and epidemiologic
studies on the etiology and risk factors for interstitial cystitis.

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 Research Related to Disorders of the Urinary Bladder, is
related to the priority area of chronic debilitating illness.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report: Stock No. 017-001-00474-0 Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC  20402-9325 (telephone 202-783-3238).

Women's Urological Health Initiative

The DKUHD Women's Urological Health Initiative is committed to
increasing research on interstitial cystitis and other urological
disorders that affect women's health.  This request is part of that
initiative.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State or local
governments, and eligible agencies of the Federal Government.
Foreign institutions are not eligible for FIRST (R29) awards.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.

Competitive renewal applications and amended applications from
previous RFAs are eligible for this RFA if the content fits within
the scope of this RFA.

MECHANISM OF SUPPORT

Support of this program will be through the NIH research project
grant (R01) and FIRST (R29) awards.  Responsibility for the planning,
direction, and execution of the proposed project will be solely that
of the applicant.  Except as otherwise stated in this RFA, awards
will be administered under PHS grants policy as stated in the PHS
Grants Policy Statement.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures. The total project period for
applications submitted in response to this RFA may not exceed five
years.  The anticipated award date will be March 1, 1996.  The
maximum dollar request for R01s is limited to $160,000 in direct
costs for the initial budget period.  The maximum dollar request for
R29s is $350,000 direct costs for five years with a maximum of
$100,000 for any one year.

FUNDS AVAILABLE

For FY 1996, $1.2 million will be committed by the NIDDK to fund
applications submitted in response to this RFA.  It is anticipated
that seven to nine awards will be made.  However, this funding level
is dependent 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 also contingent upon the availability of funds for this
purpose.

RESEARCH OBJECTIVES

Background

Women of all ages suffer from a disproportionately high rate of
disorders of the urinary bladder.  There have been very few
well-documented research studies that focus on the basic science of
the urinary bladder, the differences between the development of the
bladder in both sexes, extrinsic factors in early development that
can affect adult urinary bladder dysfunction, and the anatomy and
physiology of the pelvis and its supporting structures and the effect
on bladder function.

Purpose

The purpose of this RFA is to bring new and established investigators
from diverse research areas into the study of the pathophysiology of
normal and abnormal urinary bladder function, the etiology of
interstitial cystitis and the epidemiology of interstitial cystitis.

Collaboration between basic science and clinical science
investigators in developing approaches to the study of the urinary
bladder is encouraged.

Applications are especially encouraged from basic science
investigators in such diverse fields as biochemistry, molecular
genetics, developmental biology, molecular and cellular biology
neurophysiology, immunology, nutrition, endocrinology, epidemiology,
and pharmacology and from  clinical investigators in adult and
pediatric urology, uro-gynecology, infectious diseases, nephrology,
endocrinology, psychology and psychiatry.

Applications from currently funded investigators are encouraged if
they address new hypotheses.  Competitive renewal applications of
active grants are also within the scope of this RFA.

Examples of Research Areas

The following are examples of the basic research areas that are
applicable to this RFA.  It is emphasized that this list includes
just a few of the topics which could be considered for investigation.
It is anticipated that many successful applications will propose
areas that are not included in this list.

o  Intra- and intercellular communication in bladder tissues.

o  The biochemistry of collagen in the bladder and in the pelvic
supporting structures of the urinary bladder.

o  The molecular biology of bladder mucosa in the normal bladder, the
developing bladder and in response to extrinsic factors.

o Stromal-epithelial interactions in bladder development and
dysfunction.

o  Normal and abnormal developmental biology of the urinary bladder.

o  The role of the pelvic musculature in normal and abnormal bladder
function.

o  Growth factors and bladder pathophysiology.

o  The effects of pregnancy on the urinary bladder.

o  Ethnic and racial differences in bladder pathophysiology.

o  Factors in the urine that affect normal bladder function.

o  Studies comparing the bladder with other organs, such as the gut,
to elucidate bladder pathophysiology.

The following are examples of a few epidemiologic studies related to
interstitial cystitis that are relevant (responsive) to this RFA:

o  Relationships between interstitial cystitis and other disorders of
the urinary bladder.

o  Case-control studies comparing interstitial cystitis with control
groups to detect possible risk factors.

o  Studies that compare interstitial cystitis and chronic abacterial
prostatitis.

Although this RFA is focused on bladder dysfunction in females, it
does not preclude the study of male bladder function when it is used
to enhance the understanding of
female bladder function through comparative studies.

Basic research studies on the bladder do not have to address any
specific disease process or disorder.

Studies NOT applicable to this RFA include:

o  Studies of bladder cancer or malignant change of
urothelial tissue.

o  Studies of the clinical treatment of bladder diseases.

o  Epidemiological studies of other bladder disorders that do not
include interstitial cystitis.

o  Program project grant applications (PO1).

SPECIAL REQUIREMENTS

Annual meeting of NIDDK Women's Urological Health Investigators

Applicants who receive an award through this RFA are expected to
attend a yearly meeting (convened by the NIDDK) of investigators to
discuss progress and exchange research information.  Funds to support
the travel to these meetings may be included in the proposed budget
and can be in addition to other proposed travel.

Diagnostic Criteria for Research Studies on Interstitial Cystitis.

In order to ensure that patient selection for clinical studies is
uniform, the NIDDK has established diagnostic criteria for research
studies on interstitial cystitis (IC).  All grant applications for
research on IC that use human subjects must state that the NIDDK IC
diagnostic criteria for research will be applied to patients selected
for inclusion in the research study. The NIDDK research criteria have
been published in the JOURNAL OF UROLOGY 142(1): 139, 1989 and the
AMERICAN JOURNAL OF KIDNEY DISEASES 8(4) 353, 1989.  The criteria may
also be obtained from the Urology Program, DKUHD, as indicated in
INQUIRIES below.  This requirement does not preclude using subjects
who do not meet the criteria for comparison studies; but those who do
not meet the criteria must be specifically identified and designated
as a distinct study group.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 14508-14513), and reprinted in
the NIH GUIDE FOR GRANTS AND CONTRACTS Volume 23, Number 11, March
18, 1994.

Investigators may also obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.

LETTER OF INTENT

Prospective applicants are asked to submit by June 13, 1995 a letter
of intent that includes a descriptive title of the proposed research,
the name, address and telephone number of the Principal Investigator,
the names of key personnel and participating institutions, and the
number and title of this RFA.

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 avoid conflict of interest in the
review.

The letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 CENTER DR MSC 6600
BETHESDA, MD  20892-6600
Telephone:  (301) 594-8886
FAX:  (301) 480-3505
Email:  hammondr@ep.niddk.nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  The form is available from most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD  20892,
telephone 301/435-0714; and from the program administrator listed
under INQUIRIES.

For developing programs that deal with clinical populations,
applicants may wish to consider utilization of General Clinical
Research Center (GCRC) facilities. More information on the GCRC
program is available from the National Center for Research Resources,
telephone: (301) 594-7945.

The RFA label available in the PHS 398 application form must be
affixed to 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 2a of the
face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:

Division of Research Grants
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
also be sent under separate cover to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building
Room 6As-37F
45 CENTER DR MSC 6600
BETHESDA, MD 20892-6600

Applications must be received by August 10, 1995.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) 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 DRG 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.

Applications for the FIRST award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST award applications submitted without the required
number reference letters will be considered incomplete and will be
returned without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the DRG for
completeness and by the NIDDK for responsiveness.  Incomplete
applications will be returned to the applicant without further
consideration.  If the application is not responsive to the RFA,
NIDDK staff may contact the applicant to determine whether to return
the application to the applicant or submit it for review in
competition with unsolicited applications at the next review cycle.

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, a process may be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and assigned
a priority score.  Applications determined to be non-competitive will
be withdrawn from further consideration and the principal
investigator and the official signing for the applicant organization
will be notified.

Review criteria

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly but not exclusively in the area
of the proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects (if applicable)
will also be evaluated.

o  availability of special opportunities for furthering research
programs through the use of unusual talent resources, populations, or
environmental conditions in other countries that are not readily
available in the United States or that provide augmentation of
existing U.S. resources.

The initial review group will also examine the provisions for the
protection of human and animal subjects, and the safety of the
research environment.

AWARD CRITERIA

The anticipated date of award is March 1, 1996.  Funding decisions
will be made based on the scientific merit as determined by initial
review; availability of funds; and programmatic priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to
clarify and issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:

Ralph L. Bain, Ph.D. or Leroy M. Nyberg, Jr. Ph.D., M.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 CENTER Drive MSC 6600
BETHESDA, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
EMail:  nybergl@ep.niddk.nih.gov
        bainr@ep.niddk.nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Ms. Trude McCain
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 CENTER Drive MSC 6600
BETHESDA, MD  20892-6600
Telephone:  (301) 594-8859
FAX:  (301) 480-3504
EMail:  mccaint@ep.niddk.nih.gov

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
last 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 CFR Part 74.  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 routing 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.

.

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