Full Text DE-92-02 RESEARCH CENTERS ON ORAL HEALTH IN AGING NIH GUIDE, Volume 21, Number 10, March 13, 1992 RFA: DE-92-02 P.T. 34 Keywords: Oral Diseases Biomedical Research, Multidiscipl Behavioral/Social Studies/Service Epidemiology National Institute of Dental Research National Institute on Aging Letter of Intent Receipt Date: August 1, 1992 Application Receipt Date: November 10, 1992 PURPOSE The National Institute of Dental Research (NIDR) and the National Institute on Aging (NIA), as part of their expanding programs of research on the oral health of older Americans, invite applications from United States institutions for the support of Research Centers on Oral Health in Aging (RCOHAs). The primary goal of these centers is to provide support for interrelated, multidisciplinary, basic biomedical and behavioral research and clinical or epidemiological studies of oral health in relation to aging. The research emphasis of individual applications may differ depending on the expertise, resources, and interests of the applicant group. However, unless clearly a part of a research study, clinical treatment is not be to included. This Request for Applications (RFA) represents one mechanism in the implementation of a major NIDR initiative, the Research and Action Program for Improving the Oral Health of Older Americans and Other Adults at High Risk. Other mechanisms used by NIDR in spearheading this program include clinical core centers and research and development contracts. This RFA is for a single competition with a receipt date of November 10, 1992. Support for this initiative will be through specialized center grants (P50) for a period of five years, commencing as early as September 1, 1993. First year budgets may not exceed $500,000 in direct costs. It is anticipated that one or two awards may be made. 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, Research Centers on Oral Health in Aging, 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, hospitals, laboratories, units of State and 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 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 if these arrangements are clearly delineated and formally and officially confirmed by signed statements from the responsible officials of each institution. To be eligible for a center grant under this program, the potential applicant institution must have ongoing, independently supported research and must propose new research in the area of oral health in aging. MECHANISM OF SUPPORT RCOHAs will be supported by specialized center grants (P50) for a period of five years, commencing as early as September 1, 1993. This RFA is a one-time solicitation. Subsequent support will be contingent upon program needs and an institution's ability to compete successfully in response to an RFA. In addition to support for multidisciplinary research projects, support will be provided for core resources, the sharing of which will facilitate the total research effort. Each core unit must be utilized by at least two projects. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. FUNDS AVAILABLE Applicants may request up to $500,000 in direct costs for the first year. Whenever indirect costs are assigned to a subcontract and counted as direct costs, the direct cost maximum of $500,000 may be exceeded by the amount of the indirect costs assigned to the subcontract. Applications that exceed these limits will be returned without review. Budget increases of no more than four percent per year may be requested for each of the subsequent four years. Applicants are encouraged to seek support from other public and private sector sources, including foundations and industrial concerns, for studies that will complement and expand the research supported by the RCOHAs. A summary of the objectives and financial support for such studies must be included in the application. It is anticipated that one or two awards will be made and at least $750,000 in total cost 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. 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. RESEARCH OBJECTIVES Background In the last 10 years, there has been a considerable increase in research associated with aging. This has been principally stimulated by general increases in the life span and by demographic studies that predict a markedly increasing proportion of elderly individuals as the 21st century approaches. For example, in the United States it is expected that, by year 2030, one out of every five persons will be 65 years of age or older. Such population shifts clearly will have major effects on all facets of society, including health care. Accordingly, many clinical disciplines, including dentistry, have begun to evaluate the functional status of elderly patients. These studies have accomplished several things. Perhaps most importantly, they have shown that aging and disease are different. Many of the classical stereotypes associated with growing old have been shown to be the results of disease or the treatment of disease. These studies also have begun to define problems that clinicians will increasingly face with elderly patients, problems that may place excessive demands on current care providers, many of whom lack geriatric training or appropriate resources. There are relatively few studies that provide large-scale descriptions of oral health status in the elderly. These studies are from either Western Europe or the United States and are mostly cross-sectional in design. At least two longitudinal studies exist, however, that examine oral health. Most studies have tended to concentrate on dental and periodontal health status. From these studies, there appear to be clear trends among elderly persons to retain an increasing number of teeth and thus to experience less edentulousness. However, available data also suggest that older individuals generally suffer from more severe periodontal diseases than do young adults, and root caries is becoming an increasing problem. Some workers have conducted assessments of less commonly studied oral functions such as salivary secretion, taste, smell (to which taste is inextricably linked), nonchemical oral senses, oral motor performance (such as mastication, swallowing and speech), and mucosal integrity. These studies demonstrate that there are no alterations in the ability of parotid glands to secrete saliva among different aged persons, but the effect of age on submandibular/sublingual gland function remains equivocal. Most modern studies of gustatory function have generally concluded that alterations associated with aging are modest and quality specific. These changes do not appear to influence nutritional status. Conversely, there are several studies that demonstrate significant reductions in olfactory performance with age and such alterations may have given rise to many of the suggestions that food enjoyment is reduced in the elderly. Some studies also have indicated that there are reductions in oral motor function with age, including changes in masticatory performance, speech, and the oral phase of swallowing. Generally, other aspects of oral physiology in the elderly have received little investigative attention. Thus, there is virtually no data on the lubricator, antimicrobial and remineralizing functions of saliva in the elderly; negligible information on the integrity of the mucosal barrier and non-chemical oral senses; and, most importantly, almost no information relating subjective complaints to objective measurements of these many functional concerns. There is a great need to describe oral physiological status across the life span in healthy persons, free of overt disease and medication, as well as to provide such descriptions in patients with defined diseases and therapeutic regimens. In part, the current lack of data reflects past limitations of diagnostic tools. At present, there are a number of methods, suitable for use in population studies, that have been developed to assess the broad spectrum of oral physiological functions mentioned. They need merely to be applied. If changes are identified among the elderly, it will be important to determine if they are of biological or only statistical significance. These data would be valuable for health care planners in anticipating the treatment needs of this increasing segment of society. The NIDR and the NIA, as part of an expanding program in gerontologic oral health research, encourage the submission of applications for the support of RCOHAs. This program was initiated in 1987 by an RFA that resulted in one RCOHA being funded. The present RFA announces the first recompetition, in modified form, of the original RCOHA program. Other The RCOHA program's primary goal is to provide support for interrelated, multidisciplinary, basic biomedical and behavioral studies as well as clinical and/or epidemiological research in the broad area of oral health in relation to aging. The secondary goal is to create centers of excellence that will attract investigators of high quality to this field of endeavor, provide challenging opportunities for research training at all levels of career development, and serve as magnet organizations to foster productive research-related relationships with other institutions. Some examples of research areas to be addressed regarding oral health in the elderly might include, but should not be limited to: o Determination of the incidence and prevalence of the major oral diseases and conditions of the elderly, including root caries, periodontal diseases, edentulousness, soft tissue lesions (e.g., candidiasis, leukoplakia, and oral cancer), xerostomia, chronic pain conditions (e.g., tic douloureux, post-herpetic neuralgia, burning tongue syndrome, and atypical facial pain), and osteoporosis of alveolar bone. o Characterization of the risk factors and correlates of oral diseases and conditions in elderly populations. o Characterization of the natural history of oral disease versus oral health among persons who seek dental services and those who do not. These studies should involve an assessment of the principal variables that influence utilization of dental services by the elderly. o Exploration of the potential of using oral tissues as models to test theories of aging that focus on intracellular molecular or genetic changes. o Characterization of normal changes (e.g., in the population of pluripotential stem and amplifying cells) in skin and oral mucosa in aging, and determination of the extent to which aging affects functional aspects of the oral mucosa with particular emphasis on permeability, mucosal immunity, and turnover (cell replacement) rates. o Determination of the effects of aging on salivary flow rate and levels of salivary components (e.g., lubricator and antimicrobial factors; mineralizing reservoir) and their relationship with salivary-related functional abnormalities, noting, for example, what factors are associated with complaints of dryness, root caries or unusual dental abrasion, presence of ulcerations, fungal or other oral infections, disorders affecting taste or other sensory modalities, and motor problems such as difficulties in speech or swallowing. o Determination of the effects of aging on salivary mucous acinar cell function compared with serous acinar cell function, and on bacterial attachment and subsequent colonization of oral tissues. o Determination of whether or not and how normal aging modifies collagen metabolism, the structure and function of bone and cartilage matrix molecules, dentin, and cementum proteins, the effects of hormones, vitamins, peptide, and other endogenous factors as regulators or modulators of cellular activities relating to mineralization, and the vascularity of bony tissue and repair and remodeling functions. o Determination of alterations that may occur in the periodontal apparatus with aging. o Determination of the effects of aging on chemosensory, pain, tactile, temperature, and pressure sensation and perception. o Development of new and improvement of existing tools for the assessment of oral motor function (swallowing, mastication, and speech) in healthy and in impaired older persons. o Studies of the relation between diseases and disorders (e.g., autoimmune and neurological disorders, diabetes, and bone and joint disease) that affect oral health in the elderly, the treatments, and oral tissues. For example, these studies may include determination of the etiology and natural history of primary and secondary sicca syndromes and development of effective treatments, determination of the relationship between radiographically observed alveolar bone loss and bone changes (osteoporosis) elsewhere in the body, and determination of how clinically defined states of anxiety and depression affect oral sensory and motor functions and perception and how these interact with appetite, eating habits, and nutritional status to affect oral and general health. o Identification of the psychological and sociocultural factors that are associated with oral hygiene behavior over the life span and development and evaluation of oral health promotion and disease prevention interventions that are appropriate for the various subpopulations (e.g., institutionalized and physically and mentally impaired) of the elderly. o Development of methods to prevent root and secondary caries, new restorative materials that are particularly amenable to the oral needs and health conditions of the elderly, and an artificial saliva with mucosal protective and anticaries properties that could be "slow released" in the mouth. o Evaluation of the effectiveness of conservative versus surgical treatment for periodontal diseases at different levels of disease severity and among different subpopulations of the elderly. o Development of modifications of prosthetic appliances to make them more acceptable to all categories of elderly patients and exploration of the use of dental implants for elderly patients. SPECIAL REQUIREMENTS In order to foster communication, cross-fertilization, and potential collaboration in areas of mutual interest between RCOHA investigators and other NIDR grantees and contractors involved with research on oral health in aging, applicants must include plans in the budget requests and a statement in the applications about the willingness of the key investigators to participate in a workshop to be held at the National Institutes of Health (NIH) near the end of the second budget period. Direction and Leadership Strong and effective scientific leadership must be provided. RCOHA directors will be responsible for the organization and operation of the centers and for communication with NIDR on scientific and administrative matters. Directors will be responsible for maintaining high quality research and for ensuring effective collaboration among individual investigators. It is essential that the research projects be interrelated; they should not constitute a collection of individual projects more appropriately supported by individual research project grants. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in items 1-4 of the Research Plan AND summarized in item 5, Human Subjects. Applicants/offerors are urged to asses carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific questions(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by August 1, 1992, a letter of intent that includes a descriptive title for the RCOHA, each project and core, gives the name, address, and telephone number of the center director and the identities of other key personnel and participating institutions and departments, and identifies 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 conflict of interest in the review. The letter of intent is to be addressed to: G.G. Roussos, Ph.D. Director, Salivary Research and Oral Biology Centers Program Extramural Program National Institute of Dental Research Westwood Building, Room 505 Bethesda, MD 20892 Telephone: (301) 496-7884 FAX: (301) 496-4180 APPLICATION PROCEDURES Prospective applicants are advised to communicate with program and grants management staff of the NIDR 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 RCOHA objectives and structure and the budget format are acceptable. Applications are to be prepared on form PHS 398 (rev. 9/91), Application for PHS Grant, available at most institutional business or grants and contracts offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892 (telephone 301-496-7441). The RFA label available in the PHS 398 application 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 "Research Centers on Oral Health in Aging" and number "DE-92-02" 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 project and core must be identified by number and investigator. A consolidated budget for the complete RCOHA 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). Present a table giving the 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. Provide a summary of financial support from non-NIDR sources for studies that will complement and expand the program supported by the NIDR. Explain how these studies will further the goals of the RCOHA 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 RCOHA and discuss the background and significance of the topics being addressed. Explain how each project and core will contribute to 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 RCOHA regardless of funding source. Each project must be presented as in a research project grant application, that is, the instruction pages 19-24 of form PHS 398 must be followed. The 25-page limitation will apply to each project. Describe the core units and explain how they will relate to the projects that will utilize their resources. Abstracts (page 2, form PHS 398) must be completed for the entire application, each project, and core. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact 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: H. George Hausch, Ph.D. Chief, Scientific Review Office Extramural Program National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 496-7658 Applications must be received by November 10, 1992. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Review Procedures and Criteria Applications will be evaluated initially for scientific and technical merit by a special review committee convened by the NIDR Scientific Review Office in consultation with the NIA. Prior to the initial review, a triage mechanism may be employed to determine competitiveness among the applications received. An applicant interview or site visit may be conducted. Secondary review will be conducted by the National Advisory Councils of the NIDR and the NIA. Non-competitive or non- responsive applications and those received after November 10, 1992 or that exceed the budget limitation will be returned to the applicant. Waivers of the receipt deadline and budget limitation will not be granted. Factors to be considered in the evaluation of applications include: o The scientific merit of each proposed project, including its significance, originality, feasibility, and appropriateness and adequacy of the experimental design. o 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 extent to which the center will promote advances leading to improvements in the oral health of older individuals that could not be achieved, or that would be achieved more slowly, if the component projects were funded separately. o The competence of the investigators, the appropriateness of the proposed level of effort, and commitment to the accomplishment of the proposed research goals. o The availability of statistical and data analysis resources and evidence of the use thereof in developing research protocols. o The scientific and administrative qualifications, experience, and commitment of the director, including the ability to provide effective leadership. Provisions for selection of a replacement director if it becomes necessary. o The scientific and administrative structure and provisions for quality control during development of the application and establishment of the center; procedures for monitoring the research; and mechanisms for reviewing changes in research directions. The composition and use of internal and external advisory committees. o The scientific/technical merit and justification for core resources requested. o The institution's commitment to the center; the adequacy of its facilities, resources, and administrative capabilities. o The appropriateness of the period of support and budget requested for each project, core, and for the entire center. The extent to which complementary projects, supported from non-NIDR funds, will contribute to the cost-effectiveness of the proposed RCOHA. o If clinical studies are proposed, the availability and appropriateness of study populations and the utilization of minorities and women as study subjects. o Ethical aspects, including the provisions for the protection of human subjects and for the humane treatment of animals. Additional Information and Guidelines The inclusion of projects that are deemed to have only adequate or no scientific merit or that are considered peripheral to the RCOHA's objectives may be considered a reflection of the center director's judgement and may affect the rating of the application. Component projects lacking significant and substantial merit will not be recommended for further consideration. Projects with only adequate merit that are not deemed essential to the success of the RCOHA may be recommended for deletion. Each project deemed to have significant and substantial merit will receive a separate priority score. AWARD CRITERIA The earliest anticipated date of award is September 1, 1993. Applicants should be aware that, in addition to scientific merit, program priorities, and program balance, the total cost of an RCOHA will be considered by NIDR/NIA staff and the Councils in making funding recommendations. An additional consideration will be the extent to which complementary projects, supported by other awards, will contribute to the cost-effectiveness of the proposed RCOHA. Once funded, an RCOHA may undergo an interim review by NIDR/NIA to evaluate progress. The funding for subsequent years may be contingent on a 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 at the address and telephone number under LETTER OF INTENT. Inquiries regarding fiscal matters may be directed to: Ms. Theresa Ringler Chief, Grants Management Office Extramural Program National Institute of Dental Research Westwood Building, Room 518 Bethesda, MD 20892 Telephone: (301) 496-7437 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. .
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