CORE SUPPORT FOR PROGRAMS IN MENTAL HEALTH/AIDS RESEARCH NIH GUIDE, Volume 26, Number 32, September 26, 1997 PA NUMBER: PAR-97-110 P.T. National Institute of Mental Health Letter of Intent Receipt Date: November 1 (each year) Application Receipt Date: January 2, (each year) PURPOSE The National Institute of Mental Health Office of AIDS Research will establish Core Support for Programs in AIDS Research (CSPARs) to provide core support for multi- disciplinary research programs on the mental health aspects of HIV/AIDS. The purpose of this Program Announcement is improve and expand research by supporting infrastructure, including: subject recruitment, tracking, and retention; quality control and assurance procedures; equipment; laboratories; statistical analysis; database management; and administrative coordination. This will serve to enhance and extend the effectiveness of research related to mental health and HIV/AIDS. 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, Core Support for Programs in AIDS Research, is related to the priority area of mental health aspects of HIV/AIDS research. 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 organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign organizations are not eligible to apply. Domestic organizations may not include international components. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply. MECHANISM OF SUPPORT The mechanism of support for the CSPAR is the core center grant (P30). The applicant may propose pooling existing resources and request additional support for research infrastructure to be shared by investigators with existing related funded research. This research infrastructure support may include, e.g., subject recruitment, equipment, laboratories, statistical analysis, database management, developmental cores, and administrative coordination. Applicants must demonstrate the potential for continuing funding for projects proposed to be supported by the core. Core Support Center Grant applicants may apply for up to five (5) years of support and the grants are renewable until further notice. Construction costs are not allowable. FUNDS AVAILABLE NIMH will provide up to a maximum of $850,000 total costs for CSPAR grants. Applicants must demonstrate a funded research base of at least six peer-reviewed AIDS and AIDS-related research awards active at the time that the CSPAR is funded and throughout the award period. Sixty percent of this funded research base must be from NIMH-funded grants and 40% may be from other NIH Institutes or appropriate peer-reviewed funding from alternate sources. This research base must demonstrate synergy and collaboration for all aspects of AIDS-related behavior research, including research investigating the neurological and neurobehavioral complications of HIV infection. The research base includes grants and contracts utilizing the following mechanisms: P01, R01, R03, R21, R29, R35, R37, U01, U10, U19, and K series awards. Applicants planning to submit center application requesting $500,000 or more in direct costs in any year are advised that they must contact program staff prior to submission of the grant. Applications in this category received without prior staff contact may be delayed in the review process or returned to the applicant without review (NIH GUIDE, Volume 25, Number 14, May 3, 1996). RESEARCH OBJECTIVES The NIMH seeks to foster a synergistic approach to research on mental health issues of HIV infection. The goal of the CSPAR is to encourage the application of multiple scientific perspectives and approaches to stimulate inter- and multi-disciplinary collaboration and coordination. NIMH CSPARs are broadly based investigative endeavors, encompassing or supporting research in a variety of areas including biological, biomedical, behavioral, neuroscience, prevention, clinical sciences and services research. Some important research objectives are: 1) identify behaviors that put individuals at risk for HIV infection, and develop interventions to change those behaviors; 2) develop methods and strategies to aid HIV-infected individuals and their families in coping with HIV infection; 3) study the nervous system effects of HIV infection of the CNS; 4) identify the cellular and molecular mechanisms underlying HIV-induced CNS dysfunction; 5) develop and test potential therapeutics to prevent or treat this CNS disease; and 6) study issues influencing adherence and non- adherence, and identify methods to improve and assure adherence and compliance to drug therapy regimens. The CSPAR will enable innovative, state-of-the-art research on HIV and mental health that could not or would not be conducted without the co re support. In addition, the CSPAR should have an overall integrating theme which is clearly described, and which justifies the need for the core support to facilitate the research projects. Applicants are strongly encouraged to consult with NIMH program staff with regard to questions concerning program-specific requirements. Although the specific structure and organization of individual research core centers will vary, the following characteristics must be apparent in each application. Applicants should carefully review these characteristics because they are important factors in the evaluation and scoring of the application by peer reviewers. NIMH CSPAR applications must describe in detail the essential function of each core of the center, how each core will contribute to the overall theme and organization of the center, and how each core will be used by the participating research projects. Specific aims of the proposed components should be defined, and a time line for addressing those aims should be presented. This focus of the proposal should be clearly addressed in the Introductory section prefacing the application. Research Environment Each center must provide an environment that promotes and enhances the conduct of the highest quality, state-of-the-art research, exhibiting leadership and innovation in its particular area(s) of investigation. CSPARs are expected to serve as regional or national research resources for established and promising investigators, and provide opportunities for research training, career development, and mentoring. Applicants should be specific in describing the advantages of the overall center structure, how it will be beneficial, and how it will contribute to achieving the identified research goals. The application of multiple scientific perspectives and a synergistic approach as well as thematic integration should be defining features of the CSPAR. For competitive renewals, applicants should identify original specific aims and progress made on each specific aim as well as evidence of relevant publications produced in the previous funding period. CSPAR Director The CSPAR director must be scientifically and administratively qualified to direct the center, and able to provide leadership for the scientific program. The director will have final responsibility for the scientific, administrative, and operational aspects of the center. The center director is responsible for overall coordination and for the development of the CSPAR as a significant local, regional, or national resource. Because of the role and importance of the center director to the success of the center, the commitment of time and effort to be devoted to the center must be described and adequately justified, and an individual may not serve as director of more than one research core center grant. Training As a leader in its particular area of investigation, the CSPAR should attract new investigators and provide for mentoring and career development. The applicant institution must demonstrate that it has the capacity to train predoctoral and/or postdoctoral students for careers in HIV/mental health research, and the capacity to provide career development and mentoring opportunities for potential researchers. CSPAR grant funds may not be used to pay stipends or other trainee costs, however, the center staff are encouraged to participate in the development of training programs, and center resources may be made available for use of trainees. In addition, as regional or national resources, center applicants should also facilitate the sharing of data and methodologies as well as training in such methodologies with the scientific community. Travel Limited support is available to cover travel of the CSPAR director and other investigators to scientific meetings, justified as essential to the conduct of research under the center. Travel of technical staff for training justified as essential to enhancing the quality of the research projects is also allowed. Organization NIMH core center grants are expected to be multidisciplinary in scope, applying multiple scientific perspectives and approaches, to foster inter- and multi-disciplinary collaboration and coordination, and include a depth of expertise and experience not ordinarily present in an individual research project grant. The mechanisms to foster interactions and collaborations among center investigators should be described in detail, clearly and specifically explaining how this will result in enhanced quality, productivity and overall progress in mental health research in the center. An effective center provides an environment that encourages cross-fertilization of ideas, provides an interactive research environment, and encourages creativity and innovation. Through interactions and collaborations, participating investigators should enhance the development and productivity of their research efforts, benefiting from shared resources, formal and informal planning activities and developmental or pilot support provided through the NIMH core center grant. The CSPAR should be organized to include an administrative core, a minimum of two research cores, and a developmental core as described below. Core directors should be senior-level investigators with a history of research support. ---Administrative Core The center must have an appropriate and adequate administrative structure with an internal organization capable of planning and evaluating center activities. This should include a structure that has clear lines of authority to promote planning and evaluation activities as well as collaborations and interactions within, among and between programmatic elements of the center in an efficient and cost-effective manner. A mechanism for internal advisory, review, decision-making, and priority setting processes appropriate to conduct the activities of the center must be defined. Appropriate criteria and review processes must be established and described to sustain individual participation in the center based on productivity, research direction, and overall contribution. The administrative structure must include a standing outside advisory structure(s) charged to provide appropriate and objective advice and evaluation as needed to the center director. Administrative cores may provide support for a limited number of administrative and clerical personnel. However, salary and support for central administrative personnel usually paid from institutional overhead charges, such as budget officers, grants assistants, and building personnel are not allowed. Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment are allowed when not covered by institutional overhead charges. Salary and support for administrative activities such as public relations, fund-raising, or educational services unrelated to the research are not allowed. ---Research Cores The structure of the CSPAR will include the establishment of a minimum of two research cores to support shared resources that will enhance the ongoing research grants. Research cores can be developed around any research activity that can provide resources to basic and clinical investigators, such as behavioral intervention development, neurobehavioral/neurological assessment, information dissemination, statistical analysis, etc. Shared resources and services are intended to provide access to technology that enhances the research productivity of the center, scientific interaction and consultation. Shared resources also provide access to services that facilitate the research and strengthen the administrative and organizational cohesion of the center. The costs associated with sharing data and methodologies with the scientific community and training colleagues in the use of such methodologies are also allowed. A table should be presented indicating how the current projects will be served by the proposed cores, and a clear and detailed description of this should be included in the narrative of each appropriate research core. CSPARs may request funds for use of inpatient, residential, or outpatient facilities which are essential to the conduct of the research and must be adequately justified. CSPAR funds can also support subject recruitment and incentive costs, as well as community sanction efforts where relevant. ---Developmental Core Developmental core money may be used as start-up funds for new, innovative pilot projects by independent investigators. Developmental support may be for investigators new to AIDS research and for feasibility studies. Generally, the total amount of money allocated to pilot projects should not exceed 10% of the center grant's total annual direct costs (exceptions should be strongly justified). These projects should have the potential for developing into larger projects that could compete for funds on their own. The support of pilot projects or feasibility studies should be of relatively short duration (e.g., 1-2 years), depending upon the nature of the research. A process by which high-quality, innovative pilot proposals are identified or solicited from investigators must be developed and clearly described. The mechanism to review potential projects, make funding decisions and awards, and the manner in which projects will be monitored to ensure effective use of pilot project funds must be described. As with all research to be conducted under the center, pilot projects must comply with applicable NIH policies and the necessary human subject and animal welfare assurances must be submitted. CSPAR grantees are to provide the NIMH program officer with written notification of the initiation of new pilot projects. The notification should contain a brief description of and rationale for the planned pilot project, the amount of pilot funds to be allocated to the project, the proposed length of the project, a statement that the project will comply with applicable NIH policies and that the necessary human subject and animal welfare assurances have been submitted and obtained. Competing continuation center applications should supply information about the progress, accomplishments and relevant publications of all projects supported by the center through the pilot project mechanism. This information should also include the current funding status of completed pilot projects, and whether data generated from pilot projects provided a basis for projects with independent 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by November 1, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this announcement. 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 estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dianne Rausch, Ph.D. Office of AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443 9719 Email: dr89b@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267; fax: (301) 480-0525; Email: ASKNIH@OD.NIH.GOV. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The receipt date for all new and competitive renewal center grant applications will be once per year on January 2. The letter of intent should be submitted by November 1. 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 mail service) The application should include an overview summarizing the overall organization of the proposed CSPAR, including the cores, and is limited to 5 pages. The RESEARCH PLAN should describe the CSPAR in detail, and is limited to 25 pages, including tables, graphs, figures, diagrams, and charts. In addition, a detailed description of each core is required, limited to 10 pages each. Applications must be complete and must not exceed these page limits or they will not be accepted. Potential applicants are strongly encouraged to contact NIMH program staff early in the planning process. NIMH staff will provide preapplication consultation to all applicants for NIMH CSPAR grants. REVIEW CONSIDERATIONS 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. Applications recommended for further consideration by the review committee will receive a second-level review by the National Institute of Mental Health Advisory Council. After Council consideration, applications will be considered for funding decisions by the relevant program staff and the Institute Director. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The following aspects of the application will be evaluated in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Applicants should ensure that their applications are responsive to the research goals of NIMH and to the essential organizational and administrative characteristics of an NIMH core center as described below. Overall CSPAR Program Review Criteria o Scientific significance of the center's research program with regard to furthering research on mental health and HIV o Specific goals of the cores and a clear description of the plans and time frame to achieve those goals o Synergy of approach and cohesiveness of objectives o Impact of the existing research base, and unique contributions of the proposed center to innovation, scientific productivity, and recognition, including publications, new research grants, honors and awards o Multi-disciplinary scope, breadth, and overall quality of the center's program, and provisions for coordinating the research projects and core units o Quality of the administrative functions and overall infrastructure in promoting the center themes and research projects o Extent of collaboration among investigators within the center o Quality of plans for internal peer review of papers, chapters, and grant applications o Track record and quality of plans for mentoring and career development of promising investigators o Quality of plans for sponsoring workshops, seminars, and other educational activities for center investigators and research staff o Institutional commitment to the program CSPAR Director o Scientific and administrative qualifications of the center director o Appropriateness of the level of time and commitment to the center grant o Quality of scientific expertise and track record o Quality of administrative skills and institutional authority o Ability to participate in the development of research training programs, career development and mentoring opportunities Core Units o Evidence of cost-effectiveness and document of quality control of core units o Quality of the data analytic functions and procedures for database management, including quality assessment and control procedures, extent of use of the data for analysis, publication, and development of additional hypotheses o Quality of the core laboratories o Quality and innovation of pilot studies and quality of the procedures for evaluation and selection of new pilot study proposals o Relationship to existing grants and appropriateness of planned activities for ongoing research Research Activities o Scientific and technical merit of each component research activity and the relation of the activity to the CSPAR's overall theme o Quality and productivity of research projects using core units, and description of how the core units will increase the effectiveness of the research o Accomplishments and progress of the component research projects and core units (for competing continuations) o Accomplishments and progress of pilot studies (for competing continuations) o Qualifications, experience, and commitment to the CSPAR mission of the investigators responsible for the core units and research projects and their ability to devote the required time and effort to the program o As appropriate, the adequacy of the means proposed for protecting against risks to human subjects, animals, and/or the environment o As appropriate, the adequate representation of women and minorities in study populations Personnel o Scientific qualifications and productivity of center investigators o Quality and extent of the research expertise o Quality of plans for personnel recruitment, training, and supervision o Quality and degree of synergistic potential among the research groups Resources and Environment o Availability and accessibility of appropriate research laboratories, equipment, and subjects o Availability and accessibility of appropriate clinical facilities (if applicable) o Quality of institutional resources o Quality and degree of institutional support and commitment o Academic and physical environment as it bears on the potential for interaction with scientists from other departments and institutions Budget o Appropriateness of budget and time frame for the proposed activities o Appropriateness of procedures for making allocations to core units and, reviewing and selecting pilot projects for support Information Dissemination o Quality of plans to participate in scientific, professional, and public meetings and present research findings and, where concrete findings exist, plans for publishing the findings o Quality of plans for making data and methodologies available to the scientific community and for providing training in such methodologies o The quality of plans for participating in workshops and conferences, as well as disseminating information to other investigators and the local community when applicable AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIMH. The following will be considered in making funding decisions: quality of the application as determined by peer review, availability of funds, and program priority. INQUIRIES: Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dianne Rausch, Ph.D. Office of AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443 9719 Email: dr89b@nih.gov Direct inquiring regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.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. 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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