Full Text CA-95-021 SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN GASTROINTESTINAL CANCER NIH GUIDE, Volume 24, Number 34, September 29, 1995 RFA: CA-95-021 P.T. 34 Keywords: Cancer/Carcinogenesis Digestive Diseases & Disorders National Cancer Institute Letter of Intent Receipt Date: December 4, 1995 Application Receipt Date: February 14, 1996 PURPOSE The Organ Systems Coordinating Branch of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC) at the National Cancer Institute (NCI) invites grant applications (P50) for Specialized Programs of Research Excellence (SPORE) that address Gastrointestinal (GI) Cancers of highest incidence and mortality, i.e., colorectal and/or pancreatic cancers. The intent of this initiative is to recompete the SPORE in GI Cancer and to expand the program with the addition of at least one new SPORE through open recompetition by making awards to those institutions that can conduct the highest quality balanced translational research approaches on the prevention, etiology, screening, diagnosis, and treatment of colorectal and/or pancreatic cancers. Because basic research in pancreatic cancer has lagged behind that of the other major solid tumors, greater leeway is given for basic research studies on pancreatic cancer. However, such studies must have translational potential or significance. SPOREs are at institutions that have made or will make a strong institutional commitment to the organization and conduct of these programs. SPORE applicants will be judged on their current and potential ability to translate basic research findings into innovative research settings involving patients and populations. Each SPORE is encouraged to conduct rehabilitation and quality-of- life research. Each SPORE must provide career development opportunities for new and established investigators who wish to pursue active research careers in translational GI cancer research; develop and maintain human GI cancer tissue resources that will benefit translational research; develop extended collaborations in critical areas of research need with laboratory scientists and clinical scientists within the institution and in other institutions; and participate with other SPORES on a regular basis to share positive and negative information, assess scientific progress in the field, identify new research opportunities, and promote inter-SPORE collaborations to resolve areas of scientific controversy. Each SPORE and the "network" of SPOREs is expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality to human GI cancer. Each SPORE should support a mix of basic and clinical researchers whose formal interactive and collaborative research efforts will result in new approaches for early detection, diagnosis, therapy, and prevention and control. The SPORE mechanism is not intended to support basic research to the exclusion of clinical research or vice versa. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Specialized Programs of Research Excellence (SPORE) in Gastrointestinal Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-1 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. To be considered, applicant organizations must have (1) a minimum of three independent investigators who are successful in obtaining peer-reviewed research support directly related to GI cancer, and who together represent experience in both laboratory and clinical research, or in the alternate, a minimum of three independent investigators, each having published articles that significantly address GI cancer in peer- reviewed research journals, and who as a group represent experience in both laboratory and clinical research; (2) access to a patient care and service facility that serves GI cancer patients and, if the facility is not part of the parent institution, a statement that assures access to GI cancer patients for clinical research; the statement must be signed by the responsible officials of the applicant institution and the consortial care facility; (3) although applications must be submitted from one institution, they may include subcontracted collaborative scientific arrangements with scientists from other institutions as long as these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the parent institution receiving the award. Support will not be provided for applications with research activities focused exclusively on basic research, clinical research or trials, or epidemiological research. NCI staff (See INQUIRIES below) should be consulted if there are questions regarding any of the above requirements or exclusions. MECHANISM OF SUPPORT Support of this program will be through the P50 Specialized Center Grant (P50) mechanism. This mechanism supports any part of the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem. These grants differ from program project grants in that they are more complex and flexible in terms of the types of activities that can be supported. In addition to support for multidisciplinary research projects, support is also provided for career development, pilot research projects, specialized resources, and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed SPORE program. Awards will be administered under the Public Health Service Grants Policy Statement. FUNDS AVAILABLE This RFA is a one-time solicitation. NCI anticipates making one and possibly two awards. Applicants applying for competitive renewals may request up to five years of support. New applicants or applicants that have received P20 SPORE feasibility awards in the past may request up to three years of support. The NCI anticipates setting aside $3 million total for the initial year's funding. Funding in response to this RFA is dependent upon the receipt of a sufficient number of applications of high scientific merit. 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. NCI policy for SPORE grants establishes the following limits to the requested budgets: All new and competing renewal P50 SPORE applications may request up to a maximum annual direct cost of $1.5 million and maximum annual total cost of $2.5 million per individual SPORE. In complying with the direct cost cap of $1.5 million, the indirect costs related to subcontracts to other institutions or organizations will not apply toward the direct cost cap, but the total dollar request may not exceed $2.5 million. Future year increases are limited to four percent, but may not exceed this cap. Funding for successful P50 renewal applications will be for up to five years. Initial funding for new P50 SPOREs will be for no more than three years. Recognizing that the initial three year funding period for new SPOREs may be too short for multiple substantive scientific accomplishments, any future recompetition for this group will be evaluated on scientific accomplishment and on interim progress in pursuit of SPORE organizational, collaborative and research objectives. This would include, for example, progress toward planning, developing and implementing new innovative translational research programs, progress toward developing the careers of new scientists, progress toward procuring and distributing tissue specimens, progress toward developing substantive collaborative interactions. RESEARCH OBJECTIVES Background Gastrointestinal cancers pose major public health problems in this country. In 1995, there are an estimated 100,000 cases of colon cancer and 38,000 cases of rectal cancer with 47,500 and 7,800 deaths respectively. Although there have been recent advances in adjuvant therapy, there have been no major breakthroughs in the treatment of colorectal cancers. Animal studies have provided important insights into the etiology of colon cancer, but there have been no major advances in the prevention of this disease. Pancreatic cancer remains a significant and intransigent problem. The incidence of this cancer (24,000 cases in 1994) approaches the mortality rate (25,000 deaths). Average survival time from time of diagnosis is less than a year. There have been no advances in understanding the causes of this disease, in detecting or diagnosing it early, and there is no effective treatment. Although there have been recent advances in the biology of this disease, pancreatic cancer remains an intransigent cancer. In recent years, the scientific information base for gastrointestinal cancers has expanded significantly. Similarly, there has been increasing interest and opportunity in pancreatic research. This was documented at a workshop on pancreatic cancer convened by the NCI in 1994. The proceedings and research recommendations from this workshop are published in the International Journal of Pancreatology, Volume 16, nos. 2-3, October/November 1994. Application of this scientific base to clinical and preventive activities has not been commensurate with this expansion. Specialized Programs of Research Excellence provide focal points for sustaining and maintaining state- of-the-art research that will contribute to improved detection, diagnosis, treatment and prevention of GI cancer. SPORES will not only be expected to conduct a wide spectrum of research activities, but also to contribute significantly to the development of specialized research resources, career development of new investigators, and the expansion of the research base through collaborative research with scientists and clinicians in other institutions locally and nationwide. The research supported through this program must have translational significance. It will require interdependence between basic and clinical investigators in both the planning and implementation of research and would emphasize clinical application of basic research findings with patients and populations. Translational research also applies clinical findings to advance basic research that ultimately may lead to hypothesis-driven clinical trials or prevention and control interventions. It should be noted that clinical research that is not based on nor derived from laboratory findings is not considered translational for purposes of this RFA. Objectives The goal of this RFA is to expand the current GI Cancer SPORE program with the addition of at least one new SPORE. Each SPORE assembles critical masses of laboratory and clinical scientists to work together on GI cancer and to focus on innovative translation of basic findings into research settings involving patients and populations. The ultimate objective is to reduce incidence and mortality, and to increase and improve survival to the disease. The essential characteristics of a SPORE include (1) a strong scientific program that will have a clear impact on the human disease, (2) a strong innovative developmental or pilot research program that can respond quickly to new research opportunities, (3) a strong career development program to develop and expand the scientific cadre of investigators dedicated to translational research on human GI cancer, (4) a human GI cancer tissue procurement resource, and other resources specifically dedicated to translational research objectives, and (5) a willingness and commitment to work with other SPOREs and scientists in order to maximize research progress. The special features of SPORE grants provide opportunities for investigators with mutual or complementary interests to engage in multidisciplinary research that will impact on prevention, diagnosis, or treatment of human GI cancer, as well as rehabilitation or quality of life. Individual research projects must be highly interactive and must be conceived, planned, and implemented through the multidisciplinary interactions of independent laboratory and clinical scientists. Such interactions should demonstrate the potential for accelerating the translation of research findings into practical benefits for patients and populations. A distinguishing feature of a SPORE P50 grant is the highly dependent nature of the research objectives upon intra- and inter- project interactions. Thus, each project may, but ordinarily would not, be expected to stand on its own in the absence of interactions with other research projects. Developmental research funds provide support for highly innovative pilot projects that take maximum advantage of new research opportunities. This provides a flexible means for responding quickly to new research opportunities. Career development of new and established investigators will generate a cadre of scientists who could leave the SPORE with research experience to develop independent GI cancer research programs that emphasize translational research objectives. In order to facilitate achievement of SPORE program goals, each SPORE must develop resources specialized for GI cancer research activities. This must include human GI cancer tissue collection for research activities of the SPORE and for use by scientists who are concentrating on translational research within and outside the parent institution. The development of additional resources specialized for GI cancer research is also encouraged. Interactions among SPOREs is an important objective of this initiative. This may be in the form of research collaborations, exchange of scientists on a visiting basis, exchange of resources and materials, and other innovative ways. A requirement for all SPOREs is an annual meeting coordinated by the Organ Systems Coordinating Branch of the NCI. The purpose of the meeting is to share scientific information, assess scientific progress, identify new research opportunities, and establish priorities that will accelerate the translation of basic research findings to applied settings in patients and populations. SPECIAL REQUIREMENTS Each SPORE must include the following elements: 1. A strong institutional commitment. An institution receiving this award should incorporate the SPORE high within its institutional priorities. The institution should demonstrate a strong commitment to the program's stability and success. The application must provide a plan which addresses how the institutional commitment will be established and sustained, how it will maintain accountability for promoting scientific progress, and how the SPORE research effort will be given a high priority within the institution relative to other research efforts. This institutional commitment may be in the form of commitments to recruit scientific talent, provision of discretionary resources to the SPORE director, faculty appointments for SPORE investigators, assignment of research space, cost sharing of resources, or other ways to be proposed by the applicant. 2. A qualified principal investigator. A leader should be selected as principal investigator who can oversee and conduct planning activities, provide direction to the SPORE and ensure a translational research emphasis. 3. A substantive GI cancer patient population. Each SPORE should be recognized as a leading program in the treatment of GI cancer. The grant application must demonstrate and document access to a patient population which can participate in and can benefit from the innovative clinical and population research activities of the SPORE. 4. Research projects. Each SPORE application must include at least three approved research projects, which together represent reasonably diverse experimental approaches. Each research project must be headed by basic and clinical co- investigators. It is not necessary that both co- investigators commit equal effort to the project, but it should be evident from this collaboration that translational research objectives will be accelerated. The research must be oriented toward the most critically needed areas of GI cancer research, and toward translational activities which address new innovative possibilities in GI cancer research. As indicated above, each project must involve multidisciplinary laboratory and clinical interaction in the conception, planning, design and implementation of research. Projects should be interactive with each other whenever possible. This program will not support basic research that is without translational potential or significance nor will it support clinical studies that are not "translated" from basic research. 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 appear as a separate budget page in the application. They should not duplicate internal review and monitoring systems that are already in place at the institution. For any treatment protocols supported directly or indirectly by the SPORE, copies of 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 future protocols, to the NCI program director. Collaborative arrangements within the SPORE, within the parent institution and with other institutions are encouraged. Collaborations with scientists outside the immediate SPORE should be documented with appropriate letters of commitment as applicable. Collaborations with other institutions may involve subcontracting arrangements but an award will be made to one institution only; that institution is expected to demonstrate the full institutional commitment noted in 1. above. It is expected that all SPOREs will have a balanced approach to GI cancer that encompasses the areas of prevention, etiology, screening, diagnosis and treatment. This balanced approach may be either through research being conducted in their institution, or through collaborative associations they have developed or plan to develop with other SPOREs or with other investigators in the biomedical research community. 5. Developmental Research Funds. Each SPORE should continually allocate a significant proportion of its budget and effort to pilot projects that explore innovative ideas. It is important that SPOREs use developmental funds to stimulate projects that take maximum advantage of new research opportunities. Pilot projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE environment. The SPORE application should propose an institutional review process that selects pilot projects for funding which represent the most innovative ideas and which are likely to have the greatest impact on reducing GI cancer incidence and mortality, and increasing and improving survival and quality-of-life of GI cancer patients. These funds are intended to remain flexible and to support feasibility and pilot studies of a limited duration, e.g., two years or less, rather than the duration of the entire grant period. The expectation is that successful feasibility studies will become fully developed projects within the SPORE, or funded through other forms of research support, e.g., R29, R01. 6. Specialized Resources. The SPORE must have a dedicated activity to human gastrointestinal cancer tissue collection. This resource must benefit the specific research activities of the SPORE as well as the research activities of other scientists within and outside of the parent institution who are concentrating on translational research issues. The SPORE must be willing to participate in any national prioritization for distribution of tissues through NCI supported tissue networks. A plan must be proposed for prioritizing distribution of tissues to SPORE scientists and others based on the most innovative ideas in translational gastrointestinal cancer research. This plan should be flexible enough to accommodate and complement broader national priorities as they are developed. The development of other resources of special significance to translational research in these cancers is also encouraged. For example, human samples of normal and neoplastic tissues are not easily available. A registry that could organize material from many institutions in a form optimal for laboratory investigation would be invaluable. If the SPORE is part of an NCI-designated Cancer Center, the development of resources should not duplicate resources already provided by the center on an existing Cancer Center Support Grant (P30). The applicant should show that the P50 will become an effective, integrated research arm of the cancer center when it is supported by a P30 grant. 7. Career Development. The SPORE should demonstrate a consistent commitment to career development. A sufficient portion of the budget should be dedicated to the salaries and research activities of investigators who wish to pursue careers in translational research on GI cancer and who would acquire the necessary research experience to develop independent GI cancer translational research programs within or outside of the parent institution. These may be new investigators or established investigators who wish to change research directions. Candidates should be scientists who have demonstrated outstanding research potential but who need additional time in a productive scientific environment to establish an independent GI cancer research program. Candidates are expected to devote full time to research. Any deviation will require prior NCI approval. Recruitment should encourage the participation of qualified women and minorities where possible. To this end, each applicant should include a clear policy and plans for recruiting minorities and women. The SPORE application should propose the number of slots available, the criteria for eligibility and for selection of candidates, and describe the selection process. Also, the application should indicate prospective mentors who are already in place at the proposed SPORE, briefly describe their research programs, and describe complementary activities that contribute to the environment for career development (e.g., existing training grants, other career development mechanisms and relevant programs). 8. Annual Meeting of SPORE. GI Cancer SPOREs will be expected to participate in an annual meeting with the Organ Systems Coordinating Branch of the NCI to share positive and negative results with other SPOREs, share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations that will maximize the impact of the research on reducing incidence and mortality, and improving survival. Travel funds for the Principal Investigator and selected Project Investigators may be budgeted for this purpose. This may include Project Investigators from other institutions who are actively collaborating with SPORE investigators. In addition, travel funds should be budgeted for the SPORE Director to attend an annual SPORE Directors' administrative and planning meeting at the NCI. This Directors' meeting is in addition to the annual SPORE Investigators' meeting. A SPORE application can originate from an institution with or without an existing NCI Cancer Center Support Grant or P30 core grant. However, if a P30 grant already exists: a) the Principal Investigator of the SPORE should be a senior leader in the cancer center; b) the P30 Center Director may be the Principal Investigator of the P50 SPORE, but this is not necessary; c) lines of authority should be indicated clearly such that the SPORE is an integral part of the Cancer Center and does not interfere with the P30 chain of authority; d) a letter of commitment which delineates organizational relationships and lines of authority is required; the letter must be signed by the proposed Principal Investigator of the SPORE, the Cancer Center Director and the appropriate institutional official; e) the SPORE must be an integrated major programmatic element in the cancer center; however, there must also be a separate and distinctive institutional commitment to the SPORE as opposed to the NCI- designated Cancer Center; f) the development of resources in the SPORE should not duplicate resources already provided by the existing P30 grant; however, SPORE resources can be used to augment existing center resources to orient these resources more effectively to SPORE research objectives if this is a more efficient and more cost effective alternative; g) the applicant should describe how the P50 SPORE will interact synergistically and effectively with the existing P30 programs in order to maximize SPORE research objectives and contribute to cancer center research objectives. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 4, 1995, a letter of intent that includes the name and address of the principal investigator and other key personnel, any collaborating 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 subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Furthermore, NCI staff can discuss the most recent policies of the NCI relative to funding issues, potential problems in meeting program requirements or clarification of the peer review process before the final application is submitted. The letter of intent is to be sent to: Andrew Chiarodo, Ph.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Suite 512 6130 Executive Boulevard MSC 7386 Bethesda, MD 20892-7386 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8528 FAX: (301) 402-0181 APPLICATION PROCEDURES The research grant application form PHS 398 (Rev.5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD 20892-7762, telephone 301/710-0267, email: girg@drgpo.drg.nih.gov; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the application form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title "SPORE in Gastrointestinal Cancer" must be typed on line 2 of the face page of the application form. Complete applications are due by February 14, 1996. Applications must meet all eligibility requirements as described above and must address all programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA. Applications received after this date will not be accepted. Also, the Division of Research Grants (DRG) will not accept any application in response to this RFA, any part of which is the same as one currently being considered by any other review group or NIH awarding unit. Specific instructions for preparing a SPORE grant application are available from NCI program staff listed under INQUIRIES. These instructions should be used in preparing the application. Submit a signed typewritten original of the application, including the Checklist, and three signed exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA MD 20892-7710 BETHESDA MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities, National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (if hand-delivered or delivery service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received in response to this RFA. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed initially by the Division of Research Grants for completeness. Applications that are incomplete or have not addressed all of the required elements noted above under SPECIAL REQUIREMENTS, or do not meet the ELIGIBILITY REQUIREMENTS as noted above, will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements stated in the RFA is an NCI program staff function; this will be done stringently and will be based primarily on the clear orientation of the application to human GI cancer, translational research objectives, and an absence of duplication between the proposed research and currently supported research. Applications judged to be non- responsive to this RFA will be returned without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit and for special SPORE characteristics and requirements by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Applications judged to be competitive will be discussed and be assigned a priority score. The second level of review will be provided by the National Cancer Advisory Board. B. Review Criteria The major factors to be considered in the evaluation of all applications are given below. Additional factors are noted in a separate section below for applications from P50 SPOREs applying for competitive renewal. 1. The Institutional Commitment a) adequacy of facilities, equipment and space to promote translational research objectives; b) adequacy of institutional procedures and plans for monitoring, evaluating and assuming accountability for the general success of the SPORE; adequacy of the institutional infrastructure for assessing progress and needs; c) adequacy of recruitment objectives and plans to strengthen the scientific capabilities of the SPORE; d) presence of other tangible commitments, i.e., discretionary resources, to the SPORE, e.g., dollars and space. 2. Overall Program Organization and Capability a) the scientific qualifications and demonstrated scientific and administrative leadership capabilities of the SPORE Principal Investigator; adequacy of the time commitment of the Principal Investigator; b) the depth and breadth of the proposed research activities and plans to effectively pursue translational research objectives; c) the adequacy of access to patients and to a population for conducting current and projected therapeutic, prevention and control research; d) the adequacy of the procedures, processes, and plans for promoting interactions; e) if applicable, the adequacy of plans for synergistic and effective interactions with existing P30 programs. 3. Individual Research Projects a) qualifications and demonstrated competence of the investigators to conduct the proposed research; the adequacy of the time commitment of all key laboratory and clinical researchers associated with the project; b) clear evidence of significant multidisciplinary basic and clinical interactions in the conception, design and proposed implementation of the project; c) degree to which the project addresses an issue of substantive importance for reducing incidence and mortality or for increasing survival in human GI cancer; d) the scientific merit and adequacy of experimental design of the project; e) in clinical research components, clear evidence of full protection of human subjects, and appropriate mechanisms for the rigorous management and verification of research data; f) the adequacy of quality assurance and audit processes, and related budget for research involving clinical trials; g) the originality, novelty, and innovativeness of the experimental design and relevance to the overall goals and objectives of the SPORE; h) the degree to which the project is interactive with other projects in the SPORE conceptually, experimentally, and translationally; i) appropriateness of the budget to achieve research objectives. 4. Developmental Funds a) adequacy of the proposed process for continuously reviewing and funding pilot projects for their quality, innovativeness and potential impact on reducing incidence and mortality, and/or improving survival to GI cancer; b) quality, innovativeness and potential impact of proposed pilot projects; c) degree to which developmental funds will be used to stimulate pilot projects with multidisciplinary interactions and/or collaborative interactions with other scientists within or outside of the parent institution; d) appropriateness of the proposed budget relative to the proposed pilot projects and potential of the program to generate innovative pilot projects on a consistent basis. 5. Career Development a) the adequacy of the process for selecting candidates for career development who demonstrate potential for independent research careers or who are established investigators and are changing the direction of their research careers; b) adequacy of the policies to seek out and include qualified minorities and women in the career development program; c) adequacy of the individuals available in the program to serve as possible mentors of career development candidates; the current availability and adequacy of projects for career development candidates; d) complementary activities that contribute to the environment for career development; e) capacity of the overall program to absorb career development candidates and prepare them for independent GI cancer research careers; f) appropriateness of the budget relative to the proposed plans for sustaining a strong activity in career development. 6. Shared Resources a) adequacy of the proposed plans to develop, maintain and distribute a fresh/frozen human GI cancer tissue resource with pathological and clinical data; b) willingness to participate in any national prioritization for distribution of tissues through NCI- supported tissue networks; c) confirmation that the plan does not duplicate resources already available within the institution (e.g. as part of a Cancer Center Support Grant or P30) or through readily available national resources; d) adequacy of the justification for other specialized resources essential for the conduct of SPORE research; e) adequacy of qualifications of proposed managers of resources to conduct high quality, reliable resource operations; f) appropriateness of the requested budgets to conduct each resource operation. 7. Interactions with other SPOREs a) adequacy of plans to promote and maintain communication and integration with other SPOREs; b) willingness to interact with other SPOREs and with the NCI in sharing information, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. The above criteria apply to all new and competing applications. Additional factors to be considered in the evaluation of competing renewal applications from current P50 SPORE grantees, will be: 1. Research Projects a) progress in establishing a high quality research effort and scientific productivity in translational research over the previous funding period; b) degree to which applied researchers (e.g., clinical researchers, prevention and control researchers) are interacting with basic investigators in the planning, design, and implementation of research projects; c) collaborative efforts that have been established within and outside the SPORE institution; d) results (positive or negative) from each research project; e) degree to which each project is interacting with other projects; f) translational potential or significance of each individual research project; 2. Developmental Projects a) progress in the effective use of developmental funds to explore new research opportunities and/or stimulate the field; b) quality, innovativeness, and potential or actual impact of funded pilot projects; c) positive and/or negative results for each developmental project; d) how the SPORE has set priorities in the use of developmental funds; e) impact of developmental projects in stimulating new full translational research projects within the SPORE, or through other support mechanisms; f) impact of developmental projects in stimulating new multidisciplinary or collaborative interactions within or outside the SPORE. 3. Shared Resources a) effectiveness and efficiency of previously funded resources in meeting the specific translational research needs of the scientific projects in the SPORE; b) extent to which shared resources are being used by research and pilot projects, both within and outside the SPORE; c) quality, utility, and efficiency of the shared resources; d) progress toward establishing the GI cancer tissue resource to include pathological and clinical data; nature, quality, and distribution of tissues being procured; plans for prioritizing distribution of tissues within and outside the SPORE; 4. Other Considerations a) special efforts to recognize unique research opportunities based on incidence and mortality rates in the community or region of the SPORE; b) special efforts to enhance the research capability of the SPORE through interactions with individuals, organizations, and institutions within the community; c) progress toward meeting previously stated (above) institutional commitments; d) demonstrated effectiveness of the SPORE Director in terms of scientific and administrative leadership; e) progress in refining and improving upon the translational research infrastructure of the SPORE during the previous funding period as it relates to a) through d) above. Each component of the application will receive a recommendation of approval, or not recommended for further consideration. Approved components will receive an appropriate verbal descriptor of merit. The review group will critically examine the proposed budget for each component of the application. C. Scoring the Applications In addition to rating the merit of individual components, peer reviewers will be asked to judge the overall program in the following areas: 1) scientific merit and innovativeness; progress, if applicable; 2) evidence of interdependent, multidisciplinary design and conduct of the research; 3) impact, or potential for impacting on the disease; 4) institutional commitment. A verbal descriptor will be recorded for each of the above areas. A single numerical priority score will be assigned to the program as a whole. Although primary emphasis will be placed on scientific merit, innovativeness, and progress where applicable, significant consideration will be given to multidisciplinary interactions, potential for impacting on the disease, and institutional commitment. A recommendation for no further consideration for any required element of the program (see SPECIAL REQUIREMENTS above) will result in an overall evaluation of "not recommended for further consideration." AWARD CRITERIA The earliest anticipated date of award is December 1, 1996. Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) priority score, (b) availability of funds, and (c) programmatic priorities. The NCI anticipates making one and possibly two awards for project periods of five years for successful P50 competitive renewal, and for project periods of three years for applications from new applicants. INQUIRIES Written and telephone inquiries concerning the objectives and scope of the RFA, or inquiries about whether or not specific proposed research would be responsive, are encouraged. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. Inquiries regarding programmatic issues and requests for SPORE guidelines may be directed to: Andrew Chiarodo, Ph.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Suite 512 6130 Executive Boulevard MSC 7386 Bethesda, MD 20852-7386 Telephone: (301) 496-8528 FAX: (301) 402-0181 Email: chiaroda@dcbdcep1.nci.nih.gov Inquiries regarding fiscal or administrative matters may be directed to: Joan Metcalfe Grants Management Specialist Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800 ext. 228 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance no. 13.397. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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