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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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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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. Bethesda, Md.: Division of Research Grants, NIH.
NIH. 1990a. AIDS briefing session with the director. Office of AIDS Research. February.
NIH. 1990b. NIH Advisory Committees: Authority, Structure, Function, Members. April. NIH Publication No. 90-11. Bethesda, Md.: NIH.
OTA (Office of Technology Assessment). 1985. Review of the Public Health Service's Response to AIDS. Technical Memorandum, OTA-TM-H-24. February. Washington, D.C.: U.S. Government Printing Office.
OTA 1990. How Has Federal Research on AIDS/HIV Disease Contributed to Other Fields? Staff Paper 5 in OTA's Series on AIDS-Related Issues. April. Washington, D.C.: Health Program, OTA.
Panem, S. 1988. The AIDS Bureaucracy. Cambridge, Mass.: Harvard University Press.
Presidential Commission on the Human Immunodeficiency Virus Epidemic . 1988. Report of the Presidential Commission on the Human Immunodeficiency Virus Epidemic. June 24. Washington, D.C.: U.S. Government Printing Office.
PHS (Public Health Service). 1989. Justification of Appropriation Estimates for Committee on Appropriations, Fiscal Year 1991. Vol. 6, National Institutes of Health, Research Resources through Office of the Director. Washington, D.C.: U.S. Government Printing Office.
PHS. 1990a. Recruitment and Retention: Scientific, Medical, and Engineering Positions . October. Washington, D.C.: Office of Personnel Management.
PHS. 1990b. The Role of the Public Health Service in Combatting the HIV/AIDS Epidemic (August 31 draft). Washington, D.C.: National AIDS Program Office.
Stoolmiller, A. C. 1990. Telephone interview with Allen C. Stoolmiller, Executive Secretary, Special Review Section for the first AIDS RFA, Division of Research Grants, by Michael McGeary, May 15, 1990.
U.S. Congress. 1988a. AIDS Issues (Part 3). Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce (hearing on “Needs for AIDS Research Activities”). March 15. Serial No. 100-140. Washington, D.C.: U.S. Government Printing Office.
U.S. Congress. 1988b. Hearings on Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 1989. Part 4A. National Institutes of Health. House Committee on Appropriations, Subcommittee on the Departments of Labor, Health and Human Ser. March. Washington, D.C.: U.S. Government Printing Office.
U.S. Congress. 1988c. Therapeutic Drugs for AIDS: Development, Testing, and Availability. Hearings before the Human Resources and Intergovernmental Relations Subcommittee of the House Committee on Government Operations. April 28 and 29, 1988. Committee Print. Washington, D.C.: U.S. Government Printing Office.
U.S. Congress. 1989. Report to Accompany H.R. 2990, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 1990. House Report 101-172. 101st Cong., 1st sess. July 25.
U.S. Congress. 1990a. Hearings on Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 1991. Part 4A, National Institutes of Health. House Committee on Appropriations, Subcommittee on the Departments of Labor, Health and Human Ser. March. Washington, D.C.: U.S. Government Printing Office.
U.S. Congress. 1990b. Hearings on Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 1991. Part 4B, National Institutes of Health. House Committee on Appropriations, Subcommittee on the Departments of Labor, Health and Human Ser. March. Washington, D.C: U.S. Government Printing Office.
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U.S. Congress. 1990c. Hearings on Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, Fiscal Year 1991. Part 2, Department of Health and Human Services. Senate Committee on Appropriations, Subcommittee on Departments of Labor, H. February. Washington, D.C.: U.S. Government Printing Office.
Winkenwerder, W., A. R. Kessler, and R. M. Stolec. 1989. Federal spending for illness caused by the human immunodeficiency virus. N. Engl. J. Med., 320(June):1598–1603.
Representative terms from entire chapter:
aids funding