Full Text DK-92-05 PHYSICIAN AND SCIENTIST TRAINING PROGRAM IN UROLOGIC RESEARCH NIH GUIDE, Volume 21, Number 15, April 17, 1992 RFA: DK-92-05 P.T. 44 Keywords: Urology Reproductive Disorders Hyperplasia Inflammation Pathophysiology National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 1, 1992 Application Receipt Date: August 6, 1992 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in cooperation with the American Foundation for Urologic Diseases (AFUD), invites applications for a pilot fundamental research training program in urologic sciences. Proposed programs are expected to provide postdoctoral research training in the basic biological sciences related to the urologic disorders of interest to the NIDDK. Surveys of institutional training programs supported by the NIH have shown that those programs that train physicians and post-doctoral Ph.D.s concurrently produce more productive graduates than programs designed exclusively for either clinicians or Ph.D.s. Thus, Program Directors will be responsible for designing and directing a urologic research training program that integrates the training of physicians and individuals holding a Ph.D. degree. Each program will provide research training both for physicians who have completed at least two years of surgical training in urology and for individuals holding the Ph.D. degree trained in basic science. The total program at an awardee institution will be supported by two separate but linked awards from the NIDDK and coordinated support from the AFUD. Research training for physicians with clinical training in urology will be supported through a Program Physician Scientist Award (K12) and post-Ph.D. research training in urologically related problems will be supported by a National Research Service Award (NRSA) Institutional Training Award (T32). The AFUD will provide supplementation to the stipends (trainees supported by T32s) and salaries (participants supported by K12s) according to the schedule given under "Description of Program" below. Clinical training programs will not be considered for support in this initiative. 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, Physician and Scientist Training Program in Urologic Research, is related to the priority area of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS The grantee institution must be a domestic university, medical school, or comparable institution with a strong, well-established program of research and training in areas related to urologic disease. To qualify for a K12 award, an institution must have an adequate number of highly trained faculty in clinical and basic science disciplines as well as the interest, capability, and commitment to provide guidance to clinically trained investigators in developing research independence. The individual to be trained (T32) must be a citizen or non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551 or I-151) at the time of appointment. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT The training programs will consist of two NIH award mechanisms, the K12 and the T32. The AFUD will make separate awards to those institutions holding the K12/T32 awards to supplement the salaries (K12 participants) and stipends (T32 trainees). Each training institution will submit a K12 application and a T32 application. An applicant institution will receive both awards or neither. Holding both a K12 and a T32 will enable each grantee institution to train both physicians (supported by the K12) and Ph.D. degree holders (supported by the T32). Responsibility for the planning, direction, and execution of the proposed program will be solely that of the applicant. The total project period for applications is five years. FUNDS AVAILABLE This program will support up to five institutions for a total funding of five T32 awards and five K12 awards. The number of awards made will depend on receipt of a sufficient number of applications of high scientific merit. Up to $600,000 (total costs) will be allocated to the support of this program in FY 1993, availability of funds permitting. RESEARCH OBJECTIVES Background The urologic diseases affect a significant portion of both the pediatric and adult populations. Progress in the understanding and treatment of these diseases is hampered by lack of a sufficient number of research scientists and research clinicians in these areas. Surveys have suggested that the combination of the long period of residency training required for board certification in Urology and the low stipends awarded for support in NRSA training programs constitute a major obstacle to recruiting and training urologists for research careers. To facilitate the recruitment of individuals into research training programs in urologic diseases, the DKUHD and the AFUD have developed a joint program to supplement the NIH support with designated funds from the AFUD. Areas for research training within this program are limited to those that fall within the primary responsibility of the NIDDK. These areas are broadly defined as: prostate growth control; prostate development including benign prostatic hyperplasia (BPH); chronic inflammatory urologic disorders such as prostatitis and interstitial cystitis; the basic science and clinical aspects of urolithiasis; physiology and pathophysiology of bladder function including voiding dysfunctions such as urinary incontinence, enuresis and vesicoureteral reflux; infections of the urinary tract; male sexual function and dysfunction including the basic aspects of testicular and epididymal function; and pediatric urology. Institutions, program directors, and individual applicants should contact the appropriate staff at the NIDDK to ensure that the areas of the proposed research training fall within the purview of the NIDDK. Goals of Program The goal of this pilot program is to ensure that investigators trained in the sciences basic to the urologic diseases will be available in adequate numbers in the appropriate research areas to meet the nation's needs for research in urologic disorders and diseases. Description of the Program 1. Training to be Supported: Candidates for the K12 must hold the M.D. or equivalent degree (e.g., D.O.), must have completed the general surgery requirement for urology, and should have two years of urologic surgery training. K12 participants are expected to spend a total of at least five years in the research training experience. The research training should be divided into two phases. Phase I will occur prior to the Chief Resident year and generally will consist of two years of uninterrupted training. During Phase I the participant will undertake course work, seminars, initial research experiences and other educational experiences necessary to initiate an intensive research program during Phase II. The Chief Resident year will generally separate Phases I and II and will not be supported by this program. The Program Director will be required to develop criteria for determining when a participant has successfully completed Phase I, and to provide an appropriately detailed Phase II research plan and protocol for administrative review and approval by NIDDK Staff. Holders of the Ph.D. and other research degrees will be considered candidates for support under the T32. The emphasis of the T32 will be to support specialized training in the basic sciences relevant to the study of the genitourinary tract and urologic disorders and diseases. 2. Program Requirements: The proposed Program Director should be designated as Program Director on both the T32 and K12 applications. He/she should be able to demonstrate scientific expertise, leadership and the administrative ability to coordinate and supervise an interdisciplinary research program of this scope. He/she should also be able to demonstrate a superior record of preparing clinical investigators for independent research in academic medicine. A committee consisting of representatives from the appropriate basic and clinical science departments must be established to advise the Program Director. Graduates of this program are expected to occupy positions in academic medicine and to be competitive for the R01 or R29 research grants of the NIH. The T32 training program must provide opportunities for individuals to participate in supervised basic research experiences related to urologic disorders, optimally in basic science departments. It is expected that Ph.D. trainees will generally receive two years of support on the T32 institutional grant. T32 trainees are required to pursue research training on a full-time basis, devoting at least 40 hours per week as specified by the sponsoring institution in accordance with its own policies. Teaching or other duties should be confined to those that are part of the research training. Each candidate appointed to the K12 must be essentially full-time (75-100 percent) and have a primary sponsor recognized as an accomplished investigator in basic science research to provide the necessary guidance for the candidate's development and research plan. In some instances the candidate may have a secondary clinical sponsor for the Phase II research-intensive years. Each year, the NIDDK will hold a steering and planning meeting with all Program Directors to discuss training programs' progress and any difficulties which may be associated with this new effort. Starting in year 02, these meetings will be expanded to enable T32 trainees and K12 participants to present initial results of their current research efforts. 3. Recruitment of Trainees (T32) and Participants (K12): Applications must include a well developed plan for the recruitment of women and individuals from minority groups under-represented in biomedical and behavioral research. A primary objective of the K12 will be to provide for five years of intensive full-time research training in urologic diseases for individuals who will have had two years of training in general surgery and two years of training in urologic surgery. It is important therefore, to establish a pool of candidates who are willing and able to commit themselves to five years of research training. A primary objective of the T32 is to recruit Ph.D. scientists into research in areas of urologic disorders. Thus, it is necessary that applicant institutions develop recruitment programs designed to meet the objective of increasing the number of basic scientists investigating urologic disorders. 4. NRSA Payback Requirement: Before trainees can be appointed to an NRSA training grant, they must sign an agreement that they will fulfill the NRSA payback requirement. Recipients agree to engage in biomedical research and/or teaching for a period equal to the period of NRSA support in excess of 12 months. Recipients must begin to undertake the obligated service on a continuous basis within two years after termination of NRSA support. Applicant organizational officials responsible for recruitment of T32 trainees should familiarize themselves with the terms of the service requirements and must explain them to prospective training candidates before or at the time an appointment at the institution is offered. 5. Length of Training Periods and Stipends/Salaries for this Program: The period of training for Ph.D. T32 trainees in this program will be two years with a third year possible under exceptional circumstances. The period of training for physicians will be five years on the K12 award. For physicians, the applicant institution must define a specific timetable for integration of the training requirements into the residency program. The proposed stipends/salaries are noted in the following example. In the example it is assumed that Ph.D.s have 0 years of postdoctoral experience at the beginning of their T32 support. K12 salary levels from the NIH may not exceed $50,000 annually based on the respective institutional determination or salary scale for persons of equivalent qualifications, experience, and rank. Information on other allowable costs associated with the T32 and K12 programs may be obtained from the general announcements of the T32 and K12 grant mechanisms referenced under SPECIAL REQUIREMENTS. The following example is of a program with two physicians supported by the K12 award and four Ph.D.s supported by the T32. PROGRAM TRAINEE/ (DEGREE) SUPPORTED SUPPORT FROM YEAR PARTICIPANT BY NIH AFUD 01 #1 (Ph.D.) T32 18,600 3,000 #2 (M.D.) K12 50,000 0 02 #1 (Ph.D.) T32 19,700 5,000 #2 (M.D.) K12 50,000 500 #3 (Ph.D.) T32 18,600 3,000 #4 (M.D.) K12 50,000 0 03 #2 (M.D.) Chief Resident Year #3 (Ph.D.) T32 19,700 5,000 #4 (M.D.) K12 50,000 500 #5 (Ph.D.) T32 18,600 3,000 04 #2 (M.D.) K12 50,000 5,500 #4 (M.D.) Chief Resident Year #5 (Ph.D.) T32 19,700 5,000 #6 (Ph.D.) T32 18,600 3,000 05 #2 (M.D.) K12 50,000 15,000 #4 (M.D.) K12 50,000 5,500 #6 (Ph.D.) T32 19,700 5,000 06* #2 (M.D.) K12 50,000 17,500 #4 (M.D.) K12 50,000 15,000 07* #4 (M.D.) K12 50,000 17,500 *Budgets for the 06 and 07 years are not to be included in the present applications. However, the narrative should include a description of the training experiences during those years. It is generally permissible for sponsoring institutions to supplement AFUD and NIH stipends/salaries from non-Federal funds. This program will support up to five institutions. In year 01, one M.D. participant and one Ph.D. trainee will be admitted; in year 02, one additional M.D. and one additional Ph.D. will be recruited for a total of four individuals in training per institution. In years 03 and 04, one Ph.D. trainee will be admitted each year. The Chief Resident year will not be supported by the K12. At the end of the program, it is expected that each program will have trained four Ph.D.s and two M.D.s. To accommodate this level of training activity, each application should request training slots as indicated in the above table. SPECIAL REQUIREMENTS Applications must meet all NIH requirements for the NRSA (T32) and K12 awards. Applications must request funding for five years; however, applicants should note that the training period for physicians supported by this program will generally cover a total of 6 calendar years for each participant, including one of clinical work not supported by this program. The narrative section of the K12 application must describe the entire training experience for such individuals even though the actual project period requested is only five years. In the event that a K12 award is not competitively renewed at the end of the initial five-year project period, it is the intention of the NIDDK, availability of funds permitting, to support the completion of each enrolled participant's program under an extension of the original terms of the award. For specific information on the T32 application format, applicants should request the announcement "National Research Service Awards for Institutional Training Grants (T32): Information Statement, October 1, 1990" and the booklet "Suggestions for National Service Award Institutional Training Grant Applications, NIDDK, 1991." Copies are available from Charles H. Rodgers, Ph.D. (see INQUIRIES below). For specific information on the K12 application, applicants should request from Dr. Rodgers the booklet, "K Awards." STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS. NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 in Sections 1-4 of the Research Plan AND summarized in Section 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 included in the application, the application will be returned. 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 will be 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, but not required, to submit a letter of intent to apply to this RFA. This letter should include the name, telephone number and mailing address of the Program Director, the names of other key personnel, the name of the applicant institution and the number and title of the RFA. Such a letter of intent is not binding and it will not enter into the review of any application subsequently submitted, not is it a necessary requirement for application. Letters of intent are requested solely for planning purposes. The NIDDK staff will not provide responses to such letters. Letters of intent to this RFA, must be received no later than June 1, 1992, and are to be addressed to: Dr. Robert D. Hammond Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 603 Bethesda, MD 20892 APPLICATION PROCEDURES Separate T32 and K12 applications must be submitted on form PHS 398 (rev. 9/91) following the guidelines for each specific type of award. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441; and from the program administrator named below. The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of each 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 RFA number: DK-92-05, must be typed on page 1, line 2a of each application form and the YES box must be marked. Submit a signed, typewritten original of each application, including the checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 ** At the time of the submission, two additional copies of each application must also be sent to: Dr. Robert D. Hammond Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 603 Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will undergo an initial review by an NIDDK Initial Review Group. The T32 and K12 applications will be reviewed according to the established review criteria for each type of award. These may be obtained from the announcement "National Research Service Awards for Institutional Training Grants (T32): Information Statement, October 1, 1990," and from "K Awards." Both documents may be obtained from the staff listed under INQUIRIES. In addition, the T32 and K12 applications from a given institution will be reviewed together to evaluate the proposed integration and overall quality of potential research experiences for preparing clinical and basic scientists to undertake careers in all areas of urologic research supported by the NIDDK. Subsequent to review by the Initial Review Group, applications will be reviewed by the NIDDK National Advisory Council. AWARD CRITERIA The anticipated date of award is July 1, 1993. The following will be considered in making funding decisions: o Quality of the proposed program as determined by peer review o Availability of funds o Program balance among all applications funded. Timetable For Review and Funding Letter of Intent Receipt Date: June 1, 1992 Application Receipt Date: August 6, 1992 Initial Review Group: October/November 1992 Advisory Council Review: January/February 1993 AFUD Review: February/March 1993 Start Date of Program: July 1993 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome: Inquiries regarding program issues may be directed to either of the following: Leroy M. Nyberg, Jr., Ph.D., M.D. Director, Urology Program National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7133 Fax: (301) 402-0223 Charles H. Rodgers, Ph.D. Director, Manpower and Training Programs National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-11 Bethesda, MD 20892 Telephone: (301) 496-7573 FAX: (301) 402-0223 Direct inquiries regarding fiscal matters to: Nancy Dixon Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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