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APPENDIX A The Cancer Centers Core Grant Program: Guidelines and Procedures Robert A. Walkington The National Cancer Institute (NCI) has provided support grants, commonly called core grants, to cancer centers since 1961. The program was significantly expanded under the National Cancer Act of 1971 and subsequent amendments. Currently there are 59 centers receiving NC] support (15 basic science centers, 3 consortium centers, and 41 clinical centers. Total funding for the program in fiscal year 1989 wall be approximately $101,345,000, a slight increase over fiscal year 1988. Center core grants vary greatly in size, ranging from approximately $300,000 in total costs to more than $7 million. In fiscal year 1988 the average (mean) size of a core grant was $~.7 million. The median size was $0.9 million. Cancer Center Core Grants The core grants, formally called Cancer Center Support Grants, are "...ciesigne`d to support those activities that unit consolidate and focus cancer related research efforts in a single- administrative and programmatic structured Core grant support is intended to promote the stability and development of a center and to facilitate administrative and programmatic control of center activities. ~ ~7 The core grant provides funds for salaries of certain key staff members, operation of centralized shared resources and services, and ~ This figure does not include small phaseout grants for two centers whose renewal applications were not funded in 1988. 2 This and all subsequent quotes (unless otherwise indicated) are from: NCT, Guidelines: Cancer Center Support Grants (July, 1988~. 27

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administration of the center. The core grant also may provide developmental funding for (a) investigators who have not previously had funded grants; (b) newly-recruited investigators; (c) interim research support for investigators of the center; and (~) new shared resources. The core grants are not intended to fund laboratory and clinical research, training, education, detection, or facilities construction activities. Support of other cancer center functions depends upon federal and nonfederal funding mechanisms, such as investigator-initiated research project grants, program project grants, cancer control grants, education grants, training grants for clinical trials research cooperative agreements, research contracts, state funds, institutional funds, and private donations. Grantee Application Procedures Eligibility To be eligible to apply for a core grant, an institution must be nonprofit and have an existing base of high-quality research in the field of cancer. This base must be demonstrated by the institution having at least $750,000 in direct costs for peer-reviewed research and research training. Applicants must also demonstrate characteristics that are considered essential for the success of a cancer center. These characteristics include: o o o interdisciplinary coordination. adequate organization and facilities. adequate authority for the center director, including: J -control of appointments. -control of center space and equipment. -control of clinical-research facilities, if appropriate. "institutional commitment," demonstrated by recognition of the center as a major element within the organization, and 28

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also indicated 'by venous combinations of personnel, facilities, and financial obligations and commitments." Letter of Intent Institutions are urger! to submit a leper of intent to NCI six months before they plan to submit an application. On receipt of the letter of intent, NCI stab determines whether or not the applicant institution is eligible to apply. If eligible, NC! staff provides advice to the applicant. Allowable Budget Items The NCI has identified the categories of costs that are eligible for support under the core grant. AD costs must be related to the research programs of the center. 'The core grant is not designed to provide support for routine screening, diagnosis, treatment or rehabilitation activities, or for nonresearch education." I. Personnel The core grant can support the costs of personnel who are responsible for the overall direction of the center. Such senior leadership positions may include the center director, deputy directors, and associate directors (e.g., for clinical sciences, basic/laboratory sciences, cancer control research, and education). Centers normally group their research into a number of programs, and the major program directors "...are eligible for salary support...for the time and effort they devote to carrying out such functions as research planning, supervision, renew of results, publications, and/or grant applications, etc." Personnel costs also may be requested for staff Investigators. These are scientists who are closely associated with the cancer center and who have peer-renewed research support. "A major purpose of this partial support is to provide some of the necessary stability for a 'core' of investigators with proven records." 29

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2. Shared Resources..and Services "The core grant may include funds for laboratory and clinical research support facilities, equipment, and services that wall be used by multiple staff for projects or programs supported by peer-rev~ewed grants or contracts." Shared resources and services account for the largest amount of the core grant costs.3 Table Al.presents a summary of the shared resources and services supported by the core grant in fiscal year 1987. In that year, 519 shared resources and services were supported by more than $31 million (direct costs) in core grant funds. Figure Al shows the shared resources for an earlier year (fiscal year. 1985) broken down by major categories. Overall, approximately two-thirds of the shared resources and services were for either laboratory science resources or laboratory support. .. 3. Developmental Funds The core grant can be used to provide developmental funds for (a) new investigators, (b) interim research support for established investigators, and (c) development of new shared resources. "It is the intent that developmental funding provide a flexible means for the center director to progress toward achieving the goals of the center." The use of the funds for new investigators.is to allow up to three years of support for an individual newly arrived at an institution, or for an individual already at an institution, who is independent of a mentor, but at the beginning stages of a research career. The developmental funds also can provide for support of salary and research costs for up to 24 months for an investigator whose renewal application is approved, but not awarded because of lack of funds. Finally, developmental funds may be used to develop new shared resources and services during the continuation years of the core grant. 3 Approximately 51 percent (see Figure 5 on page 6.) 30

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TABLE Al Number and Direct Costs of Shared Resources by Category and by Type of Center (dollars in thousands), F i sea l Year 1987 CLINICAL CENTERS LABORATORY CENTERS CONSORTIUM CENTERS ALL CENTERS SHARED RESOURCE CATEGORY NUMBER COSTS NUMBER COSTS NUMBER COSTS NUMBER COSTS ANALYSIS 3 101,608 1 25,933 0 . 0 4 127,541 ANIMAL 30 3,023,147 13 874,210 0 0 43 3,897,357 BIOHAZARD 10 628,087 5 84,705 0 0 15 712,792 CANCER CONTROL 5 255, 916 0 0 1 50, 000. 6 305, 916 CHEMISTRY 6 266,185 7 599,257 0 0 13 865,442 CHROMATOGRAPHY 2 189,300 0 0 0 0 2 189,300 CLINICAL RESEARCH UNITS 16 1,353,592 0 0 0 0 16 1,353,592 CLINICAL TRIAL MANAGEMENT 11 811,865 0 0 1 73,852 12 885,717 CLINICAL - OTHER 12 708,023 0 0 0 ~ 0 12 708,023 COMPUTER & DATA RESOURCES 11 1,252,797 6 259,662 1 91,400 18 1,603,859 CYTOGENET I CS/GENET I CS 5 155, 352 0 0 ~ 0 0 5 155, 352 at, . . CYTOLOGY - ANALYTIC & IMMUNO 13 519,754 0 0 ~ . 0 0 13 519,754 ELECTRON MICROSCOPY 19 1,024,123 9 459,978 0 0 . 28 1,484,101 EPIDEMIOLOGY - STATISTICS 39 - .4,079 085 . 2~ 191,161 - :3 159,917 44 4,430,163 EQUIPMENT REPAIR/MACNINE SHOP 6 274 487 . 3 185,223 0 0 . 9 459,710 FLOW CYTOMETRY 30 ; 1,612,789 - 6 292,932 0 0 36 1,905,721 GENET I CS 0 0 2 157, 192 0 0 2 157, 192 GLASSWARE WASHING 13 1,506,187 9 593,188 0 0 22 2,099,375 ILLUSTRATION/PHOTOG/TYPESET 1 44,554 4 82,248 0 0 5 126,802 ISOTOPES 1 72,536 0 ~ 0 0 0 1 72,536 LIBRARY 9 452,468 5 204,990 0 0 14 657,458 MISCELLANEOUS 2 83,177 2 43,994 0 0 4 127,171 MOLECULAR BIOLOGY 6 190,831 1 25,530 0 0 7 216,361 MONOCLONAL ANTIBODIES 13 343,103 2 83,900 0 0 15 427,003 NMR 6 330, 721 1 34, 909 0 0 7 365, 630 ONCOLOGY NURSING 5 233,478 0 0 0 0 5 233,478 PATHOLOGY 6 232,277 7 213,188 0 0 13 445,465 PHARMACOLOGY 10 744,063 1 52,990 0 0 11 797,053 PHARMACY 6 234, 028 0 0 0 0 6 234, 028 RADIATION/RADIOBIOLOGY SVCS 9 236,833 3 52,442 0 0 12 289,275 RECEIVING/STOREROOMjBLDG SVCS 0 0 1 43,044 0 0 1 43,044 SECRETARIAL 11 716,469 5 424,841 0 0 16 1,141,310 SEMINAR 2 19,000 0 0 0 0 2 19,000 SEQUENCING 6 236,517 2 18,090 0 0 8 254,607 SHARED EQUIPMENT/INSTRUMENTS 6 295,114 10 552,640 0 0 16 847,754 spEcTRoMEIRr 5 210,342 3 104,288 0 0 8 314,630 SYNTHESIS 13 801,450 3 82,760 0 0 16 884,210 TISSUE CULTURE & MEDIA PREP 22 841,159 10 321,307 0 0 32 1,162,466 TISSUE ACQUIS & TUMOR BANKS 17 669,009 1 14,452 0 0 18 683,461 TOXICOLOGY/MUTAGENESIS TEST'G 1 47,947 1 15,020 0 0 2 62,967 TOTAL 388 S24,797,373 125 $6,094,074 6 $375,169 519 $31,266,616 SOURCE: Administrative ProfiLe Database, Cancer Centers Branch, NCI. 31

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FIGURE A1 Shared Resources by Type of Center Activity Supported, Fiscal Year 1985 240 N m 200 b e r 160 o 120 R e 0 80 u r c 40 e 8 o Laboratory Laboratory Epidemiology Clinical Adminletration Science support giostatistice Research Data Management SOURCE: Unpublished report from Administrative Profile Database, Cancer Centers Branch, NCI. 4. Other Costs The core grant also may be used to support administration, planning and evaluation, clinical research costs, and alteration and renovation. In recent years, very little money has been available for the latter two categories. Table A2 indicates how core grant funds have been budgeted by the centers during fiscal years 1985, 1986, and 1987. The majority of funds each year have gone to support shared resources and services. These figures have stayed relatively constant over time; an analysis of the use of core grants in 1977 found that 43.3 percent of the funds went to support shared services. 32

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TABLE A2 Cancer Center Core Grant Awards by Authorized Budget Categories, Fiscal Years 1985-1987 Fiscal Year Budget Category 1985 1986 1987 Senior Leaders 5,660,245 5,669,202 5,847,537 Major Program Directors 2,935,601 3,069,551 3,064,796 Staff Investigators 10,051,693 9,538,912 9,377,276 Administration 6,198,620 6,644,402 6,759,058 Planning and Evaluation 276,653 282,224 277,348 Shared Resources 26,851,824 27,732,057 31,230,837 Developmental Funds 4,507,578 4,636,293 5,074,085 Alteration and Renovation 67,831 132,500 135,000 Research Costs of Patient Care 0 0 0 Total Direct Costs 56,550,045 57,705,141 61,765,937 Indirect Costs Total Costs (Direct and Indirect) 29,681,842 31,734,842 33,513,006 86,231,887 89,439,983 95,278,943 NOTE: The figures are based on authorized direct costs, exclusive of supplements in 1986 and 1987 for IL-2 LAK studies; and excluding minority satellite supplements and the effects of administrative adjustments to direct and indirect costs. The data are voluntarily reported by centers and may cross the Federal fiscal year or be omitted when a center did not submit information. SOURCE: Data provided by the Cancer Centers Branch, NCI, from the Cancer Centers Administrative Profile Database. 33

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5. Limitations on Costs The NCI has imposed two limitations, or "caps," with regard to the amount of funds that an applicant can request. These limitations apply to the total amount of the increase that can be requested in renewal applications and on the amount of support for staff investigators that can be requested on both new and renewal applications. Allowable budget increases in- grant renewals are capped. For applications requesting 5 years of support, the average annual direct costs requested may not exceed an amount 50 percent greater than that committed or proved by' the NCT in the previous 12 months fusing the first renewal Year as the base). However, normal increases for personnel, supplies, and other expenses may be requested in future years. For example, if a grant has a current level of $1 million direct costs in the -05 year, a renewal application requesting 5 years of support must average no more than $'1.5 million per year using the -06 year as the base, i.e., inflationary increases for personnel, supplies, and other expenses may be added in years -07 to -10. Renewal applications requesting less than 5 years of support are limited to an increase of 10 percent per year. NCT also caps the proportion of a grant that can be used to support staff investigators. New applicants can request no more than 10 percent for staff investigators. In the case of renewal applications, if the current salary support exceeds 25 percent of direct costs the renewal request is limited to the current amount and must include a plan to reach the 25 percent level. If the current level of staff' investigator support is less than 25 percent, the renewal may request either 25 percent of direct costs of current grant or the current level plus an increase of no more than 10 percent of the renewal application ceiling, whichever is less. Allowable Periods of Support New applicants can request support for up to 3 years and applicants for grant renewals may request up to 5 years of support. , 34

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Review Procedures and Criteria Cancer center core grants, coded as "P-30" grants by NCI, undergo the same procedures as other grant mechanisms at NTH. They are awarded only after undergoing initial scientific "peer review" by a committee of scientists and final review and recommendation for approval by the National Cancer Advisory Board (NCAB). Final funding decisions are made by NCT for those applications approved by the NCAB. Figure A2 provides a schematic view of the NCT grants process. Current Review Procedures Current review procedures are described In Guidelines for Review of Cancer Center Support Grants (~1984), Guidelines: Consortium Cancer Center Support Grant (-f987), and Guidelines: Cancer Center Support Grant (1988), which are available from NCI. All grant applications to NTH are submitted to the Division of . . Research Grants. Core grant applications are then sent to the Division of Extramural Activities of NCT, where the- Cancer Center Support Grant Review Committee is responsible for the scientific (peer) review of the applications. .q . . .. . . . . Following receipt of an application, a site visit is arranged. The site visit is conducted by representatives of the review committee and by consultants selected for their expertise in the research areas conducted by the applicant. After the visit, the site visit team assesses the relative level of scientific merit of the application, and recommends approval or disapproval. The application and site visit report are submitted to the core grant review committee, which meets three times per year to review applications. The review is led by the committee members who were on the site visit. After the review, the committee votes for approval or disapproval. In the case of approval, a priority score is assigned. The recommendations of the renew committee and the priority score (if approved) are presented to the NCAB for final review and recommendation to NCI. While review by the core grant review committee is the usual procedure, an initial review is conducted by an ad hoc group in the case of 35

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FIGURE A2 National Cancer Institute Grants Process NC! GRANTS PROCESS act;:, / ~ RESEARCH . ~ ~ \ _ INMATES I ~ \ RESEARCH IDEA I AND PREPARES I APPucAnoN I I~TIGATOR NIH DIVISION OF RESEARCH GRANTS ASSIGNS TO STUDY SECTION AND INSl=]l-E | MANAGES I FUNDS ~ . \\ \ \ // | SUBM~S I APPUCAnON 7~ // N`UlONALINSmUTESOF HEALTH \ \ // \\ NCI MAKES FUNDING _ SELECTIONS AND ISSUES GRANT l AWARDS GRANTEE INITIAL REVIEW GROUP (NCI OR DRG) EVALUATES FOR SCIENTIFIC MERIT NCI EVALUATES PROGRAM RELEVANCE AND NEED NATIONAL CANCER ADVISORY BOARD RECOMMENDS ACTION SOURCE: Leo F. Buscher, Jr., National Cancer Insi'tute Grants Process. NIH Publication No. 86-1222. Washington, D.C.: Department of Health and Human Services, 1986. consortium grants. Since the purpose of the consortium grant program is to stimulate development of research in cancer control within a defined region, it was not felt that the existing review committee had the appropriate expertise. With consortium grant applications, the ad hoc committee conducts the site visit, recommends approval or disapproval, and assigns a priority score (if the recommendation is for approval) at the time of the site visit. The report of the ad hoc review committee is submitted directly to the NCAB. 36

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In summary, the core grant review process normally includes: (~) an initial examination of the technical adequacy and completeness of the application by NCT program staff and review staff, (2) a site visit by a team of review committee members and expert consultants, (3) review of the application by the core grant review committee, and finally, (4) secondary renew by the NCAB. According to the 1984 Guidelines for Review of Cancer Center Support Grants, "the core grant application review process focuses on the ability of the proposed program to consolidate disparate and/or scattered cancer-reiated research activities into an effective, integrated, and productive cancer center." Criteria Core grant applications are reviewed within the context of their ability to "foster and support the development of multidisciplinary programs in laboratory and clinical cancer research....tA] core grant is designed to support those activities that wall consolidate and focus cancer-related research efforts in a ingle administrative and programmatic structure....The core grant provides funds for the salaries of selected staff, for the operation of centralized, shared resources and services, and for the administration of the center." The site visitors and the review committee use the following criteria in assessing the applications: o interdisciplinary coordination. O organizational capabilities and facilities. O qualifications and authority of the director. commitment of parent institutions. o o impact of the center on the focus of cancer-related research (the sum is greater than the parts). procedures for evaluation. O need for and quality of shared resources. 37

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0 need for and quality of personnel to be supported. O need for developmental funds requested. O.. quality of protocols for clinical research projects (not peer reviewed) that will use the resources. The review criteria for consortium grants are essentially the same' except that the focus of the core support is an interinstitutional program to facilitate research in cancer control. 38