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INTERSTITIAL CYSTITIS CLINICAL RESEARCH NETWORK (ICCRN) RELEASE DATE: September 17, 2002 RFA: DK-03-003 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) LETTER OF INTENT RECEIPT DATE: October 11, 2002 APPLICATION RECEIPT DATE: November 14, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites cooperative agreement applications for up to 10 Clinical Centers to participate in the development and conduct of randomized clinical trials to evaluate novel therapies in patients with interstitial cystitis as part of the Interstitial Cystitis Clinical Research Network (ICCRN). A Data Coordinating Center will be established to provide expertise in protocol development including sample size estimation, data analysis, quality control, and data management. The Data Coordinating Center will be established through a separate cooperative agreement Request for Applications. Ancillary studies will be developed by the ICCRN investigators to be conducted in conjunction with the clinical trials. The Clinical Centers and the Data Coordinating Center will work cooperatively to conduct clinical trials sequentially or concurrently. Because there is substantial commonality in the design and conduct of clinical trials for patients with interstitial cystitis and chronic prostatitis, or the chronic pelvic pain syndrome, applicants to this RFA are invited but not required to apply to a companion RFA also being released. The companion RFA, DK-03-004 titled, Chronic Prostatitis Clinical Research Network (CPCRN) is available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-03-004.html. Investigators from the ICCRN and the CPCRN will participate in an overarching organization, the Urological Chronic Pelvic Pain Syndromes Collaborative Group (UCPPSCG), The UCPPSCG will serve to improve the efficiency of protocol development, develop common definitions and criteria, and facilitate common data collection, to permit comparisons between the clinical trials and the individual disorders. This coordination is needed in key areas of protocol development including establishment of disease and enrollment criteria, outcome measures, and identification of therapies to be evaluated. RESEARCH OBJECTIVES Background Interstitial Cystitis is a chronic disorder, diagnosed primarily in women, characterized by pelvic pain associated with urinary frequency and urgency. Despite considerable effort the etiology of interstitial cystitis has not been established. Moreover, the treatment of interstitial cystitis remains sub-optimal. Despite the availability of a large number of purported treatments for interstitial cystitis there have been very few rigorously conducted randomized clinical trials to justify the use of many of these agents. The NIDDK has a longstanding interest in clinical and epidemiological research for interstitial cystitis and chronic pelvic pain disorders in men. In 1991 the Interstitial Cystitis Database (ICDB) study was initiated. The ICDB Study was a 5-year prospective cohort study of over 600 men and women with symptoms of urinary urgency, frequency, and pelvic pain. Reports have described the longitudinal changes of urinary symptoms, the impact of interstitial cystitis on quality of life, treatment patterns and the relationship between findings from bladder biopsies with patient symptoms. As a follow-up to the ICDB Study the NIDDK issued an RFA in 1997 to establish the Interstitial Cystitis Clinical Trials Group (ICCTG) to plan and conduct randomized controlled clinical trials of promising therapies for patients with interstitial cystitis. Two clinical trials have been conducted by the ICCTG; one used oral therapy while the other trial administered treatment intravesically. Ancillary studies of various biomarkers were developed and conducted in conjunction with this trial. The NIDDK now wishes to build on the work begun by the ICCTG and conduct additional clinical trials, either sequentially or concurrently, over a second 5-year period. The NIDDK-supported program, the Chronic Prostatitis Collaborative Research Network (CPCRN), was carried out over essentially the same time period as the ICCTG. The CPCRN enrolled nearly 500 men in a prospective cohort study and also conducted a randomized clinical trial in nearly 200 men. Over the course of the ICCTG and the CPCRN it has become apparent that there were similar approaches to conduct clinical trials for these two conditions, including development/use of validated symptom indices to measure response to treatment, the need for institutions to become referral centers for these conditions in order to achieve recruitment goals, and challenges to identify novel therapies that allow for rapid accrual of clinical trial participants. Thus, investigators responding to this research solicitation are encouraged to submit grant applications to the RFA for the Chronic Prostatitis Clinical Research Network (RFA DK-03-004). Successful applicants for these RFAs will work together as the Urological Chronic Pelvic Pain Syndromes Collaborative Group with the goals to shorten the period of protocol development for the two clinical trials groups, to collect common information to permit comparisons of the clinical characteristics of these two conditions, to develop clinically relevant definitions of the urologic chronic pelvic pain syndromes, to facilitate decisions on treatments to be evaluated, and to increase the rate of accrual of study participants. Organization of the Interstitial Cystitis Clinical Research Network The Interstitial Cystitis Clinical Research Network will be a cooperative network of up to 10 Clinical Centers, one Data Coordinating Center, and the Division of Kidney, Urologic and Hematologic Diseases. Clinical Centers are responsible for proposing and prioritizing protocols, participating in protocol development, conducting the trials, developing and participating in ancillary studies related to the trials, and disseminating research findings. All individual Clinical Centers are required to participate in a cooperative and interactive manner with one another and with the Data Coordinating Center in all aspects of the network. The Data Coordinating Center will support protocol development and provide sample size calculations, statistical advice, data analysis, data management and quality control, and coordinate the activities of the Steering Committee, and overall study coordination and quality assurance. Because the protocols to be implemented by the ICCRN will be developed cooperatively specific clinical trial and ancillary study designs are not called for in this RFA. A Steering Committee composed of the principal investigators of the Clinical Centers and the Data Coordinating Center and the NIDDK Project Scientist will be the main governing body of the ICCRN. Each Clinical Center, the Data Coordinating Center, and the NIDDK will have one vote. All major scientific decisions will be determined by majority vote of the Steering Committee. The Steering Committee will have primary responsibility for the general organization of the network, finalizing common clinical protocols, facilitating the conduct and monitoring of the studies, and reporting study results. Subcommittees of the Steering Committee will be established as necessary; for example it is envisioned that committees will be established for study design, forms development, ancillary studies, recruitment, publications and presentations, and others as necessary. An independent Data and Safety Monitoring Board (DSMB) will be established by the NIDDK from among experts in urology, urogynecology, biostatistics, behavioral medicine, nursing, and ethics. The DSMB will review the protocols prior to implementation and monitor patient safety and review protocol performance at least annually. As part of its monitoring responsibility the DSMB will submit recommendations to NIDDK regarding the continuation of each study and prepare a report for principal investigators to provide to their institutional review boards (IRBs). An overarching administrative structure for the ICCRN and the Chronic Prostatitis Clinical Research Network (to be funded under RFA DK-03-004), known as the Urological Chronic Pelvic Pain Syndromes Collaborative Group, will be created to coordinate the development of protocols for each of these networks and to facilitate comparative analyses of the clinical and demographic characteristics of the trial participants as well as outcomes. It is envisioned that at a portion of the Steering Committee meetings for the ICCRN and CPCRN will be held jointly. Objectives of research program: The objectives of the research program described in this RFA are to: 1) establish a collaborative group of clinical trial centers with clinical expertise in chronic pelvic pain, clinical pain management, and interstitial cystitis 2) design randomized controlled clinical trials to treat the symptoms associated with interstitial cystitis 3) develop and conduct ancillary studies, which will provide further understanding of interstitial cystitis 4) determine if there is a different response to therapy between newly diagnosed and chronic, long-term patients with the disorder 5) recruit sufficient numbers of patients with interstitial cystitis, including an adequate number of newly diagnosed cases, into these clinical trials 6) jointly work with other Interstitial Cystitis Clinical Research Network investigators, including the Data Coordinating Center, to analyze and interpret the results of the trials 7) participate in the Urological Chronic Pelvic Pain Syndromes Collaborative Group to facilitate the efficient conduct of clinical trials in both interstitial cystitis and chronic prostatitis 8) develop a clinically relevant definition of the urologic chronic pelvic pain syndromes, based on the clinical findings from these and other related clinical studies. MECHANISM OF SUPPORT This RFA will use the NIH U01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is July 1, 2003. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award" FUNDS AVAILABLE The NIDDK intends to commit approximately $3,200,000 in FY 2003 to fund up to 10 Clinical Centers in response to this RFA. This amount includes $700,000 for the trial-wide conduct of concurrent ancillary studies. An applicant should request a project period of up to 5 years and a budget for total costs of up to $320,000 per year. The costs should be divided as follows: $250,000 total costs per year to conduct the clinical trials and $70,000 total costs each year to be set aside for ancillary studies. The protocols for the ancillary studies to be conducted by the ICCRN will be developed collaboratively by the Steering Committee. Although the financial plans of the NIDDK 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. At this time it is not known if this RFA will be reissued. The NIDDK is committed to providing support to the Clinical Centers in relation to the number of participants randomized and followed-up. To that end, in Year 2 of the program support will be provided, in part, on a per-successfully-enrolled participant basis. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Principal investigators must be physicians with clinical expertise related to interstitial cystitis and/or chronic prostatitis and the urologic chronic pelvic pain syndrome of. Experience in recruiting interstitial cystitis patients into randomized clinical trials and successfully following them is essential. Principal investigators are encouraged to establish a multi- disciplinary team including expertise in such clinical areas as chronic pain management, behavioral medicine, and other chronic pelvic pain disorders. SPECIAL REQUIREMENTS The ability to recruit (and retain a high proportion) a sufficient number of patients into the clinical trials to be performed by the ICCRN is the most important requirement for a successful Clinical Center. It is projected that each Clinical Center will need to have the capacity to randomize 4-6 study participants each month beginning in year 2 of the program and continuing through year 4. It is likely that at least one of the clinical trial protocols will require newly diagnosed cases of interstitial cystitis, representing at least one-third of the overall participants to be recruited over the life of this program. A center must also participate in a collaborative and interactive manner to develop the study protocols (both clinical trial and ancillary studies) and carry out the trials/ancillary study protocols of the Interstitial Cystitis Clinical Research Network and must be willing to participate as a member of the Urological Chronic Pelvic Pain Syndromes Collaborative Group. Cooperative Agreement Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of the award. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, the NIH Grant Policy statement. The administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee 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 this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) 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 Scientist. 1) Awardees Rights and Responsibilities The awardee(s) will have lead responsibilities in all aspects of development and implementation of the clinical trial protocols, including any modification of study design, conduct of the trials and ancillary studies, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. Modification of protocols will be approved by the Steering Committee. Awardees will follow a common protocol and manual of procedures for all clinical trials and ancillary studies conducted under this RFA. Awardees will retain custody and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies, for a period of one year after completion of the trial. After that time the NIDDK expects that data will be made available to the broader scientific community via a Central Repository to be established by the NIDDK under a separate solicitation. The collaborative protocol and governance policies will call for the continued submission of data centrally to the DCC for a collaborative database; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical data and records of individuals. The NIDDK Project Scientist, on behalf of the NIDDK, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee. 2) NIH Staff Responsibilities The NIDDK will name a Project Scientist from within the Division of Kidney, Urologic and Hematologic Diseases whose function will be to assist the Steering Committee in carrying out the study. The Project Scientist will have substantial scientific-programmatic involvement in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordinating 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 Project Scientist. The NIDDK will have final approval of all protocols. The NIDDK will assign a separate program official to be responsible for stewardship of the awarded grants. The NIDDK reserves the right to terminate or curtail the trial (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which the NIDDK cannot concur, (d) reaching a major study endpoint substantially before schedule with persuasive statistical significance or, (e) human subject ethical issues that may dictate a premature termination. 3) Collaborative Responsibilities The Steering Committee, composed of each of the Principal Investigators of the DCC and the Clinical Centers, the NIDDK Project Scientist, and the Chairman of the Steering Committee, will be the main governing board of the trials. This committee will have the primary responsibility for approval of the common clinical trial and ancillary study protocols, recruitment of participants, facilitating participant follow-up, adherence to specimen collection and shipping, monitoring of completeness of data collection and timely transmission of data to the DCC, and reporting of study results. It will also be responsible for establishing study policies in such areas as ancillary studies, publications and presentation, and performance standards. Each member of the Steering Committee will have one vote and all major scientific decisions will be determined by a majority vote of the Steering Committee. A Chairperson will be chosen either from among the Steering Committee members (but not the NIDDK Project Scientist), or alternatively, from among experts in the field of urologic chronic pelvic pain syndromes who are not participating directly in the study. Subcommittees will be established for specific purposes as needed, such as for ancillary studies, publications and presentations, quality control, recruitment, protocol adherence, among others. Each Clinical Center awardee and the Data Coordinating Center awardee agree to the governance of the study through the Steering Committee. The Steering Committee voting membership shall consist of the Principal Investigators of the Clinical Centers and the Data Coordinating Center and the NIDDK Project Scientist. An organizational structure, the Urological Chronic Pelvic Pain Syndromes Collaborative Group, consisting of awardees for the Interstitial Cystitis Clinical Research Network and the Chronic Prostatitis Clinical Research Network (to be funded under RFA DK-03-004), will be established. The awardees agree to participate in this group to facilitate the efficient design and conduct of clinical trials for both interstitial cystitis and chronic prostatitis. Members of the Collaborative Group will include Clinical Center Principal Investigators of the ICCRN and the CPCRN, the Principal Investigator(s) of the Data Coordinating Center(s) for both of the networks, and the NIDDK Project Scientist. As members of the Urological Chronic Pelvic Pain Syndromes Collaborative Group investigators will hold joint Steering Committee meetings to facilitate use of common outcome measures and other data collection and to share data from their studies. They will also share a common Data and Safety Monitoring Board. 4) Establishment of a Data and Safety Monitoring Board The NIDDK will establish an independent Data and Safety Monitoring Board with expertise from a variety of disciplines, for example, urology, urogynecology, chronic pelvic pain, biostatistics, behavioral medicine, nursing and ethics. The DSMB will be advisory to the NIDDK and will have the responsibility for reviewing and approving protocols prior to implementation. The NIDDK Guidelines on DSMB can be found at the following URL: http://www.niddk.nih.gov/patient/patient.htm#policy. Once a trial has been initiated they will have responsibility for review of patient safety, adherence to the study protocol, and evaluation of interim and final results. A joint DSMB for the Interstitial Cystitis Clinical Research Network and the Chronic Prostatitis Clinical Research Network will be established. All protocols developed by the Steering Committee will be reviewed by the DSMB and the NIDDK Project Scientist for adequacy of plans for subgroup analyses based on gender and minority group. 5) Arbitration Any disagreement that may arise in scientific/programmatic matters (within the scope of the award), between award recipient and the NIDDK may be brought to arbitration. An arbitration panel will be composed of three members; one selected by the Steering 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 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, or the rights of NIDDK under applicable statutes, regulations and terms of the award. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: John W. Kusek, Ph.D. Clinical Trials 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) 594-7735 Fax: (301) 480-3510 Email: email@example.com 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: firstname.lastname@example.org o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard Room 752, MSC 5452 Bethesda, MD 20892-5452 Telephone: (301) 594-8885 FAX: (301) 480-3505 Email: email@example.com o Direct your questions about financial or grants management matters to: Teresa Farris Marquette Senior Grants Management Specialist Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Room 758, MSC 5452 Two Democracy Plaza 6707 Democracy Boulevard Bethesda, Maryland 20892-5452 Telephone: (301) 594-7682 FAX: (301) 480-3504 Email: firstname.lastname@example.org LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (For express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: 1) Recruitment and Retention Capabilities: The application should discuss the number of participants the Clinical Center anticipates will be recruited for protocols for the Interstitial Cystitis Clinical Research Network. For the purposes of this application and these studies the definition of interstitial cystitis will not be the NIDDK research definition but will be a clinical definition based on the clinical experience of the applicant. Each applicant should describe his/her clinical definition of interstitial cystitis. This definition should only include criteria that have been published in peer-reviewed journals. The application should provide evidence that the investigators are capable of randomizing 4-6 participants per month in years 2 through 4 of the program; one-third of these participants must be newly diagnosed cases. Applicants should describe the target population from which they expect to recruit the required number of subjects as study participants, and plans for recruitment of minorities, as required. The applicant should include a brief discussion of previous relevant research efforts. The applicant should also discuss in detail the recruitment strategies to procure the expected number of study participants. Specific plans for recruitment of minority participants must also be discussed. Projections on recruitment should be based on prior experience in clinical trials. Specific plans and previous experience in retaining randomized study participants for the duration of the clinical trial should also be documented. 2) Proposed Clinical Trial Concept: The general concept draft for a single randomized controlled clinical trial to be considered by the ICCRN should be included in the application. The general concept draft, which should not exceed two pages, must be consistent with the scientific focus of the RFA. Concept issues to be considered include identification of the intervention(s) and rationale, primary and secondary outcome measures, sample size estimate, and proposed subgroup analyses based on sex/gender and minority status. 3) Evidence of Institutional Support: There should be evidence of strong institutional support for the Clinical Center (CC), including adequate space in which to conduct clinical activities and office space for staff. An organizational structure for the CC should be set forth in the application, delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow commonly agreed upon protocols. The Principal Investigator should also indicate his/her willingness to and that of their institution to participate in a funding plan that reimburses for recruitment and follow-up on a per participant basis. 4) Ancillary Studies: It is not expected that the applicants propose specific ancillary studies to be conducted by the ICCRN. These studies will be developed and designed by the ICCRN Steering Committee. Any ancillary studies proposed in the application will not be reviewed or considered in the overall priority score. 5) Willingness to Collaborate in the Network and the Urological Chronic Pelvic Pain Syndromes Collaborative Group: The applicant should indicate willingness to participate in the Network as outlined in this solicitation, fully participate in the Steering Committee meetings and abide by its decisions, and indicate prior experience in collaborative, multi-center research. Investigators must also indicate willingness to participate in the Urological Chronic Pelvic Pain Syndromes Collaborative Group. 6) Use of a General Clinical Research Center: Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. 7) Per capita reimbursement: Applicants should indicate their willingness, and that of the institution involved, to discuss a financial arrangement for reimbursement on a per-participant basis (capitation) of operational costs for each trial. BUDGET Clinical centers should prepare a budget for each year of the five years of the program not to exceed $320,000 total costs (direct and facilities and administrative costs) per year; funds for operation of the Clinical Center must not exceed $250,000 total costs for each year. Applicants must set aside a total of $70,000 (total costs) each year for five years for ancillary studies. The funds for the ancillary studies should be included in the "other" budget category. The first 8 months of year 1 will be a period of intensive protocol development with monthly meetings of the Steering Committee to be held in the Washington, D.C. area. The total percent effort for the Principal Investigator and co-investigator during this period should be 40%. It is anticipated that recruitment for the first trial will begin in year 2. Applicants should budget for key personnel for study coordination and data entry. In budget year 2, restricted by the budget cap of $250,000 total costs for Clinical Centers, the NIDDK intends to fund the Clinical Centers under a plan to reimburse on a per randomized patient basis with infrastructure costs provided for key personnel to coordinate the trial and transmit data. Beginning in year 2 and for the duration of the program, applicants should budget for three meetings each year of the Steering Committee to be generally held in the Washington, D.C. area. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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 and 5 copies of appendix material, if warranted, must be sent to Chief, Review Branch at the address listed in the Where to Send Inquiries section. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and responsiveness by the National Institute of Diabetes and Digestive and Kidney Diseases. 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 National Institute of Diabetes and Digestive and Kidney Diseases in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score o Receive a second level review by the NIDDK National Advisory Council or Board. REVIEW CRITERIA Applicants are expected to address issues identified under the following sections in this RFA: SPECIAL REQUIREMENTS; SUBMITTING AN APPLICATION/SUPPLEMENTAL INSTRUCTIONS as well as the OBJECTIVES OF THE RESEARCH PROGRAM. All applications will be reviewed according to the criteria listed below. 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. o Patient access and study population o Study design o Qualifications and experience o Willingness to participate in the Network and the Urological Chronic Pelvic Pain Syndromes Collaborative Group o Institutional resources for patient care and follow-up Patient access and study population: The ability to recruit a sufficient number of patients into the trials is essential. It is anticipated that 4-6 study participants will need to be randomized each month for the first 4 years of the Network. At least one-third of the total must be newly diagnosed cases. Applicants must provide creditable estimates of the number of patients with interstitial cystitis that they could screen each month to evaluate eligibility, provide realistic estimates for rates of participation (randomization), and identify all sources of potential study participants. Based on previous experience, applicants must specify their track record in recruiting for clinical trials of interstitial cystitis or other urological chronic pelvic pain disorders, including their achieved recruitment for each trial, the percent of goal, and their rates of follow-up at the end of the trial. Proposed Clinical Trial Concept: A brief concept draft regarding a proposed clinical trial should be included in the grant application. The draft should include the intervention(s) and their rationale, primary and secondary outcome measures, sample size estimate, and a plan for subgroup analysis based on sex/gender and minority status. Qualifications and experience: The expertise, training, and experience of the investigators and staff in interstitial cystitis clinical trials and other urological chronic pelvic pain disorders, evidence of understanding of randomized multi-center trials, administrative abilities of the Principal Investigator, study nurse and/data coordinator and the level of commitment to the program for the effective function of the Interstitial Cystitis Clinical Research Network. Willingness and ability to participate in the Network and the Urological Chronic Pelvic Pain Syndromes Collaborative Group: Applicant institution's history of collaborative research, depth of commitment, willingness to randomize patients, and ability to work with other Network centers and NIDDK. The applicant must also be willing to work collaboratively with the Urological Chronic Pelvic Pain Syndromes Collaborative Group. Institutional resources for patient care and follow-up: Adequacy of institutional resources including personnel and space. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for participants in all clinical studies. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 11, 2002 Application Receipt Date: November 14, 2002 Peer Review Date: March/April 2003 Council Review: June 11-12, 2003 Earliest Anticipated Start Date: July 1, 2003 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 Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. It is expected that the Steering Committee will place data and biological specimens collected from the trial participants after a year from their completion in a public archive established by the NIDDK, which can provide protections for the data/specimens and manage their distribution for an indefinite period of time. To facilitate this transfer of data and biological specimens applicants will have to structure informed consent statements and other human subjects procedures given the potential for wider use of data and specimens collected under this award. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93-849 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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