COOPERATIVE PLANNING GRANT FOR CANCER DISPARITIES RESEARCH PARTNERSHIP PROGRAM Release Date: August 28, 2002 RFA: CA-03-018 - (Reissued as RFA-CA-09-502) National Cancer Institute (NCI) (http://www.nci.nih.gov/) Letter of Intent Receipt Date: February 20, 2003 Application Receipt Date: March 20, 2003 This RFA is a reissue of CA-02-002, which was published in the NIH Guide on October 19, 2001. 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 National Cancer Institute (NCI) invites cooperative planning grant applications (using the U56 mechanism) in an effort to strengthen the national cancer program by developing models to reduce significant negative consequences of cancer disparities seen in certain U.S. populations. This grant will support the planning, development and conduct of radiation oncology clinical research trials in institutions that care for a disproportionate number of medically underserved, low income, ethnic and minority populations but have not been traditionally involved in NCI-sponsored research. The grant will also support the planning, development and implementation of nurturing partnerships between applicant institutions and committed and experienced institutions actively involved in NCI-sponsored cancer research. All approaches to planning are encouraged, as long as they address the following essential features: a focus on cancer disparities, radiation oncology clinical research, institutional commitment, organizational capabilities, facilities, and interdisciplinary coordination and collaboration. At this time, NCI anticipates issuing another RFA for the establishment of additional Cancer Disparities Research Partnerships in fiscal year 2003. RESEARCH OBJECTIVES Background The burden of cancer is not borne equally by all population groups in the United States. Twenty-nine years have passed since the War on Cancer was initiated, and during this period, the disparities in cancer incidence and mortality in segments of the U.S. population have continued to rise. The unequal burden is exemplified by differences in cancer morbidity and mortality as a function of gender, ethnicity and socioeconomic status. Men are about 50% more likely than women to die from cancer. The incidence of colon and rectum, and lung and bronchus cancers in Alaska Natives and African American men and women is higher than that of other ethnic groups. Death rates from prostate cancer among African American men are almost twice those of white men. The incidence of cervical cancer in Hispanic women has been consistently higher at all ages than for other women, although African American women have the highest rate of dying from cervical cancer. Five-year survival rates by selective sites among populations experiencing the negative consequences of health disparities in the U.S. (e.g., African Americans, Asians, Pacific Islanders, Hispanics, Latinos, Native Indians, native Alaskans, and/or those of low socioeconomic status) are lower than the 5-year survival rates of the rest of the population. The cancer mortality rates for lung, trachea, bronchus, and pleura for minority males and females differ widely when measured by state economic area. Examples of geographical differences are seen in a pattern of excessive prostate cancer among African American males in the Southeastern U.S., particularly in rural areas. High rates of esophageal cancer in the District of Columbia and in the Coastal area of South Carolina appear to be related to alcohol consumption, tobacco use and dietary deficiencies. Persons of low socioeconomic status generally have higher cancer death rates than persons of higher socioeconomic status. The significant negative consequences of cancer-related health disparities are also reflected in risk behaviors and health service utilization. These include higher rates of smoking among some populations (e.g. American Indians), strikingly higher rates of obesity among African Americans and Hispanics, and related dietary practices. Similarly, differentials have been documented by age, income, education, and race/ethnicity in these health practices as well as in cancer screening and treatment. Data confirm lower rates of cancer screening and early detection, differential treatment patterns, and greater frequency of a number of chronic diseases with similar risk profiles to cancer. These and many other factors contribute to more advanced disease at diagnosis, lower survival, and higher cancer death rates among certain population groups. Objectives and Scope Health care institutions providing cancer services to a disproportionate number of medically underserved, low income and/or minority populations, whether urban or rural, are not often linked to the national cancer research enterprise as effectively as they could be and often struggle to maintain state-of-the-art cancer care. As a result, radiation oncologists in these institutions have difficulty in starting, developing, and sustaining research programs either independently or collaboratively. Thus, the populations primarily served by these institutions, largely minority, ethnic, and/or low income, do not readily benefit from the rapid progress being made in cancer research in radiation oncology, and may bear an unequal burden of disease as a result. The populations targeted by this cooperative planning grant tend to access the health care system in the advanced stages of their disease and, because of this, radiation oncology usually represents a major treatment alternative. Therefore, the field of radiation oncology offers a unique opportunity to explore ways to reduce the significant negative consequences of cancer-related health disparities due to its technological base, the facility of application, and as an entry platform for inclusion of medical and surgical oncology research. These institutions, when provided the necessary resources and mentoring and supportive partnership with an experienced and committed research institution, represent an opportunity for conducting and/or expanding participation in clinical trials developed for radiation oncology and combined modality therapy as well as cultural and social-related research important to the understanding of cancer-related health disparities. The low involvement of health care institutions in cancer research that predominantly serve populations who experience the worst consequences of cancer-related health disparities must be addressed. The increased involvement of these institutions is necessary in order to develop a stronger national cancer research effort aimed at understanding the disparities of cancer incidence and mortality in those populations. This cooperative planning effort is dedicated to developing stable, long-term radiation oncology clinical research trials programs and partnerships to increase the participation of applicant institutions in the nation"s cancer research enterprise. Members of the Cancer Disparities Research Partnership (CDRP) would be expected to combine their expertise in working with affected populations to develop outreach programs that effectively reach individuals and physicians and that increase the recruitment and retention of target populations into clinical trials and prevention protocols. The four overall objectives and scope of this Request For Applications (RFA) are to solicit cooperative planning grants that would: 1) build and stabilize independent and collaborative clinical research capabilities of institutions providing radiation oncology care to populations experiencing the negative consequences of cancer-related health disparities, 2) increase the number of clinical scientists engaged in radiation oncology research by providing access to and participation in clinical trials with the target populations, 3) improve the effectiveness of the applicant institution and its partner institution in developing and sustaining activities focused on radiation oncology clinical research trials and mortality and morbidity in cancer among the target populations, continuing past the life of this grant, and 4) establish priorities for and initiate stable, long-term collaborations and partnerships that will strengthen competitive cancer research, research training and career development, education and outreach capabilities at both the applicant institution and the partner institution that address problems and issues relevant to the disproportionate cancer incidence and mortality. The most significant components of a U56 Cancer Disparities Research Partnership application are: 1) a thorough description and implementation plan of the proposed radiation oncology clinical trials research effort that must address the negative consequences of cancer disparities in the population served with the inclusion of examples of pilot clinical trials research projects, and 2) the articulation of the steps to be taken with potential partner institutions during the first year of the award to develop a comprehensive and supportive partnership relationship and the subsequent implementation of that plan over the remaining life of the grant with the selected partner. The expectation is that successful Cancer Disparities Research Partnership projects will ultimately be competitively funded grants (e.g., R03, R01, project on a P01, project on a P50). The National Cancer Institute is strongly committed to reducing cancer-related health disparities across the cancer control continuum from prevention to end- of-life. The NCI"s Strategic Plan to Reduce Health Disparities can be viewed at http://www3.cancer.gov/announcements/healthdisp.html. The Institute supports research to understand the complex causes of disparities in cancer risk, incidence, and mortality, including socioeconomic, cultural, environmental, institutional, behavioral, biological factors, and other contributing factors seen in the health care delivery system. The overall goal is to understand the causes of health disparities and to develop effective interventions to eliminate these disparities that result in significant negative outcomes. More research is needed that specifically addresses these and other cancer disparities if these trends are to be reduced and brought into balance with the rest of the population. Information about cancer incidence and mortality rates in different U.S. sub-populations can be obtained at the following website address: http://www.nci.nih.gov/atlasplus/. MECHANISM OF SUPPORT The RFA will use NIH U56 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 20, 2003. The NIH U56 is a cooperative agreement in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being actively involves as a partner with the Principal Investigator as described under the section "Cooperative Agreement Terms and Conditions of Award." At this time the NCI anticipates that there will not be a renewed competition after 5 years. If the NCI does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. FUNDS AVAILABLE The NCI plans to commit approximately $ 2.8 million in direct costs in FY 2003 to fund up to four new grants in response to this RFA. Any applicant may request a project period of up to five years and an annual budget for direct costs of up to $400,000 per year over five years, excluding one-time capital costs expended in the first year. Because the nature and scope of research and partnerships may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NCI provide for support of this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date is September 20, 2003. ELIGIBILITY REQUIREMENTS Applications will only be accepted from health care institutions accredited by the Joint Commission on Accreditation of Health Organizations or free-standing cancer centers accredited by a nationally recognized accrediting body such as the American College of Radiology, either in the United States or in territories under U.S. jurisdiction, which have Letters of Commitment from potential partners that are NCI-designated Cancer Centers, RTOG participating institutions or other NCI-sponsored cooperative group participating institutions that wish to develop comprehensive partnerships with the applicant institution. Each Cancer Center or cooperative group participating partner institution is limited to no more than one Cancer Disparities Research Partnership (U56) planning grant application. The applicant institution must be the primary provider of radiation oncology care to one or more populations identified with cancer-related health disparities (e.g., African Americans, Asians, Hispanics, Latinos, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders and/or those with low socioeconomic status as defined by the Federal poverty level or the state-defined level, if lower) at a percentage greater than the state average of that population according to the 2000 U.S. Census Bureau statistics, and have a greater cancer incidence and/or mortality than the national average according to NCI data. 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 institutions 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 o The applicant institution must have the necessary facilities to provide radiation oncology services according to current standards, such as three dimensional treatment planning and CT simulation. o The applicant institution must have a level of professional expertise that includes one or more board certified radiation oncologists and physics support at one or more full-time (40 hours) Ph.D. or MS level. o The percentage of one or more of the target populations (e.g., African Americans, Asians, Hispanics, Latinos, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders and/or those with low socioeconomic status) served by the applicant institution must be greater than the state average of that population according to the 2000 U.S. Census Bureau statistics, and have a greater cancer incidence and/or mortality than the national average according to NCI data. o The applicant institution must be a primary provider of care for the population group(s) identified in the bullet above according to the respective State Department of Health statistics. o If the applicant institution currently receives NCI research funding, it cannot exceed $100,000 annually. o If currently participating in NCI-sponsored clinical trials, the applicant institution"s accrual level must be 1% or less of the cancer patient base to qualify. o The applicant must submit base line metrics with the application as described in the Supplemental Application Guidelines. o The applicant institution must identify a Co-PI from each of the proposed partner institutions. o Any new project/program and shared resources for development in response to this RFA must not overlap in purpose and intent with existing projects/programs and shared resources funded at the applicant institution by the NCI Cancer Center Support Grant, National Center for Research Resources Infrastructure Grants, National Institute of General Medical Sciences Minority Biomedical Research Support Grant or any other peer reviewed funded program. o All recipients of CDRP U56 Planning Grant Awards will be expected to participate in an annual meeting sponsored by the Radiation Research Program (RRP) of the NCI. Travel funds for this purpose should be included in the grant application from the applicant institution. o Once a CDRP U56 grant is funded, specific guidelines for non-competing renewal applications will be provided to the grantee. The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of the award. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The administrative and funding instrument used for this program is a cooperative agreement (U56), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI/RRP Program Scientist, as described below. 1. Awardee Rights and Responsibilities a. Awardees have primary authorities and responsibilities for the project as a whole, including defining objectives and approaches, planning, implementing, clinical trials development, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, analysis and interpretation, preparation of publications, as well as collaboration with their partner and other awardees, and with assistance from NCI/RRP Program staff. b. Awardees will be required to participate on and follow the advice and recommendation of the Program Steering Committee, in meeting the intent of the initiative. c. Each partnership should plan regular meetings (no less than monthly) to discuss the progress and directions of its activities to insure that the necessary interactions are taking place. d. The Principal Investigator, Co-Investigators, and other designated investigators will attend an Annual Meeting to be organized by NCI staff in Washington D.C. e. Each partnership will submit annual progress reports to the NCI that describe the activities and accomplishments during the previous funding period as part of the Non-Competing Continuation Renewal. f. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies and agree to the appropriate sharing of methods and data among collaborating institutions. 2. NCI Staff Responsibilities The NCI/RRP Program Scientist will have substantial scientific-programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants. The NCI/RRP Program Scientist will have substantial involvement in assisting the awardee in the development of partnerships, identifying new areas of opportunity, recommending mid-course corrections on an annual basis and generally ensuring that the U56 CDRP remains focused on the intent of this initiative. The NCI/RRP Program Scientist will be involved in the following ways: a. Serve as a voting member on the Program Steering Committee, and, as determined by that committee, its subcommittees. b. Work closely with individual investigators and partners to facilitate successful collaborations. c. Facilitate access to fiscal and intellectual resources provided by NCI, NIH, RRP, industry, private foundations and federal funding agencies. e. Provide assistance in reviewing and commenting on all major transitional changes of the awardee or partner institution"s activities prior to implementation to assure consistency with the goals of this RFA. f. Help reprogram efforts, including options to modify clinical research projects/programs when they are not making headway relative to the time-line for achieving the objectives of the RFA. g. Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success. h. Organize and make final decisions on the agenda for an annual workshop that engages all of the partnerships and other participants as needed. This meeting will be held for all funded investigators to share progress and research insights that may benefit all of the projects. i. Call additional meetings/workshops of the participants to address emerging areas of high priority to the NCI and/or the problems of high cancer incidence and mortality in populations experiencing cancer disparities. An NCI Program Director from the staff of the NCI Radiation Research Program (RRP) will provide the normal level of grant stewardship and monitoring and generally ensure that the U56 CDRP grant efforts remains focused on the intent of this initiative. 3. Collaborative Responsibilities A Program Steering Committee (PSC) will be composed of the Principal Investigator from the applicant institution, who is the Principal Investigator for the award, the Co-Investigator from the institution that was selected as the partner, and the NCI/RRP Program Scientist. The Principal Investigator from the awardee institution, the co-investigator from the partner institution and the NCI/RRP Program Scientist will each have one vote. The chairperson, who will be someone other than the NCI/RRP Program Scientist, will be selected by the PSC. The PSC will meet a minimum of twice a year to review and resolve operational and implementation issues and propose recommendations for establishing or changing priorities. The PSC"s recommendations, in the form of a written annual report, are to be submitted to the leaders of the applicant institution and the partner institution, the Board of Scientific Advisors" Program Advisory Committee and to the NCI. The Program Advisory Committee (PAC) will be composed of three members of the NCI Board of Scientific Advisors and the RRP Program Director as an Ad Hoc member. The Program Advisory Committee will serve as the primary advisory board of the overall grant program with the responsibility to provide advice and make recommendations that include but are not limited to changing priorities and directions or identifying areas of new opportunity. The recommendations are to be used by the principal investigators in guiding and directing the development of the CDRP program. After appropriate discussions, the awardee generally will be expected to accept and implement the recommendations of the PAC, in those situations where the recommendations are not feasible to implement, the Principal Investigator of the applicant institution must provide a thorough explanation and rationale to the PAC. Subcommittees may be established or external advisors may be called upon to provide appropriate advice, as the PSC or PAC deems appropriate. NCI/RRP staff will serve on subcommittees, as the PSC or PAC deems appropriate. An annual meeting of all Principal Investigators, the members of the Program Advisory Committee, the RRP Program Scientist and other experts as necessary will be held to review and discuss individual progress and that of the overall CDRP Program. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipient and the NCI/RRP may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Program Steering Committee (with the NCI/RRP member not voting), or by the individual awardee in the event of an individual disagreement, a second member selected by the NCI, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. 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 grant management issues. Direct inquiries regarding programmatic issue to: Frank Govern, Ph.D. Deputy Chief, Radiation Oncology Sciences Program National Cancer Institute Executive Plaza North, 6015A 6130 Executive Blvd, MSC 7440 Bethesda, MD 20892-7440 Telephone: (301) 496-6111 Fax: (301) 480-5785 Email: governfr@mail.nih.gov Or Norman Coleman, M.D. Chief, Radiation Oncology Sciences Program National Cancer Institute, DCTD, RRP Executive Plaza North, 6015A 6130 Executive Blvd, MSC 7440 Bethesda, MD 20892-7440 Telephone: (301) 496-6111 Fax: (301) 480-5785 Email: ccoleman@mail.nih.gov Direct inquiries regarding review issues to: Referral Officer Division of Extramural Activities 6116 Executive Boulevard, Room 8109, MSC 8239 Rockville, MD 20852 (express service) Bethesda, MD 20892-8236 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: ncidearefof-r@mail.nih.gov Direct inquiries regarding fiscal or budget matters to: Eileen M. Natoli Grants Administration Branch National Cancer Institute 6120 Executive Blvd. EPS - 243 Bethesda, MD 20892 Telephone (301) 496-8626 Fax: (301) 496-8601 Email: natolie@gab.nci.nih.gov LETTER OF INTENT Prospective applicant institutions are asked to submit a letter of intent (LOI) 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 Proposed participating institutions o Number and title of the 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 allow 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: Frank Govern, Ph.D. Deputy Chief, Radiation Oncology Sciences Program National Cancer Institute Executive Plaza North, 6015A 6130 Executive Blvd, MSC 7440 Bethesda, MD 20892-7440 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 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. The application research plan should address the following elements: 1. The objectives and scope of the RFA, 2. Detailed information addressing the ELIGIBILITY REQUIREMENTS Section of the RFA, 3. Detailed information addressing the SPECIAL REQUIREMENTS Section of the RFA, 4. History and background of cancer activities as described in No. 1, Metrics Evaluation Plan of the Supplemental Application Guidelines, 5. Information in response to No. 2,3, and 4, General Information of the Supplemental Application Guidelines, 6. Partnership Plan (see Partnership Plan, Supplemental Application Guidelines), 7. Pilot and Feasibility Studies Examples (see Examples of Pilot Clinical Trials Research Projects, Supplemental Application Guidelines), 8. Budgets for each year over the course of the grant award (see CDRP Allowable Costs, Supplemental Application Guidelines). SUPPLEMENTAL APPLICATION GUIDELINES The NCI has Supplemental Application Guidelines for this RFA that have been added due to the unique aspects of this U56 CDRP RFA. The Supplemental Application Guidelines reside on the Radiation Research Program"s Website: http://www3.cancer.gov/rrp/supguide.html. 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 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 also be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, 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 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 include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and 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, 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. 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. The scientific review group will address and consider each of these in assigning your application"s overall score, weighing them as appropriate for each application. Each of these criteria will be addressed and considered by the reviewers in assigning the 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 a 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 this application bring together sufficient expertise to address an important cancer-related health disparities problem? Particularly significant, what will be the effect of these studies on addressing cancer- related health disparities? If the aims of the application are achieved, how will the collaborative undertaking advance scientific knowledge? 2. Approach. Are the conceptual framework, design, methods and analyses adequately developed, well integrated, and appropriate to the aims of the application? Do letters of commitment support the priorities and objectives of the plan for the collaborative partnership? Does the application demonstrate the ability to achieve a comprehensive partnership plan with one of the interested parties within the one-year develop period? Does the application convincingly demonstrate that these commitments will be stable and long lasting? Does the application exhibit the necessary strength for implementing radiation oncology clinical research trials? Does the applicant provide evidence about the adequacy of the resources (e.g., discretionary resources, space, faculty positions, and protected time for research? 3. Innovation. Are the approaches or methods original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigators and other researchers (if any)? Are the qualifications and experience of the collaborating investigators adequate to provide strong programmatic (e.g., scientific) and administrative leadership? Are the qualifications and experience of other key personnel of the applicant and the interested partners adequate to successfully plan for and achieve the objectives of this planning effort? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed work take advantage of the unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? How would resource/infrastructure provide long-term stability to the activities of the partnership? ADDITIONAL REVIEW CRITERIA In addition to the above criteria, the initial review group will also examine: o the scientific merit of the proposed pilot projects, o the appropriateness of proposed project budget and duration, o the adequacy of plans to include both genders, minorities (and their subgroups), and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, o the provisions for the protection of human participants, o the safety of the research environment, o the adequacy of the Data and Safety Monitoring Program to be in place prior to the start of patient protocol activity, o the adequacy of the proposed plan to share data. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt: February 20, 2003 Application Receipt Date: March 20, 2003 Peer Review Date: May/June, 2003 Review by NCAB Advisory Board: September, 2003 Earliest Anticipated Award Date: September 20, 2003 AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon the following: o the scientific merit (as determined by peer review) o the availability of funds o the geographical location o the programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Clinical trials supported or performed by NCI require special consideration. 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 the 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. 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 plan for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided that the inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the 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 Contract 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 that: a) all applications and 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 and supported by the NIH, unless that are scientific and ethical reasons not to include them. This policy applies to all initial (Type I) 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 is now available online at http://cme.nci.nih.gov/. 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 or 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 applications 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 subject 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. 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 of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to the priority areas of cancer and health disparities. 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. 93.398, Cancer Research Manpower 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 and Federal Regulations 42 CFR Parts 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant and contract 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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