Full Text HD-94-014 DEVELOPMENTAL DISABILITIES PREVENTION RESEARCH CENTER NIH GUIDE, Volume 23, Number 5, February 4, 1994 RFA: HD-94-014 P.T. 34 Keywords: PHYSIOLOGICAL/DEVELOPMENT PROCESS Disease Prevention+ Mental Retardation National Institute of Child Health and Human Development Letter of Intent Receipt Date: March 31, 1994 Application Receipt Date: May 18, 1994 PURPOSE The budget appropriation report language for the National Institute of Child Health and Human Development (NICHD) for fiscal year 1994 indicated that funds were provided to establish "... a Developmental Disabilities Prevention Research Center within a university affiliated program (UAP), which shall investigate the critical problems of prevention and amelioration of mental retardation, specifically including: a specialized research center engaged in the multidisciplinary analysis of myelinogenesis as a critical period that is highly vulnerable to nutritional status during fetal and postnatal brain development." In response to this Congressional mandate, the Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), NICHD, invites applications for a specialized research center that will develop new knowledge concerning diagnosis, prevention, treatment, and amelioration of mental retardation and developmental disabilities, with special emphasis on vulnerable periods in fetal and postnatal brain development. One specialized center may be supported in response to this request for applications (RFA). Specialized Research Centers on mental retardation are awarded funds for centralized research services and facilities and for the support of comprehensive research projects on topics deemed to be of high priority because of their significance to the etiology, diagnosis, prevention, treatment, or amelioration of mental retardation and developmental disabilities. 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. Because of the diversity of causes of mental retardation, which include genetic, infectious, metabolic, toxic, nutritional, and other factors, and the interaction of biological, behavioral, social, and cultural factors which could affect the severity of its clinical manifestations, research approaches on the prevention or amelioration of MRDD may require the collaborative efforts of several scientific disciplines. 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, Developmental Disabilities Prevention Research Center, is related to the priority area on chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) 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, provided they have an existing University Affiliated Program (UAP). Public Law 88-164, Title I, Part B authorized construction of University Affiliated Facilities, "for the purpose of assisting in the construction of clinical facilities, providing, as nearly as practicable, a full range of inpatient and outpatient services for the mentally retarded and facilities which will aid in demonstrating provision of specialized services for the diagnosis and treatment, education, training, or care of the mentally retarded or in the clinical training of physicians and other specialized personnel needed for research, diagnosis and treatment, education, training, or care of the mentally retarded..." Applicants to this RFA may collaborate, through consultation or contractual arrangements, with foreign investigators. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the NIH Specialized Center grant mechanism (P50). The applications should be prepared in a manner consistent with the information presented in the publication, National Institute of Child Health and Human Development, Research Center Programs, which is available from the NICHD office listed below. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated date of award is September 30, 1994. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Applications submitted in response to this RFA will compete for $600,000 in direct costs that will be made available for the first year of support. Only one award will be made. RESEARCH OBJECTIVES The MRDD Branch supports research that relates to the biological, behavioral and social processes that contribute to, or influence the development of, mental retardation and developmental disabilities. Prevention of MRDD, and amelioration of the clinical manifestations of those afflicted, constitute areas of special emphasis within the Branch. To accomplish its mission, the MRDD Branch provides financial support for research grants, core facilities in the Mental Retardation Research Centers, specialized research centers, research contracts for the development of research resources, and for dissemination of information to the scientific community and the public. This RFA solicits applications that will contribute to a better understanding of the causes, diagnosis, prevention, treatment and amelioration of mental retardation and developmental disabilities. NICHD encourages basic and clinical research, using animal models and human subjects, addressing genetic, environmental and other factors that affect brain development. Research on the effects of malnutrition (protein, calorie, trace metals, vitamins), on myelinogenesis is of particular interest. Research projects on the effects of various types of intervention strategies, including nutritional supplementation, on neuropsychological development, are also encouraged. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be 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 should 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 should 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 should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should 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 includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 31, 1994, a letter of intent that includes a descriptive title of the proposed research, address, and telephone number of the Principal Investigator, titles of the component subprojects and the principal investigator, core facilities, when applicable, and the director of each core, names 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 subsequent applications, the information that it contains allows Institute staff to estimate the potential review workload and to avoid possible 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 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 and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 435-0714. The RFA label available in the PHS 398 (rev. 9/91) 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. 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Susan Streufert, Ph.D. 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 May 18, 1994. 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, the applications will be reviewed for completeness by DRG, and responsiveness to the RFA by NICHD staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, Institute staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by a peer review group on the basis of relative competitiveness. In that case, the NIH will withdraw from further competition those applications judged to be non-competitive for an award and notify the applicant Principal Investigator and institutional official. Applications judged to be competitive will undergo further scientific merit review. Applications that are complete and responsive will be evaluated for scientific and technical merit by a review panel convened solely for this purpose by the Division of Scientific Review, NICHD. The second level of review will be provided by the National Advisory Child Health and Human Development Council. Review Criteria Review criteria for RFAs are generally the same as those for unsolicited research grant applications, and include: o scientific, technical, or medical significance of the application; o appropriateness and adequacy of the experimental approaches proposed to carry out the research; o coordination, interrelationship, cohesiveness, and synergism among the individual research projects and core components; relationship of the program objectives to the common theme; the advantages of pursuing the proposed research as a P50 rather than through individual research grants; o qualifications and research experience of the Principal Investigator for the entire program, and the Principal Investigators for the component projects; o participation of a suitable number of responsible, experienced investigators; o the specific scientific objectives of each project that will benefit from, depend upon, or contribute to collaborative interactions with the other component projects within the P50 (i.e., objectives that can be accomplished with greater effectiveness, and/or economy of effort, etc.); o an appropriate organizational and administrative structure for effective attainment of program objectives; o arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and internal communication and cooperation among program investigators; o availability and quality of resources and research environment; o appropriateness of the proposed budget and duration in relation to the proposed research; o when applicable, quality of proposed core facilities; o adequacy of plans for the protection of human subjects; o adequacy of plans to protect against or minimize adverse effects on animals; and o inclusion of women and minority subjects in research. AWARD CRITERIA In addition to the scientific and technical merit of the application, the following factors will be considered in making an award: o relevance to mental retardation; o access to unique populations; and o institutional commitment and support. The anticipated date of award is September 30, 1994. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the NICHD Research Center Programs guidelines and inquiries regarding programmatic, technical, and scientific 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 and administrative matters may be directed to: Mr. E. Douglas 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 are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 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. .
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