RFA-CA-01-014: IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICS)

Department of Health
and Human Services (HHS)

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IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICs) Release Date: August 7, 2000 RFA: CA-01-014 National Cancer Institute Letter of Intent Receipt Date: October 17, 2000 Application Receipt Date: November 28, 2000 This Request for Application (RFA) replaces RFA-CA-99-004, which was published in NIH Guide on March 30, 1999. PURPOSE The Biomedical Imaging Program, Division of Cancer Diagnosis and Treatment of the National Cancer Institute (NCI) invites applications for P50 Research Center Grants for the establishment of In Vivo Cellular and Molecular Imaging Centers (ICMICs). A separate Request for Applications (RFA), CA-01-010, describing a complementary initiative, the P20 Planning Grant for Pre-In Vivo Cellular and Molecular Imaging Centers (Pre-ICMICs), has also been issued. This RFA is available at: (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-01-010.html. Both of these initiatives are designed to capitalize on the extraordinary opportunity for studying cancer non-invasively, and in many cases, quantitatively due to recent advances in molecular imaging modalities, as well as molecular and cellular biology. They will facilitate the interaction of scientists from a variety of fields such as, but not limited to: imaging sciences, chemistry, radiopharmaceutical chemistry, cellular and molecular biology, pharmacology, computer science, biomedical engineering, immunology and neuroscience, and provide resources to conduct multidisciplinary research. The 5-year P50 grants described in this RFA will be appropriate for those Institutions in which investigator-initiated multidisciplinary research involving imaging and molecular technologies are currently ongoing. These efforts may be generating important preliminary data, but the teams may be loosely associated, not consistently supported and therefore lack the overall structure and resources necessary to take full advantage of emerging opportunities. The P50 Center grant will provide a formal framework through which scientific synergy can occur on a stable and continuing basis, and will provide 1) an organizational structure specifically designed to facilitate scientific cross-fertilization between seemingly disparate groups of investigators, 2) specialized resources to support research activities, 3) developmental funds for feasibility testing of new projects, and 4) career development opportunities for new and established investigators. The 3-year P20 Pre-ICMIC awards described in RFA CA-01-010 will be appropriate for those Institutions that have most of the separate scientific components necessary for productive interaction but have no previous track-record of performing multidisciplinary scientific research. Following completion of the P20 funding period, grantees will hopefully compete for a P50 award (see below) that will be competitively reviewed on the organizational and scientific progress made during the planning stage. RESEARCH OBJECTIVES Background: Imaging sciences are at a stage in which human anatomic imaging can occur in vivo at submillimeter resolution, and significant advances have occurred in molecular imaging modalities, including the nuclear medicine techniques of SPECT and PET, MR spectroscopy and optical imaging. At the same time, a myriad of new cancer-related genes and proteins are being discovered at an increasing pace by molecular and cellular biologists. However, there remains a scientific gulf between basic scientists who discover new cancer genes and intracellular pathways, any of which could serve as a diagnostic or therapeutic target, and the imaging scientists who could transform those discoveries into non-invasive means for a greater understanding of neoplasia in humans. Research Goals and Objectives: The formation of multidisciplinary research teams will stimulate and streamline cancer imaging research from inception to use in patient care. Each Institution will define the structure and research objectives that create the most synergistic and creative scientific interactions. In general, an ICMIC will provide researchers with the following critical resources: Special Features 1) The ICMICs will provide an organizational structure specifically designed to facilitate intellectual multi-disciplinary interactions between seemingly disparate groups of investigators. This structure will provide researchers with access to a concentrated pool of expertise in a wide range of disciplines, and the resources necessary to analyze and predict the likelihood of success in areas outside their immediate realm of expertise. The structure of the ICMIC will be designed to provide investigators with the means of conducting multidisciplinary research in a highly collaborative atmosphere, and the consistent access to expertise with minimal wasted time and effort. Personnel may be scientists from a variety of fields such as, but not limited to: imaging sciences, chemistry, radiopharmaceutical chemistry, cell and molecular biology, pharmacology, computer science and biomedical engineering. Other specialists in fields such as MRI physics, immunology or neuroscience, for example, may also be involved. Most importantly, ICMIC personnel must demonstrate an eagerness to collaborate outside of their own discipline. The nature of these interactions will be determined by the applicants, and emphasis will be placed on establishing creative, productive interactions. 2) The ICMICs will provide Specialized Resource Facilities and Services. A barrier to productive scientific interaction is the lack of available facilities for cross-disciplinary experiments. Demands on equipment, resources, and reagents in every scientific area are extremely high, and this demand prohibits ready access to investigators interested in expanding their studies into new areas of research. The establishment of Specialized Resources dedicated to ICMIC-related research will provide this access. The Specialized Resource(s) would be determined by the requirements of the Institution, the defined scientific goals of the Research Components of the ICMIC, and budgetary limits. Prioritization of the research projects supported through ICMIC Specialized resources would be an essential function of the ICMIC’s leadership, and the mechanism to be employed for prioritization must be delineated by the applicants. Resource facilities may be utilized by active members of the ICMIC and would also be available to investigators supported through the Development Fund (see below). 3) ICMICs will provide Developmental Funds for feasibility testing of new projects. A high priority of each ICMIC will be the identification and support of pilot projects that identify and stimulate interdisciplinary projects that will take full advantage of emerging research opportunities. The selection of projects will be through a review process established by the ICMIC’s leadership. The portfolio of ongoing projects in any given Program is expected to be extremely dynamic. This fund is not to be used to support traditional, ongoing projects that could readily be supported through R01s. It is not appropriate for projects that utilize single areas of expertise or to support the continuation of previously funded research projects, and Developmental Projects may not be supported for more than 2 years. Necessary equipment should be provided through the appropriate Specialized Resource. These projects are to be monitored closely by the ICMIC leadership. Investigators working on projects supported through the Development Fund must understand that when the projects become sufficiently mature, they will be expected to compete for independent R01 funding. Alternatively, if it becomes obvious that it will not provide the expected results, a plan should be in place for terminating a development project. 4) ICMICs will provide career development opportunities for new and established investigators. Current graduate programs are generally focused on single disciplines and may be inadequate to train the needed cadre of inter-disciplinary imaging scientists. The ICMICs will provide support for a limited number of pre-and post-doctoral trainees in a program to be defined by the applicants. Career development opportunities through the ICMIC will be expected to be highly cross-disciplinary. An example of a ICMIC structure is described below. This is just an example, and other multidisciplinary formats are encouraged. An ICMIC would be defined by a long-term, multidisciplinary scientific vision focused on the advancement of in vivo cellular and molecular imaging. In order to accomplish its long-term goals, the ICMIC may be structured into a series of Research Components. A Research Component may be defined by one or more research projects focused on a specific scientific goals, which are accomplished and readily disseminated throughout the ICMIC. For example, research project(s) focused on the discovery, characterization and refinement of new genetic targets might be accomplished within a Molecular Biology Component. A Chemistry/Radiochemistry Component might be responsible for projects aimed at designing new imaging agents directed towards targets defined in the Molecular Biology Component. A Computing/Database Component would be responsible for ongoing research in molecular modeling and structural analyses as it relates to ICMIC projects. A Biochemistry Component might be responsible for aspects of imaging agent development that encompass cell biology and pharmacology, in addition to development of kinetic models for studying complex issues involving agent delivery and metabolism. The most promising potential imaging agents would be refined and tested in the Imaging Component. Each Component would have access to ICMIC Specialized Resources, designed to provide support facilities to ICMIC research projects. Developmental Projects would be initiated in response to new discoveries made through the ICMIC, and would be supported through Specialized Resources. Opportunities for trainees would be available through the investigators involved with the ICMIC, and their ongoing projects. SPECIAL REQUIREMENTS ICMIC investigators will be expected to participate in an annual ICMIC/Pre- ICMIC workshop to share results with other ICMICs/Pre-ICMICs, share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations. Travel funds for the Principal Investigator and selected ICMIC investigators and collaborators may be budgeted for this purpose. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) P50 Specialized Centers Grant Mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for a P50 application submitted in response to this RFA may not exceed 5 years. The anticipated award date is August 1, 2001. There will be a single receipt date for P50 grants to be funded in FY 2001. However, contingent upon the future availability of funds for these grants, the NCI anticipates 2 additional receipt dates for P50 applications, one each for funding in FY 2003 and FY 2004. FUNDS AVAILABLE The NCI anticipates that two 5-year awards will be made in FY 2001, and plans to set aside $4.0 million total (to include both direct and Facility and Administrative costs) for the initial year’s funding. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. ELIGIBILITY REQUIREMENTS Applications for P50 ICMIC grants may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals and laboratories. Applications from foreign institutions will not be accepted. Foreign components of applications from domestic organizations will be accepted with adequate justification. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. If an institution has a previously funded, active P20 Pre-ICMIC planning grant, an application from that same institution for a P50 ICMIC grant can be submitted in response to this RFA. If an Institution has submitted an application for a P20 Pre-ICMIC planning grant in response to RFA-CA-01-010, that Institution is not eligible to submit a P50 ICMIC application in response to this RFA [please refer to the eligibility criteria outlined in RFA-CA-01-010 (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-01-010.html)]. All Institutions will be eligible to submit applications for future P50 receipt dates (anticipated to occur for funding in FY 2003 and 2004). Each of the lead investigators (the Principal Investigator of the ICMIC, and the Principal Investigator(s) of each Research Component) must be the principal investigator of a major, peer-reviewed research project, such as an R01, a P01, or their equivalent from another funding agency. In addition, each of the lead investigators must demonstrate that they have had significant and productive scientific interactions with at least one of the other lead investigators, either as co-investigators on funded grants and/or as co-authors on peer-reviewed publications. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Anne E. Menkens, Ph.D. Bomedical Imaging Program National Cancer Institute Executive Plaza North, Suite 800 Bethesda, MD 20892 Telephone: (301) 496-9531 FAX: (301) 480-5785 Email: am187k@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Kelli Oster Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892-7340 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8627 Email: Kelli.Oster@nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by Oct. 17, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone and FAX numbers, and email address of the Principal Investigator, 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, it allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Anne E. Menkens, Ph.D. (see contact information above) by the letter of intent receipt date listed. SCHEDULE Letter of Intent Receipt: Oct. 17, 2000 Application Receipt Date: Nov. 28, 2000 Peer Review Date: February/March 2001 Review by NCAB Advisory Board: May, 2001 Earliest Anticipated Start Date: August 1, 2001 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/710-0267, E-mail: grantsinfo@nih.gov. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. Special Instructions for Preparation of the Application 1) Budgets: The budget should be presented in logical, discrete units for each section of the application, as well as the composite ICMIC request. The standard PHS- 398 form pages 4-5 are to be completed for each individual Research Component and Specialized Resource. A single budget section should be prepared for the Developmental Component, as well as a separate budget section for the Career Development Component. Additional pages for budget justification are to be used when necessary. 2) Research Plan The following format is suggested for completing the Research Plan section (see pages 19 through 23 of the PHS 398 application brochure). The Research Plan section is not subject to the page limitations as stated in the form PHS 398. However, the suggested format and page recommendations are noted below. The application should be as concise as possible to ensure a thorough review. A. ICMIC Description (10 pages) This section should be used to present the overall vision for the ICMIC, the long and short-term scientific objectives, and how the research supported through the ICMIC will significantly advance cellular and molecular imaging technologies. Summarize the organizational structure for the ICMIC, concisely defining Research Components, Specialized Resources, the Developmental Fund and the Career Development Component. Describe how each component will contribute to the functioning of the ICMIC. The ICMIC description should serve as a broad overview of the ICMIC, with more detailed description of each component to be presented in a later section. B. Organization and Administration (20 pages, including any organizational charts) The Organizational and Administrative Component should describe all of the infrastructure and decision-making needs of the ICMIC. Appropriate for inclusion in this component would be (not necessarily in the following order): o description of the role(s) and responsibilities of lead investigators, internal and external advisory committees as well as participating investigators. o description of decision-making and oversight responsibilities for each Component and/or Specialized Resource. o description of decision-making and oversight responsibilities for the Developmental Fund, including the process for selecting, monitoring and terminating the Developmental Projects. o description of decision-making and oversight responsibilities for the Career Development Component, including the process for selecting, monitoring and terminating trainees. o description of ICMIC-sponsored activities designed to foster multidisciplinary interactions, such as regularly scheduled forums for the presentation and discussion of multidisciplinary research topics. o detailed description of Institutional commitment to the ICMIC. o commitment to interact with other ICMICs and Pre-ICMICs, including an annual Inter-ICMIC meeting in the Washington DC area. o evidence (grants and publications) of ongoing scientific interactions amongst the PI and lead investigators (may be presented in tabular format - not to be included in 20 page limit ) C. Research Components (25 pages each) Research components will be defined according to the scientific goals of the ICMIC. These components will provide the leadership and infrastructure for ongoing ICMIC research focused on achieving its long-term goals. The leader(s) of each Research Component will be responsible for ensuring that ongoing research project(s) are relevant to the ICMIC goals, and that the investigators and projects remain highly integrated with other ongoing ICMIC research. More than one Research Project may be present within each Research Component. However, each Research Project is expected to be well developed, and careful consideration will be given to the relevance and potential impact of each Project on the ICMIC goal during the review process. Research Components may rely on the support of the Specialized Resources. To ensure a sufficient level of multidisciplinary interaction, no fewer than three Research Components should be included in the application, the maximum number will be determined by the identified needs of the investigators and budgetary constraints. Include in each Research Component an overview of the scientific objective(s) of the Component, a description of how the Component will contribute to the long-term goals of the ICMIC, and a description of the specific Research Project(s) that will be supported through the Component. Each Research Project is to be presented using the format of a traditional research project [Research Plan: Include Sections a-d (Instructions for PHS 398, Pages 15-17)], but the total number of pages for each Research Component is not to exceed 25. D. Specialized Resources (10 pages each) Specialized Resources may include laboratory and clinical facilities, equipment, and services. For each Specialized Resource, describe in detail the resource(s) that it will provide to the ICMIC. In addition, describe its role in the overall functioning of the ICMIC, including how each resource will enhance multidisciplinary research, and a description of the projects that will be supported by the Specialized Resource. E. Developmental Fund (not to exceed 20 pages) This section should include a description of the Developmental Project(s) that will be initiated during the first year of ICMIC funding, including a summary of which Specialized Resources will support the projects, and to what level that support will occur. Since the Developmental Projects will be flexible, only the first year of projects should be included in the application. However, applicants should include in their budgets appropriate funds to support Developmental Projects in Years 2-5 of the award. The Developmental Fund projects must be multidisciplinary, and each is to be presented using the format of a traditional research project [Research Plan: Include Sections a-d (Instructions for PHS 398, Pages 15-17)]. The number of Developmental Projects to be initiated will be determined by the ICMIC applicants. F. Career Development Component (not to exceed 15 pages) Career Development opportunities sponsored by ICMICs will provide a limited number of investigations with access to a highly cross-disciplinary experience. The extent of the Career Development Component is to be defined by the applicant, based on the needs and capabilities of the ICMIC participants. Applicants for career development support may be new investigators or established investigators who wish to change research directions. Candidates should be scientists who have demonstrated outstanding research potential but who need additional time in a productive scientific environment to establish an independent, multidisciplinary research program. Recruitment must include qualified women, minorities, and scientists with disabilities. To this end, each applicant should propose a clear policy and plan for recruitment of career development candidates. The ICMIC application should propose the number of slots available, the criteria for eligibility and for selection of candidates, and describe the selection process. Also, the application should indicate prospective mentors who are already in place at the proposed ICMIC, briefly describe their research programs, and describe complementary activities that contribute to the environment for career development (e.g., existing training grants, other career development mechanisms and relevant programs). The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 (20817 for express service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC-8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 Applications must be received by Nov. 28, 2000. 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 announcement 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 an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. All clinical trials supported or performed by NCI require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to a data and safety monitoring board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the National Cancer Institute. 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 Division of Extramural Activities of the National Cancer Institute 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 Cancer Advisory 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. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers in assigning the overall score weighting them as appropriate for each application. The overall ICMIC applications will be reviewed using the criteria listed below. Significance: Does the ICMIC address an important imaging research problem? Are the scientific objective(s) of the Research Components, Specialized Resources, Developmental Projects and Career Development Plans appropriate and adequate to achieve the long-term goals of the ICMIC? Approach: Is the conceptual framework and the experimental design, methods and analyses proposed for each of the ICMIC components sound and feasible? Innovation: Are the experimental designs of the proposed research focused on cellular and molecular imaging, and are they original, novel, and innovative? Investigator(s): Is the ICMIC Director and leadership appropriately trained and well suited to the organizational and scientific responsibilities of the ICMIC? Is there evidence that ICMIC participants are committed to productive, multidisciplinary interactions? Have the participating investigators demonstrated significant scientific interaction and productivity prior to the submission of this application? Environment: Is there evidence of significant commitment of the institution to fulfilling the objectives of the ICMIC? 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 in the scientific environment? In addition, each ICMIC component will be reviewed using the following criteria: 1) Organization and Administration: Is the organizational, scientific and operational framework reasonable, well- integrated and appropriate to the aims of the ICMIC? Does the ICMIC employ novel approaches or methods for facilitating scientific interaction? Is the ICMIC Director and leadership appropriately trained and well suited to the organizational and scientific responsibilities associated with this project? Is there sufficient oversight and monitoring of Research Components, Specialized Resources, Developmental Funds and Career Development Programs? Is there evidence of significant commitment of the institution to fulfilling the objectives of the ICMIC? If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the ICMIC? 2) Research Components: The five criteria to be used to evaluate individual Research Components in ICMIC applications are listed below. 1) Significance. Does the Research Component address an important research problem? Does the scientific merit and experimental design of the Research Project(s) adequately address issues of substantive importance? 2) Approach. Are the conceptual research 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 translational approaches? Is there clear evidence of significant multidisciplinary basic and clinical interactions in the conception, design, and proposed implementation of the project? 3) Innovation. Does the Research Project(s) develop new methodologies or technologies? Is the experimental design of sufficient originality, novelty, and innovativeness to make it highly relevant to the overall goals and objectives of the ICMIC? 4) Investigators. Is the lead investigator and the co- investigators appropriately qualified with demonstrated competence to conduct the proposed research? Is the proposed work appropriate to the experience level of the principal investigator and project researchers? Are the proposed time commitments for all key laboratory and clinical researchers reasonable and adequately associated with the project? 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 in the scientific environment or reach out to useful collaborative arrangements? Is there evidence of adequate institutional support? Is the project interactive with other components of the ICMIC 3) Specialized Resources: Is each Specialized Resource essential for the conduct of ICMIC? Is the access to, and distribution of, Specialized Resources focused on meeting the goals of the ICMIC? Are the proposed managers of Specialized Resources adequately qualified of to conduct high quality, reliable resource operations? Are the requested budgets appropriate to conduct each resource operation? 4) Developmental Projects: Do the Developmental Projects demonstrate innovate approaches that integrate multiple scientific disciplines? Do the Developmental Projects establish new, multidisciplinary collaborations focused on cellular and molecular imaging, and are the projects original and innovative? The five review criteria delineated for the research projects will also be applied to the Developmental Projects. However, the Developmental Projects will be reviewed as a cluster , reflecting the cumulative scientific merit of the projects, rather than assigning each project an independent merit rating. 5) Career Development Program: Is the Career Development Program well justified, and does it describe a program that will successfully train investigators capable of establishing independent multidisciplinary imaging research programs? Are the proposed mentors in the Career Development Program experienced in the types of training proposed? Is the process for selecting candidates for training adequate, and does it seek out and include qualified minorities and women? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion, the provisions for the protection of human and animal subjects, and the safety of the research environment. In addition to rating the merit of individual components, peer reviewers will be asked to judge the overall program in the following areas: 1. scientific merit and innovativeness, 2. evidence of interdependent, multidisciplinary design and conduct of the research, 3. impact, or potential for impacting on the discipline of in vivo cellular and molecular imaging, 4. institutional commitment, 5. overall program organization. A verbal descriptor will be recorded for each of the above areas. A single numerical priority score will be assigned to the program as a whole. Although primary emphasis will be placed on scientific merit and innovativeness, significant consideration will be given to multidisciplinary interactions, potential for impacting on the field, and institutional commitment. AWARD CRITERIA ICMIC awards will be based primarily on the basis of scientific merit as determined by peer review, availability of funds, and programmatic priorities. 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 is provided 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. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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 clear and compelling 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 may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. 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, In Vivo Cellular and Molecular Imaging Centers (ICMICs), is related to priority area of cancer. 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. 93.394, Cancer Detection and Diagnosis Research. 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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