Full Text DK-93-14

INNOVATIVE APPROACHES TO THE STUDY OF INTERSTITIAL CYSTITIS

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFA:  DK-93-14

P.T. 34

Keywords: 
  Urogenital System 
  Disease Model 
  Biological Markers 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  February 25, 1993
Application Receipt Date:  March 25, 1993

PURPOSE

The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) is soliciting grant applications for support of studies
focused on the study of interstitial cystitis, a disorder of the
bladder also known as the painful bladder syndrome.

The NIDDK is committed to increasing research into the urologic
disorders that affect women's health.  This request is part of the
initiative to promote research in all areas of women's urologic
health.

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 Request
for Applications (RFA), Innovative Approaches to the Study of
Interstitial Cystitis, 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).

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 and local
governments, and eligible agencies of the Federal government.
Minority individuals and women are encouraged to submit as principal
investigators.

MECHANISM OF SUPPORT

Support of this program will be through the NIH research project
grant (R01).  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.  Generally, future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  The total requested project period
for applications submitted in response to this RFA may not exceed
five years.  The earliest possible award date will be September 30,
1993.  Applicants must limit their requests to not more than $100,000
direct costs for the initial budget period.

FUNDS AVAILABLE

For FY 1993, $1,500,000 will be committed by the NIDDK to fund
applications submitted in response to this RFA.  It is anticipated
that 10 to 12 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 plans of the NIDDK, the award of grants pursuant to this
RFA is also contingent upon the availability of funds for this
purpose.

Awards made from this RFA will be for the support of new projects.

RESEARCH OBJECTIVES

Interstitial Cystitis (IC) is a chronic, painful and variably
incapacitating disorder that manifests a symptom complex consisting
of pain in the region of the urinary bladder and associated pelvic
musculature and variable motor and sensory dysfunctions of the
urinary bladder.

The purpose of this RFA is to solicit applications that propose
unique, innovative approaches to the study of interstitial cystitis
from investigators who are not currently being funded by the NIDDK
for research on interstitial cystitis.   It is not the intent to fund
research in areas that are currently being supported by the NIDDK.
Applications may be submitted for both non-human basic research and
human clinical research studies.  Examples of areas that could be
studied include:

o  the role of the pelvic floor musculature and innervation in
chronic bladder pain;

o  animal models of interstitial cystitis such as the feline urethral
syndrome;

o  the relationship between bladder endothelins and the symptoms of
interstitial cystitis;

o  release of urinary histamine as a marker for interstitial
cystitis;

o  the relationship between reflex sympathetic dystrophy and the
symptoms associated with interstitial cystitis;

o  the relationship between endometriosis and interstitial cystitis;
and

o  similarities between chronic abacterial prostatitis and
interstitial cystitis.

This list is not all inclusive and is meant solely to stimulate
interest for unique, innovative proposals for research in
interstitial cystitis from diverse investigators.  Program project
grant applications (P01) are not suited to this announcement.

Since this request is for unique, innovative studies, it is
understood that there may be limited preliminary data to support the
application.  In those cases, the applicant may wish to designate the
proposal as a pilot project and reduce the number of requested
project years, budget and scope of the project to that which is
necessary for obtaining adequate data for a more extensive,
full-scale project.

SPECIAL REQUIREMENTS

Applicants who receive an award through this announcement are
encouraged 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.

In order to ensure that patient selection for clinical studies is
uniform, the NIDDK has established Diagnostic Criteria for research
studies on IC.  All grant applications that use human subjects must
state that the NIDDK IC diagnostic criteria 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.  They may also be obtained from the program staff listed
under INQUIRIES.  This requirement does not preclude using subjects
who do not meet the criteria for comparison studies, but those who
meet the criteria must be specifically identified and designated as a
study group.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are 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 must 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 must 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 must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Item 4 (Research Design and Methods) of the Research
Plan AND summarized in Item 5, Human Subjects.  Applicants 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 is defined as 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.

If the required information is not contained within the application,
the application will be returned without review.

Peer reviewers will address specifically 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 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.

LETTER OF INTENT

Prospective applicants are requested, but not required, to submit a
letter of intent to apply to the RFA.  This letter should include the
name, telephone number, and mailing address of the Principal
Investigator, the names of other key personnel, and the name of the
applicant institution, and the number and title of this RFA.  Such a
letter of intent is not binding and it will not enter into the review
of any application subsequently submitted, nor is it a necessary
requirement for application.  Letters of intent are requested solely
for planning purposes.  The NIDDK staff will not provide responses to
such letters.  Letters of intent must be received no later than
February 25, 1993 and must be addressed to:

Dr. Robert Hammond
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

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 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.

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 Dr. Judith Vaitukaitis at the National
Center for Research Resources, telephone: (301) 496-6595.

The RFA label available in the application form must be affixed to
the bottom of the face page.  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 check the YES box.

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

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Robert Hammond, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by March 25, 1993.  If an application
is received after that date, it will be returned to the applicant.
The Division of Research Grants (DRG) will not accept any application
in response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  However, it is allowable to submit the same
project as both an R01 and as a component project of a program
project.  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.  Such applications must not only include an introduction
addressing the previous critique but also be responsive to this RFA.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NIDDK staff function.  If the application is not responsive
to the RFA, the staff will contact the applicant to determine whether
it should be returned to the applicant, or held until the next
regular receipt date and reviewed in competition with all other
applications.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.
Applications may be subjected to triage by an NIDDK peer review group
to determine their scientific merit relative to other applications
received in response to this RFA.  If the number of applications is
large compared to the number of awards to be made, a preliminary
scientific peer review may be conducted and applications withdrawn
from further competition when they are not competitive for the award.
The NIDDK staff will notify the applicant and institutional official
of this action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group specifically convened
for this RFA.  Following this review, the applications will be given
a secondary review by the National Diabetes and Digestive and Kidney
Diseases Advisory Council unless not recommended for further
consideration by the initial review group.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.

o  scientific/technical merit criteria specific to the objectives of
the RFA;

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  if an application involves activities that could have an adverse
effect upon humans, animals, or the environment, the adequacy of the
proposed means for protecting against or minimizing such effects.

AWARD CRITERIA

Funding decisions will be made based on the initial review group and
national advisory council recommendations, program relevance and
availability of funds.

The anticipated date of award is September 30, 1993.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues to:

Leroy M. Nyberg, Ph.D., M.D.
Director, Urology Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7133

Inquiries regarding fiscal matters may be directed to:

Ms. Trude McCain
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467

Schedule

Letter of Intent Receipt Date:  February 25, 1993
Application Receipt Date:       March 25, 1993
Initial Review:                 June 1993
Second Level Review:            September, 13-14, 1993
Anticipated Date of Award:      September 30, 1993

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.849 (NIDDK).  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 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

.

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