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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///
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