SPECIALIZED PROGRAM OF RESEARCH EXCELLENCE IN OVARIAN CANCER Release Date: September 4, 1998 RFA: CA-98-008 P.T. National Cancer Institute Letter of Intent Receipt Date: October 1, 1998 Application Receipt Date: January 15, 1999 PURPOSE The Organ Systems Branch of the Office of the Deputy Director Extramural Science at the National Cancer Institute (NCI) invites grant applications (P50) for a Specialized Program of Research Excellence (SPORE) in Ovarian Cancer. Applicant institutions must be able to conduct the highest quality balanced translational research on the prevention, etiology, screening, diagnosis, and treatment of ovarian cancer. 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. A SPORE is encouraged to conduct rehabilitation and quality-of-life research. A SPORE must provide career development opportunities for new and established investigators who wish to pursue active research careers in translational ovarian cancer research; develop and maintain human ovarian 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 ovarian cancer. A 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 Program of Research Excellence (SPORE) in Ovarian Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. To be considered, applicant organizations must have (1) a minimum of three independent investigators who have already been successful in obtaining peer-reviewed research support directly related to ovarian cancer (R01, P01, etc.), and who together represent experience in both laboratory and clinical research; (2) access to a patient care and service facility that serves ovarian cancer patients and, if the facility is not part of the parent institution, a statement that assures access to ovarian cancer patients for clinical research; the statement must be signed by the responsible officials of the applicant institution and the consortia care facility. Although an application must be submitted by a sole applicant institution, subcontracted collaborative scientific arrangements with scientists from other institutions may be included if 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 applicant institution. Support will not be provided for applications with research activities focused exclusively on basic research, or clinical research or trials, or epidemiological research. NCI program staff listed under INQUIRIES should be consulted if there are questions regarding any of the above eligibility requirements or exclusions. MECHANISM OF SUPPORT Support of this program will be through the 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 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 PHS grants policy as stated in the PHS Grants Policy Statement. NCI policy for SPORE grants establishes the following limits to the requested budgets: A new P50 SPORE application may request a maximum annual direct cost of $1.5 million and maximum annual total cost of $2.5 million. 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 three percent but may not exceed this cap. A SPORE grant application may request up to five years of funding. FUNDS AVAILABLE This RFA is a one-time solicitation. The NCI anticipates making at least one award. Additional awards will be considered based on availability of funds. An applicant may request up to five years of support. The NCI anticipates setting aside at least $2.5 million 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. RESEARCH OBJECTIVES Background Ovarian cancer is currently the leading cause of death from gynecologic malignancy in the United States. It is estimated that 26,800 new cases of ovarian cancer will be diagnosed in this country in 1999, and that 14,200 women will die from the disease. Although the cure rate for Stage I disease is nearly 90%, the majority of patients present with disease spread beyond the ovary. Despite aggressive surgical debulking and platinum-based chemotherapy, the 5-year survival rates for women with clinically advanced disease is only 15-20%. The magnitude of this problem is reflected in the recent SEER data which indicates the 5 year survival of patients with ovarian cancer has increased only from 36% in 1976 to 46% in 1993. In 1992, the Organ Systems Coordinating Branch of the NCI convened a Workshop on Investigational Strategies for Detection and Intervention in Early Ovarian Cancer. The workshop was divided into six interrelated areas: 1) genetic events in ovarian carcinogenesis, 2) inheritance of risk, 3) early pathology and progression, 4) markers for detecting early ovarian cancer, 5) models for ovarian carcinogenesis and 6) strategies for intervening in early ovarian cancer. It became clear from this workshop that the scientific base for ovarian cancer is expanding, and that new investigators are turning to research in this field. Since then, the scientific information base for ovarian cancer has continued to expand; however, application of this scientific base to clinical and preventive activities has not been commensurate with this expansion. Based on evidence from the workshop and in view of increasing numbers of investigators entering the field, it would appear that research in this area could benefit from a SPORE. A SPORE must address the scientific information base and provide focal points for sustaining and maintaining state-of-the-art research that will contribute to improved detection, diagnosis, treatment and prevention of ovarian cancer. SPORES are not only 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, the development of improved research model systems 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 potential or significance. It will require interdependence between basic and clinical investigators in planning and implementing 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 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. Research Goals and Scope The goal of this RFA is to establish at least one new Ovarian Cancer SPORE. A SPORE assembles critical masses of laboratory and clinical scientists to work together on human ovarian cancer and to focus on innovative translation of basic findings into research settings involving patients and populations. The ultimate objective is to reduce ovarian cancer incidence and mortality, and improve survival. 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 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 ovarian cancer, (4) a human ovarian 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 ovarian 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 its dependency on intra- and inter-project interactions. Thus, each project is expected to interact inside and outside the SPORE institution. Pilot 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 funds for support of new and established investigators will generate leading scientists in the field who have the experience and capability to develop independent ovarian cancer research programs that emphasize translational research objectives. In order to facilitate achievement of SPORE program goals, a SPORE must develop resources specialized for ovarian cancer research activities. This must include human ovarian 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 ovarian 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 participating in an annual meeting coordinated by the Organ Systems 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 SPORE's stability and success. The application must provide a plan that 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 substantial ovarian cancer patient population. Each SPORE should be recognized as a leading program in the treatment of ovarian cancer. The grant application must demonstrate and document access to a patient population that can participate in and can benefit from the innovative clinical and population research activities of the SPORE. 4. Research projects. Each SPORE application must propose details for at least three research projects, which together represent diverse experimental approaches. Each 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 critically needed areas of ovarian cancer research, and toward translational activities that address new innovative possibilities in ovarian cancer research. As indicated above, each project must involve multidisciplinary laboratory and clinical interactions in conception, planning, design and implementation of research. Projects should be interactive with each other whenever possible. The SPORE program will not support basic research that is without translational potential 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 be justified. The proposed provisions should not duplicate review and monitoring systems already in place at the institution. For any ovarian cancer treatment protocol supported directly or indirectly by the SPORE, 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 SPORE, to the NCI program director. At least one research project must be on ovarian cancer prevention or early detection and screening. The NCI is particularly interested in early detection and screening efforts. There is also a strong interest in developing genetic methods for determining high risk to ovarian cancer either through inheritance or through environmental exposures. However, the NCI is open to all novel innovative approaches to prevention. 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 a SPORE will have a balanced approach to ovarian cancer that encompasses the areas of prevention, etiology, screening, diagnosis and treatment. This balanced approach may be either through research being conducted in its own institution, or through collaborative associations it has developed or plans to develop with other SPOREs or with other investigators in the biomedical research community. 5. Pilot Research Funds. A SPORE should continually allocate a significant effort to pilot projects that explore innovative ideas. It is important that a SPORE use pilot funds to stimulate projects that take maximum advantage of new research opportunities. Such 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 ovarian cancer incidence and mortality, and increasing and improving survival and quality-of-life of ovarian 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., R01. 6. Specialized Resources. The SPORE is encouraged to develop and maintain resources of special significance to translational ovarian cancer research. While all types of resources may be proposed, each SPORE must have a dedicated activity for collecting and distributing human ovarian cancer tissue. Tissue collection should include the essential pathologic and clinical information needed for conducting research. This resource should 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 ovarian cancer research. This plan should be flexible enough to accommodate and complement broader national priorities as they are developed. 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 ovarian cancer and who would acquire the necessary research experience to develop independent ovarian 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 ovarian cancer research program. Candidates are expected to devote full time to research. Any deviation will require prior NCI approval. Recruitment must include qualified women and minorities. To this end, each applicant should propose a clear policy and plan for recruitment of career development candidates. 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. Investigators participating in Ovarian Cancer SPOREs will be expected to participate in an annual meeting with the Organ Systems 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by October 1, 1998, a letter of intent that includes the name, address, and telephone number of the principal investigator and identifies the component research projects, core units and their principal investigators, 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 to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Jorge Gomez at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: grantsinfo@nih.gov. Additional instructions for preparing a SPORE grant application are available from the program staff listed under INQUIRIES. These instructions must be requested and used in preparing a SPORE application. The RFA label available in the PHS 398 (rev. 9/95) application form 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 Ovarian Cancer" must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed typewritten original of the application, including the checklist, and three signed exact photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7399 Rockville, MD 20852 (for express/courier service) It is important to send these copies at the same time that the original and three copies are sent to the Center for Scientific Review (CSR); otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received by the receipt date. Complete applications must be received by January 15, 1999. If an application is received after that date, it will be returned to the applicant without review. The CSR will not accept any application in response to this RFA that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. 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. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed by CSR for completeness and for responsiveness by the NCI. Applications that are incomplete and/or non- responsive to this RFA will be returned without further consideration. 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, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. B. Review Criteria The major factors to be considered in the evaluation of all applications are given below. 1. The Institutional Commitment, including: 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 for strengthening 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. scientific qualifications and demonstrated scientific and administrative leadership capabilities of the SPORE Principal Investigator; adequacy of the time commitment of the Principal Investigator; b. depth and breadth of the proposed research activities, and plans to effectively pursue translational research objectives; c. adequacy of access to patients and populations for conducting current and projected therapeutic, prevention and control research; d. adequacy of the procedures, processes, and plans for promoting interactions; e. adequacy of plans for synergistic and effective interactions with existing P30 programs, if applicable. 3. Individual Research Projects: The five criteria to be used to evaluate individual research projects in SPORE grant applications are listed below. Within the SPORE concept of translational research, reviewers will comment on the following aspects of the application in their written critiques. Reviewers are asked to judge the likelihood that the proposed research will substantially impact on the pursuit of the goals implied within the following criteria. Each criterion will be addressed and considered by the reviewers in assigning the overall score, after weighting the determinations as appropriate for each application. Note that the application does not need to be strong in all categories for the research to be judged likely to have a major translational impact and thus deserve a favorable priority score. For example, an investigator may propose to carry out work that by its nature is important but not innovative if it translationally moves the field forward. a. Significance. Does this study address an important research problem? Does the scientific merit and experimental design of the project adequately address issues of substantive importance for reducing incidence and mortality, or for increasing survival in human ovarian cancer? b. Approach. Are the conceptual research framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative translational approaches? Is there clear evidence of significant multidisciplinary basic and clinical interactions in the conception, design, and proposed implementation of the project? c. Innovation. Does the project develop new methodologies or technologies in the areas of prevention, diagnosis, and/or treatment of ovarian cancer? Is the experimental design of sufficient originality, novelty, and innovativeness to make it highly relevant to the overall goals and objectives of the SPORE? d. Investigators. Are the investigators appropriately qualified with demonstrated competence to conduct the proposed research? Is the proposed work appropriate to the experience level of the principal investigator and project researchers? Are the proposed time commitments for all key laboratory and clinical researchers reasonable and adequately associated with the project? e. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features in the scientific environment or reach out to useful collaborative arrangements? Is there evidence of adequate institutional support? Is the project interactive with other components of the SPORE, conceptually, experimentally, and translationally? f. The following additional factors should be evaluated for individual research projects: o evidence of full protection of human subjects for clinical research components, and appropriate mechanisms for the rigorous management and verification of research data; o adequacy of quality assurance and audit processes, and adequacy of the related budget for research involving clinical trials; o appropriateness of the budget to achieve the stated research objectives. o adequacy of plans to include both genders and minorities and their subgroups as appropriate to meet the scientific goals of the research; o plans for the recruitment and retention of research subjects and patients will also be evaluated. 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 ovarian 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. 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 ovarian 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 ovarian 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. 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; 5. overall program organization. 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. AWARD CRITERIA The earliest anticipated date of award is September 30, 1999 Applications considered by the National Cancer Advisory Board will be considered for award based upon (a) priority score, (b) programmatic priorities, and (c) availability of funds. The NCI anticipates making at least one award for a project period of five years. SCHEDULE Letter of Intent Receipt Date: October 1, 1998 Application Receipt Date: January 15, 1999 Review by NCAB Advisory Board: September 1999 Anticipated Award Date: September 1999 INQUIRIES Written and telephone inquiries concerning the objectives and scope of the RFA, and 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. For inquiries regarding programmatic issues, contact: Jorge Gomez, M.D., Ph.D. Organ Systems Branch National Cancer Institute 6130 Executive Boulevard, Suite 512, MSC 7386 Bethesda, MD 20892-7386 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8528 Email: jg1w@nih.gov For fiscal or administrative matters, contact: Cynthia W. Mead Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800 ext. 254 AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 93.397. 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 285 ) 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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