RESEARCH AND DEVELOPMENT OF SYSTEMS AND METHODS FOR CELLULAR AND MOLECULAR IMAGING RELEASE DATE: November 20, 2002 RFA: EB-03-003 National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) LETTER OF INTENT RECEIPT DATE: January 16, 2003 APPLICATION RECEIPT DATE: February 13, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available 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 Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA The National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institute of General Medical Sciences (NIGMS) invite applications for NIH Research Project Grant (R01) awards to support interdisciplinary basic research or NIH Exploratory/Developmental Grant (R21) awards to support novel pilot or feasibility studies concerned with cellular and molecular imaging and/or spectroscopy that can be broadly applied to research on biological or disease processes. The primary focus of this Request for Applications (RFA) is in vivo cellular and molecular imaging and/or spectroscopy with human/clinical emphasis including devices, methods, and contrast agents. The integration of these systems and methods with other imaging/spectroscopy modalities is also included as appropriate to support clinical investigations. Consistent with the mission of the NIBIB, this initiative supports discovery or development of cross- cutting technologies for cellular and molecular imaging and/or spectroscopy systems and methods that can be applied to research on multiple biological or disease processes. Two small animal imaging initiatives recently issued aim to support novel interdisciplinary basic research and novel feasibility studies concerned with cellular and molecular imaging/spectroscopy focused on small animals. Small animal imaging research using the R01 mechanism is supported by the RFA EB-03-002, "Systems and Methods for Small Animal Imaging" (http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-002.html), and small business initiatives using the NIH SBIR/STTR mechanisms are supported by the Program Announcement PA-03-031, "Systems and Methods for Small Animal Imaging" (http://grants.nih.gov/grants/guide/pa-files/PA-03-031.html). RESEARCH OBJECTIVES The need to support discovery and development of biomedical imaging methods was identified at several NIH workshops and conferences on biomedical imaging including a June 25-26, 1999, symposium titled "Biomedical Imaging Symposium: Visualizing the Future of Biology and Medicine", which was coordinated by the NIH Bioengineering Consortium (BECON). Three scientific areas were addressed: (1) imaging at the cellular and molecular levels such as required for the early detection of disease; (2) imaging for the clinical diagnosis, staging, and recurrence of disease; and (3) imaging applied to therapeutic applications and monitoring for various disease processes. The development of novel molecular imaging/spectroscopy methods that improve the spatial and temporal resolution, measurement sensitivity, and specificity for all three areas was identified as a critical need for this field. Molecular information is recognized as having a profound impact on approaches to diagnosing and treating diseases that have the potential of being redefined in terms of their characteristic genetic or molecular abnormalities. New forms of therapy are possible to target the abnormal gene or phenotypic pathway, and methods are needed for image guidance to track response to these new therapeutic strategies. These advances are critically related to the development of molecular probes and contrast agents that can provide the associations to specific biological processes and thus improve the sensitivity and specificity of imaging methods for early disease detection and monitoring of therapeutic response. Optimization of imaging systems and methods is required to realize the full potential of new contrast agents. The support of fundamental discovery and technical development of imaging technologies before specific disease- or organ-oriented applications is mandatory. These challenges can be accomplished effectively by multi-disciplinary teams from academia, national laboratories, and industry with expertise in the quantitative, computational, and biomedical sciences. Consistent with the recommendations of the BECON symposium and the mission of the NIBIB, the goals of this RFA are directed at basic research and/or development of in vivo cellular and molecular imaging/spectroscopy systems with a human/clinical focus. Research areas of interest include methods and contrast agents that enhance spatial or temporal resolution, measurement sensitivity, and specificity as required for the detection, diagnosis, or measurement of treatment efficacy for different disease processes. The scope of this RFA includes the integration of these systems and methods with anatomical or other functional imaging/spectroscopy methods to provide more effective tools for clinical use, the development of imaging or spectroscopy systems that have the flexibility to accommodate a variety of protocols for investigations of different diseases, and the development of platform-independent imaging methods for multi-center research. These systems, methods and applications must be designed for eventual human/clinical use. Development of in vitro imaging/spectroscopy systems and methods will be considered responsive to the RFA only if they are required to validate in vivo imaging/spectroscopy systems. Feasibility studies or proof-of-principle studies are appropriate to demonstrate the potential of the proposed systems and methods. The following research areas are examples of appropriate topics for applications in response to this RFA. This list is meant to be representative and not all-inclusive: o Discovery and development of the next generation of in vivo cellular and molecular imaging and/or molecular spectroscopy systems and methods. The research scope may include new in vivo imaging and /or spectroscopy paradigms using tomographic, stationary, image-guided, or implanted systems and methods. o Development and integration of cellular and molecular imaging and/or spectroscopy systems with other imaging or spectroscopy systems and methods such as multi-modality imaging (e.g., to include tomographic and other localized stationary, image-guided, or implanted sensors). Development of sensors or multiple sensors that take advantage of microelectromechanical (MEMS) and nanoelectromechanical (NEMS) systems are included. o Discovery and development of novel contrast agents for in vivo molecular imaging and/or spectroscopy methods. These may include molecular probes for biological processes such as gene expression at the level of transcription or translation, signal transduction for cell surface receptors, enzyme action or other metabolic processes, cell tracking, or blood flow or drug action that may impact the study of several disease processes. NIGMS is specifically interested in the application and development of molecular imaging techniques to achieve a better understanding of cellular processes and structures in which the basic biology is the goal. The National Center for Research Resources, while not a sponsor of this RFA, supports research and development similar to that solicited here. Potential applicants can visit the web site, http://www.ncrr.nih.gov/biomedical_tech.asp, or can contact Dr. Gregory Farber, farberg@ncrr.nih.gov, 301-435-0755 for information about NCRR's programs and interests. MECHANISM OF SUPPORT This RFA will use NIH R01 (Research Project Grant) and R21 (Exploratory/Developmental Grant) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2003. The R01 mechanism is recommended for applications that emphasize basic discovery or cross-cutting research that addresses specific aspects of imaging systems, methods, or contrast agents. Research periods associated with the R01 proposals are limited to five years. The R21 Exploratory/Developmental Award supports exploratory or developmental research aimed at proof-of-principle for high-risk projects where no or very little preliminary data is available. An R21 application can be for up to two years with a maximum budget request of $150,000 direct costs per year and a maximum page limit of 10 pages. R21 applications are not renewable. If sufficient results are generated during the term of the award, investigators are encouraged to apply for further funding through the R01 mechanism (or other appropriate mechanisms). This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE The NIBIB and NIGMS intend to commit approximately $9,000,000 in FY 2003 to fund 30 to 35 new and/or competitive continuation grants in response to this RFA. For R01s, an applicant may request a project period of up to 5 years and a budget appropriate for the proposed research. For R21 applications, an applicant may request a project period of up to 2 years and a budget for direct costs of up to $150,000 per year. Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. Since the total costs for a subcontract or consortium are included in the direct cost request, one additional module of $25,000 may be requested for the facilities and administrative costs associated with third party agreements. Under these guidelines, R21 applications requesting $150,000 may request $175,000 to cover the facilities and administrative costs described above. A module requested for this purpose must be clearly identified in the budget justification section of the application, and will be restricted for this purpose only at the time of award. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIBIB and NIGMS 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. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS General Clinical Research Centers: Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Meetings: Principal Investigators will be required to attend an annual meeting organized by NIBIB. Please include travel to the Bethesda, MD area as part of the budget request. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct questions about scientific/research issues to: Brenda Korte, Ph.D. Division of Biomedical Imaging National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Boulevard – Suite 200 Bethesda, MD 20892-5469 Telephone: 301-451-4774 Fax: 301-480-4973 Email: kortebr@nibib.nih.gov Catherine Lewis, Ph.D. Chief, Biophysics Branch Division of Cell Biology and Biophysics National institute of General Medical Sciences NIH/DHHS 45 Center Drive, Room 2AS-13C Bethesda, MD 20892 Telephone: 301-594-0828 Fax: 301-480-2004 Email: lewisc@nigms.nih.gov o Direct questions about financial management or grants management matters to: Ms. Florence Turska Grants Management Officer National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Boulevard – Suite 900 Bethesda, MD 20892-5469 Telephone: 301-496-9314 Fax: 301-480-4974 Email: turskaf@nibib.nih.gov 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) 435-0714, Email: GrantsInfo@nih.gov. 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. USING THE RFA LABEL: 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. 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, DHHS 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIBIB. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 CSR in accordance with the review criteria stated below. 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 an appropriate 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: o R21 MECHANISM ONLY: Since the R21 mechanism is intended to encourage exploratory/developmental research, proposals submitted as an R21 will be reviewed based on their high risk/high impact potential and whether or not the proposal is significantly distinct from those traditionally submitted through the R01 mechanism. For example, R21 projects designed to produce incremental advances in knowledge will not be considered. o 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. o 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) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 16, 2003 Application Receipt Date: February 13, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 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. REQUIRED FEDERAL CITATIONS 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 (hESC): 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 hESC 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 hESC 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 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. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.286 & 93.287 (NIBIB) and 93.821 (NIGMS) 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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