Full Text DE-93-04 NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING APPLICATIONS NIH GUIDE, Volume 22, Number 10, March 12, 1993 RFA: DE-93-04 P.T. 44 Keywords: Biomedical Research Training Oral Diseases National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1993 Application Receipt Date: September 10, 1993 PURPOSE The National Institute of Dental Research (NIDR) invites applications proposing institutional training programs in basic and clinical sciences pertaining to oral health research. The NIDR supports research on the causes, epidemiology, prevention, diagnoses and treatment of dental caries, periodontal and soft tissue diseases, craniofacial anomalies and orofacial pain. This includes normal and abnormal craniofacial development; the structure and function of teeth, jaws, oral mucosa, bone, connective tissue, salivary glands and other organs and tissues of the craniofacial complex; trigeminal neurobiology; the relationship of behavioral, social, economic and cultural factors to oral diseases and conditions; dental biomaterials; and the role of fluoride and nutrition in oral health and disease. It also emphasizes the need for research on older Americans, minority groups, and individuals with medical and handicapping conditions or who are otherwise at high risk for oral health problems. The primary objective of these training programs is to develop highly qualified, clinical investigators by supporting postdoctoral training of individuals with D.D.S., D.M.D., or equivalent dental degree, who are committed to a career in oral health research. Applications also may include pre- and postdoctoral training for basic scientists and/or short-term training for dental students in the proposed programs. Proposed training must be relevant to the goals of the NIDR, as described in the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope." Availability of this publication is described under INQUIRIES. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NRSA - Institutional Training Applications, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic non-profit, public, and private institutions and the applicant institution must have or be able to develop, the staff and facilities required for the proposed program. Levels of Training and Trainee Eligibility Several studies and advisory panels have emphasized the importance of graduate-level training leading to the Ph.D. degree in order to prepare dentists for productive careers in oral health research. However, training in oral health research is also appropriate for pre- and postdoctoral basic scientists and for dental students during their professional education. Training will be provided at one or more of the following levels: (1) dentists pursuing a Ph.D. or equivalent degree in basic science; (2) dentists pursuing postdoctoral research training; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training; and (5) pre-dental degree students pursuing a short-term research experience, usually during, but not limited to, the summer months. Preference for post-doctoral trainees must be given to individuals who have received, as of the beginning of an appointment, a D.D.S., D.M.D., or equivalent dental degree from an accredited domestic or foreign institution. If the degree has not yet been conferred, a statement, by an authorized official of the degree-granting institution, that all degree requirements have been met is acceptable. Predoctoral trainees must have received a baccalaureate degree as of the beginning date of the appointment and must be enrolled in a graduate program leading to the award of a Ph.D. or an equivalent degree in biomedical or behavioral oral health research. Trainees for short-term research experiences must be enrolled in a program leading to a D.D.S. or equivalent degree. Individuals who wish to interrupt their dental school studies for one or more years to engage in full-time research training before completing their professional degrees are eligible; however, prior approval by the NIDR is required before an appointment can be offered, as well as prior approval by the Institution. Individuals with a Ph.D. or equivalent degree may be appointed to the training grant. However, in general, they are expected to apply for an individual postdoctoral NRSA fellowship award (F32). Trainees must be citizens or non-citizen nationals 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 This RFA will use the National Institutes of Health (NIH) National Research Service Award (NRSA) Institutional Research Training Grant (T32). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years; however, awards are renewable. Trainees may receive up to five years of support at the predoctoral level and three years of support at the postdoctoral level, including any combination of support from institutional training awards and individual fellowship awards. Extensions beyond these periods require a waiver from the NIH. Dentists requiring additional time to complete training as a participant in a Ph.D. program may anticipate favorable consideration of a waiver request, contingent upon certification of the recipient's good academic standing. It is expected that postdoctoral trainees with the Ph.D., D.D.S., or equivalent degree will engage in at least two years of research training. FUNDS AVAILABLE Approximately $300,000 has been set-aside for this program. The NIDR expects to make one or two institutional training awards in response to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. Although this program is provided for in the financial plans of the NIDR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Only one training award will be made to any institution unless the training programs are in distinctly different areas of oral health research. RESEARCH OBJECTIVES The training program must provide opportunities for individuals to carry out supervised biomedical or behavioral oral health research and develop research skills. Clinical programs must have strong relationships with basic scientists that will assure trainees the opportunity to acquire the necessary foundation for future independent research. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. Applicants may request as many postdoctoral, predoctoral, and/or short-term trainee positions as can be justified. However, five or more positions for postdoctoral trainees over the five-year period must be proposed. Acceptance of postdoctoral trainees must be limited to the first three years of the five-year award, e.g,, two trainees the first year, two the second year, and one the third year. The number and types of positions awarded will be determined by peer review, program needs, and the availability of funds. Training grants may not be used to support studies leading to a D.D.S. or other similar professional degrees, or to support residencies, i.e., postgraduate training for dentists providing health care directly to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the training grant may support such research training if the trainee has shown a clear interest in a research career. Since recently graduated dentists usually have little or no prior research training, the training must include a minimum of two years of basic research training. Additional information regarding "Availability of Short-term Research Training Positions on Institutional National Research Service Awards for Students in Health-professional Degree Programs" and "National Research Service Award Institutional Research Training Grants" is given in the NIH Guide for Grants and Contracts, Vol. 21, No. 11, March 20, 1992. Stipends and Other Training Costs For predoctoral and the short-term trainees, at all levels of experience, the stipend is $8,800 per year ($734 per month). For postdoctoral trainees, the stipend is determined by the number of years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research (including industrial), teaching, internship, residency, clinical practice, or other time spent in a health-related field beyond that of the qualifying doctoral degree. The postdoctoral stipends are as follows: Years of Relevant Experience Stipend 0 $18,600 1 19,700 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 7 or more 32,300 Stipends may be supplemented by an institution from non-Federal funds. Federal funds may be used for stipend supplementation only if specifically authorized under the terms of the program from which the supplemental funds are derived. An individual may make use of Federal educational loan funds or Department of Veterans' Affairs benefits when permitted by those programs. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Degree trainees may exclude only required course tuition, fees, books, supplies, and equipment. Non-degree trainees will be required to report stipends and all monies paid on their behalf for tuition and fees. These statutory requirements went into effect January 1, 1987. The NIH is not in a position to advise students or institutions about their tax liability. In any event, changes in the taxability of stipends in no way alters the relationship between NRSA fellows, trainees, and institutions. NRSA stipends are not now, and never have been, salaries. Trainees supported under the NRSA are not in an employer-employee relationship with the NIH or the institution at which they are pursuing research training. Tuition and fees, including medical insurance, are allowable trainee costs if such charges are required of all persons in a similar training status at the institution, without regard to their source of support. Tuition at the postdoctoral level, if justifiable, is limited to that required for specific courses in support of the approved training program. Annual increments in tuition costs beyond the first year of a five-year award may not exceed six percent. Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's training, is an allowable trainee cost. Institutional costs of $1,500 per year per predoctoral trainee and $2,500 per year per postdoctoral trainee and $125 per month per short-term trainee may be requested to defray the cost of training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Indirect costs based on eight percent of total allowable direct costs, or actual indirect costs, whichever is less, may be requested. Applications from State and local government agencies may request full indirect cost reimbursement. Payback Provisions Trainees, including short-term trainees, must sign an agreement that they will fulfill the payback requirements. Trainees agree to engage in biomedical or health-related behavioral research and/or teaching for a period equal to the period of support in excess of 12 months. Trainees must undertake the obligated service on a continuous basis within two years after termination of support. Individuals who fail to fulfill the obligation through service must pay back the total amount of funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years of the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the payback service requirement and explain them carefully to prospective trainees before an appointment to the training grant is offered. For additional information, including the grounds for approving extensions of support and payback provisions, refer to the announcement in the NIH Guide for Grants and Contracts, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13, No. 1, January 6, 1984. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in item 4 on page 1, Human Subjects, and in Section B, number 5 of the Research Training Program Plan. 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 must 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 must 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 must be addressed by the applicants. If the required information is not contained within 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 that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1993, a letter of intent that includes a descriptive title of the proposed research training program, the name, address, and telephone number of the Program Director, 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Valega at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Valega early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications are to be submitted on form PHS 398 (rev. 9/91). Application forms are available at most institutional offices of sponsored research; 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 (710-0267 after 03/29/93); and from the NIDR program administrator listed under INQUIRIES. To identify the application as a response to this RFA, check "yes" on item 2a of page 1 of the application and enter "RFA: DE-93-04, NRSA - INSTITUTIONAL TRAINING APPLICATIONS." The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** At the time of submission, two additional copies of the application must also be sent to: H. George Hausch, Ph.D. Scientific Review Section National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 496-7658 (301/594-7632 after 03/29/93) This RFA is for a single competition. Applications must be received by September 10, 1993. If an application is received after that date or deemed non-responsive to the RFA, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by the NIDR Special Grants Review Committee (DSR), a standing NIH initial review group. Applicant interviews or site visits may be involved. The following review criteria will be applied: o The proposed research training and program objectives, design and direction; core curriculum; prescribed set of courses or seminars; the manner in which individual guided research activities will be selected; procedures for monitoring trainee progress; the existence of a true training program, as contrasted with fellowship training for an individual trainee; the combination of different levels of training; the appropriateness of the proposed number of trainees; the unique and/or innovative nature of the training program; resources and facilities. o The qualifications of the program director and participating faculty including the roles of specific preceptors; time commitment; ability to compete successfully for research support; current research grant holdings and pending research grant activities; specific experience in graduate research training. o Training environment: institutional commitment, the quality of the facilities, and the availability of research support; evidence of a high level of ongoing fundamental and clinical research activity; availability of equipment, facilities, and clinical resources. o Selection of trainees: plans for recruitment and criteria for the selection of trainees, availability of high-quality candidates, including minorities and women; how trainees are assigned to preceptors. o Past training record: for both new and renewal applications the past performance of the program director and preceptors in training scientists; reviewers will look for accomplishments, or potential, of the faculty in the training of scientists who will make major contributions to oral health research, as indicated by success in obtaining awards, such as fellowships, career awards, and individual research grant support, the rate at which former trainees establish independent productive research careers, recognition for outstanding scientific accomplishment, and involvement of former trainees in academic, clinically oriented, and laboratory research and their ongoing productivity. For renewal applications, the record in filling trainee positions and the completion record of trainees will be considered. Cumulative information on the career development of all former trainees, including information about their minority status, will be evaluated. Attention must be given to recruiting women and individuals from minority groups that are underrepresented, nationally, in these sciences. A plan must be included for the recruitment of these individuals. After review of the training grant application for scientific and technical merit and assignment of a priority score, the DSR will comment on the plans for recruiting women and individuals from underrepresented minority groups to the training program. In the case of renewal applications, this will include the accomplishments in recruiting women and individuals from underrepresented minority groups and in training them for research positions. No awards will be made to applications lacking this component. Applications must include a description of formal and/or informal activities related to instruction about the responsible conduct of research to be incorporated into the proposed research training program. Information must be provided on the subject matter of the instruction, the appropriateness of the instruction, the format of the instruction, the amount and nature of faculty participation, and the frequency and duration of instruction. A rationale for the plan of instruction must be provided. Progress reports on the type of instruction provided, topics covered and other relevant details, such as attendance by trainees and who taught the material, must be included in the application. No awards will be made to applications lacking this component. The announcement of this requirement was published in the NIH Guide for Grants and Contracts, Vol. 21, No. 43, November 27, 1992. Additional information regarding, "Modification of Existing Review Criteria for NRSA Institutional Research Training Grants," is given the NIH Guide for Grants and Contracts, Vol. 21, No. 11, March 20, 1992. Copies of the NIH Guide are usually available in the business or grants office of most academic institutions and from the Office of Grants Inquiries, Division of Research Grants at the address listed under APPLICATION PROCEDURES. Secondary review will be by the National Advisory Dental Research Council. Among the information the Council considers will be the report of the DSR on the plans for, and success in, recruitment of women and individuals from underrepresented minority groups. Review and Award Schedule Applications will be processed according to the following schedule: Application Initial Review Council Earliest Receipt Date Group Meeting Meeting Award Date Sep 10, 1993 Feb/Mar 1994 May/Jun 1994 Jul 1994 AWARD CRITERIA The earliest award date will be July 1, 1994. The NIDR will notify the applicant of the Council's action shortly after its meeting. Funding decisions will be made based on the DSR and Council recommendation, the need for research personnel in specified program areas, and the availability of funds. Applicants are reminded that NIDR funding decisions will take into consideration those applications that offer training at the following levels in priority order: (1) dentists pursuing a Ph.D. or equivalent degree in a basic science; (2) dentists pursuing postdoctoral research training; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training; and (5) pre-dental degree students pursuing a short-term research experience. The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training National Institute of Dental Research Westwood Building, Room 503 Bethesda, MD 20892 Telephone: (301) 496-6324 (301/594-7617 after 03/2993) FAX: (301) 496-4180 (301/594-7616 after 03/29/93) Direct inquiries pertaining to fiscal and policy matters to: Theresa Ringler, Grants Management Officer Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 496-7437 (301/594-7629 after 03/29/93) Copies of the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope," are available by written request to NIDR, P.O. Box 54793, Washington, DC 20032 AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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