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Executive Summary
The continued growth in the number of organizational units of the National
Institutes of Health (NIH) has been a cause of both concern and celebration for
decades. Numerous NIH officials and external advisory committees have suggested
that the continued creation of new units (institutes, centers, and programmatic
offices) could impair NIH's functioning by making it unmanageable and impeding
its ability to carry out its mission. Most recently, former Director Harold Varmus
argued in a 2001 article in Science that NIH would be more effective scientifically
and more manageable if it were organized into a far smaller number of larger
institutes organized around broad areas of science. Others counter that the elimina-
tion of units that focus on particular problems would reduce attention to and
funding for these problems and that a consolidation of units would reduce congres-
sional and public support and might not be politically feasible. More generally,
recent rapid increases in resources, fundamental shifts on the biomedical frontier,
and evolving health concerns make it a good moment to review whether the organi-
zational structure of NIH continues to be appropriate.
Clearly many changes have taken place in the world of science and in the nature
of the health concerns that research must address. Since the late 1990s, the NIH
budget has doubled to its current level of about $27 billion as a result of congres-
sional and presidential initiatives. In science, the importance of multi-institutional,
multidisciplinary research that relies more and more on large infrastructural invest-
ments is ever more apparent. Demographics and the patterns of illness in society are
changing, and the specter of intentional releases of harmful disease organisms by
terrorists has emerged following the attacks of September 2001. The private sector's
investments in some fields of research have increased to the point where pharmaccu-
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Enhancing the Vitality of the National Institutes of Health
tical and biotechnology companies now spend more than NIH on research and
development.
With the steady stream of change, concerns about whether NIH has become too
fragmented to address effectively the most important biomedical and health
challenges or to respond quickly enough to health emergencies have resurfaced in
Congress and in some parts of the scientific community. NIH has never been
administratively reorganized in any substantial way, only added on to, despite vast
changes in the landscape of science and the nation's health concerns during the last
half century.
CONGRESSIONAL REQUEST
In report language accompanying the FY 2001 appropriation for the Depart-
ment of Health and Human Services (DHHS), Congress directed NIH to have the
National Academy of Sciences study "whether the current structure and organiza-
tion of NIH are optimally configured for the scientific needs of the twenty-first
century." 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.
STATEMENT OF TASK
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 research. 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?
3. If restructuring is recommended, what should the new structure be?
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?
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Executive Summary
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. In addition, the
committee had members who are experienced in the management of large and
complex organizations, including a former NIH director, two former NIH institute
directors, a former university president, two persons with backgrounds in senior
management of major industrial entities, and a specialist in organizational issues.
Several Committee members also had considerable experience in government
operations.
The Committee held six two-day meetings over the ten months between July
2002 and April 2003. In its initial meetings it invited past and present representa-
tives 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 the information that was avail-
able and current trends in biomedical science and health.
THE COMMITTEE'S RESPONSE TO ITS CHARGE
The goal of the study focused on the organizational structure of NIH, but it was
not possible to address this issue satisfactorily without considering the mission of
NIH, some of its key processes, and the scientific, social, and political environment
in which NIH activities take place. Although a long series of reviews of NIH helped
to inform committee deliberations, both the nature of the charge and the 1-year
period allowed for deliberations put important constraints on the development,
character, and scope of the recommendations that could credibly be 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.
The Committee's view of its task was governed, first, by the desire to be of some
practical assistance to all those who wish NIH to continue to be an outstanding
3
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Enhancing the Vitality of the National Institutes of Health
organization. Scholars of organizational management 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, including structure, strat-
egy, and systems, the last of which includes all the formal and informal processes
and procedures that organizations rely on to function. Thus, the Committee
proceeded on the premise that its task included assessing both the organizational
configuration of NIH and the key processes and authorities that play roles in NIH-
wide decision-making. Although the borders between structure, mission, and
priorities are not well defined, the Committee tried not to take too expansive a view
, . . . . .
ot its response ~1- ltles.
Therefore, the Committee 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
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 particular
form of politics and, therefore, heavily influenced by our 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 interests of the scientific community or the priorities of any other single
set of interests with a concern about promoting health-related research and advanced
biomedical training. NIH's existing structure is the result of a set of complex evolving
social and political negotiations among a variety of constituencies including the
Congress, the administration, the scientific community, the health advocacy com-
munity, and others interested in research, research training, and public policy related
to health. Indeed the history of NIH provides clear evidence 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
modifications at this point in time should focus directly on enhancing NIH's capac-
ity to pursue major time-limited strategic objectives that cut across all the institutes
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Executive Summary
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
is not the next best organizational step for NIH to undertake, as any benefits to be
gained would be offset by the costs involved.
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
complex 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.
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 appropriate changes in the
organizational structure of NIH to take place at appropriate times. Although the
Committee does believe that the consolidation of two pairs of institutes is appropri-
ate to consider at this time, it felt that these issues ought to have the benefit of the
public process we have recommended.
The Committee was also well aware that all organizational changes, however
well thought out, potentially carry both potential risks and benefits, and it has done
its best to sort these out. The Committee recognized that the decentralized structure
of NIH, which allows a large number of 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 Committee also kept the enormous benefits
of investigator-initiated grants, including those focused on fundamental research,
firmly in mind during its deliberations. Finally, the Committee understood that it is
the quality of leadership and decision-making at all levels, as opposed to adminis-
trative structures, that are central to NIH's vitality. In the long run, the recruitment
of outstanding leadership, the commitment to individual scientists as the main
sources of new discoveries, and the reliance on the competitive review system for
determining awards will be essential to NIH's continuing success.
The fact that NIH has been working well does not mean that it could not work
better if in response to changes on the scientific frontier, new health concerns, or
other important environmental shifts some organizational modifications were
made. The intent of this report is to assess the current organizational structure of
s
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Enhancing the Vitality of the National Institutes of Health
NIH and to suggest modifications that might be appropriate to help NIH to become
even more effective in supporting research essential to the long-term goal of improv-
ing human health.
CENTRALIZATION OF ADMINISTRATIVE FUNCTIONS
NIH is an agency of the Department of Health and Human Services (DHHS),
which has recently issued instructions to consolidate administrative functions, such
as personnel management, communications, congressional liaison, and travel,
throughout the Department. The "One HHS" initiative has the stated goal of better
integrating management functions across the department's operating and staff divi-
sions. The initiative has already resulted in consolidation of some administrative
functions at NIH. DHHS has further plans for consolidating other functions at
NIH, such as budgeting, finance, and procurement, and is encouraging NIH to
consider outsourcing some of its administrative functions.
While the Committee believes that it is critical that government continue
attempts to eliminate inefficiencies, it would not serve anyone if such initiatives
result in decreasing the effectiveness of NIH as a research and training organization
or damage its ability to recruit talented leaders at all levels. Centralization of
certain functions can be effective, but is not always the best means to achieve
increased efficiencies. At times, centralization serves everyone's interests, but at
other times it serves no one's interests. The Committee believes that initiatives to
centralize or outsource from NIH key science-related functions that are difficult to
separate from the performance of its primary mission, such as aspects of grants
management, fail to appreciate how closely these administrative functions are tied
to the scientific enterprise.
Recommendation 1: Centralization of Management Functions
Any efforts to consolidate or centralize management functions at NIH, either
within NIH or at the DHHS level, should be considered only after careful study
of circumstances unique to NIH and its successes in carrying out its research
and training mission. A structured and studied approach should be used to
assure that centralization will not undermine NIH's ability to identify, fund,
and manage the best research and training proposals and programs in support
of improving health.
ORGANIZATIONAL STRUCTURE OF NIH
NIH's continuing success has been due largely to its ability to adapt to meet the
ever-changing needs and challenges posed by science, medicine, and public health.
Moreover, there is a perception that given the substantial increases in resources and
the vast expansion of the biomedical enterprise, the addition of institutes and centers
has been productive and has provided an ever broader base of support and budget
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Executive Summary
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.
The Committee carefully considered major structural changes in NIH, including
possible revisions in the number and reporting lines of institutes and centers (ICs) to
the director. The Committee considered numerous proposals for restructuring NIH
in great detail. However, as laid out in this report, it did not find a compelling
intellectual argument for major structural alterations at this time. Rather the
Committee makes recommendations for achieving many of the goals identified by
proponents of major restructuring (more authority for the NIH director, increased
responsiveness, greater flexibility, and more opportunity for coordination) primarily
by other means.
Many previous reports have suggested that increasing the number of ICs at NIH
would make it less effective. Thus, the present Committee is hardly the first to
consider these problems and deliberate over potential solutions. The Committee
notes, however, that little changed as a result of past studies. The trend toward
continued growth in the number of units in NIH has continued to the present in the
absence of an accepted process such as that suggested in the 1984 Institute of
Medicine report. The Committee believes therefore that it would be useful for
Congress to consider amending the authorizing legislation for NIH to require that
certain steps be taken in considering the creation, dissolution, or consolidation of
. . .
Organizational units.
Recommendation 2: Public Process for Considering Proposed Changes in the
Number of NIH Institutes or Centers
Either on receiving a congressional request or at the discretion of the NIH
director in responding to considerable, thoughtful, and sustained interest in
changing the number of institutes or centers, the director should initiate a
public process to evaluate scientific needs, opportunities, and consequences of
the proposed change and the level of public support for it. For a proposed
addition, the likelihood of available resources to support it should also be
assessed and the burden of proof should reside clearly with those seeking to add
an organizational element.
Despite the Committee's conclusion that a large-scale restructuring of the ICs
would not be wise now, no organization that is expected to remain effective should
have to bear the burden of a frozen organizational structure, and not all its existing
units are likely to continue to have the same relevance or independence in the future.
Therefore, the public, the scientific community, or the director of NIH, in concert
with internal and external advisers, should be able to suggest additions, subtractions,
or mergers of units to Congress at appropriate times. The Committee provides two
suggestions for potential mergers for further study: the merger of the National
7
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Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcohol-
ism and the merger of the National Institute of General Medical Sciences and the
National Human Genome Research Institute. Indeed, the Committee favors these
mergers, but believes that such changes should benefit from use of the process
outlined above. However, because of extraordinarily persuasive arguments about
exceptional needs made by a variety of groups in discussions with the Committee, it
recommends merging several clinical research components of the extramural and
intramural programs to create a National Center for Clinical Research & Research
Resources.
~ ~ . . . . .
Recommendation 3: Strengthen Clinical Research
NIH should pursue a new organizational strategy to better integrate leadership,
funding, and management of its clinical research enterprise. The strategy should
build on but not replace existing organizational units and activities in the
individual ICs' intramural and extramural research programs. It should also
include partnerships with the nonprofit and private sectors. Specifically, the
Committee recommends that several intramural and extramural programs be
combined in a new entity to subsume and replace the National Center for
Research Resources, to be called the National Center for Clinical Research and
Research Resources (NCCRRR). In addition, a deputy director for clinical
research should be appointed in the Office of the Director to serve as deputy
director and head of the new entity.
ENHANCING NIH'S ABILITY TO RESPOND TO NEW CHALLENGES
Although the Committee is not recommending a major structural reorganiza-
tion of NIH's institutes and centers, it concluded that to meet the scientific and
health goals of the nation, NIH needs new mechanisms for mobilizing and coordi-
nating funding from many units for high-priority initiatives that cut across the
purviews of individual ICs. Although co-funding of projects by multiple institutes
occurs, it is not clear to what extent these projects are true "end-to-end" collabora-
tions. Thus, "multi-institute funding" should be distinguished from "trans-NIH
initiatives," in which planning and implementation of activities involves more than
one institute from start to finish. The Committee believes that the best means to
achieve mobilization and coordination of new cross-cutting initiatives is through
the initiation via NIH-wide strategic planning of a rotating series of multiyear, but
time-limited, strategic initiatives that involve all the ICs.
Recommendation 4: Enhance and Increase Trans-NIH Strategic Panning and
Funding
a. The director of NIH should be formally charged by Congress to lead a trans-
NIH planning process to identify major crosscutting issues and their associated
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research and training opportunities and to generate a small number of major
multi-year, but time limited, research programs. The process should be con-
ducted periodically perhaps every 2 years and should involve substantial
input from the scientific community and the public.
b. The director of NIH should present the scientific rationale for trans-NIH
budgeting to the relevant committees of Congress, including a proposed target
for investment in trans-NIH initiatives across all institutes. For example, an
average target of 5% of overall NIH funding in the first year, growing to 10%
or more over 4-5 years, may be appropriate.
c. The appropriations committees should annually review budget justifications
and testimony from the NIH director and from individual IC directors about
the participation of each unit in the planned trans-NIH initiatives and the
portion of their budgets so directed. Congress should include budget targets in
the appropriations report language. The Committee recommends beginning
with 5 % of the overall NIH budget.
d. To ensure that each IC uses the target proportion of its budget for trans-NIH
initiatives of its choosing, that proportion of the annual appropriation to each
unit should be treated as "in escrow" until the NIH director affirms that the
unit has committed to its expenditure for the identified trans-NIH initiatives.
e. The President should include in the budget request, and Congress should
include in the NIH appropriation for OD, funds to support an appropriate
number of additional full-time staff to conduct the trans-NIH planning process
and "jump-start" the initiatives that emerge from this process.
To carry out the responsibilities of managing, planning, and coordinating the
programs of NIH's 27 ICs, the NIH director is assisted by a number of staff units
collectively called Office of the Director (OD) Operations. The budget for OD
Operations has not grown in proportion to NIH's research funding and is inade-
quate for the effective management of the organization. When unforeseen needs
surface, the OD is likely to have to "pass the hat" to the ICs to gather the additional
resources needed.
Recommendation 5: Strengthen the Office of the NIH Director
The Office of the Director should be given a more adequate budget to support
its management roles or greater discretionary authority to reprogram funding
from the earmarked components of its budget when necessary to meet unantici-
pated needs. In particular, if the director is given the responsibility and authority
to conduct NIH-wide planning for trans-NIH initiatives, the director's budget
will need to be amplified to take the costs of such planning into account.
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The earmarking of funds by Congress for the establishment and continuation of
programmatic offices in OD sometimes limits the director's flexibility and fluidity of
resources, as well as his or her ability to effect change across the organization. It is
difficult to ascertain whether the programmatic offices within OD have achieved
their intended goals. The time may be right to assess the effect that the program-
matic offices in OD have had, including their role in the NIH director's policy and
planning processes, whether the programs have clear goals, and whether there is a
need to "sunset" an office once it achieves its goals. The Committee believes that
the process recommended in Chapter 4 for evaluating the merits of proposed addi-
tions to or subtractions from the list of ICs should also be applied to the creation of
new offices in OD itself.
Recommendation 6: Establish ~ Process for Creating New OD Offices and
Programs
The public process recommended in Chapter 4 (Recommendation 2) for evalu-
ating a proposal to create a new institute or center or to consolidate or dissolve
institutes or centers should also be used for a proposal to create, consolidate, or
dissolve offices in OD. The process should be used to evaluate the scientific
needs, opportunities, and consequences of the proposed change, the likelihood
of resources being available to support it, and public support for it.
The pressures that exist in organizational environments such as NIH's may
make it difficult to undertake high-risk research even though such research may
offer potentially high payoff. The Committee also believes that there is a need for a
director's Special Projects Program that is outside the budgets of the ICs and is
funded as an OD line item. The goal of the program would be to provide a
mechanism to augment the funding of high-risk, innovative research projects. In a
broad sense, the Committee imagines the program to be patterned after the Defense
Advanced Research Projects Agency (DARPA).
Recommendation 7: Create ~ Directors Special Projects Program
A discrete program, the director's Special Projects Program, should be estab-
lished in OD to fund the initiation of high-risk, exceptionally innovative research
projects offering high potential payoff. The program should have its own
leader, who reports to the director of NIH, and a staff of short-term (2-4 years)
program managers to manage identified projects with advice on program con-
tent from extramural panels. The program should be structured to permit rapid
· · · ~ · ~ · · · ·' · · ~
review ant 1nltlatlon ot promising projects; 1t peer review IS ~ .eemec appropriate,
the program should use peer review panels created specifically for it and charged
with selecting high-risk, high-potential return projects. Congress should be
prepared to provide new funding in the amount of $100 million, growing to as
much as $1 billion per year for this endeavor, and commit to support it for at
least 8-10 years so that a sufficient number of projects can reach fruition and a
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full assessment of program efforts can be made. A program review should be
conducted during the fifth year to provide mid-course guidance.
The Committee is convinced that the Intramural Research Program (IRP) of
NIH should not be merely an internal extension of the extramural community but
rather should be doing distinctive research that the extramural community cannot
or will not undertake. The Committee believes that too little weight has been placed
on potentially distinctive contributions of the IRP and that both uniqueness and
quality should be essential justifications of the IRP.
Recommendation 8: Promote Innovation and Risk Taking in Intramural Research
The intramural research program should consist of research and training pro-
grams that complement and are distinguished from those in the extramural
community and the private sector. The intramural program's special status
obligates it to take risks and be innovative. Regular in-depth review of each
component of the intramural program should occur to ensure continuing
excellence. Allocation of resources to the intramural program should be closely
tied to accomplishments and opportunities. Inter-institute and intramural-
extramural collaborations should be supported and enhanced.
ACCOUNTABILITY, ADMINISTRATION, AND LEADERSHIP
Public accountability and leadership are key aspects of NIH's stewardship of
the biomedical enterprise. The Committee has suggested several ways for NIH to
enhance its public accountability and ensure the continuing vitality of its leadership.
The current deficiencies in information management methods and infrastructure
to collect, analyze, and report level-of-investment data in a timely fashion must be
addressed. The problem requires the development of an NIH-wide agreement on
what to track and publish and of a single method for coding data that uses consistent
definitions and deals with the uncertainties inherent in counting research when it is
only related but not directly applicable to a specific topic. Once developed, the
statistics should be kept current and their accuracy ensured through quality control.
NIH must also improve its tracking and analysis of the research accomplishments of
scientists trained and supported with NIH funds.
Recommendation 9: Standardize Data and Infor~nation Management Systems
For purposes of meeting its responsibilities for effective management, account-
ability, and transparency, NIH must enhance its capacity for the timely
collection, thoughtful analysis, and accurate reporting of the nature and status
of its research and training programs and public health advances. Data should
be collected consistently across institutes and centers and submitted to a cen-
tralized information management system.
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The vision of the NIH leadership regarding accountability and the procedures
and structures that the leadership adopts to enhance it are perhaps the most impor-
tant ingredients in the complex mix of policies and strategies that enable NIH to
meet its responsibilities to all its constituents. Leadership and vision may influence
particularly the extent to which accountability is reinforced and implemented at
diverse levels of the NIH system, from top management through staff to individual
intramural and extramural investigators. In the current NIH environment, reviews
of the performance of senior members of management a form of public account-
ability are too informal and ad hoc to be effective. Moreover, the processes and
criteria for review are not obvious or well defined. These reviews should consider
the extent to which the institute/center director promotes the effectiveness of NIH as
an overall entity, including supporting trans-NIH initiatives. By communicating, as
appropriate, the results of reviews to the NIH director's advisory groups, the IC
directors can demonstrate an additional level of accountability. While some aspects
of a review should be held as confidential, those elements that relate directly to the
mission and objectives of NIH should be made available to the director's advisors.
The Committee also believes that a healthy degree of turnover in leadership is
critical for sustaining the vitality of a research organization. It would provide oppor-
tunities for leading scientists across the nation to leave their positions for a set
period to come to NIH as a form of public service to provide effective scientific
leadership to critical elements of the nation's biomedical enterprise.
Recommendation 10: Set Terns and Conditions forIC Director Appointments
and Improve IC Director Review Process
a. All IC directors should be appointed for 5-year terms. The possibility of a
second and final term of 5 years should be based on the recommendation of the
director of NIH, which should include consideration of the findings of an
external review of job performance. The authority to hire and fire IC directors
should be transferred from the secretary of Health and Human Services to the
NIH director.
b. The director of NIH should establish a process of annual review for the
performance of every IC director in terms of his or her effectiveness in fulfilling
scientific and administrative responsibilities. The results of such reviews should
be communicated, as appropriate, to the Advisory Committee to the director
and/or the Council of Public Representatives.
The Committee conclucleci that review and revitalization of OD is an essential
prerequisite for accountability and leaclership. It noted that the National Science
Foundation Act of 1950 creates a term of 6 years for the National Science Founcia-
tion director and conclucleci that this has been a good mocle! for creating a system of
accountability and periodic review that has the possibility of transcending changes
. . . .
In ac ministrations.
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Executive Summary
Recommendation 11: Set Terms and Conditions for the NIH Director
Appointment
The NIH director, appointed by the President, should serve for a term of
6 years unless removed sooner by the President. The possibility of a second and
final term of 6 years should be based on a positive external review of perfor-
mance and the recommendation of the secretary of Health and Human Services.
The committee believes that the special status granted the National Cancer
Institute (NCI) by the National Cancer Act should be re-examined. Because the
President appoints the NCI director and the NCI budget bypasses the NIH director,
it is possible that an unnecessary rift is created between the goals, mission, and
leadership of NIH and those of NCI. For scientific and administrative reasons, this
special status should be reconsidered.
Recommendation 12: Reconsider the Status of the National Cancer Institute
Congress should reassess the provisions of the National Cancer Act of 1971,
particularly as they affect the authority of the NIH director to hire senior
management and plan and coordinate the NIH budget and its programs in their
entirety.
Like other federal science agencies, NIH makes extensive use of advisory com-
mittees (variously known as study sections, councils, boards, etc.) of nonfederal
scientists, health advocacy representatives, and others to ensure the best possible
input of expertise and additional perspectives on the evaluation of programs and the
development of policies and priorities. NIH had over 140 chartered advisory com-
mittees as of May 2002, more than any other federal agency. The secretary of
Health and Human Services appoints 32 committees, the NIH director appoints 74,
and the President appoints 2. In the appointment process, the President generally
follows the recommendations of the secretary and the secretary generally follows
the advice of the NIH and institute directors in filling positions, although they add
their own candidates from time to time. At times in the past, administrations have
tried to exert greater control over NIH, and there has been conflict over the per-
ceived politicization of the advisory committee appointment process. The Commit-
tee believes that it is essential that members be appointed to these advisory groups
because of their ability to provide scientific or public health expertise to the review
and approval of awards and policies. They should not be selected to advance political
or ideological positions.
There are substantial differences among institutes in the uses and roles of advi-
sory councils; some are actively involved in establishing institute goals, and others
are restricted to pro forma actions, with little advice or involvement sought by
institute personnel. Advisory councils should routinely and consistently be con-
sulted in the priority setting and planning processes of an institute, have active
involvement in decisions regarding issuance of program announcements and requests
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for applications, and work to ensure that the institute is held accountable in reach-
ing its goals and communicating with the public. The manner in which institute
directors interact with their advisory councils should be a criterion for IC director
reviews.
Recommendation 13: Retain Integrity in Appointments to Advisory Councils
and Refrain Advisory Council Activity and Membership Criteria
a. Appointments to advisory councils should be based solely on a person's
scientific or clinical expertise or his or her commitment to and involvement in
issues of relevance to the mission of the institute or center.
b. The advisory council system should be thoroughly reformed across NIH to
ensure that these bodies are consistently and sufficiently independent and are
routinely involved in priority-setting and planning discussions. Councils should
be effectively engaged in discussions with IC leadership to enhance accountabil-
ity, facilitate translation of goals and activities to the scientific community and
the public, and provide feedback to the IC director. To achieve sufficient inde-
pendence and avoid conflicts of interest, a substantial proportion of a council's
scientific membership should consist of persons whose primary source of
research support is derived from a different institute or center or from outside
NIH.
Although it is desirable to keep administrative and overhead costs as low as
possible, appropriate funding for these costs is essential to the effectiveness of any
organization, including those that sponsor research and training programs. At NIH,
the resources for those functions (for example, management of extramural activities,
some intramural research program costs, program development, priority setting,
education and outreach, acquisition and maintenance of new information tech-
nology systems, professional development, and facilities management) flow through
the Research Management and Support (RMS) budgets of the various units that
make up NIH. In the early l990s, Congress imposed limitations on RMS that
restricted its growth. In the middle l990s, RMS was reduced, and little growth has
been allowed since. In FY 2001, RMS represented 3.3% of the total NIH budget,
down from 4.5°/O in 1995. The RMS share of the total NIH budget has decreased
every year since FY 1993. The committee feels that the effectiveness of NIHis now
imperiled by the lack of adequate resources to provide appropriate support both for
its primary research mission and for meeting its accountability responsibilities.
Recommendation 14: Increase Funding for Research Management and Support
Congress should increase the appropriation for RMS to reflect more accurately
the essential administrative costs required to effectively operate a world class
$27 billion/year research organization effectively. Moreover, when additional
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Executive Summary
congressional mandates are imposed on NIH through the appropriations pro-
cess, they should include funds to cover necessary administrative costs.
Whether needs and opportunities will be accommodated in existing NIH
units or proliferation or consolidation will occur in the near future is an issue to be
addressed by future administrations, Congress, the scientific community, and the
public. NIH will continue to be shaped by the dynamics of many interacting con-
stituencies and influences. Interests will converge or conflict, depending on the
issue. The degree of convergence and divergence will continue to be influenced by
other important factors such as the level of annual congressional appropriations to
NIH. The recommendations made in this report are intended to help NIH to con-
tinue to be responsive, accountable, and effective in its leading role in the vast
international humanitarian enterprise of biomedical research aimed at a better
understanding of the human condition, the prevention and relief of disease, and the
promotion of good health throughout the stages of life.
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Representative terms from entire chapter:
advisory councils
