EXPIRED
THE HUMAN BRAIN PROJECT (NEUROINFORMATICS): PHASE I - FEASIBILITY; PHASE II - REFINEMENTS, MAINTENANCE AND INTEGRATION RELEASE DATE: December 3, 2002 PA NUMBER: PAR-03-035 (This PAR, requesting applications for the HBP, will not be reissued after it expires, see NOT-MH-05-014) (see addendum NOT-EB-03-002) EXPIRATION DATE: September 23, 2005 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib1.nih.gov/) National Institute on Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Library of Medicine (NLM) (http://www.nlm.nih.gov/) National Aeronautics and Space Administration (NASA) (http://www.nasa.gov/) National Science Foundation (NSF) (http://www.nsf.gov/) U.S. Department of Energy (DOE) (http://www.energy.gov/) Letter of Intent Receipt Dates: One month prior to receipt date Application Receipt Dates: January 21 May 21 September 22, 2003 January 21 May 21 September 22, 2004 January 21 May 20 September 22, 2005 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces PAR-99-138. The purpose of this initiative is to encourage and support investigator- initiated research on neuroscience informatics (neuroinformatics). This research will lead to the development of new web based databases, analytical tools, and knowledge management systems to foster sharing of data for all domains of neuroscience research. This program combines neuroscience and informatics (neuroinformatics) research to develop and apply advanced tools and approaches essential for efficient understanding of the structure, function and development in health and disorders of the nervous system, from the genetic to whole systems level. Research in informatics includes databases, graphical interfaces, querying approaches, information retrieval, data visualization and manipulation, and data integration through the development of integrated analytical tools, synthesis, and tools for electronic collaboration. In order for these advanced information technologies to be put to wide use by the neuroscience community, they should be generalizable, scalable, extensible, and interoperable, and be developed in concert with significant neuroscience research. RESEARCH OBJECTIVES Background In 1991, the Institute of Medicine recommended the concept of mapping the brain and brain functions and establishing databases for sharing data and information management in neuroscience (Mapping the Brain and Its Functions: Integrating Enabling Technologies into Neuroscience Research, 1991, Institute of Medicine, National Academy Press). The Human Brain Project (HBP) was initiated to achieve the goals of this report. Reflective of the ongoing Human Brain Project is the more recent report in 1999, issued by the Organization for Economic Cooperation and Development-Megascience Forum, identifying the vital national/international need for databases in the field of Neuroscience as one of the great challenges of science for the 21st century. The Human Brain Project is a broadly based federal research initiative that is sponsored by sixteen federal organizations from four federal agencies and coordinated by the NIMH through the activities of the Federal Interagency Coordinating Committee of the Human Brain Project (FICC-HBP). It is expected that the neuroscience and informatics research components will be effective scientific collaborations, rather than parallel efforts. Projects that focus only upon archival data are not appropriate for the Human Brain Project, while inclusion of legacy data is encouraged. Objectives and Goals Phase I consists of research feasibility studies on advanced technologies and novel ways to acquire, store, retrieve, manage, analyze, visualize, manipulate, integrate, synthesize, disseminate and share data about neuroscience research, including tools for electronic collaboration. Phase II consists of refinement of Phase I activities, building on accomplishments in Phase I and will include, but not limited to: expanded beta testing, with appropriate documentation and testing at multiple sites; improvements and refinement of the web based capabilities; development of appropriate models and simulation capabilities; development of neuroscience grids where necessary and appropriate; and, integration with other related websites through the creation of federations. Phase II applications should plan to ensure that neuroscience databases and analytical tools will be interoperable with other resources, incorporate the capacity for linkage with legacy data, and present a plan for continued updating and maintenance. Applications for Phase II are not required to have had Phase I support. However, they must clearly demonstrate that equivalent neuroscience and informatics research has been accomplished on databases, software or hardware, which now require Phase II activities and support. The goal of the Human Brain Project is to develop novel and innovative web based capabilities to store, analyze, share, collaborate, integrate, resolve, model, visualize, and interpret the complex experimental data from basic and clinical nervous system research. These research capabilities will facilitate understanding the nervous system by providing easy access to data and tools. These novel approaches include: o Databases, querying approaches, data acquisition, and information retrieval: The diversity of data types in neuroscience research will require unique collection tools, databases and graphical interfaces that can accommodate varied data types (e.g., numerical, textual, graphic, image, time series). o Data visualization, graphical interfaces and manipulation tools: Neuroscience research produces complex interrelated structural and functional data across the lifespan. The structural data may be quantified through visual methods and manipulations. On this basis, novel approaches are needed to manipulate, visualize, and analyze complex structural and functional data sets. o Technologies for data synthesis and integration and electronic collaboration. The creation of an advanced capability is needed for: shared virtual reality space through the use of novel forms of "groupware" with tools for data acquisition, display, interoperability, querying and manipulation; consolidation and federation of related databases and tools; use of the data and computational grid by developing appropriate middleware for community use; and creating bridging capabilities to access other field specific databases and tools, such as those associated with the Human Genome Project and the Macromolecular Structure Database, etc. Driven by considerable demands made by the diversity, quantity, and complexity of nervous system data, neuroinformatics research will enable neuroscience research to efficiently expand its knowledge. Moreover, it is likely that solutions devised through neuroinformatics research may be generalizable to a wide range of scientific fields with broad applications. These new discoveries will lay the foundation for potential new breakthroughs in biomedical research. The creation of shared neuroscience knowledge management systems, via development of new web-based databases and tools should allow enhanced horizontal and vertical integration of complex multi- and interdisciplinary data on the nervous system. Evolving from these discoveries is the potential to assemble an array of new clinical procedures, computer enhanced learning systems, and prosthetic devices that will markedly improve the diagnosis, prevention, and treatment of disorders of the nervous system. MECHANISMS OF SUPPORT This PA will use the NIH Research Project Grant (R01), Exploratory Center Grant (P20), and Program Project Grant (P01) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. R01 applications submitted under this PA use just-in-time concepts (http://odoerdb2.od.nih.gov/gmac/topics/jit_main.html). R01s also follow the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an R01 application with direct costs in each year of $250,000 or less, use the modular format. Otherwise, follow the instructions for non-modular research grant applications. R01 Mechanism The research project grant (R01) mechanism will allow investigators to work on highly focused projects related to the integration of informatics research with brain, behavioral, and/or computational research. Applications may include requests for support of expenses for travel and per diem expenses to several laboratories to initiate or explore the possibility of setting up collaboration. It is essential that the scientific questions to be pursued and the unique contribution of each potential group member be explicitly stated. P01 and P20 Mechanisms These awards provide the opportunity for several investigators using different approaches to focus on a common problem. The grants will facilitate coordinated research across disciplinary and geographic boundaries. These mechanisms are intended specifically to support interdisciplinary research and feasibility studies. Not all federal organizations will provide primary support for P01 and P20 grants. Therefore, prior to preparing an application for this mechanism, prospective applicants should contact program staff (http://www.nimh.nih.gov/neuroinformatics/agencycontacts.cfm). The Program Project (P01) is for the support of a broadly based, multidisciplinary, often long-term research program that has a specific major objective or a basic theme. A program project generally involves the organized efforts of relatively large groups, members of which are conducting research projects designed to elucidate the various aspects or components of this objective. Each research project is usually under the leadership of an established investigator. The grant can provide support for certain basic resources used by the investigators. Each project supported through this mechanism should contribute or be directly related to the common theme of the total research effort. A Program Project is required to have a minimum of three projects. These scientifically meritorious projects should demonstrate an essential element of unity and interdependence, i.e., a system of research activities and projects directed toward a well-defined research program goal. The Exploratory Grant mechanism (P20) is used to support feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of the Human Brain Project. These exploratory studies may lead to specialized or comprehensive centers. These applications are characterized by the synergy of their constituent projects (three or more). Each grant application must demonstrate the interrelationship of its constituent projects, and also indicate how the inclusion of each project will enhance the overall goals of the research. Each grant must have a combination of informatics research and basic and/or clinical neuroscience research components, with each component well integrated with one another. The Principal Investigator must have the demonstrated ability to organize, administer, and direct the grant, and must commit at least 25 percent effort to the grant and be a Project Leader on one of the research projects. Group members: Each Program Project (P01) and Exploratory Center (P20) grant will be composed of several laboratories, projects, and/or cores. It is expected that the Project Leaders of the constituent laboratories or projects will be regarded as leaders in their respective fields. Appropriate communication will be established among different laboratories, projects and cores within a given feasibility grant. With evidence of adequate electronic communication channels, individuals need not all be at the same geographic location. For information on NINDS P01 guidelines: http://www.ninds.nih.gov/funding/ppg_guidelines.htm#guidelines. NINDS will not accept applications that do not conform to the specific NINDS guidelines for a given mechanism. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign. Foreign institutions are not eligible for P01 or P20 grants. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Neuroinformatics research is expected to lead to advanced information technologies and approaches for the neuroscience community. The Human Brain Project supports investigator-initiated projects that require a neuroscience research component well integrated with an informatics research component. This initiative will provide support for either or both of these components, provided that any component for which funding is not requested is already funded under another peer-reviewed, federal research program. Each application should have substantial involvement of neuroscience and informatics researchers as principal investigators, other key personnel, or as very active consultants. In order to meet the long-term nature and breadth of this initiative, research projects with the following characteristics are sought. Generalizable: For example, algorithms for quantifying differences in three- dimensional (3-D) reconstruction of data obtained from electron microscopy should generalize to volume data from confocal microscopy and MRI of whole brains. Research performed on sophisticated platforms: This initiative is a long-term program to support research and development of advanced information technologies for the neuroscience community. Computers that are considered to be sophisticated by current standards are likely to be widely available in five or ten years. Today's low-end machines are likely to be obsolete by the time that the tools currently being developed are available to the scientific community-at-large. Extensible, scalable and interoperable: Phase I research efforts will lead to tools and approaches intended for the scientific community-at-large, rather than for an individual laboratory. In order to achieve this goal, it is important that issues of scalability and extensibility be addressed from the outset. Phase II will need to also focus on extensibility and scalability and, in addition, consider the importance of interoperability with other tools, databases and workstations. User-friendly databases and tools should be designed using classical proven approaches shown to have utility in widely used applications. Appropriate documentation also will be needed for all newly developed products. In addition, software should be created to allow for the direct collection of experimental data, and the transfer and use of the designed database analytical tool or model. Designed to assess progress: Since research and development programs are ultimately intended to be used by a wide range of laboratories, it is important that methods to assess progress towards achieving the objective of this neuroinformatics initiative be carefully addressed by an evaluation plan, in both Phase I and Phase II. This includes the development and documentation of standards by which tools are to be tested for reliability and accuracy. Permanence and Maintenance (Not required in Phase I): The lifetime value and use of hardware or software is a function of its broad utilization by the community. For this to occur, a plan must be presented in Phase II for the continued support of these capabilities. This plan can be developed using a variety of options available to the investigator; however, the plan must be viable and self-sustaining, and not be totally dependent upon support derived from federal funding. Each project will report the attainment of proposed specific aims through progress reports and the timely publication and dissemination of results, including aspects such as software, database designs, and source codes. It is strongly encouraged that researchers funded under the Human Brain Project communicate, coordinate and collaborate with each other. Supplemental funds may be competitively awarded to projects to support such interactions. A listing of investigators participating in Phase I and Phase II is located at the Human Brain Project website (http://www.nimh.nih.gov/neuroinformatics/index.cfm), and the types of data, software, and other information available from them will be shared among all grantees to minimize unnecessary duplication of effort. Grantees are expected to participate in (1) the Annual Spring Human Brain Project Meeting of Agencies and Grantees at NIH, as well as (2) an Annual Principal Investigators Meeting to be rotated among the funded sites. These meetings will promote communication among different groups of investigators. (See section on Post Award Management.) NIH is interested in ensuring that the research resources developed through this Program Announcement become readily available to the research community for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public. At the same time, NIH recognizes the rights of grantees to elect and retain title to subject inventions developed under federal funding under the provision of the Bayh-Dole Act. For inventions developed in its intramural program, NIH does file patent applications, in accord with a set of policies described at http://www.nih.gov/od/ott/200po6.htm. Grantees are encouraged to perfect copyright protection of software produced as a result of Human Brain Project funding http://grants.nih.gov/grants/policy/nihgps_2001/nihgps_2001.pdf. These should include prominent notification in the software and its documentation that the software is copyrighted. Notification could consist of the following: Copyright c [year] by [your name, the names of you and your colleagues, or the name of your institution] with funding from the Human Brain Project. This notification will identify the source of the software and help ensure that the software can be shared freely while protecting any commercial rights in it. In addition, grantees will be required to agree that they will provide the primary funding organization, upon its request and at a reasonable cost, a copy of any software produced under this Human Brain Project funding, with the understanding that the federal organizations directly involved with this Project will have the right to use such software for internal research and archival purposes only, and will not permit its distribution beyond those organizations. Application components related to ethical, legal, and social issues pertinent to this initiative are encouraged. Also encouraged are components of applications that are designed to reach out to the public, academic, and/or commercial sectors to help educate and inform about the available opportunities provided by research and development in the neuroinformatics field. Availability of Computational Resources The choice of computational resources to be used in Human Brain Project research is entirely that of the applicant and the range of appropriate resources extends across the entire spectrum of computer technology. Nevertheless, some investigators may be interested in using, or collaborating with those using supercomputers, massively parallel computers, and other advanced technologies that may not be available at their institution. To facilitate such use and collaboration, the following information is provided: The NSF supports High Performance Computer Centers and Science and Technology Centers. Individuals considering applications for supercomputer use should contact these centers early in the application development process. Cornell Theory Center, Linda Callahan, 514 Engineering and Theory Center Building, Ithaca, NY 14853-3801, Telephone (607) 254-8610, Email [email protected] National Center for Atmospheric Research, Scientific Computing Division Visitor/User Information, P.O. Box 3000, Boulder, CO 80307, Telephone (303) 497- 1225, Email [email protected] National Center for Supercomputing Applications, Melissa Johnson, 605 East Springfield Avenue, Champaign, IL 61820-5518, Telephone (217) 244-0645, Email [email protected] Pittsburgh Supercomputing Center, Robert B. Stock, 4400 Fifth Avenue, Pittsburgh, PA 15213, Telephone (412) 268-4960, Email [email protected] San Diego Supercomputer Center, Nancy Wilkins-Diehr, P.O. Box 85608, San Diego, CA 92186-9784, Telephone (619) 534-5130, Email [email protected] In addition, NASA will make available computational resources of the Bio- Visualization, Imaging and Simulation (BioVIS) Technology Center at Ames Research Center, Moffett Field, California. These resources include computer-controlled transmission and scanning electron and light microscopy for semiautomatic 3-D reconstruction of neural tissue, distributed simulation environments, physical-based modeling, neural-based learning and navigational simulations, high-performance workstations, supercomputers, and massively parallel computers. A scientist interested in using the BioVIS as part of their Human Brain Project must submit a written request for facility use to the BioVIS Director prior to submitting an application to the Public Health Service. This request must state the objectives of the intended work and the approaches to be used. This request must also provide enough information to allow BC staff to assess whether or not the intended use is within the capability of the BioVIS. In addition, this request must provide information necessary to allow BioVIS staff to determine the amount of time the proposed work will require. For online information on BioVIS please go to http://biovis.arc.nasa.gov/. The BioVIS staff will provide the requesting scientist an itemized estimate of the costs for BC resources needed to achieve the stated objectives. The scientist will use this estimate as part of the budget justification in the Public Health Service application for funds to support the Human Brain Project research. Requests for BioVIS use are to be sent to: Dr. Richard Boyle, Director BioVIS Technology Center, MS 23911, Ames Research Center, Moffett Field, CA 94035-1000. WHERE TO SEND INQUIRIES NIH encourages your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: general programmatic and scientific/research, peer review, and financial or grants management issues. Representatives from each of the participating agencies, institutes and center can be contacted for further information or clarification. o General programmatic inquiries regarding the Human Brain Project should be directed to: Stephen H. Koslow, Ph.D. Chair, FICC-HBP Office on Neuroinformatics National Institute of Mental Health 6001 Executive Boulevard, Room 6167, MSC 9613 Bethesda, MD 20892-9613 Telephone: (301) 443-1815 FAX: (301) 443-1867 Email: [email protected] A current list of Agency Contacts may be found at: http://www.nimh.nih.gov/neuroinformatics/agencycontacts.cfm o Questions regarding scientific issues, management issues, or issues on cores related to participating ICs may be directed to these individuals: National Institute of Mental Health Michael D. Hirsch, Ph.D. Deputy Director, Office on Neuroinformatics 6001 Executive Boulevard, Room 6167, MSC 9613 Bethesda, MD 20892-9613 Telephone: (301) 443-1815 FAX: (301) 443-1867 Email: [email protected] National Cancer Institute Guoying Liu, Ph.D. Diagnostic Imaging Program/DCTD 6130 Executive Boulevard, Room 6062, MSC 7412 Bethesda, MD 20892-7412 Telephone: (301) 594-5220 FAX: (301) 480-3507 Email: [email protected] National Heart, Lung, and Blood Institute Carl E. Hunt, M.D. Director, National Center on Sleep Disorders Research 6701 Rockledge Drive, Suite 10038, MSC 7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: [email protected] National Institute on Aging Molly V. Wagster, Ph.D. Neuroscience and Neuropsychology of Aging Program 7201 Wisconsin Avenue, Suite 3C307, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: [email protected] National Institute on Alcohol Abuse and Alcoholism Antonio Noronha, Ph.D. Chief, Neuroscience & Behavioral Research Branch Division of Basic Research 6001 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-7722 FAX: (301) 594-0673 Email: [email protected] National Institute of Biomedical Imaging and Biomedical Engineering John W. Haller, Ph.D. Program Director 6707 Democracy Boulevard, Suite 200 Bethesda, MD 20892-2077 Telephone: (301) 451-4780 FAX: (301) 480-4973 Email: [email protected] National Institute of Child Health and Human Development Lisa Freund, Ph.D. Director, Research Programs in Developmental Psychobiology and Neuroscience Human Learning and Behavior Branch Center for Research for Mothers and Children 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6879 FAX: (301) 480-7773 Email: [email protected] National Institute on Drug Abuse Thomas Aigner, Ph.D. Division of Basic Research 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-6975 FAX: (301) 594-6043 Email: [email protected] National Institute on Deafness and Other Communication Disorders Barry Davis, Ph.D. Director, Taste and Smell Program 6120 Executive Boulevard, Room 400C, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: [email protected] National Institute on Dental and Craniofacial Research Eleni Kousvelari, DDS, D.Sc. Chief, Cellular and Molecular Biology, Physiology and Biotechnology Branch Division of Basic and Translational Sciences 45 Center Drive, Room 4AN-18A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: [email protected] National Institute of Neurological Disorders and Stroke Yuan Liu, Ph.D. Program Director, Channels, Synapses, and Circuits Computational Neuroscience and Neuroinformatics 6001 Executive Boulevard, Room 2110, MSC 9523 Bethesda, MD 20892-9523 Telephone: (301) 496-1917 FAX: (301) 480-2424 Email: [email protected] National Library of Medicine Carol Bean, Ph.D. Program Officer, Division of Extramural Programs 6705 Rockledge Drive, Suite 301, MSC 7968 Bethesda, MD 20892-7968 Bethesda, MD 20817 (for courier/express service) Telephone: (301) 594-4882 FAX: (301) 402-2952 Email: [email protected] National Aeronautics and Space Administration Marc Shepanek, Ph.D. 300 E Street, S.W. Washington, DC 20546 Telephone: (202) 358-2201 FAX: (202) 358-4168 Email: [email protected] National Science Foundation Soo-Siang Lim, Ph.D. or Diane Witt, Ph.D. Behavioral Neuroscience and Neuroendocrinology Program Division of Integrative Biology and Neuroscience 4201 Wilson Boulevard, Room 685S Arlington, VA 22230 Telephone: (703) 292-8423 FAX: (703) 292-9153 Email: [email protected] Email: [email protected] U.S. Department of Energy Dean Cole, Ph.D. Office of Biological and Environmental Research Medical Science Division SC-73/Germantown Building 1000 Independence Avenue, SW Washington, DC 20585-1290 Telephone: (301) 903-3268 FAX: (301) 903-0567 Email: [email protected] o Direct your questions about peer review issues to: Peter M. Lyster, Ph.D. Scientific Review Administrator Center for Scientific Review 6701 Rockledge Drive, Rm. 5218, MSC 7850 Bethesda, MD 20892-7850 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 435-1256 FAX: (301) 480-2241 Email: [email protected] o Direct your questions about financial or grants management matters to: National Institute of Mental Health Joy R. Knipple Grants Management Branch 6001 Executive Boulevard, Room 6131, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: [email protected] National Cancer Institute Grants Management Branch 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800 FAX: (301) 496-8601 National Heart, Lung, and Blood Institute Raymond L. Zimmerman Grants Operations Branch 6701 Rockledge Drive, Room 7174, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: [email protected] National Institute on Aging Linda Whipp Grants and Contracts Management Office 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: [email protected] National Institute on Alcohol Abuse and Alcoholism Judy Fox Grants Management Branch 6000 Executive Boulevard, Suite 504, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4704 FAX: (301) 443-3891 Email: [email protected] National Institute of Biomedical Imaging and Biomedical Engineering Lisa Moeller Grants Management Specialist 6707 Democracy Boulevard, Room 983, MSC 5469 Bethesda, MD 20892-5469 Telephone: (301) 451-4793 FAX: (301) 480-4974 Email: [email protected] National Institute of Child Health and Human Development Douglas E. Shawver Grants Management Branch 6100 Executive Boulevard, Room 8A17F, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6999 FAX: (301) 402-0915 Email: [email protected] National Institute on Drug Abuse Gary Fleming, J.D., M.A. Chief, Grants Management Officer Grants Management Branch 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: [email protected] National Institute on Deafness and Other Communication Disorders Sara Stone Grants Management Branch 6120 Executive Boulevard, Room 400-B, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: [email protected] National Institute of Dental and Craniofacial Research Bonnie Smith Division of Extramural Research 45 Center Drive, Room 4AN-44 MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: [email protected] National Institute of Neurological Disorders and Stroke Chris Zimmerman Grants Management Branch 6001 Executive Boulevard, Room 3290, MSC 9523 Bethesda, MD 20892-9523 Telephone: (301)496-3107 FAX: (301) 402-0219 Email: [email protected] National Library of Medicine Dwight Mowery Grants Management Branch 6705 Rockledge Drive, Suite 301, MSC 7968 Bethesda, MD 20892-7968 Telephone: (301) 496-4221 FAX: (301) 402-2952 Email: [email protected] LETTER OF INTENT It is recommended that applicants contact the appropriate program official(s) listed under INQUIRIES and submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this PA 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 IC staff to estimate the potential review workload and plan the review. Each letter of intent will be distributed to all of the sponsoring agencies, institutes and center. The letter of intent is to be submitted to Dr. Stephen H. Koslow at the address listed above, by the receipt dates listed in the heading of this PA. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email [email protected]. The NIH encourages applicants to access application instructions and forms, via the Internet. Certain forms are available electronically on the NIH Home Page (http://grants.nih.gov/grants/forms.htm). Instructions for downloading documents and electronic forms can be accessed at http://grants.nih.gov/grants/edocs.htm APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on the application receipt dates listed in the heading of this PA. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: R01 Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. See additional comments below on travel support for the R01 mechanism (under SPECIFIC INSTRUCTIONS FOR THE HBP). SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the Institute/Center (IC) program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SPECIFIC INSTRUCTIONS: Each application must clearly articulate the manner in which the informatics research components relate to, and are integrated with the neuroscience research component(s). Each application must describe specific mechanisms proposed to evaluate the success of the research in terms of feasibility. R01 Mechanism: For the R01 mechanism, applicants must follow the instructions provided in the grant application form PHS 398 (rev. 5/2001). Funds to support travel to the two-day Annual Spring Human Brain Project Meeting of Agencies and Grantees should be included in the budget for the principal investigator and up to one additional key member of the research team. Funds should also be budgeted for the principal investigator to participate in the Annual Principal Investigators Meeting. P01 and P20 Mechanism: The application must describe the specific research hypotheses to be tested and how they relate to the overall research issue to be addressed. In applications for the P20 mechanism, funds to support travel to the two-day Annual Spring Human Brain Project Meeting of Agencies and Grantees should be included in the budget for the principal investigator (the director of the grant), the director of each subproject and core, and up to one additional key member from the P01 or P20 research team. Funds should also be budgeted for the principal investigator to participate in the Annual Principal Investigators Meeting. For the P01 and P20 applications only, the Research Plan Section of PHS Form 398 (Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods) should be replaced by the following: General Description of the Overall Project (Not to exceed 10 pages): The applicant must provide an overview of the proposed project and its central theme and goals, describe the general objectives, and explain the proposed contribution of each of the individual projects and cores towards achieving these objectives. Furthermore, the administrative arrangements and support necessary to effect the research should be carefully described in this section. In particular, when more than one institutional site is involved, a detailed description and supporting documentation for the administrative arrangements must be included. Detailed information on collaborations, recruitment, facilities, and resources must also be provided. Individual Projects (Not to exceed 15 pages for any one project): The applicant must describe the major objectives and goals of each individual project and its relationship to the effort of the entire group of constituent projects. Where appropriate, an Information Model should be presented to describe, define and conceptualize the problem domain. In addition, detailed descriptions should be provided on the following: Research Plan: The questions 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, the limitations of existing approaches, and how the research questions posed relate to the objectives of the Human Brain Project. In addition, the integrative relationship between the brain and/or behavioral research component and the informatics research component components should be made explicit, as should the novelty of the informatics research component. Experimental Plan: The description of the experimental design should provide the specific strategies proposed to accomplish the specific aims of the project in clear detail and should include a discussion of the innovative aspects of the approach. New methodology and its advantage over existing methodologies should be fully described. The feasibility of the proposed experiments, the potential pitfalls, alternative approaches, means of assessing success of research to meet the objectives of the Phase I or Phase II of the project, and relevance to the goals of the project as a whole should be fully discussed. The methods to be used should be cited and referenced. Cores (not to exceed 5 pages for any one core): If cores are required, the applicant must describe how each core will contribute to the goals of the overall project as well as how each individual project will draw upon a particular core. The description of each core should clearly indicate the facilities, resources, services and professional skills that the facility will provide. Moreover, clearly described information must be provided about how the collective operation of the cores will be effected in a coherent manner. Operational Plan: A description of the resources (local and collaborative) and working and logistical arrangements required to implement the research plan should be fully elaborated. If a project includes a clinical component, attention should be devoted to a description of the clinical populations and tissue resources. A distinction must be made between those resources that are already in place (including staff) versus those resources that must be added to carry out the proposed research. Permanence and Maintenance Plan: The lifetime value and use of hardware or software is a function of its broad utilization by the community. For this to occur, a plan must be presented in Phase II for the continued support of these capabilities. This plan can be developed from a variety of options; however, the plan must be viable and self-sustaining, and not be dependent upon support derived from federal funding in its entirety. SENDING AN APPLICATION TO THE NIH: 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. In addition, Phase I or Phase II should be indicated. 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) Schedule Letter of Intent Receipt Date: Dec 21 Apr 21 Aug 22 Application Receipt Date: Jan 21 May 21 Sep 22 Scientific Review: Jun/Jul Oct/Nov Feb/Mar Advisory Council Review: Sep/Oct Jan/Feb May/Jun Earliest Starting Date: Dec Apr Jul APPLICATION PROCESSING: Applications must be received by the application receipt dates listed in the heading of this PA. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications will be assigned on the basis of established PHS referral guidelines. A special scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: The research project (R01) grant funding mechanism will be used under this program announcement to allow investigators to work on highly focused projects related to the integration of informatics research with neuroscience and/or behavioral research. In contrast, the program project research grant (P01) and the exploratory center (P20) grant funding mechanism will provide the opportunity for several investigators using different approachesto focus on a common problem, and to facilitate coordinated communication acrossdisciplinary and geographic boundaries. Therefore, the initial review group needs to adequately consider differences in the respective application requirements and their major section components when applying these 5 review criteria. HBP Phase I applications are to support feasibility research on advanced technologies and novel approaches to create and render data about the brain and behavior more generalizable, scalable, extensible, and interoperable. Hence, the peer review of these applications requires a full assessment of the feasibility of these applications to accomplish their specific major stated objectives. For Human Brain Project Phase II applications, both those submitted as new applications and those representing previously funded competitive renewal (type 2) grants under the HBP program, a detailed "Progress Report" should be provided in support of the proposed project. This report, which will be considered as an important part of the initial review, should include detail about the major accomplishments to date, and currently described plans for further improvement, documentation, and multi-site testing of advanced technologies and tools for shared distribution across the wider community of neuroscientists and neuroinformaticians. Concerning the latter, relevant information should be included about the validation, expanded beta testing, and further refinement of newly developed tools; the development of appropriate models and simulation capabilities; the interoperability of information sharing; and a careful evaluation of these products for general distribution among the neuroscience and neuroinformatics research communities. The operational, maintenance and evaluation plans should be realistic and deal with relevant issues. These issues should be considered both in terms of their being state-of -the-art, yet also with perspective toward future developments. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities POST-AWARD MANAGEMENT The FICC-HBP committee maintains a Human Brain Project/Neuroinformatics web site in order to provide the public and scientists with the most recent activities of this program (http://www.nimh.nih.gov/neuroinformatics/index.cfm). Each funded grant application will be listed and briefly described (provided by the principal investigator), and links provided to connect interested parties directly to the HBP grantees' web site. The grantees' web page to which the link connects should indicate the program support from the Human Brain Project, the individual supporting Agencies/Institutes and the Logo. The individual web sites of grantees are expected to contain complete and accurate information on the activities of their funded Human Brain Project, and to be maintained by the principal investigator to ensure that it contains the most current information on the project, as well as the availability of new resources or capabilities created via this mechanism. The Human Brain Project web site also contains a listing of all publications, software, hardware, and patents that have resulted from this funding. The principal investigator shall provide, at a minimum, to the coordinating Human Brain Project Office an updated listing of these results, electronically in cold fusion, at least two times per year. This list should contain appropriate hot links to allow individuals to find either the source document and/or additional directly relevant information. Grantees are expected to participate in the Annual Spring Human Brain Project Meeting of Agencies and Grantees and the Annual Principal Investigators Meeting. These meetings will promote communications among different groups of HBP investigators, who are involved in research, curricula development, and career development and/or other cross-training activities in neuroinformatics. All publications and meeting abstracts and products resulting from HBP funding should give appropriate citation to the Human Brain Project and the funding Institutes and Agencies. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS: Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIHhas provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.279 (NIDA), 47.074 (NSF), 93.866 (NIA), 93.865 (NICHD), 93.173 (NIDCD), 93.879 (NLM), 81.049 (DOE), 93.273 (NIAAA), 93.838 (NHLBI), 93.121 (NIDCR), 93.395 (NCI), 93.287 (NIBIB), 93.853 (NINDS), 43.002 (NASA) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or 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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