Full Text DC-97-003 NIDCD-NASA CENTER FOR VESTIBULAR RESEARCH NIH GUIDE, Volume 26, Number 28, August 22, 1997 RFA: DC-97-003 P.T. Keywords: National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: December 8, 1997 Application Receipt Date: January 8, 1998 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health (NIH), in collaboration with the Life Sciences Division of the National Aeronautics and Space Administration (NASA), invites applications for the support of a center to carry out a program of ground-based research and research training in the vestibular system relevant to the research missions of both the NIDCD and NASA. The research focus of the Center shall be on: 1) the role of the vestibular system in spatial cognition (spatial orientation and spatial navigation), and/or 2) the role of the vestibular system in the control of balance and spatially directed motor performance. In addition to the conduct of research, the Center shall provide research training to predoctoral and postdoctoral trainees. 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, NIDCD-NASA Center for Vestibular Research, is related to the priority areas of physical activity fitness, educational and community-based programs, unintentional injuries, occupational safety and health, diabetes and chronic disabling diseases, clinical prevention services and human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign applicants are not eligible for this initiative. MECHANISM OF SUPPORT This RFA will use the NIH Comprehensive Center (P60) grant mechanism. The Application Guidelines for Program Project and Clinical Research Center Grants issued by the NIDCD (rev. Aug 1997) applies to this solicitation, unless otherwise noted in the present RFA, and should be consulted by the applicant. In addition, certain provisions of the NIH National Research Service Award (NRSA) Program for Institutional Research Training Grants (NIH Guide for Grants and Contracts, Vol. 26, No. 16, May 16, 1997; Vol. 26, No. 21, June 20, 1997) apply to the training component of this solicitation. The total project period for applications submitted in response to this RFA must be five years. Responsibility for the planning, direction, and execution of the proposed project shall be solely that of the applicant. FUNDS AVAILABLE This RFA is a one-time solicitation. One Center will be supported jointly by NIDCD and NASA for a project period of five years, at a level of up to $1.2 million total costs [direct cost plus facilities and administrative allowance (indirect cost)] for Year One. Budget increments for subsequent years will be limited in accordance with current NIH policy. The anticipated award date will be August 1, 1998. At present, the NIDCD and NASA have made no commitment to continue support for this initiative beyond five years. RESEARCH OBJECTIVES Background The importance of vestibular function in the spatial cognition and motor performance of humans in both the terrestrial and aerospace environments has long been recognized. Vestibular-deficient individuals, including astronauts during flight and in the early postflight period, show abnormalities in trunk and head coordination. Indeed, acute vestibulogenic changes, such as lesions of the vestibular system or the functional unloading of the otolithic gravity receptors in space, often result in dramatic symptoms of imbalance and disorientation, including reduced muscle tone, gait and postural ataxia, and illusory self-orientation and self-motion sensations. Typically, these symptoms abate as central nervous system motor programs for the reinterpretation of sensory inputs and coordination of muscle actions undergo adaptation. Spatial orientation refers to the correct recognition of one's location in space. Spatial navigation refers to the planning and execution of movement from one point to another, and is predicated on remembering changes in spatial location. Several lines of research have shown that vestibular information is important, although not sufficient, for spatial orientation and navigation. Populations of neurons ["place cells" and "head direction (HD) cells"] have been identified in the mammalian hippocampus and related thalamic and neocortical regions that appear to be part of an internal network that generates an abstract internal representation of two-dimensional extrapersonal space that an organism uses for spatial navigation. While visual landmarks become secondarily bound to this network through associative learning, the internal reference appears to be adopted in the absence of external cues. While HD cell activity appears to reflect a high degree of intersensory convergence, bilateral labyrinthectomy has been shown in one experimental model to abolish this activity. Morphophysiologic studies in the primate have described a pathway from the vestibular nuclei to the "parietal insular vestibular cortex" (PIVC) in the parietal lobe. Neurons in the region of this pathway have been shown to respond to angular acceleration of the head, but not to static head tilt or linear motion. How vestibular information reaches the subcortical limbic regions and the neocortex and how this information is used in spatial cognition remains to be demonstrated. Several lines of evidence support the contemporary view that the vestibular, somatosensory and visual systems play a direct and prominent role in terrestrial balance control, although the specific role of each remains to be elucidated. Inputs from these and other sensory modalities are integrated by the central nervous system and referenced against the brain's cognitive store to determine whether the organism or the environment is stationary or in motion. Complex activation patterns of the arm, leg, trunk, and neck muscles to reorient the body with respect to relevant cues are then generated. To date, systematic study of the contributions of the vestibular system to balance control has been limited. Early studies have underscored the primacy of proprioceptive afferent signals from the lower leg muscles in postural control. Yet, there is convincing anatomic and physiologic evidence of the convergence and interaction of the vestibular and somatosensory systems at multiple levels throughout the neuroaxis, at both the sensory input and motor output stages. Patients with vestibular loss have been shown to exhibit alterations in the magnitude, timing, pattern and adaptation of stabilizing reactions to mechanical support surface perturbations. Recent studies suggest that the vestibular system maintains the orientation and stability of the head and the trunk to shape the formation of body-stabilizing motor patterns, rather than triggering fast postural adjustments to maintain equilibrium in response to destabilizing support surface perturbations. Scope This initiative is for the recompetition of an RFA, originally issued by the NIDCD and NASA in 1992, for the support of a center to carry out a program of ground-based research and research training in balance and the vestibular system. The original RFA focused on the role of the vestibular system in the control of balance and spatially directed motor performance. The scientific purview of the present RFA has been broadened to encompass the contributions of the vestibular system to: 1) spatial cognition (spatial orientation and spatial navigation), and 2) balance and spatially directed motor performance. Applicants for this program should address one or both of these themes and include approaches to improve performance of individuals with impaired vestibular function. Knowledge generated from this research program will provide a solid empirical basis for the improved rehabilitation of patients with balance disorders and for management of the sensorimotor and perceptual difficulties associated with space travel, particularly during long-duration space missions. The Center shall employ an integrative neuroscience approach to the understanding of the vestibular bases of spatial navigation and/or balance control, encompassing a continuum of approaches from reductionistic to systems-level and integrated systems-levels. A management plan shall be developed to facilitate communication and collaborative interactions among Center investigators. The purpose of the research training component of the Center is to develop highly trained scientists to carry out the Nation's biomedical and behavioral research agenda in the balance, vestibular and motor control systems on earth and in space. The Center shall provide support for three predoctoral and two postdoctoral full-time training positions (FTTPs) per annum, to be distributed across three or more research projects of the application. The Center program director shall be responsible for the selection and appointment of all trainees. The institution must submit a completed NRSA Statement of Appointment (PHS Form 2271) for each trainee appointed to the Center. Trainee appointments shall be made in twelve month increments. No short-term trainee positions are provided by this program. To the maximum extent possible, trainees shall be provided the opportunity to rotate across two or more projects of the Center during their traineeship appointment. While stipends and otherallow able expenses for research trainees will be provided from the Center's funds, the stipend levels and the levels of support for tuition and fees, including self-only medical insurance, shall be set according to the schedule of the NRSA program. However, trainees do not need to meet NRSA eligibility requirement for citizenship or permanent residence in the United States. The time limits of support under the NRSA program are not applicable to this initiative. Furthermore, trainees on the Center do not incur a service payback obligation. The application should document the past research training record of both the program (if applicable) and the designated preceptors; indications of the success of former trainees should be included. A specific plan to recruit research trainees from underrepresented minority groups must be included within the research training component of the application. Information on this requirement of the Institutional NRSA program was published in the NIH Guide for Grants and Contracts, Vol. 26, No. 16, May 16, 1997, "NRSA Institutional Research Training Grants". Every predoctoral and postdoctoral trainee supported by the Center must receive instruction in the responsible conduct of research, including policies regarding the use of human and animal subjects. Applicants are required to include a description of their plan to provide this training. (For more information on this provision, see the NIH Guide for Grants and Contracts, Vol. 26, No. 16, May 16, 1997). SPECIAL REQUIREMENTS The program director and one additional investigator of the Center shall meet annually in the Washington, DC area with the scientific program staffs of the Division of Human Communication, NIDCD, and the Life Sciences Division, NASA, to review the progress of the Center in the areas of research, research coordination and research training. Budget requests for travel must reflect the costs associated with this meeting. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff will, on request, provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 8, 1997, a letter of intent that includes a short description of the proposed application, the name, address, telephone number and email address of the Center 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 NIDCD staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Acting Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) ATTN: Vestibular Research Center Telephone: (301) 496-8683 FAX: (301) 402-6250 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research, from the program administrator listed under INQUIRIES, as well as from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, FAX 301/480-0525, email: ASKNIH@ODROCKM1.OD.NIH.GOV. The PHS 398 form is also available electronically on the NIH Home Page at https://grants.nih.gov/grants/phs398. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. 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 (NIDCD-NASA Center for Vestibular Research, DC-97-003) must be typed on line 2 of the face page of the application form and the YES box must be marked. Instructions for completing the application are found in the PHS 398 form. 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 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 of the application must be sent to: Acting Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) Applications must be postmarked by January 8, 1998. If an application postmarked later than that date is received, it will be returned to the applicant without review. 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. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA (as judged by NIDCD and NASA program staff) will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD and NASA in accordance with the standard NIH peer review procedures. Applications that are not responsive to the RFA will be returned to the applicant without review. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. For a center grant application to receive further consideration for support, it must consist of at least three projects, each found to have significant and substantial merit, for the duration of the project period. The second level of review will be provided by the National Deafness and Other Communication Disorders Advisory Council and the NASA Life Sciences Division. Review Criteria The following review criteria will be applied by the peer review group: a. The criteria for reviewing the Center as an integrated effort are: o adequacy of plans for interaction and communication of information among the collaborating investigators; o coordination and interrelationship among the research projects and cores and the relationship of the objectives of individual projects to the common theme of the application; o demonstrated administrative and scientific skills of the Center director and his/her commitment of sufficient time and effort for effective leadership; o participation of a suitable number of appropriately qualified investigators; o organizational and administrative structure appropriate to meet the program objectives; o mechanisms in place for the internal quality control of ongoing research projects, the allocation of funds, day-to-day management, collaborative arrangements with other institutions, if any; o adequacy of resources and facilities to support the components of the Center; o institutional commitment to the requirements of the Center; and o appropriateness of the overall budget for the proposed program. b. The criteria for reviewing individual research projects are: o adherence to the scientific requirements of the RFA; o significance, approach, innovation, investigator(s) and environment(s) of individual projects, as established by the NIH for the review and rating of unsolicited research grant and other applications (NIH Guide, Vol. 26, No. 22, June 27, 1997); o commitment of the investigators, and their ability to devote the required time and effort to the project; o appropriateness of the proposed budget and timetable in relation to the scope of the research project; o adequacy of the means proposed for the protection of human and animal subjects; and o adequacy of plans for the inclusion of both genders and minority individuals in study populations. c. The criteria for reviewing core units are: o utility of the core unit to the Center and the appropriateness of each research project's use of core services; each core must provide essential facilities or services to two or more projects judged to have substantial scientific merit; o quality of the facilities and services provided through the core; o qualifications, experience and commitment of the personnel involved in the core; and o cost effectiveness of the core. d. The criteria for reviewing the research training component are: o the objectives and design of the research training component; o past research training record of both the program (if applicable) and the designated preceptors, as determined by the success of former trainees in seeking further career development and/or in establishing productive scientific careers; o caliber of the preceptors as researchers; o adequacy of the training environment, including the level of institutional commitment, quality of the research facilities and availability of appropriate courses (if applicable); o recruitment and selection plans for trainees, including trainees from underrepresented minority groups, and the availability of high quality candidates; and o adequacy of the plan for instruction in the responsible conduct of research. AWARD CRITERIA Up to one center grant will be awarded by NIDCD and NASA in response to this RFA. The anticipated date of award is August 1, 1998. The following criteria will be considered in making funding decisions: o Responsiveness of the proposed program to the purpose of this RFA; o Quality of the proposed program, as determined by peer review; and o Availability of funds for this initiative . INQUIRIES Inquiries concerning this RFA are encouraged. Consultation with NIDCD staff is strongly encouraged, especially during the planning phase of the application process, in order to ensure that the application is responsive to research and research training goals of this initiative. Direct inquiries regarding programmatic issues to: Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: daniel_sklare@nih.gov Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South 6120 Executive Boulevard, Room 400-B - MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: sh79f@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under the authority 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 grant policies and Federal Regulations at 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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