Full Text AI-93-014 CENTER FOR AIDS RESEARCH/CORE SUPPORT GRANT NIH GUIDE, Volume 22, Number 22, June 18, 1993 RFA: AI-93-014 P.T. 04 Keywords: AIDS Biomedical Research, Multidiscipl Behavioral/Social Studies/Service Disease Prevention+ National Institute of Allergy and Infectious Diseases National Institute of Mental Health Letter of Intent Receipt Date: July 16, 1993 Application Receipt Date: August 25, 1993 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Mental Health (NIMH) invite the submission of applications for Centers for AIDS Research/Core Support Grants (CFAR/CSG) from institutions conducting high quality, multidisciplinary AIDS research. The purpose of the CFAR/CSG is to provide administrative and shared research support through Core facilities to synergistically enhance and coordinate high quality AIDS and AIDS-related research projects requiring resources or services not otherwise readily obtained through more traditional funding mechanisms. 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, Centers for AIDS Research/Core Support Grant (CFAR/CSG), is related to the priority area of HIV infection. 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 Applicant institutions Applications may be submitted by domestic, non-profit and for-profit research institutions including universities, colleges, units of state and local governments and research institutes or laboratories. Both new applicants and competing renewal applicants are eligible to apply. Minority individuals and women are encouraged to submit as Principal Investigators. Foreign institutions are not eligible to apply. One CFAR per institution per funding institute CFAR/CSGs are awarded to research institutions already heavily committed to several individual programs in AIDS and AIDS-related research. In general, the purpose of the CFAR/CSG award is to enhance the impact of the unique spectrum of scientific expertise and research projects available within an institution. Thus, only a single CFAR will be supported at a given institution per funding institute, i.e., one institution may have a CFAR funded by NIAID and one funded by NIMH, but the institution will not have more than one CFAR funded by either institute. It is incumbent upon the applicant institution to demonstrate that there will be no duplication of effort, if an institution applies for a CFAR/CSG from NIAID and one from NIMH. For example, the two CFARs should not have any Cores that are the same and should not use the same grants to fulfill the Funded Research Base requirement (see below). The terms "applicant institution" and "parent institution" refer to a given location (campus). For example, institutions that are part of a larger system, such as UCLA and UC Davis, each a separate component of the university system of the state of California, could each be awarded a CFAR/CSG. See the document "CFAR/CSG Guidelines" for a list of separate organizations. However, institutions that have significant overlap in faculty, resources, and/or administration should submit only one application. Funded Research Base An applicant institution must have a continuing Funded Research Base of at least $800,000 in annual direct costs of peer-reviewed AIDS or AIDS-related research. In order to qualify for a CFAR/CSG award by the NIAID, the Funded Research Base must be NIAID-funded research. In order to quality for a CFAR/CSG award by the NIMH, 60 percent of the Funded Research Base must be from NIMH-funded research and 40 percent may be from other NIH Institutes or peer-reviewed funding from alternate sources. Both Institutes require that the Funded Research Base be distributed among at least six peer-reviewed AIDS and AIDS-related research awards when the CFAR/CSG is awarded and throughout the award period. The annual progress report (form PHS 2590) must include this information each year of the project period. Funding for an existing CFAR cannot be used to achieve any portion of the Funded Research Base. To assist NIH in the identification of centers that may be funded by NIAID or NIMH, applicants are urged to indicate, in the abstract that describes the overall proposed CFAR, how many projects which comprise the Funded Research Base are funded by NIAID and how many are funded by NIMH. Applicants are also encouraged to include a brief description of the type of research included in the Funded Research Base in the overall CFAR/CSG abstract. Qualifying Funding For all applicants: AIDS and AIDS-related research supported by the NIAID and NIMH: This includes all types of grants, cooperative agreements, and research contracts in which proposed research has been peer-reviewed and includes the following categories: P01, P50, R01, R03, R21, R29, R35, R37, U01, U10, K and F series awards, R18 (Research Demonstration and Dissemination Projects) and N01 (Research Contracts). For NIMH applicants: AIDS and AIDS-related research supported by other NIH Institutes and funding organizations outside of NIH: Funding by the latter organizations, which may not exceed the indicated percentage of the Funded Research Base (40 percent for NIMH awards), may be included if review processes for awards are substantially equivalent to those of NIH. It is the responsibility of the applying institution to demonstrate that, in these cases, the alternative peer-review mechanisms involved are equivalent to those in use at NIH and that the research so funded is of sufficient quality to warrant CFAR/CSG support. This verification may be accomplished by attaching to the application a one page document containing information provided by each alternate funding agency describing their review mechanisms and criteria for awarding funds. Excluded Funding The following should not be included in the total AIDS Funded Research Base A current CFAR, training grants including Institutional Training Grants (T32s), other P30 awards, awards from private industry, contracts and other awards that primarily fund the production of materials and/or services for support of research. MECHANISM OF SUPPORT CFAR/CSG awards will be made under the NIH Core Support Grant (P30) mechanism. This RFA is a one-time solicitation. Because the nature and scope of the research proposed in response to this RFA will vary, it is anticipated that the sizes of the awards will vary also. Responsibility for the planning, direction and execution of the proposed Center will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years of support. However, recommended support beyond the third year of the CFAR/CSG is subject to the determination by an ad hoc review committee that stated goals (milestones) have been sufficiently met. The progress report of the non-competing continuation application (PHS 2550) for the fourth year of support must demonstrate that stated CFAR/CSG goals have been met. Program staff will contact the Principal Investigator to request additional information, if required. The six milestones that must be met at the end of year three are: interdisciplinary coordination and collaboration, especially between clinical and basic research investigators; synergistic scientific collaboration; organizational capabilities of the CFAR; institutional commitment; developmental and educational commitment; and effective use of the charge back system. Additional information is provided under REVIEW CRITERIA. FUNDS AVAILABLE The NIAID has set aside a total of $7.2 million for the initial year's funding of this RFA. The NIAID anticipates making 9 to 11 awards. NIMH has set aside a total of $1.5 million and anticipates making two awards. The final number and specific amounts of awards will depend upon the scientific and technical merit, relevance to programmatic priorities and availability of funds. All applications are limited to requests for no more than $750,000 in total costs (direct plus indirect) in the first year. Increases of up to four percent are permitted for allowable recurring costs for each of the subsequent years. RESEARCH OBJECTIVES Background The human Acquired Immunodeficiency Disease Syndrome (AIDS) has reached epidemic proportions: 253,448 cases of AIDS in the United States had been reported by the Centers for Disease Control (CDC) as of February, 1993. A total of 169,623 individuals have died from this disease and its sequelae. In response to this emergency, the NIH and other research institutes are supporting studies consisting of basic and applied research concerning the AIDS epidemic. It is anticipated that these investigations will lead to achievement of disease prevention through development of effective vaccines, prevention and behavioral change strategies, and rational therapeutic strategies to control viral infection and the development of opportunistic infections and other sequelae of AIDS. The continually expanding epidemic nature of AIDS increases the urgency for critical basic and applied research in AIDS and AIDS-related projects and the timely transfer of basic research knowledge into efficacious patient treatment protocols. The genetic variability of HIV, the apparent complexity of its viral pathogenesis (still not yet fully understood), as well as the unique socio-epidemiological aspects of infection, dictate the need for implementation of a multidisciplinary approach involving the collaboration of teams of investigators possessing diverse and relevant state of the art expertise in research areas most useful for an understanding of AIDS and for the development of effective therapies. Most importantly, there is an imperative need for the timely application of new knowledge obtained in the basic research laboratory to the clinical setting as well as for the efficient translation of observations in AIDS clinics into questions which may be addressed and resolved by novel laboratory experimentation. It is precisely these aspects of AIDS research to facilitate through CFAR/CSG awards. During Fiscal Year 1988, the NIAID launched a new initiative intended to establish a number of Centers for AIDS Research (CFARs) at institutions committed to several high quality AIDS research projects, using funds specifically appropriated by Congress. Under this program, thirteen CFARs were funded for the purposes of enhancing and focusing high quality, peer-reviewed, AIDS and AIDS-related research in a synergistic manner with a resulting increase in the efficiency and effectiveness of a wide variety of research programs. In May 1992, an ad hoc Program Review Committee organized by NIAID commended the CFAR Program, and recommended several changes to enhance the Program's effectiveness in achieving its stated goals. These suggestions included: an increased emphasis on interdisciplinary cooperation and collaboration and the use of Cores by multiple, interactive groups; the establishment of at least one Clinical Core within each CFAR; maintenance of a critical level of high quality AIDS research consisting of several peer-reviewed awards; a continued demonstration of active support of the CFAR by the parent institution in terms of space, personnel, and other resources; a requirement that the CFAR Director be a Principal Investigator of peer-reviewed funded AIDS research and a leader in the field of AIDS research; encouragement of behavioral and prevention research, support of the enrollment of women and minorities in clinical trials, and support of minority investigators. The purpose of this RFA is to request new and renewal applications for the establishment of CFARs at parent institutions involved in critical, high impact AIDS and AIDS-related research projects. Funding will be provided to awardees to support the leadership and planning activities of the Center and to develop Cores of shared resources and services that will enhance and focus existing clinical and basic AIDS research in a cooperative and synergistic manner. This RFA will also provide funding for pilot projects for innovative, high risk investigations, and developmental support for new investigators in AIDS research. The goal of both of these aspects of CFAR support is to provide limited funding for development of sufficient data to enable investigators to apply for R01-type grants. Goals and Objectives of the Centers for AIDS Research The goal of the CFAR/CSG is to enhance and extend the effectiveness of groups of investigators conducting AIDS and AIDS-related research supported by peer-reviewed funding mechanisms. More specifically, the CFAR/CSG is intended to: o Encourage activities that will initiate, consolidate and focus high quality AIDS and AIDS-related research by establishing Core Support Facilities for ongoing projects funded through peer-reviewed awards. This RFA will foster multidisciplinary collaboration among scientists at the parent institution through coordinated administrative, resource and service Cores: o Promote effective synergistic collaborations and interactions especially among investigators participating in clinical and basic areas of AIDS research. Such interactions are intended to facilitate translation of information obtained in the laboratory to specifically address problems in the clinic and the field, and will enhance the possibility of observations in the clinic and the field being translated to the laboratory setting for further investigation. o Foster development of innovative and high quality research areas in AIDS research by providing support for investigators new to the field, and through the funding of pilot projects whose results can form the basis for competitive applications. o Support administration of the Center including activities such as seminars and workshops for CFAR/CSG members and AIDS investigators in general, education at all levels including community programs, and funding for the leadership responsible for organizing and sustaining the Center's activities. Scope, Restrictions and Exclusions Specifically, the CFAR/CSG will provide funding for the types of activities listed below. In general, those CFARs funded by the NIAID may have Core Facilities supporting research such as basic biology and pathogenesis of HIV, vaccine research and development, clinical trials and treatment research for HIV infection, drug development, epidemiology of HIV infection, and preclinical developmental therapeutic research for HIV and associated opportunistic infections. Those CFARs funded by NIMH may have Core Facilities supporting research such as CNS effects of HIV infection (neurobiological and behavioral studies), behavior change and preventive intervention studies, psychological and psychosocial response to HIV infection and AIDS and psychological and psychiatric treatment of persons with HIV infection and AIDS. Basic research in the area of behavioral change related to prevention of HIV infection is an area of joint interest and either NIAID or NIMH may fund Centers having Core Facilities supporting studies of this type. In addition, it is strongly encouraged that by the end of year 01 of the award and included in the non-competing, renewal application for year 02, and subsequent non-competing renewal applications, the CFAR will establish a plan of "Charge Back" for the remaining four years of funding. This will involve a gradual assumption, over the remaining period of the grant award, of greater fiscal responsibility by users of Core facilities through R01 funds and by the parent institution, with a corresponding decrease in support from CFAR/CSG funds for established Cores. (Note that the specific examples provided below are not intended to be all inclusive. Applicants are strongly encouraged to contact program staff from NIAID or NIMH listed under INQUIRIES for questions regarding the types of Cores that will be supported by NIAID or NIMH.) o Basic Science Cores. Centers are required to have at least three Basic Science Cores that support basic AIDS and AIDS-related research by investigators at the CFAR. The basic science Cores should be designed to foster collaboration among investigators representing various scientific approaches or disciplines, and should especially promote cooperation and collaboration between basic and clinical investigators. Applicants should indicate the mechanism that will be used to select users of Basic Science Cores, e.g., such as through an Internal Review Committee. Examples of such Cores that may be supported by the NIAID include, but are not limited to, Virus Culture in Biohazard Containment (BL3), Mass Spectrometry, Computer Modeling, Monoclonal Antibody Facilities, Peptide Synthesis and HPLC, DNA Synthesis and Sequencing, PCR, Transgenic and SCID/Hu Mice Facilities, Animal Models, and Flow Cytometry. Examples of such Cores that may be supported by NIMH include, but are not limited to, Mass Spectrometry, Computer Modeling, Monoclonal Antibody Facilities, PCR, Transgenic and SCID/Hu Mice Facilities, Animal Models, Flow Cytometry, Tissue Banks, Cell Line Repositories, Psychoimmunology, Neuroimmunology, and Neuroimaging. o Clinical Core. Centers are required to include a Clinical Core Support Facility that will support patient-based research. This Core should provide for collaborations with basic scientists and encourage rapid development of new clinical approaches. Activities that will not be supported by a CFAR/CSG Clinical Core include: routine screening of clinical specimens, diagnosis, treatment, or rehabilitation. Regardless of the specific type of activity performed within the Clinical Core, all activities should facilitate translation between basic and clinical research. Applicants should indicate the mechanism that the CFAR will use for selection of users of the Clinical Core, e.g., such as through an Internal Review Committee. If a Center has a clinical research entity, such as an ACTU, AVEU, CPCRA, DATRI site, or a Clinical Center, etc., the applicant institution must include information concerning all support for clinical research already in place, such as, but not limited to, biostatistical analysis, and database or repository establishment or maintenance. The types of activities that may be supported by a NIAID-funded Clinical Core include, but are not limited to biostatistical support, recruitment of subjects for clinical studies, support for epidemiological studies in areas of AIDS, community outreach, or provide modest funding for sample storage. The types of activities that may be supported by a NIMH-funded Clinical Core includes, but are not limited to biostatistical support, recruitment of subjects for clinical studies, support for epidemiological studies or behavioral epidemiological studies in areas of AIDS, neurobehavioral or psyco-sexual or psycho-social or treatment assessments, focus groups, ethnographic studies, community outreach, test development, and/or provide modest funding for sample storage. o Developmental Core. CFARs are encouraged to support three Developmental areas: Investigators New to AIDS Research, Pilot Projects, and Evolving Research Opportunities. o Administration Core. Support for the CFAR Director, who should be a recognized leader in the field of AIDS research and the Principal Investigator of at least one peer-reviewed grant, which is part of the Funded Research Base in AIDS or AIDS-related research. Support may also be requested for Core Directors, a senior administrator, an office that is a clearly separate entity to which individuals may come for information and other activities related to the CFAR, and a modest staff for support of Center activities. o The CFAR may provide salaries and limited funds for research costs for Investigators New to AIDS Research who have not previously received individual R01-equivalent support in this field. Funding will be provided until the investigator achieves independent support through a traditional research grant or equivalent, but will not exceed three years. Applicants should indicate the mechanism that the CFAR will use for selection of recipients of Developmental funding, e.g., such as through an Internal Advisory Committee. o Developmental funds may also be used for small feasibility studies, often of a risky nature, preparatory to the development of applications for independent peer-reviewed support. Examples include, but are not limited to, nurture of an especially innovative idea for which other funding is not available, exploration of an unconventional but potentially important hypothesis, and encouragement of basic/clinical, basic/prevention, and basic/behavioral research collaborations. Funding for the Pilot Projects will not exceed one year. Applicants should describe the mechanism they will use for identification and selection of Pilot Projects they will support through developmental funds. o Funding for Evolving Research Opportunities is designed to support rapidly arising, critical, evolving areas in the field of AIDS research which demand a rapid resolution. Funding for projects of this type will not exceed six months. Identification of a potential project may be brought to the attention of the CFAR from CFAR members, scientists outside of the CFAR as well as from the awarding institute. Applicants should describe the mechanism they will use for identification and selection of Evolving Research Opportunities they will support through Developmental Funds. No more than 25 percent of the total direct costs requested in the CFAR/CSG application may be for the combined salaries of the CFAR Director and Core Directors. No more than 10 percent of the total direct costs requested in the CFAR/CSG budget application may be allocated for all other categories in the administration core. o Additional Activities. Four additional activities of CFARs are encouraged. Specific examples are not meant to be all inclusive: o Identification of a Thematic area, i.e., a general area of scientific specialization that characterizes an individual Center and represents its unique contribution to the overall breadth and scope of the CFAR/CSG program. An applicant institution may already have an existing focus of research, such as Immune Reconstitution, X-ray Crystallography, Specific Animal Models, Models of Cell-Based Trafficking, Neurobehavioral Sequelae of HIV, or Behavior Change and Prevention, that can then form the focus for a Thematic Area encompassing AIDS or AIDS-related research. CFAR investigators whose AIDS or AIDS-related research is not included in the Thematic Area will be eligible to use Core Facilities, after approval by the standard internal review process developed by each CFAR, e.g., through the Internal Review Committee. o Development of minority scientists in the field of basic and clinical AIDS research through support of programs that result in the participation of minorities in high quality mainstream investigations in this area. The CFAR may: (1) fund minority investigators who are new to AIDS research as part of one or more CFAR developmental grants, and (2) facilitate development of collaborative AIDS research projects with minority investigators at other institutions which could include, but not be limited to, membership in the CFAR, training within a CFAR Core and utilization of a Core with facilities that would not otherwise be available to the minority investigators at their own institution; o The CFAR is encouraged to identify ways to use scientific knowledge gained in the laboratory and clinic to decrease the gaps in understanding AIDS among non-scientists. Support could be through Developmental funding of a project in this area. Activities in this area might include the development of a program similar to NIH's "Medicine for the Layman" at the parent institution, and outreach to community groups with information tailored to the unique needs of the particular population, supported through Developmental funds or through the Administration Core. o Finally, the CFAR is encouraged to support identification of solutions to problems regarding enrollment and maintenance of women and minority groups in AIDS clinical trials, an area that can be supported through Developmental funding or through the Clinical Core. Definitions AFFILIATED INSTITUTIONS - Affiliated Institutions are institutions that provide one or two Core Support Facilities for the CFAR. AIDS RESEARCH - AIDS research includes, but is not limited to, studies of HIV and related retroviruses; studies of the mechanism(s) by which HIV and related retroviruses infect host cells, establish productive infections and cause disease; host genetic resistance to HIV/AIDS; studies on in vivo and in vitro models of human HIV infection; epidemiologic studies on HIV and related retroviruses, including prevention and behavioral change research; preclinical studies targeted to development of therapy for HIV infection including drug design modeling; clinical trials involving therapy for HIV infection or its sequelae; clinical trials involving, or studies targeted to development of, vaccines, or other immunological or chemotherapeutic interventions to prevent HIV infection; studies concerned with diagnosis of HIV infection and AIDS; and viral detection and isolation methods. AIDS-RELATED RESEARCH - AIDS-related research refers primarily to research on opportunistic infections associated with AIDS, research on other sequelae of AIDS such as AIDS-related neoplasias and wasting syndrome. Research on opportunistic organisms must use a model system related to HIV infection and pathogenesis in humans and may include: (a) mechanisms of pathogenesis; (b) virulence factors; (c) immunoregulation, immunopathology, immunotherapy and immune prophylaxis; (d) therapeutic methods in general, (e) host resistance mechanisms; and (f) detection and assay. ALTERATIONS AND RENOVATIONS - Alteration and renovation (A&R) is defined as work required to change the interior arrangements or other physical characteristics of an existing facility or installed equipment. APPLICANT INSTITUTION - The Applicant Institution refers to the responsible university or institute applying for the CFAR/CSG award. CFAR OR CENTER - In this RFA, the terms CFAR and "Center" are interchangeable and refer to the organization of ongoing, innovative, critical, peer-reviewed AIDS and AIDS-related research through the use of Core Support Facilities. In a CFAR, these ongoing research projects and their scientific disciplines are united under a single scientific and administrative structure with a common goal: the synergistic cooperation and collaboration between AIDS investigators at the CFAR, and especially, between basic and clinical investigators involved in innovative research on AIDS and its sequelae. The definitive feature of a CFAR is the establishment of shared Core Support Facilities. Through a Developmental Core, the CFAR also supports the recruitment of new scientists into AIDS research, pilot projects, and critical evolving research requiring an unusually timely response. A CFAR may also identify a thematic area to facilitate collaboration and interaction, and may also support community outreach projects, the organization of lecture series in AIDS for scientists and non-scientists, and may place special attention to the participation of women and minorities at all levels of AIDS research and treatment through the Developmental Core. CFAR MEMBER - Individual approved by the CFAR Internal Advisory Committee to use Core Facility(s). CFAR SENIOR LEADERSHIP - CFAR senior leaders are those individuals who are involved in the overall direction of the CFAR, including the Center Director, Associate or Assistant Director(s), Core Directors and those Center Staff Investigators who are involved in the planning, implementation and evaluation of Center activities including the stimulation of scientific interactions, the recognition and pursuit of new research opportunities, the implementation of budgets and charge back systems in cores, the identification of new CFAR members, the initiation of seminars and training programs and the recruitment of faculty. CHARGE BACK SYSTEM - CFARs are encouraged to phase in a Charge Back System, a method of charging users of the Core Facility a fee commensurate with their usage of equipment, time, supplies (such as reagents) and personnel, if any, providing the service. The charge back costs would then be budgeted within the users' research grants, resulting in a gradual increase in funds from this source, and a decreased cost to the CFAR/CSG over the award period. These freed funds from the CFAR/CSG award, originally dedicated to establish the Core Support Facilities proposed in the initial application, could then be rebudgeted to the Developmental Core and/or be used to establish new Cores as the Center evolved. Applicants should be aware that program income may be generated. Institute staff will work with grantees on this issue. CORE SUPPORT FACILITY - A "Core Support Facility", or "Core", consists of a functional AIDS service unit, either clinical (including behavioral aspects) basic, developmental, or administrative, including personnel, a responsible Core Director, defined space, laboratory equipment, supplies, resources and services which is able to perform experimental procedures requiring a number of specialized techniques not available to already existing independent research projects. A primary function of the CFAR is to foster multidisciplinary approaches to collaborative research. Core Components of a CFAR must be shared by investigators participating in a variety of individual and collaborative projects. CORE DIRECTORS - Core Directors shall consist of individuals responsible for the overall technical excellence of a Core Facility including its state of readiness, its ability to perform Core activities in a timely and efficient manner, improvement or adoption of new techniques as they become available, maintenance of supplies and equipment (a function that may be delegated to appropriate personnel), supervision of personnel providing services, supervision of any training programs having to do with the core and provision of advice to an Internal Advisory Committee, if appropriate, about core membership. EVOLVING RESEARCH OPPORTUNITIES - Evolving Research Opportunities is a category within Developmental Funding that is designed to support critical, evolving areas in AIDS research which demand a rapid resolution. EXTERNAL ADVISORY COMMITTEE - An External Advisory Committee may include established investigators in the field of AIDS and AIDS-related research who are not members of the CFAR they advise, one of whom may be the Director of another CFAR. The committee should provide advice on the overall direction and progress of the CFAR, establishment of new Cores and whether the CFAR is maintaining its mission. This committee should meet at least once per year and its report should be part of the annual CFAR progress report submitted to the funding institute (NIAID or NIMH). FUNDED RESEARCH BASE - The Funded Research Base is comprised of the total amount of AIDS or AIDS-related funding received for peer-reviewed grants awarded by the NIAID, NIMH, or alternate funding agencies, including all other NIH Institutes, having review criteria and mechanisms equivalent to the NIH. See III - Eligibility Requirements. INTERNAL ADVISORY COMMITTEE - An Internal Advisory Committee of each CFAR may be comprised of the CFAR Director, Core Directors, and other investigators of the CFAR, as appropriate, who may review all applications for use of Core facilities, and may be the group having final decision upon recruitment and retention of investigators within a Core facility. Other functions of the Internal Advisory Committee may include advice concerning the necessity to establish additional Cores, and the approval of developmental grant awards. MINORITY INVESTIGATOR / MINORITY INDIVIDUAL - A minority investigator or minority individual is defined, for the purposes of this RFA, as a member of a recognized minority group that is either under-represented in biomedical research or is undeserved in terms of AIDS diagnosis and treatment. PARENT INSTITUTION - The Parent Institution is the research institution receiving a CFAR award. In exceptional cases, a CFAR award may include up to 2 core support facilities housed at a second, affiliated institution. It is the responsibility of the applicant institution to clearly demonstrate the need for a Core at a second institution. It is expected that CFAR/CSG funding will be primarily used to support investigators at the Parent Institution. PEER-REVIEWED FUNDED RESEARCH - Peer-reviewed funded research includes the following: awarded research grants, cooperative agreements and research contracts awarded by NIAID or NIMH including P01, R01, R03, R18, R21, R29, R35, R37, U01, U10, K, and F series awards, and contracts (N01). Peer-reviewed funding also includes the equivalent awards from other NIH institutes and awarded grants from the National Science Foundation as well as all other government and private institutes which meet the NIH standard for peer review. It is the responsibility of the applying institution to demonstrate that the latter funding sources, if projects with such support are submitted to fulfill the requirement for a minimum level of direct cost peer-reviewed research funding are equivalent to the NIH standard for peer review. THEMATIC AREA - A thematic area is a general area of scientific specialization that characterizes an individual Center and represents its unique contribution to the overall breadth and scope of the CFAR Program. If NIAID and NIMH each support a CFAR at an institution, the themes should be distinct and non-overlapping. SPECIAL REQUIREMENTS Reporting Procedure o Progress report As is required for all awards, Annual Progress Reports on the progress and achievements attributable to the CFAR must be submitted together with an expenditure report, using form PHS 2590. Charge back systems for the core facilities must also be clearly documented. A progress report should demonstrate the overall value of the CFAR to the field of AIDS research. This would normally include brief descriptions of the projects the CFAR/CSG has supported, the nature of the contribution of the CFAR/CSG to the project, and the overall significance of the research to which the CFAR/CSG contributed. CFAR Citation All publications including abstracts, journal articles, books, as well as internal publications reporting on research findings supported, at least in part, by CFAR/CSG funding must acknowledge this as follows: "This (project) was supported by the Center for AIDS Research/Core Support Grant (CFAR/CSG) number XX-XXXXXX from the NIAID (or NIMH)." The CFAR/CSG program should also be acknowledged in all presentations, as appropriate. Allowable Budget Items Items within the following categories of expenses may be allowed: o Shared Resources Supporting Clinical and Laboratory Research. The CFAR may include funds for clinical and/or laboratory facilities, equipment, and services that will be used by multiple staff for research supported by ongoing peer-reviewed grants and/or contracts. Specific examples of such resources include, but are not limited to, large shared equipment, biostatistics, animal facilities and services, cell culture, media preparation, glassware washing, biosafety equipment and services, photography and illustration services, secretarial pools, centralized word processing, clinical pharmacology and toxicology, immunology, virology, cell and molecular biology or immunoparameter testing services, special animal colonies, amino acid analysis, HPLC facilities, cell sorting, chemical and drug synthesis, NMR facilities, protein chemistry, radioisotope facilities, mass spectrometry labs, flow cytometry, electron microscopy, neuroimaging facilities, PCR facilities, neurobehavioral assessment. o Alterations and Renovations. Alteration and renovation of an existing structure to provide suitable facilities in which to conduct the programs of the AIDS Center may be funded by the CFAR/CSG within the limits set by PHS grants policy if there is adequate justification for such costs. Requests for alterations and renovations related to containment facilities must be consistent with and limited to the level of containment (i.e., BL2, BL2+, or BL3) that is actually required to conduct the research comprising the CFAR Funded Research Base, as described in accepted NIH guidelines for working safely with HIV. (See HHS publication No. (NIH) 88-8395, Biosafety in Microbiological and Medical Laboratories, J.H. Richardson and W.E. Barkley, eds., May 1988 (or current edition) which is available from the Government Printing Office, Washington, DC 20402 at a cost of $4.00 per copy. When ordering, refer to GPO stock number 017-40-508-3.) The policy of PHS permits up to 100 percent of the costs of alterations and renovations to be charged to a CFAR, if there is adequate justification for such renovation, in accordance with PHS policy. o Salaries. The requested percentage of an individual's salary may not exceed the percentage of effort devoted specifically to the Center. Information substantiating this level of effort must be included in the application. All requested personnel costs should be thoroughly justified in the CFAR/CSG application. o CFAR Director. This grant may provide partial salary of the Director of the CFAR. Requests for salary support are limited to 35 percent of the total salary. o Core Directors. Core Directors are CFAR members who are responsible for the maintenance of the Core facility with which they are charged. Partial salaries for Core Directors may be provided by this award. Requests for salary support are limited to 10 percent of the total salary. o Investigators Funded through Developmental Grants. CFAR investigators awarded a developmental grant may qualify for up to 50 percent full salary support by the CFAR Developmental award for a period of time not to exceed three years. Established investigators whose research is supported by R01-type funding, and who are awarded funding for small, pilot studies will not qualify for salary support by this mechanism. o Administrative, Secretarial, and Technical Support. A maximum of 1.5 FTE positions for a chief administrator and/or secretarial and/or administrative assistance for the CFAR office and Director (for matters pertaining to the CFAR) may be supported by the CFAR/CSG award. In addition, applicant institutions may also request salary support for technicians providing services to maintain a Core or to provide a service to investigators using the Core facility. o Other Administrative Costs This category includes the costs necessary for the central administration and fiscal management of the Center, including relevant and reasonable costs for reprints, graphics and publications, especially for developmental grantees. As per standard NIH policy, those costs may not duplicate or replace costs included in the parent institution's indirect cost base or already funded by another award. o Planning and Evaluation Limited costs for planning and evaluation of center activities are allowable, such as costs of an External Advisory Committee (see Special Instructions document, "Centers for AIDS Research/Core Support Grant (CFAR/CSG) - Special Instructions for Preparation of Competing Applications"), and ad hoc scientific and technical consultants. o Travel One meeting per year for all CFAR Directors and one senior scientist per Center will be held at the NIH (or at a site designated by NIAID and by NIMH) during which time improvements to Centers, problems, collaborations among Centers and significant findings will be discussed. Applicants should include travel funds specifically for this meeting when they prepare the CFAR administration core budget request. Applicants may request up to $5000 for travel beyond the funds required for the Annual Directors' Meeting for investigators funded under the Developmental Core, or other CFAR investigators. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires that applicants for NIH clinical research grants and cooperative agreements 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 must 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 MUST be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in items 1-4 of the Research Plan AND summarized in item 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 U.S. racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, and 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 disease, 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, clinical samples which may be coded for use by the applicant but could be identified by another source are not excluded. Every effort should be made and documented 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. 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 questions 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. NOTE: Peer review groups need adequate information about the composition of proposed study populations in all applications involving human subjects. To avoid delays in review of such applications, the NIAID advises that, as a minimum, the application should contain demographic data about the clinic and/or in-patient population from which study subjects will be drawn: average hospital admissions per year; percentage distribution of Black/Hispanic/other minority/non-minority populations; gender; etc. Studies using non-hospital populations, such as community-based studies, should provide similar data about populations in the area or region from which the study subjects will be drawn. In the absence of current data, historical demographic information and/or previous recruitment data for similar studies from the proposed study sites should be provided. LETTER OF INTENT Prospective applicants are requested to submit, by July 16, 1993, a letter of intent that includes a descriptive title of the proposed research, the names of key members of the proposed CFAR and their institutions, a descriptive title of each Core Components. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID and NIMH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. Applicants are encouraged to request the supporting document for the CFAR/Core Support Grant RFA "CENTERS FOR AIDS RESEARCH/CORE SUPPORT GRANT (CFAR/CSG) GUIDELINES - Special Instructions for Preparation of Competing Applications" for all information required for preparation of the CFAR/CSG application from DAIDS program staff listed under INQUIRIES. The RFA label available in the application form must be affixed to the bottom of the face page. 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. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and "YES" must be checked. Applicants must submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to Dr. Dianne Tingley at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Those judged to be incomplete will be returned to the applicant without further consideration. Those considered to be non-responsive by program staff will be returned without review. All applications received in response to this RFA will be assigned to the appropriate institute based on the referral guidelines and may be reviewed by separate scientific review groups formed by the NIAID and NIMH. Those applications that are complete and responsive may be subjected to a triage by a NIAID and/or NIMH peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID and NIMH will withdraw from competition those applications judged to be non-competitive for award and will notify the applicant and institutional business officials. Those applications judged to be competitive will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID and/or NIMH. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council or the National Advisory Mental Health Council. Specific review criteria for the CFAR/CSG, as recommended by the May 1992 ad hoc Review Committee for the CFAR/CSG program include, in order of importance: 1. The scientific excellence of the Center's AIDS and AIDS-related, peer-reviewed Funded Research Base (its strengths, its breadth and depth). This includes the following: o The presence of a critical mass of AIDS-related research. The applying institution must have a level of funding not less than $800,000 (direct costs) which includes a minimum of six individual awards. This Funded Research Base must be from NIAID funded research if the CFAR/CSG award is made by NIAID and must be 60 percent NIMH funded research if the CFAR/CSG is made by NIMH. 2. Interdisciplinary coordination and collaboration. The applicant institution should provide at least four specific examples from existing individual basic and clinical research projects demonstrating how the CFAR will fulfill its mandate to promote interdisciplinary coordination and collaboration to maximize productivity, including how the CFAR will effectively: o Promote the timely development of basic discoveries into applications in the clinical setting; o Promote the translation of observations in the clinical environment back into the research laboratory; o Encourage the use of Cores by scientists representing several disciplines or approaches to AIDS or AIDS-related research. 3. The commitment of the parent institution to the objectives and goals of the CFAR. The CFAR should be recognized as a formal organizational component within the parent institution. This includes: o A demonstration of its institutional commitment to the success of the Center by providing resources for the CFAR including appropriate space and personnel. o A willingness to adapt the provided resources to adequately address the changing needs of the CFAR; 4. The qualifications, experience, and commitment of the CFAR Director and Core Directors. This includes: o The CFAR Director should currently be a Principal Investigator of one or more peer-reviewed, AIDS or AIDS-related research projects in the CFAR Funded Research Base. He/she should have administrative experience roughly equivalent to a department head. It is strongly suggested that the director devote at least 35 percent of his or her time to the leadership responsibilities of the CFAR. o Core Directors should have sufficient knowledge and experience to direct Core activities. 5. The appropriateness and relevance of the proposed Cores and their modes of operation (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. This includes: o The mechanism the CFAR will utilize to ensure fair and appropriate selection of Core users; o Documentation of the use, utility, quality control and cost effectiveness of each Core requested to continue as part of the Center (for competing continuation applications). o Progress will be judged in part on the list of publications arising from the research supported by the Cores. At least two users are required to establish a Core. However, a greater number of users generally can be evaluated as more cost effective. o The willingness of the CFAR to augment a Charge Back System for each Core by the end of year 01 of the award. Additional information will be provided to the awardees with the Notice of Grant Award. 6. The appropriateness and effectiveness of the academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions will be reviewed. 7. The organizational capabilities of the proposed CFAR. o Appropriate advisory groups should be proposed such as an External Advisory Committee to provide appropriate advice regarding evaluation of current and future directions, which may include requirements for new Cores and an Internal Advisory Committee, which should have authority to develop priority setting processes regarding CFAR membership and recruitment, scientific directions, the use of Cores, the development of new Cores and appropriate mechanisms for reviewing the use of and administering of funds for the Developmental programs. 8. The developmental and educational commitment of the proposed CFAR. The commitment of the CFAR to the development of investigators new to AIDS and AIDS-related research, and the funding of pilot projects will be evaluated. o The mechanism by which the CFAR will select awardees for Developmental funding after the award is granted, such as through an Internal Review Committee, will be evaluated for fairness and ability to identify the candidates with most chance of this award leading to independent funding through R01 equivalent awards. The CFAR is encouraged to use a mechanism which is similar to the requirements candidates will be required to use when applying for independent funding after termination of the Developmental award. o The progress of awardees who have received Developmental funding will be reviewed in competing renewal applications: whether the investigator has received peer-reviewed funding following the termination of the Developmental Award, if the research has led to publications or answers to critical issues and if the investigator has remained in AIDS or AIDS-related research. 9. Appropriate and effective mechanisms of fiscal administration, procurement, property and personnel management, planning, budgeting, internal evaluation and other appropriate capabilities will be evaluated. In addition, procedures for recruitment of new individuals responsible for conducting essential CFAR functions and maintenance of CFAR members will be reviewed. The four optional activities of CFARs, if included as components of the application, will be evaluated. These elements of the CFAR/CSG application are desirable and strongly encouraged but are not required for the award. o The appropriateness of the choice of a Thematic Area will be evaluated in terms of its ability to identify the primary focus of the CFAR and effectiveness in promoting interdisciplinary cooperation and collaboration, and its contribution to the CFAR/CSG program as a whole. o The proposed mechanism for support of minority investigators will be evaluated. o The prevention and educational commitment of the CFAR, including seminars for scientists within and outside of the CFAR and educational programs for non-scientists will be evaluated. o The commitment of the CFAR to the identification of solutions to problems in recruitment and retention of women and minorities in AIDS clinical trials will also be evaluated. The following six milestones will be used to evaluate each CFAR near the end of year three of the award to permit funding to be continued for years four and five: o Interdisciplinary coordination and collaboration, especially between clinical and basic research investigators. The CFAR should demonstrate active and significant scientific cooperation and collaboration, especially between clinical (including behavioral) and basic investigators. Collaborative projects which involve clinical and basic research should begin to demonstrate translation of research findings between the clinic and the laboratory. o Synergistic scientific collaboration. The CFAR should provide four specific examples from ongoing research that demonstrates how the CFAR has fulfilled its mandate to promote synergistic interdisciplinary coordination and collaboration to maximize productivity. The Center should demonstrate that the CFAR promotes more effective and efficient research than can be achieved with a group of R01-equivalent grants which do not have the benefit of CFAR/CSG support. The CFAR should also demonstrate the equitable usage of each Core Support Facility among CFAR members. o Organizational capabilities. The CFAR should have established the required mechanism, such as an Internal Advisory Committee, to provide appropriate advice regarding general maintenance of the Center, such as prioritization of Core usage, CFAR membership, and regular exchange of scientific and administrative information. More global concerns, such as research directions which should also be supported by the CFAR/CSG and establishment new Core Support Facilities, should also be effectively addressed by the appropriate mechanism, such as an External Advisory Committee. o Institutional commitment. The parent institution should be able to have demonstrated its commitment to the CFAR by providing required resources such as appropriate space and personnel. In addition, as required, the parent institution should demonstrate active interest in modification of the above elements should the evolving needs of the CFAR require additional resources or services not initially required at the beginning of the award. o Developmental and educational commitment. By the end of year three, the CFAR should be able to demonstrate significant results from the award of developmental funds to Investigators New to AIDS Research or Pilot Projects, and several Centers may be able to describe scientific achievements obtained through the Evolving Research Opportunity funding. This might be through results leading to applications for independent, peer-reviewed funding, or publications. Educational programs consisting of workshops or seminars for AIDS investigators within and outside of the CFAR should be established. Educational programs for the layman and community should also be in place as well as community outreach programs. o Effective use of the Charge Back System. The CFAR should have established Charge Back Systems for each Core Support Facility by the end of year one of the CFAR/CSG and at the end of year three these should be functioning efficiently. CFAR funds that are no longer being used to support Cores established at the beginning of the award could then be available for Developmental funding or may be applied toward the development of new Core Support Facilities. AWARD CRITERIA The NIAID anticipates making 9 to 11 P30 awards as a result of this RFA, while NIMH anticipates making two awards. The final number and specific amounts of awards to be made will depend upon consideration of the following: initial scientific and technical merit review as judged by peer review; significance and relevance to NIAID or NIMH program goals in microbiology, infectious diseases, immunologic diseases, behavior change and prevention, psychological aspects of HIV infection and AIDS; national needs and program balance; evidence and degree of collaboration in proposed work; and policy and budgetary considerations, including availability of funds. INQUIRIES It is essential that prospective applicants carefully review the RFA and accompanying instructions on preparation of the application. Prior to preparing an application, prospective applicants are strongly encouraged to contact NIAID or NIMH staff. Direct inquiries regarding programmatic issues and RFA requirements to: Dr. Robert H. Bassin or Dr. Janet M. Young Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2B31 Bethesda, MD 20892 Telephone: (301) 402-0755 FAX: (301) 480-5703 Dr. Leonard Mitnick or Dr. Willo Pequegnat Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 15-99 Rockville, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Inquiries regarding fiscal matters may be addressed to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Ms. Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Inquiries regarding review matters, the letter of intent, and two copies of the application are to be addressed to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 Schedule Letter of Intent Receipt Date: July 23, 1993 Application Receipt Date: September 17, 1993 Scientific Review: December 1993 Review by NAAIDC and NMHAC: February 1994 Anticipated Award Date: March 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.856 - Microbiology and Infectious Diseases Research, 93.855 - Immunology, Allergic and Transplantation Research, and 93.242 - Mental Health Research Grants. Grants are awarded under the authority 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 the PHS grants policies and Federal Regulations, most specifically in 42 CFR 52 and 45 CFR Part 74. Under authority of Section 301 of the Public Health Service Act, as amended PL 78-410, 42 U.S.C. 241, the National Institute of Mental Health provides support for Clinical Research Centers. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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