2
Current Use of Center Awards

The National Institutes of Health (NIH) has long tracked its budget by “mechanism,” one of which is research centers. Other mechanisms include research project grants (RPGs), other research grants, research and development (R&D) contracts, research training, and intramural research. Three of the budget mechanisms—RPGs, research centers, and other research grants—account for two-thirds of NIH’s total budget. Table 2-1 is a simplified version of the mechanism table submitted with NIH’s fiscal year (FY) 2003 budget request.

As a first approximation of the use of centers by NIH, administrative data on the numbers and amounts of research center awards reported by NIH are analyzed in the first section of this chapter. These data are based on the coding system NIH uses to keep track of extramural awards, in which certain grants and cooperative agreements are coded as center awards. A later section of the chapter discusses the fact that NIH’s coding of center grants leaves out a relatively small but growing, and perhaps important, set of awards that appear to support centers but are not coded as center awards in NIH’s budget and extramural award statistics.

OVERALL NUMBER, COST, AND LOCATION OF NIH CENTER AWARDS

In February 2003, when NIH submitted its FY2004 budget request to Congress, it estimated that it would fund 1,209 research center awards in FY2003 at a cost of $2.4 billion per year. The actual number of centers is



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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 2 Current Use of Center Awards The National Institutes of Health (NIH) has long tracked its budget by “mechanism,” one of which is research centers. Other mechanisms include research project grants (RPGs), other research grants, research and development (R&D) contracts, research training, and intramural research. Three of the budget mechanisms—RPGs, research centers, and other research grants—account for two-thirds of NIH’s total budget. Table 2-1 is a simplified version of the mechanism table submitted with NIH’s fiscal year (FY) 2003 budget request. As a first approximation of the use of centers by NIH, administrative data on the numbers and amounts of research center awards reported by NIH are analyzed in the first section of this chapter. These data are based on the coding system NIH uses to keep track of extramural awards, in which certain grants and cooperative agreements are coded as center awards. A later section of the chapter discusses the fact that NIH’s coding of center grants leaves out a relatively small but growing, and perhaps important, set of awards that appear to support centers but are not coded as center awards in NIH’s budget and extramural award statistics. OVERALL NUMBER, COST, AND LOCATION OF NIH CENTER AWARDS In February 2003, when NIH submitted its FY2004 budget request to Congress, it estimated that it would fund 1,209 research center awards in FY2003 at a cost of $2.4 billion per year. The actual number of centers is

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation somewhat smaller than the number of awards, because the same site may receive multiple awards and competitive supplements. NIH does not track the number of centers, but the committee estimates that the unduplicated number of entities with center awards is approximately 1,050 after supplements and multiple awards are accounted for. Figure 2-1 graphically displays the number of center grants awarded in each state in FY2002. There were center grants in every state. California, with 179, was the state holding the most center grants in FY2002, followed by Massachusetts with 97. The median number of center awards among the states was 16. This distribution is generally in line with the overall distribution of NIH extramural awards of all kinds. Funding for center grants has generally increased in line with the overall NIH budget in recent years, constituting between 8 percent and 9 percent of the total NIH budget during the 1992 to 2003 period (Figure 2-2). In FY2002 the average center grant was $1.9 million a year. The range spanned three orders of magnitude however, from $55 thousand to $56 million, and the median annual center grant amount was only $1.3 million. The FY2004 budget request sought an increase of $167 million to fund 1,237 center grants in FY2004 (see Table 2-1). If the proposed budget FIGURE 2-1 Distribution of research center awards by state, FY2002. SOURCE: Based on data provided by NIH Office of Extramural Research, April 16, 2003.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation FIGURE 2-2 Center and research project grant (RPG) funding as percentage of NIH budget, FY1992-FY2004. SOURCE: NIH mechanism table in FY2004 Congressional Justification Budget (U.S. DHHS, 2003). increase is approved by Congress, center awards would constitute 9.3 percent of the FY2004 NIH budget, compared with 9.0 percent in 2000 and 8.9 percent in 2001. The increase in the funding of center awards since FY1992 has been approximately the same as the increase in funding for RPGs and for all research grants during the same period. There has been more of a change in the size of center grants because the number of center awards has not grown as fast as the funding. Assuming the FY2004 budget is approved, the number of center awards will have increased by 43 percent since FY1992 (from 868 to 1,237) while funding increased by 133 percent in real (i.e., inflation-adjusted) terms. In 2004 dollars, the mean center grant was $1.3 million in FY1992 and will be $2.1 million, or 64 percent larger, in FY2004. TRENDS BY INSTITUTE The National Center for Research Resources (NCRR), perhaps a special case because of its mission to provide research resources, funded the most center awards in FY2001, 313 (approximately 25 percent of the total). The National Cancer Institute (NCI) led the remaining institutes, with 140 center awards, and the National Heart, Lung, and Blood Institute (NHLBI) came in third, with 81 (Table 2-2). The National Institute on Drug Abuse funded 33, the median number of center awards among the institutes. From FY1992 to FY2001 the biggest growth in number of center

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation TABLE 2-1 NIH Budget by Mechanism (in millions of current dollars)   FY2002 (Actual) FY2003 (Estimated) FY2004 (Requested) Mechanism Number of Awards Amount of Funding Number of Awards Amount of Funding Number of Awards Amount of Funding Research Project Grants 36,231 13,017.0 38,309 14,298.1 39,520 15,203.8 Research Centers 1,137 2,116.9 1,209 2,422.4 1,237 2,589.0 Other Research Grants 5,915 1,446.1 6,213 1,608.9 6,348 1,662.2 Subtotal, Research Grants 43,283 16,580.0 45,731 18,329.4 47,105 19,455.0 Training Awards   653.3   693.2   715.5 R&D Contracts 1,999 1,797.0 2,397 2,430.4 2,438 2,779.0 Intramural Research   2,234.0   2,548.8   2,629.8 Research Mgt. & Support   785.9   920.1   968.8 Cancer Prevention & Control   486.6   539.8   551.8 Extramural Construction   117.6   457.0   0 National Library of Medicine   274.3   305.9   316.0 Office of the Director   253.5   274.0   318.0 NIH Buildings and Facilities   295.9   769.1   80.0 TOTAL   23,478.1   27,267.6   27,814.0   SOURCE: The data on which this table is based come from NIH’s FY2004 Congressional Justification Budget (U.S. DHHS, 2003). The key table is posted on the NIH website at http://www.nih.gov/news/budgetfy2004/fy2004presidentsbudget.pdf.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation TABLE 2-2 Number of Center Awards by Institute, FY1992-FY2001   1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 Percent change, 1992-2001 NIAAA 13 14 13 15 16 15 14 17 15 15 15.4 NIA 51 55 63 66 60 72 66 61 65 66 29.4 NIAID 27 10 14 14 14 14 22 14 17 19 −29.6 NIAMS 25 26 31 31 29 26 27 37 29 37 48.0 NCCAM   10 16 14 NA NCI 87 101 157 78 68 68 64 94 94 140 60.9 NIDA 25 23 34 36 30 30 32 33 34 33 32.0 NIDCD 17 16 15 16 16 18 17 17 17 19 11.8 NIDR 28 28 29 27 32 48 21 19 15 13 −53.6 NIDDK 48 61 59 59 59 57 58 65 68 69 43.8 NIEHS 18 19 22 23 24 22 25 27 27 26 44.4 NEI 29 29 30 30 31 32 33 34 37 39 34.5 NIGMS 11 10 8 10 10 9 7 9 17 26 136.4 NICHD 77 78 78 68 69 70 75 76 73 63 −18.2 NHGRI 15 14 12 12 14 16 13 20 21 26 73.3 NHLBI 65 68 68 75 78 77 82 82 81 81 24.6 NIMH 53 56 60 57 55 55 54 57 57 52 −1.9 NINR 7 7 7 6 6 7 7 9 10 19 171.4 NINDS 42 46 44 43 39 38 38 46 48 50 19.0 NCRR 230 238 241 267 278 265 257 262 283 313 36.1 All 868 899 985 933 928 939 912 989 1024 1120 29.0 All except NCRR 638 661 744 666 650 674 655 727 741 807 26.5   SOURCE: Unpublished table of Information for Management, Planning, Analysis, and Coordination (IMPAC) data provided by NIH Office of Extramural Research, October 29, 2002.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation awards was at NCRR (83 more centers), NCI (53 more), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (21 more), and NHLBI (15 more), which together accounted for two-thirds of the net gain of 253 centers during the period. Although NCRR’s total increased by 83 (most of them developmental grants for the Institutional Development Award [IdeA] program, discussed below), the base was large, and so the percentage increase was a modest 36 percent. The National Institute of Nursing Research (NINR) had the biggest percentage gain in number of centers (171 percent), followed by the National Institute of General Medical Sciences (NIGMS) (136 percent) and the National Human Genome Research Institute (NHGRI) (73 percent). The pattern of funding was similar to that of the number of center awards (Table 2-3). NCI spent the most on centers in 2001, but NHGRI spent the second largest amount, followed by NHLBI. From 1992 to 2001, NIGMS increased its funding of centers the most, by 936 percent in real terms. NHGRI was second at 587 percent, followed by NINR at 212 percent (the mean was 74 percent, the median 39 percent, excluding NCRR). In absolute terms, NHGRI had the largest gain from 1992 to 2001, $211 million, followed by NCI and NIGMS. Those three institutes accounted for 75 percent of the net increase in funding over the period. The relationship of the centers to their institutes is another matter, at least as measured by their share of the budget. NCI spends the most of any institute on centers, but centers still account for only 6.9 percent of NCI’s overall budget (Figure 2-3). Only four institutes expended more than 10 FIGURE 2-3 Center funding as a percentage of the institute’s budget, FY2002. SOURCE: Institute mechanism tables in the FY2004 Congressional Justification Budget (U.S. DHHS, 2003).

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation TABLE 2-3 Funding of Center Awards, by Institute, FY1992-FY2001 (in millions of dollars) Institute 1992 1993 1994 1995 1996 1997 1998 NIAAA $16.8 $17.3 $18.8 $19.9 $21.1 $21.9 $22.3 NIA $45.3 $51.5 $55.4 $58.3 $58.6 $61.7 $64.9 NIAID $14.8 $7.7 $9.6 $9.8 $10.4 $10.3 $14.6 NIAMS $22.5 $23.6 $25.8 $26.1 $25.2 $24.8 $27.5 NCCAM $0.0 $0.0 $0.0 $0.0 $0.0 $0.0 $0.0 NCI $145.1 $145.0 $158.7 $155.7 $162.3 $159.9 $163.5 NIDA $24.1 $26.6 $39.0 $41.4 $41.1 $42.1 $43.0 NIDCD $16.3 $17.1 $16.7 $16.3 $16.6 $18.0 $18.6 NIDR $18.5 $18.1 $19.7 $21.5 $22.9 $25.7 $23.2 NIDDK $40.6 $46.7 $51.4 $52.9 $52.7 $54.5 $56.9 NIEHS $16.9 $18.1 $20.6 $21.4 $22.1 $23.6 $23.3 NEI $7.6 $7.6 $8.1 $8.3 $9.0 $9.8 $11.2 NIGMS $7.4 $7.8 $7.0 $8.3 $9.0 $8.9 $6.7 NICHD $49.9 $49.0 $48.5 $47.6 $46.8 $51.4 $55.7 NHGRI $29.4 $31.4 $33.0 $38.0 $42.7 $53.8 $74.2 NHLBI $96.5 $96.8 $101.5 $107.0 $108.2 $110.2 $117.2 NIMH $63.8 $65.3 $69.6 $68.3 $68.9 $72.3 $74.0 NINR $1.7 $1.8 $1.8 $1.9 $2.1 $2.9 $3.0 NINDS $31.5 $31.2 $35.5 $39.2 $38.6 $36.6 $40.9 NCRR $245.9 $247.9 $264.9 $278.6 $291.5 $312.9 $335.3 All $894.4 $910.6 $985.5 $1,020.7 $1,049.9 $1,101.3 $1,175.8 All except NCRR $648.5 $662.6 $720.6 $742.1 $758.4 $788.4 $840.6   SOURCE: Unpublished table of IMPAC data provided by NIH Office of Extramural Research, October 29, 2002 (the factor used to determine real change was the gross domestic product (GDP) implicit price deflator, from Table 10.1 in OMB, 2003). percent of their budget on center awards. Both NCRR and NHGRI spent more than half their budgets on center awards. TRENDS BY ACTIVITY CODE NIH also uses a set of “activity codes” to track its expenditures that is more detailed than the budget mechanism categories. There are 13 budget mechanisms, but there are several hundred activity codes. The best-known activity code is R01, which denotes the traditional individual investigator-initiated RPG. Other commonly used activity codes are R21 (exploratory/ developmental grants), R03 (small research grants), U01 (research project cooperative agreements), K01 (research scientist development awards), and P01 (research program projects).

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation       Nominal change 1992-2001 Real change 1992-2001 1999 2000 2001 Amt. Percent Amt. Percent $24.0 $24.2 $25.0 $8.2 48.6 $4.9 24.7 $70.9 $72.3 $75.0 $29.6 65.4 $20.9 38.8 $15.9 $19.4 $22.7 $7.9 53.4 $5.1 28.7 $30.2 $29.1 $32.0 $9.4 41.9 $5.1 19.1 $13.4 $21.7 $20.8 $20.8 NA $20.8 NA $206.5 $242.9 $299.9 $154.7 106.6 $126.9 73.3 $45.9 $47.7 $47.0 $22.9 95.4 $18.3 63.9 $19.1 $16.4 $16.0 −$0.3 −2.1 −$3.5 −17.9 $23.8 $24.4 $24.1 $5.6 30.2 $2.0 9.2 $63.7 $67.0 $76.1 $35.6 87.7 $27.8 57.4 $27.6 $29.3 $31.6 $14.7 86.6 $11.4 56.5 $13.0 $14.8 $17.9 $10.2 133.5 $8.7 95.9 $7.4 $49.8 $91.1 $83.7 1135.0 $82.3 936.0 $59.1 $60.7 $60.6 $10.7 21.4 $1.1 1.9 $139.4 $170.1 $240.5 $211.2 719.5 $205.6 587.4 $122.4 $123.8 $126.7 $30.2 31.3 $11.7 10.1 $81.3 $78.5 $75.5 $11.7 18.4 −$0.5 −0.7 $3.0 $4.0 $6.2 $4.5 271.3 $4.2 211.5 $53.7 $58.9 $59.8 $28.4 90.2 $22.3 59.5 $388.9 $435.5 $588.2 $342.3 139.2 $295.0 100.6 $1,408.9 $1,590.6 $1,936.4 $1,042.0 116.5 $870.1 81.6 $1,020.0 $1,155.1 $1,348.3 $699.7 107.9 $575.1 74.4 The activity codes constituting the research center mechanism, and their definitions, are provided in Appendix B. The predominant codes for research center awards are P30 core grants, P50 and U54 specialized centers, and P60 comprehensive centers. Specialized centers were the most numerous in 2001 (383). Core grants were second in number (318), and there were far fewer comprehensive centers (44) (Figure 2-4). Growth rates were similar over the 1992 to 2001 period, with specialized centers constituting about 34 percent of the group in 1992 and 2001, core grant centers about 27 percent and 28 percent, and comprehensives 5 percent and 4 percent, respectively. In terms of dollars awarded, specialized centers had the most funding and the fastest growing budgets (Figure 2-5). Their share of the funding for the three main center types grew from 54 percent in 1992 to 64 percent in

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation FIGURE 2-4 Number of specialized, core, and comprehensive center awards, FY1992 and FY2001. SOURCE: Unpublished table of IMPAC data provided by the NIH Office of Extramural Research, October 29, 2002. FIGURE 2-5 Funding of specialized, core, and comprehensive center awards, FY1992 and FY2001 (in constant dollars). The factor used to calculate constant dollars is the GDP implicit price deflator, from Table 10.1 in OMB, 2003. SOURCE: Unpublished table of IMPAC data provided by the NIH Office of Extramural Research, October 29, 2002 2002. The comparable shares for core grant centers were 37 percent and 31 percent, and for comprehensive centers they were 9 percent and 6 percent, respectively. Among the other types of centers (not shown), one big change was in the number of P20 planning or developmental awards, primarily because of

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation growth in the NCRR IdeA program.1 The number of P20 grants in 2001 was double the number in 1992 (120 compared with 62). Most of the new P20s in 2001 were supported by NCRR and NCI, and most of the increase in funding was by NCRR, because its new P20 grants averaged more than $2.5 million compared with less than $300,000 for new P20 grants awarded by other institutes. This trend will be reinforced by the longer length of IdeA P20s being awarded by NCRR—three to five years instead of the usual one year. However, the funding involved was still relatively small—$135 million in FY2001. In constant dollars, funding for P50/U54 specialized centers increased by 110 percent from 1992 to 2001, compared with 48 percent and 12 percent for core grant centers and comprehensive centers, respectively. Several factors help explain the large relative increase in funding of specialized centers. NHGRI spending on centers went from $30 million to $240 million, and almost all of it was for specialized centers. NCI launched the Specialized Programs of Research Excellence program (SPOREs) in the early 1990s, which is funded by P50 grants, and NCI spent $100 million on SPOREs in 2001, compared with $16 million in 1992. The two institutes accounted for 57 percent of the net increase in the funding of specialized centers from 1992 to 2001. The increase in funding of specialized centers was apparently determined by NIH, because neither the NHGRI nor NCI SPORE centers were established at the urging of advocacy groups or mandated by Congress. Given these trends, it is no surprise to find that the average size of awards for specialized centers increased greatly relative to P30 core grants and P60 comprehensive centers (Figure 2-6). In constant dollars, awards for specialized centers were $2.2 million a year on average in 2001, compared with $1.4 million in 1992. The average core grant was almost as big as the average specialized center grant in 1992, at $1.2 million in 2001 dollars, but it only increased to $1.3 million in 2001. The average comprehensive center award hardly grew in real terms either. It was $1.65 million in 1992 and $1.68 million in 2001. Although not shown here, funding of the Primate Research Centers also increased sharply in real terms from 1992 to 2001, from $3.6 million a year per center, on average, to $7.5 million a year per center in 2001 dollars, but overall funding only went from $50 million to $60 million 1   The IdeA P20 center program is open to institutions in the 24 states that received less than $70 million from NIH, or had success rates of less than 20 percent for grant applications to NIH, in a recent five-year period. The program funds Centers of Biomedical Research Excellence (COBREs) and Biomedical Research Infrastructure Networks (BRINs) with P20 developmental center grants.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation FIGURE 2-6 Average size of specialized, core, and comprehensive center awards, FY1992 and FY2001 (in constant dollars). The factor used to calculate constant dollars is the GDP implicit price deflator, from Table 10.1 in OMB, 2003. because the number of centers was consolidated from 14 to 8. P20 grants also increased in size, from $323,700 a year in 1992 to $1.2 million a year in 2001 (259 percent), in 2001 dollars. SUMMARY OF NIH DATA ON NUMBER AND COST OF CENTER GRANTS NIH funded 1,120 research center grants in FY2001, at a cost of $1.9 billion. This was about 9 percent of the NIH budget. Most institutes allocated a smaller percentage of their budget to centers (the median was 6.9 percent), while a few, notably NCRR and NHGRI, devoted much more and drove up the mean. After accounting for inflation, funding of centers increased 82 percent from FY1992 to FY2001. Because this was roughly the same rate of increase as in the NIH budget as a whole, the share of NIH funding devoted to center grants did not increase appreciably over that period. If the President’s budget request for FY2004 is enacted, centers will increase their share of the NIH budget slightly, from an estimated 8.9 percent in FY2003 to 9.3 percent. There have been internal shifts in the center awards category, however, including an expansion of NCRR funding of centers relative to the other institutes (from 28 percent to 36 percent of all center funding from 1992 to 2001), and the emergence of NHGRI as a major supporter of centers. In fact, if NCRR and NHGRI are excluded from the calculation, funding for centers grew by only 37 percent in constant dollars between 1992 and 2001.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation proposal that includes mostly meritorious activities (NICHD, 1999; NIAMS, 1997). The success rate of proposals in the initial round of funding may be low, for example, when 10-12 applicants vie for, say, three center grants, but subsequent success rates for center applications are usually higher than for individual-investigator renewal applications. The large size and diverse nature of many centers also make both proposals and performance more difficult to evaluate than individual grants (see Chapter 5), and the prestige that helps attract outside funding and new researchers can make them highly sought-after awards independent of any analysis of whether they are an appropriate tool at that time and place (Korn, 2003). A further concern raised about centers is that the vertical integration expected to lead to increased interaction among basic, clinical and preventive, behavioral, and population-based research cited above may not always materialize. Evidence for this may be inferred from revisions in established programs directed at increasing this type of activity, e.g., the introduction of SPOREs to supplement NCI’s cancer centers in 1992 and reorientation of NHLBI’s 30-year-old SCOR (Specialized Centers of Research) Program in 2001, symbolized by renaming them SCCORs (Specialized Centers of Clinically Oriented Research). Similarly, attempts to use a center program to attract new researchers to a disease or field may sometimes have the opposite effect. The few good scientists already working in the field have a strong advantage in the competition for the new centers, resulting in the centers program concentrating resources still further in a small cadre of scientists.5 The merits of these positions, or at least approaches to judging their merit, are examined in more detail in Chapter 5, which deals with how to evaluate center programs. Generally, however, the committee is of the opinion that center programs are a valuable addition to NIH’s array of funding mechanisms and provide an important source of support for clinical research aimed at translating basic science discoveries into useful clinical products and practices. ALTERNATIVE RESEARCH MODELS NIH currently employs a number of alternative mechanisms besides centers to foster and support interdisciplinary research, translational research, collaborations among researchers in different places, and research resources. In addition, there are or could be alternatives within the center model itself. 5   There is a discussion of this issue with reference to the establishment of centers of excellence in autism research in NIH, 1999.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation One alternative is to fund research teams or groups without imposing a center structure. Traditionally, these enterprises have been smaller than centers tend to be, although a recent trend toward large research networks will be discussed below. The program project (P01) grant to support a small group of investigators conducting research with a common theme has a long history preceding centers (in fact, the first grants for centers, in the 1960s, were coded as P02 program projects). P01 funds support shared research facilities and services (cores) as well as the research projects. More recent alternatives include Investigator-Initiated Interactive Research Project Grants (IRPGs), in which related R01 research project grants are submitted together, and “mini” core grants, in which R24 (or U24) research resource-related grants are used to encourage already-funded investigators to work together on a problem by providing resources not available where investigators are working separately. The National Institute of Mental Health (NIMH), for example, sponsored a PA inviting applications for IRPGs for research integrating the basic behavioral sciences and public mental health.6 NIDDK recently funded R24 “mini” centers, called Digestive Diseases Research Development Centers, for investigators without access to P30 Digestive Disease Research Core Centers.7 NIGMS and NIDDK have issued a PA inviting consortia of funded investigators from different disciplines who want to collaborate on a multidisciplinary research problem to apply for R24 grants. According to the PA, the purpose of the R24 “consortium grant mechanism” is to “allow the participating investigators to (1) attract and coordinate expertise in different disciplines and approaches and (2) facilitate access to specialized resources and equipment.”8 The National Eye Institute (NEI), NCI, and NICHD are other institutes using R24 grants in this way.9 Another approach is to use cooperative agreements, such as the U01, U10, or U19, to facilitate collaboration among a number of individual investigators or small research groups in different locations and also provide for a steering committee to set overall priorities for all participants. An example is NIDDK’s Inflammatory Bowel Disease (IBD) Genetics Research Consortium, which consists of six “IBD genetics research centers” and a data coordinating center supported with U01 cooperative agreements.10 Some institutes promote interdisciplinary collaboration by providing supplements to RPGs to support such activities. The Division of Cancer 6   “Integrating the Basic Behavioral Sciences and Public Mental Health,” PA-00-078. 7   RFA-DK-01-030. 8   “Integrative and Collaborative Approaches to Research,” PA-03-127. 9   “Vision Research Infrastructure Development Grants,” PAR-02-050; “Shared Resources for Scientists Not at NCI Funded Cancer Centers,” RFA-CA-01-020. 10   RFA-DK-02-011.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Biology at NCI, for example, does this through a program called Activities to Promote Research Collaborations.11 Seven NIH institutes and two National Science Foundation divisions have sponsored a PA inviting applications for R01 grants to develop and support tools for collaborations that involve data sharing.12 In some types of clinical research (e.g., clinical trials), coordinated activities by multiple clinical centers are needed, rather than direct interactions between basic researchers and clinical investigators for translational research purposes. In these cases, NIH often uses cooperative agreements (e.g., U10, U01, and U19 awards) or contracts. NHLBI supports a series of clinical research networks to conduct clinical trials in, for example, resuscitation from cardiopulmonary arrest (U01), chronic obstructive pulmonary disease (U10), and asthma (U10).13 In FY2002, U-series awards accounted for more than 9 percent of the NIH budget ($1.8 billion), compared with the $1.7 billion spent on center awards (not counting NCRR funding of research resource centers). In recent years, it has become possible to conduct large-scale biomedical research efforts in certain areas of science, for example, genomics and proteomics, where complex problems must be tackled with large interdisciplinary teams or large-scale facilities and resources are needed, or both. One example of interactive research networks or teams is NIGMS’s Large-Scale Collaborative Project Award, known as the “glue grant” program. This program is supporting large consortia of researchers working on complex biological phenomena such as cell signaling, cell migration, and the body’s response to trauma and burn injuries. Although glue grant consortia are supported with U54 center grants, the local organizational entities are not really centers in the traditional sense. NCI is using U54 center grants to develop several networks of translational research teams, one to focus on molecular targets for cancer drug development, another on optical imaging. In other cases, institutes are using a combination of grants to create an integrated research initiative. The National Institute on Alcohol Abuse and Alcoholism (NIAAA), for example, is creating consortia addressing various problems, for example, fetal alcohol spectrum disorders and alcoholism. The consortia consist of a set of integrated research projects, each funded by a U01 cooperative agreement; several core facilities, each funded by a U24 research resource-related cooperative agreement; and a consortium 11   NOT-CA-03-035. 12   PAR-03-134. 13   “Clinical Research Consortium to Improve Resuscitation Outcomes,” RFA-HL-04-001; “COPD Clinical Research Network,” RFA-HL-03-002; “Asthma Clinical Research Network,” RFA-HL-02-029.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation coordinator.14 NCI’s Early Detection Research Network consists of 18 biomarker development laboratories, 3 biomarker reference laboratories, 9 clinical epidemiology and validation centers, and a data management and coordinating center, each funded with a U01 or R24 award and all governed by a steering committee consisting of the Principal Investigators and a representative of NCI.15 It should also be noted that the center model itself has not been static. It has been evolving from the concept of a problem-focused organizational structure that cuts across disciplinary department lines within a research institution to a concept of centers as a network involved in collaborative as well as center-specific research. The concept is that if the centers are networked to share information and conduct collaborative studies, they are more effective than when each center works on its own. The recent autism, muscular dystrophy, and rare diseases center programs have been structured so that, in addition to traditional within-center interdisciplinary and translational research activities, there is between-center collaboration coordinated by an overall steering committee. In some cases, the institute provides a separate research fund for multicenter collaborative research. Another alternative has been to use existing centers rather than create new ones for a specific disease or other problem. Some emerging research opportunities or health emergencies are met by providing supplements to centers. In another case, centers for research on fragile X syndrome, the centers are being located at centers for research on mental retardation and will become, in effect, a component of the existing centers. These alternatives have the virtue of speed and ease of implementation and take advantage of the technical and administrative experience of mature research institutions. NIH has also been experimenting with Web-based virtual laboratories, also called “collaboratories.” NCRR has funded seven collaboratories through supplemental awards to some of its existing P41 biotechnology resource centers (NCRR, 2000, 2002). One of these, the Biomedical Informatics Research Network, is developing the network, data-storage, and software tools needed for geographically separated investigators conducting research involving neuroimaging to share and use large sets of data on brain images from the molecular scale to the whole brain.16 The committee discussed some additional alternatives. One would be to allow individual investigators to apply for support of center projects 14   “Collaborative Initiative on Fetal Alcohol Spectrum Disorders,” RFA-AA-03-002; “Integrative Neuroscience Initiative on Alcoholism,” RFA-AA-01-002. 15   See http://www.cancer.gov/edrn. 16   http://birn.ncrr.nih.gov/birn/birn.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation whose form and structure are designed by the applicant rather than specified in a PA, RFA, or institute guidelines. This could lead to centers organized differently or addressing problems differently (or different types of problems) than those solicited by NIH. It might encourage collaborative translation, clinical, and population projects that investigators believe are too risky or novel to submit to study sections more oriented toward basic science projects. Another would be to broaden initiatives to reduce health disparities to encourage partnerships between centers in research-intensive institutions and rural health facilities. NIAID’s Alzheimer’s Disease Centers, for example, are affiliated with satellite diagnostic and treatment clinics that recruit minority, rural, and other underserved patients to increase the diversity of study volunteers. PROBLEMS WITH THE DATA ON CENTERS The data reported in the previous sections probably include most centers funded by NIH and are therefore useful for aggregate analysis of trends, but there are some problems: 1. Not all centers are funded by center awards. A perusal of the institute websites, RFAs, and PAs issued by the institutes, and the Computer Retrieval of Information on Scientific Projects (CRISP), NIH’s database of funded awards, revealed a number of projects called centers by NIH, but funded by awards not classified and counted as center grants. For example, during calendar year 2002, NIH issued 48 RFAs and PAs with the word “center” in the title. Of the 50 grant types offered in these RFAs and PAs,17 11 (22 percent) were coded as RPGs or other research grants rather than as center grants. Examples include NHLBI’s Centers for Reducing Asthma Disparities, which are being funded through U01 cooperative research project agreements; NIAID’s Autoimmunity Centers of Excellence, funded through U19 cooperative research program agreements; NIAID’s Asthma and Allergic Diseases Research Centers, funded by P01 program project grants; and NICHD’s Population Research Centers, which are being switched from P30 core grant support to R24 resource-related research project grants. NIAID’s Biodefense Proteomics Centers will be funded by contracts. These anomalies may reflect in part the fact that early in the formulation of the NIH budget, the Office of Management and Budget and the Department of Health and Human Services provide NIH with guidance on the amount of funding NIH should request. That guidance is specified 17   Several of the RFAs offered several types of awards, for example, a P50 center grant and a P20 planning grant.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation by mechanism. This constrains the “centers line” in the budget, and new center initiatives might therefore be funded through other mechanisms, for example, U19 or P01 awards in the RPG line or U10 awards in the other research line. 2. Not all entities supported by center awards are called centers although they function as centers. NCI, for example, supports Interdisciplinary Research Teams for Molecular Target Assessment to develop methods for preclinical and clinical research to use in assessing the effects of interventions directed at specific molecular targets. They are funded by U54 specialized center cooperative agreements. NCI also has P50 centers called SPOREs. The NIH initiative in biomedical computing is National Programs of Excellence in Biomedical Computing (NPEBC). Although called programs, NPEBCs will function like centers and be supported by U54 center grants. “NPEBC will provide a formal framework through which scientific synergy can occur on a stable and continuing basis, and will provide: (a) an organizational structure specifically designed to facilitate intellectual cross-fertilization between seemingly disparate groups of investigators; (b) core facilities to support research activities; (c) developmental funds for feasibility testing of new projects; (d) career development opportunities for new and established investigators; and (e) a broad range of educational activities, from formal undergraduate and graduate programs to courses and seminars for students and researchers, visiting scientists program or other types of training, cross-training, or educational approaches.”18 3. A number of NIH programs without “centers” in their titles and not using awards with research center activity codes share some of the features of many programs that have centers in their titles and employ awards with research center activity codes. These programs fund research entities referred to by names such as “programs,” “networks,” “consortia,” “research units,” or “clinical centers.” In many cases, these entities serve primarily as nodes in a network of sites intended to facilitate clinical trials by increasing the pool of potential patient-subjects. Funding can be by N01 R&D contracts, P01 program project grants, U01 cooperative research project agreements, U10 cooperative clinical research agreements, or U24 cooperative resource-related research project agreements; local research as well as participation in multisite projects is encouraged and sometimes included in the requirements for funding; and training clinicians and junior investigators is sometimes specified. Examples include NHLBI’s Programs of Excellence in Gene Therapy (U01), NIAID’s Acute Infection and Early Disease Research Network (U01), NIAAA’s Collaborative Initiative on Fetal Alcohol Spectrum Disorders Consortium (U01 and U24), NIMH’s Re- 18   PAR-00-102.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation search Units on Pediatric Psychopharmacology (N01), NIAID Tropical Disease Research Units (P01), and NICHD’s Cooperative Multicenter Maternal-Fetal Medicine Units Network (U10). 4. Alternative means are used to achieve some of the goals of center grants. NIH can and often does fund coordinated multi-investigator research through other types of support, although these are usually smaller scale and not necessarily interdisciplinary. These projects are not called centers and are usually not solicited by an RFA, as most center grants are. Alternatives to centers for supporting team research, including interdisciplinary and translational research, include P01 program project grants (intended to support multiple investigators conducting research with a common theme); R24 infrastructure development grants (used like small core grants); U01, U09, and U19 collaborative research projects; and IRPGs (coordinated submission of related R01 and R29 applications). Several institutes (e.g., NIAID and NINDS) publish guidelines for multiproject applications, including P01s, P50s, and U19s, regarding them all as efforts with a central focus or theme in which collaboration and interaction among investigators are expected to result in a greater contribution to the program goals than if each investigator pursued his or her project separately. 5. Some large-scale research questions are being investigated through multi-institutional networks or consortia rather than centers. In recognition of the impact of networking on certain kinds of complex research questions that cannot be addressed by a single center, some recent center programs (e.g., Autism Research Centers of Excellence) are setting aside funds from the center awards to support collaborative activities among the centers. In addition, new organizational models for conducting coordinated research by large interdisciplinary teams are emerging. One example is NIGMS’s glue grant program, which is supporting consortia investigating complex problems that benefit from the interaction among and coordinated effort of many kinds of scientists and types of research. NIGMS calls it “the next evolutionary stage of integrative biomedical science.” The glue grant is used to fund the interactions among the numerous and far-flung researchers involved in an area of research such as cellular signaling and cell migration.19 The glue grant program uses a center award—the U54 cooperative agreement—after an initial organizational phase using an RPG award—the U24 planning grant. Other examples are the cross-disciplinary networks that NINDS is forming of scientists interested in studying the neural mecha- 19   The Alliance for Cellular Signaling (http://afcs.swmed.edu/), for example, involves some 50 researchers in 20 academic institutions and several biotechnology companies, although the Alliance will have specially designed laboratory facilities at a half-dozen institutions (http://www.nigms.nih.gov/news/releases/gluegrant_release.html).

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation nisms of cognition and other complex behaviors. These Multimodal Integration Research Networks in Cognitive Neuroscience are funded by R01 grants. NIAAA has funded several interdisciplinary consortia of researchers from multiple sites as part of its Integrative Neuroscience Initiative on Alcoholism. The consortia are supported by a coordinated set of U01 cooperative agreements and distributed core facilities funded by U24s, led by a consortium coordinator and steering committee representing the principle investigators and NIAAA staff. One solution to the problems of identifying and tracking center programs is to look at what they are intended to do, regardless of what they are called or the funding mechanism used. That is, one can identify the distinctive attributes of existing center grants and attempt to sort and track them on that basis. The NIH Glossary of Terms provides the following definition:20 Center grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They provide support for long-term multidisciplinary programs of research and development. A more detailed definition is that contained in the NIH document called National Institutes of Health FY2001 Investments:21 Research Center grants are awarded to extramural research institutions to provide support for long-term multidisciplinary programs of medical research. They also support the development of research resources, aim to integrate basic research with applied research and transfer activities, and promote research in areas of clinical applications with an emphasis on intervention, including prototype development and refinement of products, techniques, processes, methods, and practices. The first of these two definitions is not specific enough to be useful in the present context. The second is specific enough to reveal that center grants are intended to support several different types of activities. An analysis of RFAs and PAs issued over the past few years confirmed that centers and center programs vary greatly in size, purpose, and organization, reflecting in part differences among research areas, for example, in the state of the knowledge, the amount of infrastructure needed for cutting-edge research, and the nature and burden of the health problem addressed. However, the committee believes that center awards fall into three broad categories, based on the kind of activity they support. 20   http://grants.nih.gov/grants/glossary.htm. 21   http://www.nih.gov/news/BudgetFY2002/FY2001investments.htm#centers.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Center Infrastructure awards, or “core” grants, fund a center’s director and core services, administrative and technical, to support a group of investigators whose research is funded by independently obtained research grants. The primary goal of center infrastructure awards is to facilitate the conduct of research on a particular disease or scientific issue by enabling interactions and collaborations among investigators and by eliminating duplication and increasing efficiency in the provision of common and often expensive research tools and services. P30 core grants are the prototype, although some center programs use other types of awards to support center infrastructure (e.g., R24 resource-related research project grants). Research Center awards fund not only core services but research projects as well. In some cases, they may also support additional activities such as community education, screening and counseling programs, and educating medical and allied health professionals about state-of-the-art diagnostic, prevention, and treatment techniques. Typically designed to encourage multidisciplinary or clinical research not being addressed by investigator-initiated projects, this group of centers includes many of the disease-based centers that Congress has mandated in recent years—e.g., Centers of Excellence for Parkinson’s disease, autism, and muscular dystrophy. P50 and P60 grants and U54 cooperative agreements are the prototypes for this category of awards, but some centers of excellence are funded with P30 core grants. Noncenter awards are also employed in some center programs—e.g., Autoimmunity Centers of Excellence (supported by U19 cooperative agreements) and Centers of Excellence for Research on Complementary and Alternative Medicine (supported by P01 program project grants). Research Resource Centers develop and provide research resources and tools to any researcher in the nation. Many of these centers are supported by NCRR (e.g., nonhuman primate centers, mutant mouse and other animal resource centers, and islet cell resource centers), although more institutes are developing such resource centers (e.g., NHLBI’s proteomic centers, NIAAA’s mouse mutagenesis centers, and NIAID’s microbial genome sequencing centers). NCRR awards to resource centers are classified as center awards (e.g., P40, P41, P51, U41, and U42). Resource centers established by other institutes are supported by a variety of noncenter award types, although NHGRI and NIGMS use the P41 biotechnology resource grant. Owing to the ambiguities of NIH’s award classification described previously, a precise estimate of how many center awards might fall into each of these categories is not possible, but a rough approximation might be:

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Center infrastructure (core) grants, 20-30 percent Research centers, 45-50 percent Research resource centers, 20-30 percent Although the taxonomy developed by the committee identifies three categories of center awards, only the first two categories, those for center infrastructure and for research centers, are the primary subject of congressional interest and legislation. The third type of center, the research resource center, although not explicitly excluded from the charge to this committee, is not the type of center that led to the congressional language mandating this study. Accordingly, subsequent discussion of centers and center programs in this report will include only centers of the first two types listed above. Both center infrastructure (core) and research center awards are intended to promote and support research organizations that conduct interdisciplinary research on a medical problem or condition, or on a set of health-related scientific questions, or both, that would not be done as effectively or at all by other modes of research. Many of these centers also have additional functions that are a prerequisite for an NIH center award, such as research training and career development, public outreach, and professional education. Finding. NIH does not consistently apply either the term “center” or center award activity codes to centers. This inconsistency makes it difficult to describe accurately the extent of research funding devoted to support of centers or evaluate the relative effectiveness of center awards or how well center programs complement other NIH-funded activities. Recommendation 1. NIH should adopt or develop a coherent classification system with functional criteria that should be uniformly applied across all institutes for the categorization of all NIH-funded centers. The three functional categories of centers offered above by the committee represent one possible system of classification. All activities that fit in one of the categories in the classification system adopted or developed by NIH should be identified as centers, regardless of the name of the program or mechanism of funding. Consistent identification of center programs and allocation to uniform categories will benefit NIH in terms of more informed public debate and understanding, greater NIH accountability, and better program evaluation. At the same time, a broad classification system such as the one we offer (NIH can adopt, revise, or replace it with its own), which includes just three types of center programs, leaves enough flexibility within the categories to

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation design each center program in the most appropriate way to achieve its particular goals. REFERENCES IOM (Institute of Medicine). 1998. Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health. Washington, DC: National Academy Press. Korn D. 2003. Statement of the Association of American Medical Colleges to the IOM Committee on NIH Centers of Excellence. Presentation to the IOM Committee on Centers of Excellence at NIH, Washington, DC. NCRR (National Center for Research Resources). 2000. NCRR Biomedical Collaboratories Workshop Report. [Online]. Available: http://www.ncrr.nih.gov/biotech/btcollabwrkshprpt10-2000.pdf [accessed December 15, 2003]. NCRR. 2002. Data and Collaboratories in the Biomedical Research Community. [Online]. Available: http://www.ncrr.nih.gov/biotech/collabmtg2002.asp [accessed December 15, 2003]. NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases). 1997. Executive Summary, Report to the Institute Director of the Centers Working Group II. [Online]. Available: http://www.niams.nih.gov/ne/reports/sci_wrk/1997/cenrptfn.htm [accessed December 15, 2003]. NICHD (National Institute of Child Health and Human Development). 1999. “Report of the Demographic and Behavioral Sciences Branch Population Centers Review.” [Online.] Available: http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf [accessed December 15, 2003]. NIH (National Institutes of Health). 1995. NIH Extramural Trends, Fiscal Years 1985-1994. Bethesda, MD: Division of Research Grants, NIH. NIH. 1999. Report of Integrative Issues Working Group. Summary of workshop: Treatments for people with autism and other pervasive developmental disorders: Research perspectives. Bethesda, MD: NIH Autism Coordinating Committee. [Online]. Available: http://www.nimh.nih.gov/research/autismworkshop.cfm [accessed December 15, 2003]. NIH. 2001. Setting Research Priorities at the National Institutes of Health. Revised edition. [Online]. Available: http://www.nih.gov/about/researchpriorities.htm [accessed December 15, 2003]. OMB (Office of Management and Budget). 2003. Historical Tables, Budget of the United States Government, Fiscal Year 2004. Washington, DC: U.S. Government Printing Office. Teitelbaum S. 2003. Statement to the IOM Committee on Centers of Excellence at NIH, Washington, DC. U.S. DHHS (U.S. Department of Health and Human Services). 2003. NIH (National Institutes of Health) FY2004 Congressional Budget Justification. [Online]. Available: http://www.nih.gov/news/budgetfy2004/fy2004presidentsbudget.pdf [accessed December 15, 2003].