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CHARACTERIZING, VALIDATING, AND COMPARING NEUROIMAGING INFORMATICS TOOLS Release Date: December 6, 2001 RFA: RFA-MH-02-008 National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute of Neurological Disorders and Stroke (http://www.ninds.nih.gov/) National Institute of Biomedical Imaging and Bioengineering (http://www.nibib.nih.gov/) Letter of Intent Receipt Date: January 25, 2002 Application Receipt Date: February 26, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE Functional magnetic resonance imaging (fMRI) is increasingly important for understanding human brain function. As with other imaging modalities, informatics tools are used at all stages of fMRI studies. As fMRI has evolved in neuroscience laboratories, investigators have created informatics tools to allow them to address particular research questions. This has resulted in a relatively small number of informatics tools that are both useful and widely used. Despite the utility and popularity of particular informatics tools, however, these tools are often poorly characterized, and few studies have been conducted to validate their use for particular purposes or to compare rigorously different tools used in fMRI. The National Institute of Mental Health (NIMH) and the National Institute of Neurological Disorders and Stroke (NINDS) solicit applications for grants to support such studies of informatics tools used widely in fMRI studies of the brain, and/or to support the development of the means to carry out such studies. Although the mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) does not focus on tools used primarily to study a single organ system, such as the brain, NIBIB solicits applications for grants to support more fundamental work on the assessment of biomedical technologies, including the characterization, validation, and comparison of informatics tools used across multiple modalities and multiple organ systems, which may include the brain. This solicitation is an activity of the Neuroimaging Informatics Technology Initiative (NIfTI), which supports targeted and coordinated service, training, and research to enhance the use, and speed the development, of informatics tools for neuroimaging. The initial focus of NIfTI will be on informatics tools used in fMRI studies. 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 Request for Applications (RFA), Characterizing, Validating, And Comparing Neuroimaging Informatics Tools, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 4 years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2002. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The participating Institutes intend to commit approximately $1.75 million in FY 2002 to fund 5 to 7 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 4 years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIMH, NINDS, and NIBIB provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES Background Over the past decade, functional magnetic resonance imaging (fMRI) has assumed a critical role in understanding human brain function at the level of neural systems. This role has been enhanced due to recent scientific and technologic advances such as the development of compatible modalities (e.g., diffusion tensor MRI), the adoption of higher field MRI instruments for fMRI studies, and a better understanding of the relationship between electrophysiological activity and the blood-oxygen-level-dependent (BOLD) signal, which is widely used in fMRI studies of brain function. Informatics tools are key to all stages of fMRI neuroimaging, they are crucial both to performing neuroimaging studies and to understanding the results of such studies. The conclusions drawn from fMRI studies regarding the relationship between functional activation signals and function of the brain should be based upon a clear understanding of the manner in which various tools affect the data at each stage of processing. Knowing that the operations performed by informatics tools are valid is also of obvious importance to interpreting the results of fMRI studies. Finally, comparing different tools to identify the conditions under, and uses to which they are best suited is significant information that neuroscientists using fMRI would welcome. Nevertheless, there is a dearth of published information about any of these very fundamental aspects of such informatics tools. The reasons for this are several, but the lack of impact that such information would have on progress in human neuroscience is not one of them. Research Scope and Objectives This RFA seeks to support studies that characterize tools, validate tools, or compare tools used in fMRI research. Particularly welcomed are such studies of tools that are now widely used. Information about such tools is likely to have a broad impact compared to information about tools used only in a few laboratories. Also solicited is research and development of the means to characterize, validate, or compare these tools. Such means might include the development of well-characterized data sets, metrics, etc, particularly welcomed are means to study tools with wide applicability for broad impact on the field. It should be noted that the research proposed in response to this RFA may be driven by problems, design, or hypotheses. General categories of research and development considered responsive to this RFA include: o Tool Characterization: Understanding how the raw data are affected by data processing performed by informatics tools, which may include an understanding of the tool"s requirements, expectations, computational and data conditions under which it operates, etc. Also considered responsive to this RFA are proposals to develop the means to carry out such characterization activities. o Tool Validation: Studies to reveal whether a particular tool gives the answer it should give, and/or development of the means to conduct such studies. o Tool Comparison: Studies to demonstrate which tool is best suited to perform which functions and under which conditions, etc., and/or development of the means to conduct such studies. General categories of tools designed for functional activation studies that such research and development might focus on include: o Spatial normalization tools o Hemodynamic response models o Statistical analysis packages used widely in fMRI o Morphometric software packages o Data visualization tools o Segmentation and feature extraction software o Image processing tools (e.g., to correct field inhomogeneities, suppress noise, enhance contrast, equalize histograms, etc.) To assure the greatest impact on neuroscience using fMRI, the tools studied should be in wide use by the fMRI neuroimaging research community. Also, the means developed to study tools should be applicable to widely used tools. In short, activities supported under this RFA should address significant practical problems and issues in the field. SPECIAL REQUIREMENTS The purpose of this RFA is to develop a body of scientific findings, and the means to produce such findings, that will likely have immediate impact on the research community using fMRI informatics tools. Therefore, applications should include a plan that describes plans for making available to the research community the data, software, or other tools (e.g., a highly characterized data set) proposed to be developed with a grant funded under this RFA. PHS policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published (see PHS Grants Policy Statement revised March 1, 2001, at http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. The intent of this policy, however, is not to discourage, impede, or prohibit the organization that develops unique research resources or intellectual property from commercializing the products. A detailed plan for how the data, software, or other tools will be made available to the research community broadly and in a timely way will be considered part of the scientific methodology for carrying out the research and, as such, the adequacy of the plan will be considered by reviewers in assessing merit. This will also be considered by the program staff of participating Institutes in determining whether the grant will be awarded. This plan as approved, after negotiation with the applicant when necessary, will be a condition of the award. The effectiveness of these efforts will also be considered in assessment of non-competitive renewals of the grant. Finally, Principal Investigators funded under this RFA and appropriate staff chosen by them are expected to attend annual meetings convened by NIMH, NINDS, and NIBIB to discuss their progress. Applicants, therefore, should include in their budget travel costs for this meeting each year. The first of these meetings will take place soon after awards are made. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their 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 It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an internet site. 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 RFA 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 give careful consideration to the issue of structuring informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Michael F. Huerta at the address listed under INQUIRIES, by the letter of intent receipt date listed. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application with any appendix materials must be sent to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the participating Institutes. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the National Advisory Councils of the participating Institutes. 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the 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, an investigator 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 this study address an important problem? If the aims of the application are achieved, how will scientific or technical knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Will the information about tools or the means to study tools produced by these studies have broad impact on the research community that uses fMRI? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the plan to make available to the research community data, software, or other tools developed in the application adequate? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. Schedule Letter of Intent Receipt Date: January 25, 2002 Application Receipt Date: February 26, 2002 Peer Review Date: June 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael F. Huerta, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7202, MSC 9645 Bethesda, MD 20892-9645 Rockville, MD 20852 for express or courier service Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: mhuerta@helix.nih.gov Yuan Liu, Ph.D. National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2110B Bethesda, MD 20892-9523 Telephone: (301) 496-3108 Email: liuyuan2@ninds.nih.gov Richard E. Swaja, Ph.D. Division of Biomedical Imaging National Institute of Biomedical Imaging and Bioengineering 31 Center Drive, Room 1B37 Bethesda, MD 20892-2077 Telephone: (301) 451-6771 FAX: (301) 480-4515 Email: swajar@nibib.nih.gov Direct inquiries regarding fiscal matters to: Ms. Carol J. Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: crobinso@mail.nih.gov Ms. Joellen Harper Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3258 Bethesda, MD 20892-9523 Telephone: (301) 496-9231 Email: harperj@ninds.nih.gov Annette Hanopole, CRA Grants Management Branch National Institute of Biomedical Imaging and Bioengineering 31 Center Drive, Room 1B37 Bethesda, MD 20892-2077 Telephone: (301)451-6768 FAX: (301) 480-4515 Email: Hanopola@mail.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.853 (NINDS), and 93.286 (NIBIB). 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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