RFA-DK-01-018: URINARY INCONTINENCE TREATMENT NETWORK: CONTINENCE TREATMENT CENTERS

Department of Health
and Human Services (HHS)

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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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