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1 Introduction By any measure, the National Institutes of Health (NIH) is an important com- ponent of a vast international humanitarian enterprise aimed at a better understand- ing of human health, prevention and relief of the burdens of disease, and promotion of good health throughout the stages of life. It is an optimistic endeavor predicated on the belief that human life can be improved through scientific investigations coupled with the rational and ethical applications of their findings. It is an enter- prise full of moral relevance because it contributes to the interests of current and future generations and to the commitment to reduce health disparities. In Democracy in America (~1835), French statesman Alexis de Tocqueville wrote of what he perceived as the peculiarly American pursuit of good health. Although achieving that goal remains elusive for many Americans, since the middle l900s the US government has invested generously in biomedical research,] believing that such activities would have great long-term benefits for the health of American citizens and others. There is broad agreement among the American people, Congress, and the Executive Branch that investing in biomedical research is socially desirable because of its health benefits, its capacity to increase understanding of the human condition, and its potential to directly or indirectly yield economic dividends. The assumption that federally funded scientific research generates economic and other benefits for the country has been fundamental to US science policy since the end of 1Biomedical research in this report includes all the following categories of research: fundamental (basic), applied, behavioral, bioengineering and biotechnology, clinical, dental, health, health services, nursing, outcomes, population-based, prevention, public health, rehabilitative, and therapeutic. 17

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18 Enhancing the Vitality of the National Institutes of Health World War II (Bush, 19451. As Donald Stokes pointed out in Pasteur's Quadrant (1997), the American public deeply values such investment in science "not only for what it is, but what it's for." The investment in human health improvement has paid handsome dividends. Age-adjusted rates of heart disease and stroke continue to decline, there has been a modest but encouraging decrease in cancer death rates, life expectancy continues to rise, infant mortality rates are falling, and the field of genomics has advanced to the point where promising new therapeutic agents are under development by biotech- nology and pharmaceutical companies. The knowledge gained from biomedical research and the large cohorts of highly trained biomedical scientists continue to be among the nation's most valuable resources. Nevertheless, new public health con- cerns, chronic illnesses, emerging or re-emerging infectious diseases, and persistent health disparities constitute continuing challenges for our biomedical and health care research enterprise. For nearly 65 years, the federal agency primarily responsible for sponsoring and conducting biomedical research has been the NIH. NIH is one of eight agencies of the Public Health Service (PHS), which is part of the Department of Health and Human Services (DHHS).2 NIH accounts for about 80% of federal funding of biomedical research and development (R&D); the Department of Defense (DOD) is the second largest supporter, at 6% (NIH, 20021. Since its formation, Congress and the Executive Branch have supported steady increases in NIH's budget. NIH is the largest public source of funding for biomedical research in the world, with an annual budget of about $27 billion. In early 2003, Congress approved an FY 2003 budget containing a 16% increase over the previous year that completed the planned 5-year doubling of NIH's budget. NIH, by most accounts, has long been considered one of the most effective and well-managed elements of the federal government and a centerpiece of its R&D system. From one categorical institute at the end of World War II, it has evolved into a federation of 27 major institutes and centers as of 2003 (see Chapter 2 for further discussion), each conducting and sponsoring research and related activities on aspects of human health and disease through grants and contracts to scientists in universities and other nonfederal research institutions. To ensure its continued effectiveness, NIH must respond in a rapidly changing environment that is characterized by a renewed appreciation of the complexity of human biology; the increasing need for cooperation among biomedical and related disciplines and scientists working in different sectors; growing investments in bio- medical research by the US corporate sector and other countries; the need to deal 2The other seven are the Agency for Healthcare Research and Quality, the Agency for Toxic Sub- stances and Disease Registry, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration.

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Introduction with new institutional arrangements in the broader scientific enterprise that generate additional incentives, conflicts, and constraints; and developments on the scientific frontier that, for example, require changes in the technologies used, the organiza- tion of research teams, and the active engagement of participants in clinical research. Equally important are the effective management of the rapidly expanded NIH budget and the challenge of managing the many organizational components of NIH- . . ,,. Institutes, centers, anc offices. ONE IMPETUS FOR THIS REPORT A persistent subject in discussions about the organization and future of NIH is the continued growth in the number of institutes, centers, and other programmatic and organizational components that have been mandated by congressional initiative in response to the demands of various interest groups. Several NIH directors have raised concerns about such growth. Former Director Tames Wyngaarden, in con- gressional testimony arguing against the creation of another institute in 1982, pointed out that "there is virtually no end to the possibilities for creation of addi- tional categorical institutes." From a scientific viewpoint, Wyngaarden noted the mismatch between the categorical structure of NIH and trends in research toward investigating the basic life processes that underlie all health and disease and away from the symptoms of specific diseases in isolation. From a managerial point of view, Wyngaarden raised the question of whether organizational complexity tends to be counterproductive (U.S. Congress, 19811. Harold Varmus, the most recent NIH director to suggest that the agency is becoming unmanageable through continued proliferation, opposed the establish- ment of NIH's two newest units, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the Center for Minority Health and Health Disparities (NCMHD). He argued that establishing program coordination units in the director's office was preferable to creating new institutes and centers for cross-cutting fields (such as bioimaging) that should not be isolated as separate entities. He also expressed a disinclination to add to the number of units that have to be managed.3 Although he began to raise the issue in various forums during the last years of his tenure as NIH director (Dennis, 1999), Varmus laid out his analysis and pro- posed solution most fully in an article published in Science (Varmus, 2001) after his departure from NIH. He acknowledged the political advantages of establishing new institutes and centers but argued that NIH would be more effective scientifically and more manageable if it were organized into a far smaller number of larger institutes 3For example, congress recommended that NIH establish an office of sioimaging and sioengineering' an idea that former NIH Director Harold varmus welcomed. However, varmus cautioned that estab- lishing a new Institute of sioengineering and sioimaging was not a good idea because such activities benefit more by being distributed among the full range of institutes and centers at NIH (NIH, 1999). 19

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20 Enhancing the Vitality of the National Institutes of Health organized around broad fields of science.4 Consolidating the existing institutes into five entities "would organize the science in a rational way" (Dennis, 1999~. Others, including many biomedical investigators, argue that at the current time the elimination of institutes, centers, or offices that focus on particular sets of problems would mean that research on the problems would not receive sufficient attention and funding and that a consolidation of units would reduce congressional and public support. Those arguments were put forth by many of the organizations and individuals that wrote or spoke to the committee. Moreover, there is a percep- tion that given the substantial increases in resources and the vast expansion of the biomedical enterprise, the addition of institutes and centers has provided for the expression of a broader set of priorities and expanded political support and budget success both for the specific interests involved and for NIH in the aggregate. While everyone understands that this expansion cannot and should not continue indefi- nitely, many see no particular difficulty with the current number of institutes and centers. Many of the arguments against the formation of additional institutes and cen- ters have focused on the adverse managerial and programmatic consequences at the NIH level (the opposite of the arguments for new institutes that stress the beneficial consequences of having one institute focused on a disease category or set of related problems) the likelihood that a new institute or center will increase the share of the budget going to overhead because each institute has a director, senior staff, and administrative units, although some of these would be needed even if the program were kept or established in an existing unit. Other arguments against adding institutes have had substantive grounds. In particular, there has been recurrent concern that adding an institute in a particular field could dilute, rather than concentrate, efforts in it. For example, many were concerned that the new NIBIB would reduce the commitment of other institutes to important opportunities in biomedical imaging and bioengineering. The same argu- ment was made against creating the separate NCMHD: there was concern that establishing such a center would lead other institutes and centers to decrease their commitments to work in minority health. 4In 2001, varmus proposed a redistribution of NIH into six units of approximately equal sizes and budgets. Five of these would be categorical institutes, committed mainly to groups of diseases the National cancer Institute, the National Brain Institute, the National Institute for Internal Medicine Research, the National Institute for Human Development, and the National Institute for Microbial and Environmental Medicine. Each of these would contain several major divisions for extramural research and an intramural research program. Each would also house offices to coordinate research training, international science, minority and women s health, and other activities, both within and among the five institutes. The sixth unit, NIH Central, would be led by the NIH director, to whom the directors of the five institutes would report. NIH Central would have responsibility for policies across NIH (e.g., on intellectual property, personnel management, or training programs), the peer-review process, scientific infrastructure (e.g., information technology, buildings and facilities, including the intramural Clinical Research Center), and thematic coordination (through links to the offices in each of the five institutes).

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Introduction All institutes and most centers are legislatively mandated, receive their own funding, and enjoy a constituency base that, given other characteristics of NIH's environment, can reduce the organizational flexibility that less federated organiza- tional structures give industry and many other government agencies, such as the National Science Foundation (NSF). In addition, as the number of institute and center directorships has increased, the recruiting and administrative burden on the NIH director has become substantial. Although some argue that NIH is becoming unmanageable, others believe that this is not the case and that substantial consolida- tion might not be programmatically desirable or politically feasible. In fact, some believe that the complex decentralized organization developed over the years has made NIH more effective in responding to research opportunities and public needs and aspirations and is an important source of its success (Congressional Budget Office, 20021. In addition to the issues surrounding the proliferation of units, recent changes in biomedical science and how it is conducted may also raise questions beyond the narrow matter of the number of components in the organization. For example, research is becoming more interdisciplinary, more dependent on a common set of research tools and technologies (including costly large-scale infrastructure, such as supercomputers and imaging machines), and more focused on fundamental processes that underlie many diseases.5 Many of those developments increase the benefits of a strategic and coordinated effort among institutes and centers in some fields and may call for a more strategic NIH-wide approach to emerging challenges than has been traditional at NIH. Those emerging opportunities do not necessarily argue for a reduction in the number of units at NIH so much as for a change in the qualitative nature of the work conducted and the depth and breadth of interactions among the units. Other trends also have caused some to believe that a review of the organiza- tional structure of the agency is necessary. For example, demographics and patterns of illness in society are changing and investment by the private sector is growing, which has altered the terrain of some areas of research in a manner that could call for an adjustment in the role of NIH within the broader biomedical enterprise. Pharmaceutical and biotechnology companies now spend more than NIH on research and development well over $46 billion per year (Pharmaceutical Research and Manufacturers of America, 2001; Biotechnology Industry Organization, 20031. In addition, the Bayh-Dole Act (PL 96-517, Patent and Trademark Act Amend- ments of 1980) created a uniform patent policy among the many federal agencies that fund research, enabling small businesses and nonprofit organizations, including universities, to retain title to inventions made in federally funded research pro- grams, thereby creating a new congressionally mandated responsibility of NIH to 5These trends have been cited by NIH leaders. See, for example, the remarks of Director Elias Zerhouni at a field hearing held by a subcommittee of the House Science Committee (Jenkins, 2002a) and presentations by Acting Director Ruth Kirschstein (Kirschstein, 2001; Haley, 2001). 21

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22 Enhancing the Vitality of the National Institutes of Health . further technology transfer and commercialization of its research results by the private sector. As a result of the steady stream of change, there have been persistent and growing concerns in Congress and in some parts of the scientific community about whether NIH has become too fragmented to address effectively the most important biomedical and health challenges or to respond quickly enough to health emergen- cies or economic challenges. Despite those persistent concerns, NIH has never been administratively reorganized in any substantial way, but only added to, despite vast changes in the landscape of science and the nation's health concerns during the last half century. CONGRESSIONAL REQUEST AND STATEMENT OF TASK In report language that accompanied the FY 2001 appropriation act, Congress directed NIH to have the National Academy of Sciences study "whether the current structure and organization of NIH are optimally configured for the scientific needs of the twenty-first century."6 Senate report 106-293 states: The Committee is extremely pleased with the scientific advances that have been made over the past several years due to the Nation's support for biomedical research at NIH. However, the Committee also notes the proliferation of new entities at NIH, raising concerns about coordination. While the Committee continues to have confidence in NIH's ability to fund outstanding research and to ensure that new knowledge will benefit all Americans, the fundamental changes in science that have occurred lead us to question whether the current NIH structure and organization are optimally configured for the scientific needs of the Twenty-first Century. There- fore, the Committee has provided to the NIH Director sufficient funds to under- take, through the National Academy of Sciences, a study of the structure of NIH. In response to the congressional request, the goal of this study was to determine the optimal NIH organizational structure, given the context of 21st century bio- medical science. The following specific questions were to be addressed: 1. Are there general principles by which NIH should be organized? 2. Does the current structure reflect these principles, or should NIH be restruc- tured? a. If restructuring is recommended, what should the new structure be? 6HRpt 106-1033, "Conference Report to Accompany H.R. 4577 - Making Omnibus Consolidated and Emergency Supplemental Appropriations for Fiscal Year 2001," December 15, 2000, endorsed the language in the Senate report calling for the NAS study of the NIH structure and asked for a report within a year of the appointment of the new NIH Director. See SRpt 106-293, "Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriation Bill, 2001," May 12, 2000.

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Introduction 4. How will the proposed new structure improve NIH's ability to conduct biomedical research and training, and accommodate organizational growth in the future? 5. How would the proposed new structure overcome current weaknesses, and what new problems might it introduce? The Committee on the Organizational Structure of the National Institutes of Health was formed to ensure that the views of the basic science, clinical medicine, and health advocacy communities were all adequately represented. The Committee also included persons who were experienced in the management of large and complex organizations, including a former NIH director, two former NIH institute directors, a former university president, two individuals with backgrounds as senior managers of major industrial entities, and a specialist in organizational issues. Several Committee members also had considerable experience in government operations. The Committee held six 2-day meetings over the 10 months between July 2002 and April 2003. In its initial meetings it invited past and present representatives of Congress, NIH, voluntary health groups, scientific and professional societies, and industry to provide perspectives on the issues before them (see Appendix A). In addition, the Committee met publicly with the current NIH director as well as several former directors. Committee members and staff also heard presentations from or interviewed NIH staff in the offices of policy and planning, budget, finance, and intramural research, and met with directors of 18 institutes or centers. Data about NIH programs and budgets were requested from NIH staff as the need emerged. Prior reports conducted about and for NIH were reviewed, as was the relevant literature. In addition, the Committee commissioned a background paper tracing the history and evolution of NIH and its institutes as a starting point for its deliberations (McGeary and Smith, 20021. Finally, several Committee members conducted town meetings at their home institutions and elsewhere, inviting scientists, administrators, and students to contribute their perspectives. Thus, the Committee was able to hear, consider, and discuss a diverse range of facts and opinions about the organizational structure of NIH. Its final report and recommendations are, however, based on the Committee's assessment of both the information available and current trends in biomedical science and health. THE COMMITTEE'S RESPONSE TO ITS CHARGE This study focused on the organizational structure of NIH, but that cannot be addressed satisfactorily without considering the mission of NIH, some of its key processes, and the scientific and social-political environment in which NIH activities take place. Although a long series of past reviews of NIH helped inform committee deliberations, the nature of the charge and the 1-year period allowed for delibera- tions constrained the development, character, and scope of the recommendations 23

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24 Enhancing the Vitality of the National Institutes of Health that the Committee could credibly put forward. Most important, the committee was not asked to address NIH's research priorities or the quality and effectiveness of the wide array of research and advanced training programs that NIH undertakes or sponsors. Even a relatively narrowly defined focus on the organizational structure of NIH was challenging because of the need to disentangle structure, procedure, policies, achievements, criticisms, and priorities. For example, the Committee debated whether its charge referred solely to the number of institutes and centers that can be effectively and responsibly managed or could it also assess the role and authority of the NIH director? Should the nature, role, and scope of the intramural research program be discussed because the program is a key structural element of NIH? Over the years many talented and energetic scientists have occupied various leadership positions at NIH and introduced a wide variety of innovative organizational initia- tives. Many of these initiatives have been successfully implemented in individual institutes, centers, and offices, but they have not moved easily from unit to unit or survived changes in leadership. What managerial mechanisms might ensure the widespread adoption of best practices by the institutes, and how might they be adopted or strengthened in place of or in conjunction with structural reorganiza- tion? One could pose numerous additional questions in an attempt to understand and define the set of activities, processes, and procedures encompassed by the term "organizational structure." And such questions cannot even be approached with- out considering the role and mission of NIH. The Committee's view of those complexities was governed by the desire to be of some practical assistance to all those who wish NIH to continue to be an effective- indeed, outstanding organization. The Committee therefore took its task to include assessing the organizational configuration of NIH both its quantitative and quali- tative aspects and the key processes and authorities that play roles in NIH-wide decision-making. Although the borders between structure, mission, and priorities are themselves not well defined, the Committee tried not to take too expansive a view of its responsibilities. In addition, Elias Zerhouni, the current NIH director, suggested to the committee at its first meeting that it would be useful for the committee to concentrate on and assess eight specific issues: 1. The effectiveness of governance mechanisms. 2. The effectiveness of decision-making processes across and within the insti- totes. 3. The balance between centralization and decentralization. 4. The need for better management tools (NIH-wide standards and methods). 5. The development of mechanisms to allocate (or redirect) resources across NIH. 6. Mechanisms for coordination of science. 7. The ability of the NIH leadership to hold institutes accountable. 8. The need for strategic human resources policies.

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Introduction Based on the advice it received from former and current NIH directors as well as its conversations with congressional staff, throughout its deliberations the Com- mittee kept a number of broadly conceived organizational ideas in mind. First, scholars of organizational management (e.g., Waterman et al., 1980) have long recognized that there is more to "organization" than structure. An organization's ability to make effective changes is influenced by a multiplicity of factors beyond the number of units on or shape of its organizational chart, for example strategy, structure, systems, staff capabilities, shared values, and behavior. "Systems" refers to all the formal and informal processes and procedures that organizations rely on to function. The word "organized" calls the question: Organized to do what? The answer typically is: Organized to build new institutional capability or new skill in this case, for example, the institutional skill to adapt research and training pro- grams to the new demands of science. To respond to change, an organization must work out its strategy preferably mixed strategies and, if necessary, restructure in order to implement those strategies. Also it will have to change other dimensions of the way it organizes itself to respond. In line with these views, the Committee believes that many potential changes in aspects of NIH other than the number of blocks on its organizational chart could improve its overall effectiveness and help it to stay at the cutting edge of biomedical research. Therefore the Committee considered numerous proposals for restructuring NIH in great detail7 but did not focus exclusively on whether or not there should be a widespread consolidation of NIH's institutes and centers. Rather, it took a more general approach, namely to inquire if there were any significant organizational changes including the widespread consolidation of institutes and centers that would allow NIH to be even more successful in the future. Although the Committee discussed on numerous occasions the advisability of the widespread consolidation of NIH, it eventually came to believe that this was not the best path for NIH to take at this time. It is important to understand that the structure of any large and complex organization, such as NIH,is not the tidy result of a compact set of compelling 7In their background paper prepared for this committee, McGeary and Smith (2002) summarized the published responses to the varmus proposal and the results of their interviews on this topic. In addition, at its inaugural meeting, July 30-31, 2002, the committee heard from Bernadine Healy, NIH director from 1991 to 1993, who suggested grouping NIH in four quite different ``clusters,, 1) federal laborato- ries and the clinical center to deal with emergency issues; 2) health and disease institutes; 3) medical and scientific institutes; and 4) a national research capacity (e.g., NCRR, NLM, large clinical trials capability). Dr. Healy was not opposed to forming more institutes she even suggested two new units for nutrition and rehabilitation. She noted, however, that abolishing institutes is easier said than done. This was reiterated by former Illinois Representative and House Appropriations Subcommittee Chair John Porter, who told the group that any attempt to eliminate individual institutes will likely meet strong political resistance. He urged the committee to think of ways to eliminate duplication and increase consolidation and accountability. 25

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26 Enhancing the Vitality of the National Institutes of Health propositions emanating from organizational theory any more than the particular organization of our complex pluralistic democracy is the result solely of the inspired thinking of political philosophers. The latter is instead the outcome of our particu- lar form of politics and, therefore, heavily influenced by our particular history and evolving cultural commitments. It is very much the same way with NIH. It would be naive to assume that NIH was or should be organized exclusively along the lines dictated either by the imperatives of the scientific agenda or the priorities of any other single set of interests with a concern about promoting health-related research and advanced biomedical training. Rather NIH's existing structure is the result of a set of complex evolving social and political negotiations among a variety of con- stituencies including the Congress, the administration, the scientific community, the health advocacy community, and others interested in research, research training, and public policy related to health. Indeed the history of NIH provides clear evi- dence that each of these communities has always had a variety of views on the appropriate organization of NIH. From any particular point of view or for any particular set of interests, the current situation is not only imperfect, but is certainly not one that either the Congress or the scientific community would designate ab initio. Rather it has evolved as a very useful and largely productive outcome of a series of political and social negotiations that took place over time. This outcome is typical of the design of important social organizations in a pluralistic democracy. NIH has become an organization that balances its many interests and the Committee felt that any major modification at this point in time should focus directly on enhancing NIH's capacity to pursue major, but time-limited, strategic objectives that cut across all the institutes and to acquire a special ability to pursue more high- risk, high-return projects. It was our view that at this moment the widespread consolidation of institutes and centers should not be a high priority as the benefits to be gained would not sufficiently offset the costs involved, particularly when there are other available options that could achieve the same benefits. What does the Committee mean by "costs"? At a minimum, because Congress created the institutes, dissolving or merging institutes would require congressional action. Any thoughtful major reorganization would necessitate a lengthy and com- plex information gathering and decision making process that would include numerous congressional hearings involving members of Congress, congressional staff, and a wide variety of interests in the various health advocacy and scientific communities. Our discussions, correspondence, and meetings made it quite clear that there would be very little agreement among these communities on what the right way to reorganize NIH is, and there would probably be dozens of conflicting ideas in play and few clear avenues for narrowing these down. Moreover these discussions and negotiations would be long and contentious ones and with a quite uncertain outcome. More importantly, the Committee is firmly convinced that many of the goals that might be achieved through large-scale consolidation of institutes could also be achieved more rapidly and effectively through other organi- zational and administrative mechanisms, as recommended in this report.

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Introduction Nevertheless, the Committee did fee! that no organization as important as NIH should remain frozen in organization space and that some regular, thoughtful, and publicly transparent mechanism is required to allow changes to take place at appro- priate times. Although the Committee does believe that the consolidation of two pairs of institutes is appropriate at this time, it felt that this issue ought to have the benefit of the public process it has recommended. Thus, as laid out in this report, the Committee did not find a compelling intellectual argument for widespread consolidation of institutes and centers at this time. It did, however, identify numerous opportunities for organizational change to improve the agency's responsiveness and flexibility and makes several suggestions for adopting an array of strategies to better accomplish NIH's research mission. The Committee was aware that all organizational changes, however well thought out, carry both potential risks and benefits, and it has done its best to sort these out. It also recognized that the decentralized structure of NIH, which allows many people throughout the scientific and advocacy communities to help to set priorities, has been and should continue to be an integral element in NIH's success. The current structure of NIH allows the public to see its many faces. The Commit- tee believes that this has been a very useful organizational response to a complicated set of scientific and political influences. The Committee was particularly mindful of the need to sustain the coalition that has made NIH the success that it is today. In addition, the Committee kept the enormous benefits of investigator-initiated grants, including those focused on fundamental research, firmly in mind during its delibera- tions. Finally, the Committee understood that the quality of leadership and decision- making at all levels, as opposed to administrative structures, is central to NIH's ongoing vitality. In the long run, the recruitment of outstanding leadership, the commitment to individual scientists as the main sources of new discoveries, and reliance on the competitive review system for determining awards will continue to be essential to NIH's continuing success. That NIH has been working well does not mean that it could not work better if in response to changes on the scientific frontier, to changes in health concerns, or to other important environmental shifts some organizational changes were made. The intent of this report is to assess the current organizational structure of NIH and to suggest modifications that might be appropriate to make NIH even more effective in supporting research essential to the long-term goal of improving human health. GENERAL PRINCIPLES BY WHICH NIH SHOULD BE ORGANIZED NIH accomplishes its objectives through the design, organization, administra- tion, and management of extramural and intramural research and training pro- grams and the provision of specialized research facilities that support the programs. In broad scope, NIH's priorities focus on scientific research that is most likely to shape the understanding, diagnosis, treatment, and prevention of society's most 27

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28 Enhancing the Vitality of the National Institutes of Health important health challenges. That focus includes strong support of fundamental scientific research that is aimed at improving our understanding of organisms, processes, biological systems, and individual and societal risk factors broadly be- lieved to be relevant to human health. It also embraces support of graduate and postgraduate training needed to ensure an adequate supply of scientists to continue to study those important health concerns. An evaluation of NIH's priorities requires explicit recognition of a number of interrelated factors. Most important in this respect is an understanding of the evolv- ing nature of the scientific enterprise, which includes not only the changing nature of science itself, but also the evolving role of other institutions and disciplines, both here and abroad, that have generally similar aims as well as the changing nature of our health concerns. Recognition of the global nature of medical and health prob- lems and their relevance to the interests and health of the people of the United States warrants special mention. Finally, and perhaps most obvious, the level of resources available to NIH clearly will affect the profile and extent of NIH's activities. Effec- tive management of its resources is especially challenging now because of the pace of scientific developments, new health priorities, the changing institutional structure of the biomedical research enterprise, and recent rapid budget growth. In going about its task, the Committee first addressed the opening question in its statement of task: "Are there general principles by which NIH should be orga- nized?" Only by arriving at an early determination of NIH's principal overall func- tion and the mechanisms in place to achieve its mission could the Committee ad- equately address the other items in its charge. Thus, an overarching mission and the mechanisms needed to meet it became the basis of the remainder of the committee's tasks. The recommendations developed by the Committee focus on modifications in basic policies and organizational structure that are designed to assist NIH in per- , . . . . . forming its primary function. The success of NIH in meeting its various challenges and, in particular, fulfilling its mission to improve health through the use of science to develop new knowledge has been outstanding. All those who have contributed to the creation and dynamic evolution of the NIH the institutions it has supported, the scientists and health professionals who have created so much knowledge and understanding, and the American people and their elected representatives have helped to reduce humankind's burden of disease, disability, and premature death. NIH has also been successful in catalyzing changes at the frontiers of science. Those changes and the recent doubling of NIH's budget make this an appropriate time to consider whether the organizational structures that have served NIH and the world so well in the past remain appropriate for its future roles. The charge to this Committee is worded in the form of a series of questions about whether there are general principles around which NIH should be organized. In the context of evaluating NIH's organizational structure, the Committee decided to describe the principles as they relate to NIH's overall mission and the basic policies, structural and otherwise, adopted to achieve it. In the end, the Committee

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Introduction agreed that articulating its view of the mission of NIH would provide the appropri- ate foundation to guide its deliberations: NIH's principal mission . . . . . . is to serve as a mechanism for efficiently and effectively oopioy~ng federal resources across a wide array of institutions and individuals in the nation's scientific community to advance the scientific frontier and ensure re- search and training in fields of special relevance to human health needs.8 Some might view this mission as stopping short of the goals of public health, that is, not including the goal to directly improve human health. The Committee was cognizant of the tension that exists among the scientific, medical, patient, and political communities about expectations of NIH. It concluded, however, that improving health as much as it is critically dependent on accurate and adequate science is a goal that also involves health providers, industry, and policy makers and is influenced by social and economic factors that range far from the research mission of NIH. Moreover, NIH is but one of eight DHHS agencies charged with a health-related mission. The other agencies Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Agency for Toxic Substances and Disease Registry, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, and the Sub- stance Abuse and Mental Health Services Administration also focus on health and complement the research mission of NIH. There is no question that these agencies must work together even more effectively to ensure that there is a continuum of federal effort and concern regarding improved health for all Americans. Based on its view of NIH's mission, the Committee agreed that there follows from this fundamental charge a list of subprinciples or basic policies and approaches that, if adhered to, would allow NIH to achieve its mission: '. The NIH research and training portfolio should be broad and integrated, ranging from basic to applied and from laboratory to population-based, in support of understanding health and how to improve it for all populations. The portfolio should reflect a balance between work in existing highly pro- ductive domains or disciplines and high-risk, groundbreaking, potentially paradigm-shifting work. It should be especially responsive whenever scien- tific opportunity and public health and health care needs overlap. 2. NIH should support research that cuts across multiple health domains and disease categories. This might require special efforts to integrate research across NIH components. 3. The NIH research and training portfolio should make special efforts to address health problems that typically do not attract substantial private 8NIH states its mission as "science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability" (NIH, 2001). 29

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30 Enhancing the Vitality of the National Institutes of Health sector support, such as prevention, some therapeutic strategies, and many rare diseases. 4. The standards, procedures, and processes by which research and training funds are allocated should be transparent to applicants, Congress, voluntary health organizations, and the general public. Moreover, a wide variety of constituencies should have input into the setting of broad priorities. 5. Extramural research should remain the primary vehicle for carrying out NIH's mission. Open competitive peer review should be the usual mecha- nism guiding extramural funding decisions. 6. The intramural research program is a unique federal resource that offers an important opportunity to enhance NIH's capability to fulfill its mission. It should seek to fill distinctive roles in the nation's scientific enterprise with appropriate mechanisms of accountability and quality control. 7. As a worId-class science institution, NIH should have state-of-the-art man- agement and planning strategies and tools. A key need is the capability for retrieving comprehensive and interpretable NIH-wide data related to its . . . various 01 electives. 8. There should be appropriate mechanisms to ensure the continuing review, evaluation, and appointment of senior scientific and administrative leaders at all levels of NIH. 9. Proposals for the creation, merger, or closure of institutes, centers, and offices should be considered through a process of thoughtful public delibera- tion that addresses potential costs, benefits, and alternatives. ORGANIZATION OF THE REPORT To place the Committee's analysis and recommendations in context, Chapter 2 provides background information about the evolution of the structure and organi- zation of NIH. Chapter 3 focuses on examples of how new discoveries are changing the conduct, review, and evaluation of science and addresses whether the NIH structure is suitably configured to adapt to these changes and to promote them. In Chapter 4, the Committee focuses on the NIH structure itself and processes for merging, consolidating, or expanding the number of its components, including a proposal to revitalize and integrate clinical research. Chapter 5 provides ideas and suggestions for reorganization that could facili- tate the conduct of increasingly important trans-NIH scientific research and enhance NIH's ability to maintain itself at the leading edge of scientific progress. The chapter proposes changes that would enhance the NIH director's authority, particularly as related to trans-NIH initiatives that should begin to constitute a larger proportion of NIH activities, mechanisms for fostering high-risk research, and the intramural research program. Chapter 6 discusses issues related to NIH's need to be publicly and financially accountable through its advisory and review processes, data systems, leadership,

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Introduction and administrative efficiency, including the budgetary and administrative issues related to managing a large research organization. Chapter 7 summarizes the recommendations made in the report in the context of their consistency with the principles and basic policies elucidated in this intro- duction. SUMMARY NIH will continue to be influenced both by scientific developments and by a changing political landscape and growth in the numbers and sophistication of scien- tific and health advocacy groups. Interests will converge or conflict depending on the degree to which issues are influenced by such factors as the state of the economy and the federal budget. It may seem easier to innovate and cooperate when the budget is increasing, but rapidly increasing budgets can also overwhelm good plan- ning and long-term strategic thinking. In any case, it is clear that when budget growth slows, especially in an era of great opportunity and need, difficult decisions arise and priorities are affected. Independently of budget issues, NIH is increasingly called on to perform in a coordinated way to address key research subjects that involve multiple institutes and to respond to immediate public health needs. An important question is whether NIH's federated and decentralized structure, as currently configured, can respond adequately and in a timely manner to those challenges. This report makes a series of recommendations aimed at increasing and enhancing NIH's ability to accomplish its . . mission. 31

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Table 2-1 Current Program Offices in the Office of the Director Year Office Established Office of AIDS Research 1988 Office of Research on 1990 Women's Health Office of Disease 1985 Prevention, which includes the Office of Rare Diseases (1993), Office of Dietary Supplements (1995), and Office of Medical Applications of Research (1977) Office of Behavioral and 1995 Social Sciences Research Major Focus Planning, coordination, evaluation, and funding of all NIH AIDS research and support of trans-NIH coordinating committees in areas of AIDS research Focal point for women's health research at NIH, including establishment of a research agenda; inclusion of women as participants in NIH-supported research; and support of women in biomedical careers Coordination of disease prevention activities, advice to director on disease prevention research; promotion and coordination of NIH-wide research on rare or orphan diseases and on the role of dietary supplements in health; work with institutes and centers to assess, translate, and disseminate results of biomedical research that can be used in delivery of health services Stimulation of behavioral and social science research throughout NIH and its integration with other research conducted or supported by NIH The Budget Process To understand how NIH has evolved, it is important to unclerstand its funding environment and budget process (see Figure 2.2~. NIH's statutory authority comes from the Public Health Service Act (PHSA) of 1944, as amended (42 U.S.C., et seq.~. Some institutes and several programs (training and facilities construction) are subject to time and dollar authorizations that require periodic renewal by Congress.~3 The last authorization, the NTH Revitalization Act of 1993, lapsed in 1996 (P.~. 103-434; the effort to renew the authorization in ~ 996 failed because of conflict over provisions about the use of fetal tissue in research. There have been no further efforts to pass a general reauthorization of NIH.~4 Since ~ 996, NTH has operated on the basis of annual appropriation bills, although technically appropriations amounting to nearly half of NIH's funding are unauthorized. In the absence of authorizations, the appropriation committees, in their legislation ant! report language, have provided guidance that is similar to the guidance that authorizing committees enact. From time to time, bills to make specific changes in the PHSA are introduced; sometimes they are passed, such as the one that established NIBIB in 2000 (P.~. 106-580) and the one that establisher! centers of excellence for research on the muscular dystrophies in 2001 (P.~. 107-84~. 13 The War on Cancer Act of 1971 was the first to impose time and dollar limits on an institute. 14 The 1994 authorization for the National Institute of Mental Health, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse (P.L. 102-321) has also lapsed. See Congressional Budget Office, 2002. 32