Full Text PA-92-104 MINORITY MENTAL HEALTH RESEARCH CENTERS NIH GUIDE, Volume 21, Number 34, September 25, 1992 PA: PA-92-104 P.T. 04, FF Keywords: Emotional/Mental Health Mental Disorders Biomedical Research, Multidiscipl National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) provides support for the development, conduct, and maintenance of Minority Mental Health Research Centers (MMHRCs) both to stimulate and enable research that could not be done without the particular facilities and environment that such centers provide. MMHRCs should provide stimulating and productive research environments in which experienced and junior mental health researchers can interact and direct their energies toward the conceptualization, development, and conduct of coordinated, multidisciplinary research on mental health issues related to minority populations. All research areas supported by the NIMH are relevant to the mental health of minority populations and are appropriate as central foci for center research. The specific minority populations that the NIMH will award grants to study include: American Indians/Alaskan Natives, Asian Americans, African Americans, Hispanics, and Native Hawaiians/Pacific Islanders. 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 (PA), Minority Mental Health Research Centers, is related to the priority areas of mental health and mental disorders and violent and abusive behavior. 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 Eligible applicant institutions include any domestic non-profit or for-profit organization that is a doctorate-granting institution and has an established relevant research capacity or is an organization with a documented affiliation with such an institution. MECHANISM OF SUPPORT Research Center support may be requested only through applications for a research grant (R01). RESEARCH OBJECTIVES The principal objective of all NIMH-supported MMHRCs is to provide a research environment in which state-of-the-art research methodologies may be applied to issues relating to the understanding and improvement of mental health and the prevention and treatment of mental illness of the specific minority group(s) selected for the focus of the MMHRC. Each MMHRC should provide an environment of scientific excellence that will assure the highest quality research and leadership in its particular area(s) of investigation. Through its activities, the MMHRC should already be, or demonstrate that it has the potential to become, a major national scientific research resource. Models for MMHRCs may vary, but they all should contain the infrastructure for implementing an overarching research plan, a plan that includes sophisticated, multidisciplinary, integrated research projects. The MMHRC should enable investigators to conduct both pilot and comprehensive studies and to formulate, develop, and test new methodologies and data-gathering techniques. The infrastructure of each MMHRC must include, at minimum, the following elements: Administrative Core: a strong administrative structure, including a scientifically and administratively well-qualified director with primary responsibility for scientific leadership and administration of the research program Methodology and Statistics Core: on-site expertise in research design methodology, data-base management, and statistical analysis Applicants must describe the Administrative Core and Methodology and Statistics Core, research plan, research areas, and the individual research projects of the MMHRC, as well as the budgets for each. Administrative Core and Methdology and Statistics Core Applicants must describe the Administrative Core, including the research program management structure of the MMHRC, and the Methodology and Statistics Core. The description must include the following information: o Relationship to the applicant institution o Description of the administrative structure of the MMHRC, including delineation of responsibilities and authorities of the MMHRC Director and his/her assistants o Description of any committee whose role is advisory on specific aspects of the MMHRCs research program o Arrangements for planning, coordinating, and evaluating the MMHRC programs o Procedures for coordinating and supervising the work of individual investigators o Procedures for coordinating specific studies conducted under the auspices of the MMHRC o Description of the organizational structure providing methodological, statistical, and data base management assistance to investigators in the MMHRC If the applicant plans to involve another corporate entity (e.g., research institute, medical school, local government) in the functions of the MMHRC, the following must 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) Research Plan, Areas, and Projects Research Plan. The research plan must describe the overarching research focus for the MMHRC. The plan should be based on a set of integrated research areas (defined below) related to the overarching focus. The research plan must specify the following: o The overall research goals and objectives of the MMHRC o The principal areas of research to be emphasized o The importance and significance of the proposed research o The disciplines to be included o Plans for coordination among the various research activities and components of the MMHRC Selection of the specific research issues must be justified in terms of: o Their concordance with NIMH research areas o The state of knowledge development 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 must describe how each research area and the individual research projects within each are linked to the central focus of the MMHRC. Applicants are also to 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 MMHRC must be included. Research Areas. A research area is defined as an important area for mental health research within which an MMHRC plans to develop and conduct interrelated research projects. Each area will include several developmental projects, pilot studies, and exploratory/feasibility studies. It is expected that the developmental and pilot projects will evolve into major studies in the ensuing years to be supported by outside funding sources. Since many mental health research areas are inherently interdisciplinary, projects within an area are encouraged to incorporate collaborative relationships among scholars representing complementary disciplines, whenever appropriate. Separate descriptions must be provided for each major research area, including summary descriptions of individual developmental research projects to be supported in each area and how these projects will relate to and support each other. Research Projects. For each individual project within a research area to be funded by the MMHRC grant, the following must be included: o A review of the relevant literature and the existing knowledge base o The objectives, hypotheses, and significance of the research o A detailed sampling plan and power analysis o A control or comparison group is encouraged, where appropriate o The design and the methodological approaches to be used in collecting and analyzing data o Relevant demographic characteristics (e.g., age, gender, social class, ethnicity) of the proposed research population(s) and sample o A list of all staff, including collaborators from other institutions, whether or not they are supported by thc MMHRC grant, with an indication of areas of expertise and estimated percent of effort to be devoted to the research project o Timetable for project development and implementation o The interrelation of this project with other research center activities o A budget and justification for project activities including staffing, equipment, and other necessary expenditures Center Budget Budgets for the MMHRC Administrative Core, Methodological and Statistical Core, research areas, and individual research projects must 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 Center Director and one other key professional staff member to attend one annual meeting with other MMHRC directors and NIMH staff o Information must be presented on cash and in-kind support, if any, for the MMHRC 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 and funding of joint tenure-line appointments for MMHRC staff The following general elements must be specifically addressed in each application: o An MMHRC will focus, in general, on hypothesis testing, methodological development, feasibility studies, and pilot studies in its initial years. Early phases of major studies can be supported by the MMHRCs initial grant. o The primary purpose of a Center is to carry out research. It is expected that research projects will be developed in ensuing years with support from separate research and research training grants from the NIMH and other research grant awarding sectors of the Federal government and from private foundations. However, initial applicants are not expected to have extensive additional research funding. 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 MMHRC grant may not be used to support formal research training activities. However, each MMHRC should include a plan for providing opportunities for research training experiences in disciplines relevant to mental health. MMHRCs may take advantage of National Research Service Award (NRSA) Fellowships, Institutional Research Training Grants, Research Scientist Development Awards for support of appropriate developing scientists, and Supplements for Underrepresented Minorities in Biomedical and Behavioral Research. o An MMHRC 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) in keeping with the Public-Academic Liaison (PAL) initiative. It is expected that such collaboration will make a significant impact on the course of treatment for minority patients who are severely mentally ill. o An MMHRC must have the following: (a) strong intellectual leadership; (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 MMHRC must be multidisciplinary, including, as appropriate, researchers from neuroscience, molecular biology, genetics, health economics, sociology, public health, epidemiology, psychiatry, nursing, social work, psychology, statistics, and demography. o An MMHRC must include a central conceptual focus for the research and involve strong, collaborative, synergistic relationships among the researchers, that will form the basis for further research and research training activities. All activities must be interrelated to reflect an integrative MMHRC rather than an uncoordinated or loosely allied network of researchers. o An MMHRC 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 MMHRCs 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 MMHRC must have an administrative structure headed by the Principal Investigator/MMHRC Director that will ensure maximum effectiveness and efficiency of operation and sound financial practices, and facilitate coordination among center personnel. The administration will be responsible for program planning, monitoring and execution, and preparation of the budget, control of expenditures, staff appointments, and space allocation. o An MMHRC must have a Principal Investigator, who serves as Director of the MMHRC, providing scientific leadership by devoting no less than 60 percent of his/her time to the center, including time spent on center research projects. The intent of this requirement is to ensure that the MMHRC and its related research projects comprise the major activity of the Principal Investigator/MMHRC Director. The Director should be an experienced senior researcher who has made contributions to mental health research. o The MMHRC Director is responsible for the planning and coordination of the center program, preparation of the budget, control of expenditures, staff appointments, and space allocation. The MMHRC Director must have sufficient authority to establish the necessary administrative and management procedures to operate an efficient center. However, the day-to-day management and the responsibility for the administrative and operational aspect of the MMHRC may be delegated. Since establishment of a new center requires considerable effort to form administrative, scientific, and community linkages within the team of collaborating investigators and their projects, the initial phase of a center's life is generally given close scrutiny by NIMH review and monitoring processes. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH/ADAMHA POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH/ADAMHA policy requires inclusion of minorities and females in research study populations. Applications in response to this announcement are required to include nonminorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. It is expected that special emphasis will be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or nonminorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. 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. Applications for support of research involving human subjects must employ a study design with minority, nonminority, and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or nonminorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. Control group comparisons are encouraged in all research. For research awards that are covered by these special instructions, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. Protection of Human Subjects The Department of Health and Human Services (DHHS) regulations for the protection of human subjects provide a systematic means, based on established internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the DHHS. The regulations require that applicant organizations establish and maintain appropriate policies and procedures for the protection of human subjects. These regulations, 45 CFR 46, Protection of Human Subjects, are available from the Office of Protection from Research Risks, National Institutes of Health, Bethesda, MD 20892. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). The number and the title of this PA, Minority Mental Health Research Centers, PA-92-XX, must be typed in item number 2a on the face page of the PHS 398 application. Applications for an MMHRC grant must include: (1) an overall organizational plan, (2) an overarching research plan, and (3) detailed plans for the research areas and individual research projects. For purposes of the page limitations of sections 1 through 4 of form PHS 398, the MMHRC 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 25 additional pages may be used for each research area that the Center will address. Application kits containing the necessary forms 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** Terms and Conditions of Support Support may be requested for a maximum project period of five years. Grant funds may be used for: o Support for resources essential to the MMHRC program including salaries of personnel responsible for the management of the MMHRC, including the Center Director o Support for resources shared across projects through the coordinating center, such as equipment and personnel to provide research design and statistical consultation, data base management services, reference services, and 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 which can be specifically identified with the project o Allowable indirect costs of the institution o Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs which promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. o Program enrichment activities such as special lectures or symposia 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 training activities. The MMHRC grant is neither expected nor intended to cover all of the costs of a successful Center program. The NIMH expects and encourages the institution and personnel attracted to such Centers to actively compete for and seek additional funding. The MMHRC 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. Non-competing continuation application materials for years beyond the initial year of support will be mailed automatically to grantees by the NIMH Grants Management Branch. Applications for continuation of funding beyond the initial grant period must be reviewed by the appropriate Initial Review Group and by the National Advisory Mental Health Council. REVIEW CONSIDERATIONS Applications for all MMHRCs will be reviewed for scientific and technical merit by an initial review group (IRG) composed primarily of non-Federal scientific experts. Final review is by the appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG recommendations are sent to applicants as soon as possible following IRG review. Review Criteria Criteria to be considered in evaluating applications for scientific/technical merit include: o Scientific, technical, or medical significance and originality of the proposed research o Appropriateness and adequacy of the research approach and methodology proposed to carry out the research o Qualifications and research experience of the Principal Investigators and staff, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to the research o Appropriateness of the proposed budget and duration in relation to the proposed research o Adequacy of the proposed means for protecting against or minimizing adverse effects to human and/or animal subjects AWARD CRITERIA The decision to fund applications will be based on a consideration of the following criteria: o Scientific merit and quality of the proposed MMHRC as determined during the review process o Availability of funds o Geographic distribution of MMHRCs o Program balance Receipt and Review Schedule All applications will be reviewed in accordance with the customary PHS review schedule: Receipt Dates Initial Advisory Council Earliest New/Renewal Review Review Start Date Oct 1/Nov 1* Feb/Mar May/Jun Jul 1 Feb 1/Mar 1* May/Jun Sep/Oct Dec 1 Jun 1/Jul 1* Oct/Nov Jan/Feb Apr 1 *Competing continuations, supplemental, and revised applications are to be submitted on these dates. Applications received after a given receipt date will be held for the next scheduled receipt date or returned to the applicant without review. INQUIRIES The NIMH program staff listed below may be contacted for further information and assistance. Potential applicants are encouraged to contact the NIMH as early as possible for information and assistance in initiating the application process and developing an application. 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. The Branches in the Division supporting investigator-initiated research include: Prevention Research Branch Services Research Branch Epidemiology and Psychopathology Research Branch Violence and Traumatic Stress Research Branch Behavioral Medicine Research Branch Contact: Ann A. Hohmann, Ph.D., M.P.H. Services Research Branch Division of Epidemiology and Services Research Telephone: (301) 443-3364 Division of Neuroscience and Behavior The Division of Neuroscience and Behavior directs, plans, supports, and conducts programs of research, research demonstrations, research training, and resource development to further understand the etiology, treatment, and prevention of mental disorders with a focus on: behavioral and social sciences, cognitive sciences, neuroimaging and neurosciences, and psychopharmacology, with special attention to minority and other special populations. The Branches in the Division supporting investigator-initiated research include: Basic Behavioral and Cognitive Sciences Research Branch Cognitive and Behavioral Neuroscience Research Branch Molecular and Cellular Neuroscience Research Branch Neuroimaging and Applied Neuroscience Research Branch Personality and Social Processes Research Branch Psychopharmacology Research Branch Contact: Stanley F. Schneider, Ph.D. Associate Director, Research Training Division of Neuroscience and Behavior Telephone: (301) 443-4347 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, clincial 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. The Branches in the Division supporting investigator-initiated research include: Schizophrenia Research Branch Mood, Anxiety, and Personality Disorders Research Branch Mental Disorders of the Aging Research Branch Child and Adolescent Disorders Research Branch Treatment Branch Contact: Leonard Lash, Ph.D. Associate Director, Research Training Division of Clinical and Treatment Research Telephone: (301) 443-3264 To address correspondence to any of the above persons, use the following address: Name Title and/or Division (noted above in each program area) National Institute of Mental Health 5600 Fishers Lane Rockville, MD 20857 For further information on grants management issues, applicants may contact: Stephen J. Hudak Chief, Grants Management Section National Institute of Mental Health 5600 Fishers Lane, Room 7C-23 Rockville, MD 20857 Telephone: (301) 443-4456 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. .
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