Full Text DE-92-01 DEVELOPMENT GRANTS: MINORITY ORAL HEALTH RESEARCH CENTERS NIH GUIDE, Volume 21, Number 6, February 14, 1992 RFA: DE-92-01 P.T. 04, FF Keywords: Oral Diseases Biomedical Research, Multidiscipl National Institute of Dental Research National Center for Research Resources Letter of Intent Receipt Date: March 1, 1992 Application Receipt Date: May 6, 1992 PURPOSE The National Institute of Dental Research (NIDR) and the Research Centers in Minority Institutions (RCMI) Program of the National Center for Research Resources (NCRR) invite applications for grants for the development of Regional Research Centers for Minority Oral Health (RRCMOH). The purpose of these Phase I grants is to enable minority dental schools or dental schools serving large minority populations to develop the necessary alliances and organizational structure necessary to compete for Phase II grants for the support of RRCMOHs. A Request for Applications (RFA) for Phase II, five-year grants for support of RRCMOHs will be available in 1994. The objectives of the RRCMOH initiative are to: (1) conduct research to improve the oral health of U.S. racial and ethnic minorities; (2) enhance the research capabilities and participation of members of racial and ethnic minorities in oral health research; and (3) develop and strengthen the minority oral health research infrastructure of minority dental schools and of majority dental schools serving large minority populations. African Americans (Blacks), Hispanics, Asians and Pacific Islanders, and American Indians and Alaskan Natives are considered to be racial or ethnic minorities. An orientation meeting for potential applicants will be conducted by NIDR and NCRR/RCMI Extramural Program staff in connection with the annual meeting of the American Association for Dental Research, March 11, 1992, in Boston, Massachusetts. Details of the time and location of the meeting are available from the NIDR staff listed below. A summary of the meeting will be available from the NIDR staff. 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, Developmental Grants for Regional Research Centers for Minority Oral Health, is related to the priority area of reducing health disparities among Americans by improving 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 Two types of United States institutions are eligible to apply: minority dental schools and other dental schools serving large populations of minorities. Only the following organizational structures are acceptable: 1. A minority dental school must propose an alliance with one or more research-intensive dental schools and may include additional alliances with one or more other minority institutions. 2. A dental school serving a large minority population must propose an alliance with one or more, research-intensive institutions and may include alliances with one or more minority institutions. If a dental school serving a large minority population also qualifies as a research-intensive institution, alliances must be proposed with one or more minority institutions. A dental school serving a large minority population is defined as one in which the patient population served consists of more than 50 percent individuals of the minority racial and ethnic groups listed above. A research-intensive institution is defined as one that received more than one million dollars in support for dental research training and research during Fiscal Year 1991. A list of organizations receiving $1,000,000 or more from the NIDR is provided as an appendix to this RFA. Additional institutions may apply. A minority institution is defined as any educational, health-care, or research institution largely staffed by or serving racial/ethnic minorities. To be responsive to this RFA, an application must propose collaborative alliances with other institutions that conform to the organizational structures listed above and address the objectives of the RRCMOH initiative. A research-intensive institution may not be the applicant organization unless it serves a large minority population. Applications proposing alliances between minority institutions without involvement of research- intensive institutions are not acceptable. Regional proximity of the allied institutions would be an asset but, for a variety of reasons, may not be possible. Applications from foreign institutions or those involving foreign alliances are not eligible. MECHANISM OF SUPPORT Phase I awards will be the National Institutes of Health developmental grants (P20). Awards will be for three years and the earliest funding date is September 1, 1992. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant institution; however periodic consultation with NIDR and NCRR/RCMI staff will be expected. This may take the form of periodic site visits. This RFA is a one-time solicitation by the NIDR and the NCRR/RCMI, unless it is determined that there is a continuing program need. A second RFA, soliciting applications for Phase II, five-year, P50 awards to support RRCMOH, will be available in 1994. The receipt of a Phase I grant will not be a prerequisite for submission of an application for a Phase II grant. FUNDS AVAILABLE If a sufficient number of highly meritorious applications are received, it is anticipated that six, three-year awards may be made. No award will exceed $225,000 in direct costs for the first year. Additional support, up to $50,000 in direct costs for the first year, may be provided to minority dental schools or other qualified minority institutions for RRCMOH-related faculty development activities. Increases in costs for subsequent years, including those for faculty development, will be limited to four percent. Award of grants pursuant to this RFA is contingent upon the availability of funds. OBJECTIVES Background Since the NIDR was established over 43 years ago, there has been a remarkable improvement in the oral health of the American population, primarily based on advances in oral disease prevention and the appropriate practice of oral hygiene. Today, almost half of all children between 5 and 17 years of age have no cavities in their permanent teeth. However, recent surveys show substantial variations in oral health among socio-demographic groups. The most rapidly growing segments of the population, minorities and the elderly, have not experienced the gains in oral health status enjoyed by many children and adolescents. There are still substantial gaps in the application of known preventives in populations at high risk of oral diseases, particularly minority populations who may not have access to dental services and other health promoting services. This disparity in oral health between minority and other population groups in America is highlighted in the NIDR Long-Range Research Plan for the Nineties, BROADENING THE SCOPE, a plan that calls for addressing all diseases affecting the oral cavity among all populations and at all ages. Representatives from the research community, including minorities, who participated in developing the plan, encouraged the NIDR to focus research on high-risk and other special care groups. They called for emphasizing social and behavioral research to develop culturally sensitive strategies for encouraging and maintaining changes in behavior. This initiative is intended to overcome institutional and cultural barriers that prevent access by minorities to oral health and well-being. In addition, it is intended to facilitate enhanced participation in the oral health research and research training enterprise available to other groups. The concept was endorsed by the National Advisory Dental Research Council (NADRC) and by an ad hoc Working Group on Regional Research Centers for Minority Oral Health, convened by the NIDR in August 1991. The necessity for a concerted effort in achieving the three major objectives of the RRCMOH initiative is based on the rapidly increasing number and diversity of minorities in the U.S. population and the generally poor status of oral health among minority populations. Between 1980 and 1990, the U.S. population increased by 10 percent. During the same period, Blacks in the population increased by 13 percent, Asians and Pacific Islanders by over 100 percent, American Indians and Alaska Natives by 38 percent, and Hispanics increased by 53 percent. The Census Bureau projects even steeper demographic growth in these groups over the next few years, further widening the gap in the oral health status of minorities and non-minorities. Although there is a clear need for more systematic, comprehensive, and usable information on the oral health status of racial and ethnic minorities, the available statistics dramatically portray a bleak picture of their oral health status. Between 1980 and 1987, U.S. school children of all races combined experienced a 36 percent decrease in dental caries, but Black school children experienced only a 20 percent decrease. Among the adult population, 18-64 years of age, during the same period, Blacks had a higher percentage of missing teeth than did Whites. Blacks also had a higher percentage (82 versus 50 percent) of decayed but untreated teeth than did Whites. In both adults and children, Blacks were 20 percent more likely to have clinical gingivitis than were Whites, and Blacks had a higher percentage of diagnosable sites with gingivitis. On all three parameters of periodontitis, depth of pockets, attachment loss, and number of pockets, the prevalence for Black adults and school-aged children exceeded those for Whites. Blacks were at much greater risk for all forms of early onset periodontitis than Whites, and Black males were 2.9 times as likely to have localized juvenile periodontitis as were Black females. With regard to oral and pharyngeal cancer in adults, Blacks experienced a one to three-fold greater incidence than did Whites, but in males, a one to five-fold greater incidence was seen. The mortality rate for oral and pharyngeal cancer among Blacks was about twice, 5.2 versus 2.8, that of Whites. Similarly, the survival rates of Blacks diagnosed with these cancers was about 22 percentage points lower than it was for Whites. Thus, on most measures of oral health status, Blacks appear to be considerably worse off than are Whites. The information available on Asians and Pacific Islanders and American Indians and Alaskan natives is too sparse for similar comparisons. Anecdotal reports of the health status of these groups indicate that they may be more disadvantaged than Blacks. Information about the oral health status of Hispanics in the United States is similarly sparse. A recent survey indicated that there are significant differences in oral health among different groups of Hispanic Americans. Dentate Cuban and Puerto Rican American adults had about twice as many missing teeth as White non-Hispanics. Cuban and Puerto Rican Americans had a higher number of filled and missing teeth than did Mexican Americans. The prevalence of dental caries in Mexican Americans was similar to that found in Blacks. Puerto Ricans and Cuban Americans had a caries prevalence between that of Black and White Americans. The prevalence of gingivitis in Hispanics was higher than that in White non-Hispanics. Puerto Rican children and adults had the highest prevalence of gingivitis among the Hispanic groups. The challenge of combating the oral health problems of Hispanics is increased by the rapid growth of the Hispanic population. The oral health status of the minority U.S. population may reflect the sparsity of minorities in the oral health manpower pool. The dearth of minority basic and clinical investigators can be attributed to the lack of opportunities for minorities to participate in research activities. According to the American Association of Dental Schools, approximately 4,000 students graduate from dental school each year, but only 216 are Black and 320 are Hispanic. Less than five percent of these, 11 Blacks and 16 Hispanics, are expected to enter research. Although the NIDR supports research training through a variety of mechanisms, very few minorities participate in these programs. For example, as of July 1991, there were only 26 self-identified minorities (15 percent) among 173 trainees supported by National Research Service Awards from the NIDR. Only 14 so-designated minorities (11 percent) were among the 129 individuals receiving training under the Career Development Award (K Series) mechanism. The Research Supplements for Underrepresented Minorities initiative seems to be a partial solution to the low level of minority participation in the traditional training mechanisms. However, it is too early to determine if this mechanism will have a sustained positive effect, and complementary approaches appear to be needed to attract and retain minorities in the research enterprise. Center Characteristics Each center will be a consortium consisting of two or more institutions, as described under ELIGIBILITY REQUIREMENTS. The consortium will be structured to foster an alliance capable of addressing each of the objectives of the RRCMOH initiative in a productive manner. A director, affiliated with the applicant institution, and a co-director affiliated with the principal collaborating institution, will be responsible for the scientific and administrative leadership. The director will be assisted by an advisory committee of staff from the principal participating institutions and consultants with appropriate research experience and accomplishments, who are not associated with the participating institutions. This committee will assist in preparation of the application and advise the director on the merits and progress of research projects and faculty development activities. The center will consist of a series of related research projects and cores, relevant to the oral health of minorities. The research projects may be of a pilot nature or a small-scale research project. Some may involve basic biomedical or behavioral research and others may be epidemiological or clinical in scope. Each project will involve participation by co-investigators from two or more of the collaborating institutions. Core resources such as center development activities, administrative services, unique clinical facilities, animal facilities, biostatistical and computer services, and shared equipment will be supported. The center development core might include meetings and other activities to explore new and expanded collaborative research and training opportunities. Budgetary constraints preclude expenditures for expensive items of equipment and renovations. In general, study populations will be drawn from the clinics and the neighborhood of the minority dental school or of the dental school serving a large minority population. Projects involving outreach to minority community organizations are encouraged. It is expected that the RRCMOHs will provide opportunities to foster the development of minority faculty as investigators. Career development is considered a natural adjunct of a productive research environment. Minority dental school applicants may request up to $50,000 per year for support of faculty development. These funds will be provided by the RCMI Program of the NCRR and are in addition to those provided by the NIDR for support of the developing RRCMOH. These activities may be conducted at any of the collaborating institutions. Formal training activities cannot be supported directly by this grant mechanism. Research training for minority high school, undergraduate and graduate students, and postdoctoral fellows at the RRCMOH is highly desirable, but must be supported from other sources, including other components of the NIH. Research-intensive dental school applicants are expected to obtain support for training and career development from other sources. However, support for development of faculty from a collaborating minority dental school or institution may be requested. It is anticipated that during Phase II, the RRCMOHs will be able to compete effectively for National Research Service Awards to support training programs and for Research Career Development Awards. A typical center might consist of three small research projects, several pilot research projects, two or more cores including that for developmental activities, and a faculty development component. Additional Information Applicants are reminded that this solicitation requests applications for Phase I grants to enable institutions to develop the necessary collaborative alliances and organizational structure necessary to compete for Phase II grants for the support of a RRCMOH. Applications must explain and justify how existing and potential human and physical resources will be utilized during the three years of developmental support to create a functioning center capable of meeting the objectives of the RRCMOH initiative. The NIDR plans to issue in FY 1995 an RFA for large Phase II grants to support RRCMOHs. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants 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 form PHS 398 in Section 2, A-D of the Research Plan and summarized in Section 2, E, Human Subjects. Applicants 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. 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 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 the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTERS OF INTENT Prospective applicants are asked to submit, by March 1, 1992, a letter of intent that includes a descriptive title of the proposed center, the name, address and telephone number of the center director, co-director, the identities of other key personnel and participating institutions, and the number and title of this RFA. 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 possible conflict of interest in the review. The letter of intent is to be addressed to: Matthew Kinnard, Ph.D. Director, Oral Soft Tissue Diseases and AIDS Program Extramural Program National Institute of Dental Research Westwood Building, Room 509 5333 Westbard Avenue Bethesda, MD 20892 Telephone: (301) 496-7784 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. NIDR staff are available to assist applicants to ensure that the objectives, structure, and the budget format for the proposed center are acceptable. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892; and from the program administrator named below. The RFA label available in 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. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box checked. The instructions accompanying form PHS 398 must be followed, 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 research project, the faculty development activities and core must be identified by number and investigator. A consolidated budget for the complete center over the entire project period must be presented (see page 5, form PHS 398). Separate detailed, annual and total budgets for the entire project period for each research project and core must be presented (use pages 4-5, form PHS 398). 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. Document the commitment of collaborating institutions to the center. 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 center and make it more cost effective. Under Section 2, Research Plans, describe the goals of the center and discuss the background and significance of the topics being addressed. Explain how each research project, core, and the faculty development activities will contribute to achieving those goals. Describe the organizational and administrative structure, the responsibilities of the director and co-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 center, regardless of funding source. Each small research project must be presented as in a research project grant application, that is, the instruction pages 19-23 of form PHS 398 must be followed. Because these are small projects, each project description is expected to be significantly less then the 20-page limit that applies to traditional research project grant applications. Each pilot project must be presented in 400 words or less. Faculty development activities must be presented as a separate project. Describe the core units and explain the manner in which the resources will be utilized by other scientifically related projects. Abstracts (page 2, PHS 398) must be completed for the entire application, each small research project, the combined pilot research projects, the faculty development activities, and the cores. Submit a signed, typewritten original of the application, including the Checklist, and four 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 must also be sent to: Dr. George Hausch Chief, Scientific Review Office National Institute of Dental Research Westwood Building, Room 519 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 6, 1992. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Applications that are incomplete, nonresponsive to this RFA, or exceed the first year budget limit of $225,000 in direct costs will be returned to the applicant without further consideration. Applications requesting support of faculty development activities may exceed the budget limit by up to $50,000 in direct costs attributable to faculty development. Waivers of the receipt date deadline and budget limitation will not be granted. However, where indirect costs are assigned to a subcontract and counted as direct costs on the parent grant, the allowable direct cost maximum may be exceeded by the amount of the indirect costs assigned to the subcontract. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by a special review committee convened by the NIDR Scientific Review Office. Applications may be subjected to triage by the committee to determine scientific merit relative to other applications received in response to this RFA. The NIDR will withdraw from further competition those applications judged by triage to be noncompetitive for award and notify the applicant and institutional official. Applications judged to be competitive will undergo further scientific merit review. This review may involve an applicant interview or site visit. The second level of review will be provided by the NADRC. Major factors to be considered in the evaluation of applications include: 1. The scientific merit of each pilot and small research project including its significance, originality, feasibility, and experimental design. 2. The technical merit and justification for core resources requested including the extent to which they will assist in developing the center. 3. The combination of the various pilot and small research projects, core units, and faculty development activities into a cohesive program that will address the center objectives. 4. The adequacy of the administrative and organizational structure to ensure efficient inter- and intra-institutional collaboration, interaction, and dissemination of information among investigators necessary to attain center objectives. 5. The competence and mix of the investigators from collaborating institutions and their commitment to the accomplishment of the research goals and objectives of the center. 6. The qualifications, experience, and commitment of the center director and co-director including their ability to provide effective leadership of the center. Provisions for selection of replacement directors if it should become necessary. 7. The composition and use of the director's advisory committee. Provisions for quality control during development of the application and procedures for monitoring research. 8. The commitment of collaborating institutions to the center; the adequacy of their facilities, resources, and administrative capabilities. 9. The effectiveness of the faculty development opportunities offered, including the quality of research experiences and mentoring to be provided. 10. The appropriateness of the period of support and budget requested for pilot and small research projects, cores, faculty development activities and for the entire center. This includes the distribution of responsibilities and funding among collaborating institutions. 11. The availability and appropriateness of study populations and the utilization of minorities and women as study subjects. The inclusion of projects that are deemed to have little or no scientific merit or that are deemed peripheral to the objectives of the RRCMOH may be considered a reflection of the director's judgement and may adversely affect the rating. Component projects without significant and substantial merit will not be recommended for further consideration. If such projects are deemed not essential to the success of the center, they will be recommended for deletion. AWARD CRITERIA 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 and NCRR/RCMI. Such circumstances will be considered in making any award. 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. Matthew Kinnard at the address under LETTER OF INTENT. Direct inquiries concerning fiscal matters to: Theresa Ringler Grants Management Officer Extramural Program National Institute of Dental Research Westwood Building, Room 518 5333 Westbard Avenue 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 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. APPENDIX U.S. Research Intensive Institutions Receiving More Than $1.0 Million for Dental Research and Research Training from the NIDR in Fiscal Year 1991 Institution City State University of Washington Seattle WA State University of New York at Buffalo Buffalo NY Forsyth Dental Center Boston MA University of Alabama at Birmingham Birmingham AL University of Florida Gainesville FL University of Pennsylvania Philadelphia PA University of Michigan at Ann Arbor Ann Arbor MI University of Iowa Iowa City IA Univ. of Texas Health Science Center at San Antonio San Antonio TX University of North Carolina, Chapel Hill Chapel Hill NC University of Rochester Rochester NY University of Minnesota Minneapolis MN University of Southern California Los Angeles CA University of California, San Francisco San Francisco CA University of Connecticut Health Center Farmington CT Virginia Commonwealth University Richmond VA Harvard University Boston MA American Dental Association Health Foundation Chicago IL University of Texas Health Science Center Houston Houston TX University of California, Los Angeles Los Angeles CA Emory University Atlanta GA Columbia University New York New York NY Louisiana State University Medical Center New Orleans New Orleans LA Medical College of Georgia Augusta GA University of Massachusetts Medical School Worcester MA Additional institutions may apply. .
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