Full Text HD-94-020 MENTAL RETARDATION RESEARCH CENTERS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA: HD-94-020 P.T. Keywords: National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 15, 1994 Application Receipt Date: July 15, 1994 PURPOSE The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), invites research center core grant applications as part of the NICHD Mental Retardation Research Program to develop new knowledge in the field of diagnosis, prevention, treatment, and amelioration of mental retardation and developmental disabilities. Four centers may be supported in response to this RFA. A Mental Retardation Research Center (MRRC) is a center to facilitate, through organization and operation, a program of biomedical and/or behavioral research related to mental retardation. Mental Retardation Research Center core grants support multidisciplinary research in areas that may lead to diagnosis, prevention, treatment, and/or amelioration of mental retardation and developmental disabilities. These grants fund core support services, administration, and development of a limited number of new research programs. The primary objective of the NICHD Mental Retardation Research Centers is to provide support and facilities for a cohesive, interdisciplinary program of research and research training in mental retardation and related aspects of human development. Public Law 88-164, Title I, Part A authorized construction of mental retardation research centers. NICHD has provided partial support for a limited number of these centers through the provision of core grants (P30), which facilitate program coordination and support central research facilities. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations. This Request for Applications (RFA) seeks applications, not only from these constructed centers, but also from other comparable institutions that meet the qualifications for a program of mental retardation research. A major goal of the MRDD Branch's Mental Retardation Research Centers is to prevent and/or ameliorate mental retardation. The degree of impairment associated with mental retardation varies in relation to the cause. Moderate and more severe mental retardation often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity can often be traced to defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, diseases, and other disorders causing brain damage. A larger proportion of cases of mental retardation is related to environmental conditions and disorders of unknown etiology. These complex problems require integrated, multidisciplinary approaches involving biomedical and behavioral sciences in a variety of settings. More than 400 mental retardation syndromes have been identified, and new ones are being discovered. Each requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the afflicted children. Therefore, one of the missions of the MRDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and amelioration of mental retardation. The purpose of a Mental Retardation Research Center is to provide a research environment that facilitates interdisciplinary collaboration among investigators who are working in areas of relevance to the prevention and amelioration of mental retardation. Such research will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development to clinical and behavioral research in which persons with mental retardation are studied. It is thought that major solutions to the problems of mental retardation may be found as a result of multidisciplinary collaboration involving a variety of approaches in the Mental Retardation Research Centers. As a result of the administrative and scientific organization within an MRRC and across the network of MRRCs, opportunities for breakthroughs will be enhanced. 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, Mental Retardation Research Centers, is related to several priority areas including nutrition, alcohol and other drugs, mental health and mental disorders, environmental health, maternal and fetal health, HIV infection, immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-011-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State or local governments. As stated in the NICHD Center Guidelines, the NICHD will not support more than one center grant (P30 or P50) in a given department or specialty unit. MECHANISM OF SUPPORT Mental Retardation Research Center grants will be supported through the center core grant (P30) mechanism. The application should be prepared in a manner consistent with the general guidelines presented in the publication titled P30 CENTER CORE GRANT GUIDELINES, which is available from the MRDD Branch office listed below. Awards will be made for a period of five years. To be eligible for award as an MRRC, the Center must provide core support for a minimum of 10 projects funded from non-university sources. The total direct costs requested for the first year of a new Center Core Grant (P30) should not exceed $500,000. Renewal applications from existing P30 Centers may request initial year direct costs up to, but not exceeding, 120 percent of the Notice of Grant Award level of direct costs for the final year of the preceding project period, or $500,000 direct costs, whichever is greater. Budget increments for subsequent years generally will be limited to four percent. Budgets of new and renewal applications will be stringently reviewed within these guidelines. Applications with budget requests exceeding these guidelines will be administratively withdrawn by NICHD and returned to the applicant. FUNDS AVAILABLE This is the seventh in a series of annual announcements. Plans are to make four awards in fiscal year 1995. The estimated funds available for the first year of support for the entire program is $3.3 million total costs. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Mental Retardation Research Center Core Grants are intended to bring together in a center scientists from a variety of disciplines to work on the common problems of mental retardation. Consequently, applications for Mental Retardation Center Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. Applicants are encouraged, but are not required, to include both biomedical and behavioral components among the topics addressed within their center. Center grant applications must include, but are not limited, among these topics at least five of the following: 1. Developmental neurobiological studies relevant to MRDD: neurophysiological, neuroanatomical, neurochemical, neuropharmacological. 2. Inborn errors of metabolism relevant to MRDD, including mitochondrial disorders: pathophysiology, recombinant DNA technology, screening, applied clinical and experimental studies, including treatment. 3. Genetic/cytogenetic disorders associated with MRDD: research on prenatal diagnosis, particularly non-invasive methods during the early stages of pregnancy on prevalent genetic causes of mental retardation such as Down syndrome or Fragile X syndrome; research on rare genetic disorders associated with mental retardation; genomic imprinting. 4. Molecular biology: gene localization, structure, function and organization; gene mapping; gene therapy; and development of animal models. 5. Toxicology and physical environmental factors in the etiology, treatment and prevention of MRDD including lead, mercury, and alcohol; developmental and behavioral teratology; subclinical levels of toxic agents and their effects on morphological and behavioral changes associated with mental retardation. 6. Effects of malnutrition (protein, calorie, micronutrients) on intellectual, behavioral, social and physical development and the intergenerational effects of malnutrition. 7. Developmental pharmacology and psychopharmacology: medication used with MRDD populations. 8. Infectious diseases in the etiology, prevention and treatment of MRDD; neurological, neuropathological, behavioral and intellectual consequences of AIDS in children. 9. Diagnosis: development and application of biomedical and behavioral methods and measures; identification of children and infants at risk for MRDD. Early interventions for infants at risk to develop MRDD: research into the process of early intervention strategies. 10. Predictive and developmental studies of perinatal problems associated with MRDD: developmental studies of low birth weight, small for gestational age, preterm and neonatally sick infants; hypoxic or ischemic insults. 11. Psychobiological processes in MRDD of conditions such as autism and Rett syndrome using methods of behavioral genetics, embryology and teratology, developmental neuroscience and psychophysiology. 12. Psychological processes in MRDD: studies of cognitive and information processing; attention and perception; sensory and motor development; family, social and affective behavior; and, motivation and personality. 13. Behavioral analyses: manipulations of interaction between behavior and environments of individuals with MRDD to reduce problem behaviors, facilitate vocational training, improve social and self-help skills, and increase acquisition of adaptive behaviors. 14. Family and community studies: parent-child and family interactions; sexual behaviors; family structure and demographic variables, including ethnic minority families with members with MRDD; family and community factors influencing developmental outcomes and adjustment; community resources; caregiver behavior; and social support networks. 15. Language and communication of MRDD populations: studies on development of alternative communication systems; ontogeny of linguistic processes. 16. Learning disabilities, dyslexia, and attention deficit disorder. 17. Residential, educational, and occupational settings throughout the life- span: effects on behavior and adjustment of MRDD individuals; learning and social behavior in educational settings; adaptation to residential environments; aberrant behavior, including stereotypies, destructive behavior, and self-injury. 18. Socioeconomic status, ethnicity, and ecological processes: interaction of MRDD individuals in multiple settings (naturalistic observation); ethnographic research; life history reporting; systematic observation of specific activities. 19. Epidemiology of MRDD: analytic and case-control studies of etiology; prevalence; follow-up of outcomes. 20. Behavior and life-styles that could affect mortality and morbidity. 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel and participating institutions, the core unit directors and principal investigators of the research projects that would use the core units, and the number and title of the RFA in response to which the application may be submitted. 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 evaluating relevance to MRDD and in planning for the review of applications. The letter of intent is to be sent to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 APPLICATION PROCEDURES Applications are to be submitted using PHS 398 (rev. 9/91). Application kits containing this form and the necessary instructions are available in most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the NIH program administrator listed under INQUIRIES. The NICHD recommends that the application be developed in consultation with the MRDD Program staff, who will provide whatever guidance is possible and appropriate in relation to both scientific and administrative issues. Applicants for P30 Mental Retardation Research Center grants should propose a program with a theme relevant to the mission of the MRDD Branch as outlined above. The program should consist of at least 10 externally funded research projects grouped according to relevant topics. These projects must be of high quality, providing a multidisciplinary approach to the problem(s) being investigated. Each project is to be summarized in accordance with the NICHD P30 Center Core Grant Guidelines. The MRRC Director should be a scientist or science administrator who can provide effective administrative and scientific leadership. The Director will be responsible for the organization and operation of the MRRC and for communication with the NICHD on scientific and operational matters. Scientific personnel and institutional resources capable of providing a strong research base in the fields specified must be available. In addition, the institution and pertinent departments are expected to show a strong commitment to the center's support. Such commitment may be provided as dedicated space, salary support for investigators, dedicated equipment, or other financial support for the proposed MRRC. Each core unit proposed for funding under the MRRC grant must be utilized by at least three federally funded research projects, at least one of which is funded by the MRDD Branch of NICHD, exclusive of research contracts, training grants, interagency agreements, and NIH-supplemental projects funded by other agencies. Program staff will make exceptions to this requirement in instances where research relevant to MRDD is assigned elsewhere within NICHD. Subprojects within a program project (P0l) will be considered as individual projects comparable to an R0l. A detailed description of each core unit proposed as part of the center must be provided with detailed budget and budget justification. A scientist must be named as responsible for each core unit proposed. The description of the core units proposed should include a rationale to show how they will support the research effort in a cost effective manner. Facilities must be available for the primary needs of the MRRC Program and require no more than modest alteration and/or renovation. Funds for new construction will not be provided. Promoting interdisciplinary collaboration among scientists working within a Center is a major goal of the MRRC Program. Each MRRC applicant should submit a plan, as part of the application, to ensure continuing interaction among participating scientists from different disciplines. Another goal of the MRRC Program is to attract scientists to the field of mental retardation research. Therefore, where appropriate, the applicant may request "New Program Development" funds for direct research support of one or more projects, not to exceed a total of $50,000 per year or 10 percent of total direct cost, whichever is less. Such funds might serve to attract new investigators to the Center, to develop a new area or program of research, or to facilitate the development of newly trained investigators' research programs. New Program Development projects should be comparable to R0l research applications in their detail and development. Each such project can provide support for only two years for any one investigator. It is a major goal of the NICHD to promote active collaboration among MRRCs. To accomplish this goal, the successful applicants will be encouraged to participate in the collaborative efforts of established MRRC programs. Some consideration should be given, in planning the program, to potential collaborative studies and projects that might be proposed for the MRRC network. The RFA label available in the PHS 398 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. Applications must be identified by checking the YES box in item number 2a on the face page of the application. 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, a copy of the covering letter and two additional copies of the application must also be sent to: Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E-03 Bethesda, MD 20892 Applications must be received by July 15, 1994. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness to the RFA. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications may be triaged by a peer review group on the basis of relative competitiveness. If so, the NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Applications judged to be competitive will undergo further scientific merit review by the NICHD Mental Retardation Research Committee at its March 1995 meeting, in accordance with the criteria stated below. Because a site visit is not a prerequisite for MRRC consideration, each application should be thorough and complete enough to stand on its own. The second-level review will be made by the National Advisory Child Health and Human Development Council at its June 1995 meeting. The anticipated date of award is August 1, 1995. Review Criteria Criteria for the initial review of applications include: o scientific, technical, or medical significance of the application; o qualifications and research experience of the Principal Investigator and scientific collaborators; o scientific and administrative leadership of the Principal Investigator; o quality of proposed core facilities; o availability and quality of resources and research environment; o quality and relevance to mental retardation of research projects that will be using the core facilities; o plans for interdisciplinary/multidisciplinary collaboration; o cost-effectiveness of the proposed MRRC; o institutional commitment; o appropriateness of the proposed budget; o adequacy of plans for the protection of human subjects; o adequacy of plans to protect against or minimize adverse effects on animals; o inclusion of women and minority subjects in research. AWARD CRITERIA In addition to the scientific and technical merit of the application, other factors will be considered in making the awards. Among these are: o centers addressing research areas of high programmatic interest to the MRDD Branch, the CRMC, and NICHD; and research areas targeted by Congress; o availability and quality of resources, especially institutional commitment; o access to unique populations; o potential to increase productivity and quality of research within the center, and stimulate interdisciplinary/multidisciplinary collaborations; o providing unique resources for the use of other Centers, and the greater research community; and o cost-effectiveness of the core facilities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues may be directed to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 Inquiries regarding fiscal matters may be directed to: Mr. Edgar D. Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 Research for Mothers and Children. Awards will be 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 grants policies and Federal Regulations 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 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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