EXPIRED
RESEARCH CORE CENTERS (P30) FOR ADVANCED NEUROINFORMATICS RESEARCH RELEASE DATE: December 4, 2002 PA NUMBER: PAR-03-037 (This PAR, requesting applications for the HBP, will not be reissued after it expires, see NOT-MH-05-014) EXPIRATION DATE: September 23, 2005 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.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 Letter of Intent o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of this program announcement (PA) is to support shared coordinated resources to facilitate collaborative, interdisciplinary and multidisciplinary efforts in neuroscience informatics (neuroinformatics). This research effort through data sharing will create new capabilities in neuroinformatics and facilitate the solution of complex systems research. Neuroinformatics combines neuroscience and informatics (information technology/computer sciences) research to develop databases and neuroscience knowledge management systems, and advanced tools and approaches essential for efficient data sharing and data integration. This PA will provide funding for two or more research projects to facilitate and build the necessary database capabilities for sharing and analyzing data or federating existing databases. It is expected that these collaborative efforts may be linked horizontally, vertically, or both and will enable the understanding and integration of data within in and across systems. This program is designed for groups of current peer-review funded investigators working on interrelated complex system problems in neuroscience. Applications for this PA must introduce new collaborative and interactive activities that will further the shared research goals and significantly enhance what could not be accomplished via individual investigator grant support alone. In addition, a new informatics capability must be the unifying feature that will be derived, with appropriate computer science expertise, and aimed at facilitating the concept of advancing the field of neuroscience research through data sharing. It is required that the participating investigators have externally funded, peer-reviewed neuroscience research grants appropriate for collaboration. Direct support of new individual neuroscience research projects is not appropriate under this PA. A high level of resources may be requested to allow participating investigators to extend their research efforts and to form a consortium to approach a research problem of overarching importance in a comprehensive and highly integrated fashion. RESEARCH OBJECTIVES Background The greatest increment in knowledge about the brain has occurred within the last two decades due to intensive, rapid technological advances in molecular and cellular neurobiology, molecular genetics, brain imaging, and other new technologies brought about through the computer information technology revolution. The progressive amount of information being generated is exponentially incremental. The basic and clinical neuroscience field has entered into a new era in which collaborative multi- and interdisciplinary research is essential to understand the structure, function, development, and plasticity of brain systems. There is an increased need, on a national and global basis, for collaborative, integrative approaches, through shared resources and facilities across research groups at diverse sites, to allow more rapid progress to be made in understanding the nervous system. The Human Brain Project (HBP) is a broadly based Federal research initiative, which is sponsored by sixteen Federal organizations from four Federal agencies and coordinated by the National Institute of Mental Health. The Human Brain Project seeks to promote the creation of novel shared neuroscience databases and knowledge management systems to integrate vast, complex information about the nervous system. For a detailed description on the research objectives of the FICC-HBP sponsored Human Brain Project/Neuroinformatics Initiative, and a listing of investigators supported under this program, refer to this program's homepage (http://www.nimh.nih.gov/neuroinformatics/index.cfm), and PAR-03-035, The Human Brain Project (Neuroinformatics): Phase I & II (http://grants.nih.gov/grants/guide/pa-files/PAR-03-035.html). Program Description This Research Core Center PA (P30) is an institutional award, made in the name of a principal investigator, to support centralized resources and facilities shared by two or more investigators with existing funded research projects. Its goal is to encourage integrative, collaborative, interdisciplinary research approaches to more effectively and efficiently solve significant questions in basic and clinical neuroscience, that cross institutional and disciplinary boundaries. These coordinated approaches can be directed horizontally, vertically, or both. The aim is to assemble teams of peer-reviewed, federally- funded, basic and clinical neuroscience investigators from diverse institutions, by providing additional excellent shared computer sciences research resources and facilities (e.g., for hardware and software development, and/or computer facilities, data processing and analysis) for their coordinated, collaborative activities. The additional funds must support activities that are likely to significantly enhance existing informatics capabilities and introduce new collaborative approaches to the neuroscience research aims to stimulate the development of new research directions, while eliminating unnecessary duplication of effort. Core Centers are encouraged to enter into cooperative arrangements with established cores in other centers or resource grants offering a similar type of service at the applicant's institution. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Research Core Center (P30) grant mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. However, the institution must demonstrate a commitment to the purposes of this PA in the specified area. The P30 mechanism will be used to support centralized informatics resources and facilities shared by investigators with existing peer-reviewed, Federally funded research projects. Allowable Costs Direct costs will be provided to support collaborative, shared informatics resources and facilities for the development of new databases and federations of databases to facilitate effective, efficient data integration. Administrative Activities: Partial or limited salary support for secretarial and administrative staff may be requested in the summary budget to the extent that it relates directly to the management of Core Grant activities, see the NIH Guide notice http://grants.nih.gov/grants/guide/notice-files/not94-276.html. Costs for all secretarial and administrative activities, including support for the Principal Investigator, ordinarily may not exceed 15% of the total direct costs of a Core Grant award in any year. Core Directors and Other Key Personnel: Salary support may not be requested. An exception will be made for the support of Information Scientists on the Informatics core. Salary support for up to 75% effort of such an individual may be requested, whether or not this individual is the director of a core. Technical Support Personnel: Salary support is allowed for personnel who bridge or add to the intellectual and technological approaches of the individual consortium components. A technician cannot be a core director. Consultant costs: To coordinate the shared use of informatics/computer equipment and resources across different core sites. Equipment: Requests for shared Informatics/computer sciences equipment are allowed. This grant mechanism is not intended for the acquisition of equipment that should be funded through other sources or through other funding mechanisms. No equipment item over $3,000 may be requested without prior discussion with FICC-HBP program staff. Supplies: Consumable supplies directly related to the operation of the Informatics cores are allowed. Travel expenses for collaborative activities are allowed. In addition, grantees are expected to participate in (1) the two-day Annual Spring Human Brain Project Meeting of Agencies and Grantees in the metropolitan Washington, D.C. area; as well as (2) the annual meeting of Principal Investigators to be rotated among the funded sites. These meetings will promote communication among different groups of investigators (see section on Post Award Management). Funds to support travel to both of these annual meetings should be included in the budget for the principal investigator and other relevant collaborator(s) as part of the research costs. Other Expenses: o Specialized training of personnel in interdisciplinary neuroinformatics research concepts and approaches. o Access to resources, such as those for software development, data analysis, bioinformatics and computational services, electronic communication media to facilitate participation of off-site laboratories and collaborative capabilities o Facilities and space for the shared use of Informatics/computer equipment. For specific policy, refer to the NIH Grants Policy Statement (Rev. 03/01) (http://grants.nih.gov/grants/policy/nihgps_2001/). o Informatics/computer equipment maintenance, maintenance contracts, computer time, and lease of computer lines. o Alterations and Renovation: Requests are allowable, but must be thoroughly justified. Cost sharing by the Institution is strongly encouraged and these arrangements should be described in the application. Funds for new construction or major alterations will not be provided. o Human subjects reimbursement and animal care per diem charges (boarding) are not allowed. 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 Foreign institutions are not eligible to apply. 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. To qualify for this mechanism, two or more peer-reviewed, Federally funded investigators need to demonstrate how their collaboration through informatics and data sharing will create both a new informatics capability for neuroscience and will add a new dimension to the ongoing investigations. On the date of this grant application submission, each collaborating unit on the Core Center grant must hold a minimum of two research project grants, with a minimum of three years of support remaining in the original project period. Research projects associated with a Core Center include individual research project grants (R01) or similar peer- reviewed project funding from other Federal agencies. A current program project/center grant (P01 or P50) subproject may count toward the minimum of two if that subproject will be an "extensive" user of the proposed central core of this application. Training grants (F32/T32), career development awards (e.g., K08/K23), small grants (R03), and exploratory/development awards (R21) do not count as part of the requisite research base, but PIs of such awards can be users of the Core Center. Cores: Core Supervision: An independent investigator, who has the expertise to supervise its use, should direct each core. Other arrangements may be proposed, but must be well justified. Research cores should be designed to furnish a group of investigators with an Informatics focus to allow them to share data in a manner that will enhance the research progress. In addition, this new informatics capability should be useful to the neuroscience community-at-large, and made available in a full and timely manner. The requested resources and facilities must facilitate the collaboration and integration of the component projects, and support a synthesis of information that would not take place if each component core project were given its own independent resource facility by itself. Each research core must have extensive usage by all collaborating investigators with funded peer-reviewed projects. A Core Center must be an identifiable organizational unit either within a single grantee institution or representing a consortium of cooperating institutions (e.g., geographic or web-based). It is strongly encouraged that researchers funded under the Human Brain Project collaborate. Supplemental funds may be competitively awarded to projects to support such interactions beyond that already funded under this award. A listing of investigators participating in the Human Brain Project Program is located at http://www.nimh.nih.gov/neuroinformatics/index.cfm. Also listed at this website are the types of data, software, and other information available from these investigators, to be broadly shared among all grantees to minimize scientifically unnecessary duplication of effort in all Phases. Grantees are expected to participate in (1) the Annual Spring Human Brain Project Meeting at NIH; as well as (2) an annual meeting of Principal Investigators to be rotated among the funded sites. These meetings will promote communication among different groups of investigators. See section on Post Award Management. Non-competitive Continuations: These reports must include information that demonstrates how the core(s) enhanced the capability of investigators and the institution for conducting research. Examples of projects or representative publications, which benefited from use of the core, should be cited. If applicable, describe collaborative studies, attraction of investigators to neuroinformatics research, and any other research-related activities made possible or facilitated by the core. Competing Continuation (renewal) Applications: In addition to the information reported in the non-competitive renewals, the applicant should include a general progress report that highlights achievements under the Core Center since the last competitive review. Include the following information: a brief summary of major accomplishments that can be attributed to the Core Center program and a brief explanation of how these accomplishments have contributed to the achievement of the stated objectives of the grant; a list of changes (if any) in professional staffing since the last competitive review; and a list of all publications, including those in press, that have resulted from the Core Center grant. (Do not include manuscripts in preparation or under review.) NIH is interested in ensuring that the unique research capability developed through this mechanism from the HBP 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. Indeed, 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 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: 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: koz@helix.nih.gov A current list of Agency Contacts may be found at: http://www.nimh.nih.gov/neuroinformatics/agencycontacts.cfm o Questions regarding scientific/research issues 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: mhirsch@helix.nih.gov 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: anoronha@willco.niaaa.nih.gov 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: taigner@nida.nih.gov 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: mshepane@hq.nasa.gov 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: slim@nsf.gov Email: dwitt@nsf.gov 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: dean.cole@science.doe.gov 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: lysterp@mail.nih.gov 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: jk173r@mail.nih.gov 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: jsimons@willco.niaaa.nih.gov 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: gf6s@nih.gov 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: GrantsInfo@nih.gov. 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 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 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. APPLICATION RECEIPT DATES: Applications submitted in response to this PA will be accepted at the application receipt dates listed in the heading of this PA. SPECIFIC INSTRUCTIONS: To identify the application as a response to this PA, check "Yes" on item 2, and the title and number of the PA must be typed on line 2 of the face page of the application form. Follow the PHS 398 instructions for "Preparing Your Application," inclusive of format specifications, page limitations, and content requirements. Note that, in accordance with the standard PHS 398 SPECIFIC INSTRUCTIONS, sections "a-d" of the Research Plan are limited to 25 pages total. In response to this PA, include the following information where indicated in these instructions: Personnel: The Core Center Director will have responsibility for overall direction of the entire Core Center (P30). Additionally, a director should be named for each research core. A research core director must be an expert with an independently funded research program that will use the core services. Detailed Budget for Initial Period of Support: A detailed overall budget for the Center Core Grant should be provided, as well as separate budgets for each of the cores, including core-related research. Direct costs may be requested that are essential for the support of the Cores, and must be fully documented and justified; salary support for administrative costs should be kept at a minimum. Budget for Entire Period of Support: Summary budget pages for the initial and entire budget periods for the Center Core Grant should be provided, presenting the aggregate budget for all administrative and core activities. Provide budget justifications here (e.g., for administrative activities) only for requests not contained in the separate core budgets that will immediately follow. Biographical Sketches: In addition, this section should include letters of commitment from each of the participating investigators that indicate their interest in joining the collaborative project. Do not exceed the two-page limitation for any individual. Other Support and Research Base Summary: Other support should be listed for all individuals listed in the Key Personnel section, with the exception of consultants. These pages should not be duplicated in the individual component projects and cores. Assurance Documentation: In addition to the assurance pages, a master table listing the status of human subject and the animal usage approval dates should be included. Letters signed by the authorized business official of each of the participating investigators' institutions committing support to the Core Center Grant project. Resources: As part of this section, be sure to address in sufficient detail the issue of accessibility of the most important informatics and computer science equipment items to collaborative investigators. Research Plan This section is presented on continuation pages in narrative fashion. Follow the PHS 398 instructions for format specifications, required page limitations, and content requirements. Within the 25 page limit per core, also provide the following information (for amended applications, an additional 3 pages per core may be used to respond to the reviews): Explicit New Neuroinformatics Capability Being Developed: o Briefly articulate the ongoing research and the new collaborative efforts with goals, objectives, and specific aims, etc. o Provide an overview of how the Core Center would be used to enhance the new neuroinformatics capability of the participating collaborators. o Interactions and interrelationships among Center members, quality and productivity of the research programs, demonstrated or potential interdisciplinary collaboration, and how establishment of a Core Center provides additional dimensions to the current research activities. Collaborating Investigators: The research base of the collaborating Core Center investigators needs to be documented. A table listing the grants, funding source and duration, the current year budget (direct cost), and their principal investigators is required. Administrative Management Plan: Include an administrative management plan that outlines the policies and procedures for access of participating and non- participating investigators to use the collaborative Core Center project resources. The application should address the flow of information within the project, and plans for how the information will be integrated into the solution of the biological problem being addressed. The mechanism to add new participating investigators and delete members whose association with the project has not been productive should be documented in the proposal. The plan should also include proposed methods for information dissemination both within the collaborative project and to the scientific community. Core Management Plan: Provide a core management plan, including an ongoing evaluation plan, to ensure consistent forward progress of the neuroinformatics core. The Core Center should define annual milestones in a tentative sequence or timetable. It is expected that the milestones will be adjusted as required on an annual basis, both to incorporate a team's scientific accomplishments and progress in the field in general, as well as to reflect the recommendations of the external advisory committee. Steering/Advisory Committees: As a function of complexity and size, the principal investigator should consider the advisability of establishing steering and/or advisory committees. A steering committee comprised of collaborating investigators and the individual core directors could be assembled on a regular (i.e., quarterly-annually) basis, to manage the Administrative Management Plan. An external advisory committee, comprised of leading experts in Neuroscience and Informatics research, could be assembled on an annual basis to meet with the steering committee to provide independent evaluation, feedback, and advice on ongoing merit, progress, and requisite modification for both the Administrative Management Plan(s) and the Core Management Plan(s). 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. 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 Administrative Review: Feb Jun Oct Scientific Review: Mar/Apr Aug/Sep Nov/Dec Advisory Council Review: Sep/Oct Jan/Feb May/Jun Earliest Starting Date: Dec Mar 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 submitted for this PA 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 An overall priority score will be assigned to the application. This score will reflect the quality of the individual cores, the leadership and administration plans, the enhancement of the research base by the core center, including the likelihood for meaningful collaboration among Core Center investigators, and overall ability of the Core Center, to provide a significant advantage beyond what could practically or efficiently be supported on individual research grants. Competitive Renewal Applications: In a competing continuation application, 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. In addition, the competitive renewal application should document the impact the Core Center has had on the field of neuroinformatics research. This includes the qualifications, experience, and commitment of the Core Center investigators and their proven ability to interact with each other and attract additional investigators to the mission areas of the Human Brain Project. It is anticipated that publications, new collaborations, and other explicit examples will arise and should be documented. 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 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 hotlinks provided to connect interested parties directly to the HBP grantees' web site. The grantees' web page to which the hotlink 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 Meetings of Agencies and Grantees and the annual Principal Investigator 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 etc., 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. NIH has 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 No. 93.242 (NIMH), 93.279 (NIDA), 47.074 (NSF), 81.049 (DOE), and 93.273 (NIAAA), 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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