and Human Services (HHS)
EXPIRED
MENTAL RETARDATION RESEARCH CENTERS Release Date: April 13, 2000 RFA: HD-00-017 National Institute of Child Health and Human Development Letter of Intent Receipt Date: June 1, 2000 Application Receipt Date: July 18, 2000 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 (P30) 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 announcement. The primary objective of the NICHD Mental Retardation Research Centers (MRRC) 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. For more than 30 years NICHD has provided support for MRRCs through the provision of core grants (P30) that facilitate program coordination, and support central research facilities, administration, and development of a limited number of new research programs. 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 from institutions that meet the qualifications for a program of mental retardation research. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Mental Retardation Research Centers, is related to several priority areas. Potential applicants may obtain Healthy People 2010 at http://www.health.gov/healthypeople/. 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 or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for these P30 grants. 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 center grant (P30) in a given university or other applicant institution. To be eligible for an award, the proposed Center must provide core support for a minimum of 10 projects funded from non-university sources. Additional eligibility criteria for the P30 are listed in the NICHD P30 CENTER CORE GRANT GUIDELINES, available from the program contact listed under INQUIRIES, below, and on the Internet at: http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) center core grant (P30) award mechanism. Responsibility for the planning, direction, and execution of the proposed work will be solely that of the applicant. Applications should be prepared in a manner consistent with the guidelines presented in the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). FUNDS AVAILABLE The NICHD intends to commit approximately $5 million in total costs (direct plus Facilities and Administrative [F & A] costs) in FY 2001 to fund up to four new and/or competing continuation grants in response to this RFA. Applicants may request a project period of five years. Because the nature and scope of the programs proposed may vary, it is anticipated that the size of awards also will vary. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The cost of a proposed Center will be a material consideration in the selection of applications for funding. The total direct costs requested for the first year of a new Center should not exceed $500,000. Competing continuation applications from existing P30 Centers may request initial year direct costs no greater than 20 percent above the level of the last year of the Type 5 award, or $500,000 direct costs, whichever is greater. Budget increments for subsequent years generally will be limited to three 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. RESEARCH OBJECTIVES Background A major goal of the NICHD Mental Retardation Research Centers Program 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 often can 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 or social 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 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 treatment or amelioration of mental retardation. Research conducted in the MRRCs 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 emerge from 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. RESEARCH SCOPE Mental Retardation Research Center Core Grants are intended to bring together scientists from a variety of disciplines to work within a Center 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 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, focused specifically on mental retardation and developmental disabilities: 1. Developmental and neurobiological studies relevant to MRDD: physiology, anatomy, chemistry, pharmacology, plasticity, and structural and functional imaging. 2. Cellular and molecular aspects of brain development: differentiation, synapse formation and modification, plasticity, trophic factors, and neurotransmitter function and modulation. 3. Inborn errors of metabolism relevant to MRDD, including mitochondrial and peroxisomal disorders and other disorders including, but not limited to, amino acid, organic acid, carbohydrate, cholesterol, nitrogen, catecholamine, and indolamine metabolism, molecular biology, pathophysiology, recombinant DNA technology, screening, applied clinical and experimental studies. 4. 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. 5. Molecular genetics of MRDD, including gene mapping, genomic imprinting, gene therapy, and gene localization, structure, function, regulation, and organization. 6. Development and characterization of animal models relevant to MRDD, e.g., gene knockout, gene repair, transgenesis, homologous recombination. 7. Prenatal therapy of genetic and structural defects using metabolic, pharmacologic, nutritional, and surgical techniques. 8. Genetic, molecular, behavioral, and biobehavioral research and therapeutic approaches to Fragile X syndrome and Rett syndrome. 9. Toxicology and physical environmental factors in the etiology, treatment, and prevention of MRDD, including lead, mercury, and other heavy metals, and toxic wastes, such as hydrocarbons and polycarbonates (PCBs), developmental and behavioral teratology, fetal alcohol syndrome, neuroimmunological toxicology, subclinical levels of toxic agents and their effects on morphological and behavioral changes associated with mental retardation. 10. Effects of malnutrition (protein, calorie, micronutrients) on intellectual, behavioral, social, and physical development, and the intergenerational effects of malnutrition. 11. Psychopharmacology, cellular and molecular mechanisms, pharmacokinetics, behavioral effects, medications used and treatment efficacies in different subpopulations of MRDD, dual diagnoses, rational drug development, combinatorial chemistry. 12. Clinical trials for the treatment, amelioration, and/or prevention of MRDD. 13. Infectious diseases in the etiology, prevention, and treatment of MRDD, neurological, neuropathological, behavioral, and intellectual consequences of AIDS in children. 14. Diagnosis: development and application of methods and measures for screening and diagnosis, identification of children and infants at risk. 15. Early interventions (biological, behavioral, environmental) for infants born at risk for MRDD, research into the process of early intervention strategies, follow-up of high-risk infants and children who are at risk due to biomedical conditions such as low birth weight and/or conditions of environmental deprivation. 16. 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. 17. Psychobiological processes in MRDD of conditions such as autism and Rett syndrome using methods of behavioral genetics, embryology and teratology, developmental neuroscience and psychophysiology, and developmental psychopharmacology. 18. Psychological processes in MRDD, including attention, cognition, information processing, perception, motor development, neuropsychology, affective, social, motivational, and personality factors. 19. Autism and autism spectrum disorders: screening and diagnosis, etiology, neurobiology, genetics, pathophysiology, developmental course, medical, biological and pharmacological approaches, behavioral intervention. 20. Behavioral analysis: manipulations of interaction between behavior and environments of individuals with MRDD in infancy, childhood, adolescence, and adulthood to effect reduction in behavior problems, or to facilitate vocational training, social and self-help skills, and learning. 21. Family and community processes: effects of family members with MRDD on family life, family, community, ethnic, socioeconomic, and cultural factors influencing developmental outcomes and use of community resources, use of social support networks, parent-child, sibling, peers, and family interactions over the life span. 22. Measurement tools to assess cognitive and behavioral development, tests that highlight abilities and disabilities, including tests for specific subpopulations, such as Fragile X, inborn errors of metabolism, Williams syndrome. 23. Residential, educational, and vocational settings throughout the life span: effects of behavior and adjustment of individuals with MRDD, learning and social behavior in these settings, adaptation to residential environments. 24. Learning disabilities, dyslexia, and attention deficit hyperactivity disorder. 25. Language and communication in MRDD populations. 26. Socio-ecological processes: individuals with MRDD from various cultural and ethnic groups in multiple settings (naturalistic observation), ethnographic research, life history reporting, and systematic observation of specific activities. 27. Hyperaggressive, destructive, and self-injurious behavior in human and animal models, including pharmacologic treatment, stereotypic behaviors, lack of compliance of mentally retarded children in family and educational settings. 28. Epidemiology of MRDD: analytic and case-control studies of etiology, incidence and prevalence, follow-up over the life span (infancy to adulthood) for outcomes. 29. Behavior and life styles that could affect mortality and morbidity. 30. Development of assistive devices (e.g., computer software) to help individuals with MRDD to learn and communicate. 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 must show a strong commitment to the Center’s support. Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated equipment, or other financial support for the proposed Center. Applications 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 (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). Each core unit proposed for funding under the MRRC grant must be utilized by a minimum of 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 (P01) will be considered as individual projects comparable to an R01. 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 each core unit proposed should include a rationale, indicating how it 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 assure 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. Description of New Program Development projects should be comparable to R01 research grant applications in their detail and development. Each such project may 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. In planning the program, some consideration should be given to potential collaborative studies and projects that might be proposed for the MRRCs network. 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 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, 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, and available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and/or ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff 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, and inclusion of children as participants in research involving human subjects, will need to be addressed at the individual project level (i.e., R01 level). However, the application must specifically address these issues for any New Program Development projects involving human subjects or core units involved in activities such as subject recruitment or testing. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed center, 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 this RFA. 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 plan the review. The letter of intent is to be sent to Dr. Felix F. de la Cruz at the address listed under INQUIRIES, below, by June 1, 2000. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E-mail: Grantsinfo@nih.gov. The RFA label available in the PHS 398 (rev. 4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-00-017. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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 2 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: CENTER FOR SCIENTIFIC REVIEW 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 should be sent to: L. R. Stanford, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E-03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by July 18, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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 CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude 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 CSR and for responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant 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 Subcommittee at its March 2001 meeting, in accordance with the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council. Review Criteria All applications responding to this RFA will be evaluated according to the review criteria for core units, New Program Development projects, and the overall center as outlined in the NICHD P30 Center Core Grant Guidelines (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm. SCHEDULE Letter of Intent Receipt Date: June 1, 2000 Application Receipt Date: July 18, 2000 Peer Review Date: March 2001 Council Review: June 2001 Earliest Anticipated Start Date: July 1, 2001 AWARD CRITERIA In addition to the scientific and technical merit of the application, as determined by peer review, factors that will be considered in making the awards include: o 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 access to unique populations, o potential to increase productivity and quality of research within the Center, and to stimulate interdisciplinary/multidisciplinary collaborations, o providing unique resources for use by other Centers and the greater research community, o cost-effectiveness of the core facilities. o cost of the Center, and o availability of funds. 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. Chief, Mental Retardation and Developmental Disabilities Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1383 FAX: (301) 496-3791 E-mail: fd14a@nih.gov Direct inquiries regarding fiscal matters to: Mr. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 E-mail: ds117g@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 authorization of Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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