EXPIRED
INNOVATIVE EXPLORATORY STUDIES AND TECHNOLOGY DEVELOPMENT IN NEUROINFORMATICS RESEARCH (R21) RELEASE DATE: December 4, 2002 PA NUMBER: PAR-03-036 (This PAR, requesting applications for the HBP, will not be reissued after it expires, see NOT-MH-05-014) (see addendum NOT-NS-03-023) (Updated contact info for NLM, see NOT-LM-05-002) EXPIRATION DATE: September 23, 2005 National Institute of Mental Health (NIMH) (http://www.nimh.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 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 program announcement (PA) encourages applications for a one-time grant award to support: innovative research directions requiring preliminary testing or development of neuroscience databases or analytical tools (neuroinformatics) research; exploration of the use of approaches and concepts new to a particular substantive area of neuroscience informatics (neuroinformatics) research; or research and development of new technologies, techniques or methods in informatics that will have a high impact upon the advancement of neuroscience 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, including tools that integrate information from different levels of organization across temporal and spatial scales. The proposed pilot studies are to involve technological, methodological,or theoretical informatics approaches to a complex neuroscience research problem that lacks sufficient preliminary data and/or a body of peer-reviewed publications. The successful outcome of these studies should make a significant contribution to the neuroinformatics and neuroscience fields. RESEARCH OBJECTIVES Background 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 through the activities of the Federal Interagency Coordinating Committee of the Human Brain Project (FICC-HBP). The HBP seeks to encourage exploratory research pilot studies having the potential to make a significant advancement in neuroscience research through the creation of neuroscience databases, knowledge management systems, and analytic tools to integrate vast, complex data and information about the nervous system. Tools that describe different levels of organization are needed to model nervous system function and the effects of abnormalities on other physiological systems. This research should involve exploration of scientific experimental hypotheses, linked with the development of new computer science technologies, or vice versa. It should represent a unique focus or direction for the conceptualization of both neuroscience and informatics research, with one being preliminary and innovative. It is intended that the additional pilot data generated by these exploratory studies, if promising, will serve as a basis for a more extensive follow-up investigation, commonly pursued through the submission of an investigator-initiated research project (R01) grant application in the field of neuroinformatics. This mechanism does not support research that is essentially the logical progression of an ongoing research program. For a detailed description on the research objectives of the FICC-HBP sponsored Human Brain Project/Neuroinformatics Initiative, 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). MECHANISM OF SUPPORT This PA will use the NIH Exploratory/Developmental Grant (R21) mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Under this program announcement, applicants for the R21 award may request direct costs of up to $100,000 per year for up to two years to support exploratory research where sufficient pilot data to support a regular research grant application is lacking. Competitive renewals of grants awarded under this program announcement will not be accepted. This PA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, applicants submitting an application with direct costs in each year of $250,000 or less must use the modular format, thus all applicants for the R21 must submit a modular budget. ELIGIBLE INSTITUTIONS You may submit an application 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. It is anticipated that most applications will be submitted by investigators with ongoing research programs who wish to change the focus of their current research effort or move into a new area of research utilizing innovative electronic and digital neuroinformatics research capabilities (methodological strategies, databases, and tools), but need additional funds to complete initial pilot studies. This PA also encourages applications from investigators conducting research outside of the basic and clinical neuroscience research field, whose expertise in methodological or technological approaches to Informatics (information technology, computers sciences, mathematics, physics, engineering) would significantly advance progress and new knowledge in this field. This announcement is not intended for new investigators planning or at the early stages of an independent research career. SPECIAL REQUIREMENTS Areas of science with sufficient existing preliminary data to support the submission of a regular research grant application do not qualify under this PA. Investigators are encouraged to consider carefully whether their research can best be accomplished through this or other grant mechanisms, such as the research project grant (R01) or the small grant (R03) program of the NIH. Although the amount of pilot data that typically accompanies an R01 application is not required as a part of this program announcement, the applicant has the responsibility to provide sufficient pilot data to demonstrate the soundness of the research plan. Moreover, since the goal of this R21 grant mechanism is to encourage a change in research from that of an ongoing research program, the appropriate expertise of key personnel and collaborators to pursue such novel research must be evident. It is strongly encouraged that researchers funded under the Human Brain Project communicate, coordinate, and collaborate across different grants. A list of investigators participating in this program is located at http://www.nimh.nih.gov/neuroinformatics/index.cfm and the types of data, software, or other information that is available from or through them will be 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 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. 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 thesoftware 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. 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. 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: [email protected] 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: [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 Grace C.Y. Peng, Ph.D. Program Director, Division of Bioengineering 6707 Democracy Boulevard, Suite 226, MSC 5469 Bethesda, MD 20892-5469 Telephone: (301) 496-9178 FAX: (301) 480-0679 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 Library of Medicine (Updated contact info for NLM, see NOT-LM-05-002) 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 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 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: 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. SPECIFIC INSTRUCTIONS: Follow the PHS 398 instructions for "Preparing Your Application" with modifications and additions as described in the sections below: 1. Face Page of the application: To identify the application as a response to this Program Announcement (PA), check "Yes" on item 2, and the number and title of the PA must be typed on line 2 of the face page of the application form. 2. Description: As part of the description, identify briefly how this application relates to the purpose of the R21 mechanism as stated in this program announcement (i.e., highly innovative research; exploration of the use of approaches and concepts new to a particular substantive area; research and development of new technologies, techniques or methods; or initial research and development of a body of data upon which significant future research may be built). Research Plan: The Research Plan may not exceed 10 pages. Item a.1, SPECIFIC AIMS The instructions for this section suggest that the applicant state "the hypotheses to be tested." Since some applications submitted in response to this program announcement may also be design- or problem-driven (e.g., development of novel technologies), or need-driven (initial research to develop a body of data upon which future research will build). In such instances, hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. Thus, the application should state the hypotheses, design, problem and/or need which will drive the proposed research. Item a.2, JUSTIFICATION AS EXPLORATORY RESEARCH In the introductory paragraph at the beginning of the research plan, amply justify the designation of the application as an initial feasibility pilot study. Explain how this project represents a change in research focus or a new research direction for your laboratory. Justify why the project would not be appropriate for submission as a regular research grant at this time, and how this project, if fruitful, would enable you to craft a research program appropriate for submission as a full-scale research grant application. Label this paragraph, "Justification as Exploratory Research." Applications that lack the introductory justification will not be reviewed and will be returned to the applicant. Some applications submitted in response to this PA may be design-driven (e.g., development of new technologies) or data-driven (e.g., database management, mining or distribution), rather than problem-driven (e.g., testing of scientific hypotheses). In the cases of design-driven or data-driven applications, the Specific Aims should state the technique/technology development needs or the data acquisition needs driving the research, rather than the experimental hypotheses to be tested. It also should well articulate the integration of neuroscience and neuroinformatics research approaches. Item b, BACKGROUND AND SIGNIFICANCE In this section, it is important to clearly elaborate upon how the application serves the purpose of this program announcement. Item c, PRELIMINARY STUDIES/PROGRESS REPORT Although preliminary data are not expected for an Exploratory/Developmental Grant application, if such data exist they should be presented. Item d, RESEARCH DESIGN AND METHODS In many cases, an Exploratory/Developmental Grant mechanism will support novel research in an area or the research and development of new technologies. Where appropriate, specific criteria by which to judge the feasibility of novel approaches (including milestones that will mark progress) should be explicitly described in this section. SENDING AN APPLICATION TO THE NIH: 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 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.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA (1) Does the proposed research represent a change in research focus or a new research direction for the laboratory that requires feasibility pilot studies, or is the proposed research the logical continuation of ongoing research efforts? (2) In the case of research that is hypothesis-driven, will the successful outcome of the proposed studies likely generate sufficient data to pursue follow-up studies and lead to a full-scale research grant application? (3) In the case of proposed research that is either technology-driven or design- driven, will the project generate a body of data, a technological advance or product that will be useful to the communication sciences community? (4) How will the successful completion of the proposed studies impact the concepts, methods, or technologies that drive the field? (5) Is the integration of Neuroscience and Informatics clear and appropriate? 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 Nos. 93.242 (NIMH), 93.838 (NHLBI), 93.866 (NIA), 93.273 (NIAAA), 93.287, 93.287 (NIBIB), 93.279 (NIDA), 47.074 (NSF), 93.865 (NICHD), 93.173 (NIDCD), 93.121 (NIDCR), 93.879 (NLM), 81.049 (DOE), and 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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