Full Text PAR-95-044 SPECIALIZED MENTAL HEALTH CLINICAL RESEARCH CENTERS NIH GUIDE, Volume 24, Number 12, March 31, 1995 PAR AVAILABLE: PAR-95-044 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) invites research grant applications for Specialized Mental Health Clinical Research Centers (CRCs). A CRC provides the infrastructure that facilitates the process of scientific discovery. A CRC contains research resources that are to be used by a cooperating group of researchers as the foundation for a research program focused around a single theme or a set of broad integrating themes such as diagnostic groups, treatment development, or age categories. As a CRC evolves, the integrating themes can be expanded or redefined through the addition or deletion of scientific expertise and funded projects. In this way, the CRC and associated projects may be used to define a broad and comprehensive perspective on clinical research and related basic science. CRCs provide infrastructure support rather than support for specific, fully developed research studies. The availability of such an infrastructure is intended to enable a greater efficiency and broaden the extent of the institution's clinical research capacity. Investigators seeking support for individual research projects or for a coordinated set of research projects should use mechanisms other than the CRC, such as a program project grant, interactive research project grant, or multi-institutional collaborative research project. The NIMH General CRC program, for CRCs lacking a specific thematic focus, has been discontinued. This program announcement supersedes the prior announcements for Specialized (SMHCRCs) and General Mental Health Clinical Research Centers (GMH-CRCs) and will govern future competitive renewals for existing CRCs as well as applications for new CRCs. NIMH support of the CRC program is based upon the view that each CRC provides a unique and essential contribution to the Nation's infrastructure for mental health research. From the national perspective, the CRCs provide the sustained and intensive focus that contribute to the development and progress of the field. The renewal of each CRC is predicated on the vital role that the CRC has in the overall development of the field and in the Nation's efforts to understand and treat severe mental disorders. The contribution of the CRC to the institutions, investigators and trainees affiliated with it should be substantial and demonstrable. Initially, a CRC is built upon a base of peer-reviewed research projects. By pooling resources from these projects and by providing common infrastructure for such components as patient acquisition, laboratories, and statistical and data base management, the CRC allows for a new, more sophisticated and more cost-effective level of research to emerge. This new level of research capitalizes upon the synergistic potential of the CRC resources, the multidisciplinary perspectives that are brought to bear upon emergent questions, and the ability to pursue innovative, high-risk research through pilot study support. Each CRC should develop procedures for scientific review of proposed protocols using its resources, and, by doing so, provide internal review, audit, and scientific guidance. This guidance is particularly valuable for research trainees and junior faculty who are beginning their research careers. There are two categories of grant applications under the CRC program: Core center grants (P30) for mature CRCs and resource-related research projects (R24) for developing CRCs. A mature CRC provides support for the infrastructure of a research program organized around one or more broad integrating themes. Through core facilities and laboratories, the CRC provides an efficient and easily accessible resource to be used as the basis for independently funded research projects. A CRC supports the development of innovative investigations through a pilot study program, with projects selected through internal scientific review. Pilot projects should be time limited, and the CRC should establish administrative procedures for monitoring their progress and for solicitation and selection of new ones. Through design consultation, data base management and statistical advice, all research affiliated with the CRC (pilots or independently funded projects) should be carried out at the highest levels of methodological sophistication. The data base of the CRC permits intensive use of data and data analytic resources through a well-coordinated research effort and may result in a reduced burden on human subjects. A well- managed data base has the potential for the development and testing of innovative and unexpected hypotheses by providing access to already collected data. Finally, by adopting common measures and procedures, CRCs can enter into multi-center collaborative relationships and thereby accelerate the progress of scientific development. A developing CRC is appropriate for those institutions that show evidence of strong track records in clinical research through support of individual project grants and show promise, by virtue of the commitment of institutional resources, recruitment of research scholars, and identification of a research focus, to develop into mature CRCs. An institution with little or no peer reviewed, extramurally funded research activity would not be eligible for a developing CRC. Such institutions should consider application for the NIMH Research Infrastructure Support Program (RISP). A developing CRC could aim at recruiting promising investigators and other professional personnel, improving clinical and research methodology, improving inpatient or outpatient clinical sites for research, strengthening existing research programs, and addressing other areas of research potential. It may contain a developmental program of core research to determine the specific form and direction that a fully developed CRC might take in future years. 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), Specialized Mental Health Clinical Research Centers (CRCs), 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) 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms available for support of this program are resource-related research projects (R24) for developing CRCs and center core grants (P30) for mature CRCs. The first-year funding cap for mature CRCs is $1 million direct costs plus indirect costs. The funding cap for developing CRCs is $300,000 direct costs plus indirect costs. An annual rate of growth consistent with the Biomedical Research and Development Price Index is allowable. Developing CRCs can be supported for a single 5-year term. Competitive renewal requests may only be for a mature CRC. FUNDS AVAILABLE In fiscal year 1994, the NIMH allocated approximately $24 million in total costs to this program. Funds available for new and competing awards in any particular year will vary. RESEARCH OBJECTIVES An NIMH CRC provides a clinical research infrastructure for investigators who receive their primary research support through other peer-reviewed sources. The purpose of CRCs is to provide a stimulating and productive research environment in which state-of-the- art clinical research and basic science can be applied to problems of diagnosis, etiology, mechanisms, and treatment of mental disorders throughout the full life cycle. Common Elements of CRCs Models for CRCs vary, as do the elements they contain, but they all are enabling mechanisms for the conduct of sophisticated clinical research studies and the development and application of basic science methods in the context of patient-oriented studies. All NIMH CRCs, whether mature or developing, provide core support for patient recruitment and follow-up, diagnosis and assessment, data base management and statistical analysis, and laboratories. CRCs must contain a program of training, career development, and research apprenticeships in clinical research, but CRC funds cannot be used for direct support of trainee stipends. Although the specific structure and organization of individual CRCs will vary, all of the following characteristics must be apparent in each application: o Each CRC must provide an environment of scientific excellence that will ensure the highest quality research and leadership in its particular area(s) of investigation. Through its activities, the CRC must already be, or demonstrate that it has the potential to become, a major national scientific research resource. Applicants should describe the overall benefit of the CRC structure and the unique role and contribution of the CRC. For CRCs seeking renewal, applicants should identify the initial findings and scientific discoveries made in the previous funding period. o Each CRC must have a scientifically and administratively qualified CRC Director. The CRC Director is appointed by the applicant academic or research institution to provide leadership for the scientific program and have final responsibility for the scientific, administrative, and operational aspects of the CRC. The Director is responsible for overall coordination and for development of the CRC as a unique national resource. o The CRC must have an administrative structure that will ensure maximum effectiveness and efficiency of scientific program planning, monitoring, execution, and, for preparation of the budget, control of expenditures and sound financial practices. A CRC must have sufficient authority to establish the necessary administrative and management procedures to carry out its responsibility. However, CRC activities must also be appropriately coordinated and integrated with the scientific, educational, and clinical programs of the parent department or institution. o The CRC must have access to, and appropriate levels of administrative control over, sufficient inpatient and/or outpatient facilities to ensure availability of patients and other research subjects. Specific agreements must be documented, establishing access of the CRC to the clinical facilities identified for inclusion. The CRC must provide state-of-the-art patient recruitment, diagnosis, assessment, and sample maintenance/subject retention services. o CRCs must provide infrastructure support for independently funded projects that require the breadth and depth of facilities available through the CRC. These would include studies where subjects are assessed from multiple perspectives, studies of unique or rare populations, long-term longitudinal studies, and others of the sort that are not easily supported by individual research project grants. Applications must include, for each integrating theme, a description of all independently funded research project grants and CRC funded pilot studies. o Expertise in experimental methodology, data-base maintenance, statistical analysis, and statistical consultation must be provided and managed through core CRC support. Consultation should be proactive and provided to CRC-affiliated investigators very early in the planning of their research studies and projects. This core often includes the development of a common data-set format which allows the examination of data from a variety of theoretical perspectives and can lead to new analyses and interpretations of the data. o CRC-supported research laboratory facilities at both the basic and clinical levels, such as neuroimaging, biochemical or neuroendocrine assays, neuropsychology and or psychophysiological studies, or neuropathology laboratories, must serve the needs of several CRC-related individual research projects with accuracy and efficiency. o CRCs may request patient bed costs or research ward costs as well as additional personnel for outpatient facilities. Such funds will be made available, however, only when it is clear that no other funds are available for such purposes and the beds or facilities are essential to the conduct of the research. CRC funds can also support subject recruitment and incentive costs and outreach activities to ensure appropriate participation by women and minorities. o CRCs may request pilot or seed money programs that provide start-up funds for new innovative pilot projects. Such high-risk preliminary studies have the potential for developing into larger projects that could then compete for funds on their own from other Federal, State, or private sources. CRCs must provide a process of scientific review for the pilot study program. o The primary purpose of a CRC is to support the conduct of clinical research. However, an important product of the clinical research effort is to develop new clinical investigators in the complex techniques and advanced theories of contemporary mental health-related research. Each CRC must include a research development component. CRCs may take advantage of National Research Service Award (NRSA) Fellowships, Institutional Research Training Grants, and Research Scientist Development Awards for support of developing scientists. o An institution may have more than one CRC, provided that the themes differ significantly in content. There is the expectation that shared resources would significantly reduce the cost of both CRCs. 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 Potential applicants are asked to send, 90 days prior to the anticipated application submission date, a letter of intent that includes a descriptive title of the proposed center, the name, address, and telephone number of the CRC Directors, identities of other key personnel, and additional participating institutions. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to offer technical assistance. The letter of intent is to be sent to the appropriate individual listed under INQUIRIES. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. 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, 5333 Westbard Avenue, Room 240, Bethesda, MD 20892, telephone (301) 710-0267. The title and number of the program announcement must be typed in Section 2a on the face page of the application. 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 express mail) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement 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 will be assigned a priority score, and receive a second-level review by the appropriate National Advisory Council. Review Criteria The following criteria apply for both developing and mature CRCs except where noted. I. Conceptualization o Quality of the conceptualization and overall approach to research on the organizing themes of the CRC o Overall scientific quality, quantity and direction of current peer reviewed research and of the proposed research projects and pilot studies that will use CRC core resources (independently supported projects are not evaluated separately, but are used in the assessment of the contribution of cores.) o Nature of the unique contributions of the CRC,including importance, innovativeness, scientific productivity, and recognition including publications, new research grants, and honors and awards o Scientific investigations and related research grant support associated with each of the major themes of the CRC; contribution of projects to overall scientific aims of the CRC o Extent of collaboration among investigators affiliated with the CRC and between the CRC and other research institutions II. Center Structure and Administration o Quality and appropriateness of the organizational structure o Quality and experience of the administrative staff o Quality and appropriateness of the plans for evaluation of CRC themes, directions, and overall organization through in-house consultation and outside review o Quality of the plans for the allocation and monitoring of resources (patients, laboratory capacity, pilot study funds, biostatistical consultation) III. Center Cores o Quality of the administrative functions and overall infrastructure to support ongoing center themes and peer reviewed projects o Quality of the recruitment, diagnosis, patient accrual and sample maintenance functions and patient tracking across protocols o Quality of the experimental methodology functions: accomplishments, activities, and plans o Quality of the data analytic functions and procedures for database management including completeness, quality assessment and control procedures, accessibility of the data, extent of utilization of the data for analysis, publication, and development of exploratory hypotheses. For competing renewal applications, a thorough database survey to determine the quality and accessibility of the database will be part of the review. For developing Center applications, review emphasis will be on skills and background of personnel involved in data base management, quality control, and statistical consultation. o Quality of the core laboratories o Quality and innovativeness of pilot studies and quality of procedures for evaluation and selection of new pilot study proposals o Kind and degree of cross-core activities and synergistic potential of the cores and independently funded projects IV. Personnel o Scientific qualifications of the CRC investigators o Quality of the depth and breadth of basic and clinical research expertise o Quality of the planned personnel recruitment, training and supervision including plans for recruiting underrepresented minority and women investigators and research staff o Quality and degree of synergistic potential among the research groups V. Center Director o Scientific and administrative qualifications of the CRC director o Quality of scientific expertise and track record o Quality of administrative skills and institutional authority VI. Resources and Environment o Availability and accessibility of appropriate research and control subjects o Availability and accessibility of appropriate research laboratories o Availability and accessibility of appropriate clinical facilities o Quality of institutional resources o Quality and degree of institutional support and commitment VII. Scientist Development Track record and quality of plan for training and career development record including recruitment and retention of promising investigators and launching of scientific careers VIII. Budget o Appropriateness of budget and time frame for the proposed activities o Appropriateness of procedures for determining allocations to cores and pilot projects IX. Information Dissemination o Quality of plans to participate in meetings and present research abstracts o Quality of plans for internal peer review of research papers, chapters, and grant applications including procedures for determining authorship and other sensitive matters o Quality of plans for participating in or sponsoring workshops and conferences for non-CRC investigators, clinicians, primary care providers, or patients and their families o Quality of plans for development of materials and instruments for use by clinicians and investigators not affiliated with the CRC X. Women and Minority Subjects o Quality 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 and the safety of the research environment. The following specific review criteria apply to applications for developing CRCs seeking renewal as mature CRCs. o Development of a research identity and focus o Success in establishing core structures, articulating the scientific program of each core and in encouraging inter-core collaborations o Success in developing administrative procedures and policies that foster the highest quality science o Success in attracting productive investigators and promising trainees Terms and Conditions Funding for developing CRCs is for a maximum 5-year period. Any renewal application must be for a mature CRC. Funding for mature CRCs can be for a maximum project period of 5 years; additional project periods may be funded following applications for competitive renewal. Funds may be requested for core support related to the administrative functions and research infrastructure of the CRC and for specific activities including inpatient bed costs, outpatient costs, subject incentive fees, pilot studies, cost of conducting community-based studies, cost of specialized consultation such as statistical and/or computer science and scientist development activities. Training costs and service costs not related to the research program are not covered under CRC 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 which is proposed. Since CRCs constitute a sustained research resource within a specific institution and provide infrastructure for training and funded research, CRCs may not be transferred to another institution without a competitive review. Departing investigators may submit competitive applications for a developing or mature CRC under the auspices of the new institution. The original sponsoring institution must notify the NIMH project officer and indicate either the date of termination or the new staffing plan. In the latter case, the project officer will determine if the new staffing plan must be peer-reviewed. Grants must be administered in accordance with the PHS Grants Policy Statement (rev. April 1, 1994). A submitted application will be reviewed as developing or mature CRC as requested; the IRG will not change categories as part of its review. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NIMH. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priorities and balance. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Mary C. Blehar, Ph.D., Acting Chief Mood, Anxiety, and Personality Disorders Research Branch Division of Clinical and Treatment Research 5600 Fishers Lane, Room 10C-16 Rockville, Maryland 20857 Telephone: 301/443-1636 FAX: (301) 443-6000 Email: MBLEHAR@AOAMH4.SSW.DHHS.GOV Barry D. Lebowitz, Ph.D., Chief Mental Disorders of the Aging Research Branch National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: BLEBOWIT@AOAMH4.SSW.DHHS.GOV Peter S. Jensen, M.D., Chief Child and Adolescent Disorders Research Branch Division of Clinical and Treatment Research 5600 Fishers Lane, Room 18C-17 Rockville, Maryland 20857 Telephone: (301) 443-5944 FAX: (301) 443-6000 Email: PJENSEN@AOAMH4.SSW.DHHS.GOV Althea M. Wagman, Ph.D., Acting Chief Schizophrenia Research Branch Division of Clinical and Treatment Research 5600 Fishers Lane, Room 18C-14 Rockville, Maryland 20857 Telephone: (301) 443-4707 FAX: (301) 443-6000 Email: AWAGMAN@AOAMH4.SSW.DHHS.GOV Robert F. Prien, Ph.D., Chief Clinical Treatment Research Branch Division of Clinical and Treatment Research 5600 Fishers Lane, Room 18-105 Rockville, Maryland 20857 Telephone: (301) 443-4527 FAX: (301) 594-6784 Email: RPRIEN@AOAMH4.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Diana S. Trunnell Office of Resource Management National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: DTRUNNEL@AOAMH1.SSW.DHHS.GOV 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use 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 routing 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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