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1 Introduction Before World War II health research was supported and conducted pre- dominantly by corporations and private foundations. The federal govern- ment played a relatively small role in health research, conducting research primarily in its own laboratories at the National Institutes of Health (NIH). Capitalizing on the contributions of basic research to the war effort, federal science programs expanded rapidly after the war. The prescient words of Vannevar Bush 45 years ago helped establish a policy for government investment in science. Bush recognized both the need for governmental support of basic research in academic settings and the need for federally supported science training programs. He proposed five basic principles that should underlie governmental support of scientific research and education: 1. Whatever the extent of support may be, there must be stability of funds over a period of years so that long range programs may be undertaken. 2. The agency to administer such funds should be composed of citizens selected only on the basis of their interest in and capacity to promote the work of the agency. They should be persons of broad interest in and understanding of the peculiarities of scientific research and education. 3. The agency should promote research through contracts or grants to organizations outside the Federal Government. It should not operate any laboratories of its own. 4. Support of basic research in the public and private colleges, uni- versities, and research institutes must leave the internal control of policy, 25
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26 FUNDING HEALTIl SCIENCES RESEARCH personnel, and the method and scope of the research to the institutions themselves. This is of the utmost importance. 5. While assuring complete independence and freedom for the nature, scope, and methodology of research carried on in the institutions receiving public funds, and while retaining discretion in the allocation of funds among such institutions, the Foundation proposed herein must be responsible to the President and the Congress. Only through such responsibility can we maintain the proper relationship between science and other aspects of a democratic system.) Although these principles initially were proposed for establishing the National Science Foundation (NSF), they were adopted readily by the health research community. Increasing appropriations and flexible research policies enabled the NIH to expand its research programs beyond the federal laboratories through a variety of extramural programs. Throughout the 1950s and 1960s, in what may be referred to as the "golden era" of health research, the federal government provided generous funding for research and training as well as support for building modern research facilities. The growing level of investment during this period resulted in tremendous scientific and clinical advances. Indeed, in this time the United States produced the world's preeminent health research enterprise. Beginning in the 1970s, however, slower budgetary growth combined with a dramatic inflation rate both reduced the buying power of research dollars and increased the competition for available resources, which then prompted wide fluctuations in the annual number of new and competing grants awarded by NIH and the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). Furthermore, these fluctuations caused un- certainty about the availability of ongoing research support. In response to these concerns, Congress, the NIH, and ADAMHA agreed to stabilize the research base through a policy to fund a fixed minimum number of new and competing research projects each year. This "stabilization policy" explicitly made individual investigator-initiated research project grants the highest priority for NIH and ADAMHA In fiscal year 1981 a minimum number of 5,000 new and competing awards was established for NIH. Initially, a minimum number of 570 awards was proposed for ADAM HA, but the administration's budget request for 1981 cut the number to 284; Congress then increased the target to 345. This policy of establishing minimum numbers of new and competing awards was pursued for the following 7 years. Over this period new and competing awards from NIH grew to all time highs, reaching 6,400 in 1987. Likewise, over the same period new and competing awards grew to nearly 600 for ADAMHA
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INTRODUCTION 27 From 1977 to 1988 the total number of research project grants sup- ported by NIH grew by one-third, from 15,500 to nearly 20,900. Similarly, the dollars committed to research project grants grew by 50 percent, from $2.5 billion to $3.9 billion, after adjustments for inflation. The ADAMHA realized similar gains. Thus, it appears there are now more U.S. scien- tists engaged in health research with more funds than at any time in the country's history. Given this historically unsurpassed level of support, why is there so much distress and concern about the opportunity for adequate research support and the pursuit of research careers within the biomedical research community? The answers to this question are complex and based, in part, on certain misperceptions of the present status of health sciences research funding. Although the stabilization policy was important in maintaining a min- imum annual number of new and competing awards, the administration's budget requests, as well as congressional appropriations for NIH and ADAMHA never were adequate to fund the required number of awards fully. This has led to arbitrary administrative cuts, referred to as "downward negotiation," in the budgets of both competing and continuing research grant awards in order to fund the agreed-upon number of new awards. Despite this downward negotiation, however, the average dollar amount of research project grants grew throughout this period. Additionally, a policy change to extend the duration of research grants was instituted in the mid 1980s, which has increased the average length of grant awards from 3 to 4 years. The number of new and competing awards by NIH dropped from 6,400 in 1987 to 6,200 in 1988, the last year of stabilization, and in 1989 the policy for setting the minimum number of grants was halted altogether. Since then, the number of new and competing awards has plummeted, dropping to 5,400 in 1989, and it is expected to decrease to 4,600 in 1990 a decline that has sent shock waves throughout the biomedical community. Simultaneously, the number of grant applications and their approval rate by peer review panels continue to rise, a trend that further suppresses the award rate which has fallen from 35 percent to less than 25 percent in the past 2 years. Even those fortunate enough to receive project funding have seen downward negotiation cut deeper and deeper into their awards. Scientists therefore no longer see a direct relationship among the amount of funding recommended by the study section, the amount awarded by the national advisory councils, and the amount of funds actually received. Although this policy to stabilize the research base was effective, it was a short-term solution, and therefore did not address the need for longer- term investments. The emphasis on numbers of research projects fueled concern that other vital components of the research infrastructure were
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28 FUNDING HEALTH SCIENCES RESEARCH being neglected specifically training and facilities. By many estimates, the supply of scientists will be grossly inadequate to meet future demands. Indeed, between 1972 and 1989 research training as a percent of research and development (R&D) grants in NIH dropped steadily from 15 percent to nearly 4.3 percent. Moreover, attrition of scientists trained in the 1950s and 1960s is expected to increase through the next decade from deaths and retirement, and as the "baby bust" continues to shrink the labor pool over the next few years, competition for high school graduates in all labor markets will intensify. Additionally, fewer students and a declining student competency in mathematics and science raise serious concerns as well about meeting the future demand for well-trained U.S. scientists. Of no less concern is the condition of U.S. research facilities and equip- ment. Several comprehensive studies of research facilities and equipment during the 1980s documented the deteriorating condition of our academic research infrastructure. Federal investment in health research facilities has declined precipitously since 1970. Only three NIH institutes (the National Cancer Institute, the National Heart, Lung and Blood Institute, and the National Eye Institute) now have construction authority, and appropria- tions for these throughout the 1980s were negligible. Many scientists and science administrators feel that the deteriorating condition of facilities and equipment will hinder their ability to successfully compete for the funds necessary to investigate challenging research questions. Other problems have surfaced in recent years that put added pressures on an already strained research establishment. Many scientists believe that Congress has assumed the responsibility for making important scientific decisions. This is reflected through an increasing practice of earmark- ing funds for research initiatives and facilities construction in legislation. Large-scale investments to address national priorities, such as AIDS, sub- stance abuse, and the Human Genome Project, are increasing competition for already-scarce research resources. Additionally, changes in federal reg- ulations concerning the handling of animals and hazardous waste, although decidedly important, are costly and will consume increasing amounts of research dollars. At a time of great scientific opportunity, our nation's ability to invest in health sciences research is being limited by large federal deficits, and although appropriations for NIH and ADAMHA have been growing slowly over the past decade, they are subject to the same fiscal constraints as other federal programs during this time of federal deficit reduction. At the same time, global competitiveness has heightened as the coalescence of the European Economic Community approaches in 1992 and political changes reshape Eastern Europe. A new biotechnology industry making pioneering advances in diagnostics, vaccines, and novel medications is emerging as a formidable arena of international competition. Success in
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INTRODUCTION 29 this arena hinges not only on research discoveries but also on our ability to apply knowledge gained. Thus, the United States must maintain its momentum in health research while contending with the need to reduce the federal deficit. A central question facing the nation-and posed by the Institute of Medicine in the formation of this committee-is whether the current resource allocation policies are adequate to sustain the United States preeminent position or whether these policies will lead to a steady erosion of U.S. R&D in the health sciences. OBJECTIVES OF THE STUDY In response to the disturbing trends discussed above, the Board of Health Sciences Policy of the IOM proposed a study to conduct a detailed review of policies for allocating health research resources. For this review a committee of 18 members was appointed that represented the larger community of researchers and administrators in academia, government, industry, and foundations. The committee was asked both to analyze the funding sources for research projects, training, facilities, and equipment by federal and nonfederal sources, and then to develop a coordinated set of funding policies to restore balance among these components of the research enterprise in order to ensure optimal use of research dollars for sustaining a vigorous health research enterprise. The committee was not asked to review the allocation of research support among specific scientific disciplines or disease areas, nor was the policy study intended to be a justification for increasing research funds. Rather, the goal of this study was to ensure that, at any given level of support, allocation policies would enable the scientific community to utilize available resources in the most efficient manner in order to create an optimal research environment and achieve society's goals for research into human disease. The committee was divided into task forces focusing on three aspects of the problem: (1) strengths and weaknesses of the current system, (2) the goals of health sciences research, and (3) optimization of the environment for health sciences research (Appendix C). In addition to drawing on its own expertise, the committee invited written comments and testimony from current and former government officials, congressional staff, foundation and voluntary health agency officials, and administrators in industry and academia (Appendix D). The committee also commissioned the following three background papers: 1. "U.S. Funding for Biomedical Research, An Update of the 1985 Report Prepared for the Pew Charitable Musts," by Z. E. Boniface. 2. "Organizational Structure and Funding Mends of NIH and ADAMHA," by M. ~ Randolph.
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30 FUNDING HEALTH SCIENCES RESEARCH 3. "The Current Status and Perceived Needs of Biomedical Research Equipment and Facilities," by D. K Abbass. BOUNDARIES AND GOALS OF HEALTH SCIENCES RESEARCH 1b identify the scientific fields relevant to this study, the committee found it necessary to define the boundaries of health research. To this end, the committee adopted the range of disciplines presented in a 1979 IOM report DHEW's Research Planning Principles: A Review.2 This range follows a continuum from basic discovery to applied health care and is summarized here: · the biomedical sciences, which inquire into the basic nature of life through deeper understanding of life processes; · the clinical sciences, which translate fundamental research into medical practice; · the population-based sciences, such as epidemiology and biostatis tics; · the behavioral and social sciences; · biophysics, bioengineering, and clinically oriented medical engi- neering and physics; · the hybrid sciences, such as nutritional and environmental sciences; · health services research, which studies the health care system; and · technology transfer. Additionally, the committee members worked from the premise that there is too little emphasis on research into disease prevention as well as in the emerging field of outcomes research (which compares the effectiveness of various treatments and/or therapies). And that therefore the following goals must be considered when developing anv new policies to allocate research funds: ~ a , · advancing the fundamental knowledge base of the health sciences; translating fundamental knowledge into improved diagnostic, treat- ment, and preventive interventions and thereby helping to alleviate suffer- ing, improve the quality of life, and enhance survival; · providing the basis for regulatory actions designed to promote safety and health; and · providing the basis for informed decision making on health policy matters, including the organization, delivery, and financing of health care. Within the context of these goals, the committee's primary task was to develop a framework for policy decisions promoting successful research in an environment that identifies, encourages, and promotes creativity. Such an environment must provide stable support for talented scientists, flexibility
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INTRODUCTION 31 and appropriate allocation of resources to meet changing demands, and laboratories and equipment that meet the scientist's needs. When the research environment is positive, supportive, and reasonably optimistic, it encourages the recruitment of new investigators and fosters the creativity of talented health researchers. This report thus focuses on the process of supporting the health sci- ences research enterprise, the people involved in the research, the project Support system itself, and the need to restore facilities and equipment. In this regard, all of the committee's recommendations were designed for a three- fold purpose. First, scientists should be educated and trained adequately for whatever branch of health sciences research they find stimulating. Second, adequate and varied grant mechanisms should be available for researchers to follow creative and meritorious endeavors throughout their scientific ca- reers. Third, laboratories must have adequate space and sufficient modern equipment for U.S. health scientists to continue performing world-class research and to train the next generation of health scientists. The optimal research environment is not a minimum (or maximum) number of partially funded grants but is instead a stable but flexible research environment. The committee traced the development of the U.S. system for support- ing research and reviewed current policies for allocating research funds. In light of the magnitude of the current U.S. investment in health sciences research, as well as recent economic, demographic, and political devel- opments that affect funding and administration of research programs, the committee felt that better mechanisms for long-range planning and coor- dination of research support could improve the use of research dollars. Definition of this coordination takes two forms: (1) coordinating support for health sciences research within the federal establishment and (2) si- multaneously, increasing communication among federal and non-federal sponsors of research. The primary objective of the recommendations In this report is to focus on the need for a forum for both communicating among supporters of health sciences research and encouraging them to develop long-range plans. It is vitally important that these processes be part of a continuous effort to monitor and revise policies to ensure the continued vigor In the nation's health sciences research enterprise. REFERENCES 1. Bush, V. 1945. Science-lathe Endless Frontier, A Report to the President on a Program for Postwar Scientific Research. Washington, D.C.: Office of Scientific Research and Development. (Reprinted By the National Science Foundation, May 1980.) 2. Institute of Medicine. 1979. DHEW,s Research Planning Principles: A Review. Washington, D.C.: National Academy Press.
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