Full Text DC-92-06 DEVELOPMENT OF A MODEL SYSTEM FOR IDENTIFYING NEONATAL HEARING IMPAIRMENT NIH GUIDE, Volume 21, Number 19, May 22, 1992 RFA: DC-92-06 P.T. 34 Keywords: Disease Model Communicative Disorders, Hearing Diagnosis, Medical National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: July 31, 1992 Application Receipt Date: August 21, 1992 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for assistance awards to support cooperative multi-center (consortium) studies of the sensitivity, specificity, and predictive efficiency of methods to identify neonatal (birth to three months) hearing impairment. The major purpose of this Request for Applications (RFA) is to increase, through consortium arrangements, the extent and depth of research leading to the development of timely and efficient methods to identify neonatal hearing impairment. 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, Development of a Model System for Identifying Neonatal Hearing Impairment, is related to the priority area of maternal and infant health. 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 organizations are eligible to apply: foreign and domestic non-profit and for-profit organizations and institutions, State and local governments and their agencies, and authorized Federal agencies. MECHANISM OF SUPPORT The support mechanism for this consortium project will be a cooperative clinical research grant (R10). This RFA is a one-time solicitation. Funding in response to this RFA is dependent upon the receipt of applications of high scientific merit. The earliest start date for the initial awards will be April 1, 1993. FUNDS AVAILABLE Awards will be made for project periods of five years. Up to $5 million total (direct plus indirect) costs is available for the entire project period of five years, or about $1 million per year total for all awards. The NIDCD anticipates making one or two awards, but the specific amount and number of awards will depend on the merit and scope of the applications received. Budget increments after the first year will be limited to approved programmatic changes and necessary cost-of-living increases. Although this project is provided for in the financial plans of the NIDCD, the award of grants pursuant to the RFA is contingent on the availability of funds appropriated for fiscal year 1993. RESEARCH OBJECTIVES Background The average age at which profound hearing loss is first detected in this country is about 2.5 - 3 years, long after the period considered critical for speech and language development. Lesser degrees of hearing loss may go undetected even longer. This delay can exacerbate the developmental consequences of early-onset hearing impairment and add to the difficulty of later habilitation. Moreover, delayed identification and intervention may impair the hearing-impaired person's ability to adapt to life in a hearing world and/or prepare for life in the hearing-impaired community. The health care of children may be compromised by their inability to communicate adequately, and their educational progress may be slowed by language impairment secondary to the hearing loss. Clinicians, well aware of these issues, have approached infant hearing screening with a number of different test methods over the years: cardiac response audiometry; respiration audiometry; alteration of sucking patterns, movement, or startle in response to auditory stimuli; measurement of acoustic reflexes; and more recently, auditory brain stem response (ABR) audiometry. Each is effective in its own way, but technical or interpretive limitations have impeded widespread application. Moreover, these approaches vary widely in their sensitivity, specificity, and predictive efficiency in identifying hearing impairment. Unlike methods used to screen for other abnormal conditions in the neonatal period (e.g., phenylketonuria, cystic fibrosis), auditory screening methods often require costly equipment and trained observers, and are relatively time consuming. When factors such as prematurity or central nervous system disorders co-exist, the interpretation of test results becomes even more complex and predictive error more likely. Today, most neonatal screening programs are focused on infants who satisfy one or more of a number of criteria for inclusion in a "high- risk registry." The preferred screening method has come to be ABR, combined with audiologic follow-up for those infants who fail the screening protocols. Despite the relatively good predictive efficiency of ABR, its cost, time requirements, and technical difficulties have discouraged the general application of this method in screening the far larger neonate population not meeting high-risk registry criteria. Recently, the attention of researchers and clinicians has turned to another technique as a candidate for a fast, inexpensive, non-invasive means of screening the hearing of infants. Otoacoustic emissions (OAEs), which are low amplitude tones that can be measured in the external ear canal, are thought to be the product of cochlear hair cell activity. The emissions may arise spontaneously or be evoked either in isolation or as the distortion products of auditory stimuli presented to the ear. In general, OAEs can be detected and measured only when cochlear function is normal (although middle ear abnormalities limit detectability); hence, the interest in the use of OAEs as an indicator of hearing status. Preliminary studies have demonstrated the feasibility of such an application; however, controlled large-population studies of normal and at-risk infants, validated by longitudinal audiologic follow-up, have not been conducted nor have optimum stimulus and recording parameters been established. In addition, general developmental influences and the effects of medical and pharmacologic factors on OAEs are largely undefined. The widespread implementation of OAEs as a general screening device must await answers to these issues. In this way, the sensitivity, specificity, predictive efficiency, and cost effectiveness of an OAE-based neonatal screening program can be compared to that of ABR which, despite its various limitations, currently represents the standard of care. Goals and Scope The goal of this RFA is to support the conduct of coordinated multicenter studies (consortium arrangements), leading to the development of a system for the identification of neonatal hearing impairment. Areas of research appropriate to the RFA may include, but are not limited to: screening normal and at-risk neonates with both ABR and OAE recordings; determining optimum stimulus and recording parameters for OAE; assessing the influence of co-existing medical factors on characteristics of ABR and OAE; assessing development- related changes in OAEs that may occur particularly during the first year, establishing monaural threshold sensitivity for pure tones and speech, evaluating sensitivity, specificity, and predictive efficiency of ABR and OAE test methods, singly and in combination; and evaluation of time and cost-efficiency of the procedures. The goals of this RFA can be met by including the above areas of research in an application encompassing three project phases: screening, follow-up, and data analysis. A pilot or start-up phase of up to four months may also be included. Emphasis should be placed on the existing and potential strengths of the applicant organizations related to the fulfillment and completion of the objectives of the RFA. Appropriate areas may include, but are not limited to: arrangements for biostatistical and/or epidemiologic support; collaborations for ensuring availability of patients; arrangements for patient accrual; arrangements for coordination among the cooperating institutions; identification of essential personnel for recruitment; and development of plans for acquiring or providing any special research skills needed. Members of the consortium are expected to participate in all phases of the project and to include with the application, the experimental protocol, data collection form, consent form, human subjects approval, and specific plans for statistical analysis. The consortium is expected to obtain an appropriate number of subjects for inclusion in this project. Applicant groups are expected to provide both the equipment and staff needed to accomplish all testing required by the protocol. The institutional costs of testing the hearing of infants usually may not be recovered from the grant. Under certain circumstances, at the discretion of the applicant and in order to ensure the active participation of the institution, the costs of testing infants entered into the high-risk registry may be recovered. In that case, the projected direct costs to the grant must be included in the budget. Other questions that may be addressed by these studies include, but are not limited to: o To what extent does the presence of middle ear abnormality influence test results? o Do pharmacologic agents administered during the perinatal period introduce confounding effects on measurement accuracy or reliability? Applicants should include, in the budget request, provision for an annual trip to the Washington, DC, area to report progress to NIDCD staff. 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 are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (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 questions(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 NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. REVIEW CONSIDERATIONS Applications will be evaluated by NIDCD program staff to determine responsiveness to the RFA. Responsive applications will then be evaluated for scientific and technical merit by a review committee convened by the Scientific Review Branch of the NIDCD solely for this purpose. A second level review will be conducted by the National Deafness and Other Communication Disorders Advisory Council. Applications that are judged non-responsive will be administratively withdrawn, and the applicant Principal Investigator and institutional business official will be notified. Should an application be judged non-responsive to this RFA, any of its constituent projects may be submitted as an investigator-initiated individual research grant (R01) at the next receipt date or later. The new application would not be considered a response to an RFA. Factors considered to be important for review include demonstrated expertise in pediatric audiology, identification audiometry, neonatology, biostatistics and physiologic methods of hearing assessment; documentation of availability of an appropriate patient population; documented plans for interaction among collaborating institutions and clinicians; administrative support by the hospitals, clinics, or medical centers for all phases of the studies; and adequate facilities and ancillary personnel. Reviewers will review the grant applications by considering the following criteria: o Appropriateness, originality, feasibility, and relevance of the proposed project to the overall goals and objectives of the RFA. o Qualifications, experience, and proposed responsibilities of the Principal Investigators and key personnel. o Scientific merit and organizational plans for implementing the proposed program. o Demonstration of availability of normal and at-risk patient populations. o Proposed collaborations among audiologists, otolaryngologists, neonatologists, nursing staff, and other key personnel within the applicant and collaborating institutions; adequacy of documented interest, capabilities, and commitment of all potential participating clinics. o Facilities and resources, and the availability of such for this project. o Adequacy of proposed overall administrative procedures and inter- and intra-institutional collaborative arrangements. o Reasonableness and appropriate justification of the proposed budget. o Plans to protect the rights and welfare of human subjects, including appropriate informed consent procedures. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91) using the instructions included in the application kit. These kits are available from the NIDCD Program Administrator cited below and from the Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. On page 1 of form PHS 398, check "yes" in item 2a and type: RFA DC-92-01: Development of a Model System for the Identification of Neonatal Hearing Impairment. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Complete applications are due no later than August 21, 1992, and must address all requirements in the RFA. Applications received after this date will be returned to the applicant without review. Also, the Division of Research Grants will not accept any application in response to this RFA that is the same as one being considered by any other review group or other NIH awarding unit. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. Submit a signed, typewritten original of the application, including the Checklist, and four signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** The photocopies must be clear and single sided. To facilitate a timely review, send one additional copy of the application and any appendix material, under separate cover to: Dr. Earleen Elkins Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Suite 400-B, Executive Plaza South 6120 Executive Boulevard Rockville, MD 20852 LETTER OF INTENT Prospective applicants are asked to submit, by July 31, 1992, a letter of intent that includes a descriptive title of the proposed project, the name and address of the Principal Investigator, the names of other key personnel and collaborating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, submission of such a document allows NIDCD review staff to estimate the review workload and avoid conflict of interest in the review. The letter of intent is to be sent 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 400B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-3458 FAX: (301) 402-6251 AWARD CRITERIA The anticipated date of award is April 1, 1993. In addition to technical merit, award decisions will be based on the responsiveness to the RFA, the availability of resources, and the composition of the study populations. 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: 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 6120 Executive Boulevard Rockville, MD 20852 Telephone: (301) 496-5061 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters and requirements for the formation of consortia to: Sharon Hunt Division of Extramural Activities Grants Management Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400-B 6120 Executive Boulevard Rockville, MD 20852 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS The NIDCD program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards will be made under the authority of the Public Health Service Act, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS Grant Policy Statement and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 or 92. The program is not subject to review by a Health Systems Agency or to the intergovernmental review requirements of Executive Order 12372. .
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