MOLECULAR BASES OF REPAIR AND REGENERATION OF THE AUDITORY RECEPTOR NIH GUIDE, Volume 21, Number 34, September 25, 1992 PA NUMBER: PA-92-106 P.T. 34 Keywords: Communicative Disorders, Hearing Biology, Cellular Biology, Molecular National Institute on Deafness and Other Communication Disorders PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites grant applications addressing the identification of the mechanisms involved in the repair and regeneration of damaged sensory epithelial cells in the auditory periphery. Innovative research on the molecular bases of the repair process should elucidate ways to initiate and control the regeneration of damaged hair cells. 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 Program Announcement (PA), Molecular Bases of Repair and Regeneration of the Auditory Receptor, is related to the priority areas of occupational safety and health; and diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or 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 Applications may be submitted by domestic and foreign, 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. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support mechanisms for this announcement include the individual research project grant (R01) and the First Independent Research Support and Transition (FIRST) Award (R29). Foreign institutions are not eligible for the FIRST Award. RESEARCH OBJECTIVES Background More than 17 million Americans suffer from sensorineural hearing impairment, which is often attributed to damage to the hair cells of the cochlea. Until recently, damage to these hair cells in mammals was considered to be irreversible. One of the most exciting discoveries of the past decade has been that the auditory sensory epithelia of birds, amphibians, and fish are capable of repair and regeneration after damage by noise or drugs. Studies have shown that the regenerated cells establish functional neural connections. In addition, precursor cells for the regenerated cells have been identified and these precursor cells appear to have mammalian homologues. Recently, regeneration of hair cells from postnatal birds has been achieved in vitro. Further elucidation of these repair and regeneration processes should lead to therapeutic advances. Research Goals and Scope The ultimate goal of this PA is to gain the knowledge needed to stimulate and control the repair processes involved in hair cell regeneration so that sensorineural hearing loss due to hair cell damage might be prevented or reversed. Investigation of the molecular and cellular mechanisms involved in the initiation and control of this repair process is amenable to methods of modern biotechnology. Innovative, multidisciplinary, state-of-the-art studies are encouraged to determine the factors that initiate and control sensory cell replacement and recovery of hearing. Studies may include, but are not limited to, the topics listed below: o improved models of hair cell damage such that the resulting auditory impairment is less variable, and therefore easier to control and study; o more specific identification of the cellular precursors of the replacement hair cells and supporting cells; o identification of the factors that trigger the regeneration response in the hair cell epithelia; o definition of the role of known mitotic growth factors and other chemical agents (for example, retinoic acid) that may control and/or trigger progenitor cell division; o development of pharmacologic agents for inducing and controlling cell replacement and auditory recovery; o investigation of the molecular and cellular bases for hair cell regeneration in the mammalian ear; o assessment of the contribution of other potential repair processes in the ear, including repair of damaged subcellular components of hair cells and repair of damaged links between sensory cells and the overlying tectorial membrane; o evaluation of the role and extent of the re-establishment of neuronal connections in the sensory organ for their contribution to the recovery of hearing; and o correlation of structural changes with measures of functional changes during the course of regeneration. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS. NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional business offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original application and five exact copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered as funding decisions are made: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Amy Donahue, Ph.D. Chief, Hearing Program Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400-B Rockville, MD 20892 Telephone: (301) 402-3458 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Sharon Hunt Grants Management Officer Division of Extramural Activities 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. 93.173. 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. .
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