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4 The Organizational Structure of the National Institutes of Health A critical focus of the Committee's attention was the growing perception that the proliferation of the National Institutes of Health's (NIH's) institutes and centers (ICs) poses numerous problems for the agency, its leadership, and the overall effec- tiveness of its research and training portfolio in light of the new opportunities and challenges described in Chapter 3. As discussed briefly in Chapter 1, the Committee deliberated extensively on a variety of proposed responses to the changing nature of the biomedical frontier. Some observers have suggested maintaining the current array of ICs but grouping them in some way into "clusters," each of which would report to a deputy director, who in turn reports to the NIH director. That arrange- ment would maintain the existence of individual ICs and might encourage strategic planning within each cluster while reducing the number of subordinates with whom the NIH director must negotiate on strategy and direction. But the creation of a new management layer between the NIH director and the individual IC directors would, in effect, make the ICs divisions of larger organizations and might decrease the status, independence, and attractiveness of IC directorships and compromise the potential of the NIH director to provide appropriate strategic leadership. Others, such as Varmus (2001), have suggested consolidating all existing insti- tutes into five or six larger institutes of about equal size, whose leaders would report to the NIH director. Such a solution might well simplify some aspects of NIH management and some have suggested it might improve the overall effectiveness of the research portfolio. But it could also risk losing the support of many of the congressional, health advocacy, and public coalitions that have contributed so much to NIH's success. As noted in Chapter 1, the Committee believes that the develop- ment of NIH's current organizational structure has been a useful response to a set of 67

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68 Enhancing the Vitality of the National Institutes of Health complicated scientific and political influences. The Committee does not find the conceptual or practical case for a wholesale reorganization sufficiently compelling to outweigh its potential adverse consequences or risks. Rather, as laid out in this and subsequent chapters, the Committee makes recommendations for achieving many of the goals identified by proponents of major restructuring (more authority for the NIH director, increased responsiveness, greater flexibility, and more oppor- tunity for coordination) primarily by other means. The Committee is aware that many previous reports have recommended the adoption of a presumption against the continual addition of units to NIH. For example, the Special Committee on Medical Research, chaired by Cyril Norman Hugh Long in 1955 (NSF, 1955), concluded in its report that the seven institutes then in NIH were sufficient. Similarly, the President's Biomedical Research Pane! stated in 1976 (Department of Health, Education, and Welfare, 1976), when there were 11 institutes, that "the creation of additional Institutes is not likely to make the NIH more effective; it might well make it less so. Therefore, if new programs are to be established, or existing programs strengthened, this should be accom- plished through the present Institutes rather than through the creation of new ones." In the same year, the report of a Congressional pane! chaired by Represen- tative Paul Rogers (US House of Representatives, 1976) noted that the "categorical" structure of the institutes was a key to the success of NIH because it had given the public, Congress, and the administration a way to understand and identify with the mission of each institute. The Rogers report also noted, however, that NIH was facing pressure for too much categorization from advocacy interests not represented by name in the institute structure; "with eleven institutes, the problem of fragmen- tation becomes very real." In 1984, an Institute of Medicine (IOM) committee chaired by Tames Ebert concluded that the current organizational structure of NIH was appropriate and effective (IOM, 19841. No new institutes had been created since 1974, but in the intervening decade, three institutes the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute for Arthritis, Diabetes, and Digestive and Kidney Diseases (NIADDK) had been elevated to "bureaus," giving their directors more authority and the flexibility to create separate divisions to house major subunits of these institutes (NIH, 19761.1 These changes were to accommodate health advocates' concerns, but pressures from 1As a result of the War on Cancer Act of 1971, NCI was elevated to a bureau with a greatly expanded budget and special authorities. NHLBI also became a bureau after the National Heart, Blood Vessel, Lung, and Blood Act of 1972 expanded its programs and budget; Congress added blood to the name of the institute in 1976. The NIADDK was raised to the bureau level in 1982, and separate divisions for diabetes, arthritis, digestive diseases, and kidney diseases were established. This was to respond to a report by the National Commission on Arthritis and Related Musculoskeletal Diseases that found the combination of topics under this institute's umbrella "incongruous." The bureau title has since been done away with (Cohen, 1993). See McGeary and Smith, 2002, for additional details.

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The Organizational Structure of the National Institutes of Health outside groups were once again building for a separate institute for arthritis and a new institute for nursing. The 1984 IOM committee argued that "NIH is now at a stage where there should be a presumption against additions at the institute level because such changes (1) fragment the scientific effort and diminish effective com- munication with key scientists in other institutes, (2) add to the burden and difficulty of effective program coordination by the NIH Director and his top staff, and (3) add to administrative costs without ensuring increased appropriations." Because there might be circumstances in which organizational change would be necessary and it would be important to recognize such circumstances, the 1984 committee recom- mended that there be a formal process to assess proposed major organizational changes in NIH, and it articulated five criteria for evaluating organizational proposals: "The activity of a new institute or other organizational entity must be com- patible with the research and research-training mission of NIH. If a major emphasis of the proposed new entity is in regulation, the delivery of services, or other non-research activities, it is not appropriate for incorporation in NIH. 2. "It must be demonstrable that the research area of a new institute or other major organizational entity is not already receiving adequate or appropriate attention. 3. "There must be reasonable prospects for scientific growth in a research area to justify the investment in a new institute or other major organizational entity. 4. "There must be reasonable prospects of sufficient funding for a new institute or other major organizational entity. 5. "A proposed change in the NIH organizational structure should, on balance, improve communication, management, priority setting, and accountability." Thus, the present Committee is hardly the first to consider these problems and deliberate over potential solutions. The Committee notes, however, that little changed as a result of past studies. The trend toward proliferation of units in NIH has continued to the present in the absence of an accepted process such as that suggested in the 1984 report. NIH's continuing outstanding success has been due largely to its ability to adapt its programs and structure to meet the ever-changing needs and challenges posed by science, medicine, and public health. As already noted, the Committee carefully considered in multiple meetings major structural changes in NIH, including possible revisions in the number and reporting lines of ICs to the director, and concluded that a wholesale consolidation of NIH's ICs into a much smaller number of units is likely to generate more disadvantages than advantages. Nevertheless the Committee believes that a thoughtful process should be in place to respond to restructuring concerns as they arise to enable NIH to modify its structure as the situation warrants 69

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70 Enhancing the Vitality of the National Institutes of Health and NIH's continuing vitality demands. Because NIH is a public institution, the American public has a stake in its success and should be welcomed into decisions about its continued vitality and growth. A broad array of people and interests should be able to engage in thoughtful and balanced discussions about changes in NIH's institutional structure to address present and emerging issues even more effectively. In line with these views, the Committee believes many changes in NIH's organi- zational structure and practices other than the number of ICs could potentially improve its effectiveness and help it to secure its continuing role in biomedical research. The Committee presents its recommendations on them in Chapters 5 and 6. The remainder of this chapter focuses specifically on issues surrounding the number of units (institutes, centers, and offices) in NIH and on the need to establish a more systematic process to address future needs for adding, consolidating, or dissolving structural units in response to changing scientific, health, or societal pressures. PROCESS FOR CREATING NEW UNITS OR DISSOLVING OR CONSOLIDATING EXISTING UNITS The Committee believes that it would be useful for Congress to consider amend- ing the authorizing legislation for NIH to require that certain steps (outlined below) be taken in considering the creation, dissolution, or consolidation of new institutes and centers. Recommendation 2: Public Process for Proposed Changes in the Number of NIH Institutes or Centers Either on receiving a congressional request or at the discretion of the NIH director in responding to considerable, thoughtful, and sustained interest in changing the number of institutes or centers, the director should initiate a public process to evaluate scientific needs, opportunities, and consequences of the proposed change and the level of public support for it. For a proposed addition, the likelihood of available resources to support it should also be assessed and the burden of proof should reside clearly with those seeking to add an organizational element. To initiate the process, the director should consult with the Advisory Commit- tee to the Director and should a consensus develop on the value of further explora- tion, the NIH director should appoint an ad hoc investigative committee, ensuring that the appropriate array of technical expertise to evaluate a particular proposal is present and that the committee has appropriate representation of the extramural scientific and voluntary health advocacy communities. Examples of steps it would be appropriate for the investigative committee to take include

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The Organizational Structure of the National Institutes of Health Inviting input from the advocates of the proposed action. Gathering input and opinion from the IC directors and other scientific leaders of NIH on the need for the proposed action. Soliciting the views of the Council of Public Representatives and other NIH advisory bodies. Holding a technical forum to be attended by the scientific community to address the scientific needs and opportunities related to the proposed action and the consequences of creating, dissolving, or consolidating one or more organizational units. Holding a public forum to gather the views of voluntary health advocacy organizations and other stakeholders. Consulting interested members and committees of Congress. After the information-gathering steps, the investigative committee should syn- thesize a set of recommendations and report them to the NIH director. The NIH director would then deliver the investigative committee's report with his or her recommendations to Congress, indicating any important disagreements with the investigative committee. Congress should allow the process to conclude before acting to create a new unit or to consolidate or dissolve an existing unit. Despite the present Committee's conclusion that a large-scale restructuring of the ICs would not be wise now, no organization that is expected to remain effective should have to bear the burden of a frozen organizational structure, and not all of NIH's existing units are likely to continue to have the same relevance or indepen- dence in the future. It is reasonable to suggest that the public, the scientific commu- nity, or the NIH director, in concert with internal and external advisers, should be able to suggest to Congress additions, subtractions, or mergers of units at appropri- ate times. OPPORTUNITIES FOR MERGERS After much consideration, the Committee came to the conclusion that a few ICs have overlapping missions and substantive foci and would work more effectively together than apart. The Committee suggests initiation of two careful studies to evaluate potential mergers. Those studies, however, would require time for detailed, open, and public evaluation of the issues as outlined in the process described above. Two particular options were raised during Committee discussions as candidates for merging: the National Institute on Drug Abuse (NIDA) and the National Insti- tute on Alcohol Abuse and Alcoholism (NIAAA); and the National Institute of General Medical Sciences (NIGMS) and the National Human Genome Research Institute (NHGRI). There are undoubtedly other mergers, additions, or closures that might be studied. The two suggested here are by no means an exhaustive list. The Committee, however, did not have the time or opportunity to review the merits of all such proposals to the extent that they deserve, which would include a thorough 71

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72 Enhancing the Vitality of the National Institutes of Health examination of the research and training programs of each institute under consider- ation. Indeed, the Committee favors these mergers, but believes that such changes should benefit from use of the process outlined above. A Proposed Merger of NIAAA and NIDA NIAAA and NIDA were originally parts of the National Institute of Mental Health (NIMH). NIAAA was established by congressional action as an organiza- tional component of NIMH in 1970. In 1974, NIAAA, NIDA, and NIMH were made autonomous institutes under the newly created Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). With the dissolution of ADAMHA in 1992, NIMH, NIDA, and NIAAA were all transferred to NIH. Over the years, there has been recurring interest in why the two institutes that focus on substance abuse and addiction are separate. As chair of the House Labor, Health and Human Services, and Education Appropriations Subcommittee, Repre- sentative John Porter asked the IC directors at every annual appropriation hearing why the two institutes had not been merged (Leshner, personal communication). More recently, questions have been raised in the Senate about the wisdom of keep- ing them separated and a National Academies study on the issue was strongly recommended in report language. To date, however, the method and implications of combining them have not been carefully investigated. The arguments for combining the two ICs stem from overlap in their missions and substantive foci. The acting director of NIDA and the director of NIAAA noted the strong association between the use of tobacco and illicit drugs and the abuse of alcohol in a recent editorial in the Journal of the American Medical Association (Hanson and Li, 20031. Similar biological and social risk factors underlie vuiner- ability to all of these substances, and there are thought to be overlapping mecha- nisms in how these substances influence the brain. In addition, prevention and treatment approaches that are fundamentally similar for abuse of alcohol and other substances make it desirable from a public health perspective to address all sub- stances of abuse when opportunities arise (Graham and Schultz, 19981. Having two separate ICs focused on addictions has resulted in the emergence of two somewhat separate scientific communities, although some investigators receive support from both institutes. The existence of two scientific societies the College on Problems of Drug Dependence and the Research Society on Alcoholism and the fact that they have not convened scientific meetings together in the last 20 years provide dramatic evidence of segregation. Few studies investigate alcohol and other substances of abuse at the same time, even though few drug addicts abuse only one 2During the 107TH Congress, S. 304, the Drug Abuse Education, Prevention, and Treatment Act of 2001, as reported by the Senate Judiciary Committee on November 29, 2001, contained a provision that called for a study of a merger of NIDA and NIAAA by the National Academies. Although the bill was enacted as PL 107-273 in November 2002, the provision relating to the study was no longer included.

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The Organizational Structure of the National Institutes of Health substance. And the exclusive focus of the two institutes on specific substances has meant that some addictions, e.g., gambling and food addictions, have received . . ... . virtual ~ y no scenic attention. Arguments against merger appear to be primarily nonscientific; for example, the alcohol industry might strongly and successfully oppose such a merger to avoid being associated, even indirectly, with considerations of illegal drugs. In the Committee's view, substantive arguments against merger are not convincing. One suggests that alcohol requires a separate institute because it is unique in affecting every cell in the body; but other abused drugs studied by NIDA, such as inhalants, also affect all cells. Another argument is that alcohol is unique among abused substances in being legal, at least for adults, and thus everything surrounding the drug is unique. On the other hand, NIDA supports a large amount of research on _ , _ . 1 1 . 1 1 1 1 1 ~ 1 1 . A ~ ~ T. A A A 1 nicotine addiction, and smoking Is also legal tor adults. A merger ot N1AAA and NIDA would seem to offer many advantages, scientifically and with respect to improved health, and should be studied carefully. The broader scientific relation- ships and physical location of these two institutes with other neurosciences insti- tutes (especially NIMH and the National Institute of Neurological Diseases and Stroke) should also be considered. A Proposed Merger of NHGRI and NIGMS NHGRI was born out of NIGMS to give intense focus and impetus to the sequencing of the human genome. Established originally as a center and later elevated to institute status, NHGRI has done a superb job in leading the inter- national effort to sequence and interpret the human genome. Its efforts have extended to the sequencing of the genomes of other organisms, whose comparative study has substantial benefits for health and other fields of research. Although the sequencing efforts have involved many other ICs, particularly NCI and NIGMS, as well as the Department of Energy and the biotechnology industry, NHGRI clearly has been the leader. Many other institutes have continued work on other aspects of fundamental genetics, including the genetics of various illnesses, and biomedical genetics has emerged as an overarching NIH high-priority field and a major venue for trans-NIH collaboration. Sequencing of the human genome was declared essen- tially complete on April 14, 2003, at the 50th anniversary celebration of the publication of the Watson and Crick paper on the double-helix structure of DNA. Biomedical researchers are building on the information to increase understanding of the functions of genes and the proteins they generate. Genetic medicine, genomics, and proteomics are among the core biomedical disciplines for the 21st century. The Committee considered whether there is still a compelling need for a separate genome research institute. NHGRI's initial charge has been successfully accom- plished, and having a continuing discrete focal point for human genomics might be useful for maintaining momentum in the field. However, it can be argued that NHGRI no longer has an essential separate mission. Many of its activities could 73

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74 Enhancing the Vitality of the National Institutes of Health easily be integrated into other ICs that have advanced their research as a result of the Human Genome Project and are integrating its findings into their missions. Among the other institutes, NIGMS has core or primary responsibility for basic biomedical research. It can be argued that the same is true for genetics and that a core responsibility for NHGRI's projects should therefore be incorporated (actually, reincorporated) into NIGMS. In recent years, NIGMS has moved decisively into larger-scale transdisciplinary research, including glue grants (see chapter 3) and other mechanisms. On balance, the Committee believes that the completion of the human genome sequencing effort offers a good opportunity to study the possibility of combining the two institutes. Moreover, ending the life of NHGRI as a separate institute would, if determined to be appropriate, provide a dramatic precedent for declaring fulfillment of a well-defined mandate. Consolidating Clinical Research Efforts Because of extraordinarily persuasive arguments about exceptional needs made by a variety of groups in discussions with the Committee, a recommendation is made in this section to consolidate several clinical research components of the extramural and intramural program to transform the National Center for Research Resources (NCRR) into a new entity, the National Center for Clinical Research and Research Resources (NCCRRR). The importance of clinical research in translating the vast knowledge emanating from basic science efforts, such as the Human Genome Project, cannot be over- stated. As the result of a wide spectrum of developments in the biomedical sciences, extensive research can now be done on the pathogenesis and pathophysiology of human disease. In addition, new developments in imaging provide novel approaches to understanding the health and disease states in humans. As described in Chapter 3, the challenge for clinical research is that most common diseases are complex, multi- etiologic disorders in which a multiplicity of genetic and other factors interact with each other. As a result, clinical research is faced with the complex challenge of identifying the resources, intellectual capital, and large cohorts of patients with appropriate phenotypes for studies. It will take a revitalized investment in clinical research, including many large-scale trials, to figure out how to tie together all the factors that contribute to particular diseases. Clinical research has always been more of an interdisciplinary "team" effort than laboratory science, but it will increasingly require larger, multi-institute studies and a level of collaboration, sharing, and cooperation that sometimes seems at odds with the image of the lone scientist working in isolation. German pathologist Werner Kollath once lamented, "Much is known, but unfortunately in different heads." If clinical research is to fulfill the promise of our nation's prolonged investment in biomedical research, then a more concerted and better coordinated effort must be mounted that will make the most of all available research and training resources. NIH already sponsors a substantial set of programs in clinical research and

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The Organizational Structure of the National Institutes of Health training through its extramural and intramural research programs. It has continued to expand efforts to support clinical research and training and attract physician- investigators, often with strong encouragement from Congress and academic leaders. For example, it has established and expanded a series of special training programs for clinical researchers collectively known as K awards. And recognizing that loans accumulated during college and medical school greatly burden young physicians and influence their choices of career paths, NIH has responded by creating competi- tive loan-repayment programs that offer up to $35,000 per year for 2 years to health professionals pursuing careers in various aspects of clinical research. The 87 general clinical research centers (GCRCs) managed by the National Center for Research Resources (NCRR) constitute a national network of NIH- supported clinical research sites hosted at academic health centers and teaching hospitals. They provide settings for medical investigators to conduct safe, con- trolled, state-of-the-art patient studies with support by the vast infrastructure of academic health centers. They also provide a crucial setting and mentorship to attract medical students, residents, fellows, and junior faculty and patients and volunteers into clinical research. In addition, each institute or center with a research program supports a broad array of clinical research through individual research grants, research centers, and collaborative group funding mechanisms. Most ICs also conduct a variety of clinical research through the intramural program. As in the growing number of jointly funded extramural research programs, ICs may cooperate in studies. Such coopera- tion is facilitated by the intramural program's Clinical Center on the Bethesda campus. NIH spent $7.6 billion on clinical research in FY 2002, estimates it will spend $8.4 billion of its roughly $27 billion budget in FY 2003 and projects spending $8.7 billion in FY 2004. The figures are complicated, however, in that the 20 clinically active ICs accounted for their "clinical research" efforts quite differently. However the funding is counted, almost all NIH institutes maintain substantial clinical research programs. For example, NCI, NHLBI, NIDA, and the National Institute of Allergy and Infectious Diseases maintain extensive clinical-trial research net- works. Many institutes award contracts to conduct specialized research and clinical trials of potential treatments. Some institutes, such as NCI, NIMH, and NIDA, also support extensive arrays of research centers that provide infrastructure support and specialized clinical research project support. NIH Director Zerhouni's Roadmap for Re-Engineering the Clinical Research Enterprise (Jenkins, 2002b; Metheny, 2003) outlines three pressures on the clinical research enterprise: the rate of growth of health care needs and expenditures requires accelerated discoveries and clinical validation; new clinical approaches will have to be more efficient than current ones; and public support and participation in clinical research are essential. 75

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76 Enhancing the Vitality of the National Institutes of Health Many initiatives to bolster, support, and improve clinical research and training are under way at NIH, including public trust initiatives, the development of clinical research informatics, and planning meetings. An NIH Steering Committee on Clini- cal Research Infrastructure has been charged with defining the scope and purpose of clinical research informatics and ensuring sufficient external consultation to build a work plan for use of information technology in clinical trials. The plan will include data standards, core elements, mode! systems, and practices. Even in light of NIH's considerable support of clinical research, the Committee sees a critical lack of coordination and standardization across NIH in its clinical research programs that cause many opportunities for collaboration and data shar- ing across fields to be lost. Clinical research is an expensive undertaking, requiring costly infrastructure and extensive administrative support to comply with regula- tory requirements and interact effectively and efficiently in the financial and recor~keeping framework of clinical medicine. In addition, clinical databases can be sizeable and support for the necessary informatics daunting. In 2003, members of the Institute of Medicine's Clinical Research Roundtable published an article (Sung et al., 2003) characterizing the current state of clinical research as "increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants." The challenging and expensive enterprise of clinical research requires mastery of a broad array of skills in clinical medical fields; the application of biostatistics to clinical trial design and analysis; adherence to the principles, precedents, and procedures of bioethics; the organization and oversight of complex projects; and the communication of complex ideas to potential trial participants and peers. Sung et al. described two kinds of translational blocks: from basic science to human studies and from clinical knowledge to clinical prac- tice, health-care decisions, and population health. The length of training required, the expense and time involved, and the complex regulatory environment of clinical research have depleted the ranks of those willing to engage in clinical research, and many fee! that this trend contributes to the inability to translate basic research findings into improved healthy To ensure the success of the clinical research system, there must be a cadre of highly trained clinical investigators for several reasons: to discern the questions to be asked; to ensure that studies are conducted with the highest quality standards; and to ensure that there are trained clinical investigators in all medical specialties enrolling patients in trials. As basic science discoveries outstrip clinical capabilities to apply them, the lag in translating clinical research to practice will continue to lengthen. This can only be addressed by providing coordinated support for stable and rigorous academic training programs, recruiting physicians to become scientists or continue their professional development through mid-career research training, 3An Institute of Medicine committee is currently developing a report on the role of academic health centers in the 21st century. The committee s report is still in preparation.

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The Organizational Structure of the National Institutes of Health and ensuring that funds are available for clinical research proposals that seek to address significant problems in the diagnosis and treatment of human disease. For these reasons, it is critical that NIH concentrate its efforts to make the most effective use of what is already a sizeable investment. NIH, the Association of American Medical Colleges (AAMC et al., 1999), and Sung et al. (2003) have concluded that NIH could enhance the contribution of the biomedical research enterprise to improved health in the United States and globally in numerous ways, including Working to build public engagement and trust in clinical research by creat- . . 1ng new partners" Alps. Developing with the Department of Health and Human Services' Office for Human Research Protections a national approach to standardizing and harmonizing regulations for protecting research subjects and improving standards of privacy protection. Supporting the development of integrated, interoperable data networks, medical record systems, and related research under a common national health information infrastructure with standards to facilitate collection and sharing of clinical research information. Facilitating establishment of national and international clinical research con- sortia to study, standardize, and share information on disease prevention, pathophysiology, diagnosis, therapies, and outcomes. Strengthening the GCRC network to include more shared resources for . . . . c" .lnlca" . Investigators. Creating national databases (consistent with the Health Insurance Portability and Accountability Act) that link the phenotypes, genotypes, risk factors, and multigenerational family histories of large numbers of people. Increasing opportunities (and funding) for clinical research training for physicians, dentists, pharmacists, public-health workers, nurses, psychologists, laboratory technicians, dieticians, computer programmers, bioengineers, and others, including education-loan repayment programs. Forging intergovernmental collaborations with related programs in the Department of Health and Human Services, such as the Centers for Disease Control and Prevention (CDC) and the Agency for Healthcare Research and Quality (AHRQY, as well as essential programs in the Departments of Veterans Affairs, Defense, Labor, and Agriculture. The perceptions that more needs to be done to translate basic research into useful health interventions and that NIH could do more to promote and facilitate clinical and other research relating to the more effective implementation of new findings often result in calls for the creation of some new entity, whether inside or outside NIH, focused specifically on clinical research. For example, in May 2003, Senator Joseph Lieberman proposed the creation of a privately funded $150 billion 77

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78 Enhancing the Vitality of the National Institutes of Health American Center for Cures, with the goal of supporting the translation of basic research discoveries into medical applications (Hawana, 20031. In the same month, the presidents of the Association of American Universities (AAU), AAMC, and the National Association of State Universities and Land Grant Colleges (NASULGC) in a letter to NCRR regarding its strategic plan, emphasized the importance of con- tinuing to revitalize the GCRCs as a way to eliminate barriers to research progress and enhance investigator access to resources and technologies (Cohen, et al., 20031. The authors proposed merging NCRR's GCRC program with the NIH Clinical Center to form a national system dedicated to translational research. The Committee also believes that the goals outlined above could be pursued better if the intramural and extramural clinical research programs of NIH worked more closely and collaboratively and if optimal use were made of the Clinical Center and the GCRCs, which together account for about 7-8% of the NIH budget. NIH is the ideal convener and organizer of a national clinical research enterprise and should lead a new effort throughout the biomedical research community to create and coordinate a national infrastructure for clinical research. The Committee believes that the time is ripe for NIH to develop and implement a series of NIH-wide strategic initiatives in clinical research that engage the energies and resources of all ICs and recommends that even greater efforts be made than just merging the activities of NCRR and the Clinical Center, as proposed by AAU, AAMC, and NASULGC. A concerted, proactive effort requires that someone in a leadership position with the attention of the NIH director and the authority to assess and coordinate efforts across NIH systematically and routinely evaluate NIH's clinical research programs in toto. Those strategic initiatives should be aimed at facilitating the widespread incorporation of new concepts and technologies in molecular genetics, cell biology, imaging, computational biology, and information sciences into clinical research practice. Such strategic initiatives will advance the missions of all ICs and revolutionize health research. By this means, NIH's strategic investments in clinical research can have a transforming effect on the practice of medicine and public health in the United States. To achieve the goals outlined above, a more coordinated and concerted effort is needed. Recommendation 3: Strengthen Clinical Research NIH should pursue a new organizational strategy to better integrate leadership, funding, and management of its clinical research enterprise. The strategy should build on, but not replace, existing organizational units and activities in the individual ICs' intramural and extramural research programs. It should also include partnerships with the nonprofit and private sectors. Specifically, the Committee recommends that several intramural and extramural programs be combined in a new entity to subsume and replace the National Center for Research Resources, to be called the National Center for Clinical Research and Research Resources (NCCRRR). In addition, a deputy director for clinical research should be appointed in the Office of the Director to serve as deputy director and head of the new entity.

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The Organizational Structure of the National Institutes of Health The Committee is well aware that there is already an associate director for Clinical Research at NIH who oversees the intramural Clinical Center. The new position of deputy director that we describe would, however, take responsibility for all combined intramural and extramural programs in clinical research. The Committee gave careful thought to how to create the recommended new entity for clinical research. The most appealing option was to transform the NCRR into the NCCRRR, retaining its responsibilities for the GCRCs and K award pro- grams and adding to these the oversight of the Clinical Center and the integration and coordination of other clinical research conducted by the ICs. The current NCRR director position would be replaced with a new position of deputy director for clinical research. Because NCRR would cease to exist, its non-clinical research programs, which are important, would have to be relocated to other venues in NIH. An attractive aspect of this option is that it does not create an additional direct report to the NIH director. The Committee also considered other approaches, for example, moving the GCRCs, K award programs, Clinical Center oversight, and overall clinical research coordination to an institute or center other than NCRR, for example, to NHLBI. Although this option potentially could put clinical research into the hands of an entity well qualified to manage it, it could also create a lack of acceptance on the part of other institutes that might defeat the intent to improve trans-NIH integra- tion of clinical research. Another idea was to create an entirely new center that combines the GCRCs, K award programs, Clinical Center, and coordination of IC clinical research under the direction of a newly created position of deputy director for clinical research. A major disadvantage of this option is that it would increase the number of direct reports to the director, which the Committee felt was undesir- able. This could be avoided if the remaining parts of NCRR were relocated, as above, and the center was dissolved as a distinct entity. The Committee decided that the best option is to build the new NCCRRR on the NCRR, adding to its responsibility for the GCRCs and the K awards for training and career development the oversight of the Clinical Center and coordination of clinical activities for which other ICs are responsible. If staff responsible for these critical aspects of NIH's clinical research and training portfolio report to a central office, there would be greater opportunity to enhance data sharing among clinical investigators, clarify, solidify, and standardize relevant policies, and identify and pool resources for high-cost, essential core infrastructure needs. A central location would also provide a well-informed opportunity for strategic planning. NCCRRR should have an advisory committee similar to those of other ICs (see also Chapter 6) and every effort should be made to ensure that investigators working in all aspects of clinical research have access to the services and resources of NIH and that the research agenda is not dominated by larger institutes. The Committee understands that there is a concern about the functions of NCRR that are not related to clinical research, such as its primate centers. Those activities of the existing NCRR that are not focused on clinical research but that are 79

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80 Enhancing the Vitality of the National Institutes of Health nonetheless essential to the overall research enterprise should be maintained as offices or branches in appropriate other locations within NIH. The Committee believes that it should be left up to the NIH director to evaluate what current NCRR functions should be retained in the new NCCRRR and which ones to position elsewhere. Each institute or center would continue to fund its own clinical research projects, collaborative groups, and trainees (as now through funding transfers to NCRR) and its use of the Clinical Center. Although planning at the Clinical Center emphasizes flexible cross-Is intramural use of the facility, it is envisioned that the new entity would assume a much stronger leadership role for the entire intramural and extra- mural NIH clinical research enterprise and work in close partnership with the academic community and the private sector. For example, the new Center could enhance and improve relations and ongoing discussions with clinical research orga- nizations outside NIH, such as the Office for Human Research Protections, the Food and Drug Administration, CDC, AHRQ, and the pharmaceutical and bio- technology industries. The goal would be to extend the resources and expertise of NIH's aggregate clinical research expertise more broadly, to more fully engage the clinical research community across the country and to develop standard tools and practices to pro- mote clinical research. For example, two key areas in which the new Center could make enormous contributions are in information technology and clinical bioinformatics. Given the great expense of clinical trials, any increased productivity achieved through automation will have a substantial impact on the number of trials that can be successfully completed and on the speed of knowledge accumulation. Another important role could be in developing, through an inclusive process with the extramural community, the area of ethical conduct of clinical research and the setting of consistent national ethical standards for NIH grantees conducting clinical research. The Committee believes that the importance of both intramural and extramural clinical research to all the ICs requires the full time and attention of one individual and his or her office within OD. Although the current and previous NIH directors have all strongly supported clinical research, it is just one of many missions that NIH must fulfill and thus has not received the full attention warranted, with efforts at promoting clinical research too ad hoc, too sporadic, and too subject to changes in NIH leadership. By consolidating many existing efforts into one organizational unit, clinical research would achieve maximal visibility and coordination. SUMMARY The Committee's conclusion was that, at the current time, a wholesale consoli- dation of NIH's ICs into a much smaller number of units would generate more disadvantages than advantages; however, a process to consider changing circum- stances and suggestions for structural change as they arise is needed. The Committee

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The Organizational Structure of the National Institutes of Health believes that Congress should consider amending the authorizing legislation for NIH to require that either on receiving a congressional request or at the NIH director's discretion in responding to public requests for a structural change, the director should initiate a public process to evaluate the scientific, medical, financial, and public costs of the proposed change. Some ICs have overlapping missions and substantive foci and would work together more effectively than apart, and the Committee recommends the immedi- ate initiation of two careful studies using the recommended process to evaluate these mergers. In addition, the Committee recommends the merger of extramural and intramural functions related to clinical research. 81

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whether these entities should be perpetuates! indefinitely. The public process for evaluating proposals to create organizational units described in Chapter 4 should also be applied to programmatic offices in the OD. Finally, to enhance the quality and innovative nature of NIH's portfolio, the Committee proposes a variety of adjustments in intramural research ant! the creation of a new program in OD to promote high-risk, high-payoff research. 82