SILVIO O CONTE FEASIBILITY CENTERS FOR NEUROSCIENCE RESEARCH Release Date: April 17, 1998 PA NUMBER: PAR-98-056 P.T. National Institute of Mental Health Letter of Intent Receipt Date: July 1 Application Receipt Date: October 20 PURPOSE The National Institute of Mental Health (NIMH) invites research grant applications for Silvio O. Conte Feasibility Centers for Neuroscience Research (CFCNR). The primary goal of this initiative is to support early stage development of interdisciplinary teams of eminent investigators to study basic or basic and clinical neuroscience issues related to the mission of the NIMH, and in doing so, to prove the feasibility of working as a cohesive, interacting research team. Demonstrating such feasibility is particularly important since it is expected that key members (the Director of the center and the heads of projects) of each team will be at the forefront of their respective research areas, and it is, therefore, unlikely that all such members will be located at the same institution. A CFCNR will conduct novel, interdisciplinary, integrative, and hypothesis driven research on a highly focused and well defined neuroscience question which is relevant to the mission of NIMH. It is expected that such research will use experimental design and technologies that are at, or exceed, those considered to be the state-of-the-art. Interdisciplinary research is paramount to better understand the structure and function of the brain in health and mental illness. Nevertheless, interdisciplinary research is often difficult to execute. This initiative is intended to facilitate the formation of new teams of outstanding investigators for this purpose. Demonstrating the feasibility of such teams to work together to address important research problems would position these teams well to apply for support for either an NIMH Conte Center for Neuroscience Research grant (which support interdisciplinary basic neuroscience research) or an NIMH Conte Center for the Neuroscience of Mental Disorders grant (which support interdisciplinary translational research integrating basic and clinical approaches). These center programs are described in PAR-98-057 and PAR-98-058, respectively. 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, Silvio O. Conte Feasibility Centers for Neuroscience Research, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Foreign institutions are not eligible for exploratory center (P20) grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as CFCNR Directors and heads of projects. MECHANISM OF SUPPORT A CFCNR will be supported by the Exploratory Center Grant mechanism (P20), which provides support for multidisciplinary and multi-investigator approaches to the investigation of a highly focused research problem of a complex nature that requires the application of diverse expertise and methodologies. Applicants for CFCNRs may request support for only one period of up to 3 years; direct costs requested may not exceed $400,000 for the first year, with only modest growth allowed for future years. Grantees demonstrating success in carrying out interdisciplinary research will be well situated to apply for either a Conte Center for Neuroscience Research grant or for a Conte Center for the Neuroscience of Mental Disorders grant. RESEARCH OBJECTIVES Background Neuroscience is built upon a wide range of disciplines, levels of analysis, approaches and technologies, and has produced a tremendous amount of highly detailed and diverse data. While the increasingly detailed level of understanding presents great scientific opportunities, it also presents challenges for individual investigators to address complex and important issues, such as the neural basis of mental health and disease. Such complex issues require interdisciplinary, multidisciplinary and integrative research approaches. These approaches can be obtained through highly interactive teams of investigators pursuing common research questions from a variety of disciplinary and technological perspectives. The Conte Feasibility Centers for Neuroscience Research provide support at the early stage of development of interactive, interdisciplinary research teams. Teams that demonstrate feasibility in performing integrative interdisciplinary research would be well situated to apply for the more comprehensive NIMH Conte Center for Neuroscience Research grant (which support interdisciplinary basic neuroscience research) or the NIMH Conte Center for the Neuroscience of Mental Disorders grant (which support interdisciplinary translational research integrating basic and clinical approaches). The CFCNRs will support either basic neuroscience research or combined basic and clinical neuroscience research. Objectives and Scope The primary purpose of a CFCNR is to support early stage development of interdisciplinary teams of eminent investigators to study basic or basic and clinical neuroscience issues related to the mission of the NIMH, and in doing so, to prove the feasibility of working as a cohesive, interacting research team. A CFCNR is characterized as follows: o The CFCNR should address one specific, well focused research hypothesis related to brain function or dysfunction, and in this process, establish the feasibility of the research team to work together. The research question may be posed in any area(s) of neuroscience related to the mission of the NIMH, and may be basic neuroscience research or combined basic and clinical neuroscience research. o It is expected that a Center will be organized specifically to address innovative, creative, and potentially high risk/high impact research questions. Centers must rigorously test proposed hypotheses and generate new ones. o A CFCNR should clearly demonstrate a high interdependence of projects and investigators, and solid evidence of integration across projects. If a CFCNR addresses basic and clinical research issues, integration and translation across these components is essential. o A CFCNR should be based upon a highly integrated multidisciplinary approach to solve the research problem. The best laboratories and investigators using the most advanced technologies should be enlisted toward this end. o The Center mechanism may not be used as a substitute for individual grant support. It is, therefore, expected that investigators participating in Centers will have independent NIH support. A Center should be viewed as a unique scientific opportunity to investigate leading edge research questions not currently being addressed. o The CFCNR Director should have a demonstrated capability to organize, administer and direct the Center. This individual should be the scientific leader of the Center, and thus must also head at least one of the constituent projects, with a minimum total time commitment of 20 percent to the Center. o Investigators heading projects in a CFCNR must be prominent scientists in basic or clinical neuroscience research. Investigators with the qualifications to contribute to a unique enterprise such as a CFCNR may be located in different geographic locations. Therefore, collaborations among different institutions are encouraged, if scientifically appropriate. o A CFCNR should provide opportunities for young investigators who have the potential for independent research careers to become skilled in the experimental strategies, approaches, and techniques of modern neuroscience research. In addition, there should be close coordination between the Center and relevant predoctoral and/or postdoctoral research training programs of the participating institutions. Special attention should also be given to the recruitment and training of minority students. o Each CFCNR should provide outreach that makes the public aware of the importance and implications of the CFCNR research for addressing basic biomedical issues and their relationship to mental illness and mental health. Research Topics The following are examples of broad research areas within the NIMH research mission that might serve as a focus for a CFCNR. This list is not exhaustive, nor are the examples meant to be mutually exclusive. o Studies that use quantitative, molecular biological and genetic approaches to investigate the development of neuronal populations related to specific behavioral functions, such as the developmental etiology of schizophrenia hypothesis, or to investigate the genetic heterogeneity of and susceptibility to mental illness in patient populations o Identification of genes that influence the development and function of receptors, channels, and their transduction mechanisms in synaptic functioning as a means for better understanding CNS drug actions and for developing new and more specific drugs o Studies combining molecular, cellular, circuit, and behavioral approaches to elucidate functional organization of systems underlying emotion, cognition, attention, perception, and language. Activities Supported To provide a suitable structure for achieving the objectives of this announcement, a Center may request funds, in addition to support for the research projects, as follows: o Institutional Environment and Resources: Funds may be requested for research resources such as equipment needed to conduct the proposed research, supplies needed to accomplish the proposed research, incidental alteration or renovation of facilities consistent with Public Health Service policy, etc. Strongly encouraged is the sharing of resources across multiple projects of the center. Funds provided through Center grants may not be used for support of trainee stipends, fees, or other expenses directly relating to training activities. o Essential Scientific Expertise: To provide the most effective combination of scientific skills, applicants may request funds to recruit scientists to augment or strengthen the skills, expertise, and capabilities of existing staff. Although recruitment may take place after the award has been made, the expertise required, the role in Center activities, and the time to be devoted to the Center should be provided in the application. It should be emphasized, however, that after the award such individuals may not be recruited to serve as a substitute for a Project P.I. 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, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE 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: http://www.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by July 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 the program announcement in response to which the application may be submitted. 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 Dr. Michael Huerta, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on October 20. 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; fax: (301) 480-0525 Email: [email protected]. The title and number of the program announcement must be typed in Section 2 on the face page of the application. A major requirement for each CFCNR is the conduct of multidisciplinary, integrative research on a highly focused research question. The application must describe the hypotheses to be tested, and the goals and approaches for the CFCNR. In addition, the proposal should clearly articulate the reasons a Center approach is needed for the proposed work as well as the unique benefits that will accrue from a Center. It should be emphasized that this Center mechanism is not meant to be a substitute for individual grant (R01) support. Therefore, the reasons that constituent projects require CCNR support should be fully justified. o General Description of the Center (Not to exceed 7 pages): Provide an overview of the entire proposed Center describing the central theme and goals. Describe how the overall Center can achieve its major objectives. Explain the proposed contribution of each of the projects in achieving the objectives of the Center. Furthermore, the administrative arrangements and support necessary to effect the research should be carefully described in the application. Shared resources should be described. When multiple institutional sites are involved, a detailed description and supporting documentation for the cooperative administrative arrangements should be included. In addition, provide detailed information on collaborations, recruitment, facilities and resources. o Preliminary Findings (Not to exceed 3 pages) Present preliminary results and evidence of competence in the areas of research proposed. o Individual Projects (Not to exceed 8 pages for any one project): Describe the major objectives and goals of each project, its relationship with the other projects, and its relationship to the overall Center. Particular emphasis should be placed on how the various research components will be integrated. In addition, detailed descriptions should be provided on the following: o Research Plan: The question to be addressed and the hypotheses to be tested by the proposed research should be highly focused and fully explained. Full discussion is required on the status of current research efforts (both within the Center and elsewhere) addressing the issue, the limitations of existing approaches, and why the particular research question lends itself to a multidisciplinary, integrative approach. In addition, the relationship between the basic and clinical science aspects of the research should be made explicit. o Experimental Plan: The application will not require extensive details for individual experiments. The description of the experimental design should outline the strategies proposed to accomplish the specific aims of the project, and should include a discussion of the innovative aspects of the approach. However, the experimental procedures need not be spelled out in great detail if those procedures have already been extensively published and universally accepted by the scientific community. Nevertheless, any new methodology and its advantage over existing methodologies should be fully described. Furthermore, the feasibility of the proposed experiments, the potential pitfalls, relevant alternative approaches should changes become necessary, and their relevance to the goals of the Center should be fully discussed. The methods to be used should be cited and referenced. It should be emphasized that this necessitates the inclusion of investigators that are considered to be leaders in their field and whose experiments are widely published and accepted by the scientific community. o Operational Plan: A description of the resources and working arrangements required to implement the research plan should be fully elaborated. If appropriate, particular attention should be devoted to a description of the clinical populations, tissue resources, etc., which will be involved as part of the Center's clinical component. A distinction must be made between those resources which are already in place (including staff) and those resources which must be added to carry out the proposed research. Also included in this section is the manner in which an external advisory board will advise the Center. Nevertheless, prospective board members should not be chosen or contacted prior to a funding decision, and, therefore, will not be named. o Research Career Development and Outreach Plans: A description of the manner in which Center activities will provide opportunities for young investigators and how the CCNMD relates to existing training programs of participating institutions should be given. Also, plans for disseminating information to the public regarding the activities of the CFCNR should be given. The completed original application and four legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/express service) At the time of submission, one additional copy of the application must be sent to: Henry J. Haigler, Ph.D. Division of Extramural Activities National Institute of Mental Health 5600 Fishers Lane, Room 9C-18 Rockville, MD 20857 REVIEW CONSIDERATIONS Applications submitted in response to this program announcement will be reviewed by the NIMH program staff to determine if they satisfy the objectives and requirements of a CFCNR as outlined in this program announcement (excluding scientific or technical merit). Applications that do not meet these objectives and requirements will not be accepted and will be returned to the applicant. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the 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 may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. Review Criteria Criteria for scientific/technical review of Research Center applications will include the following: o Intrinsic merit of the intellectual focus and research: The overall quality, scientific merit, and innovativeness of the research to be done; the likelihood that the work will lead to fundamental advances within the field, to new discoveries, and/or to new technological developments. In addition, the research conducted must center around a highly focused and well defined question. o Appropriateness of the Center approach and feasibility demonstration: The need for the Center approach; whether a Center approach will add significantly to what could be done through other modes of research support. In this respect, the integration of the projects is of utmost importance and should be explicitly described. Also, the extent to which the proposed research will indicate the feasibility of the team to work as a cohesive, interacting research group. o Integration across projects: The adequacy of the proposed Center to integrate across research projects including basic and clinical approaches (for applications that propose basic and clinical research) so that activities in each project inform and advance the others. o Research competence: The capability and scientific credentials of the Center Director and constituent project directors and participating scientists, who are expected to be regarded by their peers as leaders in, and at the forefront of, their respective fields. o Center Director credentials: Ability of the Center Director to organize, administer, and direct the Center and, in addition, be the head at least one of the proposed projects, be it basic or clinical in nature. A Center Director will devote a minimum of 25 percent of his/her time to the Center. The Director must be the scientific leader of the Center. o Institutional commitment: The nature and level of resource commitments from the home institution and from other participant institutions. Plans for interactions with the rest of the participating institutions. o Appropriateness of management plans and arrangements: The feasibility and adequacy of the organizational and administrative plans; the appropriateness of the budget; and the mechanisms to evaluate the Center's progress. o Quality and appropriateness of the outreach and research career development components of the Center's activities: The adequacy of approaches used to disseminate information regarding the Center's activities as they relate to public understanding of science and mental health and illness. The likely effectiveness of approaches to attract and involve young investigators and students who show potential for significant future contributions and independent research careers in the work of the Center. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address: o Adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. The initial review group will make an overall recommendation for approval (and assign a priority score) or disapproval of the entire Center application. Under some circumstances, it may be appropriate for the initial review group to recommend disapproval of one or more project(s). AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIMH. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. Schedule To ensure a uniform review quality, all applications will be reviewed by a single review group, which will meet once per year. In accordance with this objective, there will be one receipt date each year. Applications received after this date will be returned to the applicant without review. Letter of Intent Receipt Date: July 1 Application Receipt Date: October 20 Administrative Review: November Scientific Review: February/March Advisory Council Review: May Earliest Starting Date: July INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and letters of intent to: Michael F. Huerta, Ph.D. Division of Basic and Clinical Neuroscience Research National Institute of Mental Health Parklawn Building, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: [email protected] Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: [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 Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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