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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? CHAPTER 1 MISSION AND PURPOSES OF THE NIH INTRAMURAL PROGRAM The mission of the National Institutes of Health (NIH) is described as “to improve the health of the nation by increasing the understanding of processes underlying human health, disability, and disease, advancing knowledge concerning the health effects of interaction between man and environment, and developing and improving methods of preventing, detecting, diagnosing, and treating disease” (NIH, 1986a). To accomplish this mission, several elements have been put in place, including programs to support basic and clinical biomedical research in universities, hospitals and research institutions; programs to support research training, and programs to communicate information to scientists, health care practitioners, and the public. The intramural program complements these functions, having a distinctive role within the overall NIH program. Its contributions stem from special characteristics including an environment that encourages research unlikely to provide quick pay-offs, and a capacity to provide a meaningful response to national health emergencies. The Institute of Medicine (IOM) committee undertook a review of the mission of the intramural program for two reasons. First, the issue of privatization required consideration of whether the role of the intramural program could be achieved within a greatly altered institutional framework. Second, it was important to understand the related question of the appropriate contemporary role of the intramural program with regard to a national research environment that has changed radically in the course of the program’s life. Changes in the overall environment for biomedical research have been especially rapid in recent decades. They have occurred not only in the nature of the science being pursued and the speed of scientific change, but also in the number of scientists and institutions engaged in the pursuit of new biomedical knowledge. Consideration of the mission of the intramural program can lead to a discussion of the characteristics of the program. This is because, to many observers, it is the particular assembly of the characteristics of the program that create its distinctive place in biomedical research. The intramural program and the other major participants in biomedical research—universities, independent research institutes, and industry—have overlapping purposes, often conduct similar types of work in facilities that may resemble one another, and draw from the same employment pool. In the following sections we will describe the characteristics of the intramural program, not because they are individually unique, but because together they enable the program to fulfill its purpose.
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? Role as a Government laboratory The government has as one of its functions to provide needed products and services that the private sector cannot or will not do. Although federal money flows to other participants in biomedical research, only the intramural program is both totally federally funded and staffed with employees who work directly for the government. This confers both advantages and obligations. The major advantage derives from financing that does not depend on discrete, time-limited grants or contracts awarded on a competitive basis. As a result, scientific projects can be long-term and resource managers can use more flexible criteria and individual judgment in resource allocation decisions. As a government laboratory, the NIH intramural program is obliged to respond to congressional requests and national priorities that affect its scientific agenda. In practice, although Congress allows the program managers great discretion in establishing research priorities, there is a continuing, but beneficial tension in the appropriate balancing of congressional and scientific imperatives. The Environment The environment for science that has been created on the NIH campus enables the intramural program to pursue its goals. The importance of this setting has been recognized by many observers. The President’s Biomedical Research Panel in 1976 described the program as: “An outstanding setting for a combination of clinical and basic research experience for promising young scientists and physicians by virtue of access to an innovative research hospital that facilitates the freest communication between laboratories and clinics and between creative investigation and practical application—it includes an extraordinary diversity of scientific competence that provides unique opportunities for interchange and collaboration; the opportunity for concentration of research without a requirement for teaching or health care service; and excellent, although diminishing resources” (Report of the President’s Biomedical Research Panel, 1976). Twelve years later this IOM committee heard similar sentiments both from witnesses at its public hearing and from scientists in the intramural program. Undoubtedly, the environment plays an important role in attracting scientists to the intramural program—and is for some scientists the only setting with the freedom they need to perform creative research. The environment also plays a part in generating good science. The ability to initiate and conduct collaborative work quickly and effectively, the ease of communication across disciplines and institutes that is increasingly
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? important as scientific disciplines more often use overlapping techniques and knowledge, all contribute to the quality work at intramural NIH. In addition, the existence of clinical research beds in close proximity to basic scientists encourages an increasingly important interaction between laboratory and clinical science. The existence on the campus of a critical mass of scientists allows an interchange of ideas that facilitates collaborative research. The committee considered whether the loss of any substantial part or major characteristic of the intramural program would undermine the program’s capacity to fulfill its missions. The committee decided, for example, that a clinical research center without basic research labs would undermine a synergy and scope that is difficult to duplicate elsewhere, and that there would be a diminution in the productivity of those who work in both areas. The committee also decided that making funding of projects fully competitive with extramural grants would decrease the ability of the program to undertake long-term research and respond to identified national needs. Reducing training opportunities would interfere, the committee believes, with efforts to encourage bright graduate students to commit themselves to a career at NIH. Research Training The intramural program has historically played an important role in training scientists in both basic and clinical research. This educational mission is accomplished through postgraduate programs for M.D. and Ph.D. scientists. There are a variety of fellowship programs available for domestic and foreign researchers. Major domestic programs include Staff Fellowships, Senior Staff Fellowships, Epidemiology Staff Fellowships, Medical and Dental Staff Fellowships, Intramural Research Training Award Fellowships, and National Research Service Award Fellowships. Major programs for foreign trainees include: the Visiting Fellowships, Visiting Associates, and Visiting Scientists Programs. Programs are available for those who show little or no postgraduate experience (Staff Fellows, Visiting Fellows, Intramural Research Training Awards [IRTAs], and Medical Staff Fellows), ranging to programs for those with 3–6 years of postdoctoral experience (Senior Staff Fellows, Visiting Associates, and Visiting Scientists). Today, more than 2,150 U.S. and foreign fellows (1300 of whom are in a tenure-track type position) are receiving training and conducting research at the intramural laboratories of NIH. In addition to receiving valuable research training, this group represents over 50 percent of NIH’s scientific workforce. It provides an important pool from which the intramural program recruits scientists for permanent, tenured positions. Since the inception of the intramural research program, 25,000 M.D.s and Ph.D.s have received their training at NIH (NIH, 1988). A recent survey of the membership of the American Society for Clinical
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? Investigation (ASCI), showed that approximately one-third of its membership had, during the last three decades, receives a portion of their research training at NIH (Intitute of Medicine, unpublished data, 1988). The alumni of the various intramural fellowship programs are now among the leaders in academic medicine and biomedical research. The committee supports the commitment of the intramural program to the education of research scientists. The multidisciplinary mass of scientists on the campus provides a distinctive environment for biomedical research training—an environment that is not fully duplicated in any other setting. It is important that the intramural program continue to develop new generations of researchers for biomedical science generally as well as for the future leadership of its own laboratories. The committee believes that the greatest strength of intramural training relative to other training locations is at the postdoctoral level. Although pre-doctoral education offered on the NIH campus (including the program of the Howard Hughes Medical Institute, which shows promise in attracting bright medical students to research) is valuable, to make the best use of the resources of the intramural program, continued concentration on postdoctoral training is advisable. Basic and Clinical Research The 1953 opening of the Clinical Center on the NIH campus added a new dimension to the intramural program—a large capability for patient-related research in close proximity to basic research laboratories—and brought to the campus a new complement of physicians as well as other professionals and staff needed to run a research hospital. In 1986, the 540-bed Clinical Center, with the Ambulatory Care Research Facility, which opened in 1981, admitted nearly to 9,000 patients and was the site of more than 145,000 outpatient visits (NIH, 1987). Numerous characteristics of the Clinical Center set it apart from other locations for clinical research. The most obvious are its almost complete devotion to research and its size, which by far exceeds any other clinical research center. The average size of the extramural units in the General Clinical Research Centers Program of the NIH is only 8 beds, ranging in size form 3 to 27 (NIH, 1986b). Another difference between the Clinical Center and extramural clinical research centers is that the patient is not billed for services in the Clinical Center and there are no financial pressures for early discharge. Rather, the length of hospital stay is determined by research needs. All support services, such as laboratory and radiology are structured to foster research as well as service objectives. Patient recruitment is national and international, enabling work on rare disorders for which it is difficult to assemble a patient base of sufficient size. The physical structure of the center is designed to facilitate cooperation and interchange between bench and bedside medicine, and access to the wide range of clinical and basic scientists on campus facilitates cross-disciplinary advice and collaboration.
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? By virtue of its size and organization, the clinical research component of the intramural program plays a vital role in the national research effort—the 540 beds at the Clinical Center represent approximately half the nation’s dedicated clinical research bed complement. Moreover, the importance of bedside clinical research in the intramural program is increasing as financial pressures on teaching hospitals mount. These hospitals cannot afford to subsidize empty or under-funded clinical research beds. As cost containment pressure builds, these hospitals may have fewer opportunities to subsidize clinical research. The Application and Communication of Research The justification for the government investment in biomedical research rests ultimately on the extent to which, in the long run, the health and quality of the life of the people of the United States are improved. This does not detract from the value of undirected basic research for which potential application is difficult to foresee. Rather, it argues that taken as a whole and over the long run, the nation must benefit from the investment. For this to occur, those who use the knowledge (most often medical practitioners) must be able to learn about it in a timely and reasonably easy manner. And, the organizations that develop and bring to market the results of research (most often the pharmaceutical and biotechnology industries) must have access to basic research findings. It is also important that the government research investment is used efficiently in terms of differentiating between what is most appropriate to a federally funded laboratory and what to industrial laboratories. This committee believes that the mission of the intramural program was founded on its role in developing an understanding of basic disease mechanisms and facilitating the transfer of this knowledge to improve patient care. An important, informal mechanism for the dissemination of information has developed through a network of scientists in industry and elsewhere who trained or spent some part of their career in the intramural program and continue an informal connection. In general, the responsibility of the intramural program ends with technology transfer to academia, health care, and wherever else further applied research and development activities may be conducted. To bolster the informal flow of ideas, the government acted to encourage the smooth and rapid transfer of technology through the provisions of the Stevenson-Wydler Technology Innovation Act of 1980 (P.L. 96-480) and the Federal Technology Transfer Act of 1986 (P.L. 99–502). The first of these laws requires federal laboratories to establish an office to identify discoveries with potential commercial application. The second allows government laboratories to enter into cooperative research agreements with other organizations, including businesses, and allows some royalty payments to researchers for use of their patents.
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? Communicating research findings to physicians in a rapid and responsible way is essential to ensure that benefits are derived from research in the intramural program. This is a responsibility that NIH shares with all institutions conducting biomedical research. The pharmaceutical industry, for example, has an extensive network designed to bring new products to the attention of the practicing physician. At NIH, as elsewhere, scientific status in part depends on publication in the most respected and widely used professional journals. In addition, NIH as a whole has become increasingly committed to the need to expand its communications with the public and the medical profession. In 1975, the Journal of the American Medical Association (JAMA) started publishing “Notes from the NIH,” which reported research applicable to clinical practice. A lecture series on “Medicine for the Laymen” was initiated. Public education efforts include pamphlets on a wide range of topics, and Consensus Development Conferences produce statements that interpret findings of clinical trials and evaluates treatment methods (Harden, 1986). Long-Term Research Many characteristics of the NIH intramural program are conducive to productivity in research. Some of these were described to the committee as three freedoms—freedom to choose research topics without being restricted to the subject for which grant funding was obtained; freedom to devote all working hours to research; and freedom from the need to develop “grantsmanship” skills (Schaechter, 1988). These freedoms make the intramural program a favored locus for some of the nation’s most talented biomedical scientists and provide an environment more conducive than most to long-term research. Long-term research conducted at the intramural program has paid off—in work on protein structure and function, neurotransmitters, and the “slow virus” work that was undertaken with the realization that it might take many years after primates were injected before evidence of disease could be detected. Although today some other institutions relieve scientists of competitive pressures and are tolerant of work that may take years to become productive, the committee believes that the intramural program continues to have a major role in fostering these areas of research. The Intramural Program in Relation to the Extramural Program The coexisitence of the intramural program and extramural grants administration under the same overall control and in the same location is felt by many to be an important characteristic of NIH. The benefits of this arrangement include, in some institutes, the ready availability of active scientists to provide advice to administrators of the extramural program, and the availability of a pool of scientists who, when ready
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? to leave the bench, can bring their skills and experience to extramural grants and contracts administration. In the best of circumstances, the two programs can be thought of as complementary or collaborative efforts. In practice, the administration of extramural grants is kept at arms length from the intramural program in order to avoid conflicts of interest due to intramural scientists working in areas of research that are the topic of specific grants. Furthermore, the institutes, with the exception of NCI, separate the intramural program from the extramural program administratively, typically having a scientific director responsible for the intramural program and a deputy director in charge of the extramural program. The NCI differs from the other institutes in that each director of its four divisions is in charge of both extramural and intramural affairs. However, there are provisions to avoid conflict of interest between intramural and extramural in the review of grants. This closer association between the two programs is thought to allow more integrated scientific program planning and is enthusiastically endorsed by leaders at the NCI. There are differences of opinion about how the programs should relate to each other. The committee believes that an examination to determine the optimum structured relationship was beyond the scope of this study. The committee heard differing views on the importance and benefits of having the intramural and extramural program together at NIH. And the members of the committee also differed in their perception of the importance of the relationship. However, committee members who were unconvinced by those who argue that the linkage is vital to the welfare of the programs felt that if a belief is so strongly held it may entail intangible benefits worth preserving. The committee therefore concluded that if an organizational model under consideration for the NIH requires the separation of the intramural program from the extramural program, very important benefits would have to occur to overcome the losses that might be associated with such a separation. Conclusion Historical circumstances have created in the NIH intramural program a center that serves the nation well. The committee believes that institution-building is a precarious task in the sense that new institutional forms are far easier to contemplate than to build. The committee concluded that for the next decades, all the major components of the current program are essential in providing an environment that can fulfill the purposes of the intramural program. This does not mean that all elements of the current program reflect an adequate level of vitality or accomplishment. Adaptation through selective change will always be required in order to sustain the vitality of the program. But the full implications of any change that would divorce constituent elements from the whole must be carefully scrutinized.
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? In reasserting some of the traditional purposes of the intramural program and confirming firming the importance of some of the characteristics of the program, the committee does not want to imply that the intramural program should be preserved as an unchanging entity. Rather, the managers of the program may need flexibility to adapt and preserve what is essential to accomplish the program’s missions.
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A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? Chapter 1 REFERENCES Harden, V.A. 1986. Inventing the NIH: Federal Biomedical Research Policy, 1887–1937. Baltimore: The Johns Hopkins University Press. National Institutes of Health. 1986a. Biennial Report of the Director, NIH. Volume 1. Bethesda, MD: NIH. National Institutes of Health. 1986b. General Clinical Research Centers. A Research Resources Directory. Sixth Revised Edition. NIH Publication No. 87–1433. Bethesda, MD: NIH. National Institutes of Health. 1987. NIH Data Book. Prepared by the Office of Program Planning and Evaluation and by the Division of Research Grants. Bethesda, MD: NIH. National Institutes of Health. 1988. The Nation’s Commitment to Health Through Biomedical Research—The NIH, the NIH Intramural Research Program and the Pursuit of Scientific Excellence. White Paper prepared for the Institute of Medicine Committee to Study Strategies to Strengthen the Scientific Excellence of the NIH Intramural Research Program. Bethesda, MD: NIH. Report of the President’s Biomedical Research Panel. 1976. Submitted to the President and the Congress of the United States. U.S. Department of Health, Education, & Welfare Publication No. (OS) 76–500. Washington, D.C.: USDHEW. Schaechter, M. 1988. Testimony presented before Institute of Medicine Committee to Study Strategies to Strengthen the NIH Intramural Research Program. June 13, 1988. Photocopy.
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