PLANNING GRANT FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATION Release Date: March 28, 2002 RFA: CA-03-009 National Cancer Institute (NCI) (http://www.nci.nih.gov/) Letter of Intent Receipt Date: July 17, 2002 Application Receipt Date: August 14, 2002 This RFA is a reissue of RFA-CA-02-006, which was published in the NIH Guide on April 9, 2002. 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 planning grant applications (i.e., P20s) to help researchers and faculty in Minority Serving Institutions (MSIs) in collaboration with the researchers and faculty of NCI-designated Cancer Centers (or other institutions with highly organized, integrated research efforts focused on cancer) plan and implement focused collaborations in cancer research, cancer research training and career development or cancer education. The sole intent of the planning grant is to provide support for cancer projects and programs for a limited duration of time to perform feasibility studies and obtain preliminary data that will lead to the submission of specific competitive grant applications traditionally supported by the NCI and others. Depending on prior experience, interactions and progress in planning, applicants may apply for two-year or three-year P20 MI/CCP awards. Applicants requesting three years of support must clearly describe a planning stage, a priority setting stage, and an implementation stage. Applicants requesting two years of support who have already identified areas of potential collaboration through planning, must document prior planning activities and clearly describe a priority-setting stage and an implementation stage. Planning grants must be focused on one or two of the targeted areas that work toward the following objectives: 1. Develop collaborative research project(s) with a minority investigator; 2. Develop collaborative training and career development program(s) between MSIs and Cancer Centers designed to train minority students and scientists; and 3. Develop collaborative education programs designed to motivate minority students (e.g., high school, undergraduate, and/or graduate) to pursue cancer research careers. The final objective of the P20 must be the submission of specific competitive research grant applications (e.g., R03s, R01s, projects on P01s, projects on P50s); training and career development grant applications (e.g., T32s, K12s, R25Ts); and or cancer education grant applications (e.g., R25Es) funded by the NIH, NCI and other research funding organizations (e.g., American Cancer Society). The submission of a P20 application is not a requirement for either a Cooperative Planning Grant for Comprehensive Minority Institution/Cancer Center Partnership (U56) or a Comprehensive Minority Institution/Cancer Center Partnership (U54) offered through the NCI.. OBJECTIVES Background: Minority-Serving Institutions (MSIs) [e.g., Minority Medical Schools, Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribal Institutions (e.g., 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, mortality and morbidity 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 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 to majority populations. The prospect 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 MSIs and Cancer Centers in ways that integrate and take maximum advantage of their respective expertise and experience. Three broad areas can be targeted for focused planning, development, and implementation: 1. Cancer Research: Joint research projects may be in any area of basic, clinical, prevention, control, behavioral, or population research. Joint cancer research projects might focus, for example, on general areas of environmental carcinogenesis, molecular epidemiology, and behavioral issues related to cancer prevention, treatment and control. Successful planning efforts and pilot research projects are expected to result in the submission of competitive investigator-initiated research grant application (e.g., R03, R01, project on a P01, project on a P50). 2. Cancer Research Training and Career Development: Cancer research training programs are highly encouraged and must focus on joint programs organized and conducted by the scientists and faculty of both the MSI and Cancer Center that focus on the training of minority scientists. The NCI particularly encourages training of minority scientists in clinical, behavioral and population research; there is a huge deficit of minority scientists engaged in these research areas, areas which are highly dependent for their success on the cultural sensitivity of the researchers. These training programs must represent true collaborations that function seamlessly across the institutional boundaries of the MSI and the Cancer Center. Successful planning activities and pilot training and career development programs should result in the submission of multi-institutional training grants (e.g., T32, R25T, K12). 3. Cancer Education: Cancer education programs could focus on any effort to augment existing or create new curricula in the MSI and/or the Cancer Center that would focus on minority students at earlier stages of their educational experience (e.g., high school, undergraduate) and that would motivate them to pursue careers in cancer research. A successful planning effort in this area is expected to result in the submission of a competitive R25E application and later to institutional commitments to make these curricula an inherent component of their educational systems. MECHANISM OF SUPPORT This RFA will use NIH planning grant (P20) 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. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures (when appropriate). The anticipated award date is April 2, 2003. The Principal Investigators on behalf of the institutions are responsible for the conduct of this planning grant 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 applications for review. FUNDS AVAILABLE NCI anticipates making up to six (three-pair) two-year awards and six (three pair) three-year awards, and intends to commit approximately $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 $50,000 and $250,000 each year depending upon prior progress in planning and setting priorities. The amount requested should be specific to the stage of development; for example, planning and priority-setting stages are not as costly as the implementation stage. Third party contractual Facilities and Administrative 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, 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 will make a commitment for funding the collaboration for the full term of the award. The anticipated award date is April 1, 2003. The total project period for applications submitted in response to this RFA may not exceed three years. ALLOWABLE COSTS The P20 will provide support for: 1. Administrative costs for managing the planning effort, such as salaries for key personnel, travel for key personnel, equipment, and supplies to support an administrative structure. 2. Developmental costs for: a. Initial Planning Stage: for workshops, seminars, retreats, and other forms of communication to explore potential opportunities in cancer research, cancer training and career development or cancer education. b. Priority-setting Stage: for selecting the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application. c. Implementation Stage: for implementing pilot research projects or pilot programs in training and career development or education for the explicit purpose of obtaining preliminary data for the submission of a specific grant application(s). ELIGIBLE INSTITUTIONS Applications will only be accepted from Minority-Serving Institutions (MSIs) [eg., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs) and Tribal Institutions (e.g., Colleges)], either in the United States or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers or from other institutions that can demonstrate organized, highly integrated research efforts focused on cancer. Minority-Serving Institutions are defined as 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. 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. MSIs that offer only baccalaureate degrees, and Tribal Institutions (e.g., Colleges) are encouraged to participate in this initiative as full collaborators, especially in the development of educational programs aimed at motivating students to enter careers in cancer research. A partial list of eligible Minority-Serving Institutions can be found at the following website address: http://www.sciencewise.com/. Other institutions that meet the MSI qualifications may not be listed at this website, but they are also eligible to apply. A list of NCI-designated Cancer Centers can be found at the following website address: http://www.nci.nih.gov/cancercenters/. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The Principal Investigators must be U.S. citizens, non-citizen alien nationals, or permanent residents of the United States. SPECIAL REQUIREMENTS There are a number of Special Requirements and Provisions that each Minority Institution/Cancer Center Collaboration planning grant application must comply with: 1. Planning grants must be include one or two but not three of the following targeted areas: a) cancer research; b) cancer research training and career development; or c) cancer education. 2. When the Principal Investigator from the MSI or Cancer Center is a less experienced scientist, there must be a written "Letter of Support" from a senior member of the MSI/Cancer Center (e.g., Department Chair, Dean, Cancer Center Director) that: a) identifies a mentor who will be responsible for career and professional development of the individual, and b) that is fully supportive of this activity to ensure appropriate institutional support and provide the maximum chance of success. 3. Each collaborative planning activity must be submitted as a clear partnership between the MSI and Cancer Center. This must be done by submitting two separate 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 Cancer Center grant application and vice versa. The overall objectives 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 both differ and complement each other in achieving their common objectives. 4. Depending upon prior experience, interactions and progress in planning, the two applications must clearly describe a collaborative planning process outlining: a) Initial Planning Stage (for those applicants requesting three years of support) in which the participants must describe appropriate means of communicating and identifying areas of potential collaborations. b) Priority-Setting Stage for selecting the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application, and c) Implementation Stage of pilot project/programs in which preliminary data is acquired for the purpose of submitting a specific competitive grant application in one or two of the target areas mentioned above to the NCI or other funding agencies. 5. The direct costs of the two applications together cannot exceed $250,000 per year. The amount requested should be appropriate to the stage of development because the planning and priority-setting stages are not as costly as the implementation stage, budget requests would be expected to escalate progressively from year 1 to year 2 and 3 or year 2. If there are third party subcontract costs, only the direct costs of the subcontract will count against this cap. 6. The use of funds to support pilot projects and pilot programs must be for totally new activities that do not overlap in purpose or intent with existing funded grants (e.g., P30, P50, P01, R01, National Center for Research Resources' Research Infrastructure Grants, National Institute of General Medical Sciences' Minority Biomedical Research Support Grants, other peer- reviewed funded program). 7. All recipients of P20 MI/CCP awards will be expected to participate in an annual MI/CCP workshop sponsored by the Comprehensive Minority Biomedical Branch (CMBB) of the NCI. Travel expenses for this purpose must be included in the grant applications from the MSI and the Cancer Center institution. 8. If the application includes participation of Native American (American Indian) or similar populations, a formal letter of support for the study from the Tribal Nation Leader or equivalent authority must be included. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and are we welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: Direct inquiries regarding scientific issues to: Sanya A. Springfield, Ph.D. Chief, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7013 Bethesda, MD 20892-8347 Rockville, MD 20895 (Express courier) Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: springfs@mail.nih.gov Nelson Aguila, D.V.M. Program Director, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7013 Bethesda, MD 20892-8347 Rockville, MD 20895 (Express courier) Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: aguilah@mail.nih.gov Or Brian Kimes, Ph.D. Director, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7001 Bethesda, MD 20892-8347 Rockville, MD 20852 (Express courier) Telephone: (301) 496-8537 Fax: (301) 402-0181 Email: kimesb@mail.nih.gov Direct inquiries regarding peer review matters to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncidearefof@mail.nih.gov Direct inquiries regarding financial or grants management matters to: Ms. Barbara Fisher Grants Management Specialist National Cancer Institute Grants Administration Branch 1003 West 7th Street Suite 300 Frederick, Maryland 21701 Email: fisherb@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed P20 collaboration o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Sanya A. Springfield, Ph.D. Chief, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7013 Bethesda, MD 20892-8347 Rockville, MD 20895 (Express courier) Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: springfs@mail.nih.gov PREAPPLICATION TECHNICAL ASSISTANCE WORKSHOP The NCI strongly encourages all potential applicants to attend a pre- application Technical Assistance Workshop (TAW) scheduled for June 3-4, 2002 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 to help applicants to present their strongest case for developing an application. If one is unable to attend the TAW, the results of the workshop can be accessed at the Website: http://minorityopportunities.nci.nih.gov. In addition, NCI strongly encourages pre-application consultations with individual collaborators either as telephone conference calls, videoconferences or face-to-face meetings. In order to make these arrangements contact Dr. Sanya A. Springfield by email at springfs@mail.nih.gov or by telephone at (301) 496-7344 or Dr. Brian Kimes by email at kimesb@mail.nih.gov or by telephone at (301) 496-8537. SUBMITTING THE APPLICATION The following procedures apply to both the MSI application and the Cancer Center application, which are to be submitted as a collaborative effort: Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/01). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS 1. Face Page: Use Form Page 1 as instructed in the Form PHS 398 (rev. 5/01). On line one 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/CCP" and the number beginning with RFA-CA-03-009. 2. Description, Performance Sites and Key Personnel: Use Form Page 2 of the Form PHS 398 and list the Principal Investigator first and next the Co- Principal Investigator of the P20. The list all Key Personnel for the Administrative Core and all Pilot projects/program in this application in alphabetical. Follow the instructions provided in the Form PHS 398. 3. Table of Contents: The Table of Contents and Research Plan of the PHS 398 application are not specifically tailored to the unique objectives of the MI/CCP application. Therefore organize the Table of Contents exactly as described below: Face Page Description, Performance Sites and Key Personnel Table of Contents Detailed Budget for Initial Budget Period Total Initial Budget for all stages Planning Stage (if applicable) Priority-Setting Stage Implementation Stage Budget for Entire Proposed Period of Support Total Entire Budget for all stages Planning Stage (if applicable) Priority-Setting Stage Implementation Stage Budgets Pertaining to Consortium/Contractual Arrangements List of participating members of the MSI or the Cancer Center Biographical Sketch and Other Support of: a. Principal Investigator (not to exceed four pages) b. Co-Investigator (not to exceed four pages) c. All Key Personnel in alphabetical order of the MSI or Cancer Center Resources Collaborative Plan: Special Introduction to revised application, if applicable (not to exceed three pages) a. Background b. Letter of Support from the MSI/Cancer Center c. Chronological Estimate of each Stage d. Initial Planning Stage (as appropriate depending on prior experience) e. Priority-Setting Stage f. Implementation Stage (as appropriate depending on prior experience) g. Human Subjects h. Vertebrate Animals i. Literature Cited j. Consortium/Contractual Arrangements Appendix Checklist Personal Data 4. Detailed Budget for Initial Budget Period as appropriate to the stage of development: Use Form Page 4 of the Form PHS 398 application kit. It is expected that requested costs in the first year will be less than costs in the second or third years because planning and priority-setting are not as expensive as the implementation of a project or a program. Separately break out the budget into three sections using different Form Page 4s as follows: a) Total Initial Budget for all Stages b) Planning Stage (if applicable) c) Priority-Setting Stage d) Implementation Stage. 5. Budget for Entire Proposed Period of Support: Using Form Page 5 of the Form PHS 398, follow the instructions in the Form PHS 398 application kit. Provide specific justifications for costs for each year requested appropriate to the stage of development (e.g., total entire budget for all stages, planning, priority-setting and implementation). Costs for each year would include administrative costs and developmental costs as needed within the $250,000 direct cost cap. A three percent cost of living escalation may be included in future years 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. List all participating faculty/members of the MSI or the Cancer Center alphabetically by last name. Include for each their degree, department affiliation or equivalent, and research or other interest (e.g., research area, training, or education). 8. Biographical Sketches and Other Support: Use Biographical Sketch Format Page and follow the instructions in the Form PHS 398 application kit for: a. Principal Investigator b. Co-Principal Investigator c. Key Professional Personnel of the MSI or Cancer Center: This section should include all professional individuals who serve in middle leadership roles. The biographical sketches of those Co-Leaders of Pilot projects/programs, should be provided in the appropriate sections of this application. 9. Resources: Using Resources Format Page, follow the instructions in the Form PHS 398 application kit. 10. Collaborative Plan: The Research Plan of the PHS 398 (rev. 5/01) application is not specifically tailored to the unique objectives of the MI/CCP application. Therefore, applicants should follow the outline below: Special Introductory Statement for Revised Application (if applicable): This section should be the same for both application the MSI and Cancer Center and should be limited to three pages. Include a summary of the additions, deletions, and changes in the revised application, placing particular emphasis on responses to the criticisms and issues raised in the summary statement. Include a chronological description of activities the occurred since the original submission (meetings, research activities, etc.). The changes in the full text must be clearly marked by appropriate bracketing, indenting, or changing the type setting, unless the changes are so extensive as to include most of the text. A. Background: This section should be the same for both the MSI and the Cancer Center P20 applications and must be limited to two to three pages. It should describe the characteristics of the MSI and the Cancer Center that will contribute to the planning effort. 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. 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. B. Letter of Support: This section should be different for each application. Two to three pages are recommended. This letter of support would be required under the following situations: 1) If the Principal Investigators of the MSI or Cancer Center are less experienced individuals, this letter of support should be from a senior member of the MSI or Cancer Center (e.g., Department Chair, Dean, Cancer Center Director), respectively and should include a statement describing how Principal Investigator will be provided with appropriate mentoring and the necessary support to ensure the success of this collaborative planning effort. This support could be in the form of protected time for junior faculty to participate in and focus on the objectives of this grant and discretionary resources that will be made available to the Principal and Co- Principal Investigators. 2) If the nature of the potential application will require significant institutional commitments to ensure its success, such a training program or an education program must have the commitment both from institutional leaders of the MSI (e.g., Dean, President) and the Cancer Center (e.g., Cancer Center Director). C. Chronological Estimates of Planning, Priority-Setting and Implementation Stages: This section should be the same for the MSI and the Cancer Center application and must be limited to five pages. Each application should include a chronological table listing the specific first year, second year, and third year (as applicable) objectives that are expected to be achieved. Clearly, applicants who have had minimal interactions and progress in planning should apply for three years of support incorporating all three stages while those who have had significant opportunity to plan should apply for two years of support. For each objective, a brief statement should be made about the separate contributions of the MSI and the Cancer Center in order to achieve success. The final objective of the P20 must be the submission of a specific grant application (R03, R01, T32, K12, R25T, R25E project on Program Project Research Grant (P01) or Spore Grant (P50) to the NCI or other funding agencies. D. Initial Planning Stage: This section should be the same for each application and limited to fives pages. For three-year applicants, clearly describe the kinds of planning activities that the MSI and the Cancer Center will conduct to ensure a highly interactive and integrated effort between their faculty and scientists. Relate each planning activity (e.g., workshop, retreat, executive meeting) to specific objectives above and name the specific faculty and interests (e.g., training, clinical oncology researchers, research in prostate cancer, establishing new curriculum in nutrition, etc.) who will participate in each activity. For two-year applicants, this section should document the prior experience, interaction and progress in planning. E. Priority–Setting Stage: Clearly describe how the specific projects/programs will be prioritized and selected for implementation based on their merit and greatest potential for success. F. Implementation Stage: Three-year applicants should use the general outline below including as much information as possible about the following: Proposed project/program area Names of Co-leaders from the MSI and the Cancer Center One paragraph abstract One paragraph describing how this pilot project will relate to the overall objectives of the collaboration as described in the Background section above. Description of what aspects of the project/program will be conducted at the MSI/Cancer Center Two-year applicants should clearly describe the specific pilot projects/programs to be supported. Pilots must have co-leadership by individuals from the MSI and the Cancer Center. Each pilot project/program should include the following specific information: Title Names of the Co-Leaders from the MSI and the Cancer Center One paragraph abstract Specific Aims One paragraph describing how this pilot project will relate to the overall objectives of the collaboration as described in the Background section above. Detailed budget page for initial budget period using page DD from form PHS 398. Pilot Research Proposal (up to five pages) that should include experimental methods and design and any preliminary data with a brief description of results and stating the role of the MSI and Cancer Center investigators in the collection of data. Description of what aspects of the project/program will be conducted at the MSI and/or the Cancer Center Human Subjects** Vertebrate Animals Literature Cited **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 17 – 27 of the Form PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on page 27 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/CCP, 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/CCP, to the NCI program director. G. Human Subjects: Follow the directions and instructions provided in the Form PHS 398 application kit. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/01) application form must be affixed to the bottom of the face page of the application. 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. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH 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 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: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice- files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness to ELIGIBILITY REQUIREMENTS and responsiveness to the SPECIAL REQUIREMENTS AND PROVISIONS OF PLANNING GRANT FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATIONS by the NCI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the 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: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Those that receive a priority score will undergo a second level review by the National Cancer Advisory Board. 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 equally emphasizes cancer research, cancer training and career development and cancer education objectives. 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 expand research, training and career development opportunities for minority scientists and students. Applicants can either apply for two or three years of support depending on their previous experience, interactions and planning history, consequently reviewers must evaluate the following: 1. Strength of the evidence that the researchers and faculty of the MSI and the Cancer Center worked closely together in the preparation of the application. 2. As applicable, the degree to which the letters of support from senior faculty and/or institutional/center leaders address the need for mentoring of inexperienced Principal Investigators or for specific institutional/center commitments to ensure the success of the collaboration. 3. As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support and logistical services needed to make the collaboration successful. 4. Initial Planning Stage: For three-year applicants: a. The adequacy of the different planning methods proposed by the MSI and Cancer Center to fully explore areas of opportunity and to ensure highly interactive and integrated efforts between individual scientists (e.g., research project) and/or between faculty and scientists (e.g., training program, education program). b. The adequacy and duration of the initial planning stage needed to identify areas of potential collaboration. For two-year applicants: a. The quality and merit of the documented planning process used for identifying areas ready for prioritization and/or for pilot testing. b. 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. 5. Priority-Setting Stage: a. The adequacy of the experience and qualifications of the individuals who will take part in prioritizing and selecting specific pilot projects/programs for implementation. b. The adequacy of the process used for selecting pilot projects/programs for implementation based on their merit and their potential for successful acquisition of preliminary data during the period of requested grant support. 6. Pilot Projects/Programs For three-year applicants: a. The potential of the Co-Investigators and the collaborative plan to prioritize and implement specific pilot projects/programs. b. The likelihood that potential pilot projects/programs will emerge from this collaboration that will be successful as specific grant applications. For two-year applicants: a. The qualifications of the Co-leaders to implement the pilot project/program. b. The merit of the project/program and its feasibility to acquire the necessary preliminary data to become competitive for specific grant support (e.g., R03, R01, P01, P50, K12, T32, R25). ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. (include, if appropriate) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA The overall degree of merit for the collaboration, as reflected by one priority score will be assigned to the MSI and the Cancer Center applications. For three-year applications, the score will be based primarily on the potential to develop projects/programs that will compete successfully for specific grant support. For two-year applications, the score should be based on the merit of the specific programs proposed and their likelihood to compete successfully for grant support with appropriate preliminary data. RECEIPT AND REVIEW SCHEDULE Pre-application TAW Meeting Date: June 4-5, 2002 Letter of Intent Receipt Date: July 17, 2002 Application Receipt Date: August 14, 2002 Peer Review: November/December, 2002 Review by NCAB: February, 2003 Earliest Anticipated Award Date: April 1, 2003 NON-COMPETING CONTINUATION APPLICATION For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Application each year. AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. Each set of two applications from an MSI and a Cancer Center will compete for funds with all other collaborations in response to this RFA. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research in now available online at: http://cme.nci.nih.gov/ HUMAN EMBRYONIC STEM CELLS (HESC): Criteria for federal funding of research on HESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using HESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the HESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.398 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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