CHILD AND ADOLESCENT DEVELOPMENT AND PSYCHOPATHOLOGY RESEARCH CENTERS NIH GUIDE, Volume 22, Number 21, June 11, 1993 PA NUMBER: PA-93-092 P.T. 04 Keywords: Child Psychology/Development Psychopathology Biomedical Research, Multidiscipl National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) seeks to expand the Nation's scientific capacity to conduct research on child and adolescent mental disorders by fostering the evolution of Child and Adolescent Development and Psychopathology Research Centers (CADPRC). These Centers are essential to enable the development of new approaches and research strategies to address key scientific problems that have heretofore impeded progress in the child and adolescent mental health/mental disorders field. Thus, this program announcement represents a major NIMH commitment to the advancement of the scientific understanding of the causes, consequences, prevention, and treatment of child and adolescent mental disorders. This announcement focuses on the development of research centers whose main goal is to bridge basic science, state-of-the-art methodologies, and clinical research approaches, in order to address pressing child psychopathology-related research problems that cannot otherwise be adequately addressed by less integrated research strategies. As such, this announcement is the second part of a two-pronged approach outlined under "The National Plan for Research on Child & Adolescent Mental Disorders." While the previously released program announcement, "Implementation of the National Plan for Research on Child and Adolescent Mental Disorders," outlines major areas of research focus and opportunities, this announcement focuses on the creation of necessary research centers to develop the research infrastructure and to advance the knowledge base in critical problem areas. 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 Program Announcement, Child and Adolescent Development and Psychopathology Research Centers (CADPRC), is related to the priority areas of suicide and mental disorders in children and adolescents. 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, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The NIMH will support a maximum of two Centers in each of the first three years of the program. Funding for a Developing CADPRC (P20) (described below under RESEARCH OBJECTIVES) is for a single five-year period only. Funding for Mature Centers (P50) (described below) can be for a maximum project period of five years. Funds may be requested for core support related to the research program of the Center and for specific research and research training activities, including inpatient bed costs, outpatient costs, subject incentive fees, pilot studies, and costs of specialized consultation such as statistical and/or computer science. Training costs and service costs not related to the research program are not covered under Center grants. Actual amounts and years of support that may be approved and awarded will depend on the appropriate level of support necessary for the scientifically meritorious work that is proposed. RESEARCH OBJECTIVES A CADPRC provides research resources that are to be used by a multidisciplinary, cooperating group of researchers as the foundation for a major research program organized around a significant research question or theme. This theme should be directed toward a pressing research question that juxtaposes two or more alternative research paradigms and traditions (e.g., genetic versus environmental contributions to the development of a disorder or subclinical condition; categorical versus dimensional taxonomic approaches; preventive versus promotive interventions, etc.). These multidisciplinary teams should draw upon an expert cadre of researchers across both basic and clinical research disciplines in order to build optimal conceptual and methodologic bridges to address pressing (sometimes controversial and hotly disputed) research questions. Thus, a CADPRC's multidisciplinary team as a rule will consist of researchers from the basic sciences (e.g., developmental psychology, behavioral neuroscience, molecular genetics, etc.) and scientists from more applied, clinical research areas (psychopharmacology, child psychiatry, pediatrics, neuropsychology, clinical psychology, epidemiology, prevention, neuroimaging). Priority will be given to the creation of multidisciplinary research centers devoted to key problem areas of child and adolescent psychopathology research. In all instances, the CADPRC's main goal is to bridge state-of-the-art theories and methods from the basic sciences with pressing, clinically relevant research problems, in order to address child psychopathology research questions that could not otherwise be adequately addressed. Pilot studies pertaining to the etiology, epidemiology, development, diagnosis and classification, prevention, treatment, outcome, and rehabilitation of child and adolescent mental disorders may be supported as a part of a CADPRC, if these studies are clearly related to the thematic focus of the Center. There are two categories of grant applications under the CADPRC program: applications for "Developing Centers" and applications for "Mature Centers." The intent of these two categories is to encourage the development of research centers across a wide range of institutions at varying stages of research capacity development. Although there is no absolute criterion to distinguish who should apply in which category, the following guidelines apply: o The category of "Developing Centers" (P20) is appropriate for departments or other entities that aspire to and are in the process of developing the critical mass of research scholars necessary to conduct state-of-the-art research on child and adolescent development and psychopathology. Applicants in this category do not necessarily have strong track records in research but do show promise by virtue of the commitment of institutional resources, recruitment of research scholars to develop into fully functioning research centers. The funding cap for grants in this category is $300,000 per year, plus negotiated institutional indirect costs. This award is not renewable. o "Mature Centers" (P30) are fully developed entities or have the capacity to rapidly become mature, state-of-the-art research centers by virtue of previous commitments of institutional resources, recruitment and/or development of an existing critical mass of research scholars, the presence of substantial recent publications in peer-reviewed research journals, active research grants, etc. The funding cap for CADPRCs in this category is $1,000,000 per year, plus negotiated institutional indirect costs. Any Center application requesting more than the cap will be returned to the applicant without review. 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 are required to include both women and minorities in study populations, so that research findings can be of benefit to all persons at risk of the diseases, disorder, or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) 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 must be provided. For the purpose of the policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders, or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the review will be deferred until the information is provided. 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 that do not comply with these policies. APPLICATION PROCEDURES Preapplication Consultation. Applicants are strongly encouraged to contact the Centers program staff very early in the planning process. Telephone conversations and meetings with NIMH staff can be especially helpful in the development of a competitive application. It is often of value to the potential applicant to send a preliminary plan, no longer than 12 pages, to the program at least 90 days prior to initial submission of an intended Center grant application. The plan should summarize the present state of planning and development for establishing the proposed Center. Applicants are to use the grant application form PHS 398 (rev. 9/91). The number and title of this Program Announcement, "Child and Adolescent Development and Psychopathology Research Centers, PA-93- ," must be typed in item number 2a on the face page of the PHS 398 application form. PHS regulations concerning application page-length apply to CADPRC applications. In general, 25 pages of text are allowed for each core and research component of the Center. Application kits containing the necessary forms and instructions may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-05 Rockville, MD 20857 Telephone: (301) 443-4414 The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by the appropriate National Advisory Council whose review may be based on policy considerations as well as scientific merit. Only applications recommended for approval by Council may be considered for funding. Receipt Dates Applications will be reviewed according to the following regular schedule: New, Competing National Continuation, & Scientific/ Advisory Revised Applications Technical Council/Board Approximately Receipt Date Merit Review Review Start Date Feb 1 May/Jun Sep/Oct Dec 1 Jun 1 Sep/Oct Jan/Feb Mar 1 Oct 1 Jan/Feb May/Jun Jul 1 Applications received after the above receipt dates are subject to assignment to the next review cycle or may be returned to the applicant. AWARD CRITERIA Applications received in response to this announcement will compete with others submitted for funding. In granting awards, the following criteria are considered: o Program relevance and balance o Quality of application as documented by IRG and Council recommendations o Availability of funding o Institute priorities INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Peter S. Jensen, M.D, Chief Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 10-104 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-5944 For information regarding fiscal or grants management issues, applicants may contact: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. 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 announcement is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100, or Health Systems Agency review. The National Institute of Neurologic Disorders and Stroke (NINDS) also funds basic and clinical research concerning the etiology, diagnosis, treatment, and prevention of neurodevelopmental disorders. For further information contact: Giovanna M. Spinella, M.D. Federal Building, Room 820 Bethesda, MD 20892 Telephone: (301) 496-5821 .
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