EPIDEMIOLOGIC RESEARCH ON FEMALE PELVIC FLOOR DISORDERS
Release Date: May 25, 2000
RFA: HD-00-012
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
Letter of Intent Receipt Date: August 25, 2000
Application Receipt Date: October 25, 2000
THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.
PURPOSE
The Center for Population Research (CPR) of the National Institute of Child
Health and Human Development (NICHD) seeks applications that address
epidemiologic research on female pelvic floor disorders with the purpose of
stimulating research that contributes to greater understanding of the
development of pelvic floor disorders (such as pelvic organ prolapse, urinary
incontinence, and fecal incontinence). In response to recommendations made at
the 1998 NIH-sponsored Workshop on Pelvic Floor Disorders, emphasis will be
placed on research that describes the natural history of pelvic floor
disorders, associated risk factors, and effectiveness of risk factor
modification for primary or secondary prevention of pelvic floor disorders.
It is anticipated that studies in these under-researched areas will provide
much needed information that will substantially advance our understanding of
the disease processes of pelvic floor disorders, and identify points at which
intervention directed at modifiable risk factors can effectively prevent the
development of pelvic floor disorders.
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 is related to one or more of
the priority areas. Potential applicants may obtain Healthy People 2010 at
http://www.health.gov/healthypeople.
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. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as Principal
Investigators.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) Research Project
Grant (R01) and NICHD Small Grant (R03) award mechanisms. Information and
application instructions for the NICHD Small Grant are available in the NIH
Guide for Grants and Contracts at:
http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html. Responsibility
for the planning, direction, and execution of the proposed project will be
solely that of the applicant. This RFA is a one-time solicitation. Future
unsolicited competing continuation applications will compete with all
investigator-initiated applications and will be reviewed according to customary
NIH peer-review procedures. The anticipated date of award is July 1, 2001.
Specific application instructions have been modified to reflect MODULAR
GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.
FUNDS AVAILABLE
The NICHD intends to commit approximately $2 million in total costs [direct
plus Facilities and Administrative (F&A) costs] in FY 2001 to fund six to
eight new grants in response to this RFA. For an R01 application, an
applicant may request a project period of up to five years and a budget for
direct costs of up to $250,000 per year. For an R03 application, an applicant
may request a project period of up to two years and a budget for direct costs
of $50,000 per year, support may be requested for $50,000 (direct costs) for
one year or $100,000 (direct costs) for two years.
Because the nature and scope of the research proposed may vary, it is
anticipated that the size of each award also will vary. Although the
financial plans of the NICHD provide support for this program, awards pursuant
to this RFA are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
RESEARCH OBJECTIVES
Background
The term pelvic floor disorders refers to a group of clinical conditions that
includes pelvic organ prolapse, urinary incontinence, and fecal incontinence,
and other sensory and emptying abnormalities of the lower urinary and
gastrointestinal tracts. It is estimated that one or more of these conditions
affects up to one-third of adult women. Almost 10 percent of women will
undergo surgery for urinary incontinence or pelvic organ prolapse during their
lifetime, and 30 percent of those having surgery will have at least two
surgeries to try to correct the problem. With the steady increase in the
population of older women, the national cost burden related to pelvic floor
disorders is large in terms of direct health care costs, lost productivity,
and decreased quality of life.
Little epidemiologic information on the prevalence and incidence of pelvic
organ prolapse exists, despite the fact that this disorder is one of the most
common indications for gynecologic surgery. Population-based epidemiologic
research on pelvic organ prolapse has been hampered by the lack of validated
survey instruments for assessing the prevalence or incidence of prolapse in
different populations. Tracking of surgical procedures related to prolapse at
least provides an estimate of those women who have required surgery. Prolapse
has been reported to be the most common indication for hysterectomy in women
older than 50 years and, in one report, accounted for 13 percent of
hysterectomies in all age groups. It is estimated that 500,000 surgical
procedures for prolapse are performed annually in the United States. This may
be a consequence of the relative lack of acceptable and effective non-surgical
treatments for prolapse and, thus, the lack of intervention until advanced
prolapse has occurred. There is no consensus as to a standardized threshold
for intervention, it is not known if the effectiveness of surgery is improved
if performed early in the course of disease, thus preventing further damage to
pelvic function or support, or if intervention is best performed only when
necessary to relieve symptoms.
Vaginal delivery has been consistently identified to increase the risk of
pelvic organ prolapse and other pelvic floor disorders, although clinical
conditions may not become apparent until many years after childbirth. There
is not a clear relationship between the number of vaginal deliveries and the
risk of pelvic floor disorders. The first delivery may carry the highest risk
for some types of pelvic floor damage, such as anal sphincter disruption,
there also may be a cumulative risk of damage with subsequent births that
contribute to the eventual development of a clinical pelvic floor disorder.
Damage at childbirth may directly or indirectly affect the pelvic muscles,
nerves, connective tissue, or some combination. Little is known about factors
that minimize damage at vaginal birth and allow maximum recovery to reduce the
risk of development of pelvic floor disorders in the future. The majority of
women who have delivered vaginally do not develop prolapse, even though
changes related to vaginal birth can be identified in most parous women. It
is not known in which women these changes will ultimately progress to the
development of a clinical disorder of pelvic function or support. Little is
known about different factors that influence the progression from asymptomatic
compensated state to symptomatic clinical condition.
Compared to the state of knowledge regarding pelvic organ prolapse, more
research on prevalence and incidence of urinary incontinence already has been
performed or is in progress. The reported prevalence of urinary incontinence
in adult women in the community varies from four percent to 41 percent,
depending on the definition of incontinence used and the population under
study. Many risk factors have been studied, including age, race, reproductive
history, obesity, medical illnesses, surgical history (particularly
hysterectomy), smoking, hormone use, and physical exercise. Little is known
about the potential effectiveness of intervention directed at modifiable risk
factors to prevent the subsequent development of urinary incontinence and
other pelvic floor disorders.
Even less is known about the prevalence and incidence of other, less common,
pelvic floor disorders such as fecal incontinence. Fecal incontinence
includes the involuntary and unwanted passage of gas, or of liquid or solid
stool. It is known that women who already have one pelvic floor disorder such
as prolapse or urinary incontinence are much more likely to suffer from fecal
incontinence as well, compared to women without other pelvic floor disorders.
Vaginal birth is a strong risk factor for anal sphincter damage and subsequent
fecal incontinence, particularly if midline episiotomy had been performed at
childbirth. However, many questions remain as to the prevalence of anal
sphincter damage, both occult and clinically recognized, at the time of
childbirth, with and without episiotomy use.
In December 1999, NICHD and other NIH Institutes sponsored a Workshop on
Terminology for Researchers in Female Pelvic Floor Disorders. During this
Workshop, recommendations were made for standardization of terminology
regarding definitions of the conditions included under the general term of
pelvic floor disorders, for definitions of outcomes after intervention, and
for minimum data set collection for research studies. All grant applications
related to pelvic floor disorders are required to use these standard terms.
Interested applicants should request a copy of the proceedings of the
Terminology Workshop from the program contact listed under INQUIRIES, below.
Research Scope
On September 28-29, 1998, the NICHD, in collaboration with the Office of
Research in Women"s Health, the National Institute on Aging, the National
Institute of Diabetes and Digestive and Kidney Diseases, and the Office of
Rare Diseases, held a workshop to examine the state of basic, epidemiological,
and clinical research addressing pelvic floor disorders. A consensus emerged
that underscored the lack of a substantive knowledge base that defined
epidemiological parameters of pelvic floor disorders. Such information was
deemed critical to elucidating the multifactorial etiology of pelvic floor
disorders, and guiding new strategies for prevention and treatment of pelvic
floor disorders.
The goals of this RFA are to stimulate research related to the natural history
of pelvic floor disorders, associated risk factors, and effectiveness of risk
factor modification for primary or secondary prevention of pelvic floor
disorders. Examples of research areas deemed important for developing this
knowledge base and beyond include, but are not limited to, the following:
o The natural history of pelvic floor disorders, particularly pelvic organ
prolapse and anal incontinence, including prevalence, incidence, and
resolution of pelvic floor disorders over time.
o The promoting, intervening, and decompensating factors involved in the
transition between normal pelvic floor structure and function, latent injury,
and symptomatic condition. Age-related changes in tissue integrity, muscle
strength, and nerve function that may affect the development of pelvic floor
disorders.
o The role of specific events of the labor and delivery process in the
development of pelvic floor disorders, which may include nerve damage,
muscular damage, and/or direct tissue disruption.
o Risk factors (particularly potentially modifiable risk factors) associated
with initial development of pelvic floor disorders, and with recurrence of
pelvic floor disorders after non-surgical and surgical treatment. These may
include race, socioeconomic status, the impact of lifestyle, such as
occupational and recreational activities, presence or absence of comorbid
conditions, such as chronic lung disease, smoking, menopause, hormone use,
obesity, constipation and the effect of chronic excessive straining, previous
surgery such as hysterectomy, and other factors.
o The feasibility and effectiveness of risk factor modification for primary or
secondary prevention of pelvic floor disorders.
Because this list is not meant to be all-inclusive, prospective applicants are
encouraged to discuss their ideas for applications with the program staff
listed under INQUIRIES. In addition, prospective applicants are encouraged to
review information related to studies currently funded by NIH to avoid
unnecessary duplication. Information on funded projects is available at
http://crisp.cit.nih.gov/.
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 subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 103-43).
All investigators proposing research involving human subjects should read the
NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research, published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March
18, 1994, and available on the Internet at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
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.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects, published in the NIH Guide for Grants and
Contracts, March 6, 1998, and available on the Internet at:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLs IN NIH GRANT APPLICATIONS AND 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 a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other 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 NICHD staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent to the program staff listed under INQUIRIES
by August 25, 2000.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms are available at most institutional
offices of sponsored research, on the Internet at
http://grants.nih.gov/grants/funding/phs398/phs398.html, and 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.
As noted under RESEARCH OBJECTIVES, above, all grant applications related to
pelvic floor disorders are required to use the standard terminology as
recommended at the NIH Terminology Workshop for Researchers in Female Pelvic
Floor Disorders held in December 1999. All prospective applicants should
request a copy of the proceedings of the Terminology Workshop by contacting
Anne M. Weber, M.D., M.S. at the address listed under INQUIRIES, below.
Applications not conforming to these guidelines will be considered
unresponsive to this RFA and will be returned to the applicant without further
consideration.
Application Instructions for NICHD Small Grant (R03) Applications
The small grant (R03) research mechanism should be used for support of pilot
studies and/or exploration of novel hypotheses and strategies that are sound
and justifiable, but not sufficiently developed for the R01 mechanism. A
description of the NICHD Small Grants Program and complete application
instructions are available from the program contact listed under INQUIRIES and
on the Internet at
http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html. These applications
must be submitted according to the Modular Grant application instructions
included in the NICHD Small Grant program announcement.
Modular Grant Application Instructions for Research Project Grant (R01)
Applications
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The JUST-IN-
TIME concept allows applicants to submit certain information only when there
is the possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers, and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period. Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form Page.
o Under Personnel, list all project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus F&A costs) for each year, each rounded to the nearest $1,000. List the
individuals/organizations with whom consortium or contractual arrangements
have been made, the percent effort of personnel, and the role on the project.
Indicate whether the collaborating institution is foreign or domestic. The
total cost for a consortium/contractual arrangement is included in the overall
requested modular direct cost amount. Include the Letter of Intent to
establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm.
- Complete the educational block at the top of the Form Page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years,
- List selected peer-reviewed publications, with full citations.
o CHECKLIST: This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied in
the calculation of the F&A costs for the initial budget period and all future
budget years.
o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
Submission Instructions
The RFA label available in the PHS 398 (rev. 4/98) application form must be
stapled to the bottom of the face page of the application and must display the
RFA number HD-00-012. A sample RFA label is available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is
in the pdf format. 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 2 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:
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 should be
sent to:
L.R. Stanford, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Bethesda, MD 20852 (for express/courier service)
Telephone: (301) 496-9254
Applications must be received by October 25, 2000. If an application is
received after that 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. The
CSR 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 already reviewed, but such applications must include
an introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness to the RFA by NICHD staff. 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 NICHD 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 will be discussed, assigned a priority score, and receive a
second level review by the National Advisory Child Health and Human
Development Council (NACHHD).
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. 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 pursuit of these goals. Each of these
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. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that drive
this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the Principal Investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications also will be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects also will be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
SCHEDULE
Letter of Intent Receipt Date: August 25, 2000
Application Receipt Date: October 25, 2000
Peer Review Date: January-February 2001
Council Review: June 2001
Earliest Anticipated Start Date: July 1, 2001
AWARD CRITERIA
Award criteria that will be used to make award decisions include scientific
merit (as determined by peer review), availability of funds, and programmatic
priorities.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Anne M. Weber, M.D., M.S.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13C, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6972
FAX: (301) 480-1972
E-mail: webera@mail.nih.gov
Direct inquiries regarding fiscal matters to:
Mr. Michael J. Loewe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17J, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (Express Mail)
Telephone: (301) 435-7008
FAX: (301) 402-0915
E-mail: ml70m@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.864, Population Research. Awards are made under authorization of Sections
301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284)
and administered under NIH grants policies and Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. 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 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
routine 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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