Full Text DC-94-002 NATIONAL MULTIPURPOSE RESEARCH AND TRAINING CENTERS NIH GUIDE, Volume 23, Number 15, April 15, 1994 RFA AVAILABLE: DC-94-002 P.T. Keywords: National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: June 10, 1994 Application Receipt Date: October 20, 1994 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) announces its intent to designate and support a limited number of National Multi-purpose Research and Training Centers for the multidisciplinary study of hearing and other communication processes. The goal of these Centers is the support of basic and clinical research; research training; continuing education for health professionals; and dissemination of information to the general public, in one or more of the NIDCD program areas. A National Multipurpose Research and Training Center is a national resource and is dedicated to working with the NIDCD in furthering the goals of the NIDCD, through a multidisciplinary, coordinated approach involving basic and clinical research, research training, continuing education for health care professionals, and dissemination of information to the public. A Center may focus on one or more of the major scientific areas of the NIDCD (hearing, balance, smell, taste, voice, speech, and language), but each of the components, including the research training and continuing education components, must relate to the central theme of the Center. All of the components must be of high quality, as judged by the NIH standards for biomedical and behavioral research excellence. 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, National Multipurpose Research and Training Centers, is related to the priority area of education and community-based programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Any of the following domestic organizations are eligible to apply: non-profit institutions of higher education; other non-profit and for-profit organizations; state and local governments and their agencies; and authorized Federal agencies. Domestic institutions may include foreign components. Holding a currently funded National Multipurpose Research and Training Center, Program Project (P01), Clinical Research Center Grant (P50) or Institutional Training Grant (T32) does not preclude an organization from applying. MECHANISM OF SUPPORT National Multipurpose Research and Training Centers will be funded through the Comprehensive Center grant mechanism (P60). Competitive supplemental applications to the Center grant are not allowed. FUNDS AVAILABLE According to current budgetary predictions, it is anticipated that up to five awards will be made, some in FY 1995 and some in FY 1996. Five years of support must be requested at a direct cost not to exceed one million dollars for the first year. The award of National Multipurpose Research and Training Center grants is contingent upon the assessment of the applications by peer review and the allocation of appropriated funds for this purpose. Funding for Center grants beyond the initial period will be subject to competitive renewal. Although this solicitation is included in the plans for Fiscal Year 1995 and Fiscal Year 1996, support of grants pursuant to this request for applications is contigent upon availibility of funds for this purpose. It is anticipated that up to five new and competing renewal Centers may be funded under this RFA, some in FY 95 and some in FY96. The level of funding of individual Centers will be influenced by the individual merit of proposals, the level of support recommended by the initial scientific review, and the amount of funds available to the NIDCD. It is expected that investigators collaborating within the Center will not necessarily derive all of their support from the Center grant mechanism. However, if proposed projects within the Center grant mechanism overlap with current support (for example, with an ongoing R01), the investigator must accept the project support only within the Center grant mechanism. While the development of new instrumentation or assistive devices may be a part of the Center, support for such development alone should not be funded in the RTC. In general, funds will not be provided for the purchase and installation of expensive equipment. NIDCD staff should be consulted if an applicant has questions regarding these limitations. RESEARCH OBJECTIVES Background In 1988, Congress established the National Institute on Deafness and Other Communication Disorders in Public Law 100-553, which mandated that "the Director of the Institute shall, after consultation with the advisory council for the Institute, provide for the development, modernization, and operation (including care required for research) of new and existing Centers for studies of disorders of hearing and other communication processes". The law further specified that each Center shall conduct-- (1) basic and clinical research into the cause, diagnosis, early detection, prevention, control and treatment of disorders of hearing and other communication processes and complications resulting from such disorders, including research into rehabilitative aids, implantable biomaterials, auditory speech processors, speech production devices, and other otolaryngologic procedures; (2) training programs for physicians, scientists, and other health and allied health professionals; (3) information and continuing education programs for physicians and other health and allied health professionals who will provide care for patients with disorders of hearing or other communication processes; and (4) programs for the dissemination to the general public of information-- (A) on the importance of early detection of disorders of hearing and other communication processes, of seeking prompt treatment, rehabilitation, and of following an appropriate regimen; and (B) on the importance of avoiding exposure to noise and other environmental toxic agents that may affect disorders of hearing or other communication processes. In 1989, over 100 U.S. scientists representing various specialties in the communication sciences met to develop a research plan for the NIDCD. One panel of these scientists addressed the issue of the National Multipurpose Research and Training Centers. With the Congressional mandate providing guidance, the Task Force identified and elucidated the critical features of such Centers, that is, research, research training, continuing education, and information dissemination. In FY90, the NIDCD issued a Request for Applications (RFA) for National Multipurpose Research and Training Centers. Three Centers were funded that year. In FY91, two additional Centers were funded. The purpose of this current RFA is to request applications for: (1) new National Multipurpose Research and Training Centers and, (2) the continuation of existing National Multipurpose Research and Training Centers. Scope The purpose of the National Multipurpose Research and Training Centers (RTC) is to enhance research in hearing and other communication processes. The Centers will stimulate important areas of basic and clinical research. By utilizing a multidisciplinary approach, these Centers will provide broad-based solutions to complex human communication problems. Each Center must have research activity in the basic sciences. This activity may include disciplines such as molecular biology and genetics, cellular biology, neurochemistry, immunology, microbiology, epidemiology, and biomedical engineering. Ideally, the Center will draw together the multidisciplinary resources of the institution to investigate the etiology, diagnosis, treatment, rehabilitation, and prevention of specific communication impairments. The Center may also undertake/conduct population-based studies and genetic studies related to the specific communication disorder(s) being studied. Clinical investigations will focus on the etiology, diagnosis, treatment, rehabilitation, and/or prevention of specific impairments. Suggested areas may include: deafness and hearing disorders in children; presbycusis; balance or vestibular disorders, particularly in the elderly; aphasia; stuttering; and disorders of smell and taste. Clinical research activities may also include studies of implantable biomaterials and biomechanical diagnostic and assistive devices. Each Center should seek to establish the effectiveness of new and improved methods of detection, referral, and diagnosis of individuals at risk for developing the particular disorder(s) that is the focus of the research program of the Center. The Center will provide research training opportunities, thereby strengthening the quality and increasing the number of investigators in communication sciences. Medical and surgical residents, pre- and post-doctoral fellows, and students will benefit from research training in a multidisciplinary environment. Special emphasis may be placed on independent investigators who apply such methods as immunology or molecular biology to problems within the communication sciences. In addition, research training for clinical professionals such as otolaryngologists, speech-language pathologists, audiologists, and chemosensory psychophysicists is encouraged. Each Center will develop continuing education programs for physicians and other health care professionals who provide care to patients with disorder(s) within the research focus of the Center. Education programs should include information on current methods of early diagnosis and treatment, as well as seek to disseminate the results of research activities. Centers will also include programs for the dissemination of information to the general public on the importance of early detection of the particular disorders or impairments under study, of seeking prompt treatment, rehabilitation, and when indicated, of following an appropriate therapeutic regimen. When appropriate, these public information programs may also focus on the importance of avoiding exposure to noise or other environmental toxic agents that may affect the impairments under examination. It is essential that the continuing education and information dissemination programs develop and implement evaluation instruments/tools that measure the effectiveness of these activities so that useful techniques may be shared with other Centers and health care providers. The NIDCD expects each Center to develop its own program in accordance with local strengths, talents, interests, and resources. Each RTC must be willing to cooperate actively with other Centers awarded under this and other NIDCD Center solicitations; collaboration is encouraged. The NIDCD expects each Center to develop an External Advisory Committee. These committees should provide direction, evaluation, and input to RTC staff on a regular basis. NIDCD Health Scientist Administrators (HSAs) will coordinate plans for any special activities focusing on issues of mutual interest to the Institute and the RTCs. These may include training, information techniques, or continuing education, for example. NIDCD HSAs will be responsible for evaluating progress. To foster cooperation among Centers, the Center Directors will meet with NIDCD staff at least once a year to review progress and coordinate similar activities. SPECIAL REQUIREMENTS Applicants for the "National Multipurpose Research and Training Centers" Grant Award must propose a program that includes: 1. Basic and Clinical Research. The research program must have a central theme, involving basic research and clinical research into the etiology, diagnosis, early detection, prevention, and treatment of one or more disorders of hearing, balance, smell, taste, voice, speech, and language. There must be three or more related and integrated research projects of high quality that provide a multi-disciplinary yet unified approach to the problems being investigated. Each project must be described fully. Each individual research component must be meritorious. The Center Director coordinates all projects included in the Center and must have recognized skills as both a scientist and a research administrator. One or more cores, for the support of resources serving the research projects, may be included. These cores are most appropriate for common resources such as equipment, histologic processing, biostatistics, and so forth. 2. Research Training. The training program enables cross-disciplinary training for physicians, pre-and post-doctoral fellows, and students in the areas of communication sciences and disorders which are the focus of the RTC. The research training component of the RTC must provide research training opprortunities for individuals with varying levels of research experience. Plans for recruitment of underrepresented minorities, women, and individuals with disabilities must be included within this component of the application. The RTCs follow the NRSA guidelines for Institutional Training Grants (see the announcement in the NIH Guide for Grants and Contracts, Vol. 21, No. 11, March 20, 1992). However, high school students and undergraduates, although precluded by the NRSA program, may be supported within the research training component of the RTC. The stipend levels for these trainees will be set in accordance with the guidelines of the NIH-wide minority supplement program and the National Center for Research Resources Minority High School Students Research Apprentice Program (see the announcement in the NIH Guide for Grants and Contracts, Vol. 22, No. 45, December 17, 1993). In the preparation of an application, it is required that a description of the institution's plan to provide instruction on ethics in research training be included (see the announcement in the NIH Guide for Grants and Contracts, Vol. 19, No. 30, August 17, 1990). 3. Continuing Education. Educational programs are designed for physicians and other health and allied health professionals who will provide care for individuals with disorders of hearing or communication processes. The design, scope, and steps in the implementation of these programs are left to the applicants to develop. 4. Information Dissemination. Information from the Center is disseminated to the public and, when appropriate, technology is transferred for clinical utilization and commercial product development. This component of the RTC should include programs for the dissemination of information to the general public on the importance of prevention and early detection of disorders of the communication processes which are the focus of the Center, and on the importance of seeking prompt treatment, rehabilitation, and following an appropriate therapeutic regimen. Other Activities In addition, where appropriate, the Centers may pursue the following activities: a. Evaluation of the effectiveness of existing, new, and improved methods of habilitation and rehabilitation (especially with hearing-impaired and language-impaired children, the elderly, and multi-cultural populations); and detection, assessment, and treatment of communication disorders. b. Epidemiologic and genetic studies related to specific communication disorders. Basic and clinical research should comprise approximately fifty percent of the activity and resources of the Center. Research training should also be a significant proportion of the Center activity. The remaining resources may be distributed among information dissemination, continuing education and other activities (if included). The Center director must be a scientist who can provide strong and effective administrative leadership. The Center director will be responsible for the organization and operation of the RTC and for communication with NIDCD on scientific and operational matters. Interdisciplinary or multidisciplinary collaboration among scientists working within the Center is considered a necessity for an effective center grant. Each application should contain a plan to assure continuing interaction among participating scientists and among other NIDCD-funded research and training Centers. Scientific personnel and institutional resources capable of providing a strong research base in the field of communication sciences and disorders must be available. In addition, the applicant institution and pertinent department(s) should show a strong commitment to the Center's support. The Center should typically share common resources, including technical, clerical, and administrative personnel, instrumentation, computer resources, subject populations, and data bases. The Center may be a consortium of institutions, organizations, and medical facilities. Budget Guidelines o Five years of support must be requested at a direct cost not to exceed one million dollars for the first year. Budget increments after the first year will be limited to necessary cost-of-living increases. o Requests for travel should include an estimate for one meeting per year for the Center Director, and one other Center staff member, with NIDCD staff in Bethesda, Maryland. o Stipends for research trainees, provided from funds for the RTC, will be set at the level of the NIH National Research Service Award (NRSA) program. Trainee-related expenses should be requested in accordance with NRSA guidelines. o Consideration should be given in budget planning to those activities that would not be able to start immediately such as continuing education or information dissemination. Costs should be phased in for these activities based on realistic start dates. o All costs must be well justified by the programmatic activities of the Center. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT To facilitate NIDCD planning, applicants are requested to submit a letter of intent by June 10, 1994. The letter should include a descriptive title, names of investigators who might be involved, and names of any participants outside the applicant institution. The NIDCD requests such letters only for the purpose of providing an indication of the number and scope of applications to be received and, therefore, does not acknowledge their receipt. A letter of intent is not binding, it will not enter into the review of any application subsequently submitted, nor is it a requirement. The letter of intent is to be sent to Dr. Ralph F. Naunton at the address listed under INQUIRIES. APPLICATION PROCEDURES It may be helpful to develop applications in close communication with NIDCD extramural program officials, who will provide guidance to applicants on administrative issues prior to submission. The applicant is to prepare a complete application form PHS 398 (rev. 9/91) for a research grant application. The training component must be submitted in accordance with the section for Institutional National Research Service Awards. This form is available in the applicant institution's office of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449 Bethesda, MD 20892, telephone 301/710-0267. Applicants should utilize the instructions described in the document "Application Guidelines: National Multipurpose Research and Training Centers (RTC)," available upon request from the program staff listed under INQUIRIES. To identify the application as a response to this RFA, check "YES" in Item 2a on the face page of the application and enter the title "National Multipurpose Research and Training Centers" and the RFA number DC-94-002 in the space provided. The RFA label available in the form PHS 398 (rev. 9/91) application kit must be affixed to the bottom of the face page of the original completed application form. 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. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard Rockville, MD 20892 Applications must be received by October 20, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDCD staff function. If the application is not responsive, it will be returned to the applicant. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDCD. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted and applications withdrawn from further competition if deemed not competitive for the award. The NIDCD will notify the applicant and institutional official of this action. Those applications judged to be competitive will be further reviewed for scientific and technical merit in accordance with NIH peer review procedures by an initial review group specifically convened by the NIDCD for this RFA. A site visit or applicant interview in Bethesda, Maryland will be considered, if appropriate. The site visit team and/or IRG may recommend adjustments, as judged appropriate, in the requested budgets and periods of support for the components of the program which are deemed to be of significant and substantial merit. Following the review, the applications will be given a second level of review by the Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; Additional scientific/technical merit criteria specific to the objectives of the RFA are: 1. Review Criteria for Individual Research Projects and Other Activities o Scientific, technical, or clinical significance and originality of the proposed research; each project should be rated on its own merit. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Qualifications and research experience of the individual project principal investigator and staff, particularly, but not exclusively, in the area of the proposed research. o Availability of resources necessary for the research. o Appropriateness of the proposed budget and timetable in relation to the scope of the proposed research. o The adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals, or the environment. o Adequacy of adherence to guidelines for including gender and minority representation in any study populations. 2. Review Criteria for Individual Cores o Utility of the core to the research and training center; each core must provide essential facilities or service for two or more projects judged to have substantial scientific merit. o Quality of the facilities or services provided by this core (including procedures, techniques, and quality control and criteria for prioritization of usage). o Qualifications, experience, and commitment of the personnel involved in the core. o Appropriateness of the budget. In the case of the review of a competing continuation (renewal) application, the progress made during the past period of funding is also an important consideration in the review of projects and cores. 3. Review Criteria for Overall Center The relationship and contributions of each research component and core (excluding those recommended for no further consideration) to the overall theme of the center are discussed and evaluated. This is a separate consideration which is not influenced by the merit ratings of the individual projects. Although projects recommended for no further consideration automatically are removed from consideration as part of the overall center, this will reflect on the leadership capabilities of the principal investigator/program director. The overall center application is evaluated considering the remaining projects, supporting cores, and the administrative structure. For the center to receive a priority score, it must consist of at least three projects (each found to have significant and substantial merit) for the duration of the project period. Each core must provide essential functions or services for at least two of these projects. Specific factors to be evaluated in the consideration of the overall center are as follows: a. Scientific Considerations o Scientific merit of the program as a whole, as well as that of individual projects. o Significance of the overall program goals. o Scientific gain of combining the component parts into a center (beyond that achievable if each project were to be pursued separately). o Cohesiveness and multidisciplinary scope of the program and the coordination and interrelationship of all individual research projects and cores to the common theme. o Leadership and scientific ability of the principal investigator/program director and his or her commitment and ability to develop a well-defined central research focus and to devote adequate time and effort to the program. o Past accomplishments of the program or a demonstrated ability in mounting similar programs. Additional criteria for competing continuation (renewal) applications include: o Progress and achievements specific to this center since the previous competitive review and the documentation through publications, conferences, etc., that collaboration has occurred; o Evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions of ongoing work; o Previous performance and estimated use of the core(s); o Justification for adding new projects or cores or for deleting components previously supported. b. Administrative Considerations For all center applications (new and competing continuation), in addition to evaluating the scientific components, the review also will assess: o Academic environment and resources in which the research will be conducted, including availability of space, equipment, human subjects, animals, or other resources as required, and the potential for interaction with scientists from other departments; o Institutional commitment to the requirements of the program, including fiscal responsibility and management capability of the institution to assist the principal investigator/program director and his or her staff in following DHHS, PHS, and NIH policy; o Administrative planning and leadership capability to provide for internal quality control of ongoing research, allocation of funds, enhancement of internal communication and cooperation among the investigators involved in the program, and replacement of the principal investigator/program director if required on an interim or permanent basis; o External Advisory Committee and its proposed purpose, membership and function. o Appropriateness of the budget in relation to the proposed program; o Human subjects protection, animal welfare, and biohazard issues. 4. Review Criteria for Research Training Component o Past research training record for both the program and the designated preceptors in terms of the rate at which former trainees establish independent and productive research careers. o Past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further development. o Objectives, design, and direction of the research training program. o Caliber of preceptors as scientists including successful competition for research support. o Training environment including the institutional commitment, the quality of the facilities, and the availability of research support. o Recruitment and selection plans for appointees and the availability of high quality candidates. o The record of the research training program in retaining health-professional postdoctoral trainees for at least two years in research training or other research activities. o When appropriate, the concomitant training of health-professional postdoctorates (e.g., individuals with the M.D., D.O., D.D.S.) with basic science postdoctorates (e.g., individuals with a Ph.D., Sci.D.) will receive special consideration. 5. Review Criteria for Continuing Education Component o the major continuing education goals and functions of the sponsoring organization; o the audience served (i.e., the range of professionals who would participate); o procedures to be used to determine the continuing education needs of the audience served; o the adequacy of the proposed program content and plans for its provision; o qualifications of the individual responsible for the continuing education component and the teaching staff; o appropriateness, range, and scope of the educational programs offered to health-related professionals; o administrative support and physical facilities available for these activities; and o adequacy of evaluation methodology to determine the effectiveness of the continuing education program. 6. Review Criteria for Information Dissemination o The appropriateness of the proposed methods to assure the quality of information disseminated (for example, review by peers in the field); o the adequacy of the proposed plan for information dissemination and technology transfer; o the format and content of the information to be disseminated; o the breadth or range of audiences that will be served, with special attention to the needs of users of languages other than English; o previous experience of the applicant organization in information dissemination and technology transfer; and o adequacy of evaluation methodology to determine the effectiveness of the information dissemination programs. AWARD CRITERIA Funding decisions will be based on priority score, availability of funds, and programmatic priorities. 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: Ralph F. Naunton, M.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-1804 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Ms. Sharon Hunt Grants Management Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400-B Rockville, MD 20892 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3 . Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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