RFA-CA-01-003: PLANNING GRANT FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATION

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PLANNING GRANT FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATION Release Date: April 25, 2000 RFA: CA-01-003 National Cancer Institute Office of Research on Minority Health Letter of Intent: June 8, 2000 Application Receipt Date: July 26, 2000 PURPOSE The National Cancer Institute (NCI) and the NIH Office of Research on Minority Health (ORMH) invite planning grant applications (i.e., P20s) for the development of formal collaborations between scientists and faculty in Minority-Serving Institutions (MSIs) and scientists and faculty in Cancer Centers (i.e., NCI-designated Cancer Centers and other institutions with highly organized, integrated research efforts focused on cancer). Both MSIs with medical schools and MSIs with more focused research and education programs (e.g., Masters, and Ph.D. programs) are invited to participate in this initiative. The goals of these collaborations are to increase the involvement of scientists in minority institutions in cancer research, to expand training and career development opportunities for minority scientists and to increase the effectiveness of Cancer Centers in developing collaborative projects and programs that directly address and have the potential to reduce disproportionate cancer incidence and mortality in minority populations. The purpose of this request for applications (RFA) is to solicit planning grants (P20s) that would plan for and initiate pilot projects/programs for focused collaborations between scientists and faculty at MSIs and Cancer Centers. These collaborations would be required to demonstrate a clear mutual benefit and required to focus a major portion of their effort on developing collaborative research projects or research training and career development programs; however, planning efforts are also encouraged in the areas of cancer education and outreach to minority communities. The expectation is that these planning grants will become the basis for generating an array of competitively funded grant applications by the NCI and other cancer research funding organizations (e.g., American Cancer Society), and other grants such as multidisciplinary research grants (e.g., R01s, P01s, P50s); training and career development grants (e.g., T32s for basic scientists; K12s for clinical researchers); and or education grants (e.g., R25s). 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, Planning Grant For Minority Institution/Cancer Center Collaborations, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications will only be accepted from MSIs, either in the United States or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers or that can demonstrate organized, highly integrated research efforts focused on cancer. Minority-Serving Institutions are those in which students of minority groups, who are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders), comprise a significant proportion of the enrollments AND that have a track record of commitment to the special encouragement of minority faculty, students and investigators. A list of the eligible Minority-Serving Institutions can be found at the following website address: http://www.sciencewise.com/. A list of NCI-designated Cancer Centers can be found at the following website address: http://www.nci.nih.gov/cancercenters/ Each collaboration must be submitted as two applications, one from the MSI and one from the cancer center, but with separate complimentary budgets to achieve common goals and objectives. Each Principal Investigator must be listed as a Co-Investigator on the complimentary application (See below for further instructions). The Principal Investigators must be U.S. citizens, non-citizen alien nationals, or permanent residents of the United States. Each MSI and Cancer Center is limited to participating in no more than TWO applications either in response to this initiative for planning grants (P20s) or to the initiative for cooperative planning comprehensive partnerships between MSIs and NCI-designated Cancer Centers (U20s) or the initiative for Comprehensive Minority Institution/Cancer Center Partnerships (U54s). If participating in two applications, each application must be with a different collaborator. MECHANISM OF SUPPORT This RFA will use the P20 or planning grant mechanism. The Principal Investigators on behalf of the institutions are responsible for the conduct of this planning activity with strong commitments from the MSI and the Cancer Center enabling the success of the collaboration. This RFA is a one-time solicitation. If it is determined that there is a continuing program need, the NCI will either reissue this RFA for re-competition or invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review. If the NCI does not continue the program, awardees will be able to submit grant applications through existing investigator-initiated grant programs. ALLOWABLE COSTS The P20 will provide support for: 1. Administrative Costs (not to exceed 20% of the total direct costs) for managing the planning effort such as: a. Salaries for key personnel b. Travel for key personnel c. Travel and per diem for outside advisors d. Equipment and supplies to support an administrative structure 2. Developmental Funds for: a. Workshops, retreats, seminars and other forums to identify areas of greatest opportunity and highest priority and/or to merge existing programs and/or to create new center/ minority institution programs. b. Pilot research projects or pilot programs (not to exceed $100,000 in direct costs per project per year). c. Support for research assistants and research associates in various stages of their career development as independent scientists. d. Start-up packages for newly recruited investigators in areas of development and stabilization. Funds may NOT be used to purchase equipment unless included as part of start-up package for a faculty recruitment. (In this case, the maximum allowable costs for such equipment items cannot exceed $10,000 for research purposes without prior approval by the NCI.) FUNDS AVAILABLE This RFA is a one-time solicitation. NCI/ORMH anticipate making approximately ten 3-year awards, and plan to set aside a total of $4.0 million for the first year of funding. The total annual directs cost budgets for the MSI and the Cancer Center applications together are expected to range between $100,000 and $250,000. Third party contractual F&A costs will not be counted toward the maximum combined direct costs of $250,000. Applications exceeding the $250,000 direct cost limit will be considered unresponsive to this RFA and will be returned without further consideration. Funding in response to this RFA is dependent upon the receipt of a sufficient number of meritorious applications. Although this program is provided for in the financial plans of NCI/ORMH, the award of grants pursuant to this RFA is contingent upon the anticipated availability of funds for this purpose. Awards are not renewable. The NCI/ORMH will make a commitment for funding the collaboration for the full term of the award. The anticipated award date is March 1, 2001. OBJECTIVES Background: Minority-Serving Institutions (MSIs) [e.g., Minority Medical Schools, Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, (HSIs) Tribal Colleges] conduct high quality programs for educating minorities, and they represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in cancer research. However, MSIs have had difficulties developing and sustaining independent programs in biomedical research, and there is a paucity of minority scientists who are pursuing successful biomedical research careers. Despite various initiatives by the community and the National Institutes of Health (NIH), progress in realizing a significant increase in the number of minority scientists who are competitive for NIH research grants has been slow. More specifically, there remains a serious shortage of funded minority scientists who can conduct independent cancer research, who can focus research efforts on the disproportionate incidence and mortality rates in minority populations and who can bring the cultural perspectives that are essential to the successful conduct of many forms of research involving minority patients and populations. The NCI-designated Cancer Centers and other institutions with highly organized and integrated cancer research and training programs are geographically dispersed. Many of these centers engage in extensive outreach and education programs designed to reduce cancer incidence and mortality in the communities they serve. Yet, the progress of cancer centers in focusing on research issues of particular importance to cancer in minorities, in training minority scientists, in reaching out to and partnering with different minority populations in their communities, and in bringing the benefits of biomedical research to these populations has been slow and often disappointing. The low involvement of MSIs in cancer research and lack of significant training of minority scientists in cancer research must be addressed if we are to develop a stronger national cancer research effort aimed at understanding the disparities of cancer incidence and mortality in minorities compared majority populations. The potentials for identifying and training minority students and faculty in areas of cancer research have not been fully explored. One untried and potentially powerful approach for addressing these difficult issues is to create and sustain collaborations between the scientists and faculty of MSI's and cancer centers in ways that integrate and take maximum advantage of their respective expertise and experience. MSIs and cancer centers potentially can help each other get better and collaborate in areas that neither can do as well alone. Through planning activities dedicated to developing stable, long-term collaborations that are mutually beneficial to the scientists and faculty of MSIs and cancer centers, the objectives of NCI and ORMH are to increase the participation of MSIs in the nation's cancer research and research training enterprise, to increase the involvement and effectiveness of the cancer centers in research and research training related to minorities, and to develop more effective research, education and outreach and programs that will have an impact on minority populations. Within these objectives, four broad areas can be targeted for development: 1. Cancer Research: Cancer research or cancer research training must be a significant component of this collaborative planning activity. Joint research projects may be in any area of basic, clinical, prevention, control, behavioral, or population research. Collaborative research projects conducted primarily at the MSI may be in any area of cancer research, but research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in minority populations. Collaborative cancer research projects might focus, for example, on general areas of environmental carcinogenesis, molecular epidemiology, and behavioral issues related to cancer prevention and control. Successful planning efforts and pilot projects are expected to result in the submission of competitively funded research grant applications (e.g., R01, P01, SPORES). 2. Cancer Research Training and Career Development: Cancer research training or cancer research must be a significant component of this collaborative planning activity. Cancer research training programs can be for any areas of cancer research but must focus on joint programs organized and conduced by the scientists and faculty of both the MSI and Cancer Center. Training programs should place a high emphasis on training minority scientists and on educating majority trainees to appreciate the issues and problems associated with cancer incidence and mortality disparities in minority populations. The NCI encourages training of minority scientists in clinical research and population research; there is a clear deficit of minority scientists engaged in these research areas and they are highly dependent for their success on the cultural sensitivity of the researchers. These training programs should function seamlessly across the institutional boundaries of the MSI and the cancer center. Successful planning activities and pilot programs should result in funded multi-institutional training grants (e.g., T32, R25, K12). 3. Cancer Education: Cancer education program could focus on any effort to augment existing or create new curricula in the MSI and/or the cancer center that would appraise and culturally sensitize graduate students and postdoctoral students in research, medicine and public health of the need to reduce disproportionate cancer incidence and mortality in minority populations. A successful planning effort is expected to result in a competitively funded R25 education grant and later to institutional commitments to make these curricula an inherent component of their educational systems. 4. Cancer Outreach: Outreach programs may be defined as proactive efforts to help minority communities develop and manage their own culturally sensitive programs for educating their populations about cancer risk, early detection, screening, prevention, and treatment. MSIs and Cancer Centers would be expected to combine their expertise in working with leaders and organizations in the community to develop education programs that effectively reach individuals and physicians and that increase the recruitment and retention of racial and ethnic minorities into clinical trials and prevention protocols. The MSI/Cancer Center collaborations could help communities develop activities such as the following: (a) utilize church networks to reach and educate the citizens of minority communities about prevention, early detection and treatment of cancer; (b) work with civic organizations to develop programs that encourage life-style changes important for cancer prevention and that emphasize the importance of early detection and diagnosis; (c) develop continuing education programs for community health care providers to ensure that they are providing state-of-the art care and advice to their patients; (d) train communities to use and link these communities to the electronic information systems that can educate individuals about cancer and help them make informed decisions about their health. SPECIAL REQUIREMENTS AND PROVISIONS OF PLANNING GRANTS FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATIONS (MI/CCC) There are a number of Special Requirements and Provision that each Minority Institution Cancer Center Collaboration planning grant application (P20) must comply with: 1. Each MSI and Cancer Center is limited to participating in no more than TWO applications (see ELIGIBILITY REQUIREMENTS). If participating in two applications, each application must be aligned with a different collaborator. 2. Of the four areas being targeted by this initiative (i.e., cancer research, research training and career development, education and outreach) either cancer research or cancer research training must be the major component. 3. There must be written "Letters of Commitment" from the MSI leadership and the cancer center leadership that are fully supportive of this planning activity specifying what efforts will be made to ensure that these planning activities will have the maximum chance of success. These efforts might include protected faculty time, provisions to recruitment new faculty, space and facilities for new projects/programs, capital improvements, etc. 4. Each collaborative planning activity must be submitted as two planning grant applications, one from the MSI and one from the cancer center. The Principal Investigator of the MSI grant application must be the Co-Investigator of the center grant application and visa versa. The overall specific aims of the two applications must be the same, but the actual activities and budgets of the two applications should demonstrate how the MSI and the Cancer Center requests compliment each other in achieving their common objectives. 5. The two applications must clearly outline the mutual benefits to be gained by the MSI and the Cancer Center as a result of the collaboration. 6. The total direct costs of the two applications together cannot exceed $250,000. If there are third party subcontract costs, only the direct costs of the subcontract will count against this cap. 7. No more than 20% of the total direct costs of the collaboration can be devoted to Administrative Core expenses. 8. Pilot research projects originating from the MSI can be any research relevant to cancer, but research originating at the Cancer Center should focus on problems highly relevant to areas of cancer disparity in minority populations. 9. There must be a common planning and evaluation component shared between the MSI and the Cancer Center. The planning process should identify opportunities and set priorities for collaboration. This must involve external expert advisors (e.g., as individuals or as a committee) who provide written formal evaluations of the planning effort with their recommendations. These evaluations must be included as part of the Non-Competing Continuation Application progress reports submitted to the NCI each year. 10. The use of Developmental Funds to support pilot projects and pilot programs must be for totally new activities that do not overlap with or duplicate any existing funded grants (e.g., P30, SPORES, P50, P01, R01, RCMI, or MBRS). 11. In using Developmental Funds to support pilot research projects or pilot research training, education or outreach programs, each project/program must be co-led by individuals from both the MSI and the Cancer Center. 12. The MSI and the Cancer Center must have a common process in place for selecting and closing pilot projects or programs and recruitment of new investigators on the basis of their merit and productivity and their relationship to overall priorities and objectives as determined through collaborative planning activities and this process must serve as the basis for distributing Developmental Funds. The rationale for using all Developmental Funds would have to based on careful planning and evaluation activities conducted by the P20 MI/CCC program. No individual pilot project/program can exceed $100,000 in direct costs per year. 13. All recipients of P20 MI/CCC Planning Grant Awards will be expected to participate in an annual meeting sponsored by the Comprehensive Minority Biomedical Branch (CMBB) of the NCI. Travel for this purpose can be included in the grant applications from the MSI and the Cancer Center institution. 14. Once a P20 MI/CCC grant is funded, specific guidelines for Non-Competing renewal applications will be provided to the grantees. 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 subpopulations must be included in all NIH-supported biomedical research projects involving human subjects, unless clear and compelling rationale and 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 "NIH Guidelines for Inclusion of Women and Minorities as subjects in Clinical Research", which have been published in the federal register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contract, 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 and supported by the NIH, unless that are clear and compelling 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 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 PREAPPLICATION MEETING The NCI /CMBB and the ORMH strongly encourage all potential applicants to attend a pre-application Technical Assistance Workshop (TAW) on May 12-13, 2000 in New Orleans, LA. Since this is an entirely new concept for the NCI and for the applicant population, it will give staff the opportunity to clarify any perceived ambiguities in the RFA and help applicants to present their strongest case for developing an application. If one is unable to attend the technical assistance workshop the results of the workshop can be accessed at the Web site http://deainfo.nci.nih.gov/cmbs/index.htm. These results will be posted by July 1, 2000. In addition, NCI strongly encourages pre-application consultations with individual collaborators either as telephone conference calls or as face to face meetings. In order to make these arrangements contact Dr. Sanya A. Springfield at by email at springfs@mail.nih.gov or by phone at (301) 496-7344 or Dr. Brian Kimes by email at kimesb@mail.nih.gov or by phone at (301) 496-8537. 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. LETTER OF INTENT Prospective applicants are asked to submit by June 8, 2000, a letter of intent (LOI) that includes a descriptive title of the proposed P20 collaborations, address, and telephone number of the Co-Investigators, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allow NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the program staff members listed under INQUIRIES by the letter of intent receipt date. APPLICATION PROCEDURES The following procedures apply to both the MSI application and the cancer center application, which are to be submitted as a collaborative effort: Applications are to be submitted using the Form PHS 398 (rev. 4/98) using the SUPPLEMENTAL INSTRUCTIONS provided below and at http://deainfo.nci.nih.gov/cmbs/index.htm on or before July 26, 2000. A Form PHS 398 (rev. 4/98) application kit is available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Phone: (301) 710-0267; FAX: (301) 480-0525; Email: grantsinfo@nih.gov. Forms are also available on the following NIH website: http://grants.nih.gov/grants/funding/phs398/phs398.html. NOTE: The RFA label available in the PHS 398 (rev.5/95) application form must be affixed to the bottom of the face page of the application and title "P20 MI/CCC " must be typed on line 2 of the face page of the application form and the YES box must be marked. Type the RFA number on the label. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for the review. 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. A cover letter must be attached to the application clearly defining the MSI or Cancer Center collaborator; this will allow the NCI to assemble the two applications as one package for peer review. Submit signed, typewritten originals of the cover letters, the MSI application and the Cancer Center application with their checklists, and three signed photocopies to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 or Bethesda, MD 20817-7710 (for express/courier service) At the time of submission, two additional copies of the cover letter and application must be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) As noted above the instructions for the Form PHS 398 do not entirely apply to the submission of a P20 MI/CCC grant application. Accordingly, the NCI strongly suggests that you follow the SUPPLEMENTAL INSTRUCTIONS below, which have been adapted to accommodate the Form PHS 398, and the special needs of this P20 MI/CCC RFA. These instructions include all of the information that will be needed by the peer reviewers of your applications. SUPPLEMENTAL INSTRUCTIONS 1. Face Page: Use page AA as instructed in the Form PHS 398. On line 1 provide a title that is representative of your collaboration or partnership. This title should be the same for both the MSI application and the Cancer Center institution's application. For line 2 enter the title "P20 MI/CCC" and the number beginning with RFA-00-XXX. Remember to fix the RFA label that comes with the Form PHS 398 to the bottom of the Face Page. 2. Description, Performance Sites and Key Personnel: Use page 2 of the Form PHS 398 and follow the instructions provided in the Form PHS 398. 3. Table of Contents: Organize the Table of Contents as described below: Content Page Number Face Page Description, Performance Sites and Key Personnel Table of Contents Detailed Budget for Initial Budget Period: a. Administrative Core b. Developmental Core Budget for Entire Proposed Period of Support a. Administrative Core b. Developmental Core Budgets Pertaining to Consortium/Contractual Arrangements (e.g., more than one MSI/Cancer Center is involved) Biographical Sketch of Principal Investigator (not to exceed two pages) Biographical Sketch of Co-Investigator (not to exceed two pages) Biographical Sketches of Key Professional Personnel of the MSI or Cancer Center (not to exceed two pages for each individual) Biographical Sketches of External Advisors (not to exceed two pages for each individual) List of participating members of the MSI or the Cancer Center Other Support of Principal Investigator, Co-Investigator and Key Personnel Resources Plan for Developing the Collaboration: a. Background b. "Letter of Commitment" from the Institution or Cancer Center c. Objectives (with expected times for completion; these should be the same in both the MSI and the center applications) d. Scientific and Administrative Leadership e. Planning Activities f. Method of Evaluating and Prioritizing Pilot Research Projects and Pilot Programs that will use Developmental Funds g. Proposed Pilot Research Projects (if known) to be supported with Developmental Funds h. Proposed Pilot Programs (if known) to be supported with Developmental Funds i. Faculty Recruitment to be supported with Development Funds j. Annual Evaluation of Progress k. Human Subjects l. Vertebrate Animals m. Consortium/Contractual Arrangements n. Check List 4. Detailed Budget for Initial Budget Period: Use DD (Form page 4) of the Form PHS 398 application kit. Separately break out the budget using different Page 4s under the headings: a) Administrative Core; and b) Developmental Core. a) For the Administrative Core denote all the costs for salaries of both scientific and administrative personnel; travel and per diem for scientific and administrative personnel and outside advisors; and equipment and supplies to support the administrative needs of the planning effort. The corresponding Principal Investigator of the partner P20 application should be listed as the Co-Investigator with no salary. b) For the Developmental Core use separate page 4s for costs for each of the following: 1. Developmental Funds/Workshops and Retreats: within this budget specifically denote the workshop, retreat, etc. by title and break out the costs by category 2. Developmental Funds/Pilot Research Project 1 with title, Pilot Research Project 2 with title etc. 3. Developmental Funds/Pilot Program 1 (e.g., training, education, and/or outreach) with title; Pilot Program 2 with title etc. 4. Developmental Funds/Faculty Recruitment 1 with title etc. 5. Budget for Entire Proposed Period of Support: Using Page EE (Form Page 5) of the Form PHS 398, follow the instructions in the Form PHS 398 application kit. Provide specific justifications for costs in the first year but only provide costs for future years only when there are specific items requested in future years that exceed standard costs of living increases. 6. Budgets Pertaining to Consortium/Contractual Arrangements: Use this category if more than one MSI or Cancer Center is being linked in a collaboration. In this case, one of the MSI/Cancer Center institutions would have to serve as the primary grantee and subcontract for the consortial involvement of the other MSI/Cancer Center. 7. Biographical Sketch of Principal Investigator: Use Page FF (Form page 6) of the Form PHS 398 and follow the instructions in the application kit. 8. Biographical Sketch of the Co-Investigator: Use Page FF and follow the instructions in the Form PHS 398 application kit. 9. Biographical Sketch of Key Professional Personnel of the MSI or the Cancer Center. Use Page FF as above. This section should include all professional individuals who serve in middle leadership roles. The biographical sketches of those Co-Leaders of Pilot projects/programs and resources, as well as any named individuals who are going to be recruited should be provided in the appropriate sections of this application. 10. Biographical Sketches of External Advisors: Use Page FF and follow instructions in the Form PHS 398 application kit. The same advisors will also be included in the sister application. 11. List of participating faculty/members of the MSI or Cancer Center alphabetically by name. Include for each individual their degree, department affiliation or equivalent, and research or other interest (e.g., research area, training, education, or outreach). 12. Other Support: Using Page GG, provide other support only for the Principal Investigator, Co-Investigator and other key professional personnel at either the MSI or the Cancer Center and follow the instructions in the Form PHS 398 application kit. 13. Resources: Using Page HH, follow the instructions in the Form PHS 398 application kit. 14. PLAN FOR DEVELOPING THE COLLABORATION: a) Background: This section should be the same for MSI and Cancer Center P20 MI/CCC applications. It should describe the characteristics of the MSI and the Cancer Center that will contribute to a planning effort resulting in specific mutual benefits and complementation of each partners strengths and weakness to accomplish goals and objects that neither could achieve as successfully alone. It should clearly denote the nature of the interactions and deliberations that occurred and the individuals involved between the MSI and the Cancer Center during the preparation of these applications. b) Letter of Commitment: The MSI institutional leadership (e.g., Dean, President) and the Cancer Center leadership (e.g., Center Director, Dean) should include a statement describing how the MSI or Cancer Center will provide the necessary support to ensure the success of this collaborative planning effort. This support could be in the form of protected time for faculty to participate in and focus on the objectives of this grant, faculty appointments that will be dedicated to this effort, discretionary resources that will be made available to the Principal and Co-Investigators and purchase of sophisticated equipment for critical infrastructure needs. When Cancer Centers are NOT NCI-designated Cancer Centers, there should be a clear summary of the qualities of the institution that demonstrate that it has a highly organized and integrated cancer research program comparable to an NCI-designated cancer center. c) Objectives (with Expected Times for Completion): This section should be the same for the MSI and the Cancer Center application. Each application should list the specific interim and final objectives that are expected to be achieved in chronological order with the expected times (e.g., months, years) for completion during the period requested in this grant. For each objective, a brief statement should be made about the separate contributions of the cancer center and the MSI in order to achieve success and realize mutual benefits. A final objective in planning a focused collaboration might be the submission of a joint training grant (T32) to the NIH or a joint Program Project Research Grant (P01). d) Scientific and Administrative Leadership: Briefly describe how the Principal Investigator was chosen in terms of his/her qualifications and experience to provide leadership and cohesion for this effort and to promote collaboration and cooperation in achieving the common objectives as outlined in the Background and Objectives sections above. Also, if there are other mid-level leaders who will play a significant role in determining the success of this planning grant, provide the same information for them. e) Administrative Core (No more than 10 pages): Describe the leadership and specific functions of the administrative core to provide the necessary regular day-to-day oversight, coordination, support, and logistics services needed to make this partnership function effectively. This might include organizing meetings, workshops, and retreats; documenting the results of activities; providing critical secretarial services, etc. f) Planning Activities: Describe the kinds of planning activities that the MSI and the Cancer Center will conduct to ensure a highly interactive and integrated effort between the faculty and scientists of the MSI and the faculty and scientists of the Cancer Center. Relate each planning activity (e.g., workshop, retreat, executive meeting) to specific objectives above and denote the specific faculty by name and their interests (training clinical oncology researchers, research in prostate cancer, establishing new curriculum in nutrition, etc.) who will participate in each activity. Describe what advice and oversight role for planning will be asked of the External Advisors. g) Method of Evaluating and Prioritizing Pilot Research Projects, Pilot Programs, Faculty Recruitment that will use Developmental Funds: Describe how the Developmental Funds will be allocated based on the merit of proposals and their potential to successfully achieve the objectives of this planning effort. Describe the shared role of MSI and the Cancer Center faculty by name and expertise in accomplishing this task. Do not forget the requirement for co-leadership of developmental activities (e.g., pilot research projects). THE USE OF DEVELOPMENTAL FUNDS IN PARTS g., h., i., and j. BELOW IS INTENDED TO BE VERY FLEXIBLE AND RESPONSIVE TO THE PLANNING AND PRIORITY SETTING ACTIVITIES OF THE MSI AND THE CANCER CENTER DURING THE COURSE OF THE GRANT h) Proposed Pilot Research Projects to be Supported with Developmental Funds: Pilot research projects must have co-leadership by individuals from the MSI and the cancer center. Each Pilot Project should include the following: 1. Title 2. Names of the Co-Leaders from the MSI and the Cancer Center 3. One paragraph abstract 4. One paragraph describing how this pilot project relates to the overall objectives of the collaboration as described in the Background and Objectives section above. 5. Detailed budget page for initial budget period using page DD from form PHS 398. 6. Biographical Sketches of Co-Leaders 7. Research Proposal (no more than two pages) 8. Describe what aspects of the research proposal will be conducted at the MSI and/or the Cancer Center 9. Human Subjects** **NOTE: (1) All NIH-supported biomedical or behavioral research projects involving human subjects must consider appropriate inclusion of Gender and Minorities and Children as noted on pages 16 and 17 and 27-33 of the Form PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on pages 17 and 18 of the Form PHS 398 instructions; (3) Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. Funds should be budgeted for these activities and should be justified. The proposed provisions should not duplicate review and monitoring systems already in place at the institution. For any cancer treatment protocol supported directly or indirectly by the P20 MI/CCC, informed consent forms, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols subsequent to funding of a P20 MI/CCC, to the NCI program director. i) Proposed Pilot Programs to be Supported with Developmental Funds: Pilot Programs require co-leadership by individuals from the MSI and the Cancer Center. Use a format adapted from the Pilot Research Project format above. See NOTE above for Pilot Research Projects in case this applies to any Pilot Program using human subjects that will be funded by this grant. j) Faculty Recruitment to be Supported with Developmental Funds: Depending upon the nature of the proposed planning activity, recruitment of faculty or additional mentored research of existing faculty may be necessary to build the Research capability of a MSI. The following information should be provided for Faculty Recruitment: Individual who are known: 1. Provide the Biographical sketch of the individual 2. Describe how the individual fulfills the objectives of the planning grant as described in the Background and Objectives sections above 3. Describe the nature of the position that provides the necessary stability (e.g. tenure track) and resources (e.g. space) to promote success. 4. Describe the location of the individual at the MSI or the cancer center and how this location will best achieve the objectives of the planning grant. Individual who are not known (i.e., planned for): 1. Describe the number and expertise of the individuals to be recruited over the three year period of this grant in order to strengthen its capabilities (e.g., epidemiology, prostate cancer, breast cancer, behavioral research, outcomes research, community outreach, molecular genetics) in those areas needed to fulfill its objectives. Budget: The budget can provide salary and start-up packages for new recruitments. Provide a three year budget plan that relates to the costs expected to be incurred by this grant in years 1 through 3 using pages EE of the Form PHS 398 for recruitment and plans to provide as these individuals are incorporated into the permanent faculty of the MSI and/or the faculty/membership of the Cancer Center. k) Regular External Evaluation of Progress: This section should be the same for the MSI and the Cancer Center planning grant applications. Describe the expertise of the individual external advisors and the rationale for their selection relative to the objectives of this planning effort. This planning activity is required to use External Advisors (EAs) shared by the MSI and the Cancer Center to evaluate progress and provide recommendations on a regular basis. Written reports by these EAs must be submitted to the MSI/Cancer Center and included in the annual progress report to the NCI. These reports should summarize the EAs' evaluation of progress and provide the EA's recommendations for improvement. l) Human Subjects: Follow the directions and instructions provided in the Form PHS 398 application kit. m) Vertebrate Animals: Follow the directions and instructions provided in the Form PHS 398 application kit. 15. Checklist - See instructions in the Form PHS 398 application kit. 16. Appendix Materials REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by Center for Scientific Review (CSR) and responsiveness to ELIGIBILITY REQUIREMENTS and responsiveness to the SPECIAL REQUIREMENTS AND PROVISIONS OF PLANNING GRANTS FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATIONS by the NCI. Incomplete and/or non-responsive applications will be returned to the application without further consideration. Applications that are complete and responsive to the RFA will be evaluated by the appropriate peer review group convened by the Division of Extramural Activities of the NCI. The initial review group will first evaluate the applications for meeting the criteria in the General Features below. Those applications that meet the criteria in the General Features (intent of the RFA) will be further evaluated for scientific and technical merit in accordance with the other review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process by 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 (NCAB). Both the application from the MSI and the application from the Cancer Center will be reviewed together as ONE collaboration. Review Criteria: This initiative is quite broad in scope and can include objectives ranging from cancer research to cancer training, to cancer education to cancer outreach. Under these circumstances, the review criteria are not organized under the traditional headings of Significance, Approach, Environment, Investigator and Innovation typically used for NIH research grants. Reviewers will have to use considerable flexibility in determining the merit of a broad range of possibilities that can strengthen the research capabilities of minority institutions, expand training and career development opportunities for minority scientists and increase the effectiveness of cancer centers in developing programs with the potential to reduce disproportionate cancer incidence and mortality in minority populations. 1.General Features: a. Strength of the evidence that MSI and the Cancer Center worked closely together in the preparation of these applications. b. Strength of the evidence that the MSI and the Cancer Center have clearly identified the mutual benefits to be gained from this collaboration. c. Feasibility of achieving the interim and final objectives proposed within the expected time periods for completion as a focused collaboration. d. Degree to which this plan, if fully successful, will result in a stable cancer research capability for the MSI and/or result in the significant, successful training of more minority cancer researchers. e. If applicable, the degree to which this plan, if fully successful, will enhance the ability of the Cancer Center through research and/or training and education and/or outreach to more directly and successfully address the disproportionate incidence and mortality rates in minority populations. Those applications satisfying the criteria listed under General Features will be evaluated according to the following criteria. Each criteria includes additional guidance to reviewers. 2. Scientific and Administrative Leadership: The adequacy of the qualifications and experience of the Principal Investigator and Co-Investigator from the MSI and the Cancer Center to provide strong programmatic (e.g., scientific) and administrative leadership. If applicable, the adequacy of the qualifications and experience of other key personnel in both the MSI and the Cancer Center to successfully plan for and achieve the objectives of this planning effort. 3. Letters of Commitment from the MSI and the Cancer Center (NCI-designated Cancer or institution with highly organized, integrated research efforts focused on cancer): The degree to which the letters of commitment from the MSI and the Cancer Center address and fully support the objectives of the proposed planning effort. The degree to which the Cancer Center, if not an NCI-designated Cancer Center, demonstrates a highly organized and integrated cancer research focus. The appropriateness of the level of authority of officials committing to this joint effort within the MSI and the Cancer Center. 4. Administrative Core: The adequacy of the Administrative Core to provide the necessary day-to-day oversight, coordination, support and logistic services needed to make the collaboration function successfully. 5. Planning Activities: The adequacy of the different methods proposed by the MSI and Cancer Center to assess capabilities, define areas of mutual benefit and establish priorities for implementation that will have the greatest success in achieving the proposed objectives. The appropriateness and adequacy of the specific faculty and scientists identified from the MSI and the Cancer Center to contribute effectively to each aspect of this planning effort. The quality and merit of planning process used for any specific priorities declared ready for pilot testing at the time of the application. The adequacy of the proposed use of the External Advisors in the planning processes. 6. Method of Evaluating and Prioritizing the Use of Developmental Funds: The adequacy of the experience and qualifications of the individuals who take part in evaluating specific pilot projects, pilot programs, recruitment for using Developmental funds. The adequacy of the criteria used for selecting pilot projects, pilot programs, recruitment etc. for funding based on their merit and their potential to meet the proposed objectives of the planning effort. The adequacy of the evidence based on any specific pilot projects, pilot programs, recruitment etc. proposed for support with Developmental Funds that the process for allocating developmental funds works effectively. 7. Proposed Pilot Projects/Programs The qualifications of the Co-leaders from the MSI and the Cancer Center to develop the project/program. The merit of the Pilot Project/Program, and the degree to which it contributes to the objectives of the collaboration. Potential to develop into a competitively funded grant application (r01, P01, P50, K12, T32, R25). The options will be either to recommend support at the recommended budget levels or to recommend no support because it has either: a) low merit; b) low relevance to the objectives of the collaboration; and/or c) low potential to develop into a competitive grant application. 8. Proposed Recruitment: (if applicable) The quality of each specific individual recruitment proposed relative to background and ability to contribute substantially to strengthening areas of high priority. The quality of the plan to recruit individuals with the kinds of qualifications that will satisfy the most important needs in strengthening the future capability of the collaboration to fulfill its objectives. The adequacy of the commitments of the MSI and Cancer Center to provide new positions for this planning effort. 9. Evaluation of Progress by External Advisors: The adequacy of the expertise and qualifications of the External Advisors to provide appropriate evaluation and advice and recommendations for making mid-course corrections based on the objective of this planning effort. The adequacy of the plan for using the External Advisors effectively. 10. Other Considerations: The initial review group will also examine: the appropriateness of the proposed budgets and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for scientific goals of the research and plans for recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or the justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. Overall Evaluation and Scoring of Application: The overall degree of merit for the collaboration, as reflected by one priority score that will be assigned to the MSI and the Cancer Center applications, will be determined considering the following: 1. The extent to which the MSI and Cancer Center applications together satisfy the General Feature above (i.e, overall intent of this initiative). 2. Taken together, the quality of the individual sub-components as proposed in the MSI and Cancer Center P20 applications. AWARD CRITERIA Each set of two applications from an MSI and a Cancer Center will compete for funds with all other partnerships in response to this RFA. Applications recommended by the NCAB will be considered for award based upon (a) scientific and technical merit as determined by peer reviewers; (b) the program priorities of the NCI and the ORMH; and (c) availability of funds. Schedule: Pre-application Meeting Date: May 12-13, 2000 Letter of Intent Receipt Date: June 8, 2000 Application Receipt Date: July 26, 2000 Peer Review: October/November, 2000 Review by NCAB: February, 2001 Earliest Anticipated Award Date: March 1, 2001 NON-COMPETING CONTINUATION APPLICATION For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Application or Progress Reports each year. INQUIRIES Written, telephone, fax and e-mail inquiries concerning this RFA are encouraged especially during the planning phase of these applications. Below is a listing of program (i.e., scientific management), grants administration (i.e. fiscal management) and review (i.e., management of peer review process) staff of the National Cancer Institute who are available to for inquiries: Direct inquiries regarding scientific or programmatic issue to: Sanya A. Springfield, Ph.D. Chief, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7010 Bethesda, MD 20892-8347 Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: springfs@mail.nih.gov Or Brian Kimes, Ph.D. Director, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 700 Bethesda, MD 20892-8347 Telephone: (301) 496-8537 Fax: (301) 402-0181 Email: kimesb@mail.nih.gov Direct inquiries regarding fiscal or budget matters to: Ms. Barbara Fisher Grants Management Specialists National Cancer Institute 6120 Executive Blvd. EPS/243 Bethesda, MD 20892 Telephone (301) 496-8626 Fax: (301) 496-8601 Email: Bf18m@nih.gov Direct inquiries regarding review matters to: Ms Toby Friedberg Referral Officer Division of Extramural Activities 6116 Executive Boulevard, Room 8062, MSC 8239 Rockville, MD 20852 (express service) Bethesda, MD 20892-8239 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398, Cancer Research Manpower. 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. 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 and contract 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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