Full Text HD-95-012 MENTAL RETARDATION RESEARCH CENTERS NIH GUIDE, Volume 24, Number 12, March 31, 1995 RFA: HD-95-012 P.T. 04 Keywords: Mental Retardation Biomedical Research, Multidiscipl Disease Prevention+ National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 12, 1995 Application Receipt Date: July 14, 1995 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 (P30) applications as part of the Institute's 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 Request for Applications (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 MRRCs 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. The 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 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 result 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 large 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. Several 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 affected 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 MRRCs. As a result of the administrative and scientific organization within a Center 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, and immunization and infectious diseases. 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- 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. For the purpose of this RFA, the NICHD will not support more than one mental retardation and developmental disabilities research center grant (P30 or P50) in a given university or other applicant institution. MECHANISM OF SUPPORT Mental Retardation Research Center grants will be supported through the center core grants (P30) mechanism. The application should be prepared in a manner consistent with the general guidelines presented in the publication titled NICHD P30 CENTER CORE GRANT GUIDELINES, which is available from the program staff listed under INQUIRIES. Awards will be made for a period of five years. To be eligible for an award, the Center must provide core support for a minimum of 10 projects funded from non-university sources. The cost of a Center will be a material consideration in the funding decision. 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 eighth in a series of annual announcements. Plans are to make four awards in fiscal year 1996. The estimated funds available for the first year of support for the entire program is $3.5 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 Research 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 among these topics at least five of the following that are focused specifically on mental retardation and developmental disabilities: 1. Developmental neurobiological studies relevant to MRDD: neurophysiology, neuroanatomy, neurochemistry, neuropharmacology, neuroplasticity. 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, essential fatty acids) 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. 10. Early interventions for infants at risk to develop MRDD: research into the process of early intervention strategies. 11. 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. 12. Psychobiological processes in MRDD of conditions such as autism and Rett syndrome using methods of behavioral genetics, embryology and teratology, developmental neuroscience and psychophysiology. 13. Psychological processes in MRDD: studies of cognition and information processing; attention and perception; sensory and motor development; family, social and affective behavior; and motivation and personality. 14. 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. 15. 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. 16. Language and communication of MRDD populations: studies on development of alternative communication systems; ontogeny of linguistic processes. 17. Learning disabilities, dyslexia, and attention deficit disorder. 18. 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 stereotypes, destructive behavior, and self-injury. 19. 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. 20. Epidemiology of MRDD: analytic and case-control studies of etiology; prevalence; follow-up of outcomes. 21. Behavior and life-styles that could affect mortality and morbidity. 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 are 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 28, 1994 (FR 59 14508-14513) 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. The Director, Division of Scientific Review, NICHD, may also provide additional relevant information concerning the policy. Because P30 funds in general do not directly support research projects, the issue of minority/gender representation will need to be addressed at the individual project level (e.g., R01 level). However, the application will specifically need to address these issues for any new program development projects involving human subjects or core units that focus on human subject recruitment. LETTER OF INTENT Prospective applicants are asked to submit, by May 12, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, 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 a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Felix F. de la Cruz at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at 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 program administrator listed under INQUIRIES. Applicants for P30 Mental Retardation Research Center grants must 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. SPECIAL REQUIREMENTS 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 have 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 Center. 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-supplemented 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 Center 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 costs, 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. The descriptions of New Program Development projects in the application should be comparable to ROl research grant 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 Centers' programs. Some consideration should be given, in planning the program, to potential collaborative studies and projects that might be proposed for the Mental Retardation Research Centers network. The RFA label available in the PHS 398 (rev. 9/91) application kit 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 must be typed on line 2a of the face page of the application form and the YES box must be marked. 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 or courier service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 Applications must be received by July 14, 1995. If an application is received after that date, 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, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NICHD staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NICHD staff will return the application without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by the NICHD Mental Retardation Research Committee at its March 1996 meeting in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second-level review will be made by the National Advisory Child Health and Human Development Council at its June 1996 meeting. The anticipated date of award is August 1, 1996. Review Criteria In addition to the specific criteria listed in the NICHD P30 Guidelines, reviewers will evaluate: o scientific, technical, or medical significance and originality of proposed research; 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 of research projects that will be using the core facilities; o plans for interdisciplinary/multidisciplinary collaboration; o institutional commitment; o appropriateness of the proposed budget; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects (if applicable) will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. 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 relevance of research projects accessing the core facilities to mental retardation and related developmental disabilities. o availability and quality of resources, especially institutional commitment and support; 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 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: 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 Building 6100, Room 4B09 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1383 FAX: (301) 496-3791 Email: CRUZF@HD01.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: Mr. Edgar D. Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A07 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: SHAWVERD@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 Research for Mothers and Children. 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 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 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 routing 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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