RFA-DE-02-003: RESEARCH INFRASTRUCTURE AND CAPACITY BUILDING FOR MINORITY DENTAL INSTITUTIONS TO REDUCE ORAL HEALTH DISPARITIES

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RESEARCH INFRASTRUCTURE AND CAPACITY BUILDING FOR MINORITY DENTAL INSTITUTIONS TO REDUCE ORAL HEALTH DISPARITIES RELEASE DATE: February 14, 2002 RFA: RFA-DE-02-003 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov) LETTER OF INTENT RECEIPT DATE: March 15, 2002 APPLICATION RECEIPT DATE: April 17, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION Purpose of this RFA Research Objectives Mechanism(s) of Support Funds Available Eligible Institutions Individuals Eligible to Become Principal Investigators Special Requirements Where to Send Inquiries Letter of Intent Submitting an Application Peer Review Process Review Criteria Receipt and Review Schedule Award Criteria Required Federal Citations PURPOSE OF THIS RFA The National Institute of Dental and Craniofacial Research (NIDCR) and the National Center on Minority Health and Health Disparities (NCMHD) invite applications from minority dental schools for the development of research infrastructure and capacity to carry out research aimed at reducing oral health disparities. The purposes of this Request for Application (RFA) are to augment and strengthen the institutional infrastructure and capacity for these institutions to conduct basic, clinical and behavioral research with the objective of reducing oral health disparities through support of assessment and planning activities as well as the development of collaborative research arrangements with other, research intensive, institutions. Minority dental schools represent a rich source of talent containing the cultural sensitivity and perspective needed for studying health disparities in craniofacial, oral and dental health. However, these institutions have not yet totally developed nor sustained a critical mass of faculty and research resources to conduct scientifically meritorious research on diseases and disorders that disproportionately affect the populations they serve. The intent of this research infrastructure program is to strengthen the research environments of minority dental schools through grant support to develop and/or expand existing capacities for conducting research in oral health disparities. RESEARCH OBJECTIVES Background As described in the "Oral Health in America: A Report of the Surgeon General" (NIH Pub No. 00-4713) oral, dental and craniofacial diseases and disorders are among the most common health problems affecting the people of the U.S. Diseases and disorders affecting the mouth and its surrounding tissues go beyond dental caries and periodontal diseases. They include birth defects such as cleft lip and palate, oral soft tissue lesions, chronic oral- facial pain conditions, oral and pharyngeal cancers, dentofacial injuries, and many other diseases and disorders. Oral manifestations of systemic diseases (i.e., Sjogren"s syndrome, diabetes and HIV infection) and side effects from drugs and/or treatment add to the burden of oral illness. Many of these craniofacial, oral and dental diseases and disorders have a disproportionately higher burden on particular population subgroups, and addressing disparities in oral health among diverse populations of the United States continues to be a major focus of the research supported by NIDCR as outlined in the Institute"s document "A Plan to Eliminate Craniofacial, Oral and Dental Health Disparities." This plan is available on the NIDCR homepage (http://www.nidcr.nih.gov/research/health_disp.asp). The plan emphasizes that eliminating oral health disparities requires more than an understanding of the biology and lifestyle of an individual, it also must take into account the political, social and cultural environment where an individual lives. The need to understand the unique social and cultural context of particular population groups that exhibit health disparities in the U.S. points to a pivotal role that minority dental schools play in improving the oral health of these populations. Dental schools at minority institutions represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in basic, clinical, epidemiological, and behavioral research. These schools conduct high quality programs for educating minorities to pursue clinical practices, however, they have had difficulties in developing and sustaining independent programs in biomedical, clinical and behavioral research. The limited involvement of minority dental schools in oral health research and the lack of a significant number of minority scientists trained in this area must be addressed if we are to develop a stronger national oral health research effort aimed at understanding the disparities caused by oral diseases and conditions. The prospect of establishing an oral health research program in a minority dental school that is collaborating with a research-intensive academic center would take maximum advantage of their respective expertise and experience. Objectives and Scope This two phase initiative is designed to provide resources to minority dental schools for the development (Phase I) and implementation (Phase II) of an institutional plan to enhance their infrastructure for research, to recruit and/or retain personnel with research expertise relevant to the objectives of this solicitation, and to establish partnership/collaborations with other institutions that will lead to research aimed at reducing oral health disparities. Specific Objectives During Phase I, the applicant will be required to carry out a needs assessment and, from it, develop a comprehensive plan to expand and sustain the research infrastructure. During Phase II, the institutions will be expected to implement the proposed strategies for research infrastructure and capacity building. At the end of the funding period the awardees will be expected to have strengthened their capacity to proceed with the submission of scientifically meritorious developmental grants for specific research areas to reduce oral health disparities, to have established partnerships/collaborations with other academic institutions, and to have initiated training and career development programs relevant to the mission of the NIDCR. For purposes of this announcement, infrastructure enhancement and capacity building may be defined as both personnel and equipment in a biomedical research environment. Examples include but are limited to the following: o Limited research equipment support (up to $10,000) o Support for collaborative linkages with established scientists at other institutions o Special courses/seminars for faculty or students o Administrative support for managing the project o Faculty development and release time o Consultant expertise o Limited costs associated with establishing research linkages with community oral health treatment services o Limited library/information resources o Pilot work that forms the basis for individual research projects (Phase II of this RFA) o Data management and statistical analysis needs (Phase II of this RFA) To ensure the success of this initiative, the Principal Investigator must organize an Internal Advisory Committee and a Scientific and Program Advisory Committee. Internal Advisory Committee The Internal Advisory Committee will be comprised of staff of the minority dental school. The committee will have the responsibility for directing and monitoring the activities of the U24 program. This committee must define the chain of responsibility for decision making and administration beginning at the level of the Dean and including all key staff (e.g., Sponsored Programs Administrator and Department Chair). This committee will establish a time- line for proposed activities. This committee must also develop opportunities for information exchange, seminar presentations, and research training opportunities for faculty and students. Scientific and Program Advisory Committee The Scientific and Program Advisory Committee will be composed of approximately six members of distinguished senior scientists and collaborating partners. This Committee must provide a multidisciplinary and objective perspective, expert attention to the many factors during the course of the research program, and considerable judgment. Additional members with specific scientific expertise may be added during Phase II to ensure an adequate review of the scientific program relative to the research projects proposed. This Committee will also review the proposed pilot projects for Phase II. The chair of the Committee will be elected by and from the Advisory Committee. Annually, the committee will assess the productivity of the grant, make recommendations for the future direction of the Infrastructure and Capacity Building initiative, and provide advice and guidance about personnel matters and the allocation of resources. This Committee will also review the proposed pilot projects for Phase II. The SPAC"s recommendations, in the form of a written annual report, are to be submitted to the Principal Investigator and NIDCR. This report will be used by the Principal Investigator to guide and direct the development of the U24. The Principal Investigator generally will be expected to accept and implement the recommendations of the SPAC, in those situations where the recommendations are not feasible to implement, the Principal Investigator must provide a thorough explanation and rationale to the NIDCR. The application should include plans for the development of the Committee, but should not include specific names. The Principal Investigator, NIDCR staff, other ex-officio members and consultants are non-voting members of this Committee. Specific information on the application requirements of Phase I and II is described in the section under SUBMITTING AN APPLICATION. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) U24 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. However, at this time, it is not known if this RFA will be reissued. The anticipated award date is September 30, 20002. This RFA uses just-in-time concepts. The U24 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." It is not known, if this RFA will be reissued. The total project period for an application submitted in response to this RFA may not exceed three years. The three-year award will include a one-year Planning Phase (Phase I) and a two-year Implementation Phase (Phase II). The submitted application must describe plans for both Phases. It is critical that the application contain strong evidence of the minority institution"s commitment of fund to this initiative for Phases I and II. This may be in the form of matching funds (real dollars), faculty release time, etc.). However, Phase II plans proposed in the application will be considered to be preliminary pending the outcome of Phase I and awardees are expected to submit a more-detailed supplemental application for Phase II, on August 1, 2003, at which time NIDCR will conduct an interim Peer Review of the Phase II supplemental/application. The peer review will allow for an evaluation of progress made during Phase I as well as serve as an assessment of detailed plans for Phase II relative to the goals and objectives of this RFA. The interim Peer Review will be composed of outside consultants selected by NIDCR. Award of Phase II funds will be contingent on successful outcome of the interim Peer Review. Awardees are expected to continue support of the research programs after the initial three years through regular competitive NIH research and training programs or from other sources. FUNDS AVAILABLE The NIDCR intends to commit approximately $1 million in FY 2002 to fund up to three new grants in response to this RFA. Phase I is a one-year project and a budget of $350,000 total costs. Phase II will be funded for two years up to $500,000 total costs per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each grant will vary. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBILE INSTITUTIONS You may submit an application if your institution is a minority dental institution. Minority dental institutions are defined as a Historically Black College/University or a Hispanic-Serving Institution either in the United States or in territories under U.S. jurisdiction. The applicant must propose collaborative affiliations with other entities. The collaboration can be with entities from within the parent institution as well as other institutions and should be for the purpose of facilitating and addressing the objectives outlined in this RFA. For example, partnerships/collaborations may include but not be limited to with the Centers for Research to Reduce Oral Health Disparities, academic health centers including schools of public health, the National Center for Research Resources (NCRR) Research Centers for Minority Institutions (RCMI) Clinical Research Infrastructure Initiative, the National Institute of Neurological Disorders and Stroke (NINDS) Specialized Neuroscience Centers, and the National Cancer Institute (NCI) Comprehensive Minority Institution/Cancer Center Partnership. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATAORS The individual submitting the application should be a senior institutional official, e.g., Dean, Associate Dean/Director for Research, or an individual who has received a competitive or independent research award funded by NIH. SPECIAL REQUIREMENTS There are a number of Special Requirements and Provisions that each minority institution must comply with: o Each minority dental school is limited to applying for only ONE Research Infrastructure and Capacity Building for Minority Dental Institutions to Reduce Oral Health Disparities award. o Where applicable, NIDCR encourages applicants to build on existing research projects, and training and career development opportunities developed from the Regional Research Centers in Minority Oral Health or other NIDCR funded grants. o The application must include a "Letter of Commitment" from the minority dental school"s leadership committing to the establishment of the Infrastructure Grant. The letter should detail the resources the institution is willing to provide including office and laboratory space, guarantees of protected time for faculty and students to perform the research and training activities and other administrative responsibilities for the Principal Investigator and other key staff. o For each collaborative partner there must be written "Letters of Commitment" from the institution illustrating the level of support, including any additional resources necessary to ensure that these partnerships will have the maximum chance for success. Cooperative Agreement Terms and Conditions of Award Cooperative Agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The following Terms and Conditions of Awards are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92, and administered under the NIH grants Policy Statement. The administrative and funding instrument used for this process is a cooperative centers agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and programmatic involvement with the awardee is anticipated during the grant award. The NIH purpose is to support and stimulate the activity by working jointly with the recipient in a partner role, but it is not to assume direction, prime responsibility or a dominant role in the activity. The prime responsibility for the research resides with the awardees, although some activities may be carried out as collaboration among the awardees with coordination and facilitation by the NIDCR-DPHPS staff as described below. 1. Awardees Rights and Responsibilities: a. Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. b) Awardees will retain custody of and have primary rights to data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. c) The Principal Investigator must organize an Internal Advisory Committee. The committee will be comprised of staff of the minority dental school. They will also have the responsibility for directing and monitoring the activities of the U24 program. The committee must define the chain of responsibility for decision-making and administration beginning at the level of the Dean and including all key staff (e.g., Sponsor Programs Administrator and Department Chair). This committee will also establish a time-line for proposed activities. This committee must also develop opportunities for information exchange, seminar presentations, and research training opportunities for faculty and students. d) The Principal Investigator must organize a Scientific and Program Advisory Committee that will be composed of approximately six members of distinguished senior scientists and collaborating partners. This committee must provide a multidisciplinary and objective perspective, expert attention to the many factors during the course of the research program, and considerable judgment. Additional members with specific scientific expertise may be added during Phase II to ensure an adequate review of the scientific program relative to the research projects proposed. The chair of the committee will be elected by and from the Advisory Committee. Annually, the committee will assess the productivity of the grant, make recommendations for the future direction of the Infrastructure and Capacity Building initiative, and provide advice and guidance about personnel matters. The SPAC"s recommendations, in the form of a written annual report, are to be submitted to the Principal Investigator and NIDCR. This report will be used by the Principal Investigator to guide and direct the development of the U24. The Principal Investigator generally will be expected to accept and implement the recommendations of the SPAC, in those situations where the recommendations are not feasible to implement, the Principal Investigator must provide a thorough explanation and rationale to the NIDCR. The Principal Investigator, NIDCR staff, other ex-officio members and consultants are non-voting members of this committee. e) Awardees agree to follow the advice and recommendations of the Scientific and Program Advisory Committee, whenever possible, in meeting the intent of this initiative. d) The Principal Investigator and collaborators/partners should plan and budget for regular meetings to discuss the progress and direction of its activities and to ensure that the necessary interactions are taking place. e) The Principal Investigator, collaborative partners, and other designated individuals will attend an annual meeting to be organized by NIDCR staff in Washington, DC. The budget must include costs for attendance of this meeting. f) The Principal Investigator will submit annual progress reports (including recommendations of the Scientific and Program Advisory Committee) to the NIDCR that describe activities and accomplishments during the previous funding period. 2. NIDCR-Division of Population and Health Promotion Sciences (DPHPS) Staff Responsibilities a) The NIDCR-DPHPS Project Coordinator will have substantial scientific/programmatic involvement in the award performance period through contributions to the planning and assessment activities, providing technical assistance, advice on future directions and ancillary support, and coordination beyond normal program stewardship for grants. The Project Coordinator will also provide assistance to recipients of the award in developing collaborative research and funding assignments, the institutional environment, resources and other infrastructure and administrative areas. b) The NIDCR-DPHPS Project Coordinator together with the External Advisory Committee will help the applicant institution and Principal Investigator establish reasonable time lines to achieve the developmental goals of this initiative. c) The NIDCR-DPHPS Project Coordinator will organize an annual meeting of all funded Principal Investigators or their designees to share progress and research insights that may benefit all of the projects. d) The NIDCR-DPHSP Program Director, who is responsible for normal program stewardship will work closely with the Principal Investigators to facilitate collaborations with other NIDCR-funded research scientists and to leverage the resources available for this effort. The Program Director will also assist, where warranted, in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients. 3. Arbitration When an agreement between an awardee and NIDCR staff cannot be reached on scientific/programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the awardee, one person selected by NIDCR staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CRF Part 16. WHERE TO SEND INQUIRIES Written, email and telephone inquiries concerning this RFA are encouraged, particularly early in the application development process. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ms. Lorrayne Jackson Project Coordinator Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN24J Bethesda, MD 20892-6402 Telephone: (301) 594-2616 Fax: (301) 480-8318 Email: Lorrayne.Jackson@nih.gov Dr. Ruth Nowjack-Raymer Program Director Health Disparities and Health Promotion Research Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research 45 Center Drive, Room 3AN-44D Bethesda, MD 20892-6402 Telephone: (301) 594-5394 Fax: (301) 435-8254 Email: Ruth.Nowjack-Raymer@nih.gov Direct your questions about peer review issues to: Dr. George Hausch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 Fax: (301) 480-8303 Email: George.Hausch@nih.gov Direct your questions about financial or grants management matters to: Mr. Kevin Crist Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Fax: (301) 402-1517 Email: Kevin.Crist@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: O Descriptive title of the proposed research O Name, address, and telephone number of the Principal Investigator O Names of other key personnel O Participating institutions O 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 a subsequent application, the information that it contains allows NIDCR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. George Hausch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Allowable Costs NIDCR recognizes that institutions are different and require different types of research infrastructure development activities and initiatives, depending upon particular needs and circumstances. Accordingly, this announcement provides general rather than specific guidance on the types of developmental activities appropriate under the Research Infrastructure and Capacity Building for Minority Dental Institutions to Reduce Oral Health Disparities Award. Support may be requested for, but is not limited to, the following: 1. Administrative costs (not to exceed 20% of the total direct costs per year) for managing the partnership, such as salaries for key personnel and equipment to support an administrative structure. 2. Planning and evaluation may include the costs for travel for internal and external activities (key personnel), travel and per diem for the Scientific and Program Advisory Committee members, workshops, seminars, retreats and other forums to strengthen, stabilize and consolidate interactions and cooperation in areas of existing high priority, to identify new areas of opportunity and high priority as the partnership evolves, and for recruitment and resources. 3. Developmental costs for: a. selecting the areas of greatest promise for implementation of specific types of research programs based on potential to result in a successful research publication or grant in Phase I, and b. for the purchase of equipment (up to $10,000) or conduct of pilot programs in training and career development in Phase II. Direct costs for construction, renovation or for salaries for teaching or other non-research activities are not allowable in this grant. Application Requirements The application should contain the following: Phase I Institutional Research Development Plan (Year 1) o Describe the approach that will be used for assessing your institution"s (including other schools and departments) capacity to conduct state-of-the- art research on basic and clinical research related to oral health disparities (applicants are encouraged to use outside, independent expertise to provide leadership in this step of the assessment), o Provide a description of all research activities that currently exist in the dental schools as well as in the academic health center including school of public health or at institutions at additional sites deemed by the applicant institution to fall within a feasible distance for frequent interactions and research collaborations, o Propose a process for identifying gaps and opportunities in health disparities research which the minority institution intends to address in this award (if applicable, include a description of health-disparities related ongoing basic and clinical research or studies funded previously that have potential for further study), o Provide a description of equipment, space and other resources available to support the development of the plan and the extent to which the enhancement of these resources is needed, and o Provide a detailed statement of the minority institution"s leadership financial commitment (matching funds/real dollars) to sustaining and supporting the development of their research infrastructure and enhancing their capacity to carry out research aimed at reducing oral health disparities throughout the funding period and beyond the award. The statement must address specific resources that will be dedicated to the objectives of this RFA, protected time for faculty, space that will be dedicated to this effort, and discretionary resources that will be made available to the Principal Investigator. Phase I may include funding for technical assistance for: a) identifying a consultant with expertise in evaluating the minority institution"s infrastructure, b) conducting workshops, seminars, retreats and other forms of communication to identify the area of research and the research intensive academic center(s) with which to partner. At the end of Phase I, the dental school must identify a promising area of research in oral health disparities, a collaborating academic health center(s) and should provide a detailed description of the steps to establish the research program. Phase II - Implementation of the Institutional Research Development Plan (Years 2-3): o Description of procedures to be used to translate the results of the assessment obtained in Phase I into an implementable action plan that will result in infrastructure development during Phase II (include plans for administration of research, recruitment and retention of individuals experienced in conducting research, staff training and mentoring, statistical and other data management consultation, and collaboration with other institutions). o A time-line outlining the process and steps to establish the necessary infrastructure to support the research program, o Provide a detailed statement of the minority institution"s leadership financial commitment (matching funds/real dollars) to implementing Phase II of this RFA. The statement must address specific resources that will be dedicated to the objectives of this RFA, protected time for faculty, space that will be dedicated to this effort, and discretionary resources that will be made available to the Principal Investigator. o Description of the proposed area(s) of research, short-term pilot projects may be proposed, evidence of procedures for selecting pilot projects and the quality and scientific merit of the project. o Plans for initiation of a training program for faculty/students in the area of research identified, and o Evidence of a strong collaboration with a research-intensive institution for research and research training. By completion of Phase II, it is anticipated that the minority dental school and its collaborators will be prepared to submit scientifically meritorious applications for support of research on reducing oral health disparities. In addition, NIDCR encourages pre-application consultations with individual partnerships either as telephone conference calls, videoconference meetings, or meetings at which the involved individuals are present. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/01) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 must marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies and all appendix material of the application must also be sent to: Dr. George Hausch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 APPLICATION PROCESS: Applications must be received by April 17, 2002. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to the RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Applications must meet all eligibility requirements as described above and must address all programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness to eligibility requirements and responsiveness to the Special Requirements and Provisions by the NIDCR. Incomplete and/or non-responsive applications will be returned to the applicant 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 Division of Extramural Activities (DEA) at NIDCR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Dental and Craniofacial Research Council and by the National Center on Minority Health and Health Disparities Council. Review Criteria The goals of NIH-sponsored research are to advance our understanding of biological systems, improve the control of disease, and enhance health. For this RFA, the review criteria are not organized under the traditional headings of Significance, Approach, Environment, Investigator and Innovation typically used for NIH research grants. Reviewers will have to use considerable flexibility in determining the merit of a broad range of possibilities that can strengthen the research capabilities of minority dental schools, expand training and career development opportunities for minority faculty and students, and to increase the effectiveness of minority dental schools in establishing partnerships/collaborators with other institutions that will lead to research aimed at reducing oral health disparities. With respect to Phase I Planning: Adequacy of the proposed processes to develop a plan for creation and/or enhancement of research infrastructure and capacity, which will ultimately translate into initiation of new or the enhancement of existing research aimed at reducing oral health disparities. The adequacy of the plan is evidenced by: a. Adequacy of the conceptual framework for the needs assessment addressing the gaps and opportunities of the institution and the institution"s capacity to conduct biomedical, behavioral or clinical research on oral health disparities, b. Acknowledgement of potential problems and consideration of alternatives c. A well-prepared application that is reflective of close, effective interaction between the Principal Investigator, co-investigators and collaborators. d. The adequacy and duration of the initial planning stage needed to identify areas of potential collaboration. e. The quality and merit of the documented planning process used for identifying areas for ready prioritization including the selection of leadership to carry out the process. f. Appropriateness and adequacy of the description of all research activities, equipment, research space that currently exist in the dental school as well as in the academic health center including school of public health or at institutions at additional sites deemed by the applicant institution to fall within a feasible distance for frequent interactions and research collaborations. g. The qualifications, experience and time commitment of the Principal Investigator. h. The appropriateness and adequacy of the specific faculty and scientists identified for the Internal Advisory Committee from the minority dental school and their ability to contribute effectively to each aspect of this planning effort. i. The adequacy of the qualifications and experience of each proposed member of Scientific and Program Advisory Committee to evaluate and monitor the progress of the partnerships in achieving its priorities and objectives, to recommend mid- course changes in approaches and tactics, and to help the partnership evaluate and take advantage of new opportunities. j. Adequacy of the proposed processes to modify initial Phase II plans using information gained from the Phase I assessment. With respect to Phase II Implementation Plan: Appropriateness and adequacy of the plan for creation or enhancement of research infrastructure and capacity that will ultimately translate into initiation of new or enhancement of existing research aimed at reducing oral health disparities. The adequacy of the plan is evidenced by: a. Extent to which the plan will build on current institutional support for conducting research to reduce oral health disparities and significantly augment and improve the support of research, b. Extent to which the plan will enhance institutional capacity and individual faculty research development plans and the degree to which the components enhance one another in achieving the overall objectives. c. Likelihood that research projects in the area of oral health disparities will emerge from this effort and that such projects will be of sufficient scientific merit to be successful in securing competitive grant support. d. Quality and appropriateness of the proposed organizational and administrative structure proposed. Is the organizational and administrative structure deemed likely to support meeting the goals of this solicitation? e. Appropriateness of the collaborators/partners identified for achieving the goals/ objectives outlined in the RFA. f. Degree to which the resource/infrastructure identified will contribute to the overall priorities and objectives of the implementation plan. g. Degree to which the proposed resource/infrastructure will provide long- term stability to the activities of the minority dental institution. h. Adequacy of the implementation plan to recruit individuals that are committed to basic and clinical research to reduce oral health disparities. i. Adequacy of the design and quality of each of the internal planning and evaluation processes proposed to achieve the objectives and priorities of the implementation plan. For both Phase I and II Level of institutional support to ensure achievement of objectives of this RFA as evidenced by: a. Assurances of both direct and "in-kind" support and, specifically, the adequacy of the resources (e.g., discretionary resources, space, faculty positions, protected time for research, etc.) that the minority dental school and the collaborators/partners will provide to promote the successful improvement of the achievement of the priorities and objectives of this partnership. b. Letters of support and the degree to which the letters of support from the institutional leaders address the need for mentoring of inexperienced Principal Investigator/investigators or for specific institutional commitments to ensure the success of the collaboration. c. The level of authority of officials committing to this joint effort at the minority dental school and collaborators/partners that gives confidence that these commitments will be stable and long lasting. d. The degree to which the letters of commitment from the leadership of the minority dental school and the collaborators/partners address and fully support the priorities and objectives of the implementation plan of the partnership. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 15, 2002 Application Receipt Date: April 17, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: O Scientific merit (as determined by peer review) O Availability of funds O Programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of a NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase II clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy required education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identified(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLS IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in a NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.121 (NIDCR) Oral Diseases and Disorders Research Awards and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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