Full Text PA-96-007 RESEARCH ON THE MENTAL HEALTH OF MINORITY POPULATIONS NIH GUIDE, Volume 24, Number 40, November 24, 1995 PA NUMBER: PA-96-007 (see replacement PAR-04-060) P.T. 34, FF Keywords: Population Studies Emotional/Mental Health National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) announces support for the development, conduct, and maintenance of research program projects (RPPs) (P01) focusing on the mental health of minority populations. RPPs should provide stimulating and productive research environments in which a multidisciplinary group of experienced and junior mental health researchers can interact and direct their energies toward research activities and projects on a unified issue related to the mental health of minority populations. All research areas supported by NIMH are relevant to the mental health of minority populations and are appropriate as the central focus for program project research. The specific minority populations NIMH will award grants to study include: American Indians/Alaskan Natives, Asian Americans, African Americans, Hispanics, and Native Hawaiians/Pacific Islanders. Studies of ethnic subpopulations within these broad categories are also encouraged. This program announcement supersedes PA-92-122, Minority Mental Health Research Centers, issued September 1992. 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 PA, Research on the Mental Health of Minority Populations, is related to the priority area of mental health and mental disorders. 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 202-512-1800). 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. Foreign institutions are not eligible for program project grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The program project (P01) grant mechanism will be used. This mechanism supports broadly-based, multidisciplinary, multiproject, often long-term research programs that have a specific major objective or basic theme. To qualify for support, a program project must consist of at least three research subprojects as recommended by peer review. Applications may request support for up to five years. Annual awards will be made subject to continued availability of funds and progress achieved. The funding cap for these RPPs is $600,000 direct costs per year per award plus negotiated indirect costs. Investigators who are developing RPPs are encouraged to discuss budgetary issues with program staff listed under INQUIRIES. RESEARCH OBJECTIVES The principal objective of this program is to provide a research environment in which state-of-the-art research methodologies may be applied to an interdependent set of projects relating to a single major focus in mental health research. The research focus may include the understanding and improvement of mental health and the prevention and treatment of mental illness among the specific minority group(s) selected under this announcement. Each RPP should provide an environment of scientific excellence that will ensure the highest quality research and leadership in its particular area of investigation. Through its activities, the RPP should be, or demonstrate that it has the potential to become, a major national scientific research resource. It is expected that other research projects will be developed by the RPP investigators with support from separate research and research training grants from private foundations and from NIMH and other research grant awarding sectors of the Federal government. However, applicants who are developing RPPs are not expected to have extensive additional research funding. Infrastructure The RPP should enable investigators to conduct both pilot and comprehensive studies and to formulate, develop, and test new hypotheses, methodologies, and data-gathering techniques. Models for organization of RPPs may vary, but they all must contain the infrastructure for implementing an overarching research plan and a plan that includes sophisticated, multidisciplinary, integrated research projects. This infrastructure must include, at minimum, an administrative core and a methodology and statistics core, as described below. Administrative Core. Program projects must have a scientifically and administratively well-qualified director who has primary responsibility for the scientific leadership and administration of the research program and a strong administrative structure. The description of that structure should include the following information: o Relationship to the applicant institution o Description of the administrative structure of the RPP, including delineation of responsibilities and authorities of the RPP Director and his/her assistants o Description of any committee whose role is advisory on specific aspects of the RPP's research program o Arrangements for planning, coordinating, and evaluating the RPP research projects o Procedures for coordinating and supervising the work of individual investigators o Procedures for coordinating specific studies conducted under the auspices of the RPP If the applicant plans to involve another corporate entity (e.g., research institute, medical school, local government, etc.) in the functions of the RPP, the following should be included: o Description of the nature of the arrangements and lines of authority o Letter(s) of agreement signed by the responsible officer of each associated organization stating that cooperation, research facilities, services, or other relevant assistance will be available on a continuing basis (Submit as an appendix to the application) o Appropriate clearances from each associated organization that state that the proposed research meets that institution's research review requirements (including Institutional Review Boards responsible for activities involving human subjects) Methodology and Statistics Core. Applicants should describe an organizational structure to provide on-site expertise in research design methodology, data-base management, psychometrics (if instrument development is to be included in the research activities), and statistical analysis to the investigators of the RPP. Research Focus and Projects An RPP will focus, in general, on methodological development, feasibility studies, and pilot studies in its initial years. Early phases of major studies can be supported by the RPP's initial grant. Research Focus. The research plan should describe the overarching research focus for the RPP. The research plan must specify the following: o The overall research goals and objectives of the RPP o The principal area of research to be emphasized o The importance and significance of the proposed research o The professional disciplines to be included among the research faculty o Plans for coordination among the various research activities and components of the RPP Selection of the specific research focus and projects must be justified in terms of: o Their concordance with research areas of interest to NIMH o The state of scientific knowledge o The feasibility of performing proposed research (e.g., availability of measurement instruments, populations to study) o Access to the target minority groups or subgroups in sufficient numbers o The potential impact of the research on the mental health of the minority populations under study The research plan should describe how the individual research projects are linked to the central focus of the RPP. Applicants should also describe the types of further programmatic steps that might be taken in future years to build upon early findings. In addition, a statement describing relevant, current and planned research, training, and service grant support that will be available to the RPP should be included. Research Projects. For each individual project to be funded by the RPP grant, all of the sections of the PHS 398 application are required, including Specific Aims, Background and Significance, Progress Report, Research Design and Methods, Inclusion of Women and Minorities, and Protection of Human Subjects. Applicants must show how each project is related to the central research focus of the program project. In addition, separate budgets and budget justifications for each project are also required (see below). General Characteristics of the RPP The following elements should be specifically addressed in each application: o An RPP must have the following: (a) strong intellectual leadership, at the administrative level and in each of the research projects; (b) the availability of mental health researchers, especially members of the minority group(s) who have experience in mental health-relevant research for that minority group; and (c) the availability of promising junior researchers who are either graduate students or junior faculty. o An RPP must be multidisciplinary, including, as appropriate, researchers from biological sciences (e.g., neuroscience, molecular biology, genetics) and the social and behavioral sciences (e.g., health economics, sociology, public health, epidemiology, psychiatry, nursing, social work, psychology, statistics, and demography). o An RPP must include a central conceptual focus for the research and involve strong, collaborative, synergistic relationships among the researchers, which will form the basis for further research and research training activities. All activities must be interrelated to reflect an integrative RPP rather than a loosely allied network of researchers. o An RPP must have access to the target minority groups or subgroups in sufficient numbers to accomplish its goals. This access must be documented by letters of collaboration from relevant local and national groups. Clinically-focused RPPs should provide access to and appropriate levels of administrative control over sufficient inpatient and/or outpatient facilities to ensure availability of patients/clients for specific research projects. o An RPP must have an administrative structure headed by the Principal Investigator/RPP Director that will ensure maximum effectiveness and efficiency of operation and sound financial practices, and facilitate coordination among program project personnel. The administration will be responsible for program planning, monitoring, execution, preparation of the budget, control of expenditures, staff appointments, and space allocation. o An RPP must have a Principal Investigator, who serves as Director of the RPP, providing scientific leadership by devoting no less than 60 percent of his/her time to the program project, including time spent on program project research. The intent of this requirement is to ensure that the RPP and its related research projects comprise the major activity of the Principal Investigator/RPP Director. The Director should be an experienced senior researcher who has made contributions to mental health research. o The RPP Director is responsible for the planning and coordination of the program project, preparation of the budget, control of expenditures, staff appointments, and space allocation. The RPP Director must have sufficient authority to establish the necessary administrative and management procedures to operate an efficient program project. However, the day-to-day management and the responsibility for the administrative and operational aspect of the RPP may be delegated. o An important product of the research effort is to develop scientists who are familiar with the complex techniques and advanced theories of contemporary mental health-related research. Funds from the RPP grant may not be used to support formal research training activities. However, each RPP should include a plan for providing opportunities for research training experiences in disciplines relevant to mental health. RPPs may take advantage of National Research Service Award (NRSA) Fellowships and Institutional Research Training Grants, Research Scientist Development Awards for support of appropriate developing scientists, and Supplements for Underrepresented Minorities in Biomedical and Behavioral Research. The RPP Director is encouraged to contact NIMH program staff regarding application for these support mechanisms. o An RPP should establish, when appropriate to the central focus of the research, a collaborative relationship with public facilities where severely mentally ill patients are cared for on both inpatient and outpatient basis (e.g., State hospitals, community mental health centers, or ambulatory programs). Since establishment of a new program project requires considerable effort to form administrative, scientific, and community linkages within the team of collaborating investigators and their projects, the initial phase of a program project's life is generally given close scrutiny by NIMH review and monitoring processes. The RPP will be required to submit detailed annual progress reports, including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modification in long-term research plans. Presentation in scientific meetings and publication in refereed journals should be included. Also, inventions reporting, financial status reports, final reports, and other reports are required to be filed in accordance with PHS policy. Budget Budgets for the RPP administrative core, methodological and statistical core, and individual research projects should be presented in aggregate and separately and must be fully justified. In addition, the following need to be reflected in the budgets: o The travel budget request should include funds for the Program Project Director and one other key professional staff member to attend one annual meeting with other RPP directors and NIMH staff in the Washington, DC area. o Information should be presented on cash and in-kind support, if any, for the RPP by the applicant institution. In-kind support may include such items as university- supported faculty and graduate students who will participate in the program to supplement the core staff, funding of joint tenure-line appointments for RPP staff, office space, supplies, and equipment. Grant funds may be used for: o Support for resources essential to the RPP program including salaries of personnel responsible for the management of the RPP, including the Program Project Director o Support for resources shared across projects through the coordinating program project, such as equipment and personnel to provide research design and statistical consultation, data base management services, reference services, or scientific secretarial services o Expenses clearly related and necessary to conduct research projects o Support for individual projects at the developmental stage, which can include salaries, supplies, travel, special consultations, and publication costs o Direct costs that can be specifically identified with the project o Allowable indirect costs of the institution o Only costs required by the research may be requested for research- related treatment, rehabilitation, or prevention services and programs These costs must be justified in terms of research objectives, methods, and designs that promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. Grant funds may not be used for establishing, adding a component to, or operating a treatment, rehabilitation, or prevention/intervention service program or for formal research training activities. The RPP grant is neither expected nor intended to cover all of the costs of a successful program project. NIMH expects and encourages the institution and personnel attracted to such program projects to actively compete for and seek additional funding. 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 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. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and, if assigned to the NIMH, will be accepted on a once a year receipt date of June 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032 - MSC 7762, Bethesda, MD 20892-7710, telephone 301/710-0267, Email: [email protected]. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for an RPP grant must include: (1) an overall organizational plan; (2) an overarching research plan; (3) detailed plans for the research projects; and (4) letters of collaboration from relevant local and national groups assuring access to target minority groups. For purposes of the page limitations of sections 1 through 4 of PHS 398 form, the RPP organizational plan (including the administrative core and the methodology and statistics core) and the overarching research plan should be considered one component with a 25-page limit. A maximum of 10 additional pages may be used to describe each research project that the program project will undertake. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o integration of research projects and adherence to a central research theme; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; 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 will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. A minimum of three subprojects recommended for support by the review committee is required for a program project to be considered for funding. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Applicants are strongly encouraged to contact program staff listed below before they begin the application process. This contact can provide the applicant the opportunity to clarify issues and ask questions. It will also provide NIH notice that an application under this program announcement will need review. Direct inquiries regarding programmatic issues to: Division of Epidemiology and Services Research The Division of Epidemiology and Services Research directs, plans, supports, and conducts programs of research, research demonstrations, research training, and resource development in prevention, clinical services and service systems research, epidemiology, psychopathology, assessment, classification, violence and traumatic stress, law and mental health, and health and behavior, with special attention to minority and other populations. Ann A. Hohmann, Ph.D., M.P.H. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: [email protected] Division of Neuroscience and Behavioral Science The Division of Neuroscience and Behavioral Science directs, plans, supports, and conducts programs of research, research demonstrations, research training, and resource development to further understand the etiology, and pathophysiology of mental disorders with a focus on: behavioral and social sciences, cognitive sciences, and neurosciences, including neuroimaging, neurophysiology, neuropsychopharmacology, and cellular and molecular neurobiology, with special attention to minority and other special populations. Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: [email protected] Division of Clinical and Treatment Research The Division of Clinical Research directs, plans, supports, and conducts programs of research, research demonstrations, research training, and resource development in psychopathology, classification, assessment, etiology, genetics, clinical course, outcome, and treatment of mental disorders with emphasis on schizophrenic disorders, affective and anxiety disorders, and mental disorders of children and adolescents, the elderly, minorities, and other special populations. The Division also coordinates the Institute's medications development program. Matthew Rudorfer, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Email: [email protected] Applicants including a focus on the mental health issues for persons with AIDS, persons who are HIV positive, or persons who are at risk of contracting the virus are encouraged to contact the following staff member: Leonard L. Mitnick, Ph.D. Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: [email protected] Applicants including a focus on mental health issues for persons who live in rural areas are encouraged to contact the following staff member: Kathryn M. Magruder, Ph.D., M.P.H. Office of Rural Mental Health Research National Institute of Mental Health 5600 Fishers Lane, Room 10-104 Rockville, MD 20857 Telephone: (301) 443-9001 FAX: (301) 443-4045 Email: [email protected] Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Bethesda, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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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