Full Text DK-95-007 BASIC AND EPIDEMIOLOGIC RESEARCH RELATED TO DISORDERS OF THE URINARY BLADDER NIH GUIDE, Volume 24, Number 12, March 31, 1995 RFA: DK-95-007 P.T. 34 Keywords: Epidemiology Urogenital System Etiology Pathophysiology National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Date: June 13, 1995 Application Receipt Date: August 10, 1995 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD), of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), solicits grant applications for support of basic research studies focused on the pathophysiology of normal and abnormal urinary bladder function in females and epidemiologic studies on the etiology and risk factors for interstitial cystitis. 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 RFA, Basic Research Related to Disorders of the Urinary Bladder, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). Women's Urological Health Initiative The DKUHD Women's Urological Health Initiative is committed to increasing research on interstitial cystitis and other urological disorders that affect women's health. This request is part of that initiative. 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 or local governments, and eligible agencies of the Federal Government. Foreign institutions are not eligible for FIRST (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Competitive renewal applications and amended applications from previous RFAs are eligible for this RFA if the content fits within the scope of this RFA. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01) and FIRST (R29) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date will be March 1, 1996. The maximum dollar request for R01s is limited to $160,000 in direct costs for the initial budget period. The maximum dollar request for R29s is $350,000 direct costs for five years with a maximum of $100,000 for any one year. FUNDS AVAILABLE For FY 1996, $1.2 million will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that seven to nine awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. 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 Women of all ages suffer from a disproportionately high rate of disorders of the urinary bladder. There have been very few well-documented research studies that focus on the basic science of the urinary bladder, the differences between the development of the bladder in both sexes, extrinsic factors in early development that can affect adult urinary bladder dysfunction, and the anatomy and physiology of the pelvis and its supporting structures and the effect on bladder function. Purpose The purpose of this RFA is to bring new and established investigators from diverse research areas into the study of the pathophysiology of normal and abnormal urinary bladder function, the etiology of interstitial cystitis and the epidemiology of interstitial cystitis. Collaboration between basic science and clinical science investigators in developing approaches to the study of the urinary bladder is encouraged. 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, uro-gynecology, infectious diseases, nephrology, endocrinology, psychology and psychiatry. Applications from currently funded investigators are encouraged if they address new hypotheses. Competitive renewal applications of active grants are also within the scope of this RFA. Examples of Research Areas The following are examples of the basic research areas that are applicable to this RFA. It is emphasized that this list includes just a few of the topics which could be considered for investigation. It is anticipated that many successful applications will propose areas that are not included in this list. o Intra- and intercellular communication in bladder tissues. o The biochemistry of collagen in the bladder and in the pelvic supporting structures of the urinary bladder. o The molecular biology of bladder mucosa in the normal bladder, the developing bladder and in response to extrinsic factors. o Stromal-epithelial interactions in bladder development and dysfunction. o Normal and abnormal developmental biology of the urinary bladder. o The role of the pelvic musculature in normal and abnormal bladder function. o Growth factors and bladder pathophysiology. o The effects of pregnancy on the urinary bladder. o Ethnic and racial differences in bladder pathophysiology. o Factors in the urine that affect normal bladder function. o Studies comparing the bladder with other organs, such as the gut, to elucidate bladder pathophysiology. The following are examples of a few epidemiologic studies related to interstitial cystitis that are relevant (responsive) to this RFA: o Relationships between interstitial cystitis and other disorders of the urinary bladder. o Case-control studies comparing interstitial cystitis with control groups to detect possible risk factors. o Studies that compare interstitial cystitis and chronic abacterial prostatitis. 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 through comparative studies. Basic research studies on the bladder do not have to address any specific disease process or disorder. Studies NOT applicable to this RFA include: o Studies of bladder cancer or malignant change of urothelial tissue. o Studies of the clinical treatment of bladder diseases. o Epidemiological studies of other bladder disorders that do not include interstitial cystitis. o Program project grant applications (PO1). SPECIAL REQUIREMENTS Annual meeting of NIDDK Women's Urological Health Investigators Applicants who receive an award through this RFA are expected 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 may be included in the proposed budget and can be in addition to other proposed travel. Diagnostic Criteria for Research Studies on Interstitial Cystitis. 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 Urology Program, DKUHD, as indicated in INQUIRIES below. 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 distinct study group. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS 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 is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS Volume 23, Number 11, March 18, 1994. Investigators may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by June 13, 1995 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 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 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 and Digestive and Kidney Diseases 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8886 FAX: (301) 480-3505 Email: hammondr@ep.niddk.nih.gov 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; 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; and from the program administrator listed under INQUIRIES. 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 the National Center for Research Resources, telephone: (301) 594-7945. The RFA label available in the PHS 398 application form must be affixed to the face page of the application. 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 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: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building Room 6As-37F 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Applications must be received by August 10, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) 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 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, but such applications must include an introduction addressing the previous critique. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the DRG for completeness and by the NIDDK for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIDDK staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. 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, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be notified. Review criteria 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 adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects (if applicable) will also be evaluated. o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or that provide augmentation of existing U.S. resources. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA The anticipated date of award is March 1, 1996. Funding decisions will be made based on the scientific merit as determined by initial review; availability of funds; and programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify and issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ralph L. Bain, Ph.D. or Leroy M. Nyberg, Jr. Ph.D., M.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER Drive MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 EMail: nybergl@ep.niddk.nih.gov bainr@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Trude McCain Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER Drive MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8859 FAX: (301) 480-3504 EMail: mccaint@ep.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 last 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. The PHS strongly encourages all grant and contract 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 routing 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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