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Chapter ~ INTRODUCTION The National Institutes of Health (NIH) has earned a reputation for excellence in the support ant conduct of research to improve the health of the American people. It has maintained its leadership position in the international scientific community even in the face of considerable changes in its political ant social environment. But pressure continues to mount for change in the mission and organiza- tional structure of NIH. The future success of NIH depends on it and the rest of the Public Health Service adopting a more unified and coordinated approach to meeting the nation's health research needed The Mission of NIH Any study of the organizational structure of the National Institutes of Health must begin with its mission. The simplest and most complete statement of that mission can be found in one of its own publications: The mission of the National Institutes of Health (NTH) is to improve the health of the people of the United States by increasing our understanding of the processes underlying human health and by acquiring new knowledge to help prevent, detect, diagnose, and treat disease. NIH accomplishes this mission by: supporting research in universities, medical schools, hospitals, ant research institutions in this country and abroad; conducting research in its own laboratories and clinics; supporting Braining for promising young researchers; helping to develop and maintain research resource -lo; identifying research findings that can be applied to the care of patients, and helping to transfer such advances to the health care system;

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8 . promoting effective ways to communicate biomedical information to scientists, health practitioners, and the public; and developing and recommending policies related to ache conduct and support of biomedical research.! Efforts by NIH to fulfill this mission have brought it recognition as an extraordinary national resource. In every recent session of Congress, however, bills have been introduced to change the organizational structure of NIH. Proponents of such changes see them as a way to enhance research in neglected areas. Opponents see them as administratively costly and scientifically ineffective. They fear that these changes, combined with funding limitations, could diminish the agency's flexibility to respond to emerging research opportunities. The mission of NIH demands that its leaders pursue two principal objectives: (1) to be responsive to health needs, achieving reductions in the burden of illness by capitalizing on Scientific opportunities, and (2) to promote basic Science and maintain Standards of scientific excellence. Although it sometimes seems that these two objectives are contradictory rather than complementary, such is not the case. Both must be pursued with equal vigor, creative leadership, and hard work if the NIH is to continue its successful record. The task of this committee, as we see it, is to provide guidance for the pursuit of these two objectives. This report examines procedures and institutional patterns to meet these objectives and recommends criteria to guide the organization's further evolution. The Organizational Structure of NIH The genius of the institution in shaping scientific excellence to health needs is found in the interplay between the categorical research institutes and the disciplinary Study aectiona. A complete description and analysis of this structure appear in Appendix B. None of the research organizations that we have investigated in the United States or abroad has a more effective structure for mobilizing scientific research against disease. "Categorical" refers to the fact that most of the research institutes at NIH are focused on a category of disease or health problem and have both clinical and basic research components. Because of their association with diseases, the institutes provide for two-way communication with Congress and the public. They enable Congress to appreciate the accomplishments of the institutes and to understand and support their further goals. At the same time, the structure enables Congress to express public concerns and priorities about the need for research on current health problems. One important exception to this categorical organizational plan is the National Institute of General Medical Sciences, which has the vital

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9 responsibility for supporting basic biomedical sciences, such as molecular biology and genetics, that do not fit fully into any of the categorical ins t itutes . The other part of the organizational plan is a set of disciplinary study sections , independent from the institutes, that review research grant applications for scientific merit, as described in Appendix B. The peer review study sections ensure that the best available scientific talent and ideas are brought to bear on the problems identified through the categorical institutes, and that the source of future scientific resulte--basic research--is continually repl enished . In many ways, the study sections are the glue that horde the categorical system together. In addition, NIH has a strong intramural research program that is managed by the categorical instituter with effective NIH-wide coordination ant scientific communication. This program complements the categorical/disciplinary extramural program of the institutes and provides attractive opportunities for scientists in basic and applied research, thus enabling NIH to recruit and retain the best scientists and scientific managers. NIH also relies on advice from highly qualified external scientists, especially those on the study sections and other advisory committees. These scientists and menage re transfo.= a structure that would appear unwieldy to a management analyst into an effective means for simultaneously furthering scientific excellence and being responsive to the needs of society. This gamut of research notwithstanding, NIH is repeatedly confronted by those who seek more research results that will have practical applications. In the past four years alone, there have been proposals for at least eleven new institutes at NIH, with three of there proposals introduced as legislation.2 There also have been at least four legislative proposals to transfer existing agencies into NIH.3 And Congress continues to consider modifications of the legislative basis of the NIH mission and authority. Recommendat ions In order to preserve ant enhance an effective and appropriate organizational structure the committee makes recommendations in three areas. Chapter 2 analyses the effect of major organizational changes in the past and recommends both a process ant a set of criteria to guide future changes. Chapter 3 explores the NIH relationship with the rest of the Department of Health and Human Services and with Congress and the public, and describes a mechanism to ensure that NIH and the other agencies of the Public Health Service are making adequate contributions to the nation's health research effort. Finally, Chapter 4 analyzes the internal organization of NIH, including structures for dealing with issues that cross institute lines, and suggests a series of measures to ensure a manageable structure for NIH and its overall responsiveness to health needs ant scientific opportunities.