Full Text DE-95-001 ORAL HEALTH RESEARCH CLINICAL CORE CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: DE-95-001 P.T. 04 Keywords: Oral Diseases Etiology Pathogenesis Epidemiology Disease Prevention+ National Institute of Dental Research Letter of Intent Receipt Date: January 13, 1995 Application Receipt Date: June 13, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites grant applications for the support of Oral Health Research Clinical Core Centers (OHRCCCs). The primary goal of these centers is to enhance the nation's oral health clinical research capability and, thereby, facilitate the transfer from the laboratory to the clinic of fundamental knowledge of the etiology, pathogenesis, epidemiology, prevention, diagnosis and treatment of oral diseases and dysfunctions. This Request for Applications (RFA) consolidates under one umbrella and announces the first recompetition of all the NIDR clinical core center programs. 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, Oral Health Research Clinical Core Centers, 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 by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. However, domestic applications may include international components. Applications with key personnel such as center directors or principal investigators who are minority individuals and/or women are encouraged. Although an application must be submitted from a single institution, it may include consortia arrangements with other institutions. Applicant institutions must provide clear evidence of having a suitable clinical research base to ensure appropriate utilization of the added resources that the NIDR would provide through the OHRCCC. This must include meritorious ongoing clinical research projects and/or the capability to develop such clinical research. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) center core grant (P30). Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. This RFA is a one-time solicitation. Subsequent support will be contingent upon program needs and availability of funds. The total project period for applications submitted in response to the present RFA must be five years. The earliest possible award date will be December 1, 1995. In addition to support for pilot and feasibility studies, support will be provided for shared resources and facilities (core units), the sharing of which will facilitate the total research effort. Each core unit must be utilized by at least two projects. Applicants must limit their requests to not more than $300,000 direct costs for the initial budget period. Where indirect costs are assigned to a subcontract and counted as direct costs, the direct cost maximum of $300,000 may be exceeded by the amount of the indirect costs assigned to the subcontract. Budget increases of no more than four percent per year for recurring costs may be requested for each of the subsequent four years. Included in the direct cost maximum of $300,000 are funds with a limit of $45,000 for the support of specified pilot and feasibility studies, each of which must not exceed $20,000 in direct costs per year and may last for a maximum period of two years. Applications that exceed these limits will be returned without review. Pilot and feasibility studies are the only research projects that will be directly supported by this mechanism. The OHRCCC will not provide direct funding for ongoing research projects. These must be funded through other sources or support mechanisms. FUNDS AVAILABLE It is anticipated that up to four to five awards will be made and up to $2,250,000 in total costs will be committed for the first year of support for the entire program, if a sufficient number of applications of high scientific merit are received. The receipt of three competing continuation applications is anticipated. These applications will compete for the awards along with other applications received in response to this RFA. Although this program is provided for in the financial plans of the NIDR, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Applicants are encouraged to seek additional support from other public sources and private sector sources, including foundations and industrial concerns, for activities, including information transfer and outreach programs, that will complement and expand the OHRCCCs. A summary of the objectives and financial support for such activities must be included in the application. RESEARCH OBJECTIVES Background Establishment of the NIDR's Clinical Research Core Centers program was recommended by an expert panel and highlighted in a 1985 report, requested by Congress, on NIDR's use of the center and other large grant mechanisms. A number of additional advisory groups, including the National Advisory Dental Research Council, have reaffirmed the need for expansion in clinical research and the use of core centers to expedite the translation of new knowledge from the laboratory to the clinic. The NIDR initiated this program on October 20, 1989 by issuing an RFA on Clinical Dental Research Core Centers (CDRCCs). The primary goal of these centers was to facilitate clinical research relevant to the pathogenesis, diagnosis, early detection, prevention, control and treatment of oral diseases and dysfunctions. The intent of this program was to provide the resources and facilities necessary to develop and to conduct clinical research at the level of sophistication necessary to expedite the translation of basic scientific knowledge into new and better methods for improving the oral health of the nation. Two CDRCCs were funded on September 30, 1990. A second RFA on Clinical Core Centers for Oral Health Research (CCCOHR) was issued by NIDR on January 4, 1991. This type of center was intended to facilitate and stimulate clinical research to improve oral health in adults, senior citizens, and other groups at high risk for oral diseases. Such groups include individuals with systemic diseases (e.g., diabetes), undergoing medical treatments (e.g., chemotherapy or radiation), or having oral conditions (e.g., xerostomia) that increase the risk for oral diseases or tooth loss, and rural residents and members of minority groups who have not shared the gains in oral health seen in many segments of the U.S. population. One CCCOHR was funded on September 15, 1991. Another major objective of the clinical research core center programs was to encourage expanded funding from other public and private sector sources (e.g., industry, foundations, or other government agencies) for both ongoing and new clinical research projects utilizing the center core units, thereby contributing to the cost- effectiveness of these centers. In addition to support for core units, funds were available for pilot and feasibility studies. Moreover, it was expected that the applicant institution would have ongoing clinical research projects and/or the potential to develop, through complementary non-NIDR funding, clinical research projects which would utilize the core units. Preliminary data suggest that considerable progress already has been made toward the original goals of the existing centers. Highlights of progress include success in attracting substantial funds and in- kind contributions from other public and private sector sources, establishment of one or more training courses in clinical research methodology, and contributions to several significant research advances. The present RFA on OHRCCCs consolidates under one umbrella and announces the first recompetition of the original clinical research core center programs. Center Goals and Scope The primary goal of the OHRCCCs is to provide the shared resources and facilities necessary to develop and to conduct clinical research at the level of sophistication necessary to expedite the translation of basic scientific knowledge into new and better methods for improving the oral health of individuals of all ages and of all segments of the U.S. population irrespective of the afflicting oral disease or dysfunction. The centers, thereby, are intended to: provide nuclei around which additional clinical studies, funded through government or private sources, can be conducted; encourage increased collaboration among the various disciplines of oral health clinical research and among basic and clinical scientists with expertise relevant to this initiative; and serve as magnet organizations to foster productive research-related relationships with other institutions. The secondary goal of the OHRCCCs is to foster the development of clinical research scientists at all levels of career development by providing improved opportunities for collaboration and expanded environments for clinical research. The clinical research supported by these centers must be relevant to the attainment of the NIDR's objectives. Research areas of interest include, but are not limited to: the epidemiology, etiology, pathogenesis, diagnosis, prevention and treatment of dental caries, periodontal and soft tissue diseases, oral cancer and manifestations of AIDS, salivary gland disorders, craniofacial anomalies and orofacial pain; trigeminal neurobiology; the relationship of behavioral, social, economic and cultural factors to oral diseases; biomaterials, pulp biology and implants; the role of fluoride and nutrition in oral health and disease; and clinical research to improve oral health in the elderly, women, minorities, and other groups at high risk for oral diseases. Center Characteristics Each OHRCCC must be a clearly defined organizational entity within a dental school or dental research institution with a director responsible for management of the center. Strong and effective scientific leadership must be provided. The application should specify provisions that will be made for replacement of the director with a suitably qualified alternative should circumstances require. OHRCCC directors will be responsible for the organization and operation of the centers and for communication with the OHRCCC advisory panels and with the NIDR on scientific and administrative matters. Directors will be responsible for maintaining high-quality research efforts and for ensuring effective collaboration among OHRCCC scientists. It is essential that the various elements of the OHRCCC be interrelated and that their utilization facilitates an enhanced quality and quantity of clinical oral health research. Funding of an OHRCCC is intended to support shared resources and facilities (core units) that will enhance and extend the effectiveness of clinical research related to improving the oral health of the nation. Each center must include a minimum of three core units. One unit must be an administrative core. A biostatistics core unit also is mandatory. The biostatistics component may be incorporated into the administrative core. Other cores proposed must directly relate to ongoing and planned oral health clinical research activity of the center. Descriptions of core units include: o Administrative Core: Funds for the center director and administrative staff will be provided. This core unit should ensure that OHRCCC participants are provided with shared support services that enhance their research. The director will be responsible for monitoring the overall quality and the scope of center activities. The administrative core may provide limited funds to facilitate improved accrual of patient populations for pilot studies for subsequent studies supported through collateral funding. The director will convene an advisory panel of experts from outside the applicant institution at least once a year to review center activities and provide a written report on the progress of the center. This report may be included in the center's annual progress report to the NIDR. The center director will be expected to utilize panel recommendations in guiding and strengthening OHRCCC activities. Pilot and feasibility studies also will be administered through the administrative core and will remain under the purview of the center director. o Biostatistics, Experimental Design, Data Management and Analysis Core: This core will provide the staff and other resources needed to enhance programs of clinical research through the application of epidemiology, sampling, biostatistics, and related support methodologies. Specifically, it should foster and strengthen biostatistician-clinical investigator interaction in the design and conduct of clinical research. o Diagnostics Core: May provide and develop methods and/or instrumentation to detect early signs or markers of oral disease or dysfunction and to monitor the efficacy of treatments. o Laboratory Core: May provide resources and scientific expertise to carry out adjunct studies on clinical trial patients or general population samples. Animal resources may be included where appropriate. Laboratory cores could include, for example: behavioral/social sciences, biomaterial sciences, pharmacology, microbiology, immunology, nutrition, or molecular biology. The composition of the laboratory core(s) should reflect the resource needs and added research opportunities arising from ongoing clinical research activities. o Unique Clinical Facilities Core: May provide resources to facilitate research that cannot be carried out in conventional health-care settings, such as the use of mobile units for clinical studies involving elderly or physically disabled individuals or worksite-based dental operatories for preventive interventions with employed adults. The above descriptions are not intended to include the full range of possible activities. Inclusion of core units of all these types in a single proposed center is not required nor even necessarily advisable. In structuring OHRCCC proposals, applicants should consider their institution's areas of special clinical research potential, its profile of currently funded clinical research projects, and determine which areas present the greatest need for shared resources. Cores may provide support for personnel, including the necessary expertise to direct cores, equipment, supplies, services, facilities, and limited travel. In addition, they may provide funds for the integration of activities with other research centers in the same or related biomedical or behavioral/social science areas for purposes of program enrichment. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. This award also will provide up to $45,000 (i.e., no more than 15 percent of direct center costs) for pilot and feasibility studies. These are the only research projects that will be directly supported by this mechanism. The OHRCCC will not provide direct funding for ongoing research projects. These must be funded through other sources or support mechanisms. Each pilot or feasibility study must not exceed $20,000 in direct costs per year and must not extend for a period of more than two years. The goals of the pilot and feasibility studies are to provide start-up funds for new projects, to develop young investigators under the direction of experienced clinical scientists and to encourage established investigators to utilize recent research techniques in addressing areas of oral health concerns. Research plans for pilot and feasibility projects to be carried out during the first and second years of the award and detailed procedures for the review and selection of future such projects by advisory panels and the center director must be included in the application. SPECIAL REQUIREMENTS Each OHRCCC will be expected to establish, as an integral component of its mandatory biostatistics core unit, a plan that includes offering a regularly scheduled workshop and/or intensive minicourse. This plan should foster training in clinical oral health research methodology for basic scientists and clinicians, either with or without prior postdoctoral research experience. This may be accomplished through utilization of OHRCCC resources and/or associated projects and training grants supported by the NIH or by other public or private sources. Applicants should provide details of this plan in their applications and include pertinent funds, if any, in their budget requests. 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 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, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or 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 January 13, 1995, a letter of intent. This must include a descriptive title for the OHRCCC and each pilot and feasibility project and core, give the name, address, and telephone number of the center director and the identities of other key personnel and participating institutions and departments, and identify this RFA by number and title. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains is helpful in planning for the timely review of applications. It allows NIDR staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be addressed to Dr. G.G. Roussos at the address listed under INQUIRIES. APPLICATION PROCEDURES Prospective applicants are encouraged to communicate with program and grants management staff of the NIDR's Extramural Program as early as possible in the planning phase of application preparation. Advice and suggestions by staff may materially assist applicants to ensure that the OHRCCC's objectives and structure and the budget format are acceptable. Applications are to be prepared on form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-710-0267. The RFA label available in the PHS 398 application form kit must be affixed to the bottom of the face page of the original and the original must be placed on top of the entire package. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, in order to identify the application as a response to this RFA, the RFA title "Oral Health Research Clinical Core Centers" and number "DE-95-001" must be typed in item 2a of the face page of the application form and the YES box must be checked. The instructions accompanying form PHS 398 must be followed as far as possible, but some modification will be necessary. For example, a new Table of Contents must be prepared giving page numbers for all items in the application. Pagination must be consecutive throughout the application. Each pilot or feasibility project and core unit must be identified by number and investigator. A consolidated budget for the complete OHRCCC for the entire project period must be presented (use page 5, form PHS 398). Separate detailed, annual and total budgets for the entire project period for each project and core must be presented (use pages 4-5, form PHS 398). In addition, a summary table must be included providing budget totals for each project and core and for the entire program, for all years of support. Direct and indirect costs are to be given. Funds may be requested for professional, technical, and administrative personnel, consultant services, equipment, supplies, travel, patient costs directly related to the research, minor renovations and other costs. Detailed justification of the budget requests will be required. Specific attention should be given to efforts to contain costs and ensure cost-competitive implementation of center goals. Accordingly, provide a summary of additional financial support from non-NIDR sources for activities that will complement and expand the program proposed for support by the NIDR. Explain how these activities will further the goals of the OHRCCC and make it more cost-effective. Awardees will be expected to update this information on an annual basis. Under Research Plan, describe the goals of the center and explain how each proposed core and pilot/feasibility project will contribute toward achieving those goals. Describe the administrative structure, the responsibilities of the center director, individual investigators, advisory groups, and the proposed mechanisms for monitoring scientific progress. Describe the relationship of all existing and pending institutional research projects that may be relevant to the OHRCCC regardless of funding source. Each core unit must be presented as in a research grant application, that is, the instruction pages 19-24 of form PHS 398 should be followed. The 25-page limitation will apply to each core unit. Each pilot/feasibility study must be presented as in a small grant application, that is, the Research Plan may not exceed ten pages. Additional instructions and guidelines, in this connection, are to be found in the NIDR Small Grant Program announcement PA-91-36: NIH GUIDE, Vol. 20, No. 12, March 22, 1991, and in its modification by the notice that appeared in the NIH GUIDE, Vol. 22, No. 1, January 8, 1993. Abstracts (page 2, form PHS 398) must be completed for the entire application, each core unit, and for each pilot and feasibility study proposed for initiation during the first two years of the award. Whenever appropriate, the application must: (a) delineate all consortia arrangements and formally and officially confirm them by signed statements from the responsible official(s) of each institution; (b) be accompanied by firm funding commitments that ensure that appropriate clinical research projects will be active at the time of an OHRCCC award; and (c) include a letter of agreement from either the GCRC program director or principal investigator should the applicant identify a GCRC as a resource for conducting the proposed research. 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** At the time of submission, two additional copies of the application must also be sent to: Dr. H. George Hausch Extramural Program National Institute of Dental Research Natcher Building, Room 4AN-44F 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by June 13, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and responsiveness by the NIDR. Incomplete applications will be returned to the applicant without further consideration. If NIDR staff find that the application is not responsive to the RFA, it will be returned 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 review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Secondary review of the applications will be conducted by the National Advisory Dental Research Council. Major factors to be considered in the evaluation of the applications include: o The scientific merit of cores and pilot projects. This element involves, but is not limited to: (a) the availability of a base of meritorious ongoing clinical research projects or proposed projects with firm funding commitments permitting optimal utilization of OHRCCC resources; (b) the extent to which the center will expedite the translation of basic scientific knowledge into new and better methods for improving oral health; (c) the feasibility and relevance of plans for fostering training in clinical research methodology; (d) the scientific/technical merit and justification for requested core resources; (e) the scientific merit, appropriateness and relevance of pilot and feasibility projects proposed to be conducted during the first two years of the award; and (f) the ability to recruit individuals from appropriate study populations (i.e., women, subpopulations of minorities and disabled individuals) as defined by the NIH guidelines along with provisions for their protection from research risks and the humane treatment of any animal research subjects that may be used. o The experience of the director and key staff. This element involves, but is not limited to: (a) the scientific, clinical and administrative qualifications, experience and commitment of the center director and his/her ability to provide effective leadership as well as the provisions for selection of his/her replacement should it be necessary; and (b) the competence and commitment of the key center staff participating in core units and pilot/feasibility studies. o The scientific and administrative structure of the center. This element involves, but is not limited to: (a) the provisions for quality control during the development of the application and establishment of the center; (b) the procedures for monitoring the research; (c) the mechanisms for reviewing changes in research direction; (d) the composition and use of internal and external advisory committees; (e) the commitment of the institution to the proposed center; and; (f) the combination of the various projects and core units into an effective and cohesive program, and the adequacy of plans to ensure efficient collaboration, interaction, and dissemination of information among investigators. o The budget and period of support for the center. This element involves, but is not limited to: (a) the adequacy of the budget justification for each pilot and feasibility project and core resource as well as for the entire center; and (b) the extent to which complementary projects, supported from non- NIDR funds, will contribute to the cost-effectiveness of the proposed OHRCCC. o In the case of a competing continuation application, the progress made toward the original goals of the existing center in terms of: (a) success in attracting funds and in-kind contributions from other public and private sector sources; (b) establishment of one or more courses in clinical research methodology; and (c) contribution to significant research advances. The inclusion of pilot projects or cores deemed to have limited scientific merit or that are considered peripheral to the OHRCCC's objectives may be considered a reflection of the center director's judgement and may adversely affect the rating of the application. Component pilot projects or cores lacking significant and substantial merit will not be recommended for further consideration. Pilot projects or cores with only adequate merit that are not deemed essential to success of the OHRCCC may be recommended for deletion. AWARD CRITERIA The earliest anticipated date of award is December 1, 1995. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the OHRCCC to the NIDR will be considered by NIDR staff and the National Advisory Dental Research Council in making funding recommendations. One consideration will be the extent to which complementary projects, supported from non-NIDR funds, will contribute to the cost-effectiveness of the proposed OHRCCC. In circumstances in which applications have similar scientific merit, but vary in cost- competitiveness, the NIDR is likely to select the more cost- competitive application for funding. Once funded, an OHRCCC may undergo an interim peer review by NIDR to evaluate progress. Funding for subsequent years may be contingent on successful outcome of this review. 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: Dr. G.G. Roussos Extramural Program National Institute of Dental Research Natcher Building, Room 4AN 18A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-5500 FAX: (301) 480-8318 Email: roussosg@de45.nidr.nih.gov Direct inquiries regarding grants management issues to: Ms. Theresa Ringler Extramural Program National Institute of Dental Research Natcher Building, Room 4AS-55 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Email: rubinstein@de45.nidr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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