RFA-DA-02-001: NEUROIMAGING TECHNOLOGY DEVELOPMENT TO ASSESS BRAIN AND BEHAVIOR IN PEDIATRIC POPULATIONS

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

NEUROIMAGING TECHNOLOGY DEVELOPMENT TO ASSESS BRAIN AND BEHAVIOR IN PEDIATRIC POPULATIONS Release Date: October 26, 2001 RFA: RFA-DA-02-001 National Institute on Drug Abuse (http://www.nida.nih.gov) National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov) National Institute of Biomedical Imaging and Bioengineering (http://www.nibib.nih.gov) Letter of Intent Receipt Date: February 19, 2002 Application Receipt Date: March 19, 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 The purpose of this RFA is to support studies that will address methodological and technical issues associated with the use of rapidly developing neuroimaging technology in assessing brain and behavioral development in child and adolescent populations, particularly those exposed to drugs of abuse or those with developmental or acquired communication disorders. More specifically, studies are sought in two major areas: (1) the neuroimaging tools themselves, the parameters they are measuring, their sensitivity in measuring these parameters, and problems and concerns that are inherent in their operation and in their use, particularly in infants, children and adolescents, and (2) broader issues related to the design of studies using specific neuroimaging techniques, including selection of independent and dependent variables, common threats to validity and reliability, and identification of the strengths and limitations of various components of design. 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 RFA, Neuroimaging Technology Development to Assess Brain and Behavior in Pediatric Populations, 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) exploratory/developmental grant (R21) award mechanism. This mechanism for this RFA will support up to three years of research with a direct cost not to exceed $100,000 per year. 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 three 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 June 2002. For further information on the R21 mechanism, see http://grants.nih.gov/grants/guide/pa-files/PA-98-004.html. 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 Funds available for this initiative are $2,000,000 in FY 2002 to fund 12 to 15 new and/or competitive continuation grants in response to this RFA. 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 NIDA, NIDCD, 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 With the rapid development of brain imaging technology, a new generation of imaging techniques has emerged that holds great promise for their ability to reveal structural and functional brain alterations during development in infants, children and adolescents. These areas of research are of particular interest because of their potential in determining the neurobiological impact of exposure to drugs of abuse on these populations. In addition, the potential exists to explicate the neurobiological bases of childhood communication disorders and expand our understanding of certain brain- behavior relationships. Included among the advanced neuroimaging techniques are positron emission tomography, single photon emission computed tomography, structural and functional magnetic resonance imaging, magnetic resonance spectroscopy, magnetic resonance perfusion imaging, diffusion tensor imaging, magnetoencephalography, and optical imaging. Electroencephalographic and evoked potential recording techniques also have made considerable progress, especially in combination with other brain imaging modalities, and would be included. In addition to the application of these technologies, development of new technologies or modalities that combine existing technologies are encouraged. Each of these technologies used alone or in combination with others and with neurologic and behavioral assessments has the potential to reveal specific aspects of the puzzle of brain development. As the relationship between structural development of the postnatal central nervous system and the functional capacities of children from birth to adolescence gradually unfolds, the potential for identifying early delays in cognitive development and for mounting effective treatment and prevention strategies greatly increases. The rapidly expanding body of research using these sophisticated imaging techniques has unveiled some of the strengths and limitations inherent in the use of the technologies themselves. Moreover, brain imaging studies of infants, children and adolescents present an additional set of unique technical and methodological challenges that become even more complicated when the research questions involve such populations as children exposed to drugs of abuse or those with communication disorders. Exploration and resolution of these potential threats to validity and reliability, and the challenges they pose to research designs using brain imaging techniques, must be resolved before the techniques should be widely accepted and utilized as standard research tools. Areas of Interest Applications should have the potential to strengthen research on: 1) the neurobiological impact of exposure to drugs in pediatric populations, 2) the neurobiological bases of childhood communication disorders, or 3) the development of new technologies and the novel application of existing technologies to this research area. Research applications in these broad categories might include, but are not limited to: o Studies of both physical and statistical methods for monitoring, controlling and minimizing brain motion and noise artifacts, especially in real time o Development and testing of standardized protocols for acclimatizing subjects to imaging procedures (to minimize head movements and allow maximal time subject time in scanner) o Identification of the factors that most affect brain image quality, and development and testing of methods to control these variables o Studies using combinations of neuroimaging techniques to increase spatial and temporal resolution o Research validating the measurement of dependent variables in brain imaging studies and their consistency across brain areas and between subjects o Studies identifying optimum equipment standards for specific neuroimaging modalities and the constraints these place on the availability of the equipment for research o Research focusing on the relative advantages and disadvantages of varying methods to increase the sensitivity of a neuroimaging technique for use in a pediatric population o Identification and testing of modifications that could be made to equipment or procedures to make specific brain imaging methods more adaptable for a pediatric population for example, developing methods to decrease acquisition time in a magnet o Methods to determine coordinates and structural features (i.e., templates) of the brain during various stages in development, as well as development and refinement of cortical flattening methods and warping techniques o Studies on the developmental aspects of neurovascular coupling o Development of stimulus generation and appropriate neurocognitive (including speech and language) tasks that are amenable to study in the magnet and to pediatric populations o Determination of appropriate criteria for matching in between-group designs in the context of constraints imposed by the technology and the age of the subjects o Research identifying specific variables that should be controlled in the design of studies based on a selected brain imaging method in the pediatric population o Studies to determine the optimal experimental designs for specific neuroimaging methods used in pediatric populations o Development of mathematical or computational models for analyzing neuroimaging data that can be standardized for comparison across research sites o Studies that analyze neuroimaging data using different statistical approaches to explore for potential convergence of results o Research focusing on criteria for the selection and implementation of age- appropriate cognitive tasks that will be suitable for neuroimaging studies o Studies that assess the value of using more than one imaging technique as a mechanism for cross-validation of methods 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 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 these policies. 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. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA"s Home Page at http://www.nida.nih.gov/ under Funding or may be obtained by calling (301) 443-2755. 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 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. 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 all 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 CSR staff to estimate the potential review workload and plan the review. Send the letter of intent (by receipt date listed in the heading of this RFA) to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 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 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) 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 and responsiveness by the CSR and responsiveness by NIDA, NIDCD, and NIBIB. 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 CSR 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 appropriate National Advisory Councils. 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. Applications may include hypothesis-driven research as well as technology- or design-driven research. 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. Further, the R21 mechanism is intended for exploratory, developmental research. It is essential to consider the application in the context of the R21 mechanism. The applicant must establish both the novelty and the potential impact of the project. In keeping with the exploratory/developmental nature of the R21, preliminary data are not expected. However, the application must be well-reasoned and scientifically sound. Where appropriate, specific criteria by which to judge the success of novel approaches (including milestones that will mark progress) should be explicitly described. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced and how will this work expand or improve upon existing methods? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? For the R21 mechanism, a strong rationale and conceptual framework may be sufficient for establishing the feasibility of the project, in lieu of preliminary data. (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. o The adequacy of the proposed plan to share data, if appropriate. Schedule Letter of Intent Receipt Date: February 19, 2002 Application Receipt Date: March 19, 2002 Peer Review Date: June 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit (as determined by peer review), availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Joseph Frascella, Ph.D. Chief, Clinical Neurobiology Branch Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4237, MSC 9559 Bethesda, MD 20892-9559 Telephone: (301) 443-4877 Fax: (301) 443-6814 Email: jf80t@nih.gov Judith Ann Cooper, Ph.D. Chief, Scientific Programs Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders/NIH Executive Plaza South, Suite 400C 6120 Executive Boulevard, MSC 7180 Bethesda, MD 20892-7180 Phone: (301) 496-5061 Fax: (301) 402-6251 Email: jc148m@nih.gov Joan T. Harmon, Ph.D. Senior Advisor for Program National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Boulevard, Room 697 Bethesda, MD 20892 Phone: (301) 594-8813 Fax: (301) 480-3503 Email: joan_harmon@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 Fax: (301) 594-6847 Email: gf6s@mail.nih.gov Sara Stone Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders/NIH Executive Plaza South, Suite 400B 6120 Executive Boulevard, MSC 7180 Bethesda, MD 20892-7180 Phone: (301) 402-0909 Fax: (301) 402-1758 Email: ss115y@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279 (NIDA) and No. 93.173 (NIDCD). 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices