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Home > About NIH |
Setting Research Priorities at the National Institutes of Health |
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Overview Given the importance of medical research in fighting disease and improving the nation's health, the enormous range of possible subjects of research, and the thousands of talented investigators who seek funding, the National Institutes of Health (NIH) must make choices about where and how it spends its money, approximately $20 billion in fiscal year 2001. The process of choosing is routinely called setting priorities, a phrase that is shorthand for the application of principles and mechanisms the NIH uses for evaluation and judgment. Making choices is complex and often difficult: the NIH's mission and its history demonstrate that no one thing — no single disease, no single investigator, no single Institute, no single method of funding research — comes first or claims permanent priority over others. The principles and mechanisms that guide the NIH in the continuous activity of managing its budget are the subject of this booklet. Some observations about the influences and facts that condition the process may add clarity. It is important, however, to keep in mind that this booklet describes the ways things work at the NIH now; it is neither a prescription nor a defense. Managing the NIH's budget requires many decisions. The appropriations process, from the President's request through final passage of the bill by the Congress, obligates each Institute to determine how to allocate its own funds among many different activities of science — including investigator-initiated grants, the intramural research program, and research training, among others. These decisions are governed by the Institute's research objectives. Each Institute also decides which specific research grant applications to fund among those proposed by researchers working at universities or other research centers and whether to emphasize certain research topics within its domain. The net effect of these decisions determines how much of the entire NIH budget is devoted to work in certain scientific disciplines (e.g., neurosciences, microbiology, genetics) or on certain diseases. It is also important to note that past decisions — for example, the creation of an Institute, the establishment of research centers, and the awarding of grants to individual investigators (averaging four years) — have longer lives than the annual appropriations. This leaves only a part of the entire budget available each year for new opportunities. Assessing research according to money spent on
specific diseases is imprecise.
There is, consequently, no "right" amount of money, percentage of the budget, or number of projects for any disease.
There are limits to planning science.
Consequently, an average of slightly more than half of each Institute's budget supports the best research grant proposals without regard to specific applicability to a disease, but rather in expectation that their results will contribute to advances against diseases within their purview, to research in other Institutes, and to our knowledge generally. It is also true, however, that a decision to increase support of one area of medical science — by design, according to a directive, or in response to a critical opportunity — now usually comes at the expense of something else and affects the planning of future research. Decisions to create new Institutes or to expand research into specific diseases were historically accompanied by very large increases in the NIH budget. No programs had to be cut or attenuated. While appropriations for the NIH have increased substantially over the last five years, both the costs of research and the Institutes' portfolios have also grown. Consequently, directives to spend more on a specific disease or the need to respond to swiftly emerging threats (e.g., West Nile Virus) constrain spending on other diseases or on fundamental research. Various criteria shape the NIH's budget.
The complexity of both planning budgets and spending money are apparent. With no claim to a monopoly on good ideas, the NIH seeks opinions and counsel from many quarters:
How the NIH solicits and acquires opinion and advice is detailed in "The Institutes" and "The Role of the NIH Director," the last two sections of this booklet. Some examples include:
The final responsibilities for the complex and imperfect process of evaluating opinion, assembling the individual Institutes' portfolios, and determining expenditures remain with the NIH Director and the directors of the Institutes. Evaluating opportunities and public health needs
is complex.
The emphasis the NIH places on funding unsolicited proposals from investigators from individual laboratories (investigator-initiated research) does not dismiss the efforts of advocates of disease-oriented research or propose they should not do more to advance their causes. Nor does the emphasis erect a wall between basic research and clinical research. Workshops on autism, Parkinson's disease, spinal cord injury, and diabetes mellitus have proved how profitable such collaboration can be. It is also a responsibility of scientists to explain science and scientific progress to the public. Medical science is slow and difficult; its advances do not occur at equal rates on all fronts; the long-term relevance of basic science to treating human disease may be hard to see; scientists may be inexpert in explaining the connection between their work and the nation's health. The many criteria, standards, and influences that all operate simultaneously on the NIH are of themselves complex. There is, however, another component: science is not like other businesses. To explain this proposition, the next section expands on some ideas already here and presents some new ones.
Although the word "science" comes from the Latin scientia meaning "known things," scientists and the practice of science exist because of what we do not know. The aim of science is to move what we do not know into the realm of known things and then, with a greater store of knowledge, begin again, as if advancing a frontier. This basic truth about science makes it different from other enterprises. Many industries normally manage their resources, labor, and money to produce the same or similar products over and over. Science deploys its resources and talents to explore new areas and produce fresh results, which are not endlessly replicated, but which prepare the way for future and different explorations. Advancing Scientific FrontiersThe many disciplines of medical research contribute to our store of knowledge and to one another, and all deserve exploration and funding. Discoveries that will increase our knowledge of the causes, progression, and treatment of asthma, for example, may stem from epidemiological, clinical, and molecular research, conducted by teams of investigators building on the discoveries of their predecessors, including those in other fields. Since it is impossible to know with certainty which area will produce the next important discovery, the community of science, of which the NIH is a part, has to be open to all ideas. No one field has all the answers, but investigators in many different fields can ask the questions that will provide more knowledge about disease and health. The uncertainty of where the most valuable discovery lies makes the setting of priorities tremendously difficult. But this uncertainty also fosters a creative and collaborative tension within the scientific community (and among the various Institutes at the NIH) which in turn imposes the discipline of evaluation, competition, and productivity on the choices we make about spending public money. To approach it differently, science and the management of science are neither chaotic nor navigation by dead reckoning. Given the NIH's internal rigor and the legitimate interests of the public, including advocacy and patient groups, the Congress, and other scientists, expenditures for medical research are always in public view. Though different from other enterprises, science has businesslike aspects: Applications for grants are subject to peer review (which is discussed later in this booklet) and rated for merit, and investigators define and justify the goals and budgets of their research with precision. It is a striking characteristic of science that it requires both creativity and precision to generate ideas and results. The precision with which investigators and administrators describe the targets and outcomes of research, however, cannot alter the inescapable truth that many of the results of research are unpredictable, given the pursuit of unknown things. The investigator examining patients with ataxia telangiectasia, a rare genetic disease, who discovers something new about the origins of cancer has not "stumbled" on a discovery, but rather has put himself or herself in a position to make the discovery and to bring it into the realm of known things which would not have happened otherwise. This unpredictability has three important implications of its own. First, science is by nature structured and self-correcting so that either a predicted or an unforeseen discovery has the advantage of adding to basic scientific knowledge and giving new direction to further inquiries. This self-correction, carried out under public scrutiny of the results, means that science operates in a dynamic marketplace in which an absolute or top-down control would be stifling. Control from the top or by directive grows inefficient as workers duplicate one another's labor or merely produce the same results; it tends to be slow to respond to new discoveries which can make the original grand design obsolete overnight. Science's self-correction, on the contrary, demands more approaches and is quicker to adapt to change. Second, scientific work is not a commodity that can simply be bought. Shifting priorities is more than the redistribution of dollars — more money alone does not solve problems. Recruiting new talent by advertising a new scientific opportunity, inviting scientists in allied fields to look across the fence, and training new investigators to work in a new area will produce more meritorious applications for funding and, most important, better results in the treatment of human disease. Third, science and its administrators must constantly reevaluate and often change their priorities in light of new discoveries. Very simply, science itself sets its priorities as it refreshes and enlarges our knowledge: The more we know, the better the questions we can ask and the more wisely we can spend our money. It is by asking as many questions as we can and by prudently spending what we have that the NIH can identify and pursue the most promising medical priorities. As priorities shift or acquire sharper focus, we are better able to look across the spectrum of scientific disciplines and of diseases. Our constantly renewed knowledge enables us to examine, for example, the effects of pesticides not on one kind of cancer but on all cancers, or to ask the next big question — what turns genes on or off? — with the confidence that we will soon begin to find answers which in turn will allow us to target diseases like Alzheimer's disease, cancer, and diabetes. There are many reasons that America is blessed with a robust community of medical science and that the NIH is recognized as the world's greatest medical research organization. The freedom to explore, the training in our colleges and universities, an enthusiastic public, and an understanding Congress have all contributed to the nation's preeminence in medical research. And so, in part, has the community of science itself because of its abilities to refresh its priorities in order to seek opportunities that are ripe for pursuit and capture.
There is a romantic and persistent image of scientists as lonely geniuses who pursue and capture new knowledge, making breakthroughs or inventing miracle drugs in inspired isolation. It may have been true when Archimedes jumped out of his bathtub and shouted "Eureka!" It is certainly not true today. The nature of scientific enterprise is both historical and collegial, not momentary or isolated. It is historical because it builds, sometimes slowly, on previous work and on a continuum of knowledge and information. It is collegial because scientific inquiry today is complex and requires collaboration among researchers from many disciplines. A principal investigator, conducting basic research, may bring training and experience in biology to an inquiry into a certain protein's role in Alzheimer's disease, for example. But the principal investigator is just that — the first person leading a team, often a first among equals, whose ideas for research become the point of departure for a particular project. That project itself may require the skills and experience of other biologists, but also of chemists, physicists, computer scientists, experts in imaging, engineers, pharmacists, biostatisticians, and ethicists. No one person could master so much historical knowledge, manage so much information, or conduct work in so many different disciplines, each of which requires constant refreshment of knowledge and skill. In this sense, science does proceed like other businesses. It relies on teamwork to obtain the advantage of the division of labor, followed by a synthesis of results. The teams may often be large and composed of the principal investigator's peers, rather than of graduate assistants and postdoctoral fellows, whose compensation must be appropriate to their experience, contribution, and standing in their professions. Moreover, the equipment needed in contemporary research is expensive, often because a device may be one of a kind or not produced for a mass market. The growing size of research teams and the increasing expense of research equipment are not historical anomalies or a scientific fad. They have been growing and increasing for years and, given the requirements of research, especially in areas now opened up by the completion of the sequencing of the human genome, will continue to grow and increase. It was fortunate timing that Congress set out to double the NIH's budget over five years beginning in Fiscal Year 1999, enabling the funding of the large and complex teams that worked so swiftly on the Human Genome Project and many other projects in the NIH portfolio. It will be no less important for medical research to have future funding adequate to supply the human resources and the material assets necessary to continue the pursuit and capture of opportunities that will lead to greater and greater understanding of human disease and human health. That of course is the overarching priority of the NIH. Throughout this booklet, the words, "opportunity" and "promise" recur frequently, obviously because the NIH gives greater priority to fuller promises and more accessible opportunities. Both promise and opportunity depend on two things: first, on the scientific continuum that has presented them and , second, on the researchers and physical assets necessary to pursue, capture, and exploit them. For the public, and especially those who are ill or have a sick relative or friend, the final exploitation of scientific knowledge comes through clinical research which is aimed at producing a therapy — a drug or a vaccine, for example — that will treat, slow, or even cure a disease. Yet the scientific community has known for more than 20 years that there is a shortage of highly trained clinical researchers. Harold Varmus, shortly after he resigned as Director of the NIH, stated that "We simply cannot deliver the enormous promise of the genetics revolution without close attention to careers in clinical research." In response, the NIH has augmented its support of both clinical research and careers in clinical research by redirecting funds to these ends, a commitment that is reflected in the new Clinical Research Center on the NIH campus in Bethesda, Maryland, and in an expanding portfolio of grants that help researchers train for clinical careers or mentor young researchers in the field. Moreover, clinical research, like basic research as characterized above, is not a lonely or low-cost occupation either. Clinical research requires large teams to treat and monitor the progress of many patients through several stages of clinical trials, often in widely geographically separated medical centers. It needs many of the disciplines associated with basic research as well as experts in epidemiology, behavioral studies, outcomes analysis, and research in health policy and delivery. Its aims are different from those of basic research, but its promise, its complexity, and its demands on resources are equivalent in importance. The complexity and cost of both basic and clinical research simply reflect the nature of the scientific enterprise today and , of course, condition the setting of priorities at the NIH. The rest of this booklet describes the principles and processes by which the NIH and its Institutes set their priorities and make their choices. It will also consider in greater detail the roles played by the Congress and the Administration, by professional societies, and by organizations focused on particular diseases in funding the research that brings what we do not know into the realm of known things.
Decisions made in the NIH's early years still shape the agency's structure and activities. The NIH as we know it today is rooted in the preamble to the Constitution establishing the promotion of the general welfare as a goal of government. Throughout this country's history, citizens have looked to government to provide health care to specific populations, for collection of vital statistics on health, and for sanitation and control of infectious diseases. Although the NIH was born on Staten Island in 1887, with another name and a mission to conduct research on infectious diseases, the modern NIH took shape shortly after World War II, when science came to be seen as a public good and supporting health research became a focus for public and congressional enthusiasm and funding. In 1946, the NIH intramural research program (the research conducted by government scientists on the NIH campus in Bethesda, Maryland, since 1938) was joined by the NIH extramural research program. This occurred when wartime government medical research contracts at universities and medical schools around the country were transferred to the NIH and converted into grants. The transfer was an important event, for it firmly established the importance of enlisting scientists in the country's medical schools and universities in the national research effort to understand disease and health. Just after the extramural research program began providing grants to scientists in universities and medical schools, the NIH recognized it needed a system to help select the highest quality research grant applications for funding. This rapidly evolved into the NIH peer review system, which relies chiefly on non-government scientists to review grant applications for scientific merit. The NIH also recognized that supporting research demands a greater commitment than simply funding individual research projects. Since 1947, NIH grants have included compensation to the institutions where the research is conducted for the expenses of maintaining the research facilities and for administering the grants. Training future generations of laboratory and clinical researchers also became an established goal of federal funding of science. The intramural research program on the Bethesda campus — which primarily focused on basic or laboratory science — was enhanced by the opening of its research hospital, the Clinical Center, in 1953. This addition acknowledged the importance of translating discoveries made in the laboratories to the bedside through clinical research, and provided a way of taking questions raised through observation of patients back to the laboratory for exploration. The need to fund both laboratory research and clinical research thus became an established principle. Encouraged by the availability of public funding, growing numbers of investigators around the country — many of them trained on the Bethesda campus — directed their efforts to basic and clinical research and applied to the NIH for research grants. The NIH cultivated the cadre of talented, well-trained scientists eager to propose their ideas to the NIH for funding, thus creating the investigator-initiated research application as a way of tapping the best ideas to understand health and combat disease. The following two decades saw significant increases in funding for the NIH and the development of new programs. New Institutes continued to appear in response to legislative or executive decisions. The establishment of each new Institute represented a decision about the priority to be given to a certain area of medical research. Each of the NIH Institutes has been provided a separate, annual budget from the Congress, thus positioning each of them as a primary locus for setting priorities and making budget decisions within their domains. (See Appendix for list of Institutes)
How the NIH Funds Medical Research Most of the NIH's budget supports the individual research projects conceived of and conducted by either government scientists working on research on the NIH campus (about 1000 Principal Investigators — tenured and tenure track) or scientists based elsewhere (about 45,000 NIH fellows, research grant recipients, and trainees), at universities, medical, dental, nursing, and pharmacy schools, schools of public health, non-profit research foundations, and private research laboratories. These scientists have been trained in one or more disciplines of science and are committed to enhancing knowledge related to human health and disease through research. NIH support of these research projects includes the salaries of scientists and technicians and the cost of equipment such as lasers or computers; of supplies such as chemicals and test tubes; and of procedures conducted with research patients. Funding medical research also includes paying the costs associated with research, such as maintenance of buildings, electricity and library services, care of laboratory animals, and salaries of administrative staff who, for example, handle the financial aspects of the grants and set up review panels to ensure that patients participating in research are adequately protected. This is true for all research, whether conducted in the intramural program by government scientists or through the extramural program by NIH-funded scientists in universities and medical schools or by scientists working in industry. These associated costs account for about 30 percent of the total cost of research projects. In fiscal year 2000, approximately 10 percent of the NIH budget was spent in the intramural program and more than 83 percent of the NIH budget was used to fund research by scientists working elsewhere across the country (see figure 1). In the extramural program, the NIH emphasizes funding investigator-initiated applications that originate with individual scientists. These Research Project Grants (or RPGs) can fall anywhere along the continuum of medical research, from molecular and cellular investigations to studies of new drugs to treat human illness. In Fiscal Year 2000 the NIH funded approximately 35,000 RPGs; the most common type, known as an R01 grant, supports a single project and a single principal scientist. Some Research Project Grants are called program project grants and support multi-disciplinary projects conducted by several investigators working on different aspects of a research problem. Yet another way the NIH supports research is through research centers. This type of grant is awarded to research institutions under the leadership of a center director and a group of collaborating investigators. Center grants fund multi-disciplinary programs of medical research and also support the development of research resources, aimed at integrating basic research with applied research and promoting research on clinical applications. Another part of the NIH's budget is spent on research and development contracts, which are awarded to non-profit and commercial organizations for work requested and overseen by the NIH staff. For example, development of the drug Taxol® for treating breast and ovarian cancer resulted from NIH contracts aimed at developing better methods for isolating the anti-cancer agent from the Pacific yew tree and for clinical trials of its efficacy. The NIH also supports training that enables young scientists to become skilled investigators who are available to apply their talents to future medical challenges. Trainees, who are at the predoctoral or postdoctoral level, are supported through grants either to them as individuals or to their institutions such as medical schools and universities. Most of the cost is for stipends for the students. In recent years, the NIH has focused on enhancing the quality of training and improving the prospects for under-represented minorities rather than on increasing the total number of students in research training. An imperative of supporting medical research is making a commitment to scientists to fund their work for a period of time sufficient for the projects to produce results. Research takes time. NIH grants are awarded for an average of four years; therefore, the bulk of each Institute's annual budget is already committed to funding the remaining years of research projects. The need to continue funding projects over multiple years is an important criterion when deciding to fund new projects. Accordingly, in any given year, only about 25 percent of the total funds allocated for research projects is available to fund new projects.
Assessing Health Needs and Scientific Opportunities Deciding how and where to distribute the NIH's money — that is, determining the requirements of basic and clinical research, identifying whether a grant, contract, or center is the best means of funding a particular area of research, and responding to the emergence of new medical problems and new patient advocacies — is a challenge the NIH faces each year. It requires fresh assessment of the nation's health needs and renewed evaluation of scientific opportunity. Yet there are many ways of assessing health needs and many facets to identifying, and sometimes creating, scientific opportunities. Assessing the health needs of the nation.
Using any one of these criteria to make funding decisions would produce a different result:
All of these criteria for weighing and weighting health needs are justifiable, yet applying any one of them exclusively would cause the neglect of some classes of diseases altogether. Moreover, any of these criteria used exclusively would, for example, under-fund research on rare diseases, research that has taught us much about the diseases themselves and a great deal about normal human biology, other diseases, and new approaches to treatment. For example, ataxia telangiectasia, xeroderma pigmentosum, and Bloom's syndrome are very rare inherited disorders that lead to an increased risk of cancer and hypersensitivity to ultraviolet radiation, X-rays, and some chemicals that cause mutations in DNA. Nonetheless, research into these diseases has not only helped people with those conditions, but has provided considerable knowledge about the causes of cancer in general. Funding the continuum of research, from basic
inquiries to clinical applications. Consequently, the NIH uses no one measure exclusively, but all of these measures to assess the nation's health needs. The evidence of improved health in the past 50 years overwhelmingly demonstrates the importance of complementary accomplishments in basic and applied research. To continue improving the nation's health, the NIH also factors into its funding decisions current and evolving scientific opportunities. Assessing scientific opportunities. Work in blood lipid research and heart disease illustrates how health needs and scientific opportunities coincide. Nearly 55 years ago, the NIH identified research on coronary heart disease as an important health priority. This disease is caused by atherosclerosis, the build up of lipids (fatty substances) in the heart's main arteries, which can block blood flow and thereby cause the death of heart tissue — that is to say, a heart attack. Progress in this area was slow at first, but then scientists began to associate lipids (such as cholesterol, carried in the blood) with the development of atherosclerosis in humans. In the early 1960s, research on the NIH Bethesda campus led to a way of classifying various types of lipid abnormalities in families. This work led to meaningful associations between variations in lipid metabolism and atherosclerotic heart disease. In addition, through carefully planned, long-term epidemiologic studies (studies of the occurrence and distribution of disease in large groups of people), the understanding emerged that risk factors such as blood cholesterol levels and cigarette smoking, as well as high blood pressure (which was recognized much earlier as a predictor of premature death) can make people susceptible to disease. Identifying scientific opportunities in basic, clinical, and epidemiological research on lipid metabolism has resulted in phenomenal progress in understanding the underlying processes that lead to atherosclerosis, as well as its prevention and treatment.
For example, benefits from this research include the development of cholesterol-lowering drugs and prescriptions for changes in behavior (less dietary fat, no smoking, more exercise), with a dramatic decrease in age-adjusted mortality from heart disease as a consequence. Still, many challenges in coronary heart disease remain. Future targeted areas of research include an analysis of why cholesterol accumulates in artery walls and ways to facilitate its removal, and prevention of the accelerated form of atherosclerosis which causes between 30 and 40 percent of grafts to become narrowed again after bypass surgery. Capitalizing on scientific opportunity depends, in part, on individual scientists designing specific research projects they believe have the greatest significance and offer the best chance of producing important knowledge. Therefore, the NIH places great reliance on investigator-initiated research — projects conceived by individual scientists and submitted to the NIH to undergo review by other scientists and be considered for funding. Sometimes, the NIH solicits research applications through Program Announcements (PAs) and Requests for Applications (RFAs), as described in more detail later in the booklet. Review for scientific merit is conducted by groups of predominantly non-government scientists (with knowledge in a relevant area) convened as panels called study sections. Currently, there are about 125 study sections, which normally meet three times a year to review grant applications. The merit of a research proposal is assessed by several criteria, including: the importance of the problem or question; the innovation employed in approaching the problem; the adequacy of the methodology proposed; the qualifications and experience of the investigator; and the scientific environment in which the work will be done. Currently, slightly more than one in three grant applications received by the NIH is ultimately funded. (See figure 2) In addition to judging the scientific merit of individual research grant applications, the study sections, in aggregate, have another important effect on the science supported by the NIH. After each study section reviews and rates the grant applications assigned to it by NIH staff, the relative ratings of applications from all study sections are then integrated. Because, for the most part, grants are funded in order of their rating relative to other applications in the same field, the fact that a study section has been constituted in a particular area usually guarantees that at least some applications in that area of science will be funded. Because of this effect, the NIH must monitor changes occurring in science to ensure that study sections, as groups, are appropriately constituted so that they can assess the research applications in all areas of scientific endeavor. The creation of new study sections, the restructuring of established study sections, and the use of special panels has such an important effect upon the areas of science funded by the NIH that any proposed changes of the study sections are carefully evaluated.
Each of the 27 Institutes and Centers, has a separate annual budget from the Congress and, most critical to the question of priorities, a mission established by the Congress. To decide which grants to fund and which programs to support in terms of its mission, the director of each Institute confers with the Institute's program leaders. Like the director, they are scientists knowledgeable in research relevant to the Institute's mission and responsible for administering that area of research. The director also confers with members of the Institute's national advisory council (as mandated by the Congress), which meets three or four times a year to review all grant applications eligible for funding (after peer review) and to make recommendations on matters of policy and research emphasis. The council, which is composed of both scientific and public members with expertise relevant to the Institute's mission, may also make recommendations to the Institute director about funding particular, meritorious grants that are seen as very important but which may not have received the best scores from scientific reviewers. The council may also review and comment on special initiatives proposed by the Institute or, for example, on research training policies. The director engages in discussions with scientists in the extramural program and intramural investigators, with groups of patients and their families interested in research on particular diseases, with professional and scientific groups, with representatives of the Administration and members of Congress, and with the public. (See figure 3) Directors seek advice on many issues, including:
Funding the highest quality science. Research projects emerge from the creativity, skill, and knowledge of extramural scientists who submit grant applications to the NIH. These are reviewed by panels of scientists who are expert in the proposed field of research. Intramural scientists are also peer reviewed by special groups called Boards of Scientific Counselors, consisting of scientific experts chosen mainly from outside the government (see section on the Intramural Research Program). Thus, it is the highest rated projects that form the backbone of the science funded by the Institutes and by the NIH as a whole. The outstanding ideas of scientists objectively rated for their own merit and against publicly stated criteria, like those listed in the previous section, guide the funding decisions of the NIH. Creating research opportunities. Although funding is usually determined by the scientific merit of research applications, an Institute may determine that an area of research is of such great promise that funding is provided even if the grant application does not have as high a relative rating as other applications. Only the Institute director has the authority to make this decision and it requires his or her awareness of the whole picture of the Institute's mission. The Institute director may determine that some laboratory research areas are in need of greater attention and require more funding or that some areas are prepared for translating laboratory or animal studies to patients in clinical research studies. The Institute director discusses these decisions with council members (and others) before funding this research. The Institutes may also collaborate on common research interests or to advance certain topics of research. For example, both the National Institute of Neurological Disorders and Stroke and the National Heart, Lung, and Blood Institute are interested in stroke, and osteoporosis is of interest to five Institutes (the National Institute of Arthritis, and Musculoskeletal and Skin Diseases, the National Institute on Aging, the National Institute of Dental and Craniofacial Research, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Child Health and Human Development). Each Institute brings a different perspective and expertise to an issue, so their collaborations encourage a multi-disciplinary approach to research problems. Sometimes, Institutes co-fund research projects that are important to the mission of each. The Institutes sometimes also co-fund research programs with agencies outside the NIH when a scientific opportunity is promising for both agencies. For example, the National Cancer Institute has collaborated with the Department of Defense on breast cancer studies, and the National Heart, Lung, and Blood Institute has worked with the Centers for Medicare & Medicaid Services, formerly known as the Health Care Financing Administration, on clinical trials of lung reduction surgery in the late stages of emphysema. The Intramural Research Program. Ideas from outside the NIH also influence research choices. For example, in 1971 President Nixon signed the National Cancer Act, making cancer research a national priority. The Congress, responding to constituents, has also influenced NIH priorities by occasionally identifying research areas that the Institutes should consider more intensely. The Institute directors meet with congressional members and staff throughout the year, and formally during the annual budget hearings, to discuss the research advances of each Institute during the past year and describe their plans for the next. Through both the Administration and Congress, as well as through patient advocacy groups, the public influences the Institutes' decisions. In addition, the national advisory councils set up by each Institute and other NIH advisory committees include members specifically designated as "public" representatives. After the publication of the first edition of this booklet in 1997, an Institute of Medicine report suggested that the public input to the NIH's activities should have a more formal presence. In response, the NIH created the Council of Public Representatives (COPR and pronounced "copper"), a forum for discussing issues affecting the broad development of NIH policy and research programs with the Director of the NIH. The 20 men and women who serve on COPR are diverse in age (from their 20s to their 70s), geography, and ethnicity. All have some personal or professional association with physical or mental disease as patients, advocates, scientists, volunteers, public officials, students, or academics. They have raised important issues for the NIH, including establishing models for public participation in NIH activities, patient access to clinical trials, and health disparities among various populations, among others. COPR normally meets twice a year, with telephone conferences as needed, and the members serve overlapping terms to promote continuity. Proposals and opinions from scientists, the Congress, the Administration, and the public assure that the Institutes establish their priorities in the light of many views. Ultimate responsibility for the allocation of financial and other resources of an Institute rests with the Institute director. After careful evaluation of all of the factors described above, the Institute director determines how and where the Institute's resources will be distributed.
Though each Institute within the NIH determines how it will deploy its talent and funds, the NIH Director plays an active role in shaping the agency's activities and outlook. With a unique and critical perspective on the whole of the NIH, the Director is responsible for providing leadership to the Institutes and for constantly identifying needs and opportunities, especially for efforts that involve multiple Institutes. The Director stays in touch with each Institute's priorities and accomplishments through regular senior staff meetings, discussions with scientific interest groups (scientists who have interests in a specific area and can provide guidance in answering scientific questions), and briefing sessions with Institute directors. The Director also seeks advice from special panels of experts convened to address issues that are of interest to more than one Institute, e.g., reviews of NIH support of research relevant to human gene therapy, the NIH investment in clinical research, the operation of the NIH intramural research program, and the effectiveness of the NIH peer review procedures. In addition to this flow of information from scientists, the Director is advised through discussions with the Administration, usually through the Department of Health and Human Services (DHHS), and with the Congress. Within the NIH, the NIH Director is primarily responsible for advising the President on his annual budget request to Congress on the basis of extensive discussions with the Institute Directors. The formulation and presentation of the NIH budget provides an established framework within which priorities are identified, reviewed, and justified. A key strategy of the NIH Director in the past few years is the identification of Areas of Research Emphasis, broad categories of NIH-sponsored research that show extraordinary promise and productivity. Each year, the NIH Director requests proposals from the Institutes for areas of research that would benefit from special emphasis. Five broad areas of emphasis have been identified for fiscal year 2000; "Eliminating Health Disparities," "Exploiting Genomic Discoveries," "Reinvigorating Clinical Research," "Neuroscience Research," and "Biomedical Computing." The Institutes are encouraged to develop new initiatives within these Areas of Research Emphasis and to respond to emerging health needs through both inter- and intra-Institute efforts. The NIH Director uses these proposals to build the President's budget in order to ensure that new initiatives are meritorious and timely and that budget increases are used to capitalize on recent scientific developments. The Director has two additional tools to identify and fund NIH research efforts. First, the Director may, following a clearly defined process, transfer up to one percent of the total NIH budget among Institutes. Second, the Director has a Discretionary Fund. Both are used to jump-start particularly exciting or urgent areas of research:
Program offices in the Office of the Director are also responsible for enhancing some of the cross-Institute coordination of, for example, disease prevention, rare diseases, women's health, and behavioral and social science research. Another program office is the Office of AIDS Research, which has been given broad legislative authority to plan, coordinate, evaluate and budget all NIH AIDS research. Many other diseases under study at the NIH require the input of more than one Institute. While the Institutes themselves enjoy close collegial relationships and employ a number of mechanisms to foster their collaborations, the NIH Director has a unique overview of the range of endeavors across the entire NIH. The Director thus can influence all the Institutes to focus on matters of importance to them all and to the nation's health.
All of the activities described here have the common purpose of informing the NIH of scientific opportunities and of important needs in public health. Recognizing needs — and establishing priorities among them — stimulates the most promising medical research and advances our knowledge. The continuing dialogue between the public and scientists ensures a system that is both stable and responsive — a system that effectively and efficiently meets its goal to improve the nation's health through medical research.
Appendix:
Institutes and Centers of the National Institutes of Health*
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