Full Text DK-94-012 INTERSTITIAL CYSTITIS AND OTHER BLADDER DISORDERS OF WOMEN NIH GUIDE, Volume 23, Number 3, January 21, 1994 RFA: DK-94-012 P.T. 34, II Keywords: Urogenital System Infectious Diseases/Agents 0715123 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 15, 1994 Application Receipt Date: April 26, 1994 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in association with the Office of Research in Women's Health (ORWH), Office of the Director, NIH, solicits research grant applications for support of basic and clinical studies focused on the normal and abnormal function of the urinary bladder, specifically as it relates to the urinary bladder disorders of women: interstitial cystitis, urinary tract infections, urinary incontinence, and the basic bladder physiology of women. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Interstitial Cystitis and Other Bladder Disorders of Women, is related to the priority area of chronic debilitating illness. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed five years. The earliest possible award date will be September 30, 1994. FUNDS AVAILABLE For FY 1994, $2,500,000 will be committed by the NIDDK in association with the ORWH to fund applications submitted in response to this RFA. It is anticipated that 10 to 15 awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plan of the NIDDK the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The DKUHD/ORWH Women's Urological Health Initiative is committed to increasing research into the urological disorders that affect women's health. This request is part of that initiative. Women of all ages suffer from a disproportionately high rate of disorders of the urinary bladder. These disorders have many features in common: they are usually chronic; go through periods of remission and exacerbation; and have no universally effective strategy for cure, treatment, or prevention. Although there have been many speculative theories about the discrepancy between incidence of bladder disorders in females and males, there have been no well-documented research studies that focus on the basic science of the urinary bladder in females, the differences in development of the male and female bladders, extrinsic factors in early development that can affect adult urinary bladder dysfunction, the interrelationship between the most common urinary bladder disorders of women, i.e., interstitial cystitis, urinary tract infections, and urinary incontinence, and how the treatment of one disorder can affect the development of another disorder. Purpose The purpose of this RFA is to bring new and established investigators from diverse scientific and clinical areas into the study of women's urological disorders. Collaboration between basic science and clinical investigators in developing approaches to the study of the urinary bladder and its disorders in women is an emphasis of this solicitation. Applications are especially encouraged from basic science investigators in such diverse fields as biochemistry, molecular genetics, developmental biology, molecular and cellular biology, neurophysiology, immunology, nutrition, endocrinology, epidemiology, and pharmacology; and from clinical investigators in adult and pediatric urology, gynecology, infectious diseases, nephrology, endocrinology, psychology, and psychiatry. Applications from investigators currently funded for research in women's urological health are encouraged if the application addresses a new hypothesis. Applications to continue an existing funded project are not within the scope of this RFA. Examples of Research Areas The following are examples of research areas that are applicable to this RFA. It is emphasized that this list includes just a few of the topics that could be considered for investigation. It is anticipated that many of the successful applications will propose areas that are not included in this list. o The relationship between interstitial cystitis and recurrent urinary tract infections; epidemiological studies, effects of infection on the bladder epithelium and subsequent mucosal immunological abnormalities. o Intra- and intercellular communication in bladder tissues. o The molecular biology of bladder mucosa in the normal bladder, the developing bladder and in response to extrinsic factors. o Relationships between bladder epithelial and musculoskeletal tissues. o The urethra and the development of bladder disorders of women. o Comparative studies of molecular biology of bladder development, especially relating early extrinsic influences on latter bladder abnormalities. o The role of the pelvic musculature in normal and abnormal bladder function; its relationship to the frequency, urgency, and pain symptoms of interstitial cystitis. o The molecular biology and genetics of bladder urothelial turnover, factors that affect turnover, urothelial turnover in interstitial cystitis, and urinary tract infections. o Factors that affect the development of urinary incontinence. o Factors affecting solute and ion transport through bladder epithelium. o The relationship between vulvovestibulitis and other female urinary tract disorders. o Studies of the psychological effects of chronic bladder disorders, comparative studies of the various disorders. o The molecular biology of collagen synthesis in the normal and dysfunctional bladder. o The effects of pregnancy on the urinary bladder. o Ethnic and racial differences in bladder disorders of women. o Environmental factors in the development of interstitial cystitis and other bladder disorders. o Factors in the urine that affect normal bladder function. o Novel approaches to the treatment of interstitial cystitis. o Studies comparing the bladder with other organs such as the gut to elucidate bladder pathophysiology. o Pilot studies of clinical trials for the treatment of interstitial cystitis. Although this RFA is focused on bladder dysfunction in females, it does not preclude the study of male bladder function when it is used to enhance the understanding of female bladder function by comparative studies. For example, included in the scope of this RFA are: o studies that compare interstitial cystitis with chronic abacterial prostatitis, as a means of elucidating the pathogenesis of interstitial cystitis; o studies of differential hormone effects on the developing bladder of both sexes in relation to an adult female bladder disorder such as interstitial cystitis, urinary tract infections, or urinary incontinence. Studies of bladder cancer or malignant change of urothelial tissue are not acceptable for this RFA. Program project grant applications (PO1) are not suited to this RFA. SPECIAL REQUIREMENTS Annual meeting of NIDDK Women's Urological Health Investigators Applicants who receive an award through this RFA are encouraged to attend a yearly meeting (convened by the NIDDK) of investigators to discuss progress and exchange research information. Funds to support the travel to these meetings should be included in the proposed budget and can be in addition to other proposed travel. Diagnostic criteria for research studies on interstitial cystitis and other clinical disorders. In order to ensure that patient selection for clinical studies is uniform, the NIDDK has established Diagnostic Criteria for research studies on Interstitial Cystitis (IC). All grant applications for research on IC that use human subjects must state that the NIDDK IC Diagnostic Criteria for Research will be applied to patients selected for inclusion in the research study. The NIDDK research criteria have been published in the JOURNAL OF UROLOGY 142(1): 139, 1989 and the AMERICAN JOURNAL OF KIDNEY DISEASES 8(4) 353, 1989. The criteria may also be obtained from the Deputy Director, Urology Program, DKUHD, listed under INQUIRIES. This requirement does not preclude using subjects who do not meet the criteria for comparison studies, but those who do not meet the criteria must be specifically identified and designated as a study group. The Diagnostic Criteria for other urological diseases that are studied must also be defined in the research grant application. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Item 4 (Research Design and Methods) of the Research Plan AND summarized in Item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations; i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention [and preventive strategies], diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit by March 15, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of key personnel, the participating institutions, and the number and title of the RFA to which the application may be submitted. Such letters are requested for the purpose of obtaining an indication of the number and scope of applications to be received. The letter of intent is not binding, is not a requirement for submission, and does not enter into the review of the application. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The form is available from most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267. For developing programs that deal with clinical populations, applicants may wish to consider utilization of General Clinical Research Center (GCRC) facilities. More information on the GCRC program is available from Director, General Clinical Research Program, National Center for Research Resources, telephone (301) 594-7945. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent, under separate cover to: Dr. Robert Hammond Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by April 26, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, the staff will contact the applicant to determine whether it should be returned to the applicant, or held until the next regular receipt date and reviewed in competition with all other applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition if they are judged to be not competitive for the award. The NIDDK staff will notify the applicant and institutional official of this action. Those applications judged to be competitive will be further reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following this review, the applications will be given a second level review by the NIDDK Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally the same as those for unsolicited research grant applications: o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o if an application involves activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects. AWARD CRITERIA Funding decisions will be made based on the initial review group and national advisory council recommendations, program relevance and balance, and availability of funds. The anticipated date of award is September 30, 1994. INQUIRIES: Written and telephone 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: Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Disease Westwood Building, Suite 3A-05 Bethesda, MD 20892 Telephone: (301) 594-7556 FAX: (301) 594-7501 Inquiries regarding fiscal matters may be directed to: Ms. Trude McCain Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Disease Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: March 15, 1994 Application Receipt Date: April 26, 1994 Initial Review: June/July 1994 Second Level Review: September 1994 Anticipated Date of Award: September 30, 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |