RFA DE-91-01 l/ll/9l NIH Guide RESEARCH CENTERS IN ORAL BIOLOGY RFA AVAILABLE: DE-91-01 P.T. 04; K.W. 0715148, 0710030, 0785035, 0710070, 1002027, 1002019, 0710095 National Institute of Dental Research Letter of Intent Receipt Date: June 1, 1991 Application Receipt Date: September 16, 1991 PURPOSE The National Institute of Dental Research (NIDR) invites applications from United States institutions for support of Research Centers in Oral Biology (RCOB). The primary goal of the RCOB program is to broaden and strengthen the scientific base underlying the national capability to improve oral health. The RCOBs bring teams of investigators into collaborative relationships to conduct interdisciplinary and multidisciplinary research. Clinical research will be supported only to the extent that it is a direct extension of the basic research conducted by center investigators. The NIDR uses other mechanisms, including categorical centers and clinical core centers, to support clinical research focussing on the principal oral diseases and conditions. BACKGROUND INFORMATION During the late 1960's, the NIDR initiated a program of Dental Research Institutes and Centers to strengthen the inadequate scientific base of dental research. This program was highly successful in achieving this objective. In the mid-1970's, advisors recommended that NIDR utilize the research center support mechanism to focus on specific oral health problems. This recommendation was based on the need for a coordinated attack on these problems, combining basic and clinical research approaches. As a result, NIDR developed a categorical research centers program and initiated centers on periodontal diseases and caries research. Subsequently, categorical and thematic centers were funded, which focussed on orofacial pain, craniofacial anomalies, materials science, and oral health and aging. The National Advisory Dental Research Council recommended instituting the RCOB program to provide support for multidisciplinary research centers that bring together the diverse resources of an institution to apply emerging technologies to investigate important basic science problems relevant to oral health and diseases. This program was initiated in 1987 by a Request for Applications (RFA) that resulted in four RCOBs being funded. The present RFA announces the first recompetition of the RCOB program. RESEARCH GOALS AND SCOPE The RCOB program's primary goal is the expansion of the scientific base which underlies the nation's capability to prevent and control oral diseases and disorders and to improve oral health. The secondary goal is to create centers of excellence that will attract investigators of high quality to dental research, 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. Support will be provided for interdisciplinary and multidisciplinary studies in basic biomedical research areas relevant to the mission of the NIDR. Examples of research areas that are particularly appropriate for study in a RCOB include: immunology; microbiology and virology; genetics; developmental biology; tissue structure and function; tissue repair and regeneration; salivary glands and secretions; nutrition; and neurobiology. Clinical research will be supported only to the extent that it is a direct extension of the basic research conducted by center investigators. Support for substantial clinical studies and clinical trials must be derived from other sources. Support will not be provided for a research program that has as its single focus a categorical or thematic area already targeted by NIDR for support. 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 Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. 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 question(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. MECHANISM OF SUPPORT RCOBs will be supported for five years with funding projected to start on December 1, 1992. Renewal support will be contingent upon program needs and an institution's ability to compete successfully in response to an RFA. Awards are contingent upon the availability of appropriated funds. All policies and requirements that govern the research grant programs of the PHS will apply to the awards. The NIDR anticipates making four awards, not to exceed $750,000 each in direct costs for the first year of the award if a sufficient number of applications of high scientific merit are received. Applicants are encouraged to seek complementary support from other federal government or nonfederal sources. DIRECTION AND LEADERSHIP Strong and effective scientific leadership must be provided. RCOB directors will be responsible for the organization and operation of the program 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 components and projects be interrelated; they should not constitute a collection of individual projects more appropriately supported by individual research project grants. REVIEW PROCEDURES AND CRITERIA Applications will be evaluated by a special review committee convened by the NIDR Scientific Review Branch. Prior to the initial review, a triage mechanism may be employed to screen out applications that are noncompetitive or nonresponsive to the RFA. An applicant interview or site visit may be included. Secondary review will be conducted by the National Advisory Dental Research Council. Applications in response to this announcement must be received by September 16, 1991, so they can be reviewed and considered for funding in Fiscal Year 1993. Noncompetitive or nonresponsive applications and those received after September 16, 1991 or that exceed the budget limitation will be returned to the applicant. Waivers of the receipt deadline and budget limitation will not be granted. Major factors to be considered in the evaluation of applications include: 1 The scientific merit of each proposed project, including its significance, originality, feasibility, and experimental design. 2 The combination of the various components, projects, core units, and pilot projects into an effective and cohesive program, and the adequacy of plans to ensure efficient collaboration, interaction, and dissemination of information among investigators. 3 The competence of the investigators and their commitment to the accomplishment of the proposed research goals. 4 The availability of statistical and data analysis resources and evidence of their use in developing research protocols. 5 The qualifications, experience, and commitment of the director, including the ability to provide effective leadership of the project. Provisions for selection of a replacement director if it should be necessary. 6 The scientific and administrative structure of the program, including provisions for quality control during development of the application; procedures for monitoring the research; and mechanisms for reviewing potential pilot projects. The composition and use of internal and external advisory committees. 7 The institution's commitment to the program; the adequacy of its facilities, resources, and administrative capabilities. 8 The appropriateness of the period of support and budget requested for each component, 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 RCOB. 9 If clinical studies are proposed, the availability and appropriateness of study populations and the utilization of minorities and women as study subjects. 10 Ethical aspects, including the provisions for the protection of human subjects and for the humane treatment of animals. ADDITIONAL INFORMATION AND GUIDELINES 1 Applicants may request up to $750,000 in direct costs for the first year with no more than four percent increases in each subsequent year. Where indirect costs are assigned to a subcontract and counted as direct costs, the allowable direct cost maximum of $750,000 may be exceeded by the amount of the indirect cost assigned to the subcontract. Applications that exceed these limits will be returned to the applicant. Applicants are encouraged to seek support from other sources, including foundations and industrial concerns, for studies that will complement and expand the program supported by the NIDR. A summary of the objectives and financial support for such studies and an explanation of how they will further the goals of the RCOB and make it more cost effective should be included in the application. 2 A typical RCOB consists of 5-7 projects distributed among 2-3 major components and served by 2-3 core units. Each core unit must be utilized by at least two projects. Limited support ($35,000 per year) will be provided for pilot or feasibility projects. 3 RCOB directors will meet once a year with each other and with NIDR staff and consultants to exchange information and ideas, assess progress, resolve actual or potential problems, and explore opportunities for collaboration. The funds for these meetings must be included in the budget. 4 An interim review may be conducted by NIDR to evaluate progress. The funding for subsequent years may be contingent on a successful outcome of this review. 5 The inclusion of projects that are deemed to have only adequate or no scientific merit or that are considered peripheral to the RCOB's objectives may be considered a reflection of the Director's judgement and may affect the rating of the application. Component projects devoid of merit will be disapproved. Projects with only adequate merit that are not deemed essential to the success of the RCOB may be recommended for deletion. Each component and project recommended for approval will receive its own priority score. 6 Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of an RCOB to the NIDR will be considered by NIDR staff and the Council in making funding recommendations. An additional consideration will be the extent to which complementary projects, supported from non-NIDR funds, will contribute to the cost effectiveness of the proposed RCOB. TIMETABLE Letter of Intent.........................June 1, 1991 Receipt of Applications............September 16, 1991 Advisory Council Review.....................May 1992 Projected Award Date...................December 1992 METHOD OF APPLICATION Prospective applicants should communicate with program and grants management staff of the Institute'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 RCOB's objectives and structure and the budget format are acceptable. At a minimum, prospective applicants are urged to submit, by June 1, 1991, a letter of intent that identifies this RFA; includes a descriptive title for the RCOB, each component and project; gives the name, address, and telephone number of the Director and the names of other key personnel; and identifies participating institutions and departments. It should be addressed to the Director, Extramural Program, NIDR. The letter of intent is not binding nor is it a prerequisite for acceptance of an application but it will assist staff in planning for the timely review of applications. Applications must be prepared on Form PHS 398 (Rev. 10/88), Application for PHS Grant, which can be obtained from the Division of Research Grants, NIH, or from the institution's Office of Research and Sponsored Programs. To identify the application as a response to this RFA, check "yes" on Item 2 of page 1 of the application and enter the title "Research Centers in Oral Biology" and the RFA number DE-91-01. Use the RFA label provided in the PHS-398 application package. 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 component, project and core must be identified by number and investigator. A consolidated budget for the complete RCOB for the entire project period must be presented (use page 5, 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. Not more than $35,000 each year may be requested for a group of pilot or feasibility projects. 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 RCOB and make it more cost effective. Under Section 2, Research Plans, describe the goals of the RCOB and discuss the background and significance of the topics being addressed. Explain how each component, project, core, and the pilot projects will contribute to achieving those goals. Describe the administrative structure, the responsibilities of the Director, individual investigators, 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 RCOB regardless of funding source. Each project must be presented as in a research project grant application, that is, the instruction pages 19-23 of Form PHS-398 should be followed. The 20-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. Each pilot project to be conducted during the first 2 years of the award must be presented as a concept in 200 words or less. Concepts for pilot projects to be conducted in subsequent years must be submitted later in noncompeting continuation applications (Form PHS 2590), prior to their initiation. Abstracts (page 2, Form 398) must be completed for the entire application, each component, project, and core. The original and four copies of the complete application must be received by September 16, 1991, at: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** Two copies of the application, letters of intent, and all inquiries should be directed to: Director Extramural Program National Institute of Dental Research National Institutes of Health 5333 Westbard Avenue, Room 503 Bethesda, MD 20892-4500 Telephone: (301) 496-7723 This program is described in the Catalog of Federal Domestic Assistance No. 93.845. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 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.