URINARY INCONTINENCE TREATMENT NETWORK: CONTINENCE TREATMENT CENTERS
Release Date: October 12, 2000
RFA: DK-01-018 (Limited competition, see RFA-DK-06-501)
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: December 7, 2000
Application Receipt Date: December 28, 2000
PURPOSE
The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) has a substantial and longstanding interest in research on
bladder and urinary continence disorders. Surgery, behavioral and
medical therapies are the most common interventions for urinary
incontinence, but their long-term outcomes have not been rigorously and
systematically evaluated. The NIDDK, in collaboration with the
National Institute of Child Health and Human Development (NICHD),
recently initiated the Urinary Incontinence Treatment Network (UITN).
The primary goal of the UITN is to assess the long-term outcomes of the
most commonly applied treatments for women with the diagnoses of stress
and mixed urinary incontinence. The UITN, a multi-center consortium of
investigators, is supported by cooperative agreements and includes four
vanguard Continence Treatment Centers (CTCs) and a single
Biostatistical Coordinating Center(BCC). These CTCs and the BCC have
developed a protocol for implementation. The purpose of this
solicitation is to add up to four CTCs to the UITN to increase the
number of patients enrolled and to enhance the ethnic and racial
diversity of the study population.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of Healthy People 2010 , a
PHS-led national activity for setting priority areas. This
RFA, Urinary Incontinence Treatment Network-Continence Treatment
Center ,is related to one or more of the priority areas. Potential
applicants may obtain a copy of Healthy People 2010 at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic, for-profit and non-profit
institutions, public and private organizations, such as universities,
colleges, hospitals, units of State and local government, and eligible
agencies of the Federal government. Foreign institutions are not
eligible to apply. Racial/ethnic minorities, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
MECHANISM OF SUPPORT
The administrative and funding instrument to be used for these awards
will be the cooperative agreement (U01). The cooperative agreement is
an assistance mechanism in which substantial NIDDK scientific and
programmatic involvement is anticipated during the performance of the
activity. Under the cooperative agreement, the NIDDK"s purpose is to
support and encourage the recipient"s activities by working jointly
with the awardees in a partnership role, but not to assume direction,
prime responsibility, or dominance. Details of the responsibilities,
relationships, and governance of a study funded under a cooperative
agreement are described under the section entitled "Terms and
Conditions of Award."
The total project period for applications submitted in response to this
RFA must not exceed four years. The anticipated award date is July 1,
2001. At this time, the NIDDK has not determined whether or how this
solicitation will be continued beyond the present RFA.
FUNDS AVAILABLE
The NIDDK plans to make four awards. Approximately $1,000,000 total
cost (direct plus facilities and administrative costs) is expected to
be available per year under this RFA. It is anticipated that the award
for each CTC will be about $250,000 total cost per year.
The number of awards to be made is dependent on the receipt of a
sufficient number of applications of high scientific merit and
availability of funds. Although this program is provided for in the
financial plans of the NIDDK, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a
sufficient number of applications of outstanding scientific and
technical merit.
RESEARCH OBJECTIVES
A. Background
Urinary incontinence is a complex condition that affects females and
males of all ages. However, the prevalence of urinary incontinence is
significantly higher in women than in men. The factors influencing a
patient’s decision to seek care are not well-described and the criteria
by which the clinician selects therapy are not uniform. Diagnostic
criteria that delineate the various categories and subcategories of
urinary incontinence are neither well defined nor utilized by many
physicians. In addition, factors that may predict a successful outcome
of treatment have not been examined systematically. There are numerous
options available for the treatment of urinary incontinence, including
surgery, pharmaceuticals, behavioral modification, and prostheses.
Combinations of these therapies are frequently utilized. Much of the
literature pertaining to surgical intervention suggests that there is
marked improvement for continence during the immediate and short-term
post-operative period. There are, however, very few well-designed
observational studies that document the outcomes of invasive
interventions over a longer period of follow-up. The clinical studies
reported to date suffer from a number of methodological shortcomings,
including short follow-up, inadequate sample size (and thus low
statistical power), uncertain diagnostic criteria for patient
selection, inadequate measurement of quality of life, uncertainty about
the relevance of reported clinical and patient-related outcomes,
absence of documentation of post-operative complications, and high
rates of patients lost to follow-up (thus introducing possible bias
into results).
Despite the frequent use of surgery for urinary incontinence, there is
no consensus on which procedure(s) offers the optimal long-term
improvement and greatest patient satisfaction. No rigorously
conducted long-term studies have been performed to date that evaluate
the most commonly performed surgical procedures utilizing accepted
outcome measures. In addition, although the use of pharmacological
therapy and behavioral interventions prior to and post-surgery for
urinary incontinence is common, these adjunctive interventions have not
been evaluated in a standardized fashion. Therefore, a well-designed
prospective cohort study which assesses surgical, pharmacological, and
behavioral approaches to the management of urinary incontinence is
needed to provide both physicians and patients with the information
necessary to make well-informed decisions about the best treatment
options. Recently, the NIDDK in collaboration with the NICHD and
successful applicants (four CTCs and a BCC) from a prior RFA began
protocol development for a prospective cohort study of surgical
procedures for urinary incontinence. It is anticipated that the
awardees under this RFA will follow the protocol developed by this
vanguard group of investigators.
B. Research Goals and Scope of the Activity
The purpose of this RFA is to solicit applications from investigators
to serve as Continence Treatment Centers as members of the Urinary
Incontinence Treatment Network to participate in a four-year
prospective cohort study of women who have undergone different surgical
procedures for urinary incontinence. Information will also be
collected in a standardized manner on the use of pharmacological and
behavioral therapy in addition to surgery. The study will be conducted
collaboratively, using standardized entry criteria, uniform measures of
outcome, validated instruments to assess quality of life and sexual
function and other important patient-reported outcomes, over a four-
year period. The investigators of the CTCs will also participate in
data analysis, making presentations at scientific meetings, and writing
manuscripts for publication in peer-reviewed journals. It is
anticipated that the personnel requirements of a CTC will include
expertise in urology, urogynecology and behavioral therapy as related
to the treatment of urinary incontinence in women.
Applicants are encouraged to develop collaboration with other
investigators as subcontractors to establish satellite centers in order
to increase the available pool of eligible patients with the primary
goal of enhancing racial and ethnic diversity of the population.
Phases Of Study For Budget Considerations
The study will be conducted in two phases with the activities described
below. This information is provided to assist applicants in developing
an accurate budget.
Phase I (Months 1-42). Recruitment of the full study cohort,
collection of baseline and follow-up data on surgical, pharmacological,
and behavioral treatments and interim data analysis.
During the first 12 months of this Phase, recruitment of patients to be
enrolled in the cohort study will be carried out. It is anticipated
that the follow-up of patients will be completed in month 42. Interim
data analysis and reporting of selected findings will occur throughout
this Phase.
Phase II (Months 43-48). Final data analysis, reporting of results,
and close-out of Continence Treatment Centers.
Study Components
Continence Treatment Center: A Continence Treatment Center is an
institution that is actively involved in the recruitment, evaluation,
treatment, and follow-up of study participants. It should consist of
an interdisciplinary team of clinical investigators and persons
experienced in behavioral therapy the appropriate support personnel,
such as a research coordinator, data entry and clerical staff. It is
preferred that the clinical investigators at a CTC include both a
urologist and a urogynecologist with demonstrated training and
experience in the diagnosis and surgical treatment of female urinary
incontinence. Similar expertise is expected of each satellite center
established under subcontracts from the CTC. It is assumed that either
a urologist or a urogynecologist will serve as the principal
investigator of a CTC. Other clinicians with similar training and
experience may also be included as co-investigators.
It is not expected that each CTC will have expertise available to them
for all of the currently utilized surgical procedures for urinary
incontinence, nor is it required that CTCs alter their current clinical
practice patterns to participate in this study. It is expected,
however, that each CTC will have experience with behavioral therapy and
pharmacological treatment. In addition, applicants are encouraged to
complement their own clinical site surgical expertise and patient
enrollment potential by establishing collaborations with other
investigators who treat large numbers of women with urinary
incontinence as previously described. The primary focus of
establishing satellite sites should be to enhance recruitment of racial
and ethnic minority women. CTC investigators must be capable of
recruiting and retaining a sufficient number of women for the proposed
cohort study. CTCs should document the available target population
from which study participants can be recruited. This documentation
should include, in tabular form, the number of female urinary
incontinence patients for each five-year age range and by
race/ethnicity. The investigators must also include in their
description of their target population, the sources of referral of
their patients, and the percentage who are prior treatment failures and
the percentage of women who have undergone an initial surgical
procedure for urinary incontinence. Realistic estimates of the rate of
participation of women who have undergone surgery for urinary
incontinence and are willing to join the study and be followed at the
CTC must be provided. The investigators should list and document
strategies and techniques that have been found to be effective in
patient recruitment for other clinical studies. The Principal
Investigator and co-investigators should document previous experience
in collaborative clinical investigation because they will be required
to submit protocol-specified data to the BCC expeditiously and to
collaborate with an already established Urinary Incontinence Treatment
Network. CTCs must work in concert with the BCC and must be willing to
submit to data audits and other data quality control procedures as
established by the study protocol.
Steering and Planning Committee
The primary governing body of the study will be the Steering and
Planning Committee comprised of each of the principal investigators of
the CTCs and the BCC, the Chairperson of the Steering and Planning
Committee, and the NIDDK Project Scientists (described in detail under
Terms and Conditions). The Steering and Planning Committee will, in
addition to developing the study protocol (the vanguard CTCs and the
BCC only), propose interim and final data analysis plans, and, along
with their staff at the CTCs, recruit, perform surgery, provide
pharmacological and behavioral therapy and provide follow-up for study
participants. The members of the Steering and Planning Committee will
serve as chairs of the various subcommittees of the UITN.
Executive Committee
An Executive Committee, including the Chairperson of the Steering and
Planning Committee, the Principal Investigator of the BCC, NIDDK
Project Scientists, and when necessary, Chairpersons of the various
subcommittees of the Steering and Planning Committee, will be
established. The purpose of this committee is to handle problems that
arise during the interim of regularly scheduled Steering and Planning
Committee meetings.
External Advisors
An independent group of experts in urology, urogynecology,
biostatistics, clinical trials, behavioral medicine, nursing, and
ethics who are not otherwise involved in the study will be recruited by
the NIDDK to review periodically the progress of the study (described
in detail under Terms and Conditions).
Project Scientists
The NIDDK will identify two Project Scientists for the study. The
Project Scientists will assist the Steering and Planning Committee and
external advisors in carrying out the study (described in detail under
Terms and Conditions).
TERMS AND CONDITIONS OF AWARD
The following terms and conditions will be incorporated into the award
statement and provided to each Principal Investigator as well as to the
institutional officials at the time of the award. These terms are in
addition to, not in lieu of, otherwise applicable Office of Management
and Budget (OMB) administrative guidelines, HHS Grant Administration
Regulations at 45 CFR Part 74 and 92, and other HHS, and NIH Grants
Administration policy statements.
The participating Clinical Treatment Centers will have primary
responsibility for recruiting a sufficient number of patients (with a
focus on recruiting racial and ethnic minority participants),
maintaining high rates of follow-up and data collection, obtaining data
of high quality, and interpreting, presenting, and publishing findings
from the study. It is expected that the Clinical Treatment Centers
will carry out the protocol now being developed by the four vanguard
CTCs and the BCC.
1)Awardees Rights and Responsibilities
Awardees will have substantial and lead responsibilities in all tasks
and activities. These include patient recruitment and follow-up, data
collection, quality control, final data analysis and interpretation,
and preparation of publications. The awardees agree to work
cooperatively with the other CTCs and the BCC and agree to follow the
common protocol and Manual of Operations developed by vanguard CTCs and
the BCC. The awardees agree also to transmit all study data to the BCC
for combination and analysis. Awardees will retain custody of and have
primary rights to their data developed under these awards, subject to
Government (e.g., NIDDK, NIH, or PHS) rights or access consistent with
current HHS, and NIH policies.
2) NIDDK Staff Responsibilities
The NIDDK will name two Project Scientists from within the Division of
Kidney, Urologic and Hematologic Diseases whose function will be to
assist the Steering and Planning Committee in carrying out the study.
One Project Scientist will have clinical expertise in urinary
incontinence and the other will have experience in the development and
conduct of multicenter clinical studies. The Project Scientists will
be entitled to one vote between them for all key study group
subcommittees. The Project Scientists will have substantial
scientific-programmatic involvement in quality control, interim data
analysis, safety monitoring, and final data analysis and
interpretation, preparation of publications, and coordination and
performance monitoring. The dominant role and prime responsibility for
these activities resides with the awardees for the project as a whole,
although specific tasks and activities in carrying out the studies will
be shared among the awardees and the NIDDK Project Scientists.
The NIDDK Project Scientists will have voting membership on the
Steering and Planning Committee and, as determined by that committee,
its subcommittees and will have one vote between them. One of the NIDDK
Project Scientists will also serve as Executive Secretary of the
external advisors.
The NIDDK reserves the right to terminate or curtail the study (or an
individual award) in the event of difficulties in recruiting
participants to the study, maintaining high rates of patient follow-up
and data collection and in timely data transmission, achieving high
levels of data quality, working with cooperatively or other major
breaches of the protocol, or human subject ethical issues that may
dictate a premature termination.
3) Collaborative Responsibilities
The administrative and funding instrument used for this program is the
cooperative agreement (U01), an assistance mechanism (rather than an
acquisition mechanism), in which substantial NIH scientific and/or
programmatic involvement with the awardees is anticipated during the
performance of the activity. Under the cooperative agreement, the NIH
purpose is to support and/or stimulate the recipient’s activity by
involvement in and otherwise working jointly with the award recipient
in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity. Consistent with
the cooperative agreement concept, the dominant role and prime
responsibility for the planned activity reside with the awardees for
the project as a whole, although specific tasks and activities in
carrying out the activity will be shared among the awardees and NIDDK
Project Scientists.
The Steering and Planning Committee, composed of each of the Principal
Investigators of the CTCs, the Principal Investigator of the BCC, the
NIDDK Project Scientists, and the Chairman of the Steering and Planning
Committee, will be the main governing board of the study. This
committee will have the primary responsibility for developing the
common protocol (note the study protocol will be developed by the
vanguard CTCs and the BCC), facilitating the conduct of participant
follow-up, monitoring completeness of data collection and timely
transmission of data to the BCC, and reporting the study results. It
will also be responsible for establishing study policies in such areas
as access to patient data, ancillary studies, publications and
presentations, and performance standards. Each member of the Steering
and Planning Committee will have one vote (NIDDK Project Scientists
will have one vote between them), and all major scientific decisions
will be determined by a majority vote of the Steering and Planning
Committee. A Chairperson will be chosen from among the Steering and
Planning Committee members (but not one of the NIDDK Project Scientist
or Biostatistical Coordinating Center Principal Investigator), or
alternatively, from among experts in the field of urinary incontinence
who are not participating directly in the study. The vanguard CTCs and
the BCC have developed a study protocol for implementation by the
additional CTCs to be funded under this RFA. Subcommittees will be
established from among members of the full complement of CTCs and the
BCC on topics such as ancillary studies, publications and
presentations, quality control, recruitment, protocol adherence, among
others. An independent group of External Advisors, selected by the
Director, NIDDK, will review periodically the progress of the study.
This group will include experts in the relevant medical,
epidemiological, statistical, behavioral medicine, nursing, and ethics
fields who are not otherwise involved in the study. The External
Advisors will review the study protocol and evaluate results, monitor
data quality, participant safety, and provide operational and policy
advice to the Steering and Planning Committee and to the NIDDK
regarding the status of the study. One of the NIDDK Project Scientists
will serve as Executive Secretary of the group.
An Executive Committee comprised of the Steering and Planning Committee
Chairperson, the Principal Investigator of the BCC, and the NIDDK
Project Scientists also will be convened to effect management decisions
required between the Steering and Planning Committee meetings, as
needed for efficient progress of the cohort study. Each member of the
Executive Committee will have one vote (the NIDDK Project Scientists
are entitled to one vote between them). The Executive Committee will
report its actions to the Steering and Planning Committee on a regular
basis. Meetings of the Executive Committee will generally be by
conference call.
4) Arbitration
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between recipients and the NIDDK may be
brought to arbitration. An arbitration panel will be composed of three
members, one selected by the Steering and Planning Committee (with the
NIDDK member not voting) or by the individual awardee in the event of
an individual disagreement, a second member selected by NIDDK, and the
third member selected by the two prior selected members. This special
arbitration procedure in no way affects the awardee"s right to appeal
an adverse action that is otherwise appealable in accordance with the
PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45
CFR Part 16.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups
and their sub-populations 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 policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 1003-43).
All investigators proposing research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research" published in the NIH Guide for Grants
and Contracts on August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to provide
a description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable, and b) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
Because the prevalence of urinary incontinence in women is
substantially greater than in men and because treatment of urinary
incontinence is markedly different in men and women, participation in
the prospective cohort study planned under this initiative will be
restricted to women.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons
not to include them.
However, the NIDDK has determined that the urinary incontinence cohort
study proposed in this solicitation does not require inclusion of
children since the surgical techniques utilized for adult women are not
routinely used in the treatment of urinary incontinence among children,
and the etiology of urinary incontinence in children (male and female)
is substantially different from that in adult women so as to require a
separate cohort study.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained
within specified page limitations. Unless otherwise specified in an
NIH solicitation, Internet addresses (URLs) should not be used to
provide information necessary to the review because reviewers are under
no obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit, by December 7, 2000, a
letter of intent that includes a descriptive title of the proposed
research, name, address, and telephone number of the Principal
Investigator, identities of other key personnel and participating
institutions, and number and title of the RFA in response to which the
application may be submitted. 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 the
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, Digestive, and Kidney Diseases
6707 Democracy Boulevard
Room 653, MSC 5452
Bethesda, MD 20892-5452 (for express/courier service use 20817)
Telephone: (301) 594-8885
FAX: (301) 480-3505
APPLICATION PROCEDURES
Applications must be submitted on the standard research grant
application form PHS 398 (rev. 4/98). Application kits are available
at most institutional offices of sponsored research and may be obtained
from the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail:
GrantsInfo@nih.gov.
The RFA label in the form PHS 398 (rev. 4/98) 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. For purposes of identification
and processing, item 2 of the face page of the application must be
marked "YES" and the RFA number and the words "Urinary Incontinence
Treatment Network-Continence Treatment Centers" must be typed in.
The RFA label and line 2 of the application should both indicate the
RFA number. The RFA label must be affixed to the bottom of the face
page. Failure to use the label could result in delayed processing of
the application such that it may not reach the review committee in time
for review.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf format.
Submit a signed, typewritten original of the application, including the
checklist, and three signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (For express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive, and Kidney Diseases
6707 Democracy Boulevard
Room 653, MSC 5452
Bethesda, MD 20892- 5452 (for express/courier service use 20817)
Applications must be received by December 28, 2000. If an application
is received after this date it will be returned to the applicant
without review. The Center for Scientific Review (CSR) 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.
Information for Prospective Applicants
1. Information on the Web
A website will be established to contain questions of general interest
asked by prospective applicants and their answers. Prospective
applicants are encouraged to check this website frequently while
preparing an application. The website can be reached through the
following URL: http://www.niddk.nih.gov/fund/crfo/rfas.htm.
2. Information to be Included in Applications
Information on Patient Pool: Detailed information on the number, age,
race, ethnicity of women who have undergone surgery for urinary
incontinence during the past three years at the applicant institution
and any proposed satellite sites should be provided. Information on
the number of cases of new versus repeat surgical procedures in this
patient population must also be provided.
Characterization of Pharmacological and Behavioral Treatment Received
by Target Patient Population: The type of pharmacological treatment and
behavioral therapy utilized must be described, including the frequency
of their use as adjunctive to or prior to surgery for urinary
incontinence.
Previous Experience and Prior Participation in a Collaborative Program:
To promote the development of a collaborative program among the
awardees, the applicant should present evidence of prior experience in
working cooperatively with other institutions serving to recruit
patients into studies of urinary incontinence and similar multicenter
clinical studies and follow them long-term.
Institutional Support: There should be documentation of strong
institutional support for the study, including adequate space in which
to conduct clinic activities. An organizational structure for the study
should be set forth in the application, delineating lines of authority,
communication and responsibility for dealing with problems in all
general areas as well as stated willingness to follow the commonly
agreed upon protocol developed by the vanguard CTCs and the BCC.
Suggested Personnel Requirements: The staff of a CTC should include
urologists and urogynecologists with documented expertise in the
treatment of female urinary incontinence. The CTC team is anticipated
to include members who perform in roles similar to those cited below.
Members may be full or part-time and may serve in more than one
capacity, as appropriate. The application must describe the expertise
of key scientific, technical and administrative personnel and include a
mechanism for replacing key professional or technical personnel should
the need arise. The following suggested roles are intended to be
illustrative, not prescriptive:
o Principal Investigator to provide overall scientific guidance.
o Physician(s)/clinicians with expertise in the surgical,
pharmacological and behavioral management of patients with urinary
incontinence.
o Project Coordinator who can provide full-time attention to
administration and management of the cohort study.
o Individual(s) for clerical and technical support, including data
entry.
3. Budget Preparation by Year
Applicants must include an adequately justified year-by-year budget,
reflecting the major changes in the proposed activities as the study
progresses through its various phases. Note that budgets are NOT to be
prepared in modules.
Phase I (Months 1-42): The budget should reflect the level of effort
necessary to recruit the entire study cohort and perform baseline and
follow-up studies. Interim reports and manuscripts describing the
findings of the study will also be prepared.
Phase II (Months 43-48): The major activities of this phase are patient
close-out, collaboration with the BCC on analysis of the data, and
preparation of final reports and manuscripts.
The project will require meeting approximately every four months in the
Washington, D.C. area for each year of the study. The travel budget
should be estimated based on travel for the Principal Investigator, a
co-investigator and a Study Coordinator. Key personnel from satellite
centers may also be included in the travel budget.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR
and for responsiveness by the NIDDK. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
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, all
applications will receive a written critique and may undergo a process
in which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review
by the National Diabetes and Digestive and Kidney Diseases Advisory
Council.
Review Criteria
Applicants are expected to address issues identified under Information
To Be Included In Application. In the written comments, reviewers
will be asked to discuss the following aspects of the application in
order to judge the likelihood that the proposed research will have a
substantial impact on the goals of this solicitation. Each of the
criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score.
The design for the cohort study has been developed by the vanguard CTCs
and the BCC. Therefore, it is not necessary to provide a proposed
design in the grant application.
Review Criteria for Continence Treatment Centers
o Significance: The applicant must demonstrate an understanding of the
need for conducting a prospective cohort study of different surgical
procedures for urinary incontinence in women.
o Recruitment Capabilities: The major emphasis of this RFA is the
ability to recruit a large number of women who are candidates for
surgery for urinary incontinence and follow them prospectively post-
surgery. Recruitment of racial and ethnic minority women should be
described in detail. The importance of complete follow-up of study
participants and collection of high quality data should be considered.
The use of behavioral and pharmacological treatment prior to or after
surgery must be considered. Procedures for the maintenance of the
long-term participation of study subjects must be provided. The number
of surgical procedures for new and repeat procedures for urinary
incontinence must be described for the past three years.
o Investigator: This criterion will focus on the following questions:
Is there documented evidence of the investigator"s training and
experience relevant to the operation of a CTC for urinary incontinence
studies? Is there evidence of successful collaborative interactions
with other investigators under a common protocol in multi-center study?
o Environment: Does the clinical environment in which the work will be
done contribute to the probability of success? Is there evidence of
institutional support and commitment for the proposed program?
o Staff Qualifications: Documented specific competence and relevant
experience of professional, technical, and administrative staff
pertinent to the operation of a CTC and the ability to carry out
urinary incontinence treatment studies.
o Documented experience in surgical, pharmacological and behavioral
treatment for urinary incontinence is required. Demonstrated knowledge
of clinical aspects of urinary incontinence is also required.
o Resources: Documented adequacy of the proposed facility and space is
necessary. Evidence of institutional support and commitment is also
required.
o Data Management and Transmission: Adequacy of plans to ensure
complete, reliable, and timely transmission of the study data.
o Cooperative Experience: Evidence of prior experience in working
collaboratively to carry out a developed study protocol. Willingness
to work cooperatively in this study is required.
o Collaboration between Centers: For those applications proposing
collaborative efforts between two applicants from different
institutions to form a single CTC additional factors to be considered
would include the advantages of collaboration in terms of cost and
recruitment capabilities. The organizational/administrative plan for
such arrangements needs to be clearly delineated.
In addition to the above criteria, in accordance with NIH policy,
applications will also be reviewed with respect to the following.
o The reasonableness of the proposed budget.
o The adequacy of the proposed protection for humans or the
environment, to the extent they may be adversely affected by the
interventions proposed in the application. The initial review group
will also examine the safety of the research environment.
Schedule
Letter of Intent Receipt Date: December 7, 2000
Application Receipt Date: December 28, 2000
Special Review Committee: March/April, 2001
NIDDK Advisory Council: May, 2001
Anticipated Award Date: July 1, 2001
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit as determined by peer review
o Availability of funds
o Cost
o Geographic distribution
o The frequency and type of surgical procedures exhibited by a CTC
o Recruitment of racial and ethnic minorities
INQUIRIES
Written and telephone inquiries concerning this RFA are strongly
encouraged.
Direct inquiries regarding programmatic issues to:
John W. Kusek, Ph.D.
Clinical Trials Program Director or
Leroy M. Nyberg, Ph.D., M.D.
Urology Program Director
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 617
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
Fax: (301) 480-3510
Email: kusekj@extra.niddk.nih.gov
or nybergl@extra.niddk.nih.gov
Direct inquiries regarding fiscal and administrative matters to:
Trude Hilliard
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone: (301) 594-8859
FAX: (301) 480-3504
Email: hilliardt@extra.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 amended by Public
Law 99-158, 42 USC 241 and 285) and administered under Public Health
Service 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 Public Health Service strongly encourages all grant and contract
recipients to provide a smoke-free work place 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 routine
education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with
the Public Health Service mission to protect and advance the physical
and mental health of the American people.
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