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6
Accountability, Administration, and
Leadership
Public accountability and leadership are key aspects of the National Institutes
of Health's (NIH's) stewardship of the biomedical enterprise because of the impera-
tives to maintain public trust, reassure Congress that the public's interest is being
served, and ensure that NIH's tactical and strategic objectives for its research and
training programs are thoughtfully selected, effectively pursued, and responsive to
NIH's research mission, national health concerns, and the need to prepare the next
. . . .
generation ot sclentlsts.
Accountability is a critical and challenging aspect of leadership. It is especially
challenging for an organization like NIH, which serves a broad array of constituen-
cies and is devoted to research and training, in which outputs can be difficult to
measure, market discipline is largely absent, and there is incomplete agreement on
what metrics are the most appropriate. On the one hand, too mechanistic a system
of accountability may fail to capture the nuances of scientific progress and indeed
may stifle it or lead to an illusion of precision. On the other hand, too loose a system
of accountability may lead not only to a potential loss of public confidence and trust
but also to uncertainty about whether NIH's efforts are achieving, even in an
. . . .
approximate way, its ol electives.
This chapter focuses on means by which NIH can enhance its public account-
ability and ensure the continuing vitality of its leadership, both of which are influ-
enced by and have a capacity to alter the agency's organizational effectiveness.
Specifically, the Committee focused on the need for improved NIH-wide data
gathering and coordination, increased attentiveness to hiring and review of senior
leaders, and better use of the advisory committee system. Important additional
aspects of NIH's ability to meet its scientific and public health mission are the
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Enhancing the Vitality of the National Institutes of Health
availability of sufficient resources in its management-support network to accom-
plish its goals, and the ability to direct administrative functions in the best interest
, . . . . .
Ot its research ~ anc training mission.
ANNUAL MECHANISMS FOR PUBLIC ACCOUNTABILITY
Each year, NIH must complete two processes for accounting to Congress and
the President on its progress in meeting its goals, conforming to its mission, and
justifying its request for appropriations for the next fiscal year. Those processes,
developing the budget and responding to the Government Performance and Results
Act (GPRA) of 1993, are not sufficient to meet all accountability needs but they do
provide useful starting points.
The Budget Process: Congressional Justification
Every fall, each institute or center (IC) with an appropriation must prepare a
congressional justification budget (the CT) that details accomplishments of the pre-
ceding year, current initiatives, and plans.) The process of preparing the CT is labor-
intensive; programs in each IC are surveyed for data and material considered crucial
for justifying programs and budgets. Each IC's information is submitted to the
Office of the Director (OD), where it is reviewed and then compiled with all the
other IC's CTs and submitted to the Office of Management and Budget (OMB). The
exception to this process is the National Cancer Institute (NCI), which under the
National Cancer Act of 1971 develops a "bypass budget" that goes directly to the
President and OMB.
The budget process is, perhaps, the most powerful accountability mechanism
used by NIH, forcing the agency and its various units to justify their places in the
programs of the President. It is both a planning and an accountability process. As in
other federal agencies, the deadlines of the budget process drive the planning and
priority-setting process. In addition, the capacity to influence the congressional
appropriation process is one of the major ways in which NIH leadership can coor-
dinate activities across NIH. Thus, development of the annual CT provides the
perfect opportunity for NIH to respond to the Committee's call for more investment
in trans-NIH initiatives, as described in Chapter 5. If all ICs were required to
account for trans-NIH activities in their CJs, the NIH director, the Secretary of
Health and Human Services, and Congress would have a better sense of progress in
this category of work.
iThe formal title is "Justification of Estimates for Appropriations Committees." The CJ has a section
for each IC, consisting of a set of tables and budget narrative (see Department of Health and Human
Services, 2002).
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Accountability, Administration, and Leadership
The New Approach to the Government Performance and Results Act
Under GPRA, every major federal agency must ask itself some basic questions
every year: What is its mission? What are its goals and how will it achieve them?
How can it measure performance? How will it use performance results to make
improvements?
GPRA forces a shift in the focus of federal agencies away from such traditional
concerns as staffing and activity levels toward a single overriding issue: results.
GPRA requires agencies to set goals, measure performance, and report on accom-
plishments annually. Every NIH IC goes through an annual process in which
program managers are asked to review their portfolios for scientific accomplish-
ments that provide evidence of meeting goals and missions.
Until 2003, NIH tracked the success of its programs through a comprehensive
overview of its progress by reviewing and compiling scientific advances and external
recognition of NIH-supported investigators. Starting in 2003, however, NIH is
using more specific and transparent goals to measure research outcomes; the Com-
mittee supports this change.
The new framework being used by NIH characterizes goals on the basis of the
likelihood that they will be attained and the time targeted for completion. For
FY 2004, there are 27 goals arranged according to their likelihood of success and
years to completion; the longest time line is set at 10 years (Table 6.11. According to
NIH, the goals must be credible to researchers, the public, and other NIH stake-
holders and should be as specific as possible to address definable problems. Goals
that lend themselves to annual reporting and reports of incremental progress are
encouraged. NIH goals must also coordinate with the overall Department of Health
and Human Services (DHHS) plan, as well as those of the Centers for Disease
Control and Prevention (CDC), the Agency for Healthcare Research and Quality
(AHRQY, the Food and Drug Administration, the DHHS "Healthy People 2010"
initiative, and the President's Management Agenda.
COUNCIL OF PUBLIC REPRESENTATIVES
NIH created the Council of Public Representatives (COPR) and Public Liaison
Offices in response to an Institute of Medicine (IOM) report (IOM, 1998), which
recommended that such bodies be created to formalize and systematize communi-
cation with the public at the highest levels of NIH. The scope and activities of
COPR are evolving, but its charge is broad. COPR is a federal advisory committee
of 21 members of the public from across the country who are chosen through an
open nomination and application process. Its role is to advise the NIH director on
public input and participation in NIH's activities, research priority setting, and
outreach programs and efforts. Thus, COPR provides a formal mechanism for
public input at the level of the NIH director, but there are multiple additional
opportunities for public input across NIH. In addition, each institute has public
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Enhancing the Vitality of the National Institutes of Health
TABLE 6.1 NIH GPRA Research Outcomes
RISK 1-3 years 4-6 years 7-10 years
High la Conduct medications 2a By 2007, demonstrate 3a Identify at least one
development with use of the feasibility of islet clinical intervention that
animal models, and begin transplantation in will delay the progression,
to conduct Phase I and II combination with immune delay the onset, or prevent
trials of two potential tolerance induction for Alzheimer's disease.
treatments for alcoholism: the treatment of type 1
cannabinoid antagonist diabetes in human clinical 3b By 2010, develop one
Rimonabant and studies. universal antibiotic effective
corticotropin-releasing against multiple classes of
hormone antagonist 2b By 2009, evaluate the biological pathogens.
Antalarmin. efficacy of two novel
approaches to prevent 3c Determine the efficacy of
lb By 2006, develop one weight gain and/or treat using salivary diagnostics to
or more prototypes for a obesity in clinical trials monitor health and diagnose
low-power, highly in humans. at least one systemic disease
directional hearing aid by 2013.
microphone to help 2c Develop methods that
hearing-impaired persons can classify at least 75%
better understand speech of proteins from
in a noisy background. sequenced genomes
according to evolutionary
origin and biological
structure.
2d By 2007, develop an
HIV/AIDS vaccine.
continues
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Accountability, Administration, and Leadership
TABLE 6.1 Continued
RISK 1-3 years 4-6 years 7-10 years
4a By 2005, develop two
new animal models to use
in research on at least one
agent of bioterror.
4b By 2005, develop
improved animal models
that best recapitulate
Parkinson's Disease (PD)
5a By 2007, evaluate the
efficacy of three new
treatments for HIV
infection in phase II/III
human clinical trials in
an effort to identify drugs
that are more effective,
less toxic, and/or simpler
to use than the current
based on emerging scientific recommended HIV
findings of genetic or treatment regimen.
environmental influences,
or interactions of genes
and the environment on
the development of PD.
4c By FY 2007, identify
20 small molecules that
are active in models of
nervous system function
or disease and show
promise as drugs,
diagnostic agents, or
research tools.
5b Establish the
,.. . . .
ettlcacy ot statlns In
. · ,
preventing progression or
atherosclerosis in children
with Systemic Lupus
Erythematosis (SLE or
lupus ) .
5c Expand the range of
available methods to be
used to create, analyze,
and utilize chemical
libraries, which can be
used to discover new
medicines. Specifically,
use these chemical
libraries to discover 10
new and unique chemical
structures that could
serve as the starting point
for new drugs.
6a Identify the genes that
control the risk for the
development of age-related
macular degeneration and
glaucoma in humans.
6b By 2011, assess the
efficacy of at least three new
treatment strategies for
reducing cardiovascular
morbidity/mortality in
patients with type 2 diabetes
and/or chronic kidney
disease.
6c By 2012, develop a
knowledge base on
Chemical Effects in
Biological Systems using a
"systems toxicology" or
toxicogenomics approach.
continues
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Enhancing the Vitality of the National Institutes of Health
TABLE 6.1 Continued
RISK 1-3 years 4-6 years 7-10 years
7a By 2005, evaluate 10
commonly used botanicals
for inhibition/induction of
enzymes that metabolize
drugs as a method of
identifying potential
botanical/drug
interactions.
7b By 2006, integrate
nanotechnology-based
components into a system
capable of detecting
specific biomarker(s)
(molecular signatures) to
establish proof of concept
for a new approach to the
early detection of cancer,
and, ultimately, cancer
preemption.
7c By 2005, create the
next generation map
of the human genome,
a so called "haplotype
map" (HapMap), by
identifying the patterns
, . . .
at genetic varlatlon
across all human
chromosomes.
Low
8a By 2007, determine
the sequence of an
additional 45 human
pathogens and three
invertebrate vectors of
infectious diseases.
8b Identify and
characterize two
molecular interactions
of potential clinical
significance between
bone-forming cells and
components of bone.
Such interactions are
defined as those having
. ... .
slgnlilcant Impact on t :le
accrual of bone mass or
the actual mechanical
performance of bone
(i.e., fracture resistance
in laboratory animals).
8c Build a publicly
accessible Collection of
Reference Sequences to
serve as the basis for
medical, functional, and
diversity studies. A
comprehensive Reference
Sequence Collection will
serve as a foundation for
genomic research by
providing a centralized,
integrated, non-redundant
set of sequences, including
genomic DNA, transcript
(RNA), and proteome
(protein product)
sequences, integrated with
other vital information
for all major research
organisms.
9a By 2009, assess the
. , .
impact ot two major
Institutional Development
Award (IDeA) programs on
the development of
competitive investigators and
. . .
t :lelr capacities to compete
for NIH research funding.
9b By 2010, demonstrate
through research a capacity
to reduce the total years lost
to disability (YLDs) in the
U.S. by 10% by:
1) developing treatment
algorithms to improve the
management of treatment-
resistant and recurrent
depression and
2) elucidating the
mechanisms by which
depression influences at least
two comorbid physical
illnesses (e.g., heart disease,
cancer, Parkinson's disease,
or diabetes). Major
depression is now the
leading cause of YLDs in
the nation.
9c By FY 2010, identify
culturally appropriate,
effective stroke prevention
programs for nationwide
. . . . . .
Implementation In minority
. .
communities.
Source: National Institutes of Health, 2003.
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Accountability, Administration, and Leadership
relations activities with a major focus on communicating with and receiving input
from diverse stakeholders.
COPR provides a relatively new opportunity for receiving public input and
increasing accountability to a broad constituency. These and other institutional
changes within NIH were designed to increase public accountability, although there
has been no formal evaluation of the impact of these changes on indicators of public
accountability. Furthermore, no criteria have been proposed to assess and monitor
public accountability or the effectiveness of mechanisms to improve or assure it at
different levels.
CHALLENGES TO ACHIEVING PUBLIC ACCOUNTABILITY
The committee heard anecdotal evidence that priority setting-criteria often are
not transparent to the interested public (for example, voluntary health organiza-
tions) and that efforts to follow indicators of success have been limited by lack of
well-developed data systems suitable for tracking expenditures and research, train-
ing, and other NIH-sponsored activities in relation to institutional goals or priorities.
Because the American public is diverse, it is difficult to know what degree of
public accountability is achievable at various levels, and how broadly public
accountability should be implemented. Likewise, the public is likely to have divided
views on what constitutes or fulfills public accountability. Indeed, in practice much
of the monitoring of accountability may fall to advocacy organizations, which may
or may not represent the diverse views of the spectrum of individuals suffering from
various illnesses. Such organizations also might not advocate health research that
cuts across diseases; this may lead to tensions over the accountability mechanisms
used by Congress and the administration, including for example the level of appro-
priations for particular ICs, the formation of new ICs, NIH leadership approval,
and program and project mandates included in authorizations and report language.
Given the barriers at both levels of translation (described in Chapter 3 and Sung
et al., 2003), another challenge to addressing accountability is the weak link be-
tween research results on the one hand and public knowledge and perceptions of
their significance, potential impact, and NIH's role on the other. Several institute
directors told the Committee that when NIH-supported extramural research results
are reported, credit is given primarily to the investigators and their institutions
without linking them to NIH's support. Giving credit to individual ICs may also
minimize the importance of NIH's combined efforts. Thus, media acknowledgment
of NIH's role is often minimal or absent, and this can create misleading impressions
of NIH's public accountability. NIH officials told the committee that although there
is no overarching (NIH-wide) communication plan, efforts are under way to develop
one that mirrors the agency's "Roadmap," one that will review research plans from
the perspectives of various audiences to determine whether NIH is communicating
effectively. There is no doubt that communicating the depth and breadth of NIH's
activities and missions is a challenging task, but doing so and doing so with credibil-
109
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Enhancing the Vitality of the National Institutes of Health
ity is essential to bolstering public confidence in the agency and enhancing its
accountability.
DATA GATHERING AND REPORTING
A related problem in achieving accountability is that, given the large research
and training portfolio of NIH, it is difficult to track NIH's many scientific contribu-
tions and make information about them available in a manner that is understand-
able to all constituents. One of the most common types of questions asked by
Congress and the public is how much research on specific diseases is being funded?
Such data provide only an approximation of the level of effort devoted to objectives,
but individuals and groups concerned about specific diseases or health problems
often use them as a measure of input and effort to assess aspects of the NIH research
and training portfolio of most interest to them. Even NIH officials complained to
the Committee that such data are difficult to gather and are usually suspect because
each IC uses its own method to estimate its investment. Although senior
management at NIH has long recognized that the absence of a standard method for
"coding" is a serious problem, no concerted effort to develop one has yet produced
results.
NIH officials often point out that statistics on spending by disease may not be
very useful precisely because there are no simple relationships between measures of
the burden of disease and how NIH allocates funding. Health needs are an impor-
tant factor, but there is rarely a straightforward one-to-one relationship between
health needs and research funding allocations, let alone estimated incidence, preva-
lence, or burden of disease. Furthermore, the scientific opportunities for progress
vary greatly among diseases in sophistication of the current knowledge base,
promising lines of inquiry, and availability of sufficient researchers and facilities.
Therefore, the amount of research support that can be linked directly to a specific
disease not only is difficult to establish but is not by itself an adequate measure of
how much or how well NIH is progressing against the disease. Nor does it reflect
the potential relevance of basic research to multiple specific diseases (IOM, 1998) in
that it is sometimes difficult to know which research is most relevant to the health
problem involved.
Despite those challenges, the Committee concludes that the current lack of an
information management method and infrastructure to collect, analyze, and report
investment data in a timely fashion must be addressed. It is particularly important
for NIH leadership to improve the quality and analysis of its data on the allocation
of NIH funds by disease for planning and priority-setting purposes. The problem
requires the development of an NIH-wide agreement on what to track and publish
and a single method for coding data that uses consistent definitions and deals with
the uncertainties inherent in counting research that 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 information management
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Accountability, Administration, and Leadership
must also be improved to meet goals in tracking scientists trained and supported
with NIH funds.
NIH is currently instituting substantial upgrades in its business, grant tracking,
and clinical research-protocol IT systems, but these upgrades will not address the
problem under discussion here. The committee recognizes that developing an addi-
tional informatics system to gather data on the nature of NIH's diverse research and
training programs consistently and uniformly is likely to be expensive and time-
consuming and will require substantial resources and personnel. However, the
development of such a system would provide invaluable information to all parties
interested in NIH's programs Congress, other Executive Branch agencies, the pub-
lic, the research community, and the leadership of NIH itself. Indeed, the effective
management of NIH's research and training programs require such a capacity,
which therefore would constitute a worthwhile investment. It also would provide
the most reliable information for consideration of proposals to add, merge, or
eliminate institutes, centers, and offices. Congress, which is likely to be one of the
main beneficiaries of an improved information system, should consider the need for
additional resources for this purpose in the budget process.
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 collec-
tion, thoughtful analysis, and accurate reporting of the nature and status of its
research and training programs and public health advances. Data shouic! be
collected consistently across institutes and centers and submitted to a central-
· · ~ ~
Alec information management system.
BUILDING ACCOUNTABILITY THROUGH LEADERSHIP
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
the extent to which accountability is reinforced and implemented at diverse levels of
the NIH system, from top management through staff and to individual intramural
and extramural investigators.
Although there have been performance plans for IC directors and senior scien-
tists since Director Harold Varmus established them in the 1990s, the current
administration has required a formal performance assessment for all supervisory
personnel throughout the government. All supervisory personnel at NIH therefore
are required to develop a "performance contract" listing the items each person is
accountable for, which is the basis of an annual assessment. The NIH director must
negotiate his or her performance contract with the Secretary of Health and Human
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Enhancing the Vitality of the National Institutes of Health
Services. Likewise the NIH director negotiates a contract with each of the more than
40 people who are his direct reports.
The earlier system for performance plans was general in its approach, but the
new contracts are more specific, for example, "increase the prevention and public
awareness of diabetes." Relevant items cascade down from the top; for example,
the diabetes goal is in the President's contract with the Secretary, who then delegates
it to the NIH director, who assigns it to the appropriate senior staff. Thus, the
performance contracts are a mechanism for senior management to convey what is
important to their subordinates. Outreach and communication factors are major
items in the contracts of IC directors.
IC directors are also involved in two other types of review:
Every 5 years, IC directors are reviewed for their overall performance,
including scientific leadership, management of their institute or center, and
outreach and communications.
Every 4 years, IC directors who conduct their own research are evaluated
scientifically, as are all intramural scientists. That means that the Board of
Scientific Counselors of the institute in which the research is performed
oversees the review. Most directors conducting their own research do so in
another institute to avoid conflict of interest.
Most senior government officials are in the top ranks of the government service
system or in the Senior Executive Service (SES) and are covered by a variety of civil
service provisions under Title 5 of the personnel law that protect them from dis-
missal and loss of rights without considerable effort on the government's part. But
salaries for SES personnel are capped. To be able to offer higher salaries and attract
the nation's most distinguished scientists, NIH obtained permission 10 years ago to
place its senior positions under Title 42 of the law. Title 42 allows NIH to offer
higher salaries, although people hired under this authority lose many of the civil
service protections provided under Title 5 and must accept 5-year terms as opposed
to permanent employment. Most directors chose to move into the Title 42 pro-
gram, so they are, in fact, already subject to 5-year renewable terms. Under this
system the Secretary of Health and Human Services retains approval authority for
appointments. Thus, the NIH director can only recommend, but not appoint, senior
leadership in the agency. The committee concludes that this lack of authority hinders
the ability of the NIH director to form a cohesive senior leadership team to achieve
NIH goals.
The committee also concludes that in the current NIH environment, reviews of
leadership a form of public accountability are too informal and ad hoc to be
effective. The processes and criteria for review are not obvious or well defined. One
of the more obvious criteria for review, in addition to scientific excellence and
leadership skills, should be an individual's performance in imagining and engaging
in creative collaborations with colleagues in other institutes and centers, as such
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Accountability, Administration, and Leadership
collaborations will be an increasingly important aspect of moving some of the most
needed new NIH initiatives forward. And the informal review process has changed
and depends on the particular policies and practices of the sitting NIH director and
the personnel system in which a given IC director resides.
The committee also believes that a healthy degree of turnover in leadership is
critical for sustaining the vitality of a research organization. It also provides the
opportunity for leading scientists across the nation to leave their positions for a set
period and to come to NIH as a form of public service and, in part, to provide
effective scientific leadership to critical elements of the nation's biomedical
enterprise.
Recommendation 10: Set Terms and Conditions for IC 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.
By communicating, as appropriate, the results of reviews to the NIH director's
advisory groups, the IC directors can demonstrate an additional level of account-
ability. 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 concluded that review and revitalization of the OD is an essen-
tial prerequisite for accountability and leadership. The committee noted that the
National Science Foundation Act of 1950 (42 U.S.C. 1861 et seq.), as amended,
creates a term of 6 years for the NSF director and concluded that this has been a
good mode! for creating a system of accountability and periodic review that has the
possibility of transcending changes in administrations.
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
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Enhancing the Vitality of the National Institutes of Health
term of 6 years should be based on a positive external review of performance
and the recommendation of the secretary of Health and Human Services.
Finally, the Committee believes that the special status granted NCI by the
National Cancer Act should be re-examined. The National Cancer Act of 1971, in
addition to making the NCI director a Presidential appointee, created the President's
Cancer Panel, composed of two scientists and one management specialist who
provide progress reports to the President on the status of NCI's research. The act
also replaced the National Cancer Advisory Council with an 18-member National
Cancer Advisory Board composed of scientists and laypersons offering guidance
and advice to NCI on all major initiatives. In addition, the act allows the NCI
director to submit the institute's budget directly to the President, bypassing the NIH
director in the process.
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. NCI is by far and has been for
some time the largest NIH institute (approximately 17% of the total NIH budget).
It is not in the interests either of NIH's overall research and training programs, or of
NCI, for the NIH director to have such limited authority. In addition, as the biologi-
cal and cellular basis of cancer becomes more widely understood, the basic science
underlying cancer research has direct implications for the etiology and progression
of numerous other diseases, for example the autoimmune, infectious, and even
cardiovascular diseases. Thus, for scientific and administrative reasons, NCI's 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.
It should be noted that the requirement that NCI prepare a bypass budget every
year has some positive aspects in that the institute must undertake an annual strategic
planning process. This useful exercise should not be dropped if NCI changes its
administrative status as recommended above. Rather, all ICs should be required to
develop an annual strategic plan, if they are not already doing so.
THE ADVISORY COMMITTEES
Like other federal science agencies, NIH makes extensive use of advisory com-
mittees 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 char-
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Accountability, Administration, and Leadership
tered advisory committees as of May 2002, more than any other federal agency.2
The Public Health Service Act (PHSA) authorizes appropriate scientific and techni-
cal peer review of biomedical and behavioral research grant and cooperative agree-
ment applications, research and development contracts, and research conducted at
NIH through its advisory committees.
As described in greater detail in Chapter 2, NIH uses several types of advisory
committees. Those groups can be located in the Center for Scientific Review (CSR)
(the study sections) or the councils and boards created and used by individual
institutes that choose not to use CSR for review of particular initiatives. National
Advisory Councils and Boards perform the second level of peer review for research
grant applications and offer advice and recommendations on policy and program
development, program implementation, evaluation, and other matters of impor-
tance for the mission and goals of the IC; and they provide oversight of research
conducted by IC intramural programs. The dual review system, which separates the
scientific assessment of proposed projects from policy decisions about scientific
areas to be supported and the resources to be allocated, permits a more objective
evaluation than would result from a single level of review. NIH can make awards
only if they have been approved by a national advisory council and the Secretary,
and this helps to insulate NIH from pressure by a member of Congress or the
administration to fund a particular project. The national advisory councils are also
charged with providing advice on policies and programs, although several studies
have found that members of the national advisory councils do not always fee! they
play a strong role in policymaking.3 The dual system of review provides the respon-
sible NIH officials with advice about both scientific and societal values and needs
(NIH, 1992b).4
In the appointment process, the President generally follows the recommenda-
tions of the Secretary, and the Secretary generally follows the advice of the NIH and
IC directors in filling positions, although they add their own candidates from time
to time. During the 1972-1974 period, when the Nixon Administration was trying
to exert greater control over the NIH budget, there was conflict with the scientific
community over the perceived politicization of the advisory committee appointment
process; this issue re-emerges from time to time and is of current concern to the
scientific and health advocacy communities (e.g., Bass et al., 20031. Moreover as a
general matter, the success of any scientific enterprise is dependent on the encourage-
2They have 4,298 members, 75% of whom are members of initial review groups that evaluate appli-
cations for research funding. See overview and list of committees by appointing officials at http://
wwwl .od.nih.gov/cmo/about/index.html.
30ne study was conducted by the Institute of Medicine's Committee for a Study of the Organizational
Structure of the National Institutes of Health in 1984. The other was conducted in the mid-199Os by a
committee appointed by the NIH director. Neither report was made public. Copies are in the posses-
sion of the authors.
4Contracts are subjected to a similar peer review process, except that the second level of review is by
senior IC staff.
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Enhancing the Vitality of the National Institutes of Health
ment of a wide variety of independent views. The Committee 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.
Several related issues emerged during the committee's deliberations with respect
to NIH's advisory council system. First, there are important differences in the use
and roles of the councils among ICs. Some councils are actively involved in setting
institute goals and planning. In other cases, council actions are pro forma, with little
advice or involvement sought from council by institute personnel. In still other
cases, council members might also be grantees of the institute, and thus might fee!
constrained in expressing strong views or views that differ from than those held by
institute or program staff. Those issues highlight a missed opportunity for NIH.
Advisory councils should routinely and consistently be consulted in the priority
setting and planning processes of an institute. They should have active involvement
in decisions regarding issuance of program announcements and requests for
applications, which often reflect an institute's priorities and responses to emerging
opportunities or demands. They should be working to ensure that the IC is held
accountable in reaching its goals and communicating with the public. They should
understand and be supportive of relevant trans-NIH initiatives. Finally, a criterion
for review of every institute director should be how he or she interacts with and uses
the expertise of his or her advisory council.
Under Section 406 of the PHSA, national advisory councils have up to 18
members appointed by the Secretary and nonvoting ex officio members from NIH
and other federal agencies. Two-thirds of the appointed members are to be "from
among the leading representatives of the health and scientific disciplines (including
not less than two individuals who are leaders in the fields of public health and/or
social sciences) relevant to the activities of the national research institute" and one-
third "from the general public and shall include leaders in the fields of public policy,
law, health policy, economics, and management." The Committee believes that the
advisory council system should guarantee that ICs receive independent and qualified
advice. Their members therefore must be reasonably free of conflicts of interest. In
addition, if NIH is to achieve the goal of increased trans-NIH collaborations, it will
be important to have cross-fertilization of institutes through advisory council mem-
bership. For example, it would be useful to have a cancer researcher (who receives
funding from NCI or the American Cancer Society) serve on the council of the
National Institute of Environmental Health Sciences or the National Institute of
Child Health and Human Development.
Recommendation 13: Retain Integrity in Appointments to Advisory Councils
undo Refrain Advisory Council Activity undo Membership Criteria
a. Appointments to advisory councils should be based solely on a person's
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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 accountability,
facilitate translation of goals and activities to the scientific community and the
public, and provide feedback to the IC director. To achieve sufficient indepen-
dence 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.
RESEARCH MANAGEMENT AND SUPPORT
Although administrative or overhead costs are often suspect in the eyes of those
who would like to see more money going directly to research or training, at appro-
priate levels they are essential to the effectiveness of any organization, including
those that sponsor research and training programs. Similarly, the effectiveness of
those responsible for the wide array of necessary administrative services depends on
their leadership and management capabilities and their ability to keep administra-
tive and overhead costs deployed in a manner that best supports the primary missions
of the organization.
In the case of NIH, the resources for administrative and overhead functions
flow through the Research Management and Support (RMS) budgets of the various
units that make up NIH. These budgets, collectively, support all the administrative
costs of operating NIH, including management of extramural activities (planning,
receipt, peer review, and awards), some intramural research program costs, pro-
gram development, priority setting, education and outreach, acquisition and main-
tenance of new information technology systems, professional development, and
facility management. Given the structure and funding mechanisms of NIH, the
aggregate RMS budget is composed of 25 budget line items, one from each of the
ICs that receive separate budget appropriations from Congress. RMS is functionally
distinguished from the NIH OD, which is responsible for strategic leadership and
receives a separate appropriation.
The administrative costs of NIH have been scrutinized regularly over the last
few decades. In the early 1990s, congressional limitations were imposed that
restricted inflationary and program growth of the RMS budget. A 1997 manage-
ment study by Arthur Anderson (National Institutes of Health, 1997b) led to many
management improvements, including
· Centralization and improvement of purchasing programs
· Conversion of the mail service to an outsourced performance-based contract
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Enhancing the Vitality of the National Institutes of Health
· Development of generic position descriptions
· Hiring of a Chief Information Officer, and
· Creation of a Central Service Review Committee to review the budgets of
central service organizations (NIH, unpublished draft report).
In FY 1996, the NIH appropriation contained language that reduced RMS by
7.5% below the FY 1995 level. Despite growth in the overall NIH budget, the RMS
reduction was not made up in FY 1997 nor was any growth provided; in FY 1998,
an increase of only 1% was allowed. In contrast, from FY 1995 to FY 1999, the
extramural program grew at a rate seven times that of RMS. In the FY 2001
budget, RMS represented 3.3% of the total NIH budget, down from 4.5% in 1995.
Since FY 1993, the RMS share of the total NIH budget has decreased every year.
From FY 1984 through FY 1999, inflation, based on the Gross Domestic Product,
increased 58.3%. During the same period, RMS grew 96.2%, while overall NIH
grew 217.6%, more than four times the growth rate for RMS (NIH, unpublished
draft).
At the same time, the growth in the NIH budget and the rise in congressionally
mandated activities have increased the administrative requirements needed to
operate a growing and diverse research organization; for example, GPRA is a labor-
intensive and expensive annual exercise required by Congress. Other new program-
matic requirements have involved the establishment of centers, registries, and other
funding requirements, all of which add costs for which RMS must be further
stretched.
To accommodate RMS reductions, many institutes have implemented measures
to reduce costs, such as introducing modular grant applications and awards, stream-
lining reviews, and converting to electronic-based research administration. Those
are laudable goals under any circumstances, but adverse consequences of the
restricted RMS budget seem to be growing. Many are concerned that the strain on
the system harms the peer review system, stretches staff too thin, limits business
oversight and scientific review, and hinders the ability to respond to increasingly
complex research programs and conduct trans-NIH initiatives. NIH's own assess-
ment of the negative impact of the restricted RMS budget found seven areas being
adversely affected: stewardship of public funds; scientific advice and program devel-
opment; public health education and community outreach; information technology
acquisition, maintenance, and training; staffing issues; professional development;
and facilities management (NIH, unpublished draft). There may have been good
reason in the past to celebrate the containment of costs, but the Committee feels that
the effectiveness of NIH is now imperiled by the lack of adequate resources to
provide appropriate support both for its primary research mission and for meeting
. . . . . . .
its accountal ~1- sty response AL 1tles.
Other groups have also suggested that RMS funding be raised to provide
adequate means for accomplishing NIH's primary goals and to ensure a capacity for
strategic planning and evaluation of its programs. In 1998, an IOM committee
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Accountability, Administration, and Leadership
recommended that Congress "adjust the level of funding for RMS so that NIH can
implement improvements in the priority-setting process, including stronger
analytical, planning, and public interface capacities" (IOM, 1998~. In 2001, the
Federation of American Societies for Experimental Biology also recommended in-
creasing RMS. The growing mismatch between the most essential or mandated
administrative requirements and the RMS resources available to pay for them must
be addressed.
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 worId-ciass
$27 billion/year research organization. Moreover, when additional congres-
sional mandates are imposed on NIH through the appropriations process, they
should include funds to cover necessary administrative costs.
SUMMARY
NIH uses resources in various ways to enhance public accountability, leader-
ship, and management efficiencies. However, improvements can be made.
First, NIH must commit to developing an improved system for gathering,
managing, and reporting data to facilitate public engagement, strategic planning,
management of the research and training portfolios, congressional justifications,
. ... . .
ant scenic communication.
Second, increased attention to the system of hiring and periodic and systematic
review of IC directors will revitalize the leadership, invigorate the overall scientific
community, and facilitate change and evolution of NIH's mission and goals. The
NIH director should have the authority to appoint IC directors, including the direc-
tor of NCI, with the goal of building a team that shares a vision and a plan.
Congress should revisit the special status of NCI to determine whether it continues
to meet the needs of the current NIH organization and structure.
Third, leadership must make better use of the advisory committee system, which
should be a consistent source of independent advice.
Fourth, in order to operate a worId-class research agency, NIH must be provided
sufficient resources to support its management needs.
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fellow of AAAS ant! many other professional societies. He has received numerous awards from
both professional and lay groups for his national leadership in science, mental illness and mental
health, and substance abuse ant! addiction.
Gilbert S. Omenn, MD, PhD, University of Michigan (IOM)
Gilbert S. Omenn is Professor of Internal Medicine, Human Genetics, ant! Public Health at the
University of Michigan. From ~ 997 to 2002 he was also UM Executive Vice President for
Medical Affairs and Chief Executive Of ficer of the University of Michigan Health System.
Previously he was professor of medicine and environmental health and Dean of the School of
Public Health & Community Medicine at the University of Washington. He served as Associate
Director of the White House Office of Science and Technology Policy and then the Office of
Management and Budget in the Carter Administration, and chaired the
Presiclential/Congressional Commission on Risk Assessment and Risk Management from 1994-
97. He has been a National Institutes of Health Research Career Development Awardee, a
Howard Hughes Medical Institute Investigator, and founding director of the University of
Washington Robert Wool! Johnson Clinical Scholars Program. His research is focused on
proteomics and cancer prevention, as well as health promotion for older adults, science-based
risk analysis, and the ethical, legal, and public health policy aspects of genetics. Dr. Omenn
holds an MD from Harvard and a PhD in genetics *om the University of Washington.
Franklyn G. Prendergast, PhD, Mayo Cancer Center
Franklyn Prendergast is Director of the Mayo Clinic Cancer Center in Rochester, Minnesota, and
Professor of Biochemistry and Molecular Biology. His research focus is in structural protein
biology and bioimaging. He is a recipient of the E.E. Just aware! of the American Society of
Experimental Biology. He is a member of the American Association for the Advancement of
Science, the American Society for Biochemistry and Molecular Biology, and Sigma Xi. He
earned his PhD in biochemistry from the University of Minnesota and his medical degree from
the University of the West Indies.
Stephen J. Ryan, MD, University of Southern California (IOM)
Stephen Ryan is Professor of Ophthalmology and Dean, Reck School of Medicine of USC and
Senior Vice President for Medical Care, University of Southern California. His research relates
to macular degeneration, ocular trauma, retinal detachment, ant! other retinal diseases. He
previously served as Chairman of the Department of Ophthalmology at USC and as a member of
the National Advisory Eye Council for the NE! of the NIH. He is a member of the Institute of
Medicine and currently serves as President of the National Alliance for Eye and Vision
Research. He earned his MD from Johns Hopkins University.
Samuel C. Silverstein, MD, Columbia University (IOM)
Samuel C. Silverstein is John C. Dalton Professor of Physiology ant! Cellular Biophysics and
Professor of Medicine at the Columbia University College of Physicians and Surgeons. His
research focuses on structure and function of polymorphonuclear and mononuclear leukocytes
ant! endothelial cells in innate immunity, in diseases associated with chronic inflammation such
as atherosclerosis ant! Alzheimer's disease; and in host defense against infectious micro-
organisms inclucling Legionella pneumophila and M. tuberculosis. He has server! on the Councils
of the American Society for Cell Biology (! 988-92), and the National Institute of Allergy ancl
120
Representative terms from entire chapter:
public accountability
