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7 Putting Principles into Practice This study was requested by Congress because of growing concerns that the National Institutes of Health (NIH) is becoming too fragmented to be coordinated adequately to address fundamental changes in science or respond quickly enough to health emergencies. The Committee stands in a long line of bodies convened to review some aspect of NIH's administrative structure. The effectiveness of NIH's organization and the effects of having an increasing number of institutes and centers (ICs) has been a recurring concern for nearly half a century. Many of the blue- ribbon committees, panels, and commissions that have looked at NIH, beginning with the Long Committee in 1955 (NSF, 1955), have concluded that there were enough ICs and recommended against adding new ones. A 1984 Institute of Medi- cine (IOM) committee acknowledged that new institutes might be necessary under some circumstances but recommended a presumption against establishing them unless specific criteria were met through an orderly process. Despite the judgment of the past review groups that NIH should not add ICs, the net result of the dynamics of NIH's political support has been a steady incremental expansion in the number of major units over the years. The same review groups have also generally found that NIH is a successful organization, whatever the number of ICs at the time an indication that prolifera- tion is not necessarily harmful. The importance of health problems, the rich oppor- tunities for research progress in the biomedical and behavioral sciences, and past successes in advancing research and its applications are certainly major factors in explaining the degree of NIH's budgetary and structural growth. Although the present Committee concluded that in some ways NIH as currently structured presents some difficult management and programmatic challenges, it also concluded 121

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122 Enhancing the Vitality of the National Institutes of Health that, at the current time, widespread consolidation or restructuring would not necessarily be the best way to resolve those challenges. In fact, NIH has been productive in part because it is a federation of many specialized and quasi-indepen- dent units, and its complex decentralized structure, which has made NIH effective in responding to research opportunities and public needs, is an important source of its success. Despite the strength imparted by decentralization, there are circumstances in which organizational, rather than structural, change or some form of administrative modification is desirable. Significant operational changes could improve the strength, responsiveness, vitality, and accountability of NIH, the world's greatest biomedical research agency. The congressional request for this study set a goal of determining the optimal organizational structure for NIH in the context of 21st century biomedical research science. But the organizational structure of NIH cannot be addressed satisfactorily without considering its mission, some of its key processes, and the scientific, social, and political environments within which its activities take place. The Committee therefore interpreted its mandate to consider aspects of NIH's organizational struc- ture beyond the number of administrative units. In its charge, the Committee was asked to determine whether there are general principles by which NIH should be organized. As set out in Chapter 1, the Commit- tee concluded that NIH's principal mission is to serve as a mechanism for efficiently and effectively deploying federal resources across a wide array of institutions and individuals in the nation's scientific community to advance the scientific frontier and ensure research training of special relevance to human health needs. It then provided as "principles" nine basic policies or goals that would allow NIH to achieve its mission. Consideration of these nine policies or goals provided the frame- work for the Committee's response to the remaining questions contained in its charge: Does the current structure reflect these principles, or should NIH be restructured? If restructuring is recommended, what should the new structure be? How will the proposed new structure improve NIH's ability to conduct biomedical research and training, and accommodate organizational growth in the future? How would the proposed new structure overcome current weaknesses, and what new problems might it introduce? . POLICIES AND RECOMMENDATIONS Each basic policy or goal identified by the Committee was explored in the context of NIH's organizational structure to determine whether structure enhanced or impeded efforts to achieve it:

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Putting Principles into Practice 1. 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 sector support, such as prevention, some therapeutic strategies, and many rare diseases. The Committee made several recommendations aimed at achieving those goals. Most important, it made a case for expanding the role of the director of NIH to lead a trans-NIH planning process to identify major cross-cutting issues and opportuni- ties and generate a small number of major high-priority research initiatives. In addition to continuing generous funding for investigator-initiated research projects, the Committee finds compelling the case for multiyear planning that would mobilize coordinated funding from many ICs for a strategic, but revolving set of high- priority trans-NIH projects. Planning and implementation of such initiatives should involve substantial input from the scientific community and the public, and Congress should ensure the necessary funding to conduct the process. The Committee also recommends that Congress revisit the special status granted the National Cancer Institute (NCI) to determine whether its unique position hinders coordinated plan- . . . .. lung ant programmatic activities. The Committee proposes the creation of a Director's Special Projects Program to fund the initiation of high-risk, exceptionally innovative research projects offer- ing high potential payoff. Suggestions are made as to how the program should operate and be funded. To improve the agility and responsiveness of NIH, the Committee recommends that the Office of the Director (OD) be given a more adequate budget to support its management roles or greater discretionary authority to reprogram funding from the earmarked components of its budget when necessary to meet unanticipated needs. The Committee concluded that the authorities of the NIH director should be increased to facilitate more overall planning and control of the NIH research agenda. Moreover, funding for OD Operations has not kept pace as NIH has expanded and has not grown in proportion to NIH's research budget. As a result, the OD is unable to respond to unexpected needs of NIH as a whole without appealing for 123

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124 Enhancing the Vitality of the National Institutes of Health support from the ICs. In particular, if the NIH director is given the responsibility and authority to conduct NIH-wide planning for trans-NIH initiatives, as recom- mended in this report, the director's budget will need to be increased to take the costs of such planning into account. Finally, to enhance the quality and innovative nature of NIH's portfolio, greater attention must be paid to clinical research, with an effort to coordinate across the ICs in their intramural and extramural programs. Some clinical research efforts should be merged. Efforts must be made to ensure that the intramural programs are of the highest quality and are open to collaboration internally and with the extramural commu- n~ty. 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. The Committee concludes that NIH lacks the information management meth- ods and infrastructure needed to collect, analyze, and report data adequately, ap- propriately, and in a timely fashion. In particular, it is incumbent on NIH leadership to improve the quality and analysis of its data on the allocation of NIH funds by disease for planning and priority-setting purposes. NIH should enhance its capacity for the timely collection, thoughtful analysis, and accurate reporting of the nature and status of its research and training programs. Data should be collected consis- tently across ICs and submitted to a centralized information management system. The Committee concluded that NIH is not making the best use of its advisory council system to improve transparency, include a broader community in planning and priority-setting, and assess the effectiveness of its programs. The Committee recommends that the advisory council system be thoroughly reformed to ensure that these bodies are consistently and sufficiently independent and are routinely involved in priority-setting and planning discussions. 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. In general, the Committee concluded that the existing peer review system serves the extramural community well, although it has the potential to deter high-risk research outside the mainstream of scientific consensus. The Committee therefore recommends additional mechanisms to promote such research, such as a Director's Special Projects Program and other measures to increase the responsiveness of NIH when needs call for a more immediate reaction than that typically resulting from extensive peer review. However, any effort to change administrative procedures,

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Putting Principles into Practice e.g., those associated with grants management, should be carefully assessed before being implemented to ensure that changes in the name of efficiency do not thwart NIH's mission. 6. The intramural research program (IRP) 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 enter- prise, with appropriate mechanisms of accountability and quality control. Given the time and resources available for it to complete its task, the Committee did not attempt to systematically evaluate the quality of the IRP. The Committee is, however, convinced that the significant efforts of recent years to reinvigorate the IRP and respond to various advisory committee recommendations have met with considerable success and that there is a promising trend toward improved overall quality in the IRP. The Committee applauds recent efforts to improve the program overall. Nevertheless, the balkanization of the IRP persists because of its multiple institutional budgetary and programmatic lines, which reinforce the "stovepipes" and continue to make it difficult for NIH senior management to ensure that the IRP supports NIH's overall strategies and plans. The Committee suggests that it would be useful to consider mechanisms to foster interactions among the IRPs of the individual ICs, such as large-scale reassignments of space to bring similar programs from individual ICs together to create synergies. Another potentially productive avenue to explore would be to reduce the balkanization of the IRPs by clustering programs that share common themes, approaches, and tools. In the Committee's view, the IRP should not be merely an internal extension of the extramural community but rather should perform distinctive research that the extramural community cannot or will not undertake. The Committee recommends that each IC's IRP have research and training components that distinguish it from the extramural community while complementing extramural programs and taking advantage of the unique environment provided at NIH for intramural research. Inter-institute and intramural-extramural collaborations should be supported and enhanced. 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 on electives. The effectiveness of NIH as a research agency depends on a wide array of administrative services, the resources for which flow through the Research Manage- ment and Support (RMS) budgets of the various NIH units. The allocation for RMS in recent years has been too low for NIH to operate a worId-class $27 billion/year research organization and should be increased. The Committee recommends that 125

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126 Enhancing the Vitality of the National Institutes of Health Congress increase RMS to reflect more accurately the essential administrative costs that are required to operate NIH effectively. Moreover, when additional congres- sional mandates are imposed on NIH through the appropriations process, they should include funds to cover necessary administrative costs. The Committee recognizes that developing the appropriate systems for data collection and management is likely to be an expensive long-term undertaking that will require substantial resources and personnel. However, such a system would provide invaluable information to all parties interested in NIH's programs Con- gress, other Executive Branch agencies, the public, the research community, and NIH leadership itself and therefore would constitute a worthwhile investment. It also would provide the most reliable information for considering any proposals to add, merge, or eliminate institutes, centers, and offices. 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. The vision and skills of NIH leadership are perhaps the most important ingredients in the complex mix of policies and strategies that enable NIH to meet its responsibilities to all its constituents. Moreover, NIH leadership at all levels is responsible for setting goals according to mission, implementing the goals, and assessing progress toward them. Leadership and vision may influence particularly the extent to which accountability is reinforced and implemented at diverse levels of the NIH system, from top management through staff and to individual intramural and extramural investigators. It is the quality of leadership and decision-making, as opposed to administrative structures, that is central to NIH's vitality. In the long run, recruitment of outstanding leaders is essential to NIH's continuing success. The Committee concluded that more rigorous measures are needed to ensure that NIH leadership is periodically revitalized and reviewed. It developed series of recommen- dations regarding the review and appointment of IC directors, including terms of appointments and the NIH director's authority to make such appointments, and reassessment of the special status of the NCI director. The Committee suggests establishing 6-year terms for the NIH director. 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. The Committee concluded that, at the current time, the costs of a wholesale consolidation of NIH are likely to outweigh the benefits. Nevertheless, NIH should have sufficient flexibility to consider additions, reductions, or consolidations of NIH administrative units. The NIH director and the public should be able to suggest additions, subtractions, or mergers of units to Congress at appropriate times. How-

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Putting Principles into Practice ever, there should be a formal process for considering proposals for additions, reconfigurations, or reductions that arise from the scientific community, advocacy groups, or Congress. It is not so much the number of units that predicts the success of NIH, but rather the justification of the existence of a given unit and its proven merit. The Committee concludes that there should be a more formal and systematic approach to making changes in NIH's organizational structure. The Committee recommends that on receiving a congressional request or at the discretion of the NIH director in responding to a public request, the director should initiate a public process to evaluate its scientific needs, opportunities, and consequences, the likeli- hood of available resources, and the level of public support to create a new institute, center, or office, or to consolidate or dissolve units. The Committee does not sug- gest criteria for making such decisions, as they are likely to change in light of scientific opportunities, fiscal constraints and opportunities, and health needs. But the establishment of an open system by which such decisions are made provides an opportunity for developing criteria case-by case. SUMMARY NIH is increasingly called on to undertake research that involves multiple insti- tutes, multiple disciplines, and complex diseases to be responsive to new challenges, such as public health emergencies and the threat of acts of bioteorrism. A key question posed to the Committee was whether NIH's decentralized structure has become too fragmented to respond adequately to those challenges or whether, on the contrary, it is well suited to respond to changes in opportunity and need. Related questions included whether, to help equip NIH for the future, the director's authorities should be increased and in what way or whether managerial mechanisms should be strengthened or new ones adopted in place of or in conjunction with structural reorganization. The Committee's view of those complexities was governed by the desire to be of some practical assistance to all who wish NIH to continue to be an effective- indeed, outstanding organization. Thus, the Committee proceeded on the premise that its task included assessing the organizational configuration of NIH and the key processes and authorities that play roles in trans-NIH 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. It concluded on the one hand that in many ways NIH is performing exceptionally well, using decentralization as a strength. On the other hand, it made multiple recommendations to enhance NIH's vitality and accountability through change, augmentation of existing structures, modifications of policies and practices, and measures that aim to transcend decentralization. Whether needs and opportunities will be accommodated in existing NIH units or proliferation or consolidation will occur in the near future is an issue to be addressed by administrations, Congress, the scientific community, and the public. 127

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128 Enhancing the Vitality of the National Institutes of Health NIH will continue to be shaped by the dynamics of many constituencies interacting. Interests will converge or conflict, depending on the issue. The degree of conver- gence and divergence will continue to be influenced by other factors such as annual appropriations. The recommendations made in this report are intended to help NIH to continue to be responsive, accountable, and effective in its leading role in the vast international humanitarian enterprise aimed at a better understanding of the human condition, the prevention and relief of the burdens of disease, and at the promotion of good health throughout the stages of life.