CORE SUPPORT PROGRAM FOR MENTAL HEALTH/AIDS RESEARCH Release Date: August 23, 1999 (see correction NOT-MH-02-008) PA NUMBER: PAR-99-153 (see replacement PAR-03-142) National Institute of Mental Health Letter of Intent Receipt Date: December 1 (each year) Application Receipt Date: January 2 (each year) PURPOSE This program announcement (PA) replaces PAR-97-110, which was published in the NIH Guide, Vol. 26, No. 32, September 26, 1997. This revision includes an increase in the maximum amount that can be requested for a Center, and an expanded description of the Center organization and review criteria reflecting the goal of NIMH to fund multi-disciplinary research programs addressing broad issues on the mental health aspects of HIV/AIDS. The National Institute of Mental Health (NIMH) Office of AIDS Research will establish Centers to Support 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 is to provide a mechanism to facilitate currently funded investigators in improving and expanding research infrastructure, including administrative coordination, subject recruitment, equipment, laboratories, statistical analysis and database management. This utilization of resources will 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 Program for Mental Health/AIDS Research, is related to the priority areas of mental health and mental disorders and AIDS research. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/ 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. Eligibility NIMH AIDS Funded Research Base Applicants must demonstrate a minimum funded research base of four NIMH-funded research grants, and at least two more peer-reviewed AIDS and AIDS-related research awards at the time that the CSPAR is funded and throughout the award period. The additional grants may be from other NIH Institutes or from peer-reviewed funding from alternate sources. This research base must demonstrate synergy and collaboration for AIDS-related behavior research or research investigating the neurological and neurobehavioral complications of HIV infection. The research base includes grants and contract utilizing the following mechanisms: P01, R01, R03, R21, R29, R35, R37, U01, U10, U19, and K series awards. NIMH will provide up to a maximum of $2,000,000 total costs per year for a CSPAR grant. NIMH CSPARs are expected to provide a resource for maximizing the synergy and innovation that can result from research crossing disciplines, approaches and levels of analysis. By providing a resource of shared expertise and resources, it is expected that unnecessary duplication of effort and support will be eliminated. Applicants must provide a thorough justification of the level of funding requested, with detail describing how the Center will promote research interactions and collaborations that cross disciplines, technical and theoretical approaches, and levels of analysis. As an NIMH Center, the applicant must also provide detailed descriptions of how each component of the Center will provide the resources to enhance and expand research addressing mental health issues and HIV/AIDS. MECHANISM OF SUPPORT The mechanism of support for the CSPAR is the core center grant (P30). The purpose of this core support grant is to provide a mechanism that will allow currently funded investigators to consolidate and expand resources that will enhance and extend the effectiveness of research related to mental health and HIV/AIDS. 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., administrative coordination, subject recruitment, equipment, laboratories, statistical analysis, database management, and developmental cores. Applicants must demonstrate the potential for continuing funding for projects proposed to be supported by the core. RESEARCH OBJECTIVES The NIMH seeks to foster a synergistic approach to research on mental health issues of HIV infection. The goal of the Core Support Program for AIDS Research (CSPAR) is to encourage the application of multiple scientific perspectives and approaches to stimulate inter- and multi-disciplinary collaboration and coordination which will: 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 and the consequences; 3) study the effects of HIV infection on the nervous system; 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 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 core support. Through this core support program, NIMH seeks to encourage outstanding scientists to cooperate to bring together expertise, approaches, and advanced technologies to a multi-disciplinary study of problems related to mental health and HIV. 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. Thematic integration is a defining feature of Center grants. CSPAR grant applications may be submitted in any of the scientific areas supported by the NIMH. Applicants are strongly encouraged to consult with appropriate NIMH program staff for questions concerning program-specific requirements. 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. Although the specific structure and organization of individual research 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 Center applications must describe in detail the essential function(s) of each component of the Center, and how this component contributes to the overall theme and organization of the Center, leading to successful achievement of the overall goals of the Center. Specific aims of the proposed components should be clearly defined, with delineation of a timeline for implementation and a mechanism for evaluating the achievement of these aims. This overall purpose and the goals of the Center should be clearly addressed in the Introductory section prefacing the application. o Research Environment Each Center must provide an environment that promotes the conduct of the highest quality, state-of-the-art research, exhibiting leadership and innovation in its particular area(s) of investigation. Through its activities, the CSPAR must demonstrate that it is a significant regional or national scientific research resource. Applicants should be very specific in describing the advantages of the overall Center structure, how it will be beneficial, and how it will contribute to advancing the field. The application of multiple scientific perspectives and a synergistic approach as well as thematic integration should be defining features of the Center. For competing continuations, applicants should identify original approved specific aims and clearly describe the progress made on each specific aim as well as evidence of relevant publications produced in the previous funding period. o CSPAR Director The CSPAR Director must be scientifically and administratively qualified appropriate to the nature and complexity of the research objectives of the Center. A critical requirement is the ability of the CSPAR Director to demonstrate leadership for the scientific program and the team of individuals involved. 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 Center as a significant local, regional, or national resource. Because of the role and importance of the Center Director to the success of the Center, an individual should not serve as director of more than one research Center grant. In addition, it is expected that the Center Director will make a significant and justifiable commitment of time and effort to the Center. o Training As a leader in its particular area of investigation, the CSPAR should attract new investigators and provide for mentoring and career development. An important component related to the Center and its research efforts is the training, career development and mentoring of new investigators who show potential for significant contributions and independent research careers. The applicant institution must therefore 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. Center grant funds may not be used to pay stipends or other trainee costs, however, the Center staff may 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. o Travel Limited support is available to cover travel of the Center 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. o Organization NIMH Center grants are expected to be multi-disciplinary 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 in a well organized plan that explains how this will result in enhanced quality, productivity and overall progress in 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. The applicant should describe clearly how interactions and collaborations of participating investigators will enhance and expand 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 research Center grant. The CSPAR should be organized to include the cores listed below. o Administrative Core The Center must have appropriate and adequate administrative structure with an internal organization capable of planning and evaluating Center activities. A strategic plan must be outlined which identifies the immediate and long term goals of the Center. A process for implementing the activities to achieve the goals set by the Center should be clearly defined. 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 clearly defined. Appropriate criteria and review processes must be established 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 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, with a detailed description of their responsibilities for the Center and strong justification for the level of support requested. 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 allowable. 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. o Research Cores The structure of the CSPAR will include the establishment of at least two research cores to support shared resources that are not easily funded through standard research granting mechanisms. The number and goals of the research cores should be reflective of the overall level of funding requested for the Center. Research cores can be developed around any research activity that can provide resources to basic and clinical investigators. The research cores are expected to be used as shared resources and services and are intended to provide access to technology that enhances the research productivity of the Center, scientific interaction and consultation. These shared resources also provide access to services that facilitate the research and strengthen the administrative and organizational cohesion of the Center. Research within the core structure is allowed when directed toward improving and expanding the resource. Each research core should clearly describe a plan for identifying new or expanded services that it provides. In addition, each research core should clearly describe a plan for identifying potential users of the shared resources, and for providing the resources to investigators who may request them. The potential benefits of these resources and a mechanism to evaluate these benefits must be detailed in the description of the core. Centers may request funds for use of inpatient, residential, or outpatient facilities which are essential to the conduct of the research such as patient bed costs, research ward costs, outpatient facility and other health services costs. Such funds will be made available, however, only when it is clear that no other funds are available and the services are essential to the conduct of the research. Center funds can also support subject recruitment and incentive costs, as well as community sanction efforts where relevant. The costs associated with sharing data and methodologies with the scientific community and training colleagues in the use of such methodologies are also allowed. o Developmental Core Developmental core money may be used as start-up funds for new, innovative pilot projects by independent investigators. Developmental support may be used for pilot projects by investigators new to AIDS research and for feasibility studies. Generally, the total amount of money allocated to pilot projects should not exceed 10 percent 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. The mechanism to review potential projects and make funding decisions, and the manner in which projects will be monitored and evaluated must be clearly described to ensure effective use of pilot project funds. 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. 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 current funding status of completed pilot projects, and whether data generated from pilot projects provided a basis for projects with independent funding. o Budgetary Items and Supportable Activities Allowable costs in NIH grants are governed by rules set forth in the NIH Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated on the Notice of Grant Award. Under these rules, the Center Director has flexibility to meet unexpected Center requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the Center (as shown on the Notice of Grant Award). The Center is intended to provide reasonable costs for any or all of those activities noted below which are clearly related to the specialized research needs of the Center and allowed by NIH policy. 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 available on the web at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 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 6001 Executive Boulevard, Room 6209, MSC 9619 Bethesda, MD 20892-9619 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at January 2 of each year. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: [email protected]. The application is also available at https://grants.nih.gov/grants/funding/phs398/phs398.html Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at https://grants.nih.gov/grants/guide/notice-files/not98-030.html The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Potential applicants are strongly encouraged to contact NIMH program staff early in the planning process. To facilitate the review process, the application should be organized according to the outline described here. (1) An overview should include an overall description of the proposed Center, including objectives and integrating theme; justification of Center goals and proposed organization; evidence of the cohesiveness of the proposed Center; a brief description of background and responsibilities of the Center Director, key personnel, and participating investigators; a diagram illustrating the organization and function of the programmatic and advisory structure of the Center (limited to 10 pages). (2) A Research Plan should include a detailed description of the goals of the scientific projects, an action plan to achieve those goals, and a short and long term time line to meeting the goals; the strengths and opportunities of the proposed Center; methods to be used; information about resources and facilities available to the Center; policies and procedures for strategic planning, monitoring and evaluating the Center activities; an overview of the core structure, including a justification for specific cores and a plan for how the cores will interact with the Center functions; and a description of how the Center will facilitate the existing science at the Institution (limited to 25 pages). (3) A detailed description of each individual Core should include the aims and activities of the core and a description of how the aims will be met; a justification and description of the personnel within each core; the proposed users and anticipated percent of time that is expected; a plan for outreach to other potential users; resources and environment; and a plan for evaluating the activities of the core (limited to 10 pages for each core). The receipt dates for all new and competing continuation Center grant applications will be January 2. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIMH 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 NIMH Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Applications will be reviewed using the following review criteria. Applicants should ensure that their applications are responsive to the research goals of NIMH and to the essential organizational and administrative characteristics of a NIMH Center as described below. Overall Center Program Review Criteria o Scientific significance of the Center research program to furthering research on mental health and HIV o Extent of thematic integration o Synergy of approach, cohesiveness of objectives o Unique strengths and contributions of the Center, including significance, 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, the core units, and the research projects, and provisions for coordinating the research projects and core units o Quality of the administrative functions and overall infrastructure in relation to Center themes and research projects o Extent of collaboration among investigators within the Center and with other research institutions o Participation of a suitable number of responsible, experienced investigators o Arrangements for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements and internal communication and cooperation among investigators o Quality of plans for internal peer review of papers, chapters, and grant applications including procedures for determining authorship and other sensitive matters 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 Center Director o Scientific and administrative qualifications of the Center Director o Evidence of strong leadership potential 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 provide research training, 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 Qualifications, experience, and commitment to the Center mission of the investigators responsible for the core units 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 (Overall Center and Cores) 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 (Overall Center and Cores) 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 (Overall Center and Cores) o Appropriateness of budget requested o Timeline for the proposed activities o Appropriateness of procedures for making allocations to core units and, reviewing and selecting pilot projects for support Information Dissemination (Overall Center and Cores) 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 non-researcher investigators and the local community when applicable AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to the Institute. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES 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 6001 Executive Boulevard, Room 6209, MSC 9619 Bethesda, MD 20892 Telephone: (301) 443-7281 FAX: (301) 443 9719 Email: [email protected] Direct inquiries regarding fiscal matters to: William F. Caputo Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-6004 FAX: (301) 443-6885 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998). 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, and 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.
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||