PHYSICIAN AND SCIENTIST TRAINING PROGRAM IN UROLOGIC RESEARCH NIH GUIDE, Volume 26, Number 37, November 7, 1997 RFA: DK-98-005 P.T. National Institute of Diabetes and Digestive and Kidney Diseases American Foundation for Urologic Diseases Letter of Intent Receipt Date: February 11, 1998 Application Receipt Date: March 11, 1998 PURPOSE To meet the demand for adequate numbers of skilled investigators in urology, 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 the continuation of a joint program for research training in urology. Each applicant will submit an application for training basic medical scientists in biological sciences related to urologic diseases of interest to the NIDDK and an application for training physicians for a future in urology research. Clinical training programs will not be considered 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. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-512-1800). ELIGIBILITY REQUIREMENTS Only domestic, non-profit, private or public institutions may apply for this program. The applicant institution must be able to demonstrate possession of the staff and facilities required for the proposed program. The training program director at the institution will be responsible for the selection and appointment of the trainees and the overall direction of the program. Except as otherwise stated in this RFA, awards will be administered under Public Health Service grants policy as stated in the PHS Grants Policy Statement. To be eligible for consideration under this RFA, each applicant institution must submit two applications: one for the training of Ph.D. basic scientists (T32), and a separate one for the training of physician scientists (K12). Each application must be complete and the two applications must be submitted as a single package. If the two application are not submitted, the application will be considered incomplete and will be returned without review. Basic science trainees must be citizens or non-citizen nationals of the United States or must have been lawfully admitted for permanent residence (i.e., have possession of a currently valid Alien Registration Receipt Card I-551 or I-151, or be in possession of other legal verification of such status). Postdoctoral trainees on National Research Service Award (NRSA) Institutional Training Grants (T32) must have at the beginning of the appointment a Ph.D. or comparable doctoral degree in science from an accredited domestic or foreign institution. These candidates are expected to spend at least two years in the training experience. For purposes of this RFA only, candidates who possess a clinical degree (M.D., D.O., D.D.S., D.V.M.) would not be eligible for appointment on this T32. NRSA-supported training is limited to three years without a waiver issued by the awarding unit. An information pamphlet concerning requirements for Institutional Training Grants may be obtained by calling Ask NIH, 301-710-0267, or you may obtain information on the internet: https://grants.nih.gov/training/careerdevelopmentawards.htm. Postdoctoral NRSA trainees must sign a payback agreement form (PHS form 6031) in the first 12 months of support. One month of obligation is incurred for each month of support. The 13th and subsequent months of NRSA support do not incur further obligation and are considered acceptable payback service for the prior 12 months of support. Physician scientist trainees must hold the M.D. or equivalent degree (D.O.), must have completed the general surgery requirement for urology and ideally should have two years of urologic surgery training. These candidates are expected to spend at least three years but may spend up to five years in the training experience. Candidates appointed under this program must be U.S. citizens or non-citizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. All other eligibility requirements appertaining to candidates for a Mentored Clinical Scientist Development Award apply. An information pamphlet concerning the K12 may be obtained by calling AskNIH, 301-710-0267, or you may use the internet: https://grants.nih.gov/training/careerdevelopmentawards.htm. Appointment of women and minority groups underrepresented nationally in the biomedical and behavioral sciences are encouraged. The following groups have been identified as underrepresented nationally in the biomedical and behavioral sciences: African Americans; Hispanics; Native Americans; Alaskan Natives; and Pacific Islanders. Candidates for appointment, Ph.D. or M.D. (D.O.), may not hold nor apply concurrently for any other PHS research project grant at the time of appointment to the T32 or the K12. MECHANISM OF SUPPORT The training programs will combine two NIH award mechanisms, the NRSA T32 grant and the Mentored Clinical Scientist Development Program Award (K12). Supplemental funding to the T32 and K12 awards will be provided by AFUD. All conditions pertaining to appointments on these award mechanisms must be met. Each training institution must submit a T32 application and a K12 application to train Ph.D. and M.D. degree holders. Those holding basic research degrees will receive training on the T32 while those holding the M.D. will receive training on the K12. Although the basic concept of this program requires integration of training experiences across the two support mechanisms, the emphasis of the NRSA is to develop specialized programs for training in basic sciences relevant to the study of the genitourinary tract and urologic disorders and diseases. Those supported by the K12 will have clinical training and will have demonstrated research promise in urology. The K12 enables the candidate to undertake a program of formal course work and also investigate a well defined basic science problem under the sponsorship of a senior investigator in that area. The program is intended to facilitate the transition from supervised research training to a career as an independent investigator. 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. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. Future unsolicited continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. If the NIDDK determines that there is a sufficient continuing program need, a new request for applications will be announced. The total project period for applications submitted in response to the present RFA should be for five years. The anticipated award date is September 30, 1998. FUNDS AVAILABLE For FY 1998, $600,000 in total direct costs for year 01 will be committed. It is anticipated that up to four awards will be made. This level of support depends on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. Each new applicant should request one trainee on the T32 and one trainee on the K12 for year 01, and two for each grant mechanism for years 02 through 05. Competing continuation applications should request two trainee positions on each of the two grant mechanisms for years 06 through 10. RESEARCH OBJECTIVES The urologic diseases affect a significant portion of both the pediatric and adult population. Progress in the understanding and treatment of these diseases is hampered by the lack of a sufficient number of research scientists and research clinicians in these areas. Surveys demonstrate that an obstacle to recruiting and training urologists for research in urologic diseases is the combination of the long period of residency training required for board certification in Urology, and the low stipend awarded for support in NRSA and career training programs. To facilitate the recruitment of individuals into research training programs in urologic diseases, the DKUHD and the AFUD have developed the present program to supplement the NIH support with designated funds from the AFUD. Areas for research training within this program are limited to those which fall within the primary responsibility of the NIDDK. These areas are broadly defined as: prostate growth control and development including BPH; chronic inflammatory urologic disorders such as prostatitis and interstitial cystitis; the basic science and clinical aspects of urolithiasis; the physiology and pathophysiology of bladder function including voiding dysfunctions as in 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 should there be any question of research areas falling within the purview of the NIDDK. A primary objective of the K12 program is to provide for a continuous period of intensive full-time research training in urologic diseases for individuals who have two years of training in general surgery and two years training in urologic surgery. It is important to establish a pool of candidates who are willing and able to commit themselves to an additional period of research training. A primary objective of the T32 is to recruit Ph.D. scientists into research in areas of urologic disorders. It is necessary that institutions develop recruitment programs designed to meet the objective of increasing the number of basic scientists investigating urologic disorders. Applicant institutions must include a well developed plan for the recruitment of women and individuals from underrepresented minority groups in biomedical and behavioral research. SPECIAL REQUIREMENTS The NRSA training program must provide opportunities for individuals to participate in supervised research in urologic disorders at the post-Ph.D. level. Programs must be able to provide state-of-the-art training experiences relevant to urologic disease research in basic science departments. As noted elsewhere in this announcement, trainees should receive at least two years of support on the T32. Candidates for the Mentored Clinical Scientist Development Program grant must hold the M.D. or equivalent degree (D.O.), have completed general surgery required for urology and have two years of specialty surgery training. These candidates, as noted, are expected to spend a minimum of three years in training. It is understood that if a trainee opts for a five-year training experience, that the trainee will take a year off to complete his/her Chief Resident year. Subsequent to the Chief Resident year, the individual may once again be appointed to the K12 grant. The grantee institution must be a medical school or comparable institution with a strong, well established research and training program in areas related to urologic disease, have adequate numbers of highly trained faculty in clinical and basic science disciplines, have a record of providing postdoctoral training, and have the interest, capability and commitment to provide guidance to clinically trained individuals in the development of research independence. The Program Director 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 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 be competitive for the NIH R01 research grant. Applicants should provide a statement in the application giving permission to DKUHD staff to share their application and Summary Statement with program officials of AFUD. Only grants being considered for funding would be shared with AFUD officials. This is necessary in view of the unique funding relationship between the DKUHD and AFUD in continuing the present training program. Supplemental funding by AFUD will be direct to the participating institution and will not incur indirect cost allowances by the NIH. Proposed stipends for the training program are noted in the following example. In the example, it is assumed that Ph.D.s have 0 years of postdoctoral experience at year 01 of the NRSA award, and that the M.D. trainee opts for five years of training. Salary levels on the Mentored Clinical Scientist Program Award may not exceed $50,000/year based on the respective institutional determination or salary scale for persons of equivalent qualifications, experience and rank. Other allowable costs associated with the two programs may be obtained from the relevant program information pamphlets. The following example is for a new program with two M.D. and four Ph.D. trainees: YEAR SLOTS DEGREE AWARD NIH* AFUD 01 1 Ph.D.#1 T32 $20,292 $3,000 01 1 M.D.#1 K12 $50,000 0 02 1 Ph.D.#2 T32 $20,292 $3,000 02 1 Ph.D.#1 T32 $21,420 $5,000 02 1 M.D.#1 K12 $50,000 $500 02 1 M.D.#2 K12 $50,000 0 03 1 Ph.D.#1 T32 $25,600 $5,000 03 1 Ph.D.#2 T32 $21,420 $5,000 03 1 Ph.D.#2 K12 $50,000 $500 03 1 M.D.#1 Chief Resident Year 04 1 Ph.D.#2 T32 $25,600 $5,000 04 1 Ph.D.#3 T32 $20,292 $3,000 04 1 M.D.#1 K12 $50,000 $5,500 04 1 M.D.#2 Chief Resident Year 05 1 Ph.D.#3 T32 $21,420 $5,000 05 1 Ph.D.#4 T32 $20,292 $3,000 05 1 M.D.#1 K12 $50,000 $15,000 05 1 M.D.#2 K12 $50,00 $5,500 06 1 M.D.#1 K12 $50,000 $17,500 06 1 M.D.#2 K12 $50,000 $15,000 07 1 M.D.#2 K12 $50,000 $17,500 * All stipends paid under a T32 will conform to the standard NRSA stipend schedule in effect at the time. Values shown are current as of the publication of this RFA. Maximum salary allowance under the K12 is currently $50,000 plus fringe benefits annually. It is permissible for sponsoring institutions to provide additional funds to AFUD and NIH stipends from non-federal funds. You may wish to consult Dr. Charles H. Rodgers (301-594-7717) for further information on salary compensation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by February 11, 1998, a letter of intent that includes a descriptive title of the proposed research; the name, address and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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 Drive, Room 6AS-37F, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of 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 2 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, plus three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DR, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 BETHESDA, MD 20892-6600 Applications must be received by March 11, 1998. 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 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. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria T32 Applications: o Past research training record for both the program and the designated preceptors in terms of the success of former trainees in establishing independent and productive research careers; o Past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further development; o Objectives, design, and direction of the research training program; o Caliber of preceptors as researchers including successful competition for research support; o Training environment including the institutional commitment, the quality of the facilities, and the availability of research support; o Recruitment and selection plans for appointees and the availability of high quality candidates; o The record of the research training program in retaining health- professional postdoctoral trainees for at least two years of research training or other research activities; o When appropriate, the concomitant training of health- professional postdoctorates (e.g., individuals with the M.D., D.O.) with basic science postdoctorates (e.g., individuals with a Ph.D., SC.D.) will receive special consideration. K12 Applications: o The experience and success of the Program Director in managing career development programs; o The plans for selection and recruitment of clinical candidates with the potential to develop as an independent investigator; o For renewal applications, the research career path of candidates who have terminated support under this award within the past five years; o Likelihood that the career development plan will contribute substantially to the scientific development of the candidates; o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates; o Usefulness of the research plans as a vehicle for developing the research skills as described in the career development plan; o Scientific and technical merit of the research questions, design and methodology; o Appropriateness of the faculty mentor's research qualifications in the area(s) of this application; o Quality of the environment for scientific and professional development; and o Applicant institution's commitment to the appropriate balance of research and clinical responsibilities. AWARD CRITERIA The anticipated date of award is September 30, 1998. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by the initial review group. The following will be considered in making funding decisions. o Quality of the proposed training programs as determined by the initial review group; o Availability of funds; and o Concurrence of AFUD in funding those whose scientific ratings exceed the minimal funding criteria. Schedule Letter of Intent Receipt Date: February 11, 1998 Application Receipt Date: March 11, 1998 Review by Advisory Council: September 1998 Anticipated Award Date: September 30, 1998 INQUIRIES 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: Charles H. Rodgers, Ph.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 Email: [email protected] Leroy Nyberg, 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) 594-7718 Email: [email protected] Direct inquiries regarding fiscal and administrative matters to: Ms. Nancy Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8854 Email: [email protected] 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, 42USC 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 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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