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ENHANCING THE VITALITY OF THE NATIONAL T N STITUTE S OF H EALTH ORGANIZATIONAE CHANGE TO MEET NEW CHALLENGES Committee on the Organizational Structure of the National Institutes of Health Board on Life Sciences National Research Council Health Sciences Policy Board Institute of Medicine NATIONAL RESEARCH COUNCIL INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee respon- sible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract/Grant No. N01-OD-4-2139 between the National Academy of Sciences and the National Institutes of Health. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authorks) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-08967-0 (Book) International Standard Book Number 0-309-52573-X (PDF) Library of Congress Conrol Number 2003113301 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http:// www.nap.edu Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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THE NATIONAL ACADEMIES Advisers to the Nation on Stienre, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of ~ - ~clences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engi- neers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www. nationa l-academies.org

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CO1\/IMITTEE ON THE ORGANIZATIONAL STRUCTURE OF THE NATIONAL INSTITUTES OF HEALTH HAROLD T. SHAPIRO, Chair, Princeton University, Princeton, New Jersey NORMAN R. AUGUSTINE, Lockheed Martin Corporation, Bethesda, Maryland J. MICHAEL BISHOP, University of California, San Francisco, California JAMES R. GAVIN III, Morehouse School of Medicine, Atlanta, Georgia ALFRED G. OILMAN, University of Texas Southwestern Medical Center, Dallas, Texas MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, Maryland DEBRA R. LAPPIN, Princeton Partners Ltd., Denver, Colorado AI~AN I. LESHNER, American Association for the Advancement of Science, Washington, DC GILBERT S. OMENN, University of Michigan, Ann Arbor, Michigan FRANKLYN G. PRENDERGAST, Mayo Clinic Cancer Center, Rochester, Minnesota STEPHEN J. RYAN, University of Southern California, Los Angeles, California SAMUEL C. SILVERSTEIN, Columbia University College of Physicians and Surgeons, New York, New York HAROLD C. SLAVKIN, University of Southern California, Los Angeles, California JUDITH L. SWAIN, Stanford University School of Medicine, Stanford, California LYDIA VILLA-KOMAROFF, Whitehead Institute, Cambridge, Massachusetts ROBERT H. WATERMAN, Waterman Group, Inc. Hillsborough, California MYRL WEINBERG, National Health Council, Washington, DC KENNETH B. WYLIE, University of California, Los Angeles, California MARY WOOLLEY, Research!America, Alexandria, Virginia JAMES B. WYNGAARDEN, Duke University, Durham, North Carolina TADATAKA YAMADA, GlaxoSmithKline, King of Prussia, Pennsylvania STAFF FRANCES E. SHARPLES, Study Director, Board on Life Sciences, Division on Earth and Life Studies (DELS) FREDERICK ]. MANNING, Senior Program Officer, Board on Health Sciences Policy, Institute of Medicine ROBIN A. SCHOEN, Senior Program Officer, Board on Life Sciences, DELS BRIDGET K.B. AVILA, Senior Project Assistant, Board on Life Sciences, DELS LYNN CARLETON, Research Intern, Board on Life Sciences, DELS KATHI E. MANNA, Writer NORMAN GROSSBLATT, Senior Editor, DELS v

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COMMITTEE ON THE ORGANIZATIONAL STRUCTURE OF THE NATIONAL INSTITUTES OF HEALTH HAROLD T. SHAPIRO, (>hair, Princeton University, Princeton, New Jersey NORMAN R. AUGUSTINE, Lockheed Martin Corporation, Bethesda, Maryland I. MICHAEL BISHOP, University of California, San Francisco, California {AMES R. GAVIN III, Morehouse School of Medicine, Atlanta, Georgia ALFRED G. OILMAN, University of Texas Southwestern Medical Center, Dallas, exas MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, Maryland DEBRA R. LAPPIN, Princeton Partners Ltd., Denver, Colorado ALAN I. LESEWER, American Association for the Advancement of Sciences Washington, DC GILBERT S. OMENN, University of Michigan, Ann Arbor, Michigan FRANKLYN G. PRENDERGAST, Mayo Clinic Cancer Center, Rochester, Minnesota STEPHEN l. RYAN, University of Southern California, Los Angeles, California SAMUEL C. SILVERSTEIN, Columbia University College of Physicians and Surgeons, New York, New York HAROLD C. SLAVKIN, University of Southern California, Los Angeles, California JUDITH L. SWAIN, Stanford University School of Medicine, Stanford, California LYDIA VILLA-KOMAROFF, Whitehead Institute, Cambridge, Massachusetts ROBERT H. WATERMAN, Waterman Group, Inc., Hilisborough, California MYRL WEINBERG, National Health Council, Washington, DC KENNETH B. WELLS, University of California, Los Angeles, California MARY WOOLLEY, Research!America, Alexandria, Virginia {AMES B. WYNGAARDEN, Duke University, Durham, North Carolina TADATAKA YAMADA, GlaxoSmithKline, King of Prussia, Pennsylvania Staff FRANCES E. SHARPLES, Study Director, Board on Life Sciences, Division on Earth and Life Studies (DELS) FREDERICK l. MANNING, Senior Program Officer, Board on Health Sciences Policy, Institute of Medicine ROBIN A. SCHOEN, Senior Program Officer, Board on Life Sciences, DELS JOAN ESNAYRA, Program Officer, Policy and Global Affairs Division BRIDGET K. B. AVILA, Senior Project Assistant, Board on Life Sciences, DELS LYNN CARLETON, Research Intern, Board on Life Sciences, DELS KATHI E. MANNA, Writer NORMAN GROSSBLATT, Senior Editor, DELS v

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BOARD ON LIFE SCIENCES COREY S. GOODMAN, Chair, Renovis, Inc., South San Francisco, California R. ALTA CHARD, University of Wisconsin, Madison, Wisconsin {OANNE CHORY, The Salk Institute for Biological Studies, La Jolla, California {EFFREY L. DANGL, University of North Carolina, Chapel Hill, North Carolina PAUL R. EHRLICH, Stanford University, Stanford, California DAVID l. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, California BARBARA GASTEL, Texas A&M University, College Station, Texas {AMES M. GENTILE, Hope College, Holland, Michigan LINDA GREER, Natural Resources Defense Council, Washington, DC ED HARLOW, Harvard Medical School, Cambridge, Massachusetts KENNETH F. KELLER, University of Minnesota, Minneapolis, Minnesota GREGORY A. PETSKO, Brandeis University, Waltham, Massachusetts STUART L. PIMM, Duke University, Durham, North Carolina {OAN B. ROSE, Michigan State University, East Lansing, Michigan GERALD M. RUBIN, Howard Hughes Biomedical Research, Chevy Chase Maryland BARBARA A. SCHAAL, Washington University, St. Louis, Missouri RAYMOND L. WHITE, University of California, San Francisco, California Staff FRANCES E. SHARPLES, Director ROBIN A. SCHOEN, Senior Program Officer ROBERT T. YUAN, Senior Program Officer KERRY A. BRENNER, Program Officer MARILEE K. SHELTON-DAVENPORT, Program Officer EVONNE P. Y. TANG, Program Officer BRIDGET K. B. AVILA, Senior Project Assistant DENISE GROSSHANS, Senior Project Assistant LYNN CARLETON, Project Assistant/Research Intern BHAVIT SHETH, Project Assistant SETH STRONGIN, Project Assistant vl

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Preface The strong system of federal support for US science and technology has pro- duced five decades of discovery and innovation that have not only literally changed the way we live, but deepened our understanding of the human condition, of our position in the universe, and of our relationship to other forms of life. This use of public resources is widely agreed to have yielded great social dividends for the citizens of our country and beyond. In many ways, the National Institutes of Health (NIH) is unsurpassed among the array of federal agencies that support scientific research, providing 80% of the federal government's contribution to biomedical research. From a humble beginning in the late 19th century as a one room laboratory with a $300 government allocation, NIH has grown into a $27 billion per year organization that justifiably enjoys enormous public and congressional support. NIH's success in its mission of science in pursuit of fundamental knowledge and the application of that knowledge to extending healthy life and reducing the burdens of illness and disability has been enormous. NIH's investment in biomedical research has helped produce remarkable results in terms of declining rates of disease, longer life expectancy, reduced infant mortality, and improved quality of life. All those who have played a role in making NIH such a success over the years have earned the gratitude of current and future generations. This report was undertaken in response to a congressional request that wisely acknowledged the fact that the world we live in is changing rapidly. In such a world, all enterprises, be they large or small, need to be able to adapt to change if they are to continue to be effective. Indeed in a rapidly changing environment, the greatest risk to successful organizations is the danger of becoming entrenched in the . . vll

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. . . V111 Preface very things that have made them successful at the expense of some needed adapt- ability. Science and the understanding of health and disease that emerges from science together with an evolving set of health concerns are among the most fast paced areas of change. An organization such as NIH that is dedicated to research and training related to the nation's health concerns must continually consider new ways to meet the challenges of the future. What Congress wants to know is whether NIH's "organizational structure" is right for the times? As NIH's budget and the number of its organizational units have grown, the complexity of its operations and the ability of its director to manage the overall enterprise have become extremely challenging, especially in light of the loosely federated structure that Congress has established for the NIH. Moreover, all would agree that there surely are some limits to the number and variety of units that any organization's structure, even a loosely federated one, can accommodate. The highly decentralized structure that NIH has evolved over its long history is, in fact, one that most of NIH's constituencies prefer, celebrating the benefits and tolerating the costs of this form of organization. Moreover, these constituencies have often pointed to NIH's obvious success, as if that settled the issue. While NIH's success is to be celebrated, success alone does not answer fully the question of whether there is a better way to proceed, particularly as one faces a future where the world of biomedical science is being rapidly transformed in virtually all its dimensions. In carrying out its task, our Committee discovered that defining an optimal degree of centralization or decentralization for NIHis not a simple matter. Indeed the right balance between centralization and decentralization is likely to shift over time as circumstances change. The current level of decentralization, together with the institutional relationships among the institutes and centers on the one hand and the study sections and advisory committees on the other, has the great strength of mobilizing a vast array of talent to participate in key decisions. In addition, this mode of operation has the added benefit of helping to secure the support of a large number of constituencies that can point to one or more facets of the organization that reflects their most important concerns. On the other hand, this complex and decentralized organizational structure makes it more difficult for the NIH director to mobilize significant resources to focus on new programs of strategic importance that should engage all the institutes and centers, to support broad based inter- disciplinary efforts, and to cooperate in other ways across existing organizational and bureaucratic boundaries. What became clear to us was that there is no compelling set of management principles that would help either in defining an optimal organizational structure or in identifying the optimal balance between centralization and decentralization for a research organization like NIH, which must not only productively interact with an unusually complex network of constituencies, but also must deal with the inevitable uncertainties and tensions involved in setting a research agenda. In fact, we recognized that the vitality of NIH is only modestly dependent on its formal admin- istrative and organizational structure, but is very dependent on other aspects of the

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Preface organization's culture and reward system, particularly its capacity to attract and obtain high quality leadership at all levels. In light of such considerations, it was not possible, or useful, to constrain our efforts narrowly to matters that relate purely to NIH's organization chart. While we tried to take a modest approach to our task, the strong and inevitable symbiosis among mission, priorities, and organi- zation meant that we had to consider aspects of all these matters. In the end, our Committee decided that while the current organizational struc- ture of NIH represents a fundamentally useful response to the legitimate demands made by its varied constituencies, some changes are needed to help NIH meet effectively the new demands of the next decades. While there may be no particular number of institutes and centers that can be shown to be optimal, we came to believe that NIH would be well advised to forge a new set of strategies that could be available to re-deploy some of the efforts of the existing institutes and centers or focus new resources on a revolving set of strategic trans-NIH initiatives that seem compelling. This report presents a variety of ideas identified by the Committee as opportunities for organizational change to improve the agency's responsiveness and flexibility and assist it to continue to accomplish its mission successfully. Readers of this report should not interpret its recommendations as in any way seeking to undermine the primacy of investigator-initiated science or of the excellent peer review system in place at NIH. The Committee believes that the tens of thousands of NIH-supported scientists working at a couple of thousand institutions must remain the bedrock of NIH's programs. Though not perfect, NIH's peer review system is the best guarantee we have overall that scientists will carry out research that is of high quality and high potential for scientific progress. I wish to thank all the members of the Committee for their valuable contribu- tions and for their insights into both the scientific and societal issues surrounding this project. The reviewers provided helpful comments that ultimately helped strengthen the report, and I thank them for myself and on behalf of the entire Committee. I also wish to acknowledge the National Academies staff (Fran Sharples, Rick Manning, Robin Schoen, Bridget Avila, and Lynn Carleton) for their thorough and thoughtful assistance with all aspects of the preparation of this report. loan Esnayra assisted with the pre-study preparations. Kathi Hanna did a superb job in assisting with the writing of the report and was an active participant in many of our discussions. Finally, since we believe the work of NIH to be of ethical significance for both current and future generations, it is our hope that our efforts and our recommendations will stimulate a thoughtful discourse aimed at assisting NIH to move from strength to strength. Harold T. Shapiro, Chair Committee on the Organizational Structure of the National Institutes of Health 1X

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Acknowledgments This report is the product of many individuals. We would like to thank all those people and organizations that provided information and opinions to the committee. A list may be found in Appendix A of this report. Some of the descriptive information in this report was based on a background paper prepared for the National Academies by Michael McGeary and Philip M. Smith. This paper has proved highly useful and we very much appreciate the work done by McGeary and Smith to help get the Committee on the Organizational Structure of the National Institutes of Health off to a good start. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: David Baltimore, California Institute of Technology William G. Barsan, University of Michigan Arthur I. Bienenstock, Stanford University Enriqueta C. Bond, Burroughs Welicome Fund Charles A. Bowsher, Comptroller General of the United States (former) Steve Hyman, Harvard University xl

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X11 Acknowledgments Richard D. Klausner, The Bill & Melinda Gates Foundation David Korn, Association of American Medical Colleges Richard A. Rettig, RAND Leon E. Rosenberg, Princeton University Edward M. Scoinick, Merck Research Laboratories John Seffrin, American Cancer Society Harold Varmus, Memorial SIoan-Kettering Cancer Center Raymond White, University of California, San Francisco Although the reviewers listed above have provided constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Floyd Bloom of The Scripps Research Institute and Mary lane Osborn of the University of Connecticut Health Center. Appointed by the National Research Council, they were responsible for making certain that an inde- pendent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and . . . t" be institution.

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Contents Executive Summary 1 Introduction The Evolution of NIH'S Organizational Structure New Opportunities, New Challenges: The Changing Nature of Biomedical Science 4 The Organizational Structure of the National Institutes of Health Enhancing NIH's Ability to Respond to New Challenges 6 Accountability, Administration, and Leadership Putting Principles into Practice References Appendixes A Sources of Information Provided to the Committee B Acronyms and Abbreviations C Committee Member Biographies x/// 1 17 33 51 67 83 103 121 129 135 139 143

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