IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICs) Release Date: August 7, 2002 (see addendum NOT-CA-02-025) RFA: CA-03-015 National Cancer Institute (NCI) (http://www.nci.nih.gov/) LETTER OF INTENT RECEIPT DATE: October 21, 2002 APPLICATION RECEIPT DATE: November 25, 2002 This RFA is a reissue of RFA-CA-01-014, which was published in the NIH Guide on August 7, 2000. THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism 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 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). This initiative is 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. ICMICs 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, physics, computer science, biomedical engineering, immunology, pathology 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 or 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. 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 funding for several Research Components. Research Components will apply multidisciplinary approaches to the integration of molecular imaging and cancer. Individual research projects will be structured in order to maximize the utilization of the Specialized Resources (see below). The Research Components will be similar in size and scope to a typical R01 or subproject of a P01, and will be expected to meet the same standards of preliminary data in support of the hyptheses. P01. 3) 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). 4) 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. 5) 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. SPECIAL REQUIREMENTS ICMIC investigators will be expected to participate in ICMIC/Pre-ICMIC workshops and investigators meetings as necessary 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 July 1, 2003. There will be a single receipt date for P50 grants to be funded in FY 2003. However, contingent upon the future availability of funds for these grants, the NCI anticipates 1 additional receipt date for P50 applications to be funded in FY 2004. FUNDS AVAILABLE NCI intends to commit approximately $4,000,000 total costs in FY 03 to fund 2 new ICMIC grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $2,000,000 per year. 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 NCI 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. 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 Domestic Applications from foreign institutions will not be accepted. Applications from institutions which are current recipients of P50 ICMIC awards will not be accepted. Foreign components of applications from domestic organizations will be accepted with adequate justification. 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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Anne E. Menkens, Ph.D. Bomedical Imaging Program National Cancer Institute Executive Plaza North, Room 6068 Bethesda, MD 20892 Telephone: (301) 496-9531 FAX: (301) 480-3507 Email: am187k@nih.gov o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncidearefof@mail.nih.gov o Direct your questions about financial or grants management matters to: Eileen Natoli Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS-243 Bethesda, Maryland 20892 Telephone: 301-496-8791 Fax: 301-496-8601 Email: natolie@gab.nci.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Anne E. Menkens, Ph.D. Biomedical Imaging Program National Cancer Institute Executive Plaza North, Room 6068 Bethesda, MD 20892 Telephone: (301) 496-9531 FAX: (301) 480-3507 Email: am187k@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. SUPPLEMENTAL INSTRUCTIONS: 1) Budget(s): The budget(s) should be presented in logical, discrete units for each section of the application using the standard PHS-398 form pages 4-5. The budgets to be submitted should include: a) A detailed composite budget for the entire ICMIC b) A separate budget for Administrative and Organizational activities c) A separate budget for each individual Research Component d) A separate budget for each Specialized Resource e) A single budget section for the Developmental Component f) A single budget 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 application should be as concise as possible to ensure a thorough review. A. ICMIC Description (not to exceed 10 pages) This section should be used to present the overall vision for the ICMIC. This summary should include the long and short-term scientific objectives, a description of the ICMIC as an integrated functioning unit, 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, and their relationships to each other. In addition, describe relationships between the ICMIC and other research, academic, and administrative units of the institution (such as centers, institutes, departments) and the central administration.. The ICMIC description should serve as an overview of the ICMIC, with more detailed description of each component to be presented in a later section. B. Organization and Administration (not to exceed 20 pages, including any organizational charts). A separate budget should be prepared and included for centralized administrative and organizational activities. 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 Research Component. o description of decision-making, oversight responsibilities and anticipated utilization for each Specialized Resource. If existing resources are to be utilized by the ICMIC, state explicitly how they differ from new Specialized Resources to be established as a part of the ICMIC, and what arrangements have been made to ensure access by ICMIC Investigators to those existing resources. 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 Inter-ICMIC meetings in the Washington DC area. C. Research Components (not to exceed 25 pages each) Research Components will define the scientific projects supporting the long-term goals of the ICMIC, and are 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 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. 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. The total number of pages for each Research Component is not to exceed 25. Describe each Research Component in sufficient detail to enable reviewers to judge the scientific merit from the written application. Do not present separate "subprojects." All projects are to have a single theme, project leader and budget. Following the description of the scientific goals, each Research Component should summarize exactly how the project integrates with the goals of the ICMIC, how it will communicate and complement the other Research Components, and how it will utilize the Specialized Resources. Describe in this section the relevance of the project to the primary theme of the ICMIC and the collaborations with investigators within the ICMIC. Explicitly state which Specialized Resources will be used by this Research Component, and, if possible, quantitate the anticipated usage of Specialized Resources in tabular format. This summary should not exceed 1-2 pages, which are included in the 25 page limit for each Research Component section. D. Specialized Resources (not to exceed 15 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. 1. Using a Form PHS 398 Continuation Page, denote "Specialized Resource" and the Specialized Resource director"s name. If there is to be more than one core component, prepare a separate section for each core (i.e., Specialized Resource A, Specialized Resource B, etc.). 2. For each Specialized Resource, describe the role of the Specialized Resource as a core to the ICMIC as a whole. Clearly present the facilities, resources, services, and professional skills that the core component provides. 3. To aid in the review, it is suggested that a table to show the estimated or actual proportional use of this Specialized Resource by each project, be included in the application. Justify this core component by discussing ways in which these centralized services improve quality control, produce an economy of effort, and/or save overall costs compared to their inclusion as part of each project in the P50 ICMIC. 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. The description of decision-making and oversight responsibilities,including the process for selecting, monitoring and terminating the Developmental Projects should be included in the "Organization and Administration" Section of the application. This section should include only the scientific portion of the Developmental Projects. The Developmental Projects should provide an avenue for introducing and integrating new investigators and innovative technologies / methodologies into the ICMIC infrastructure (in specific) and molecular imaging (in general). It should not be viewed as a supplemental source of funding for investigators that are already heavily invested in the success of the ICMIC. 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 also 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 trainees 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 and minorities. 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). 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 three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. 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 NCI program staff. Incomplete 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 (DEA) at NCI 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 Those that receive a priority score will undergo 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 cancer-related 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? Do the individual Research Components interact appropriately with the other Research Components and Specialized Resources? Innovation: Are the experimental designs of the proposed research focused on cellular and molecular imaging of cancer, 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? 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. a) Significance. Does the Research Component address an important research problem related to cancer imaging? Does the scientific merit and experimental design of the Research Project(s) adequately address issues of substantive importance? b) 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? c) 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? d) 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? e) 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? 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: The Developmental Projects will be reviewed as a "cluster", reflecting the cumulative scientific strength of the projects and the process, rather than assigning each project an independent meritrating. Do the Developmental Projects demonstrate innovate approaches that integrate multiple scientific disciplines? Do these projects reflect a careful selection process focused on scientific quality and innovation? Do the Developmental Projects establish new, multidisciplinary collaborations focused on cellular and molecular imaging of cancer, and are the projects original and innovative? 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. 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. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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 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: October 21, 2002 Application Receipt Date: November 25, 2002 Peer Review Date: February/March 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 1, 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. 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 or 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 for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ 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. A continuing education program in the protection of human participants in research in now available online at: http://cme.nci.nih.gov/ 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. 93.394, Cancer Detection and Diagnosis Research, 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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