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1
Introduction
By any measure, the National Institutes of Health (NIH) is an important com-
ponent of a vast international humanitarian enterprise aimed at a better understand-
ing of human health, prevention and relief of the burdens of disease, and promotion
of good health throughout the stages of life. It is an optimistic endeavor predicated
on the belief that human life can be improved through scientific investigations
coupled with the rational and ethical applications of their findings. It is an enter-
prise full of moral relevance because it contributes to the interests of current and
future generations and to the commitment to reduce health disparities.
In Democracy in America (~1835), French statesman Alexis de Tocqueville wrote
of what he perceived as the peculiarly American pursuit of good health. Although
achieving that goal remains elusive for many Americans, since the middle l900s the
US government has invested generously in biomedical research,] believing that such
activities would have great long-term benefits for the health of American citizens
and others. There is broad agreement among the American people, Congress, and
the Executive Branch that investing in biomedical research is socially desirable
because of its health benefits, its capacity to increase understanding of the human
condition, and its potential to directly or indirectly yield economic dividends. The
assumption that federally funded scientific research generates economic and other
benefits for the country has been fundamental to US science policy since the end of
1Biomedical research in this report includes all the following categories of research: fundamental
(basic), applied, behavioral, bioengineering and biotechnology, clinical, dental, health, health services,
nursing, outcomes, population-based, prevention, public health, rehabilitative, and therapeutic.
17
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18
Enhancing the Vitality of the National Institutes of Health
World War II (Bush, 19451. As Donald Stokes pointed out in Pasteur's Quadrant
(1997), the American public deeply values such investment in science "not only for
what it is, but what it's for."
The investment in human health improvement has paid handsome dividends.
Age-adjusted rates of heart disease and stroke continue to decline, there has been a
modest but encouraging decrease in cancer death rates, life expectancy continues to
rise, infant mortality rates are falling, and the field of genomics has advanced to the
point where promising new therapeutic agents are under development by biotech-
nology and pharmaceutical companies. The knowledge gained from biomedical
research and the large cohorts of highly trained biomedical scientists continue to be
among the nation's most valuable resources. Nevertheless, new public health con-
cerns, chronic illnesses, emerging or re-emerging infectious diseases, and persistent
health disparities constitute continuing challenges for our biomedical and health
care research enterprise.
For nearly 65 years, the federal agency primarily responsible for sponsoring and
conducting biomedical research has been the NIH. NIH is one of eight agencies of
the Public Health Service (PHS), which is part of the Department of Health and
Human Services (DHHS).2 NIH accounts for about 80% of federal funding of
biomedical research and development (R&D); the Department of Defense (DOD) is
the second largest supporter, at 6% (NIH, 20021. Since its formation, Congress and
the Executive Branch have supported steady increases in NIH's budget. NIH is the
largest public source of funding for biomedical research in the world, with an
annual budget of about $27 billion. In early 2003, Congress approved an FY 2003
budget containing a 16% increase over the previous year that completed the planned
5-year doubling of NIH's budget.
NIH, by most accounts, has long been considered one of the most effective and
well-managed elements of the federal government and a centerpiece of its R&D
system. From one categorical institute at the end of World War II, it has evolved
into a federation of 27 major institutes and centers as of 2003 (see Chapter 2 for
further discussion), each conducting and sponsoring research and related activities
on aspects of human health and disease through grants and contracts to scientists in
universities and other nonfederal research institutions.
To ensure its continued effectiveness, NIH must respond in a rapidly changing
environment that is characterized by a renewed appreciation of the complexity of
human biology; the increasing need for cooperation among biomedical and related
disciplines and scientists working in different sectors; growing investments in bio-
medical research by the US corporate sector and other countries; the need to deal
2The other seven are the Agency for Healthcare Research and Quality, the Agency for Toxic Sub-
stances and Disease Registry, the Centers for Disease Control and Prevention, the Food and Drug
Administration, the Health Resources and Services Administration, the Indian Health Service, and the
Substance Abuse and Mental Health Services Administration.
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Introduction
with new institutional arrangements in the broader scientific enterprise that generate
additional incentives, conflicts, and constraints; and developments on the scientific
frontier that, for example, require changes in the technologies used, the organiza-
tion of research teams, and the active engagement of participants in clinical research.
Equally important are the effective management of the rapidly expanded NIH budget
and the challenge of managing the many organizational components of NIH-
. . ,,.
Institutes, centers, anc offices.
ONE IMPETUS FOR THIS REPORT
A persistent subject in discussions about the organization and future of NIH is
the continued growth in the number of institutes, centers, and other programmatic
and organizational components that have been mandated by congressional initiative
in response to the demands of various interest groups. Several NIH directors have
raised concerns about such growth. Former Director Tames Wyngaarden, in con-
gressional testimony arguing against the creation of another institute in 1982,
pointed out that "there is virtually no end to the possibilities for creation of addi-
tional categorical institutes." From a scientific viewpoint, Wyngaarden noted the
mismatch between the categorical structure of NIH and trends in research toward
investigating the basic life processes that underlie all health and disease and away
from the symptoms of specific diseases in isolation. From a managerial point of
view, Wyngaarden raised the question of whether organizational complexity tends
to be counterproductive (U.S. Congress, 19811.
Harold Varmus, the most recent NIH director to suggest that the agency is
becoming unmanageable through continued proliferation, opposed the establish-
ment of NIH's two newest units, the National Institute of Biomedical Imaging and
Bioengineering (NIBIB) and the Center for Minority Health and Health Disparities
(NCMHD). He argued that establishing program coordination units in the director's
office was preferable to creating new institutes and centers for cross-cutting fields
(such as bioimaging) that should not be isolated as separate entities. He also
expressed a disinclination to add to the number of units that have to be managed.3
Although he began to raise the issue in various forums during the last years of
his tenure as NIH director (Dennis, 1999), Varmus laid out his analysis and pro-
posed solution most fully in an article published in Science (Varmus, 2001) after his
departure from NIH. He acknowledged the political advantages of establishing new
institutes and centers but argued that NIH would be more effective scientifically and
more manageable if it were organized into a far smaller number of larger institutes
3For example, congress recommended that NIH establish an office of sioimaging and sioengineering'
an idea that former NIH Director Harold varmus welcomed. However, varmus cautioned that estab-
lishing a new Institute of sioengineering and sioimaging was not a good idea because such activities
benefit more by being distributed among the full range of institutes and centers at NIH (NIH, 1999).
19
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Enhancing the Vitality of the National Institutes of Health
organized around broad fields of science.4 Consolidating the existing institutes into
five entities "would organize the science in a rational way" (Dennis, 1999~.
Others, including many biomedical investigators, argue that at the current time
the elimination of institutes, centers, or offices that focus on particular sets of
problems would mean that research on the problems would not receive sufficient
attention and funding and that a consolidation of units would reduce congressional
and public support. Those arguments were put forth by many of the organizations
and individuals that wrote or spoke to the committee. Moreover, there is a percep-
tion that given the substantial increases in resources and the vast expansion of the
biomedical enterprise, the addition of institutes and centers has provided for the
expression of a broader set of priorities and expanded political support and budget
success both for the specific interests involved and for NIH in the aggregate. While
everyone understands that this expansion cannot and should not continue indefi-
nitely, many see no particular difficulty with the current number of institutes and
centers.
Many of the arguments against the formation of additional institutes and cen-
ters have focused on the adverse managerial and programmatic consequences at the
NIH level (the opposite of the arguments for new institutes that stress the beneficial
consequences of having one institute focused on a disease category or set of related
problems) the likelihood that a new institute or center will increase the share of
the budget going to overhead because each institute has a director, senior staff, and
administrative units, although some of these would be needed even if the program
were kept or established in an existing unit.
Other arguments against adding institutes have had substantive grounds. In
particular, there has been recurrent concern that adding an institute in a particular
field could dilute, rather than concentrate, efforts in it. For example, many were
concerned that the new NIBIB would reduce the commitment of other institutes to
important opportunities in biomedical imaging and bioengineering. The same argu-
ment was made against creating the separate NCMHD: there was concern that
establishing such a center would lead other institutes and centers to decrease their
commitments to work in minority health.
4In 2001, varmus proposed a redistribution of NIH into six units of approximately equal sizes and
budgets. Five of these would be categorical institutes, committed mainly to groups of diseases the
National cancer Institute, the National Brain Institute, the National Institute for Internal Medicine
Research, the National Institute for Human Development, and the National Institute for Microbial and
Environmental Medicine. Each of these would contain several major divisions for extramural research
and an intramural research program. Each would also house offices to coordinate research training,
international science, minority and women s health, and other activities, both within and among the five
institutes. The sixth unit, NIH Central, would be led by the NIH director, to whom the directors of the
five institutes would report. NIH Central would have responsibility for policies across NIH (e.g., on
intellectual property, personnel management, or training programs), the peer-review process, scientific
infrastructure (e.g., information technology, buildings and facilities, including the intramural Clinical
Research Center), and thematic coordination (through links to the offices in each of the five institutes).
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Introduction
All institutes and most centers are legislatively mandated, receive their own
funding, and enjoy a constituency base that, given other characteristics of NIH's
environment, can reduce the organizational flexibility that less federated organiza-
tional structures give industry and many other government agencies, such as the
National Science Foundation (NSF). In addition, as the number of institute and
center directorships has increased, the recruiting and administrative burden on the
NIH director has become substantial. Although some argue that NIH is becoming
unmanageable, others believe that this is not the case and that substantial consolida-
tion might not be programmatically desirable or politically feasible. In fact, some
believe that the complex decentralized organization developed over the years has
made NIH more effective in responding to research opportunities and public needs
and aspirations and is an important source of its success (Congressional Budget
Office, 20021.
In addition to the issues surrounding the proliferation of units, recent changes
in biomedical science and how it is conducted may also raise questions beyond the
narrow matter of the number of components in the organization. For example,
research is becoming more interdisciplinary, more dependent on a common set of
research tools and technologies (including costly large-scale infrastructure, such as
supercomputers and imaging machines), and more focused on fundamental processes
that underlie many diseases.5 Many of those developments increase the benefits of a
strategic and coordinated effort among institutes and centers in some fields and may
call for a more strategic NIH-wide approach to emerging challenges than has been
traditional at NIH. Those emerging opportunities do not necessarily argue for a
reduction in the number of units at NIH so much as for a change in the qualitative
nature of the work conducted and the depth and breadth of interactions among the
units.
Other trends also have caused some to believe that a review of the organiza-
tional structure of the agency is necessary. For example, demographics and patterns
of illness in society are changing and investment by the private sector is growing,
which has altered the terrain of some areas of research in a manner that could call
for an adjustment in the role of NIH within the broader biomedical enterprise.
Pharmaceutical and biotechnology companies now spend more than NIH on
research and development well over $46 billion per year (Pharmaceutical Research
and Manufacturers of America, 2001; Biotechnology Industry Organization, 20031.
In addition, the Bayh-Dole Act (PL 96-517, Patent and Trademark Act Amend-
ments of 1980) created a uniform patent policy among the many federal agencies
that fund research, enabling small businesses and nonprofit organizations, including
universities, to retain title to inventions made in federally funded research pro-
grams, thereby creating a new congressionally mandated responsibility of NIH to
5These trends have been cited by NIH leaders. See, for example, the remarks of Director Elias
Zerhouni at a field hearing held by a subcommittee of the House Science Committee (Jenkins, 2002a)
and presentations by Acting Director Ruth Kirschstein (Kirschstein, 2001; Haley, 2001).
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Enhancing the Vitality of the National Institutes of Health
.
further technology transfer and commercialization of its research results by the
private sector.
As a result of the steady stream of change, there have been persistent and
growing concerns in Congress and in some parts of the scientific community about
whether NIH has become too fragmented to address effectively the most important
biomedical and health challenges or to respond quickly enough to health emergen-
cies or economic challenges. Despite those persistent concerns, NIH has never been
administratively reorganized in any substantial way, but only added to, despite vast
changes in the landscape of science and the nation's health concerns during the last
half century.
CONGRESSIONAL REQUEST AND STATEMENT OF TASK
In report language that accompanied the FY 2001 appropriation act, Congress
directed NIH to have the National Academy of Sciences study "whether the current
structure and organization of NIH are optimally configured for the scientific needs
of the twenty-first century."6 Senate report 106-293 states:
The Committee is extremely pleased with the scientific advances that have been
made over the past several years due to the Nation's support for biomedical research
at NIH. However, the Committee also notes the proliferation of new entities at
NIH, raising concerns about coordination. While the Committee continues to have
confidence in NIH's ability to fund outstanding research and to ensure that new
knowledge will benefit all Americans, the fundamental changes in science that have
occurred lead us to question whether the current NIH structure and organization
are optimally configured for the scientific needs of the Twenty-first Century. There-
fore, the Committee has provided to the NIH Director sufficient funds to under-
take, through the National Academy of Sciences, a study of the structure of NIH.
In response to the congressional request, the goal of this study was to determine
the optimal NIH organizational structure, given the context of 21st century bio-
medical science. The following specific questions were to be addressed:
1. Are there general principles by which NIH should be organized?
2. Does the current structure reflect these principles, or should NIH be restruc-
tured?
a. If restructuring is recommended, what should the new structure be?
6HRpt 106-1033, "Conference Report to Accompany H.R. 4577 - Making Omnibus Consolidated
and Emergency Supplemental Appropriations for Fiscal Year 2001," December 15, 2000, endorsed the
language in the Senate report calling for the NAS study of the NIH structure and asked for a report
within a year of the appointment of the new NIH Director. See SRpt 106-293, "Departments of Labor,
Health and Human Services, and Education and Related Agencies Appropriation Bill, 2001," May 12,
2000.
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Introduction
4. How will the proposed new structure improve NIH's ability to conduct
biomedical research and training, and accommodate organizational growth
in the future?
5. How would the proposed new structure overcome current weaknesses, and
what new problems might it introduce?
The Committee on the Organizational Structure of the National Institutes of
Health was formed to ensure that the views of the basic science, clinical medicine,
and health advocacy communities were all adequately represented. The Committee
also included persons who were experienced in the management of large and
complex organizations, including a former NIH director, two former NIH institute
directors, a former university president, two individuals with backgrounds as senior
managers of major industrial entities, and a specialist in organizational issues.
Several Committee members also had considerable experience in government
operations.
The Committee held six 2-day meetings over the 10 months between July 2002
and April 2003. In its initial meetings it invited past and present representatives of
Congress, NIH, voluntary health groups, scientific and professional societies, and
industry to provide perspectives on the issues before them (see Appendix A). In
addition, the Committee met publicly with the current NIH director as well as
several former directors. Committee members and staff also heard presentations
from or interviewed NIH staff in the offices of policy and planning, budget, finance,
and intramural research, and met with directors of 18 institutes or centers. Data
about NIH programs and budgets were requested from NIH staff as the need
emerged. Prior reports conducted about and for NIH were reviewed, as was the
relevant literature. In addition, the Committee commissioned a background paper
tracing the history and evolution of NIH and its institutes as a starting point for its
deliberations (McGeary and Smith, 20021. Finally, several Committee members
conducted town meetings at their home institutions and elsewhere, inviting scientists,
administrators, and students to contribute their perspectives. Thus, the Committee
was able to hear, consider, and discuss a diverse range of facts and opinions about
the organizational structure of NIH. Its final report and recommendations are,
however, based on the Committee's assessment of both the information available
and current trends in biomedical science and health.
THE COMMITTEE'S RESPONSE TO ITS CHARGE
This study focused on the organizational structure of NIH, but that cannot be
addressed satisfactorily without considering the mission of NIH, some of its key
processes, and the scientific and social-political environment in which NIH activities
take place. Although a long series of past reviews of NIH helped inform committee
deliberations, the nature of the charge and the 1-year period allowed for delibera-
tions constrained the development, character, and scope of the recommendations
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Enhancing the Vitality of the National Institutes of Health
that the Committee could credibly put forward. Most important, the committee
was not asked to address NIH's research priorities or the quality and effectiveness
of the wide array of research and advanced training programs that NIH undertakes
or sponsors.
Even a relatively narrowly defined focus on the organizational structure of NIH
was challenging because of the need to disentangle structure, procedure, policies,
achievements, criticisms, and priorities. For example, the Committee debated
whether its charge referred solely to the number of institutes and centers that can be
effectively and responsibly managed or could it also assess the role and authority of
the NIH director? Should the nature, role, and scope of the intramural research
program be discussed because the program is a key structural element of NIH? Over
the years many talented and energetic scientists have occupied various leadership
positions at NIH and introduced a wide variety of innovative organizational initia-
tives. Many of these initiatives have been successfully implemented in individual
institutes, centers, and offices, but they have not moved easily from unit to unit or
survived changes in leadership. What managerial mechanisms might ensure the
widespread adoption of best practices by the institutes, and how might they be
adopted or strengthened in place of or in conjunction with structural reorganiza-
tion? One could pose numerous additional questions in an attempt to understand
and define the set of activities, processes, and procedures encompassed by the term
"organizational structure." And such questions cannot even be approached with-
out considering the role and mission of NIH.
The Committee's view of those complexities was governed by the desire to be of
some practical assistance to all those who wish NIH to continue to be an effective-
indeed, outstanding organization. The Committee therefore took its task to include
assessing the organizational configuration of NIH both its quantitative and quali-
tative aspects and the key processes and authorities that play roles in NIH-wide
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. In addition, Elias Zerhouni, the current NIH director,
suggested to the committee at its first meeting that it would be useful for the
committee to concentrate on and assess eight specific issues:
1. The effectiveness of governance mechanisms.
2. The effectiveness of decision-making processes across and within the insti-
totes.
3. The balance between centralization and decentralization.
4. The need for better management tools (NIH-wide standards and methods).
5. The development of mechanisms to allocate (or redirect) resources across
NIH.
6. Mechanisms for coordination of science.
7. The ability of the NIH leadership to hold institutes accountable.
8. The need for strategic human resources policies.
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Introduction
Based on the advice it received from former and current NIH directors as well
as its conversations with congressional staff, throughout its deliberations the Com-
mittee kept a number of broadly conceived organizational ideas in mind. First,
scholars of organizational management (e.g., Waterman et al., 1980) have long
recognized that there is more to "organization" than structure. An organization's
ability to make effective changes is influenced by a multiplicity of factors beyond the
number of units on or shape of its organizational chart, for example strategy,
structure, systems, staff capabilities, shared values, and behavior. "Systems" refers
to all the formal and informal processes and procedures that organizations rely on
to function. The word "organized" calls the question: Organized to do what? The
answer typically is: Organized to build new institutional capability or new skill in
this case, for example, the institutional skill to adapt research and training pro-
grams to the new demands of science. To respond to change, an organization must
work out its strategy preferably mixed strategies and, if necessary, restructure in
order to implement those strategies. Also it will have to change other dimensions of
the way it organizes itself to respond. In line with these views, the Committee
believes that many potential changes in aspects of NIH other than the number of
blocks on its organizational chart could improve its overall effectiveness and help it
to stay at the cutting edge of biomedical research.
Therefore the Committee considered numerous proposals for restructuring NIH
in great detail7 but did not focus exclusively on whether or not there should be a
widespread consolidation of NIH's institutes and centers. Rather, it took a more
general approach, namely to inquire if there were any significant organizational
changes including the widespread consolidation of institutes and centers that
would allow NIH to be even more successful in the future. Although the Committee
discussed on numerous occasions the advisability of the widespread consolidation
of NIH, it eventually came to believe that this was not the best path for NIH to take
at this time.
It is important to understand that the structure of any large and complex
organization, such as NIH,is not the tidy result of a compact set of compelling
7In their background paper prepared for this committee, McGeary and Smith (2002) summarized the
published responses to the varmus proposal and the results of their interviews on this topic. In addition,
at its inaugural meeting, July 30-31, 2002, the committee heard from Bernadine Healy, NIH director
from 1991 to 1993, who suggested grouping NIH in four quite different ``clusters,, 1) federal laborato-
ries and the clinical center to deal with emergency issues; 2) health and disease institutes; 3) medical and
scientific institutes; and 4) a national research capacity (e.g., NCRR, NLM, large clinical trials
capability). Dr. Healy was not opposed to forming more institutes she even suggested two new units
for nutrition and rehabilitation. She noted, however, that abolishing institutes is easier said than done.
This was reiterated by former Illinois Representative and House Appropriations Subcommittee Chair
John Porter, who told the group that any attempt to eliminate individual institutes will likely meet
strong political resistance. He urged the committee to think of ways to eliminate duplication and
increase consolidation and accountability.
25
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Enhancing the Vitality of the National Institutes of Health
propositions emanating from organizational theory any more than the particular
organization of our complex pluralistic democracy is the result solely of the inspired
thinking of political philosophers. The latter is instead the outcome of our particu-
lar form of politics and, therefore, heavily influenced by our particular history and
evolving cultural commitments. It is very much the same way with NIH. It would be
naive to assume that NIH was or should be organized exclusively along the lines
dictated either by the imperatives of the scientific agenda or the priorities of any
other single set of interests with a concern about promoting health-related research
and advanced biomedical training. Rather NIH's existing structure is the result of a
set of complex evolving social and political negotiations among a variety of con-
stituencies including the Congress, the administration, the scientific community, the
health advocacy community, and others interested in research, research training,
and public policy related to health. Indeed the history of NIH provides clear evi-
dence that each of these communities has always had a variety of views on the
appropriate organization of NIH. From any particular point of view or for any
particular set of interests, the current situation is not only imperfect, but is certainly
not one that either the Congress or the scientific community would designate ab
initio. Rather it has evolved as a very useful and largely productive outcome of a
series of political and social negotiations that took place over time. This outcome is
typical of the design of important social organizations in a pluralistic democracy.
NIH has become an organization that balances its many interests and the Committee
felt that any major modification at this point in time should focus directly on
enhancing NIH's capacity to pursue major, but time-limited, strategic objectives
that cut across all the institutes and to acquire a special ability to pursue more high-
risk, high-return projects. It was our view that at this moment the widespread
consolidation of institutes and centers should not be a high priority as the benefits
to be gained would not sufficiently offset the costs involved, particularly when there
are other available options that could achieve the same benefits.
What does the Committee mean by "costs"? At a minimum, because Congress
created the institutes, dissolving or merging institutes would require congressional
action. Any thoughtful major reorganization would necessitate a lengthy and com-
plex information gathering and decision making process that would include
numerous congressional hearings involving members of Congress, congressional
staff, and a wide variety of interests in the various health advocacy and scientific
communities. Our discussions, correspondence, and meetings made it quite clear
that there would be very little agreement among these communities on what the
right way to reorganize NIH is, and there would probably be dozens of conflicting
ideas in play and few clear avenues for narrowing these down. Moreover these
discussions and negotiations would be long and contentious ones and with a quite
uncertain outcome. More importantly, the Committee is firmly convinced that
many of the goals that might be achieved through large-scale consolidation of
institutes could also be achieved more rapidly and effectively through other organi-
zational and administrative mechanisms, as recommended in this report.
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Introduction
Nevertheless, the Committee did fee! that no organization as important as NIH
should remain frozen in organization space and that some regular, thoughtful, and
publicly transparent mechanism is required to allow changes to take place at appro-
priate times. Although the Committee does believe that the consolidation of two
pairs of institutes is appropriate at this time, it felt that this issue ought to have the
benefit of the public process it has recommended.
Thus, as laid out in this report, the Committee did not find a compelling
intellectual argument for widespread consolidation of institutes and centers at this
time. It did, however, identify numerous opportunities for organizational change to
improve the agency's responsiveness and flexibility and makes several suggestions
for adopting an array of strategies to better accomplish NIH's research mission.
The Committee was aware that all organizational changes, however well
thought out, carry both potential risks and benefits, and it has done its best to sort
these out. It also recognized that the decentralized structure of NIH, which allows
many people throughout the scientific and advocacy communities to help to set
priorities, has been and should continue to be an integral element in NIH's success.
The current structure of NIH allows the public to see its many faces. The Commit-
tee believes that this has been a very useful organizational response to a complicated
set of scientific and political influences. The Committee was particularly mindful of
the need to sustain the coalition that has made NIH the success that it is today. In
addition, the Committee kept the enormous benefits of investigator-initiated grants,
including those focused on fundamental research, firmly in mind during its delibera-
tions. Finally, the Committee understood that the quality of leadership and decision-
making at all levels, as opposed to administrative structures, is central to NIH's
ongoing vitality. In the long run, the recruitment of outstanding leadership, the
commitment to individual scientists as the main sources of new discoveries, and
reliance on the competitive review system for determining awards will continue to
be essential to NIH's continuing success.
That NIH has been working well does not mean that it could not work better
if in response to changes on the scientific frontier, to changes in health concerns,
or to other important environmental shifts some organizational changes were
made. The intent of this report is to assess the current organizational structure of
NIH and to suggest modifications that might be appropriate to make NIH even
more effective in supporting research essential to the long-term goal of improving
human health.
GENERAL PRINCIPLES BY WHICH NIH SHOULD BE ORGANIZED
NIH accomplishes its objectives through the design, organization, administra-
tion, and management of extramural and intramural research and training pro-
grams and the provision of specialized research facilities that support the programs.
In broad scope, NIH's priorities focus on scientific research that is most likely to
shape the understanding, diagnosis, treatment, and prevention of society's most
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Enhancing the Vitality of the National Institutes of Health
important health challenges. That focus includes strong support of fundamental
scientific research that is aimed at improving our understanding of organisms,
processes, biological systems, and individual and societal risk factors broadly be-
lieved to be relevant to human health. It also embraces support of graduate and
postgraduate training needed to ensure an adequate supply of scientists to continue
to study those important health concerns.
An evaluation of NIH's priorities requires explicit recognition of a number of
interrelated factors. Most important in this respect is an understanding of the evolv-
ing nature of the scientific enterprise, which includes not only the changing nature
of science itself, but also the evolving role of other institutions and disciplines, both
here and abroad, that have generally similar aims as well as the changing nature of
our health concerns. Recognition of the global nature of medical and health prob-
lems and their relevance to the interests and health of the people of the United States
warrants special mention. Finally, and perhaps most obvious, the level of resources
available to NIH clearly will affect the profile and extent of NIH's activities. Effec-
tive management of its resources is especially challenging now because of the pace of
scientific developments, new health priorities, the changing institutional structure of
the biomedical research enterprise, and recent rapid budget growth.
In going about its task, the Committee first addressed the opening question in
its statement of task: "Are there general principles by which NIH should be orga-
nized?" Only by arriving at an early determination of NIH's principal overall func-
tion and the mechanisms in place to achieve its mission could the Committee ad-
equately address the other items in its charge. Thus, an overarching mission and the
mechanisms needed to meet it became the basis of the remainder of the committee's
tasks. The recommendations developed by the Committee focus on modifications in
basic policies and organizational structure that are designed to assist NIH in per-
, . . . . .
forming its primary function.
The success of NIH in meeting its various challenges and, in particular, fulfilling
its mission to improve health through the use of science to develop new knowledge
has been outstanding. All those who have contributed to the creation and dynamic
evolution of the NIH the institutions it has supported, the scientists and health
professionals who have created so much knowledge and understanding, and the
American people and their elected representatives have helped to reduce
humankind's burden of disease, disability, and premature death. NIH has also been
successful in catalyzing changes at the frontiers of science. Those changes and the
recent doubling of NIH's budget make this an appropriate time to consider whether
the organizational structures that have served NIH and the world so well in the past
remain appropriate for its future roles.
The charge to this Committee is worded in the form of a series of questions
about whether there are general principles around which NIH should be organized.
In the context of evaluating NIH's organizational structure, the Committee decided
to describe the principles as they relate to NIH's overall mission and the basic
policies, structural and otherwise, adopted to achieve it. In the end, the Committee
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Introduction
agreed that articulating its view of the mission of NIH would provide the appropri-
ate foundation to guide its deliberations:
NIH's principal mission
. . . . . .
is to serve as a mechanism for efficiently and effectively
oopioy~ng federal resources across a wide array of institutions and individuals in
the nation's scientific community to advance the scientific frontier and ensure re-
search and training in fields of special relevance to human health needs.8
Some might view this mission as stopping short of the goals of public health,
that is, not including the goal to directly improve human health. The Committee
was cognizant of the tension that exists among the scientific, medical, patient, and
political communities about expectations of NIH. It concluded, however, that
improving health as much as it is critically dependent on accurate and adequate
science is a goal that also involves health providers, industry, and policy makers
and is influenced by social and economic factors that range far from the research
mission of NIH. Moreover, NIH is but one of eight DHHS agencies charged with a
health-related mission. The other agencies Agency for Healthcare Research and
Quality, the Centers for Disease Control and Prevention, the Agency for Toxic
Substances and Disease Registry, the Food and Drug Administration, the Health
Resources and Services Administration, the Indian Health Service, and the Sub-
stance Abuse and Mental Health Services Administration also focus on health and
complement the research mission of NIH. There is no question that these agencies
must work together even more effectively to ensure that there is a continuum of
federal effort and concern regarding improved health for all Americans.
Based on its view of NIH's mission, the Committee agreed that there follows
from this fundamental charge a list of subprinciples or basic policies and approaches
that, if adhered to, would allow NIH to achieve its mission:
'. 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
8NIH states its mission as "science in pursuit of fundamental knowledge about the nature and behavior
of living systems and the application of that knowledge to extend healthy life and reduce the burdens of
illness and disability" (NIH, 2001).
29
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30
Enhancing the Vitality of the National Institutes of Health
sector support, such as prevention, some therapeutic strategies, and many
rare diseases.
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.
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.
6. The intramural research program 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 enterprise with
appropriate mechanisms of accountability and quality control.
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 01 electives.
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.
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.
ORGANIZATION OF THE REPORT
To place the Committee's analysis and recommendations in context, Chapter 2
provides background information about the evolution of the structure and organi-
zation of NIH. Chapter 3 focuses on examples of how new discoveries are changing
the conduct, review, and evaluation of science and addresses whether the NIH
structure is suitably configured to adapt to these changes and to promote them.
In Chapter 4, the Committee focuses on the NIH structure itself and processes
for merging, consolidating, or expanding the number of its components, including a
proposal to revitalize and integrate clinical research.
Chapter 5 provides ideas and suggestions for reorganization that could facili-
tate the conduct of increasingly important trans-NIH scientific research and enhance
NIH's ability to maintain itself at the leading edge of scientific progress. The chapter
proposes changes that would enhance the NIH director's authority, particularly as
related to trans-NIH initiatives that should begin to constitute a larger proportion
of NIH activities, mechanisms for fostering high-risk research, and the intramural
research program.
Chapter 6 discusses issues related to NIH's need to be publicly and financially
accountable through its advisory and review processes, data systems, leadership,
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Introduction
and administrative efficiency, including the budgetary and administrative issues
related to managing a large research organization.
Chapter 7 summarizes the recommendations made in the report in the context
of their consistency with the principles and basic policies elucidated in this intro-
duction.
SUMMARY
NIH will continue to be influenced both by scientific developments and by a
changing political landscape and growth in the numbers and sophistication of scien-
tific and health advocacy groups. Interests will converge or conflict depending on
the degree to which issues are influenced by such factors as the state of the economy
and the federal budget. It may seem easier to innovate and cooperate when the
budget is increasing, but rapidly increasing budgets can also overwhelm good plan-
ning and long-term strategic thinking. In any case, it is clear that when budget
growth slows, especially in an era of great opportunity and need, difficult decisions
arise and priorities are affected.
Independently of budget issues, NIH is increasingly called on to perform in a
coordinated way to address key research subjects that involve multiple institutes
and to respond to immediate public health needs. An important question is whether
NIH's federated and decentralized structure, as currently configured, can respond
adequately and in a timely manner to those challenges. This report makes a series of
recommendations aimed at increasing and enhancing NIH's ability to accomplish its
. .
mission.
31
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Table 2-1
Current Program Offices in the Office of the Director
Year
Office Established
Office of AIDS Research 1988
Office of Research on 1990
Women's Health
Office of Disease 1985
Prevention, which includes
the Office of Rare Diseases
(1993), Office of Dietary
Supplements (1995), and
Office of Medical
Applications of Research
(1977)
Office of Behavioral and 1995
Social Sciences Research
Major Focus
Planning, coordination, evaluation, and funding of all NIH
AIDS research and support of trans-NIH coordinating
committees in areas of AIDS research
Focal point for women's health research at NIH, including
establishment of a research agenda; inclusion of women as
participants in NIH-supported research; and support of women
in biomedical careers
Coordination of disease prevention activities, advice to director
on disease prevention research; promotion and coordination of
NIH-wide research on rare or orphan diseases and on the role of
dietary supplements in health; work with institutes and centers
to assess, translate, and disseminate results of biomedical
research that can be used in delivery of health services
Stimulation of behavioral and social science research throughout
NIH and its integration with other research conducted or
supported by NIH
The Budget Process
To understand how NIH has evolved, it is important to unclerstand its funding
environment and budget process (see Figure 2.2~. NIH's statutory authority comes from the
Public Health Service Act (PHSA) of 1944, as amended (42 U.S.C., et seq.~. Some institutes
and several programs (training and facilities construction) are subject to time and dollar
authorizations that require periodic renewal by Congress.~3 The last authorization, the NTH
Revitalization Act of 1993, lapsed in 1996 (P.~. 103-434; the effort to renew the authorization in
~ 996 failed because of conflict over provisions about the use of fetal tissue in research. There
have been no further efforts to pass a general reauthorization of NIH.~4
Since ~ 996, NTH has operated on the basis of annual appropriation bills, although
technically appropriations amounting to nearly half of NIH's funding are unauthorized. In the
absence of authorizations, the appropriation committees, in their legislation ant! report language,
have provided guidance that is similar to the guidance that authorizing committees enact. From
time to time, bills to make specific changes in the PHSA are introduced; sometimes they are
passed, such as the one that established NIBIB in 2000 (P.~. 106-580) and the one that
establisher! centers of excellence for research on the muscular dystrophies in 2001 (P.~. 107-84~.
13 The War on Cancer Act of 1971 was the first to impose time and dollar limits on an institute.
14 The 1994 authorization for the National Institute of Mental Health, the National Institute on Alcohol Abuse and
Alcoholism, and the National Institute on Drug Abuse (P.L. 102-321) has also lapsed. See Congressional Budget
Office, 2002.
32
Representative terms from entire chapter:
intramural research
