Full Text CA-95-004 BREAST CANCER SURVEILLANCE RESEARCH NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: CA-95-004 P.T. 34 Keywords: 0715036 Diagnosis, Medical Biomedical Research, Multidiscipl National Cancer Institute Letter of Intent Receipt Date: February 14, 1995 Application Receipt Date: April 21, 1995 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Surveillance Program (SP). New applicants and applicants currently funded under SP initiatives are invited to respond to this Request For Applications (RFA) to design and conduct breast cancer surveillance research. This is a follow-up to a cooperative agreement in which three awards began in 1994. Cancer surveillance research requires a strong interface between methodologic techniques and cancer control initiatives in prevention, early detection, and treatment. The purpose of the Breast Cancer Surveillance Research initiative outlined in this RFA is to examine thoroughly the operational aspects of breast cancer screening practices in the United States by conducting analytic research designed to assess the effectiveness, efficiency, and cost of screening programs as they relate to the reduction of breast cancer mortality. This may include studies of medical decision models for workup of women with positive screening tests, studies of utilization of emerging new technologies in breast cancer screening and diagnosis, and studies of biological differences among cancer related to detection methods. The intent of this RFA is to broaden the current Surveillance projects in areas that have not as yet been adequately covered, specifically among urban African-Americans and rural areas. This initiative also encourages interdisciplinary approaches to research on the basic biology and immunobiology of breast cancer to determine if there is a difference in screened detected and non- screened detected cases. It is not only important to determine the need for change in screening practices but to stimulate other breast cancer research. In order to more fully understand the effect of breast cancer screening on cancer outcome, data on breast cancer screening practices and tumor biologic characteristics need to be collected and linked to data from quality controlled population-based tumor registry programs. Examples of such registry programs are those affiliated with the NCI's Surveillance, Epidemiology, and End Results (SEER) Program or members of the North American Association of Central Cancer Registries (NAACCR) who meet comparable standards for completeness, quality, and timeliness of reporting and registry operations. A description of the NCI guidelines for these standards is available upon request from the program staff listed under INQUIRIES. Responses to this RFA would initiate mechanisms to accomplish these goals, study the utilization of state-of-the-art and emerging new technologies in breast cancer screening, and increase knowledge of the differences in basic biology and immunology of breast cancer by method of detection. 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, Breast Cancer Surveillance Research, is related to the priority area of cancer surveillance and data systems. This information (surveillance and data systems) is used to understand the health status of the population and to plan, implement, describe and evaluate public health programs that control and prevent adverse health events. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, cancer centers, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. Since this RFA concerns breast cancer surveillance research in the United States, a domestic application may not include an international component. New applicants and those with currently funded programs are eligible as described below. A Breast Cancer Surveillance Research applicant may be, but is not limited to, a hospital, a clinic, a group of practicing physicians, or a consortium of hospitals and/or clinics and/or physicians that agree to work together with a Principal Investigator and a single administrative focus. Although a Health Maintenance Organization (HMO) can be part of an application, it should not serve as the sole population base for the surveillance activities. It is essential that an applicant show evidence of the ability to access and organize data collection from at least three different facilities, which include: mammography facilities, pathology laboratories, and a quality-controlled, population-based cancer registry. If this expertise does not reside within one institution, an applicant may put together a group with the necessary expertise, which may involve the use of several institutions and/or organizations. Each applicant must have access to a resource unit that supports research data management and statistical analyses locally. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) cooperative agreement mechanism (U01). The cooperative agreement is an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated to assist awardees in the planning, direction, and execution of the proposed project. The anticipated average amount of the direct cost awards will be $250,000 per year per award. The anticipated date of award is December 1995. The total project period for applications submitted in response to the RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all other unsolicited applications and be reviewed by a standing Division of Research Grants (DRG) study section. If the NCI determines that there is a sufficient continuing program need, a request for new and competitive continuation applications will be announced. FUNDS AVAILABLE The NCI has determined that it will continue its support of programs that monitor progress against cancer through breast cancer screening. Approximately $8,000,000 in total costs for five years will be committed to fund applications that are submitted in response to this RFA. It is anticipated that up to three awards will be made to applicants who successfully demonstrate that they can develop a "multi-institutional group" with the ability to access mammography and pathology facilities, and a cancer registry. Awards will be made to applicants who demonstrate a willingness to collaborate with researchers working in the same research area, principally awardees who have formed the working Consortium as a response to the previous RFA. First year costs may include development of computer systems dedicated to this research, if needed. Following is the estimated total cost support available for all awards by fiscal year: FY 96 $1,000,000 FY 97 1,500,000 FY 98 1,500,000 FY 99 2,000,000 FY 2000 2,000,000 Total $8,000,000 This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. For purposes of budgeting, funds should be requested for up to three persons to attend two meetings in Bethesda, Maryland, during each of the five years of award. RESEARCH OBJECTIVES A. Background Breast cancer is the second leading cause of death among women. In 1993, an estimated 46,000 women will die of breast cancer, while 182,000 new female cases will be diagnosed. Approximately one woman in every eight will develop breast cancer in her lifetime (Miller, Ries, Hankey et al, 1992). Screening for breast cancer can reduce mortality among women aged 50 and older. A controlled trial that started in the early 1960s demonstrated a 30 percent reduction in breast cancer mortality among women screened by mammography and clinical breast examinations (Shapiro, Venet, Strax, Venet, 1988). More recent studies confirmed the effectiveness of screening mammography in reducing breast cancer mortality, (DHHS, PHS, "Healthy People 2000") notwithstanding the recent conflicting results from the Canadian study (Miller, Baines, To, Wall, 1992). A review of the breast cancer screening data indicates an under utilization of mammography in surveys conducted as late as 1979 (Howard, 1987). Eight to eleven years later, breast cancer screening with mammography had become an increasing part of the health care picture. Data from 1987 and 1990 National Health Interview Surveys (NHIS) showed that screening with mammography had reached 59 percent of women over 40 years of age at some time by 1990 (compared to 45 percent in 1987), and 33 percent had a screening exam in the last year (compared to 17 percent in 1987) (Kessler, Breen, 1992). Although data from the 1992 NHIS show increases in screening across all age and race groups, these increases are smaller than the increases in the late 1980s (Breen and Kessler, unpublished data from the 1992 NHIS public use data tapes). These percentages were higher than previous surveys, and were part of an increasing trend that suggested annual mammography was as high as 40 percent in surveys of the Behavioral Risk Factor Surveillance System (BRFSS) of the Centers for Disease Control (CDC). In addition, analyses of the 1987 BRFSS data showed considerable state-to-state variation in screening rates. Rates of participation by population characteristics are also obtained. This project will provide the opportunity to investigate differences in the actual provision of screening services, and by doing so, assist in evaluating the population benefit of these increased screening activities. Data on another critical component of breast cancer screening, the physical examination, are also available from the NHIS. Makuc, Freid, and Kleinman reported on breast physical examination rates from 1973 and 1985 (Makuc, Freid, Kleinman, 1989). They showed a substantial increase in prevalence of examinations during this interval for black women in the U.S., but virtually no change among white women. By 1985, approximately 70 percent of white and black women had received a breast physical examination within the past two years. Recent survey results indicate that while the usage of mammography is increasing, the usage of clinical breast exam along with mammography may be declining. A comparison of mammography utilization rates among white women 64 to 75 years of age in five communities of the NCI Breast Cancer Screening Consortium showed that rates had increased significantly (from 19-33 percent in 1978-88 to 35-59 percent in 1991 across all five areas). However, among women who had a mammogram, the percent who also had a clinical breast examination decreased between the 1978-88 survey and the 1991 survey (p=.001 using logistic regression pooled across all sites) (Coleman, Feuer, NCI Breast Cancer Screening Consortium, 1992). Since clinical breast exam, along with mammography, is recommended as a screening test for breast cancer detection, data need to be collected on this screening test as well when feasible. Research is needed on the effectiveness, efficiency, and cost of breast cancer screening programs in the United States, on the medical decision models for workup of women with abnormal screening tests, and on the utilization of emerging new technologies in breast cancer detection. Of major interest is whether or not there are differences in biology, clinical management, and outcome between screened detected and non-screened detected cases. These areas of cancer surveillance research require a strong interface between methodologic techniques and cancer control initiatives in prevention, early detection, and treatment. Investigators affiliated with mammography facilities, pathology laboratories, and a population-based cancer registry are encouraged to work together to answer these questions. B. Goals and Scope The objectives of this RFA are to foster research collaborations and interactions among basic researchers, clinical investigators, and applied researchers affiliated with quality-controlled population- based tumor registries. The focus of these collaborations is to advance research in breast cancer screening methods, technology, clinical work-up of women with abnormal screening tests, and differentials in the biology and immunobiology of breast cancers in relationship to detection methods. Specifically, the objectives of the Breast Cancer Surveillance Research Project are to conduct analytic research on breast cancer screening in order to assess the operation (including cost) of screening programs and policies in the U.S., and associated decision models for workup of women with positive screening tests. The research must be amenable to extending implementation in a multi- group setting using comparable data, which may include, but is not limited to, the following: o recommended screening policies o target groups for screening o rates of women screened o influence of screening on trends in breast cancer incidence and intermediate outcomes (e.g., stage) o quality assurance procedures o use of state-of-the-art technology o results of screening examinations, including predictive values, sensitivity, and specificity o follow-up of screened women o effect of screening on changes in breast cancer prognosis Under the previous release of this RFA, three awards were made. However, incomplete coverage of several key populations will limit our understanding the current implementation of breast cancer screening in the U.S. Specifically, coverage of African-Americans and rural populations is less than optimal. This RFA encourages applicants who can address one of these two groups, although consideration will be given to applicants who can perform unique and important research in other populations. Secondary objectives of the Breast Cancer Surveillance Research Project extend the operational focus of breast cancer screening programs to incorporate basic and clinical research on emerging technologies in breast cancer detection and on biological differences of tumors associated with detection modality. Specifically, these objectives are to conduct research such as, but not limited to, the following: 1. Studies of the utilization of state-of-the-art and emerging new technologies in breast cancer screening and diagnosis. Technologies of interest include, but are not limited to, o improvement in conventional mammography such as technological development in grid design and composition o magnetic resonance and stereotactic fine needle aspiration and biopsy o cytology of nipple aspirate. 2. Studies designed to determine whether or not there are differences in biology, clinical management, and outcome between screened detected and non-screened detected cases. Studies may include, but are not limited to, o basic biology and immunology of breast cancer to determine whether there is a difference in screened detected cases and non-screened detected cases o genetic alterations among women with breast cancer detected through screening and those with breast cancer which was non-screened detected. The above research topics are given as examples. Each applicant may submit more than one research plan, and each research plan, depending upon the nature of the proposed study, may or may not be a collaborative study. However, the potential for extension to a multi-institutional setting should be addressed. An additional five- page limit will be allowed for each additional research plan. The Breast Cancer Surveillance Research Project by its very nature will bring together multidisciplinary health professionals to accomplish the goals and objectives of the proposal. Thus, it is important that applicants for this project demonstrate a track record of interdisciplinary activity and interactive "know-how." Furthermore, this concept builds on several ongoing efforts related to data collection in breast cancer screening programs. Examples include CDC's projects in providing breast and cervical cancer screening to low income populations, NCI's Specialized Programs of Research Excellence in Breast Cancer (SPORES), the American College of Radiology's mammography lexicon, and NCI's SEER Special Studies. The applicant must establish the availability and potential of a linked data base between breast cancer screening, registry, and pathology data sources. This data must serve as a foundation or "core" for the conduct of health services and basic biologic research. The quality of this data base must be demonstrated in the application clearly; however, this should be seen as a basic component and not as research in itself. The research topics suggested in the paragraphs about objectives above must build on this data base. As such, an applicant may wish to limit their application to one or two strong research proposals along with the establishment of the data base to maintain a balance in the application and allow for a reasonable budget. SPECIAL REQUIREMENTS Study Organization The NCI will convene a meeting for new award recipients to join the NCI's Breast Cancer Surveillance Consortium. This Consortium consists of one voting member from each award recipient (the Principal Investigator or designee) and one voting member from the NCI (the Program Director or designee). The awardees to this Consortium will review the established group procedures and goals, and work with other investigators to plan and set priorities for cooperative group studies. The NCI Program Director will coordinate and facilitate the interactions of the Consortium institutions and will review their activities for relevance to the objectives of the RFA and programmatic considerations. Terms and Conditions of Award Under the cooperative agreement, a partnership will exist between the recipient of the award and the NCI, with assistance from the NCI in carrying out the planned activity. The following terms and conditions pertaining to the scope and nature of the interaction between the NCI and the investigators will be incorporated in the Notice of Grant Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Nature of NCI Staff Involvement" and "Responsibilities of Awardees" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; DHHS grant administration regulations 45 CFR 92; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. The inability of an awardee to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of award. 1. Awardee Rights and Responsibilities a. Nature of Involvement with Consortium The award recipients must be willing to join the established NCI Breast Cancer Surveillance Consortium for the purpose of planning, developing, and conducting collaborative projects which share a common protocol, study design and research objectives, and comparable data collection procedures. Within this framework, the awardees will have primary and lead responsibility for the project as a whole, including research design and protocol development, and the planning, conduct, analysis, publication and interpretation of their studies. Data from these collaborative projects will be pooled for joint analysis, interpretation and publication of results in accord with policies and procedures established by the Consortium. The Consortium will convene as needed to discuss collaborative study progress and address scientific-technical aspects of implementation. In addition, when relevant, the award recipients will provide reports on progress of other funded projects external to the collaborative activities. The award recipients (Principal Investigator or designee) must attend Consortium strategy session meetings and cooperate fully as active participants in the development and implementation of collaborative projects. Each awardee must access three different kinds of facilities for the purpose of data collection and analysis regarding breast cancer screening practices. Access to existing records and collection of new information is required for: mammography facilities, pathology laboratories, and a quality-controlled, population-based cancer registry. Since this project includes substantial involvement in the use of the facilities' records and practices, the awardee must ensure collaboration among the three facilities throughout the award for purposes of this research project. b. Strategy Sessions and Meeting Attendance The awardee must agree to send at least one representative to each of the Consortium meetings. In most cases, two representatives will be necessary because of the wide range of substantive and methodological discussions during these strategy sessions. c. Data Collection and Management Award recipients: 1. Must cooperate in the establishment of comparable data collection techniques for collaborative studies; 2. Ensure that the tripartite multi-institutional group is able to implement the data collection procedures to be developed by the Consortium members; 3. Ensure that the population-based registry data are compatible with SEER Program standards; and 4. Make all data required by any collaborative Consortium study available for pooled analyses. Awardees are required to collect prospective detailed data directly from breast cancer screening facilities and from pathology records, and to link these data to population-based cancer registry data. These unique linkages are required in order to conduct research on breast cancer screening programs and to facilitate investigator initiated research on the immunobiology, cell biology, molecular genetics and endocrinology of breast cancer. The awardees will retain custody of and primary rights to their data. However, the NCI Program Director or designee will have access to all data generated under collaborative studies conducted under this award. The NCI Program Director or designee may review data management and analysis procedures for collaborative studies under mutually agreeable circumstances. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA. 2. NCI Staff Responsibilities a. Establishment of Consortium The NCI Program Director will convene a meeting for the recipients of this RFA to join the Consortium, when the awards have been made. Principal Investigators from each of the award recipients will meet with the NCI Program Director to build a cooperative organizational unit, referred to as the Consortium. The Program Director may designate a staff person in the Surveillance Program to assume some duties of this role as needed. b. Strategy Sessions The NCI Program Director or designee, in cooperation with the Consortium Coordinator, will sponsor strategy sessions when indicated, attended by Principal Investigators and other appropriate staff from the Consortium and appropriate NCI staff. c. Data Management Each awardee will retain custody of and primary rights to their data and is responsible for statistical analysis of local data, computer processing and statistical interpretations. However, for any collaborative studies among the Consortium members, the NCI is willing to assist in providing data analysis and statistical evaluation from existing resources for pooled analyses. For these collaborative studies, the Consortium members will be responsible for the study design, planning and interpretation of the data. The NCI Program Director will have access to all data generated under this award and will periodically review the data management and analysis procedures for the Consortium. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA). d. Monitoring and Program Review In addition to normally prescribed duties of program and grants staff, an on-site program review will occur as early as 10 months but no later than 18 months after award. The program review will be conducted to evaluate progress of the Consortium, particularly the collaborative projects. The inability of a Consortium member to meet the performance requirements set forth in the Terms of Cooperation in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 3. Collaborative Responsibilities Awardees to this request must agree to join the existing Breast Cancer Surveillance Consortium. The Consortium members will establish a leader (Consortium Coordinator, chosen from awardees) who will administratively preside at all Consortium meetings. The Consortium Coordinator, other members of the Consortium, and the NCI Program Director (Associate Director, Surveillance Program, DCPC) have established administrative procedures (i.e., meeting dates, guidelines for reporting, etc.) and methods by which all scientific/analytic requirements of the RFA will be met. The new awardees will review these procedures and work with the Consortium to determine the need for any changes. Awardees will be required to accept and implement the common protocol and procedures approved by the Consortium. The Consortium will convene as needed to discuss collaborative study progress and address scientific-technical aspects of implementation. At Consortium meetings, members will strive to develop collaborative protocols and comparable standards for data collection and management, examine the areas of commonality, and discuss progress toward the agreed upon goals in all of the RFA scope of activities. These range from development of data collection instruments to more complex procedures such as the study protocol required to answer research questions in the collaborative studies proposed by the Consortium. Timelines will be established, revised and refined; Consortium members will collectively address and solve problems within the project; outstanding research questions will be defined and existing ones will be prioritized; data will be analyzed and prepared for "pooled" statistical analyses to answer agreed upon research questions requiring pooled analyses. At these meetings, information relevant to collaborative studies will be reviewed and discussed, including such issues as overall Consortium performance and the science of current or proposed collaborative studies. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by the Consortium investigators and the NCI Program Director. The Principal Investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into collaborative studies. The NCI Program Director will provide assistance and guidance as needed, for example, in developing shared study protocols, selecting data elements, obtaining cooperation from the three types of facilities, linking databases, and analyzing pooled data on the operational aspects of screening. Communication at the various stages of protocol development is encouraged. 4. Arbitration Process The Terms and Conditions of Award require that the NCI Program Director make post-award decisions related to program performance and programmatic decisions on scientific-technical matters. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the NCI Program Director. An arbitration panel (with appropriate expertise) composed of one member selected by the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, NCI. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. 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 provisions that are substantially different from the 1990 policies. Investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 14, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It 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. Brenda K. Edwards at the address listed under INQUIRIES. APPLICATION PROCEDURES Because the Terms of Cooperation (discussed in the Special Requirements Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. 1. In addition to providing a complete research plan based on the kind of resources immediately available to the applicant, each applicant must delineate its catchment area for each of the three facilities (mammography, pathology, and tumor registry). Each applicant will project how the research plan could be expanded as resources within the Consortium become available. 2. A designated Principal Investigator is required. An associate Principal Investigator should be named to assure continuity in the event of resignation of the Principal Investigator. The qualifications and experience of both must be described. 3. Each applicant must provide the qualifications and experience of all proposed support personnel, as well as a description of the proposed duties for each position. 4. Multiple research affiliations and related funded research are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing projects will be resolved. 5. Quality control procedures must be described in detail. It is essential that the quality control of the cancer registry be described. 6. The availability of facilities, including mammography facilities, pathology laboratories, and quality controlled population-based cancer registries, must be described. A statement of commitment from each participating institution or organization and/or documentation of collaborative arrangements must be provided. Each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. 7. Each applicant's capability and expertise to manage the data must be described. Data management includes development of data collection forms, procedures for data transmittal, procedures for data entry, data editing, compilation, and analysis, as well as procedures for quality control and verification of submitted data. Statistical data collection comparability must exist among the tripartite local facilities and the collaborative research project. Each applicant must provide evidence of their willingness to pool statistical data for analysis as required for collaborative studies. Each applicant's ability to manage data from local facilities and to participate in multi-institutional collaborative studies must be described. 8. Applicants need to demonstrate that they can successfully develop a tripartite organization of local facilities and show evidence that they will successfully participate in a Consortium and conduct collaborative studies. This will be the primary mechanism by which the NCI Program Director will relate to all principal award recipients over the duration of the period of the RFA. 9. The applicant must describe how the issue of confidentiality will be addressed, describing how the records of patients will be protected. The applicant must include evidence and knowledge of legal issues pertaining to the collection and analysis of data. Specific state laws and their impact on the project must be fully explained. 10. Each applicant must submit at least one research plan separate from the construction of the research data base in the application, with an additional five page limit being allowed to describe each additional study. 11. In the event several projects or components are proposed, the format of the program project grant should be used in which separate budgets are used. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267; and from the NCI program official named below. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a 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, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Failure to submit these copies may delay the review and consideration of an application for award in FY 1996. Applications must be received by April 21, 1995. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate peer review group convened by the NCI. As part of the initial merit review, a process (triage) 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 competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria The following factors will be considered in evaluating the scientific merit of each response to the RFA: 1. Scientific merit of each research plan within the application that includes analytic research on breast cancer screening plus one or more of the following: utilization of state-of-the-art and emerging new technologies in breast cancer screening and diagnosis, biology of screened detected and non-screened detected cases, and other investigator proposed studies. 2. Appropriateness of plans to develop or modify current data collection practices to conform to standards set by Consortium members which should include: o evidence of obtaining cooperation of radiologists, pathologists, surgeons, tumor registrars, etc., necessary for data collection efforts; o description of how data systems in the area will be linked to cancer registry and plans to solve anticipated problems with data linkage. The development of a data base linking breast cancer screening facilities to registries and pathology laboratories will be considered as a basic requirement of the application. The establishment of this data base is necessary for the research priorities for this RFA to be completed. Establishment of this data base must be described succinctly so that reviewers can determine its viability. However, the mere establishment of the data base is not equivalent to responsiveness to the RFA. 3. Scientific, technical, or medical significance and originality of proposed breast cancer research that uses the database; i.e., whether or not new technologies are employed in breast cancer screening and diagnosis, basic biology and immunobiology of screened detected versus non-screened detected breast cancer, genetic alterations among women with breast cancer detected through screening versus those with breast cancer that was non-screened detected, economics of breast cancer screening techniques, or some other area of breast cancer research which uses the database. The scientific merit of the study objective(s), design, and methodology. 4. Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 5. Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research should include: o demonstration of a track record of interdisciplinary activity and interactive "know-how"; o experience in the management of large data sets; o personnel with credentials and experience in cancer registration, breast cancer pathology, mammography and other breast cancer screening technology, breast cancer biology, biostatistics, and computer programming. 6. Adequacy of time (effort) that the Principal Investigator and staff would devote to establishing the database and conducting the proposed studies. 7. Availability of resources necessary to perform the research. 8. Commitment to conduct pooled analyses of combined data across cooperative agreements in the Consortium for research objectives that require pooled analyses of data. 9. Availability of a population for surveillance coverage and research which complements the existing projects. Current studies sponsored by NCI include the ethnically diverse population in and around San Francisco, a Health Maintenance Organization in the Seattle area, a relatively homogeneous population although representative of the catchment area, and the area surrounding Denver, Colorado, which has a sizable Hispanic population. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Subsequent to the scientific merit of the proposed projects, consideration will be given to the appropriateness of the proposed budget and duration in relation to the proposed research as part of the review process. AWARD CRITERIA The anticipated date of award is December 1995. In addition to the technical merit of the application, the NCI will consider how well the proposed research meets the goals and objectives of the program as described in the RFA, as well as the level of total costs requested. Awards will be given to Principal Investigators/ applicants who demonstrate they can successfully develop the essential elements required in a tripartite local organization, which shows evidence that they will successfully participate in collaborative studies conducted by the Consortium. The Consortium is the primary entity by which the NCI Program Director will relate to all principal award recipients over the duration of the period of the project. Funding criteria will be weighted toward those applications that demonstrate a capability for collaborative studies involving all three facilities (clinical/radiology, pathology/laboratory science, and population-based quality controlled cancer registry) and scientifically meritorious research studies that address the full scope of the RFA. Strong consideration will be given to the potential of having geographical and racial representation in the study population within the Consortium. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Brenda K. Edwards, Ph.D. Surveillance Program National Cancer Institute Executive Plaza North, Room 343 Bethesda, MD 20892 Telephone: (301) 496-8506 FAX: (301) 402-0816 Email: edwardsb@dcpceps.nci.nih.gov Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93,399. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74; DHHS grant regulations at 45 CFR part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Coleman EA, Feuer EJ, NCI Breast Screening Consortium. Breast cancer screening among women 65-74 years of age in 1987-88 and 1991. Ann Intern Med. 1992;117:961-966. Howard J. Using mammography for cancer control: an unrealized potential. Cancer. 1987;37:33-48. Kessler LG, Breen N. Screening mammography doubles between 1987 and 1990. 1992(in review). Makuc DM, Freid VM, Kleinman JC. National trends in the use of preventive health care by women. Am J Public Health. 1989;79:21-26. Miller AB, Baines CJ, To T, Wall C. Canadian National Breast Screening Study. Can Med Assoc J. 1992;147:1459-1488. Miller BA, Ries LAG, Hankey BF, Kosary CL, Edwards BK (eds). Cancer Statistics Review: 1973-1989, National Cancer Institute. NIH Pub. No. 92-2789, 1992. Shapiro S, Venet W, Strax P, Venet L. Periodic screening of breast cancer: the Health Insurance Plan Project and its sequelae, 1963-1986. Baltimore, MD: The Johns Hopkins University Press; 1988. .
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