Full Text DE-97-001 SHORT-TERM TRAINING FOR ORAL HEALTH CLINICAL TRIALS NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA: DE-97-001 P.T. 44 Keywords: Oral Diseases Clinical Trial National Institute of Dental Research Letter of Intent Receipt Date: December 15, 1996 Application Receipt Date: January 14, 1997 PURPOSE The National Institute of Dental Research (NIDR) invites new applications for National Research Service Award (NRSA) Short-Term, Institutional Training Programs in the design and conduct of oral, dental and craniofacial clinical trials. The objective of the programs to be supported through this Request for Applications (RFA) is to provide short-term training for oral health research personnel interested in becoming active members of teams that conduct clinical trials sponsored by government and industry. Background The need for an increased number of appropriately trained personnel in clinical or patient-oriented research (POR) has been highlighted in numerous recent reports and studies. POR 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 (or colleague) directly interacts with human subjects in either an outpatient or an inpatient setting" (NIH, 1994). The personnel need for POR is especially great in oral, craniofacial and dental health research. The responsibility for ensuring the availability of sufficient numbers of competent POR clinical scientists to meet the expanding opportunities resulting from basic and clinical research rests with the government, academia, and industry. Strong recommendations that the NIDR encourage the training and career development of clinical investigators, and specifically of personnel knowledgeable about clinical trials, have been made by the NIDR Dental Research Programs Advisory Committee, the National Advisory Dental Research Council, the Institute of Medicine (IOM) task force on clinical research in dentistry (which was part of the 1994 study by the IOM Committee on Addressing Career Paths for Clinical Research), and at an NIDR meeting in 1993 on training requirements for dental oral, and craniofacial clinical trials. This RFA is one of several NIDR initiatives to address these critical needs in POR. The objective is to help develop a cadre of well-trained investigators who are knowledgeable about the design and conduct of clinical trials in oral health research, and who can function as effective members of clinical trial teams. 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. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Short-Term Training for Oral Health Clinical Trials, 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: 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 schools, dental research institutions, schools of public health and universities. Consortia arrangements are encouraged. An institution may have no more than three concurrent NRSA short-term training grants from the NIDR: one conventional grant for dental students, one for training of women and minority dental students, and one resulting from this RFA. Trainee Eligibility Preference for training must be given to individuals who: (1) have received a D.D.S./D.M.D., Ph.D., both an R.D.H. and Master"s degree, or equivalent degrees from an accredited domestic or foreign institution, (2) hold postdoctoral, resident, or faculty appointments in dental, dental hygiene, medical, or public health schools, advanced dental education/research institutions, or universities, or private industry positions that are involved with clinical trials, and (3) demonstrate a commitment to clinical oral health research. Consideration also may be given to those who recently have completed a graduate program related to oral health or a clinical dental specialty program, but have not yet obtained a full-time research position. 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. Non-citizen nationals, although not citizens of the United States, owe permanent allegiance to the U.S. They are generally born in lands that 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 made as a result of this RFA will be the National Institutes of Health (NIH), NRSA Short-Term Institutional Research Training Grant (T35). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the program director. The total project period for applications submitted in response to this RFA must be five years. This RFA is a one-time solicitation. Awards may be renewable depending on program needs, availability of funds, and submission of a successful competing application. It is anticipated that awards will be made by September 15, 1997. FUNDS AVAILABLE The NIDR expects to make up to three new awards, each with five positions, at a total first year cost of approximately $90,000 for all 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, these awards are contingent upon the availability of funds. RESEARCH OBJECTIVES The program must provide opportunities for individuals with a variety of training, research, and clinical backgrounds to develop skills in the design and conduct of clinical trials for dental, oral and craniofacial conditions. There is no expectation that these short-term training programs will allow participants to serve as principal investigators or directors of clinical trials immediately. The courses are expected to enable trainees to become active and integral members of clinical trials teams, be able to evaluate and interpret published reports of clinical trials critically, and be able to communicate these skills to predoctoral and postdoctoral students, oral health professionals, and scientists in private industry. The program must include a core curriculum of formal instruction in the design, conduct, analysis, and presentation of results from single center and multicenter clinical trials. Topics such as the following should be included: study organization and administration, including roles and responsibilities of team members, developing specific aims and primary and secondary endpoints for the trial, principles of hypothesis testing, importance and use of preliminary studies, preparing a detailed clinical protocol (containing at least inclusion and exclusion criteria, patient assignment procedures, study designs and potential biases, randomization, sample size calculations), issues related to patient availability, recruitment, and retention, data integrity, management, quality control, and analysis, appropriate use of oral, dental, and craniofacial indices and measures, quality assurance of biological specimens and other individual measures, such as radiographs, protection of human participants, biohazard safety of employees and subjects, informed consent and assent, ethics in research and scientific integrity, responsible conduct of research, statutory mandates, such as the inclusion of women and minority subjects in trials funded by the NIH, the need for and purposes of a data and safety monitoring board, government regulatory issues, especially from the Food and Drug Administration, and issues related to trials performed by private industry. There should be opportunities for practical experiences such as observing and participating in various phases of ongoing clinical trials. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. Each applicant may request up to five positions for each year over the five-year period. The number 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. The length of the short-term training experience and of trainee support may vary from one to three months per year and the training must be full-time, during this period. Successful trainees may be reappointed for a continuing course of training, not to exceed two appointments. Program directors and potential trainees should be aware that an individual may receive up to three years of NRSA support at the postdoctoral level, including any combination of support from institutional training awards and individual fellowship awards. Appointments on these short-term training programs will be included in the calculation of the total period of NRSA support. Extensions beyond the three year period require a waiver from the NIDR. However, well-qualified potential trainees may anticipate favorable consideration of a waiver request. People receiving support under individual or other institutional NRSA training grants are not eligible for appointment to these short- term programs. Training grants may not be used to support studies leading to a D.D.S./D.M.D. 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 (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 postdoctoral trainees, the annual 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. Stipends will be prorated on a monthly or weekly basis. The postdoctoral annual stipends are as follows: Years of Relevant Experience Stipend Less than 1 year $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. Institutional costs of $2,500 per year per postdoctoral trainee ($1,500 per year per predoctoral trainee), prorated on a weekly or monthly basis, may be requested to defray the cost of training related expenses, such as tuition, fees, supplies, consultant costs, equipment, and other expenses. Fringe benefits are not provided by this award. No allowance will be provided for dependents or for an individual"s travel to the training site. An indirect cost allowance based on eight percent of total allowable direct costs or actual indirect costs, whichever is less, may be requested. Payback Provisions All postdoctoral trainees must sign an agreement to fulfill NRSA payback requirements. They incur one month of payback obligation for each month of support in the first twelve months of support. This obligation will be satisfied by continuing on a NRSA training grant for an additional 12 months. For payback obligations which are not satisfied in this way, trainees must engage in biomedical or health-related behavioral research and or teaching for a period equal to the period of support up to 12 months. The obligated service must be undertaken continuously 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 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 new 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 of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 15, 1996, a letter of intent that includes a descriptive title of the proposed short-term 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 James A. Lipton, D.D.S., Ph.D. at the address under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Lipton early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications must be submitted on the grant application 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 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov, and from the and from Dr. Lipton at the address listed under INQUIRIES. Each applicant may request up to five positions for each of the five years of the award. The exact length of the proposed training experience is left to the discretion of the applicant and may vary from one to three months. The budget request must correspond to the proposed training period(s). 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. 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, and the frequency and duration of instruction, and the amount and nature of faculty participation. 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 of the face page of the application and enter "RFA: DE-97-001, Short-term Training for Oral Health Clinical Trials." 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 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2372 This RFA is for a single competition. Applications must be received by January 14, 1997. If an application is received after that date it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be reviewed for completeness and responsiveness to the RFA by DRG and NIDR staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Remaining applications may be subjected to triage by a special grants review committee, convened by the NIDR Scientific Review Section, 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 for scientific and technical merit by the review committee. The following review criteria will be applied: o The proposed research training and program design, the core curriculum, the opportunities for observing and participating in various phases of ongoing clinical trials, the quality of such practical experiences, the appropriateness of the length of the proposed training program, the unique or innovative aspects of the training program. o The qualifications of the program director and participating faculty including the roles of specific instructors or preceptors, their time commitment, ability to compete for research support, current clinical trials activities and experience in graduate clinical research training. o Procedures for recruitment and selection of trainees, including women and minorities, availability of high-quality candidates, and how the trainees will be mentored and their progress monitored. o Training environment: institutional commitment, the quality of the facilities, and the availability of research support, level of ongoing clinical research activity, availability of equipment, facilities, and clinical resources. o The quality of instruction in the responsible conduct of research and scientific integrity. Secondary review will be by the National Advisory Dental Research Council. Among the information the Council considers will be the report of the special review committee on the plans for recruiting women and individuals from underrepresented minority groups. The NIDR will notify the applicant of the Council"s action shortly after its meeting. Schedule Letter of Intent Receipt Date: December 15, 1996 Application Receipt Date: January 14, 1997 Initial Review Group Meeting: February or June 1997 Council Meeting: June or September 1997 Earliest Date of Award: September 15, 1997 AWARD CRITERIA Funding decisions will be based on the recommendations of the special review committee and the National Advisory Dental Research Council. The earliest award date is September 15, 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 45 Center Drive, Room 4AN-18J, MSC 6402 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 grants management issues to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-44A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 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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