Full Text DE-96-006 NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING NIH GUIDE, Volume 25, Number 24, July 19, 1996 RFA: DE-96-006 P.T. 44 Keywords: Biomedical Research Training Oral Diseases Dentistry Clinical Medicine, General National Institute of Dental Research Letter of Intent Receipt Date: September 13, 1996 Application Receipt Date: October 22, 1996 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. The objectives are: (a) to develop highly qualified oral health research investigators, especially clinician scientists, by supporting postdoctoral training of individuals with a health professional degree who are committed to a research career in the basic biomedical, behavioral and clinical sciences pertaining to craniofacial, oral, and dental health and disease; (b) to provide re- training opportunities for mid-career scientists and clinical researchers to obtain expertise in particular basic or behavioral sciences relevant to the NIDR areas of research emphasis; and (c) to train pre- and early post-Ph.D. biomedical and behavioral scientists. Background Programs must be relevant to the research goals of the NIDR. Primary emphasis is placed upon understanding, preventing, diagnosing, and treating craniofacial, oral, and dental diseases and disorders. Current special areas of interest include: inherited diseases and disorders, including the development of teeth and bone; emerging and re-emerging infectious diseases, including bacterial, viral, fungal and parasitic disorders and AIDS; neoplastic diseases; chronic disabling diseases, such as osteoporosis and related bone disorders, temporomandibular joint disorders, pain, neuropathies and neurodegenerative diseases, and other systemic disorders with oral manifestations; biomimetics, tissue engineering and biomaterials; and behavior, health promotion, and environment. These new areas of NIDR research emphasis encompass an extensive breadth of basic and behavioral sciences, including molecular and cell biology, neuroimmunology, human and molecular genetics, bioengineering, computer science, molecular epidemiology, clinical trials methodology, biobehavioral medicine, outcomes research, cognitive psychology, medical sociology and health services research. To offer the most appropriate training, applicants are encouraged to consider developing, as deemed necessary, interdisciplinary collaborations among various components of their health science center as well as with other regional academic institutions and private industry so that trainees are provided the strongest background in the particular basic, clinical, and behavioral/social sciences. The NIDR has a strong interest in the training of individuals who will be able to pursue clinical research studies, including clinical trials. 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 translation and transfer of fundamental knowledge to improve oral health care of the public. For this purpose, clinical research is defined as research conducted with human subjects for which the investigator directly interacts with individuals in either an outpatient or an inpatient setting. It is often referred to as patient-oriented or patient-related research. It includes such topics as the characterization of normal and diseased function, evaluation of new diagnostic and therapeutic techniques and devices, patient compliance and disease prevention regimens, drug trials, assessment of health care practices by various population subgroups, and epidemiologic and biobehavioral studies. There is a pool of mid-career oral health researchers, including basic and behavioral scientists and clinical investigators, who wish to update their scientific expertise and keep current with the rapid knowledge developments in the basic, behavioral, and clinical sciences. It is important to provide some re-training mechanism that would enable these individuals to remain viable, active, contributing members of the scientific research community. Additional training also would be relevant for scientists who desire to change their scientific focus and redirect their research efforts toward craniofacial, oral, and dental health and disease. 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 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public, and private institutions, such as dental or medical schools and research institutions. Local collaborations or regional consortia are encouraged where relevant to the field of training being offered and feasible to establish. This is especially important for programs which provide training in interdisciplinary fields, such as tissue engineering, molecular epidemiology, and behavioral medicine. Only one application may be submitted by an institution, unless the proposed training programs are in distinctly different areas of craniofacial, oral, and dental health and disease. Levels of Training and Trainee Eligibility Training in an NIDR area of emphasis is to be provided at one or more of the following levels: (1) dentists, physicians, or other health professionals pursuing postdoctoral clinical research training; (2) mid-career scientists and clinical researchers who wish to re-train in a basic or behavioral science area related to craniofacial, oral, and dental health and disease; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) dentists wishing to pursue a Ph.D. or equivalent degree in a basic biomedical or behavioral science, although these individuals are encouraged to enter an Institutional Dentist Scientist Award program if they also desire to obtain training in a clinical specialty; and (5) Ph.D. degree holders pursuing postdoctoral research training, although generally they are expected to apply for an individual postdoctoral NRSA fellowship (F32 mechanism). Preference should be given to post-doctoral trainees who have received, as of the beginning of an appointment, a dental or medical 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 professional 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. Short-term predoctoral research training positions cannot be requested through this RFA. Instead, these types of positions must be supported through NRSA Short-Term Institutional Training grants (T35 mechanism). 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 continuation application, depending on programmatic needs and the availability of funds. The anticipated award date is July 1, 1997. 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. It is expected that postdoctoral trainees with Ph.D., D.D.S./D.M.D., M.D. or equivalent degrees will engage in not less than two years training. However, those mid-career scientists and clinical researchers who seek re- training in basic or behavioral science research can spend between one to two years in the program, depending on the desired level of expertise to be obtained and the period of time allowed by their home institutions for sabbatical or leave-of-absence. 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 all awards is $270,000 in the first year. 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 research and develop research skills in an area of NIDR emphasis related to craniofacial, oral, and dental health and disease. Clinical research programs must have strong relationships with basic or behavioral scientists to ensure that trainees will have the opportunity to acquire the necessary foundation for independent investigation. 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 six postdoctoral positions over the five-year period, with two appointments in each of the first, second, and third years. In order to address the need for clinical investigators, applicants must allocate not less than two postdoctoral positions to trainees with a declared interest in receiving training to conduct clinical research. Such appointments must be made in the first and second years of the award. The remaining postdoctoral positions may be allocated to basic, behavioral, or clinical research trainees in any of the research emphasis areas relevant to the NIDR's mission. At least one of these positions should be for re-training a mid- career scientist or clinical research investigator. 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 dental, medical, 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. 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, Vol. 23, No. 21, June 3, 1994. Copies of the NIH Guide are usually available through the NIH Home Page, as well as in the office of sponsored research of most academic institutions and from the Office of Extramural Outreach and Information Resources, at the address below. Stipends and Other Training Costs For predoctoral trainees at all levels of experience, the current stipend is $10,008 per year. For postdoctoral trainees, stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. The stipend is not provided as a condition of employment with either the Federal Government or the sponsoring institution. Stipend level for the first year of NRSA support 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 current postdoctoral stipend levels 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 The stipend for each subsequent year of NRSA support is the next level in the stipend structure and begins on the anniversary appointment date. No departure from the standard stipend schedule may be negotiated between the institution and trainee. Stipend Supplementation - Stipends may be supplemented by an institution from non-Federal funds to offset the cost of living. Other NIH funds may not be used to supplement stipends. Under no circumstances may Public Health Service (PHS) funds be used for supplementation. 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 and the program whose funds are to be supplemented. 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. Tuition and fees - Beginning in Fiscal Year 1997, the NIH will offset the combined cost of tuition, fees, and self-only health insurance at the following rate: 100 percent of all costs up to $2,000 and 60 percent of costs above $2,000. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience funded by the training grant, and only if such charges are required of all persons in a similar training status at the institution, without regard to their source of support. Annual increases in tuition costs beyond the first year of a five-year award will not be allowed. Family medical insurance is not allowable under an NRSA award. For a description of this policy change, refer to the NIH Guide for Grants and Contracts, Volume 25, No. 2, February 2, 1996. Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's training, is an allowable trainee cost in the amount of $800 per year per trainee. 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 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, teaching in a health professional school, college, or high school, or engaging in additional research training for more than 20 hours per week for a period equal to the period of support, up to 12 months. Clinical practice and administrative responsibilities not directly related to scientific research are unacceptable for payback service. 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 September 13, 1996, 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. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov; and from Dr. Lipton at the address listed under INQUIRIES. For competitive continuation applications, cumulative information on the career development of all former trainees, including information about their minority and gender status, must be included. For new applications, data should be provided about the career accomplishments of individuals who have completed research training programs at the institution(s). 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 2 on the face page of the application and enter "RFA: DE-96-006 after Number and NRSA - Institutional Training Awards" after Title. 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 October 22, 1996. 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. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDR in accordance with the standard 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, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Dental Research Council. 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, especially mid-career basic or behavioral scientists and clinical research investigators, and 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, basic, and behavioral 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: September 13, 1996 Application Receipt Date: October 22, 1996 Initial Review Group Meeting: February 1997 Council Meeting: June 1997 Earliest Award Date: July 1, 1997 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, 1997. 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 R. 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) 480-8301 Email: rubinstein@de45.nidr.nih.gov 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 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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