Full Text MH-94-007 RESEARCH TRANSITION GRANT PROGRAM IN MENTAL HEALTH SERVICES NIH GUIDE, Volume 23, Number 6, February 11, 1994 RFA: MH-94-007 P.T. Keywords: National Institute of Mental Health Application Receipt Date: May 6, 1994 PURPOSE Clinical mental health services research focuses on the process and quality of care and the effectiveness in "real world" settings of clinical interventions whose efficacy has been demonstrated in controlled clinical research environments. The purpose of this Request for Applications (RFA) is to stimulate the development of programs of clinical mental health services research at institutions that currently have strong programs in mental health clinical research, but are not engaged in extensive clinical mental health services research. A second goal of this RFA is to bring the expertise of mental health clinical researchers and general health services researchers into the clinical mental health services research field and to promote their collaborations with each other and with clinical mental health services researchers. Collaborations of this kind are greatly needed to bring new resources and talents to bear on the task of improving delivery of clinical mental health services in the nation. The development of programs focusing on the special mental health services issues of the following populations are strongly encouraged: minorities; persons who are homeless; persons who live in rural areas; or persons with AIDS, who are HIV positive, or are at risk of contracting the AIDS virus. Expansion of the nation's clinical mental health services research infrastructure is a major priority of the National Institute of Mental Health (NIMH) and is in response to recommendations made by the National Advisory Mental Health Council and by the Extramural Science Advisory Board. This RFA addresses recommendations set forth in the Clinical Services Research section of Caring for People with Severe Mental Disorders: A National Plan of Research to Improve Services and in the National Plan for Research on Child and Adolescent Mental Disorders. 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, Research Transition Grant Program in Clinical Mental Health Services, is related to the priority areas of alcohol and other drugs, mental health, mental disorders, and violent adn abusive behaviors. 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 public and private non- profit and for-profit organizations, including universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government except for those institutions with extensive, ongoing collaborations between clinical mental health investigators and mental health services researchers. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the resource-related research project (R24). The R24 mechanism is used to support research projects that will enhance the capability of resources to serve biomedical research. The Research Transition Grant Program (RTGP) will be used by the National Institute of Mental Health (NIMH) to enhance research capability and clinical mental health services research program. Each award will be limited to five years of funding and is nonrenewable. This RFA is a one-time solicitation. FUNDS AVAILABLE It is anticipated that at least $2.5 million in total costs will be made available so that a minimum of five awards can be made. Each award will have a maximum yearly total cost amount of $500,000. RESEARCH OBJECTIVES Background. The Research Transition Grant Program (RTGP) in Clinical Mental Health Services is part of an integrated NIMH approach to institutional infrastructure development made up of several types of grants including: NIMH Developing Clinical Research Centers, Research Infrastructure Support Program (RISP) grants, Child and Adolescent Mental Health Services Research Centers, and Social Work Research Development Center grants. Together these provide a continuum of research infrastructure support for institutions with varying levels and types of mental health research activity. The RTGP grants are designed to enable institutions with current programs in clinical mental health research to develop into major clinical mental health services research settings, thus increasing the number of investigators obtaining extramural funding for work in the services research field. Expansion of the nation's clinical mental health services research infrastructure is a major priority for NIMH because it is essential for improving the care received by adults (including the elderly), adolescents, and children who suffer from mental and emotional disorders, particularly the most severe disorders. Mental Health Services Research. The field of mental health services research examines the impact of the organization, financing, management, and delivery of mental health services on the quality, cost, access to, and outcomes of care. There are two major components of services research: service systems research and clinical services research. Service systems research focuses on questions related to the organization, financing, and integration of mental health services. Clinical mental health services research focuses on the process and quality of care and the effectiveness in community settings of clinical interventions whose efficacy has been demonstrated in controlled clinical research environments. This RFA seeks to enhance the clinical mental health services component of services research. The four major areas of clinical mental health services research are assessment research, treatment research, rehabilitation research, and outcomes research. Examples of research topics in these four areas include, but are not limited, to: Assessment Research o Studies of the barriers to the accurate recognition and diagnosis of mental disorders, with special attention to (a) patient variables, such as culturally related beliefs or response patterns; and (b) provider variables, such as knowledge and attitudes about mental disorders o Research on the reliability, validity, and stability of symptom, quality-of-life, functioning, social status, and vocational status measures, particularly for individuals from different socioeconomic, ethnic, or cultural groups Treatment Research o Research on the applicability and effectiveness of clinically efficacious treatments in "real world" settings, such as community mental health centers, nursing homes, or primary care practices. o Studies of the relationship between the process of providing mental health services (e.g., therapeutic alliance) and outcomes of care (e.g., continuation in care and improved functioning) Rehabilitation Research o Studies to determine what types and combinations of rehabilitation services are most beneficial for severely mentally ill individuals with different clinical, social, and economic circumstances o Research on ways to maximize effective use of family expertise and client preferences in planning rehabilitation services Outcomes Research o Studies of the reliability and validity of instruments in multiple outcome domains (clinical, rehabilitative, humanitarian, and public welfare), particularly for understudied populations, e.g., persons who are homeless, migrants, minorities, rural residents o Research testing the performance over time of instruments measuring inherently unstable patient or client characteristics SPECIAL REQUIREMENTS Applicant institutions should describe a comprehensive and coherent plan of modification to the institution's current research environment that will expand the capacity of the clinical research program to carry out extramurally-funded, clinical services research. The plan must demonstrate the actual commitment of institutional resources, which may include hiring mental health services researchers, providing mental health training to institutional investigators experienced in health services research, and/or providing services research training to clinical investigators. However, a substantial commitment to a services research perspective is essential. A central philosophical principle underlying this program is that different institutions will require different types and amounts of development in clinical services research. Therefore, this RFA does not prescribe in any detail the nature of the activities to be applied for or supported. The following types of support may be requested under this program: o Partial salary support for clinical mental health services research faculty o Training expenses in clinical mental health services research, such as tuition remission or course fees, for junior clinical faculty o Research patient recruitment, diagnosis, assessment, and follow-up o Consultation from clinical mental health services research investigators o Biostatistical and data-base management o Small equipment and research instruments o Research technicians and assistants o Developmental, feasibility, and/or pilot studies The application should present a plan for the proposed RTGP. It should assess the current institutional and faculty capacity to conduct clinical mental health services research, identify unmet needs, and describe the activities to develop the institutional infrastructure and faculty capacity to conduct this research. The application should contain the following: o Statements of objectives, substantive clinical services research focus, and justification o Specification of the proposed research area and plan for development, including brief abstracts of ongoing and proposed clinical services research projects o Overview of the research development plan for the institution, including plans for recruitment and retention of faculty skilled in clinical services research o Assessment of institutional capacity, including interest and availability of senior faculty and experienced clinical mental health services investigators o Description of the institutional commitment to substantial financial support of a clinical mental health services research program o Description of equipment, space, and other facility resources that are available for clinical mental health services research and identification of needed enhancement o Assessment of junior faculty interest and capability to engage in clinical mental health services research and identification of training, mentoring, and consultation proposed to enhance the capacity to develop extramurally- fundable research o Description of procedures to be used to solicit, review for scientific merit, monitor, and evaluate the outcome of pilot or feasibility studies, including measures to assure the protection of human subjects o Abstracts of pilot projects approved for support pending the award of funding for the RTGP Applications are limited to 25 pages. 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. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research; from the Office of Grants Information Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the Grants Management Branch, National Institute of Mental Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone 301/443-4414. The RFA number MH-94-007 and the title, Research Transition Grant Program in Clinical Mental Health Services, must be typed in item number 2a on the face page of the PHS 398 application form; the YES box must also be marked. Applicants must specify that the R24 mechanism is being used. Applicant institutions will need to demonstrate that they: (1) have a strong base of ongoing clinical mental health research activities; (2) need additional support to establish and maintain collaborative working relationships between clinical and services researchers; and (3) have the potential for building a mental health services research program that will equip them to compete effectively in future years for clinical mental health services research grants. The RFA label available in the PHS 398 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. All applications must be received by May 6, 1994 and will be reviewed in July. Applications received after the receipt date will be returned to the applicant without review. Submit, in one package, a signed original of the application, including the Checklist, and three signed copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of the submission, two additional copies of the application must also be sent to: Wright Williamson, M.S.W. Division of Extramural Activities National Institute of Mental Health 5600 Fishers Lane, Room 9C-14 Rockville, MD 20857 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by an initial review group (IRG) convened by the NIMH 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. Criteria to be considered in evaluating applications for scientific/technical merit include: o Scientific and technical significance and originality of the focus of the proposed development plan and research o Appropriateness and adequacy of the proposed development plan and the potential for the plan to effect significant and lasting improvements in the institution's ability to conduct extramurally-funded clinical mental health services research o Nature, amount, and duration of non-Federal commitment to the project o Capability of the Principal Investigator and other senior staff to provide leadership in the effort to enhance the institution's clinical mental health services research capacity o Adequate representation of minorities and women o Appropriateness of the proposed budget o Adequacy of the proposed means for protecting against or minimizing adverse effects to human subjects AWARD CRITERIA Awards will be made on or before September 30, 1994. As part of the NIMH Public-Academic Liaison (PAL) initiative, special encouragement is given to applications that involve active collaborations between academic researchers and public sector agencies in planning, undertaking, analyzing, and publishing research pertaining to persons with severe mental disorders. The PAL initiative is based on the premise that important new advances in understanding and treatment of severe mental disorders can result from improved linkages between the Nation's scientific resources and the public sector agencies and programs in which many persons with severe mental disorders receive their care. The scope of the PAL initiative encompasses public sector agencies of all types that deal with children, adolescents, adults, and elderly persons with severe mental disorders. Factors considered in determining which applications will be funded include IRG and Council recommendations, PHS program needs and priorities, and availability of funds. INQUIRIES Potential applicants should contact NIMH staff as early as possible for information and assistance in initiating the application process. The NIMH program staff member listed below may be contacted for further information about mental health services research and for technical assistance in developing an application. Ann A. Hohmann, Ph.D., M.P.H. Services Research Branch National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 For further information on grants management issues, applicants may contact: Diana S. 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 RFA is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100. .
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