RFA-HD-00-012: EPIDEMIOLOGIC RESEARCH ON FEMALE PELVIC FLOOR DISORDERS

Department of Health
and Human Services (HHS)

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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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