Full Text DE-95-007 NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING AWARDS NIH GUIDE, Volume 24, Number 18, May 19, 1995 RFA: DE-95-007 P.T. 44 Keywords: Biomedical Research, Multidiscipl Behavioral/Social Studies/Service Oral Diseases National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1995 Application Receipt Date: September 11, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites new and competing applications proposing National Research Service Award (NRSA) Institutional Research Training Grant (T32) programs in basic biomedical, behavioral and clinical sciences pertaining to oral health research. The primary objective is to develop highly qualified, clinical investigators by supporting postdoctoral training of individuals with a D.D.S., D.M.D., or equivalent degree, who are committed to a career in oral health research. The secondary objective is training of pre- and post-Ph.D. biomedical and behavioral scientists in oral health research. Background Several NIDR and NIH advisory groups and reports from the Institute of Medicine and National Research Council, National Academy of Sciences, have called attention to the need to expand the pool of clinical investigators in order to take advantage of opportunities for transfer of fundamental knowledge to improve oral health care of the public. For this purpose, the term clinical is defined as research conducted with human subjects or on material of human origin such as tissues, specimens, and cognitive phenomenon, for which the investigator directly interacts with human subjects in either an outpatient or an inpatient setting. It is often referred to as patient-oriented or patient-related research. It includes characterization of normal and diseased human function, evaluation of new diagnostic and therapeutic techniques and devices, patient compliance and disease prevention regimens, drug trials, assessment of various health care practices by various population subgroups, and epidemiological studies. In order to address the need for clinical investigators, applications must allocate not less than two postdoctoral positions to trainees with a declared interest in receiving training to conduct clinical research. The remaining positions may be allocated to basic or clinical research training, in the array of biomedical and behavioral research areas pertaining to the NIDR's mission. Programs must be relevant to the research goals of the NIDR including: the causes, epidemiology, prevention, diagnosis, and treatment of dental caries, periodontal and soft tissue diseases, oral cancer, oral manifestations of AIDS and HIV infection, and craniofacial anomalies; orofacial pain; temporomandibular disorders; structure and function of teeth, jaws, oral mucosa, bone, connective tissue, and salivary glands; behavioral, social, economic, and cultural factors related to oral diseases and disorders; biomaterials; fluoride and nutrition; and research on older Americans, gender differences, minorities, those with medical problems and disabilities, and individuals and groups at high-risk for oral health problems. 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 Awards, 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 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 by domestic, public, and private institutions such as dental schools and dental research institutions. Only one application may be submitted by an institution, unless the proposed training programs are in distinctly different areas of oral health research. Levels of Training and Trainee Eligibility Training is to be provided at one or more of the following levels: (1) dentists pursuing postdoctoral clinical research training; (2) dentists pursuing a Ph.D. or equivalent degree in basic biomedical or behavioral science; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training, although generally, they are expected to apply for an individual postdoctoral NRSA fellowship (F32). Preference must be given to post-doctoral trainees 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 of the appointment and 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. 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, as well as by the institution, is required before an appointment can be offered. No short-term research training positions may be requested through this RFA. Instead, these types of positions may be supported through NRSA Short-Term Institutional Training grants (T35). Trainees must be citizens or noncitizen nationals of the United States, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551). Noncitizen nationals, although not citizens of the United States, owe permanent allegiance to the U.S. They are generally born in lands which are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards resulting from this RFA will be the National Institutes of Health (NIH), NRSA Institutional Research Training Grants (T32). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for each application submitted in response to this RFA may not exceed five years. Awards may be renewable upon submission of a successful competing application, depending on programmatic needs and the availability of funds. The anticipated award date is July 1, 1996. Trainees may receive up to five years of NRSA 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 Ph.D., D.D.S., or equivalent degrees will engage in not less than two years training. FUNDS AVAILABLE In response to this RFA, the NIDR expects to make up to three new or competing continuation awards, each with two postdoctoral positions in the first year. The estimated total funding for the first year of support is $240,000. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. 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 to ensure that trainees will have the opportunity to acquire the necessary foundation for 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 must request at least six postdoctoral positions over the five-year period, with two appointments in each of the first, second, and third years. Applicants must allocate not less than two postdoctoral positions to trainees interested in receiving training to conduct the type of clinical research defined under Background. Such appointments must be made in the first and second years of the award. The remaining positions may be allocated to basic or clinical research trainees, in any of the research areas relevant to the NIDR's mission. Up to three predoctoral positions may be requested for the five year period. The number and types of positions awarded will be determined by the initial review group's assessment of scientific and educational merit, 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, or other training for dentists providing care 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 or clinical research training. Applicants are reminded of the importance the NIDR places on recruitment and retention of women and underrepresented minorities to sponsored training and career development programs. Where feasible, women and minority mentors should be involved as role models. Additional information regarding NRSA Institutional Research Training Grants is given in the NIH Guide for Grants and Contracts (NIH Guide), Vol. 23, No. 21, June 3, 1994. Copies of the NIH Guide are usually available in the office of sponsored research of most academic institutions and from the Office of Grants Information, Division of Research Grants, at the address below. Stipends and Other Training Costs For predoctoral trainees, at all levels of experience, the stipend is $10,008 per year. 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 $19,608 1 20,700 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. Other NIH funds may not be used to supplement stipends. Non-NIH Federal funds may not be used for stipend supplementation unless 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. Reimbursement of tuition and fees, including self-only medical insurance, will be consistent with NIH policy. They 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 increases in tuition costs beyond the first year of a five-year award will not be allowed. 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 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 - reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs, exclusive of tuition, fees, and equipment, is allowed. Payback Provisions Postdoctoral trainees must complete and sign a Payback Agreement Form (PHS 6031) to fulfill the NRSA payback requirement when they are appointed initially to a research training grant. Postdoctoral trainees in the first twelve months of postdoctoral NRSA support incur one month of obligation for each month of support. Postdoctoral trainees in the thirteenth and subsequent months of NRSA support are not required to sign the Payback Agreement Form and do not incur a service payback obligation. The thirteenth and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. Individuals appointed to their initial NRSA postdoctoral period in a project funded in response to this RFA and who continue under that award for two years have fulfilled their obligation by the end of their second year. Service payback obligations also can be paid back by conducting biomedical or health-related behavioral research or teaching for more than 20 hours per week for a period equal to the period of support, up to 12 months. Postdoctoral NRSA recipients must begin to undertake any remaining obligated service on a continuous basis within two years after termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the Division of Extramural Research, NIDR, specifying the need for additional time and the length of the required extension. Recipients of NRSA support are responsible for informing the Division of Extramural Research, NIDR, of changes in status and address. 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 announcements in the NIH Guide, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13, No. 1, January 6, 1984, and "Modification of the NRSA Service Payback Obligation," Volume 22, No. 27, July 30, 1993. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies concerning the inclusion of women in study populations, and concerning the inclusion of minorities in study populations, which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1995, 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 conflicts of interest in the review. The letter of intent is to be sent to Dr. James A. Lipton at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Lipton early in the planning phase of application preparation. This will help ensure that applications are responsive to the RFA. Applications are to be submitted on form PHS 398 (rev. 9/91). Application forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301/710-0267, and from Dr. Lipton at the address listed under INQUIRIES. Applicants must request six postdoctoral positions over the five-year period, with two appointments in each of the first, second and third years. Applicants must allocate not less than two postdoctoral positions to trainees interested in receiving training to conduct the type of clinical research defined under Background. Such appointments must be made in the first and second years of the award. The remaining positions may be allocated to basic or clinical research trainees, in any of research areas relevant to the NIDR's mission. Three predoctoral positions may be requested for the five year period. No positions may be for short-term training. A plan must be included for the recruitment of women and individuals from minority groups that are nationally underrepresented in these sciences. No awards will be made to applications lacking this component. Where possible, women and minority preceptors should be included, to serve as role models. Cumulative information on the career development of all former trainees, including information about their minority and gender status must be included. 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 rationale, subject matter, appropriateness, format, frequency, and duration of instruction; and the amount and nature of faculty participation. Progress reports in competing and non-competing continuation applications must include the type of instruction, topics covered, and other details, such as attendance by trainees and names of the instructors. No award will be made if an application lacks this component. Information regarding, "Modification of Existing Review Criteria for NRSA Institutional Research Training Grants," is given in the NIH Guide, Vol. 21, No. 11, March 20, 1992. To identify the application as a response to this RFA, check "YES" on item 2a on the face page of the application and enter "RFA: DE-95-007, NRSA - Institutional Training Awards." 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 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 also must be sent to: H. George Hausch, Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN.44F Bethesda, MD 20892-6402 Telephone: (301) 594-2372 This RFA is for a single competition. Applications must be received by September 11, 1995. 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 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 reviewed for completeness and responsiveness to the RFA by NIH staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Remaining applications may be subjected to triage by the NIDR Special Grants Review Committee, a standing NIH initial review group, to determine their merit, relative to others received in response to the RFA. The NIDR will withdraw applications judged to be noncompetitive and notify the applicant. Applications judged to be competitive will be evaluated further for scientific and educational merit by the review committee. The following review criteria will be applied: o Research training program objectives, design, and direction: Management structure; core curriculum and available courses or seminars; how guided research activities are selected and trainees are assigned to preceptors; procedures for monitoring progress; existence of a true training program, as contrasted with fellowship training for an individual; appropriateness of the number of trainees; unique and innovative aspects. o Program director, faculty and preceptors: Administrative and scientific qualifications, roles, time commitment, ability to compete for research support, and experience in graduate research training. o Training environment: Institutional commitment; evidence of ongoing fundamental and clinical research; availability of research support, equipment, facilities, and clinical resources. o Selection of trainees: Plans for recruitment and criteria for selection of trainees, availability of high-quality candidates, including minorities and women. o Past training record: For new and renewal applications, potential or performance in training scientists as indicated by former trainees' success in obtaining research grant support, establishing independent research careers, and involvement in clinical and basic oral health research. o Recruitment and retention of women and minority trainees: After review of the application for scientific and educational merit and assignment of a priority score, the Special Grants Review Committee will comment on plans for recruiting women and underrepresented minorities. For renewal applications, this will include accomplishments in recruiting and retaining women and underrepresented minorities and training them for research careers. o Responsible conduct of research: The quality of scientific integrity instruction. The second level of review will be by the National Advisory Dental Research Council (NADRC). Among the information the NADRC considers will be the report of the Special Grants Review Committee on the plans for, and success in, recruitment and retention of women and individuals from underrepresented minority groups. The NIDR will notify the applicant of the NADRC's action shortly after its meeting. Schedule Applications will be processed according to the following schedule: Letter of Intent Receipt Date: August 10, 1995 Application Receipt Date: September 11, 1995 Initial Review Group Meeting: February 1996 Council Meeting: June 1996 Earliest Award Date: July 1, 1996 AWARD CRITERIA Funding decisions will be based on the Special Grant Review Committee's and NADRC's recommendations; the need for research personnel in particular program areas, including the need to train clinical investigators; and the availability of funds. The earliest award date is July 1, 1996. 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: James A. Lipton, D.D.S., Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-18J Bethesda, MD 20892-6402 Telephone: (301) 594-2618 or 594-7710 FAX: (301) 480-8318 Email: liptonj@de45.nidr.nih.gov Direct inquiries pertaining to fiscal matters to: Mr. Martin Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. 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 not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. .
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