4

Supporting the NIH AIDS Research Program

The success of the NIH AIDS research program depends not only on identifying the most important scientific questions and promising research opportunities and having an effective structure for managing the research effort, but also on adequate levels of high-quality resources to support the research effort. These resources include funds for the research itself, in the form of grants, contracts, and intramural projects, and for research training programs and facilities and equipment grants. They also include NIH's review apparatus for research grant and contract applications and proposals. Finally, NIH's own staff and facilities are important resources, because it takes people in offices and laboratories to plan AIDS research activities, conduct intramural research, award extramural grants and contracts, evaluate results, and determine new areas of research opportunities and needs.

AIDS research funding has expanded greatly, especially during 1986 –1990, and it is slated to increase another 8.7 percent in fiscal year 1991. Some observers point to this expansion as adequate and call for maintenance, if not actual reduction, of AIDS funding levels. Yet the epidemic is still growing and spreading, and it threatens to persist for years to come. Important research advances have been and will continue to be made. Nevertheless, some research areas are underdeveloped, and scientific progress in others calls for an expansion of effort. This situation calls for a careful assessment of the adequacy of AIDS research funding. Among areas of particular concern for NIH are the inadequate facilities and staffing limits that have created an imbalance between the size of programs and the size of the staff to plan, implement, coordinate, and evaluate them. These limits have been eased, but it will take careful planning to bring staffing in line with program requirements. This chapter reviews the status of research funding, grant review resources, and NIH staffing and facilities; assesses their adequacy; and makes recommendations for strengthening NIH support of the AIDS research effort.

FUNDING AIDS RESEARCH

The committee does not believe that increased funding alone is a panacea for all of the problems noted in the NIH research effort. For this reason, the recommendations for increasing the effectiveness of management of the AIDS research program were presented first, in Chapter 2, and issues concerning appropriate balance and coordination among research areas were addressed in Chapter 3, before funding levels were considered. Funding is an input measure of research effort that is only indirectly related to the variables of most interest, which are research output and the quality and significance of that output. NIH's primary mechanism for assuring research quality, the



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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH 4 Supporting the NIH AIDS Research Program The success of the NIH AIDS research program depends not only on identifying the most important scientific questions and promising research opportunities and having an effective structure for managing the research effort, but also on adequate levels of high-quality resources to support the research effort. These resources include funds for the research itself, in the form of grants, contracts, and intramural projects, and for research training programs and facilities and equipment grants. They also include NIH's review apparatus for research grant and contract applications and proposals. Finally, NIH's own staff and facilities are important resources, because it takes people in offices and laboratories to plan AIDS research activities, conduct intramural research, award extramural grants and contracts, evaluate results, and determine new areas of research opportunities and needs. AIDS research funding has expanded greatly, especially during 1986 –1990, and it is slated to increase another 8.7 percent in fiscal year 1991. Some observers point to this expansion as adequate and call for maintenance, if not actual reduction, of AIDS funding levels. Yet the epidemic is still growing and spreading, and it threatens to persist for years to come. Important research advances have been and will continue to be made. Nevertheless, some research areas are underdeveloped, and scientific progress in others calls for an expansion of effort. This situation calls for a careful assessment of the adequacy of AIDS research funding. Among areas of particular concern for NIH are the inadequate facilities and staffing limits that have created an imbalance between the size of programs and the size of the staff to plan, implement, coordinate, and evaluate them. These limits have been eased, but it will take careful planning to bring staffing in line with program requirements. This chapter reviews the status of research funding, grant review resources, and NIH staffing and facilities; assesses their adequacy; and makes recommendations for strengthening NIH support of the AIDS research effort. FUNDING AIDS RESEARCH The committee does not believe that increased funding alone is a panacea for all of the problems noted in the NIH research effort. For this reason, the recommendations for increasing the effectiveness of management of the AIDS research program were presented first, in Chapter 2, and issues concerning appropriate balance and coordination among research areas were addressed in Chapter 3, before funding levels were considered. Funding is an input measure of research effort that is only indirectly related to the variables of most interest, which are research output and the quality and significance of that output. NIH's primary mechanism for assuring research quality, the

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH peer-review system for ranking research applications, is discussed in a later section of this chapter. If not a sufficient condition for high-quality research results, however, adequate funding surely is a necessary one, especially in a completely new area of research that lacks an existing body of researchers, ongoing studies, appropriate facilities and equipment, and training programs. This section reviews the history of AIDS research funding at NIH, in total and by institute, mechanism, and category of research; it also assesses its adequacy, its impact on non-AIDS research funding and progress, and the appropriateness of its allocation among categories of research, types of research support, and research mechanisms. History of AIDS Funding NIH and Its Institutes The AIDS epidemic was first recognized in early 1981, a time of severe fiscal stringency in the federal budget that constrained the initial federal response (Office of Technology Assessment, 1985; Lee and Arno, 1986; Panem, 1988) and continues to affect federal action. The NIH budget for fiscal year 1981 was $3.57 billion, just 4.2 percent higher than the previous year's, and it increased only 2 percent–to $3.64 billion–in fiscal year 1982. After inflation, NIH's research purchasing power, using the biomedical research and development price index, actually declined by 5.6 percent in 1981 and by 6.1 percent in 1982, regaining its 1980 level only in 1984 (NIH, 1989a:Table 7). Yet despite the constraints on funding, some researchers in NIH's intramural programs and extramural projects and centers found AIDS to be an urgent medical problem, as well as an interesting scientific puzzle, and they began to study it. The syndrome was first recognized and described by NIH grantees in mid-1981, and the first AIDS patient was admitted to the NIH clinical center in September 1981. Before the end of that year, NCI viral epidemiologists began studies; NCI held a national conference on Kaposi's sarcoma and AIDS-related opportunistic infections; general clinical research centers supported by the National Center for Research Resources became involved in AIDS studies; and NIAID supplemented grants to its extramural sexually transmitted disease centers and other researchers to study AIDS. In the first several years, support for AIDS research had to be reprogrammed from other areas of research. Congress first appropriated additional funding for AIDS research at NIH in a supplemental appropriations bill in July 1983, which provided about $9 million of the $21.7 million that NIH spent on AIDS in fiscal year 1983. The recent substantial growth in AIDS funding started in 1986 when Congress began “earmarking” AIDS funding in the regular appropriations to the institutes (Figure 4.1). As a result, AIDS funding began to increase more quickly than funding for non-AIDS activities (Table 4.1)–between 81 and 111 percent per year in fiscal years 1986 through 1988, and about 25 percent per year in fiscal years 1989 and 1990. In part because of the AIDS funding, NIH's budget went from $3.6 billion in 1981 to $7.6 billion in 1990, an increase of 112 percent. After inflation, the increase was 51 percent (using the gross national product deflator), or 28.8 percent (using the biomedical research and development price index). AIDS funding accounted for 18.5 percent of the overall NIH increase ($741 million of the $4 billion). AIDS activities have grown steadily as a proportion of NIH spending, from less than 0.1 percent in fiscal year 1982 to 9.8 percent in fiscal year 1990 (Figure 4.2 and Table 4.2).1 Most of 1   Although the fiscal year 1991 appropriation for AIDS represented an increase of 8.7 percent, the appropriation for non-AIDS research was also larger. Consequently, the AIDS share of the NIH budget dropped slightly, to 9.7 percent.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH the NIH AIDS funding (53.1 percent in fiscal year 1990) goes to NIAID; much of the rest goes to four other institutes: NCI (20.3 percent), National Center for Research Resources (NCRR; 6 percent), NHLBI (5.7 percent), and NICHD (3.6 percent). The remaining 11.3 percent is spread among the remaining NIH units (Table 4.3). Because it receives more than half the AIDS funding at NIH, nearly half (47.3 percent in fiscal year 1990) of NIAID's overall budget is devoted to AIDS. AIDS funding amounts to 9.1 percent of NCI's budget, 6.1 percent of NICHD's, and less than 4 percent of most other units. It is a larger set of activities for the Fogarty International Center and the units providing intramural and extramural research support (NCRR, Buildings and Facilities, and the OD; Table 4.4). Because of AIDS funding, NIAID went from being the sixth largest institute in 1981 (23 percent the size of NCI, the largest institute at that time) to the third largest institute in 1990 (51 percent the size of NCI, still the largest NIH component). Research Support Mechanisms Early in the NIH response to the AIDS epidemic, intramural research accounted for a large proportion of the agency's AIDS effort (47 percent in 1982, 31 percent in 1983, 27 percent in 1984, and 25 percent in 1985; Table 4.5). In comparison, intramural research accounted for only about 12 percent of NIH's non-AIDS budget during that time. The use of contracts was prominent in the early years, reaching 53 percent and 43 percent of the AIDS budget in the 1986–1987 fiscal years when the large extramural programs, such as the AIDS clinical trials units, were being launched. In those years contracts accounted for about 6 percent of the non-AIDS budget (Table 4.6). The AIDS effort has relied less on grants, especially on research project grants, than has non-AIDS research. The proportion of AIDS funding going to research project grants (RPG) reached a low of 19 percent in 1986, during a time when the proportion of non-AIDS funding for such grants was increasing steadily (from 50 percent in 1982 to 56 percent in 1986). This trend in AIDS funding was reversed in 1987 when the large contracts for ACTUs were converted to cooperative agreements, which are classified as RPGs. In 1990 RPGs account for only 39 percent of the AIDS budget (compared with 59.5 percent of the non-AIDS budget; Table 4.5 and Table 4.62). In addition, compared with non-AIDS programs, relatively more of the AIDS RPG dollars go to RFA-initiated cooperative agreements with ACTUs, national cooperative groups for drug and vaccine development, and other large programs in which NIH staff play a role in decision making. About 60 percent of RPGs have been individual investigator-initiated R01s (Table 4.7), but the bulk of RPG funding goes to cooperative agreements (U01s) and research project grants (P01s), most of which are solicited by NIH through RFAs. This is because most of the non-R01 grants are very large. U01s for AIDS clinical trials units and national cooperative drug and vaccine discovery groups, for example, are in the range of $0.5 to $1 million. As Table 4.7 shows, however, the proportion of research grants solicited by RFAs has decreased. NIH's standard planning mode has been, first, to let the public, through Congress, indicate broad priorities among health problems by appropriating a certain amount for each categorical entity of NIH (institutes, centers, and divisions), and, second, to allow NIH and the scientific community to identify the research efforts that are needed to address priority problems. These 2   These figures refer to overall AIDS expenditures, including extramural research, intramural research, and program support activities. In 1990 RPGs accounted for 51 percent of the AIDS budget for extramural grants and contracts, compared with 71 percent of the non-AIDS extramural budget.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH efforts rely on grants, especially individual investigator-initiated grants, as the mechanism of support, and on the peer-review system, in which research applications are rated for scientific merit by disciplinary study sections of experts. Through these processes NIH supports a high proportion of basic research initiated by individual investigators as well as more directed efforts to apply the results of basic research in clinical practice and public health prevention and control programs. Thus, in fiscal year 1990, more than 60 percent of NIH's non-AIDS budget supported basic research (Figure 4.3), and 59.5 percent of the non-AIDS budget supported investigator-initiated grants (research project grants) rather than research centers, contracts, intramural research, or other research mechanisms (Table 4.6). Some of the larger institutes with a more explicit disease focus, such as NCI and NHLBI, have substantial applied efforts (e.g., drug screening and development, clinical trials) and prevention and control programs (antismoking, cholesterol and blood pressure control), but they still devote half of their resources to basic research. NIH's emphasis on basic research and its traditional posture of waiting for high-quality research proposals turned out to be too slow in the case of AIDS. As public and congressional pressure mounted in the mid-1980s to expand AIDS research, NIH pursued several routes: it quickly expanded its intramural efforts and, extramurally, expedited grant review, used RFAs and RFPs to stimulate research in specific areas, funded some applications with relatively lower peer-review scores, and used directive mechanisms (e.g., cooperative agreements, contracts) to support specific approaches. It is for these reasons that less of the NIH AIDS budget than the non-AIDS budget goes to research project grants. The share of AIDS research funds for basic research is also comparatively lower, although the exact figure is unknown. The large-scale programs initiated through RFAs and supported by cooperative agreements–AIDS clinical trials units, the national cooperative drug and vaccine development groups, and so forth–are classified as research project grants; on the other hand, some fundamental research in immunology and virology of relevance to AIDS research is funded through the non-AIDS budget. Although the share of the AIDS budget going to research and development contracts has been greatly reduced (down from 53 percent in 1986), it still accounts for more than 26 percent of the AIDS budget in 1990 (compared with 5.5 percent of the non-AIDS budget3). Reliance in the AIDS program on intramural research is also higher –16.5 percent of AIDS funding compared with 10.8 percent of non-AIDS funding–although this figure includes a substantial clinical treatment program mandated by Congress. Categories of Research NIH has used several sets of research categories for tracking AIDS funding over the course of the epidemic. Currently, NIH uses the so-called Mason categories, which are also used by the PHS to track AIDS activities in all its agencies (see Table 4.8 for a breakdown of NIH spending in fiscal years 1989–1991). Yet none of the sets of functional categories used to report the content of the PHS AIDS program have been especially suited to a scientific characterization of NIH's program. It is not possible to determine how much of the AIDS budget goes to such basic science areas as immunology, virology, molecular biology, and microbiology, or to categories of biomedical research, such as epidemiology and natural history, etiology, pathogenesis, therapeutics, and vaccine development. From 1984 to 1989, NIH used the Charlottesville functional categories, which came closest to those used by the PHS; the agency used projected rather than actual data for 1989 and 1990, however (Table 4.9). The committee was unable to obtain a parallel breakdown of non-AIDS categories for comparison. 3   Looking just at the extramural part of the budget, 35 percent of the AIDS extramural budget went for contracts, compared with 7 percent of the non-AIDS extramural budget.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH Figure 4.4a, based on data in Table 4.9, shows that research on pathogenesis and clinical manifestations and therapeutic studies (preclinical drug and vaccine development and clinical trials research) have dominated AIDS funding at NIH. Figure 4.4b, which presents the same data but as a percentage of total funding, reveals that budget allocations among the broad categories of research have been relatively stable since 1988, with about 40 percent of the effort devoted to the development of therapies ($305.8 million in fiscal year 1990), a third to epidemiology and pathogenesis ($254 million), 10 percent to vaccine development and testing ($83.9 million), and about 3 percent to public health-oriented activities, especially public information, blood supply protection, and HIV test development ($21.1 million). Breakdowns of the therapeutics category into preclinical and clinical phases or into anti-HIV and other AIDS drugs are not available. The approximately 33 percent for pathogenesis and clinical manifestations breaks down into about 13 percent epidemiology (natural history and surveillance) and 20 percent pathogenesis. By way of comparison, NCI obligations for preclinical and clinical treatment research accounted for 33.5 percent of NCI's budget in fiscal year 1990 ($548 million of $1.6 billion; NCI, 1990:16). Epidemiology accounted for 5.7 percent ($93.2 million) and cancer prevention and control for 4.9 percent ($80.2 million; NCI, 1990:19). Adequacy A major part of the committee's charge was to consider the adequacy of the AIDS research effort at NIH. As noted earlier, the AIDS program has become the third largest NIH research program, after cancer and heart disease, involving nearly 1,200 staff (out of NIH's total employment of 14,000 FTEs in fiscal year 1991) and nearly 10 percent of the total NIH budget. Indeed, federal spending on HIV/AIDS research is approaching that for cancer and heart disease and exceeds spending for other diseases that cause more deaths–cerebrovascular disease and chronic obstructive pulmonary disease, for example (Winkenwerder et al., 1989). HIV is not a chronic disease, however; it is a fatal infectious disease that will continue to spread unless steps are taken to prevent transmission. The effectiveness of prevention efforts depends in turn on behavioral and biomedical knowledge about how the virus spreads and causes disease. Moreover, because deaths from AIDS primarily affect young persons, the ratio of research spending to burden of illness looks more equal when years of potential life lost before age 65 are used as a comparison measure. In 1987 the YPLL for AIDS was 432,000, compared with 1.8 million for cancer, 1.5 million for heart disease, 246,000 for stroke, and 131,000 for bronchitis and emphysema (CDC, 1990:10). Unlike the rates for chronic diseases, however, the YPLL for HIV/AIDS will increase steeply, as the number of deaths per year continues to grow, to between 1.2 and 1.4 million in 1991 and between 1.5 and 2.1 million in 1993 (Buehler, 1990). The PHS estimates that, by 1991, HIV/AIDS could rank third in YPLL from disease (PHS, 1990b). The committee reviewed carefully the size and composition of the budget for AIDS-related research, aware of a general perception that the problem is receding and that the current level of effort is adequate. The committee finds, however, that the epidemic of HIV infection and AIDS is a severe global public health emergency that is growing and spreading, increasing still further the burden of illness and death and placing severe stresses on the nation's health care system. Containing this disease must be a high national priority. More effective interventions are urgently needed. The NIH AIDS program must respond in a balanced way to gaps in needed knowledge, emerging scientific opportunities, changes in the epidemic (for example, as the virus moves into new populations or responds to improved treatments), and other, unforeseen contingencies. The

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH question of program balance is thus an evolving one that should be addressed through the planning and priority-setting process recommended in Chapter 2. At this time, for instance, promising scientific developments in vaccine research urge additional research, which will require substantially more resources than the $79 million devoted to it last year (fiscal year 1990). The committee reviewed the adequacy of investment in fiscal year 19904 in each program area discussed in Chapter 3, taking into account (1) the state of current knowledge, (2) scientific opportunities in each area, and (3) the overall balance desired in a comprehensive long-term research program. As noted above, recent advances in vaccine research should be exploited, which not only calls for increased support of research grants but also of such research resources as reagents, research animals, and animal and laboratory facilities and equipment. The committee also concluded that a balanced long-range program should invest more in undirected individual investigator-initiated research, given the lack of fundamental knowledge about HIV, its transmission and pathogenesis, and clinical manifestations in and immune response of the host. A number of unfunded scientific opportunities exist. Although about 37 percent of the research grant applications are rated as outstanding or excellent by scientific peer-review groups, 5 funding will be available for only about 25 percent of the nearly 1,000 AIDS grant applications expected to be approved for fiscal year 1991. Progress in treating and preventing HIV infection and AIDS would probably be accelerated if these highly rated projects were funded and all awarded grants–new, renewal, and continuing–were funded fully. Other areas of AIDS-related research are relatively underdeveloped and should be expanded. The committee believes that behavioral research, nursing research, development and testing of therapies for AIDS-related opportunistic infections and cancers, and research training are examples of fields that have received relatively little support and deserve a much greater investment by NIH as part of a long-range effort to reduce HIV infection and deal with its consequences. The committee has recommended that about 3 percent of the AIDS budget go to the support of research training, triple the current level. Small, beginning programs such as behavioral research and nursing research on patient care will require large percentage increases for several years to reach an adequate level of effort. NIH has placed increased emphasis on OI drug development and testing in the last two years, and further increases are needed. Also of importance is a balanced emphasis on training and facilities as well as on research project funding (IOM/NAS, 1990). Training was addressed in Chapter 3; greater attention should also be paid to maintaining the other aspects of the research program–facilities and equipment–that make good research possible. There are also possibilities of greater efficiency in some of the large-scale programs that have been running for at least several years, which could result either in greater effort for the same budget or in freeing up dollars for other, higher-priority programs. The committee has recommended, for example, that epidemiology studies be evaluated to ensure that each is worthwhile, given potential alternative uses of the funds at this time. The committee is also aware that NIH expects to improve the performance of the ACTG within its current budget, in part by 4   1990 is used as the base because it is the last year for which there are figures on actual program obligations, by funding mechanism, by institute and program, and by functional area. The fiscal year 1991 budget was under consideration during the time of the study. The administration had asked for $800.2 million for AIDS research, an increase of 8.1 percent (2.1 percent after inflation using the biomedical research and development price index). On October 20, 1990, after the last committee meeting, Congress appropriated an overall increase of $700 million for NIH as a whole, compared with the $354 million requested by the administration. At the time this report went to press in late December 1990, NIH planned to use about $4 million of the additional increase for AIDS, for a total AIDS budget of $804.6 million in fiscal year 1991, an increase of 8.7 percent (2.7 percent after inflation). 5   Applications with scores between 100 and 150 are considered “outstanding”; those between 150 and 200 are considered “excellent” (see NIH, 1989b).

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH redefining its mission to focus on studies that are not likely to be undertaken by the private sector but also by increasing efficiencies in protocol development, laboratory services, and patient accrual and retention. In the opinion of the committee, increased management efforts and program activity in a number of areas would not be adequately accommodated within the present level of effort ($740.5 million in 1990 dollars). 6 The committee estimated that the net effect of its recommendations could increase costs on the order of magnitude of 25 percent over the current level of effort. This figure is admittedly a very rough estimate; it would be less if there were significant savings in existing activities and more if there were major breakthroughs that needed to be exploited. The committee believes that an increase of this magnitude could be productively absorbed at once in most areas, although some underdeveloped areas may take several years to build up. The detailed phasing in of any increases that occur should be an integral part of the long-range planning effort recommended in Chapter 2. Many people believe that the budget for NIH as a whole is inadequate and that there is an immediate crisis in funding a sufficient number of competing grants this fiscal year and next to maintain the nation 's biomedical research momentum (NAS/IOM, 1990). The committee is acutely aware that many other areas of biomedical research could justify larger budgets in an absolute sense. Advances in containing and controlling HIV infection and AIDS rest on the overall strength of the institutes of NIH. Taking resources from its other components to expand the AIDS research program would impede progress in biomedical research and the AIDS program itself, which is an integral part of NIH and dependent on a wide range of its activities. Recommendation 4.1: Implementing the long-term AIDS research program recommended by this committee will require a larger budget to ensure that the most promising basic science opportunities are supported, that underdeveloped areas of research are expanded, and that research resources are adequate to support the planned level of research effort. These opportunities and needs could justify an immediate increase of as much as 25 percent in NIH's budget for AIDS research; the exact timing of the increase should be an integral part of the long-range plan recommended by the committee. It is essential that any such budget increases be new funds and that they not be derived at the expense of ongoing NIH programs. Impact on Non-AIDS Research It is impossible to know what NIH's research budget would be today if AIDS had never happened. Although it is very clear that NIH appropriations for AIDS grew much more quickly than non-AIDS research, it does not necessarily follow that non-AIDS research funding suffered because of the increases in AIDS monies. In comparison with funding for the research programs of other non-defense agencies, NIH has done comparatively well, achieving real growth most years except in 1982 and 1986 (Figure 4.5). A definite benefit for the slower-growing non-AIDS programs is that AIDS funds have supported some immunology, molecular biology, and other basic research that might otherwise not have been possible, although, as already noted, the share of the AIDS budget going to basic research is relatively small. 6   It would take $783.5 million to sustain this level of expenditures in fiscal year 1991 after inflation (using the biomedical research and development price index).

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH Interviews at NIH and on Capitol Hill indicate that from at least 1985 through fiscal year 1989, the AIDS budget was considered separately from the non-AIDS budget at NIH, and there is little reason to believe that the funds appropriated to AIDS would have gone to non-AIDS activities if there had not been a separate AIDS budget. Today, however, the situation is changing. A perception at the appropriations committee level that AIDS and non-AIDS funding shares were out of balance and that AIDS research should compete with non-AIDS studies in priority setting at the institutes resulted in no formal AIDS earmark in fiscal year 1990 for the first time since 1984. Although the institutes are expected to maintain the detailed budgets submitted in the congressional justification, including those for AIDS, lack of an earmark means that “the precise amount expended is determined by the institutes based on the quality of applications submitted and competing research priorities,” according to the House appropriations committee in its report (U.S. Congress, 1989:22–23). “This process relies on the judgment of the peer review system and scientific advisory boards which are the backbone of NIH's quality control system. Use of this process could result in a somewhat higher or lower final figure for AIDS. ” During fiscal year 1990 NIH basically allocated funding according to the amounts in its original budget submission but used the flexibility of not being restricted to a certain budget amount for AIDS to include closely related basic research in immunology and microbiology in the AIDS program (U.S. Congress, 1990a:61, 1156). The House appropriations committee report on the 1991 appropriations bill stated the committee 's preference of continuing to suggest an approximate target figure for AIDS activities in the report stage rather than setting a precise amount in statutory language (U.S. Congress, 1990c:25).7 The committee believes that the basic knowledge base for understanding and controlling AIDS is inadequate and has already recommended an expansion of basic research as part of a balanced long-term AIDS research program. In the past, NIH has defined AIDS research narrowly to encourage well-established researchers to shift emphasis from ongoing research in other areas. This goal has been met, and the artificial distinction between AIDS research and AIDS-related basic research has outlived its usefulness. Recommendation 4.2 NIH should adopt NIAID's recent redefinition of AIDS research (to include closely related basic research in immunology, virology, molecular biology, cellular biology, and other related areas) for use throughout its institutes. Spillover Effects of AIDS Research on Non-AIDS Efforts AIDS research has depended heavily on earlier national investments in studies in such fields as retrovirology, cellular immunology, clinical trials, and infectious disease epidemiology. Indeed, without this earlier research, the progress already experienced in identifying and characterizing the causal agent of AIDS and in developing several efficacious therapies would have been impossible. For example, the “War on Cancer” in the 1970s supported a greatly expanded research program on the virology and immunology of retroviruses. When it was suspected that AIDS was a retrovirus, the investigators and facilities involved in work on retroviruses were quickly mobilized to work on HIV, which allowed scientists in only a short time to learn a great deal about the virus and how it causes disease. In addition, the techniques developed to screen for anticancer drugs were used for anti-HIV drugs, which is how zidovudine, or AZT, was originally identified. 7   Subsequently, the December 1990 conference report on NIH funding for fiscal year 1991 did not contain specific earmarks for AIDS.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH Conversely, the intense scientific work on HIV and the disease it causes has contributed important new information to the basic and clinical research knowledge bases. Investigation of the molecular biology of HIV will soon make it the best understood of all retroviruses, and that knowledge can add understanding to work on viruses in general and on other retroviruses in particular. The discovery that CD4 is the receptor for HIV has contributed to research progress on the interaction of viruses with their specific receptors. A major effort is under way to understand the molecular controls that determine the level and timing of viral replication. These studies will provide important insights into the control of latency and of replication of other viruses, as well as better understanding of the control of normal cellular genes. In addition, as a result of AIDS research, the CD4 molecule has been cloned and sequenced and its crystal structure is under analysis, which will add to knowledge about the role of CD4 in the function of the immune system. In general, AIDS studies are making important contributions to resolving basic problems in immunology. Not surprisingly, a survey of scientists and clinicians by the congressional Office of Technology Assessment (OTA) found that most of those interviewed believed that federally funded research on HIV/AIDS had already contributed substantially to the basic science fields of virology, immunology, microbiology, and molecular biology. Specialists in a number of clinical medicine areas, especially the disciplines of infectious disease, oncology, neurology, hematology, and pulmonary medicine, reported substantial contributions of HIV/AIDS research to their areas as well. Experts in drug and vaccine development, diagnostics, epidemiology, and behavioral sciences also cited substantial benefits from AIDS/HIV research (OTA, 1990:7–12). GRANTS POLICY AND ADMINISTRATION One of NIH's key resources is a large-scale process for identifying high-quality research ideas and productive investigators worthy of funding support. NIH's grant review system maintains a pipeline of research proposals deemed to have high scientific merit by other scientists. At the beginning of the epidemic, AIDS, as a new disease, did not have a community of dedicated researchers or such a pipeline. Consequently, NIH resorted to ad hoc arrangements to expedite the review and award of AIDS research proposals before developing a permanent set of review groups and procedures. Problems in Responding to the AIDS Epidemic Under NIH's grant review process, an investigator proposes a well-designed research project that addresses an important scientific question. Review and, if the application is successful, approval occur in two stages. A scientific peer-review group or study section conducts an initial review of the application and decides whether to approve and recommend it for funding; the group then scores it on a scale from 100 (outstanding) to 500 (acceptable; NIH, 1989b:11). The application then goes to the appropriate institute or institutes for review and approval for funding by the institute's national advisory council. Most institutes fund a few applications with scores below the cutoff point (the lowest score normally funded) to address areas of “high program relevance.” If an institute determines more research is needed in an area, it can use a variety of devices to stimulate investigator interest and applications, ranging from workshops to program announcements (stating the institute's interest in receiving applications on a particular topic) to RFAs that state the number of grants and level of funding the institute will devote to that set of applications. If an institute has a strong programmatic interest in a particular area of study or type of research, it can offer program project or center grants to support larger-scale research efforts,

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH or it can use a cooperative agreement. In these latter cases, and in the case of most RFAs, institutes rather than Division of Research Grants (DRG) groups review the applications. Funding extramural research usually takes nine months from receipt of a grant application to award, but the process can take longer if, as with AIDS in the early years of the epidemic, the research area is new and investigators must be encouraged to apply. In those first years NIH was criticized for neglecting extramural research on AIDS, for taking too long to review research proposals, and for funding low-quality applications (OTA, 1985:41). For example, NCI, after cosponsoring with CDC a national conference on Kaposi's sarcoma and opportunistic infections in September 1981, began to develop an RFA for studies of AIDS. It was nearly a year before the RFA was issued in August 1982. At that time, however, NIH took various steps to expedite the review and award process. A large ad hoc review committee was formed, and mail ballots were used to make the first awards beginning in March 1983 (Stoolmiller, 1990). NIH also expedited extramural research by supplementing ongoing grants for research on sexually transmitted diseases (through NIAID) and Kaposi's sarcoma (through NCI). Subsequently, AIDS research grant applications were reviewed by the DRG in the usual manner–by regular chartered study sections or by ad hoc review study sections–although arrangements were often made to add ad hoc members with AIDS expertise to regular study sections (Maurer, 1990). As noted earlier, NIH in those years was criticized for funding studies with relatively poor peer-review scores (see Table 4.10; OTA, 1985:42), a problem that has continued to be a concern of the scientific community. These concerns have not been mitigated by the fact that institute review groups of AIDS experts rather than disciplinary DRG study sections review many AIDS grant applications. Concerns remain because some of the studies are large, complicated projects, often solicited by the institute with an RFA, and funded through cooperative agreements, which involve institute staff in the direction of a project. By 1986 NIAID's AIDS grant application review workload had become so large that the institute chartered a 51-member AIDS research review committee. Its work was carried out by four subcommittees: (1) basic research I (immunology); (2) basic research II (virology); (3) clinical applications, prevention, and treatment; and (4) epidemiology and technology transfer (NIH, 1990b:38). Meanwhile, DRG continued to review individual investigator-initiated grant applications. By 1987 AIDS applications in the areas of virology and immunology were overloading the DRG study sections to which they were assigned. In response NIH established a special review committee, Special Study Section A, to handle AIDS virology and immunology applications. This arrangement, which was first used for the January 1987 round of grant reviews (Maurer, 1990), remained in place until the initiation of the expedited review of all AIDS research grant applications that began with the February/March 1988 receipt deadline. Until then, other nonvirology, nonimmunology AIDS applications were reviewed by regular chartered study sections. The Current System Division of Research Grants Capacity Because of concerns about the workload and speed of AIDS grant review, in 1988 Congress began to appropriate funds designated for staff positions (FTEs) for grant review work; it also mandated an expedited review process in which reviews and awards were to be made within six (rather than nine) months of receipt of the grant application. By this time, the number and quality of unsolicited applications had begun to improve. At NIAID, for example, from fiscal year 1987

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH to fiscal year 1988, the number of solicited applications (e.g., stimulated by an RFA) dropped from 250 to 130, and the number of unsolicited applications increased from 150 to more than 400. As a result, the ratio of solicited to unsolicited grant awards dropped from more than 2 to 0.5, and most of the solicited awards were for the large NIAID AIDS programs–for example, the national cooperative drug discovery groups, the AIDS research centers, Programs of Excellence for Basic Research in AIDS, and AIDS clinical trial units. The priority scores of unsolicited grants improved, whereas the number of solicited grant awards with priority scores greater than 175 fell sharply (NIH, 1989a). With the advent of the six-month expedited award policy, DRG designated separate dates for the receipt of AIDS proposals, and AIDS grant review sections proliferated, from three in 1988 (immunology, virology, epidemiology/behavior) to five in 1989 (sections for preclinical drug discovery/development and clinical research were added). In 1990, seven sections were formally chartered (the epidemiology and behavior section was split in two and neuroscience was pulled out of the clinical section). By the January 1990 review round, the study sections were averaging about 50 applications (from 40 to 70), compared with the 75 or 80 handled by the regular virology and immunology sections during each round (Meier, 1990). DRG's successful management of this process indicates that it has the capacity to handle an increased number of basic science and other individual investigator-initiated grants as recommended by this committee. Quality of AIDS Research Applications As noted earlier, the average priority scores and priority score distributions for AIDS and non-AIDS grants began to converge by fiscal year 1988. In fiscal year 1989, priority scores at the 50th percentile for AIDS and non-AIDS grant applications and awards were comparable for both individual investigator-initiated grants (R01s) and for all research project grants (including R01s; Table 4.11); this was true for each institute (Figure 4.6). The distribution of priority scores for AIDS and non-AIDS grant applications–as measured by the mean priority score in each decile, for example (Table 4.12)–is also similar. Success of AIDS Research Applications Until recently AIDS grants have had higher award rates (the percentage of approved applications that are funded) than non-AIDS grants. The award rate for all AIDS research project grants was 34 percent in fiscal year 1989, compared with 27 percent for non-AIDS grants ( Table 4.13); by fiscal year 1991 both will be about 25 percent. Conclusion NIH was not well prepared at first to speed the review and award of grants to meet the urgency of the epidemic of HIV infection and AIDS. Review and award procedures were expedited but on an ad hoc basis, and the strain on already busy DRG and institute staff was heavy. Initially, NIH relied on contracts and then on RFA-solicited cooperative agreements and program project grants rather than on traditional investigator-initiated grants to launch studies quickly and attract productive researchers. High-quality proposals were scarce, and some awards went to applications with relatively poor peer-review ratings.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.3 Percentage of National Institutes of Health AIDS Funding by Institute, Center, and Division, Fiscal Years 1990–1991 Unit 1990 Percent 1991 Percenta National Cancer Institute 20.3 20.0 National Heart, Lung, and Blood Institute 5.7 5.4 National Institute of Dental Research 0.6 0.8 National Institute of Diabetes and Digestive and Kidney Diseases 0.7 0.7 National Institute of Neurological Disorders and Stroke 2.2 2.1 National Institute of Allergy and Infectious Diseases 53.1 53.8 National Institute of General Medical Sciences 2.0 2.1 National Institute of Child Health and Human Development 3.6 3.9 National Eye Institute 0.7 0.7 National Institute of Environmental Health Sciences 0.6 0.6 National Institute on Aging 0.1 0.1 National Institute of Arthritis and Musculoskeletal and Skin Diseases 0.2 0.2 National Institute on Deafness and Other Communication Disorders – 0.1 National Center for Research Resources 6.0 5.9 National Center for Nursing Research 0.1 0.4 Fogarty International Center 0.7 0.7 National Library of Medicine 0.1 0.1 Office of the Director 1.6 1.6 Buildings and Facilities Program 1.7 1.2 Total 100.0 100.0 aEstimated. SOURCE: Division of Financial Management, National Institutes ofHealth. TABLE 4.4 AIDS Funding as a Percentage of Total Funding by Institute, Center, and Division, Fiscal Years 1990–1991 Unit 1990 Percent 1991 Percenta National Cancer Institute 9.1 9.4 National Heart, Lung, and Blood Institute 3.9 3.9 National Institute of Dental Research 3.4 4.4 National Institute of Diabetes and Digestive and Kidney Diseases 0.9 1.0 National Institute of Neurological Disorders and Stroke 3.3 3.0 National Institute of Allergy and Infectious Diseases 47.3 47.7 National Institute of General Medical Sciences 2.1 2.1 National Institute of Child Health and Human Development 6.1 6.5 National Eye Institute 2.3 2.2 National Institute of Environmental Health Sciences 1.9 1.3 National Institute on Aging 0.4 0.3 National Institute of Arthritis and Musculoskeletal and Skin Diseases 0.7 0.8 National Institute on Deafness and Other Communication Disorders – 0.5 National Center for Research Resources 12.6 14.2 National Center for Nursing Research 2.9 7.2 Fogarty International Center 31.6 30.5 National Library of Medicine 0.6 0.6 Office of the Director 11.0 13.4 Buildings and Facilities Program 19.2 5.6 Total 100.0 100.0 aEstimated. SOURCE: Division of Financial Management, National Institutes ofHealth.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.5 National Institutes of Health (NIH) AIDS Funding (percentage) by Mechanism, Fiscal Years 1982–1991 Mechanism 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991a Research grants                     Projects 20.1 41.5 32.6 28.0 18.8 30.9 40.5 38.3 39.0 39.3 Centers 19.0 5.8 3.8 5.3 4.7 4.1 8.3 8.7 7.9 7.7 Other 0.2 0.1 0.4 1.4 1.3 0.9 2.8 2.5 1.8 1.7 Total 39.4 47.4 36.8 34.7 24.8 35.9 51.7 49.5 48.7 48.7 Research training –b – <0.1 0.2 <0.1 0.1 0.7 1.1 1.0 1.2 Research and development contracts 13.4 21.5 34.9 39.1 53.4 42.9 29.4 27.7 26.7 26.5 Intramural research 47.2 31.1 27.2 25.1 20.1 16.9 14.0 15.5 16.5 16.9 Research management and support – – 1.0 0.9 1.5 2.4 2.8 3.6 3.5 3.8 All otherc – – – – 0.1 1.8 1.4 1.8 3.5 2.9 Total NIH 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 AIDS funding (millions of dollars) $3.4 $21.7 $44.1 $63.7 $134.7 $260.9 $430.6 $602.3 $740.5 $804.6 aEstimated. bNo funds allocated. cAllocations for the National Library of Medicine, Office of the NIH Director, Buildings and Facilities program, and extramural construction grants. SOURCE: U.S. Congress (1989:136–137) for 1982–1988; Division of Financial Management, NIH, for 1989–1991. TABLE 4.6 National Institutes of Health (NIH) Non-AIDS Funding (percentage) by Mechanism, Fiscal Years 1982–1991 Mechanism 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991a Research grants                     Projects 50.3 52.3 53.4 54.4 56.0 57.2 57.7 58.3 59.5 56.0 Centers 9.6 9.3 9.6 9.3 9.0 8.7 8.5 8.3 8.1 8.7 Other 5.7 5.5 5.5 6.1 5.9 5.9 5.8 5.5 4.7 5.1 Total 65.6 67.0 68.4 69.8 70.9 72.8 72.0 72.1 72.3 69.8 Research training 4.1 4.1 3.7 4.3 4.1 3.9 3.8 3.7 3.7 4.0 Research and development contracts 8.8 7.9 7.4 6.9 5.4 6.3 6.0 5.6 5.5 5.4 Intramural research 12.4 12.3 11.9 11.0 10.5 10.5 10.6 10.6 10.8 10.6 Research management and support 5.1 5.0 4.8 4.3 4.0 3.9 4.2 4.3 4.0 4.6 All othera 3.9 3.6 3.8 3.6 5.0 3.6 3.3 3.7 3.6 5.7 Total NIH 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 Non-AIDS funding (billions of dollars) $3.6 $4.0 4.4 $ 5.1 $5.2 $5.9 $6.1 $6.5 $6.8 $7.5 aEstimated. SOURCE: U.S. Congress (1989:134–135) for 1982–1988; Division of Financial Management, NIH for 1989–1991.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.7 Number of AIDS Research Project Grants (RPG) by Type and Proportion Solicited by Requests for Applications (RFA), Fiscal Years 1986–1988   R01s   Solicited by RFA Fiscal Year Total RPGs Number Percent P01s U01s Other RPGs Number Percent 1986 182 111 61 17 42 12 57 31 1987 292 182 62 24 62 24 142 78 1988 501 307 61 45 101 48 90 29 NOTE: Abbreviations: R01, traditional (individual investigator-initiated) research grant; P01, program project grant; U01, cooperative agreement. SOURCE: Division of Research Grants, National Institutes of Health. TABLE 4.8 National Institutes of Health AIDS Funding (in thousands of dollars) by Mason Functional Categories Category Fiscal Year 1989 Budget Authority Fiscal Year 1990 Appropriation Fiscal Year 1991 President's Request Basic science research       Biomedical research       HIV and HIV genome 62,120 66,320 71,887 Immunology 37,954 44,911 48,075 Blood/blood products 11,063 12,154 8,879 Diagnostic methods/reagents development 7,869 10,853 11,956 Animal models and related studies 29,683 36,308 39,264 Subtotal 148,689 170,546 180,061 Neuroscience and neuropsychiatric research 16,645 20,324 21,669 Behavioral research       Mechanisms of behavior and behavior change 3,863 4,188 4,530 Prevention of high-risk behaviors 1,315 611 642 Subtotal 5,178 4,799 5,172 Therapeutic agents       Development 131,421 163,712 176,082 Clinical trials 103,840 139,966 150,306 Subtotal 235,261 303,678 326,388 Vaccines       Development 49,238 64,301 70,499 Clinical trials 10,581 14,332 15,631 Subtotal 59,819 78,633 86,130 Research enhancement       Training 6,473 8,253 9,445 Construction (extramural) 4,940 –a – Subtotal 11,413 8,253 9,445 Total, basic science research 477,005 586,233 628,865

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH Category Fiscal Year 1989 Budget Authority Fiscal Year 1990 Appropriation Fiscal Year 1991 President's Request Risk assessment and prevention       Surveillance–diseases associated with HIV 7,206 8,263 8,981 Population-based research       Transmission       Sexual 33,201 37,353 43,290 Intravenous drug abusers 8,583 10,683 11,460 Hemophilia populations 4,692 4,676 4,856 Blood recipient/donor studies 9,420 9,400 8,839 Perinatal infection 18,480 23,341 25,254 Occupationally related 83 83 100 Other/miscellaneous 13,560 16,245 17,284 Subtotal 88,019 101,781 111,083 Natural history and cofactors 12,717 16,154 16,951 Subtotal 100,736 117,935 128,034 Information and educational/preventive services       High-risk or infected persons       Health education/risk education 2,057 1,797 1,826 Counseling, testing, partner notification 275 344 369 Perinatal AIDS prevention projects 447 560 601 Subtotal 2,779 2,701 2,796 School and college-aged youth–national efforts 533 668 716 General public and special programs       National–treatment trials and therapy, information services 7,017 10,014 10,846 Regional, state, and local 9 540 820 Subtotal 7,026 10,554 11,666 Health care workers and providers       Education and training centers 999 1,249 1,342 Other types of training 1,110 1,164 1,264 Subtotal 2,109 2,413 2,606 Subtotal 12,447 16,336 17,784 Total, risk assessment and prevention 120,389 142,534 154,799 PHS-wide activities–       construction (PHS facilities) 4,900 14,765 16,500 Grand total 602,294 743,532 800,164 aNo funds allocated. SOURCE: National AIDS Program Office, Office of the Assistant Secretaryfor Health, U.S. Department of Health and Human Services.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.9 National Institutes of Health AIDS Funding (thousands of dollars), by Charlottesville Functional Categories, Fiscal Years 1984–1990 Category 1984 1985 1986 1987 1988a 1989b 1990b Pathogenesis and clinical manifestations Epidemiological studies 16,202 20,468 27,848 38,964 59,869 87,896 98,598 Virology 1,500 2,500 2,983 8,843 25,651 21,399 33,305 Surveillance 40 600 1,979 620 1,387 1,736 3,267 Etiologic agent and co-factors 5,521 9,224 12,412 22,465 30,490 45,734 53,223 Immunologic studies 6,534 9,683 15,215 20,038 28,539 29,283 40,376 Simian AIDS 2,589 2,351 3,541 8,057 11,627 17,564 19,248 Psychosocial factors 38 124 39 692 4,976 4,739 5,968 Subtotal 34,424 44,950 64,017 99,679 162,539 208,351 253,985 Therapeutics Studies of therapeutic intervention 7,680 10,332 38,437 105,922 174,350 232,630 278,234 Drug purchase and distribution –c 500 9,564 16,132 16,284 22,755 27,519 Subtotal 7,680 10,832 48,001 122,054 190,634 255,385 305,753 Vaccine development and evaluation 2,379 4,839 13,300 26,174 44,333 70,926 83,886 Public health control measures Information/education 573 643 1,682 5,253 7,215 5,386 8,717 Prevention of transfusion-related AIDS 22 536 622 1,733 3,196 4,033 4,000 Development and evaluation of blood tests 1,015 1,879 6,866 5,782 6,548 9,684 8,419 Subtotal 1,610 3,058 9,170 12,768 16,959 19,103 21,136 Patient care and health care needs Treatment demonstration project – – 95 90 295 – 50 Bioethics and safety 28 58 84 142 86 337 348 Subtotal 28 58 179 232 381 337 398 Multidisciplinary AIDS research – – – – 58,439 49,697 87,512 Total, National Institutes of Health 44,121 63,737 134,667 260,907 473,285 603,799 752,670 aIncludes $23,935 of no-year extramural construction funds in the National Center for Research Resources and $18,780 in Building and Facilities construction appropriated in fiscal year 1988 that will be obligated in fiscal year 1989. bEstimated. cNo funds budgeted or allocated. SOURCE: Division of Financial Management, National Institutes ofHealth.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.10 Comparison of AIDS and Non-AIDS Priority Scores for Research Grants, Fiscal Years 1982–1985, National Institutes of Health   AIDS Research Grants   1982 1983 1984 1985 Priority Score Rangea NCI NCI NHLBI NIAID NCI NHLBI NIAID NCI NIAID 100–180 13 8 0 12 8 4 20 17 8 181–200 4 5 1 2 1 0 4 0 0 201–250 6 7 0 2 6 3 4 0 1 251–300 1 10 1 1 0 0 0 1 0 300+ 0 0 0 0 1 0 0 0 0 Total AIDS grants 24 30 2 17 16 7 28 18 9 Paylineb for non-AIDS grants 183 181 195 166 184 201 167 172 159 NOTE: Abbreviations: NCI, National Cancer Institute; NHLBI, National Heart, Lung, and Blood Institute; NIAID, National Institute of Allergy and Infectious Diseases aAll research grants are reviewed for scientific merit and receive a score ranging from 100 (best) to 500 (worst). bThe payline is the score dividing funded and unfunded grants. SOURCE: Division of Financial Management, National Institutes ofHealth, May 16, 1986. TABLE 4.11 Priority Scorea at 50th Percentile for Applications and Awards, AIDS and Non-AIDS R01s and All Research Project Grants, Fiscal Year 1989   AIDS Non-AIDS R01sb     Applications 242 235 Awards 160 153 Research project grantsc     Applications 240 231 Awards 161 153 a100 is best score, 500 is worst. bTraditional individual investigator-initiated grants. cIncludes R01, R22, R23, R29, R35, R37, R43, R44, P01, P42, U01, and National Institute of General Medical Sciences P41 (no National Library of Medicine or National Center for Research Resources grants). SOURCE: Division of Research Grants, National Institutes of Health.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.12 Comparison of Peer Review Scores of AIDS Grant Applications with Scores of All Other Grant Applications Reviewed in Division of Research Grants Study Sections, Council Year 1989a Mean Priority Score, by Deciles   Mean Priority Score First Decile Second Decile Third Decile Fourth Decile Fifth Decile AIDS applications             All 254 135 155 176 199 225 Type 1b 259 135 155 176 199 225 Type 2c 199 135 154 175 200 224 All other applications             All 240 133 153 170 191 212 Type 1b 251 133 153 170 191 213 Type 2c 210 133 153 170 190 212 aCouncil year 1989 includes applications received for consideration at national advisory council meetings held in January, May, and October 1989. bType 1 applications are applications for funding of new research projects. cType 2 applications are applications for continued funding of research projects for which previous grants are running out or expiring. (Also included are type 9 applications, which are also competing renewal applications that are changing institutes.) SOURCE: Division of Research Grants, National Institutes of Health. TABLE 4.13 AIDS and Non-AIDS Individual Investigator-Initiated Grants (R01s) and All Research Project Grants (RPG), Fiscal Year 1989 Grant Type Reviewed Approved Awarded Success Ratea (percentage) Award Rateb (percentage) Recommendation Ratec (percentage) AIDS R01s 700 638 205 29.0 31.8 91.1 Non-AIDS R01s 15,191 14,714 3,971 27.0 26.0 96.6 AIDS RPGs (includes R01s) 886 790 273 30.5 34.2 89.2 Non-AIDS RPGs (includes R01s) 19,521 18,317 5,383 29.4 27.5 93.5 aNumber awarded divided by number reviewed. bNumber awarded divided by number approved. cNumber approved divided by number reviewed. SOURCE: Division of Research Grants, National Institutes of Health.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.14a Cumulative Summary of AIDS Staffing (in full-time equivalents [FTE]) by Unit, National Institutes of Health Unit 1982 1983 1984 1985 1986 1987 1988 1989 1990a 1991b Institute, center, or division                     National Cancer Institute 20 31 72 85 98 129 146 188 281 300 National Heart, Lung, and Blood Institute –c – – 1 1 5 9 18 23 35 National Institute of Dental Research – – 1 2 4 8 10 16 18 19 National Institute of Diabetes and Kindney Diseases – – – – – 5 5 10 10 10 National Institute of Neurological Disorders and Stroke 1 2 10 11 16 21 23 40 40 40 National Institute of Allergy and Infectious Diseases – 12 45 46 57 119 158 229 306 343 National Institute of General Medical Sciences – – – – – – – 2 2 2 National Institute of Child Health and Human Development – – – – – 10 12 21 22 25 National Eye Institute – – – – 1 1 1 4 5 7 National Institute of Environmental Health Sciences – – – – – 2 6 7 7 8 National Institute on Aging – – – – – 1 2 3 5 5 National Institute of Arthritis and Musculoskeletal and Skin Diseases d – – – – – – – 2 3 4 National Institute on Deafness and Other Communication Disorderse – – – – – – 1 – – – National Center for Research Resources – – – – – 3 5 7 7 7 National Center for Nursing Researchf – – – – – – – 2 2 4 Fogarty International Center – – – – – – 2 3 3 3 Subtotal 21 45 128 144 177 304 379 552 735 813 National Library of Medicine – – – – – – – 2 7 8 Office of the Director – – – – – 2 7 16 35 37 Clinical center 6 14 40 47 58 90 131 – – – Division of Research Grants – – – – – 3 10 193 295 325 Office of Research Services – – – – – – 10 – – – Total 27 59 168 191 235 399 537 763 1,072 1,183 aEstimated. bRequested. cNo FTEs allotted. dThe National Institute of Arthritis and Musculoskeletal and Skin Diseases was established in 1986. eThe National Institute on Deafness and Other Communication Disorders was established in 1988. fThe National Center for Nursing Research was established in 1986. SOURCE: Division of Financial Management, National Institutes ofHealth, January 28, 1989.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH TABLE 4.14b Cumulative Summary of AIDS Staffing (in full-time equivalents [FTE]) by Administrative Area, National Institutes of Health Administrative Area 1982 1983 1984 1985 1986 1987 1988 1989 1990a 1991b Intramural 21 45 118 129 145 224 275 378 498 555 Research management and support –c – 10 15 28 80 104 174 237 258 Office of the Director and Central Services 6 14 40 47 58 95 158 211 337 370 Total 27 59 168 191 235 399 537 763 1,072 1,183 aEstimated. bRequested. cNo FTEs allotted. SOURCE: Division of Financial Management, National Institutes ofHealth, January 28, 1989. TABLE 4.15 Staffing Levels (in full-time equivalents [FTE]) for the of Health AIDS and Non-AIDS Programs,   FTEs Fiscal Year Total AIDS Non-AIDS 1981 12,637 0 12,376 1982 12,689 27 12,662 1983 13,414 59 13,355 1984 13,661 168 13,493 1985 13,100 191 12,909 1986 12,540 235 12,305 1987 12,720 399 12,321 1988 13,249 537 12,712 1989 13,204 763 12,441 1990a 13,214 887 12,327 1990b 13,779 1,072 12,707 1991a 14,133 1,183 13,031 aPresident's budget request. bRevised budget (January 1990). SOURCE: Division of Financial Management, National Institutes ofHealth, January 29, 1989.

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THE AIDS RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH REFERENCES Ad Hoc Consultants to the NIH AIDS Executive Committee. 1986. Future Directions for AIDS Research: Report to Congress from the Ad Hoc Consultants to the National Institutes of Health AIDS Executive Committee. November. Bethesda, Md.: National Institutes of Health. Balz, D. 1990. Raises set for federal executives. Washington Post, December 13. Buehler, J. W. 1990. Table of estimates of years of potential life lost before age 65 for HIV/AIDS. Centers for Disease Control, Atlanta, Ga. CDC (Centers for Disease Control). 1990. Fact Book FY 1990. Atlanta, Ga.: CDC. IOM/NAS (Institute of Medicine/National Academy of Sciences). 1988. A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? Washington, D.C.: National Academy Press. IOM/NAS. 1990. Funding Health Sciences Research: A Strategy to Restore Balance. Washington, D.C.: National Academy Press. Lee, P. R., and P. S. Arno. 1986. The federal response to the AIDS epidemic. Health Policy 6:259–267. Maurer, B. A. 1990. Letter from Bruce A Maurer, Chief, Immunology, Virology, and Pathology Review Section, Division of Research Grants, to Michael McGeary, June 6, 1990. Meier, G. W. 1990. Interview with Gilbert W. Meier, Executive Secretary, AIDS and Related Research Study Section 2 (epidemiology and population studies) and Section 6 (behavioral research), Division of Research Grants, by Michael McGeary, June 1, 1990. NAS/IOM. 1990. Forum on Supporting Biomedical Research: Near-Term Problems and Options for Action. Summary. Washington, D.C.: National Academy Press. NCI (National Cancer Institute). 1990. 1992 (By-Pass) Budget Estimate. September. Bethesda, Md.: National Cancer Institute. NIH (National Institutes of Health). 1989a. AIDS planning session with the director. Office of AIDS Research. January. NIH. 1989b. Orientation Handbook for Members of Scientific Review Groups. June. 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