and Human Services (HHS)
EXPIRED
COOPERATIVE PLANNING GRANT FOR COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP Release Date: March 19, 2001 RFA: RFA-CA-02-007 (see replacement RFA-CA-03-008) National Cancer Institute National Center on Minority Health and Health Disparities Letter of Intent Receipt Date: July 9, 2001 Application Receipt Date: August 13, 2001 This RFA is a reissue of RFA-CA-01-008, which was published in the NIH Guide on April 25, 2000. PURPOSE The National Cancer Institute (NCI) and the National Center on Minority Health and Health Disparities (NCMHD) invite cooperative planning grant applications (i.e., U56) for the planning and development of Comprehensive Minority Institution/Cancer Center Partnerships between Minority-Serving Institutions (MSIs) and NCI-designated Cancer Centers (or groups of Centers) in order to develop a stronger national cancer program aimed at understanding the reasons behind the significant cancer disparities and impact on minority populations. The lack of significant training opportunities for minority scientists in cancer research and the low level of involvement of MSIs in competitive cancer research have represented two major obstacles to developing a stronger national cancer research effort aimed at understanding the reasons behind the significant disparities of cancer impact on minority populations. The NCI and the NCMHD have created a potentially powerful approach that can help the MSIs and Cancer Centers integrate and take maximum advantage of their expertise and experience to get better and partner in areas that neither could do as well alone. This new initiative, the Minority Institution/Cancer Center Partnership (MI/CCP), offers two cooperative agreement assistance mechanisms, a U56 for planning and developing an MI/CCP and a U54 for developing and implementing an MI/CCP. The cooperative planning application (U56) represents the first step before achieving a Comprehensive Minority Institution/Cancer Center Partnership (U54) but is not a prerequisite for applying for a U54 (for U54 guidelines, go to: http://deainfo.nci.nih.gov/cmbs/index.htm. Both mechanisms are aimed at helping MSIs and Cancer Centers to achieve the following long-term objectives: to increase the cancer research capabilities at the MSIs; to increase the number of minority scientists engaged in cancer research and other cancer-related activities; and to improve the effectiveness of Cancer Centers in developing and sustaining activities focused on the disproportionate incidence, mortality and morbidity in minority populations in the region the Cancer Center serves. The U56 Comprehensive Minority Institution/Cancer Center Partnership must achieve goals that are of clear mutual benefit and must be predominantly focused on cancer research and one or more of the following targeted program areas: cancer training and career development, cancer education or cancer outreach. Applicants are expected to work toward the following objectives: 1. Build and stabilize the independent, competitive cancer research projects and cancer research training and career development programs at MSIs; 2. Create stable, long-term collaborative relationships between MSIs and Cancer Centers in the areas of cancer research, cancer training and career development, cancer education and/or cancer outreach that increase the emphasis on problems and issues relevant to the disproportionate cancer incidence and mortality in minority populations; 3. Improve the effectiveness of the Cancer Center research, cancer training and career development, cancer education and cancer outreach activities specifically designed to benefit minority populations in the region the Cancer Center serves. OBJECTIVES Background: Since the War on Cancer was initiated, the disparities in cancer incidence, morbidity and mortality in underserved racial and ethnic minorities have continued to rise. For example, the incidence of colon and lung cancers in Alaska Native and African-American men and women is higher than that of other ethnic groups; five-year survival rates in Native American, African American, Hawaiian, and Hispanic Americans are lower than those of Japanese and White Americans; and patterns of prostate cancer among African American males compared with White males, seen in the Southeastern U.S., particularly in rural areas still remain higher http://www.nci.nih.gov/atlas. Clearly, more research is needed that specifically addresses these and other disparities if they are to be eliminated by 2010 (President’s Initiative on Race and Health Disparities). Minority-Serving Institutions 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, they 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, 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 well-trained minority scientists who can conduct independent cancer research, who can focus research efforts on the disproportionate burden of cancer in minority populations, and whose cultural perspectives are essential to the successful conduct of many forms of research involving minority patients and populations. The NCI-designated Cancer Centers are geographically dispersed, research intensive organizations with well-organized programs for training cancer scientists. They are the only organized units supported by the NCI that conduct research; sponsor research training in the basic, clinical and population sciences; provide information services; and develop and sustain educational and outreach programs that benefit their communities. 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 racial and ethnic minority populations in their communities, and in bringing the benefits of cancer research to these populations has been slow and often disappointing. The U56 MI/CCP offers four broad areas to target for development: 1. Cancer Research: Joint cancer research projects must be the most significant component of a U56 Cooperative Planning Grant for Comprehensive Minority Institution/Cancer Center Partnership. Joint pilot research projects may be in any area of basic, clinical, prevention, control, behavioral or population research. 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. Joint cancer research projects at MSIs might focus, for example, on general areas of environmental carcinogenesis, molecular epidemiology, and behavioral issues related to cancer prevention, treatment and control. The expectation is that successful pilot research projects will become the basis for full research projects in the U54 MI/CCP or to become competitive grant applications (e.g., R03, R01; project on a P01; project on a P50). 2. Cancer Training and Career Development: Cancer training and career development programs must focus on joint programs between MSI and Cancer Center(s) that place an emphasis on the training of minority scientists and on educating majority trainees to appreciate the issues and problems associated with cancer disparities in minority populations. 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 that 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. For example, new training programs might provide graduate students in MSIs the opportunity to fulfill their research requirements in Cancer Center laboratories using state- of-the-art equipment and mentoring by Cancer Center investigators; or masters programs in an MSI might be linked formally to doctoral training programs in Cancer Centers. Clinical research training programs at MSIs might also include rotations dealing with minority cultural-patient issues for majority trainees and clinical training programs at the Cancer Center might offer the use of current methodologies for national and international electronic communication on diagnosis and treatment of cancer for minority trainees. Successful pilot activities in this area may lead to full projects in the U54 MI/CCP application or the submission of a competitive training grant application (e.g. T32, K12, R25T). 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 apprise and culturally sensitize graduate and postdoctoral students in research, medicine and public health of the need to reduce disproportionate cancer burden in minority populations. A successful pilot effort may result in a full project in the U54 MI/CCP application or an NCI education grant (R25E) and later to institutional commitments to make these curricula an inherent component of their educational systems. 4. Cancer Outreach: Cancer 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 minority leaders and organizations in the community to develop outreach 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 U56 MI/CCP could help communities develop activities such as: (a) utilizing church networks to reach and educate the citizens of minority communities about prevention, early detection and treatment of cancer; (b) working 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) developing continuing education programs for community health care providers to ensure that they are providing state- of-the-art care and advice to their patients; and (d) training communities to use and link their communities to the electronic information systems that can educate individuals about cancer and help them make informed decisions about their health. SPECIAL REQUIREMENTS SPECIAL REQUIREMENTS AND PROVISIONS OF COOPERATIVE PLANNING GRANT FOR COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIPS (U56) There are a number of Special Requirements and Provisions that each Cooperative Planning Grant for Comprehensive Minority Institution/Cancer Center Partnership must comply with: 1. Each MSI and Cancer Center is limited to applying for no more than ONE Comprehensive Minority Institution/Cancer Center Partnership application (either a U56 or a U54). 2. Of the four areas being targeted by this initiative, (i.e., cancer research, cancer training and career development, cancer education and cancer outreach) cancer research is required and 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 cooperative planning activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. Additional resources would include protected faculty time (i.e., release time with grant funds), provisions for recruitment of new faculty, space and facilities for new projects/programs, capital improvements, etc. 4. Each U56 MI/CCP activity must be submitted as a clear partnership between the MSI and the Cancer Center. This must be done by submitting two separate 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 priorities and objectives for implementation 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 these priorities and 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 cooperative planning partnership. For example, both the MSI and Cancer Center benefit from a broader range of resources and approaches than are available at any one institution, however, the MSI will be exposed to state-of-art technology and have greater access to information services while the Cancer Center benefits by having a greater diversity of students, faculty and researchers participating in cancer-related activities and more access to minority patients for clinical protocols. 6. The direct costs of the two applications together cannot exceed $500,000 per year. If there is a third party subcontract, only the direct costs of the subcontract will count against this cap. 7. No more than 20% of the total direct costs of the partnership can be used for Administrative Core expenses. 8. There must be a common Planning and Evaluation Core shared between the MSI and the Cancer Center(s) proposals with: a. Internal Processes for workshops and other forums to identify areas of new opportunity as well as for strengthening, stabilizing and merging existing projects/programs. Internal processes must also have a evaluation and prioritization process in place for reviewing internal proposals for pilot projects/programs, recruitment of research associates, new investigators and establishment of resources and infrastructure on the basis of their merit and potential to contribute effectively to achieving high priority goals and objectives. b. External Processes, in which a Program Steering Committee evaluates overall progress on an annual basis, make recommendations for establishing priorities, changing direction and identifying areas of new opportunity to accomplish mutual objectives more successfully. The evaluation and recommendations must be in the form of a written report and must be included as part of the Non-Competing Continuation Application submitted to the NCI each year. The rationale for using Developmental Core funds would have to be based on these planning and evaluation processes. 9. In using Developmental funds to support pilot projects/programs, each activity must be co-lead by individuals from both the MSI and the Cancer Center. No pilot project/program can exceed $100,000 in direct costs per year or continue for no more than three years. The expectation is that successful pilot projects/programs will become full projects/programs in the U54 MI/CCP applications or will become competitively funded grant applications (e.g., R03; R01; R25T; R25E; P50; T32; P01; K12). Third party facilities and administrative costs are in addition to the direct costs requested. 10. Any new project/program and shared resources for development must be totally new activities that do not overlap in purpose or intent with existing grants and shared resources (e.g. P30; P50; National Center for Research Resources Infrastructure Grants, National Institute of General Medical Sciences Minority Biomedical Research Support Grants or any other peer- reviewed funded programs). Resources should augment the research capability of the MSI, the collaborative research between the MSI and the Cancer Center, and/or specifically support and enhance research focused on minority issues. Resources can augment existing Cancer Center resources, or they can be entirely new resources, as long as they are tailored to the common objectives and priorities of the partnership. Resources can be located either at the MSI or the Cancer Center or divided but shared between the MSI and the Cancer Center. TERMS AND CONDITIONS OF AWARD Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92 and administered under the NIH Grants Policy Statement. The administrative and funding instrument used for this program is a cooperative agreement (U56), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Coordinator. These are summarized below: 1. Awardee Rights and Responsibilities a. Awardees will have primary responsibility for the project as a whole, including research design and conduct, data collection, data quality control, data analysis and interpretation and preparation of publications, as well as collaborations with other awardees. Awardees will retain primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the research tools and research materials they develop available to the cancer research community. b. Awardees agree to follow the advice and recommendations of the Program Steering Committee, whenever possible, in meeting the intent of this initiative. c. Each partnership should plan regular meetings (no less than monthly) to discuss the progress and directions of its activities and to ensure that the necessary interactions are taking place. For partnerships including members from other institutions, plans and extend meeting via teleconferencing, videoconferencing or web conferencing (for more frequent meeting), as well as face-to-face meetings (semiannually or quarterly) should be described. d. The Co-Investigators and other designated investigators will attend an Annual Meeting to be organized by NCI Program Coordinator in Washington, D.C. In addition, the Co-Investigators will be voting members of the Program Steering Committee that meets once year. e. Each partner will submit annual progress reports (including the PSC annual meeting evaluation and recommendations) to the NCI that describes activities and accomplishments during the previous funding period as part of the Non- Competing Continuation Renewal. f. Intellectual Property. Each applicant must provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Procedures must be described for resolution of legal problems should they arise. Your attention is directed to P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions were also published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 19, No. 23, June 22, 1990). All Awardees must adhere to the policy for distribution of unique research resources produced with PHS funding, published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 25, No. 23, July 12, 1996). The Guide can be accessed electronically at http://grants.nih.gov/grants/guide/index.html. All awardees must also adhere to the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 Federal Register 72090). The Principles and Guidelines can be accessed electronically at: http://www.nih.gov/od/ott/RTguide_final.htm. Procedures must be described, that address how awardees will approach such distribution/dissemination, including acknowledgment of the terms of any related technology licenses or sponsored research agreements which Institution may have. Awardees shall include the following terms concerning intellectual property rights, or provide an alternative plan. NCI acknowledges that some commercial collaborators that are members of applicant partners, or who provide agents to applicant partners, may require that Institution agree to grant to them certain intellectual property rights, as described by the terms below. If an Institution voluntarily agrees to the described terms, then they should appear in the Institution's partner application. NCI recognizes that Institutions' ability to access agents from commercial collaborators for this effort may be limited absent such a voluntary agreement, or a substantially similar independent agreement between Institution and commercial collaborators providing agents. However, in no event will the award of a cooperative agreement be dependent upon the described terms' being part of an Institution's partner application. Rather, Institution's partner application may provide Institution's own plan for accessing agents from commercial collaborators. In no event, however, will an award be made absent incorporation of either the terms below, or Institution's own plan. "Institution agrees to grant to commercial collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Institution Inventions for research purposes only; and (ii) a time-limited first option to negotiate an exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to sub-license, to all Institution Inventions on terms to be negotiated in good faith by the collaborator and Institution. The collaborator shall notify Institution, in writing, of its interest in obtaining such an exclusive license to any Institution Invention within six (6) months of the collaborator's receipt of notice of such Institution Invention(s). In the event that a collaborator fails to so notify Institution, or elects not to obtain an exclusive license, then the collaborator's option shall expire with respect to that Institution Invention, and Institution will be free to dispose of its interests in such Institution Invention in accordance with Institution's policies. If Institution and collaborator fail to reach agreement within ninety (90) days, (or such additional period as collaborator and Institution may agree) on the terms for an exclusive license for a particular Institution Invention, then for a period of six (6) months thereafter Institution shall not offer to license the Institution Invention to any third party on materially better terms than those last offered to collaborator without first offering such terms to collaborator, in which case collaborator shall have a period of thirty (30) days in which to accept or reject the offer. Institution agrees that notwithstanding anything contained herein to the contrary, any inventions, discoveries or innovations, whether patentable or not, which are not Subject Inventions as defined in 35 USC 201(e), arising out of any unauthorized use of the collaborator's agent and/or any modifications to the agent, shall be the property of the collaborator (hereinafter "Collaborator Inventions"). Institution will promptly notify the collaborator in writing of any such Collaborator Inventions and, at collaborator's request and expense, Institution will cause to be assigned to collaborator all right, title and interest in and to any such collaborator inventions and provide collaborator with assignment or other documents). Institution may also be conducting other research using the agent under the authority of a separate Material transfer Agreement (MTA) with the collaborator. Inventions arising thereunder shall be subject to the terms of the MTA, and not to this clause." g. Protection of Proprietary Data. The ability to publish new results in a timely and intellectually unconstrained manner is fundamental to the academic enterprise. This need must be balanced with the legitimate requirements of commercial collaborators to protect the proprietary or confidential information that they provide concerning their proprietary agents. Commercial collaborators also may require exclusive access to the raw and primary data generated in studies of their agents. Therefore, NCI urges that the following statement also be incorporated in Partner applications: "Raw and primary data may be provided exclusively to the NCI, industrial collaborators, and the FDA, as appropriate. This provision shall not affect the investigators' right to disseminate their research findings through publications or presentations." 2. NCI Staff Responsibilities The NCI Program Coordinator will be responsible for normal stewardship of the award and may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative. In addition, the NCI Program Coordinator will also have substantial scientific-programmatic involvement during the conduct of this activity through technical assistance, advice and coordination, as follows: a. Serve as full participating and voting member of the Program Steering Committee. b. Work closely with individual investigators and partners to facilitate collaborations. c. Assist the partnership efforts by facilitating access to fiscal and intellectual resources provided by NCI, NIH, NCMHD, industry, private foundations and federal funding agencies. d. Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by Cancer Center Support Grants, Research Centers at Minority Institutions Infrastructure Grants, Minority Biomedical Research Support Grants or other peer reviewed funding mechanisms. e. Interact with each partner, coordinate approaches between partners, and contribute to the adjustment of projects/programs or approaches as warranted. f. Provide assistance in reviewing and commenting on all major transitional changes of an individual partner's activities prior to implementation to assure consistency with the goals of this RFA. g. Coordinate activities with other ongoing studies supported by NCI to avoid duplication of effort and encourage sharing and collaboration in the development of new clinically useful agents and methodologies. h. Coordinate access to other resources from NCI including NCI sponsored agents for pre-clinical and clinical testing, assistance in IND filing, etc. i. Link the approaches developed from these partnerships to each other and to other NCI Cancer Centers and NCI-supported networks to ensure that information is shared and utilized on the widest basis possible. j. Help reprogram efforts within the peer reviewed scope of work, including options to modify projects/programs when projects/programs are not making headway relative to the time-line for achieving the objectives of the RFA. k. Assist the Program Steering Committee in the evaluation of new pilot and full projects/programs when requested as replacements for ongoing activities. l. Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success. m. Recommend the approval of new faculty recruits to ensure that they fall within the bounds of the areas prioritized for development and stabilization. n. Organize and recommend an agenda for an annual workshop that engages all of the partnerships and other participants as needed. This meeting will be held for all funded investigators to share progress and research insights that may benefit all of the projects. o. Call additional meetings/workshops of the participants to address the problems of high cancer incidence and mortality in minority populations and other emerging areas of high priority to the NCI and NCMHD. The dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the projects/programs will be shared among the awardees and the NCI Program Coordinator. 3. Collaborative Responsibilities of the Program Steering Committee A Program Steering Committee (PSC) must be composed of the Co-Principal Investigators of each partnership, NCI Program Coordinator, and up to six external advisors with the scientific expertise necessary to provide appropriate advice relative to the objectives of the U56 and for providing the most objective advice. The PSC will meet once a year and serve as the primary advisory board of the U56 Program and will have the responsibility of making recommendations for establishing priorities, changing directions and identifying areas of new opportunity based on continuing evaluation. The PSC's recommendations, in the form of a written annual report, are to be submitted to the leaders of the MSI and the Cancer Center and the NCI and is to be used by the Principal Investigators to guide and direct the development of the U56 program. The Principal Investigators and the NCI Program Coordinator will each have one vote. The chairperson, who will be someone other than the Principal Investigators or NCI Program Coordinator, will be selected by the PSC. Subcommittees with additional ad hoc advisors may be established by the PSC as necessary in order to meet its planning, priority setting and evaluation responsibilities. Awardees generally will be expected to accept and implement the recommendations of the PSC; in those situations where the recommendations are not feasible to implement, the Co-Principal Investigators must provide a thorough explanation and rationale to the NCI. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Program Steering Committee (with the NCI member not voting), a second member selected by NCI, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) cooperative planning grant (U56) award mechanism. The U56 mechanism may support any part of a full range of research development from very basic to clinical. The U56 is a cooperative agreement, an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activities. Under a cooperative agreement, the NIH's purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient in a partner role and will not assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the activities to be funded under the cooperative agreements awarded for this Program are discussed below under "Terms and Conditions of Award." 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. The Principal Investigators on behalf of the institutions are responsible for the conduct of this activity with strong continuing commitments from the MSI and the Cancer Center enabling the success of the partnership. ALLOWABLE COSTS The U56 will provide support for: 1. Administrative costs (not to exceed 20% of the total direct costs) for managing the partnership, such as salaries for key personnel; equipment and supplies to support an administrative structure. 2. Planning and Evaluation may include the costs for travel for internal and external activities (key personnel; travel and per diem for Program Steering Committee members, workshops, seminars, retreats and other forums to strengthen, stabilize and consolidate interactions and cooperation in areas of existing high priority; to merge existing cancer programs into consolidated collaborations; to identify new areas of opportunity and high priority as the planning partnership evolves; and for reviewing pilots/full projects/programs, recruitments and resources. 3. Developmental costs for: a. Pilot cancer research projects or pilot programs (cancer training and career development, cancer education and/or cancer outreach (not to exceed $100,000 in direct costs per year per project/program for no more than three years). The planning partnership would have the flexibility to discontinue projects/programs and start new projects/programs based on the regular evaluation of progress; the funding of pilot projects/programs through other competitive sources; and identification of new opportunities through formalized planning, evaluation and priority setting activities. b. Resources and infrastructure (e.g., tissue resources) that augment the cancer research capability of the MSI, the collaborative research of the MSI and the Cancer Center, and/or specifically enhance research focused on minority issues. Shared infrastructure could be placed in either the MSI or the Center or in both locations. 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 prioritized for development and stabilization. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI/NCMHD anticipate making up to 12 (six pair) 5-year awards and plan to set aside an estimated total of $5.0 million (including direct costs and costs for facilities and administration) for the initial year's funding of the program. The maximum combined direct cost budget of the MSI and the cancer center together is $500,000. Third party sub-contractual facilities and administration costs will not be counted toward the maximum combined direct costs of $500,000. Applications exceeding the $500,000 direct costs limit will be considered unresponsive to the 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/NCMHD, 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/NCMHD will make a commitment for funding a partnership for the full term of the award. The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date is April 1, 2002. ELIGIBILITY REQUIREMENTS Applications will only be accepted from Minority-Serving Institutions (MSIs) [e.g., 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 groups of centers) that wish to develop comprehensive partnerships. MSIs 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 education and research programs (e.g., Masters and Ph.D. Programs) are invited to participate in this initiative. MSIs that offer only baccalaureate degrees, and Tribal Colleges are also invited to participate in this initiative as sub- contractual partners in Minority Institution/Cancer Center Partnerships. A partial list of eligible Minority-Serving Institutions can be found at the following website address: http://www.sciencewise.com/. Other institutions that meet MSI qualifications may not be listed on the 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/. The Principal Investigators must be U.S. citizens, non-citizen alien nationals, or permanent residents of the United States. PREAPPLICATION TECHNICAL ASSISTANCE WORKSHOP The NCI strongly encourages all potential applicants to attend a pre- application Technical Assistance Workshop (TAW) on May 6-8, 2001. Since this is a 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 support. 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. In addition, NCI encourages pre-application consultations with individual partnerships either as telephone conference calls, videoconference meetings, or as face to face meetings. In order to make these arrangements contact Dr. Sanya A. Springfield by email at [email protected] or by phone at (301) 496-7344 or Dr. Brian Kimes by email at [email protected] or by phone at (301) 496-8537. 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 for inquiries: Direct inquiries regarding scientific or programmatic issues to: Sanya A. Springfield, Ph.D. Chief, CMBB, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7018A Bethesda, MD 20892-8347 Telephone: (301) 496-7344 Fax: (301) 402-4551 Email: [email protected] Or Brian Kimes, Ph.D. Director, OCTR, ODDES National Cancer Institute 6116 Executive Blvd. Suite 7000 Bethesda, MD 20892-8347 Telephone: (301) 496-8537 Fax: (301) 402-0181 Email: [email protected] Direct inquiries regarding fiscal or budget matters to: Ms. Barbara Fisher Grants Management Specialist National Cancer Institute 6120 Executive Blvd. EPS/243 Bethesda, MD 20892 Telephone: (301) 846-1015 Fax: (301) 496-8601 Email: [email protected]. Direct inquiries regarding review matters to: Ms. Toby Friedberg NCI Referral Officer Division of Extramural Activities 6116 Executive Boulevard, Room 8109, MSC 8239 Rockville, MD 20852 (express service) Bethesda, MD 20892-8239 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent (LOI) to program staff members listed under inquiries by July 9, 2001 that includes a descriptive title of the proposed U56 partnership, 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 the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential peer review workload and plan the review. SCHEDULE Preaplication Technical Assistance Workshop Date: May 6-8, 2001 Letter of Intent Receipt Date: July 9, 2001 Application Receipt Date: August 13, 2001 Peer Review: October/November, 2001 Review by NCAB: February, 2002 Earliest Anticipated Award Date: April 1, 2002 NON-COMPETING CONTINUATION APPLICATION For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Application. APPLICATION PROCEDURES The following procedures apply to both the MSI and the Cancer Center applications: 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 August 13, 2001. A Form PHS 398 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: [email protected]. 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. 4/98) application form must be affixed to the bottom of the face page of the application and the title "U56 MI/CCP" 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 partner and the Co-Principal Investigator; this will allow the NCI to assemble the two applications as one package for peer review. Submit signed, typewritten originals of the cover letters, 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 applications must be sent to: Ms. Toby Friedberg NCI Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109 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 this U56 grant application. Accordingly, NCI strongly recommends that you follow the SUPPLEMENTAL INSTRUCTIONS below, which have been adapted to accommodate the Form PHS 398 and the special needs of this U56 MI/CCP RFA. These instructions include all of the information needed by peer reviewers of your applications. All clinical trials supported or performed by NCI require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI Program Coordinator to a data and safety monitoring board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. 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. 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 partnership. This title should be the same for both the MSI and the Cancer Center institution's applications. For line 2 enter the title "U56 MI/CCP " and the number of this RFA, RFA-CA-02-007. Remember to affix 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 exactly 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. Planning and Evaluation Core c. Developmental Core Budget for Entire Proposed Period of Support a. Administrative Core b. Planning and Evaluation Core c. Developmental Core Budgets Pertaining to Consortium/Contractual Arrangements (e.g., more than one MSI/Cancer Center is involved) Biographical Sketch of the Principal Investigator (not to exceed two pages) Biographical Sketch of the 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 Program Steering Committee Members (not to exceed two pages for each individual) List of all participating members of the MSI or the Cancer Center Other Support of Principal Investigator, Co-Investigator and Key Personnel Resources IMPLEMENTATION PLAN FOR THE PARTNERSHIP: (not to exceed 25 pages) Introduction to revised application (if applicable) A. Background and Objectives B. "Letter of Commitment" from the MSI or Cancer Center C. Chronological Review of Planning and Priority-setting Processes D. Scientific and Administrative Leadership E. Administrative Core F. Planning and Evaluation Core 1. Internal Processes 2. External Processes G. Development Core 1. Pilot projects/programs 2. Resources and infrastructure 3. Research Associates/Assistants 4. Recruitment(s) H. Human Subjects I. Vertebrate Animals J. Literature Cited K. Consortium/Contractual Arrangements L. Intellectual Property Appendix Material Checklist 4. Detailed Budget for Initial Budget Period: Use Form DD (Form page 4) of the Form PHS 398 application kit. Separately break out the budget into three sections using different Page 4s as follows: a. Administrative Core: Denote the costs for personnel, supplies, travel etc. needed to provide administrative oversight, coordination and cohesion of the partnership. b. Planning and Evaluation Core: Delineate the costs separately for: 1. Internal processes (e.g., workshops, retreats, committees, seminar series, and ad hoc consultants to strengthen, stabilize and merge existing programs and the process for evaluating and prioritizing the use of developmental funds and the process for deciding which areas using developmental funds should be continued or be discontinued. 2. External processes should include the Program Steering Committee, which must meet once a year and evaluate the progress of the partnership as a whole toward accomplishing its objectives and make recommendations for changing direction or strategy to accomplish mutual objectives more successfully. External processes could also include special seminar series inviting experts to make presentations to partnership participants that relate to the objectives of the partnership and then serve as ad hoc advisors in areas under development. c. Developmental Core: Separately delineate the funds being requested for all Pilot projects/programs, resources, research associates and recruitment. Remember that individual Pilot projects/programs cannot exceed $100,000 in direct costs. 5. Budget for Entire Proposed Period of Support: Using Form EE (form page 5) of the Form PHS 398, break out the total budgets separately for: a) Administration Core; b) Planning and Evaluation Core; and c) Developmental Core Funds. Provide justifications for costs in future years only when there are specific items requested in future years that exceed standard cost-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 the partnership. In either case, one of the MSIs or Cancer Centers would have to serve as the primary grantee and subcontract for the consortia involvement of the other MSI or Cancer Center. 7. Biographical Sketches of the Principal Investigator (not to exceed two pages). Use Form FF (form page 6) of the Form PHS 398 and follow the instructions in the application kit. 8. Biographical Sketches of the Co-Principal Investigator (not to exceed two pages). Use Form FF (form page 6) of the Form PHS 398 and follow the instructions in the application kit. 9. Biographical Sketches of Key Professional Personnel of the MSI or Cancer Center (not to exceed two pages for each individual). Use Form 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 Program Steering Committee Members (not to exceed two pages for each individual) other than the Co-Principal Investigators and NCI Program Coordinator. Use Form FF as above. 11. List all participating faculty/members of the MSI or the Cancer Center alphabetically by name. Include for each their degree, department affiliation or equivalent, and research or other interest (e.g., research area, training, education, or outreach). 12. Other Support: Using Form Page GG of the Form PHS 398 kit, provide other support only for the Principal Investigator, Co-Investigator and all other key professional personnel at either the MSI or the Cancer Center. 13. Resources: Using Form Page HH, follow the instructions in the Form PHS 398 application kit. 14. IMPLEMENTATION PLAN FOR THE PARTNERSHIP Special Introductory Statement for Revised Application (if applicable): This section should include a summary of not more than five pages 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. The changes in the text of the application should 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 and Objectives: This section should be the same for both the MSI and the Cancer Center U56 applications. It should (1) discuss the general rationale and the mutual benefits that the MSI and the Cancer Center expect to derive from the partnership and the ways in which the MSI and the Cancer Center believe they can help each other develop stronger cancer programs, (2) clearly outline the immediate priorities of the partnership derived from a careful planning process that relates to mutual benefits, (3) present focused objectives in the areas of cancer research, cancer training and career development, cancer education and/or cancer outreach that the partnership believes can be achieved during the grant period for each priority, (4) present a projected time-line for achieving each objective and (5) discuss other areas of opportunity that the partnership will consider as the relationship between the partners evolves. 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 detailed statement of their long-term commitment by noting the specific resources that will be dedicated to the priorities of this partnership as outlined in the Background and Objectives section above. These resources 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 made available in those areas where recruitment will be needed, space 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. The letter should clearly explain how the MSI and the Cancer Center leadership would be responsible and accountable for following the progress of this effort and doing what is needed to sustain it. C. Chronological Review of the Prior Planning and Priority-setting Processes: This section should be the same for both the MSI and Cancer Center applications and should provide a clear indication that this partnership was derived from careful planning and priority-setting processes based on each partner's strengths and weaknesses and potential to complement each other and help each other become stronger in areas of opportunity. In chronological order present each process used in planning for and setting the priorities and objectives for this application. Briefly describe the nature of each planning activity (e.g., meetings of higher institutional officials, planning committees, steering committees in areas of opportunity, workshops of MSI faculty and Cancer Center members, retreats of MSI faculty and Cancer Center members), its purpose, the individuals that participated from the MSI and the Cancer Center, and its outcome. D. Scientific and Administrative Leadership: Briefly describe how the Principal and Co-Investigators were chosen in terms of their 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 section above. Also, if there are other mid-level leaders who will play a significant role in determining the success of this partnership, 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 day-to-day oversight, coordination, support, and logistical 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 and Evaluation Core (This section must be the same for each application): 1. Internal Processes: Document each internal planning and evaluation activity (e.g., regular forums and seminars, workshops, retreats etc.) and include the individuals from the MSI and the Cancer Center who will be involved. (Face-to-face informal meetings between collaborators have been found to be the most effective method of communication. In instances where there is a problem of distance between partners, applicants are encouraged to consider other methods of communication including e-mail, teleconferences, and videoconferences). This should include how the progress of the partnership will be reported to institutional leaders and must include a review and evaluation process for initiating and closing all pilot and full projects and programs based on their merit and potential for achieving the objectives of the partnership and their actual progress. This process must also be used to determine which resources and infrastructure needs of the partnership will be established and which kinds of recruitment of faculty will be implemented. 2. External Processes: Program Steering Committee: Excluding the Co-Principal Investigators and the NCI Program Coordinator, describe how each Program Steering Committee member was chosen to provide unbiased, rigorous, expert evaluation of progress, to provide recommendations for improvement based on the objectives and priorities of the implementation plan of the partnership and to provide insights and advice for taking advantage of new objectives and initiatives as they emerge during the course of the grant period. NOTE: THE USE OF DEVELOPMENTAL FUNDS IN PART G 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 G. Developmental Core 1. Pilot Projects/Programs: Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 in direct costs per year or continue for longer than three years, should be provided in the following format: (1). Title (2). Names of the Co-Leaders from the MSI and the Cancer Center (3). One paragraph abstract stating the objectives of the project/program (4). One paragraph describing how this pilot project/program relates to the overall priorities and objectives of the partnership as described in the Background and Objectives section above. (5). Detailed budget page for initial budget period using page DD from the Form PHS 398. (6). Biographical Sketches of Co-Leaders (no more than 2 pages) (7). Proposal (up to five pages) (8). Describe which aspects of the pilot project/program will be conducted at the MSI and 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 U54, 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 U54, to the NCI Program Coordinator. 2. Resources/Infrastructure: Resources and Infrastructure needs (e.g., minority tissue resource, minority patient accrual core, clinical research management core) of the partnership should be presented in the following format: (1). Title (2). Co-Leaders from the MSI and Cancer Center who lead the activity (3). The experience of key technical personnel, if applicable, who will be responsible for the day-to-day operation. (4). Detailed budget for the initial budget period using form page DD from the Form PHS 398 (5). Budget for entire proposed period of support using form page EE from the Form PHS 398 (6). Biographical Sketches of Co-Leaders (no more than 2 pages) (7). Description of the resource/infrastructure and how it will further the priorities and objectives of the partnership (no more than one page) (8). Commitment of space for the resource. (9). Justification for the location of the resource at the MSI, the Cancer Center or both. 3. Research Associates/Assistants: Individuals who are known: (1). Provide the biographical sketch of the individual. (2). Describe how the individual fulfills the priorities and objectives of the partnership as described in the Background and Objectives section above. (3). Describe the nature of the position that provides the necessary stability 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 needs of the partnership. Individuals who are planned for: Describe the number and expertise of the individuals that the partnership plans to recruit over the five-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 priorities and objectives. 4. Recruitment to be supported with Developmental Funds: Individuals who are known: (1). Provide the biographical sketch of the individual. (2). Describe how the individual fulfills the priorities and objectives of the partnership as described in the Backgrou
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