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Report
on the Organizational Structure and Management of the NIH
Report to the Director of the National Institutes of Health on the
Organizational Structure and Management of the NIH from the Council
of Public Representatives
December 2, 2002
Council of Public Representatives:
- Nancye W. Buelow
- Ellen Grant Bishop
- Evelyn J. Bromet
- Luz Claudio
- Debra S. Hall
- Kimberly Hinton
- Vicki Kalabokes
- Barbara B. Lackritz
- Debra Lappin
- Ted Mala
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- Isaac D. Montoya
- Rodrigo Muñoz
- Rosemary B. Quigley
- Bob Roehr
- Lawrence B. Sadwin
- Len J. Tamura
- Zelda Tetenbaum
- Donald E. Tykeson
- Doug Q. L. Yee
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Letter from Dr. Zerhouni
Harold T. Shapiro, Ph.D.
Chairman, Committee on the Organizational Structure of the NIH
Woodrow Wilson School of Public and International Affairs
Princeton University
355 Wallace Hall
Princeton, NJ 08544
Dear Dr. Shapiro:
At the request of the National Institutes of Health (NIH) council of
Public Representatives (COPR), I am forwarding the enclosed report as
prepared by the Council. The independent conclusions and recommendations
in this report regarding the organizational structure and management
of the NIH cover a range of topics specifically from the public perspective.
As you may be aware, the COPR is a forum for discussing issues affecting
the broad development of agency policy, programs, and research goals
and for advising the NIH Director on these matters. It also advises
and assists the NIH Director to enhance public participation in NIH
activities, to increase public understanding of the NIH, and to bring
important matters of public interest forward for discussion in public
settings. The COPR membership comprises a variety of backgrounds, cultures,
and geographic origins; its twenty-one members all share a vital interest
in the work of the NIH.
I trust you and the committee will find this report helpful in your
deliberations.
Sincerely,
Elias A. Zerhouni, MD
Director
CC:
Fran Sharples, Ph.D.
Enclosure
INTRODUCTION
The Council of Public Representatives (COPR) was created as the public
voice of the American people, in the broadest and least encumbered sense,
to the Director of the National Institutes of Health (NIH). This report,
stimulated in part by a study underway by the Institute of Medicine
(IOM), is a piece of the ongoing dialogue on how the NIH can best manage
biomedical research on behalf of all Americans.
The American public supports NIH research with its wallets and by putting
their very bodies on the line to make clinical trials possible. They
will continue to do so only if they trust that research and the people
who conduct it. Maintaining and enhancing that essential trust requires
constant, diligent work on the part of the NIH that is based upon five
key principles:
- Empowering patients and the public as full partners in the research
process
- Promoting transparency of operations and information
- Treating the whole patient, not simply the disease
- Strengthening the link of bench to bedside
- Enhancing communications as integral to all of these functions
In this report we use these five principles to analyze aspects of the
structure and function of the NIH that may be considered by the IOM
committee. We believe they are integral to guiding any reorganization.
We also offer recommendations for the NIH Director to consider in conjunction
with the IOM committee report. An appendix contains additional thoughts
and recommendations that are important for the Director to consider.
KEY POINTS
- Any reorganization of the NIH should be less concerned with the
organizational chart of that body than with its functionality. Most
observers believe that the present structure, while complex and at
times vexing to navigate, has produced remarkable success in advancing
biomedical research and has contributed greatly to improving health
in the United States and the world.
- Structural changes potentially could diminish the link between the
bench and the bedside. The experience gained in treating patients
can lead to insights that can be pursued in the lab, and vice versa.
We are wary of changes that might diminish these ties.
- Biomedical research will fulfill its promises only through combining
the high tech cutting-edge science with the high touch of human interactions.
The process begins with the collaborative establishment of research
priorities and continues through decisions on individual health and
care.
- The focus should be on creating mechanisms that better respond to
the breadth of interests of those with a stake in biomedical research
and that offer greater flexibility in recognizing and supporting innovative
ideas, many of which may challenge or even threaten the status quo.
The pressure for new Institutes and Centers arises when people feel
that their concerns are not being addressed. Simply restructuring
the organizational chart of the NIH will do little by itself to reduce
those pressures.
- Leadership, openness, flexibility, and money are all important qualities
in ensuring success at the NIH, but most important of these is leadership.
Continuity of leadership is essential. At the very least, the Administration
and the NIH should act to ensure that senior positions at the NIH
are filled promptly.
In sum, the goal in changing the existing framework of the NIH should
be to create mechanisms that embrace and are responsive to all constituencies,
including the American public, as partners in the research process;
that facilitate collaborative interactions between those partners; and
that are more open to change and new ideas.
PROLIFERATION OF INSTITUTES AND CENTERS
The proliferation of Institutes and Centers has occurred primarily
through two mechanisms: one arising from a perceived need on the part
of the NIH, as with the National Human Genome Research Institute, and
the other as a consequence of the NIH being seen as insufficiently responsive
to specific constituencies, as was the case with the National Center
for Complementary and Alternative Medicine. This also holds true for
the formation and establishment of the Council of Public Representatives
(COPR).
The greater administrative burden of those added structures can be
a legitimate cost of including valid constituent interests that may
arise from time to time. However, we remain generally skeptical of the
need to create additional Institutes and Centers. Although a consolidation
or clustering of some existing structures has a certain logic, one must
also consider the internal and political costs associated with such
activity and choose priorities wisely. What might initially seem logical
or rational on paper often does not remain so when one examines the
details.
Organizational rationality should not be an end in itself. Rather,
the purpose of any reorganizations should be to significantly improve
functionality and/or reduce administrative costs. Because the nature
of research and "known truths" is constantly changing, so
too the framework within which to conduct that research must be flexible
and evolving.
Furthermore, not only is disease complex, so too are patients. Even
a "simple" disease often can initiate a cascade of increased
risks for other afflictions. The comorbid patient is the rule, not the
exception. The public realizes the limitations of treating disease and
demands that the focus of treatment be on the whole patient, not his
or her parts. Research must reflect that demand.
There is value in having overlapping and redundant responsibilities,
particularly in a process such as research, where both goals and the
paths to those goals often are not yet fully known. It is one way of
reducing the risks of orthodoxy, where a single approach and set of
gatekeepers can preclude support for differing approaches. It also can
induce some degree of competition, which often is a good thing.
Creation of the Office of AIDS Research is a useful case study in how
to manage structural change. Former NIH Director Harold Varmus has written
of it as "a compromise to avoid an especially contentious fusion
of AIDS programs into a full-fledged Institute." It was, in his
eyes, at least a partial success in reining in the further proliferation
of Institutes.
An important factor in that outcome was the decision by AIDS activist,
historically one of the most potent advocacy communities and then at
the peak of its influence, not to seek such an Institute. Much of the
reason why is that the NIH, particularly through the leadership of Anthony
Fauci, mad extraordinary and groundbreaking efforts to include the affected
community as partners in shaping the research agenda. Community leaders
had a stake in the process, bought into the outcome, and felt no need
to carve out a special Institute.
Recommendations:
- The NIH should do a better job of educating both the general and
targeted publics to underlying principles of biomedical research,
such as, genomics, cell signaling, and other broad areas that underlay
all biological functioning. It should better demonstrate how trans-NIH
research affects specific areas of disease and contributes to better
outcomes for the whole patient. This may relieve some of the pressure
to create additional institutes and centers.
- The NIH should do a better job of integrating all constituencies
as partners in all aspects of research, to increase the "buy
in" into that process and the priorities that it sets. It should
better identify and make explicit existing expenditures in disease
areas as part of demonstrating its commitment to individual disease
areas and to the concept of transparency.
- The U.S. Congress should enact legislation mandating the process
through which Institutes and Centers will be created, so that it guarantees
ample opportunity for public comment on such structural changes such
as:
- A process for the creation of new Institutes and Centers must
be identified.
- The public must be involved in determining how that process
is constructed.
- The public itself must encompass public participation.
- The Congress should mandate that this process be used in the
creation of new Institutes and Centers.
OFFICE OF THE DIRECTOR
Biomedical research today is moving in the direction of a multidisciplinary
approach to discovery, in part because of increasingly sophisticated
research tools and computational power are giving us the ability to
handle the complexity of large data sets and to integrate them in ways
that are orders of magnitude greater than they were even a decade ago.
This central fact of contemporary biomedical research supports the idea
of greater role for the Office of the Director at the NIH. That office,
unlike every other one at the NIH, uniquely has the broad responsibility
of advancing health-not a specific disease, or approach, or organ, but
the overall health and well-being of the American public. It should
be given the resources necessary to fulfill that mandate.
We do not mean to suggest a centralized or directed approach to research;
that would be antithetical to the principles at the core of the NIH
since its founding. Rather, we seek to equip the Director with the tools
necessary to facilitate and integrate research on a trans-NIH basis,
so that he may truly be first among equals.
The budget of the Office of the Director has not kept pace with the
growth in the overall NIH budget, even while it has take on added responsibilities.
Over the last decade, the total NIH budget has increased by 125%, whereas
the Director's budget has increased only by 88%. It has shrunk from
0.4% to 0.3% of the total budget.
Recommendation:
- The Office of the Director needs additional funds in order to perform
existing functions properly. As that Office takes on new tasks, sufficient
funding should be added to properly implement those new tasks.
Research Leadership: One option in strengthening the
hand of the Director is to give that Office more money that can be awarded
on a discretionary basis to shifting priorities and emerging opportunities
across all of the NIH. We encourage that to some extent, through we
wish to avoid creation of a parallel administrative bureaucracy (and
pressures for funding) that might arise from placing extraordinarily
large sums in the Office.
We believe another mechanism offers equal or greater opportunity to
promote better-integrated research and enhance the authority of the
Director. It would encourage Institutes and Centers to pursue research
that the Director has identified as NIH priorities. It would not give
the Director and absolute veto over trans-Institute research, which
still could be conducted with other funds, but it would help to direct
a portion of their funding toward centrally defined priorities.
Recommendation:
- Mandate that each Institute and Center spend a minimum "floor"
amount of its research budget on trans-Institute programs approved
by the Director.
We believe the commitment to such trans-Institute programs should be
significant. Some have suggested that the floor be 20% of the total
budget, but we are not prepared at this point to offer any guidance
on budgetary targets.
Administrative Consolidation: The larger Institutes generally
have a critical mass to efficiently carry out most administrative functions.
It is clear that many of the smaller Institutes and Centers do not have
those scales of operations. Certain functions could more rationally
be carried out on a centralized basis. We recognize that NIH has already
carried out many of these efforts and we support them.
Data Systems and Nomenclature: The promise of enhanced
health based on knowledge of the human genome ultimately will require
huge data sets for maximum understanding of those complex interactions.
That will not be achieved through single studies but through the integration
of data from vast numbers of studies.
Failure to implement standardization, and even delay in doing so, carries
a price that is measured in deferred development of therapy, increased
risk in clinical trials, and patient deaths. The recent development
of harmonized mechanisms of reporting serious adverse events in gene
transfer trials, which the NIH and the Food and Drug Administration
are implementing, is a useful model for broader application.
Recommendation:
- The NIH must establish single, unitary standards for data collection
and integration that apply to all NIH-sponsored research activity.
The actual performance of many of these tasks need not be centralized,
and in many instances may benefit from bing decentralized. Voluntary
compliance is always preferable; however, it may become necessary
to arm the Office of the Director with both the tools and the power
to expedite this process in a timely manner.
Communications: The NIH devotes tremendous resources
to and effectively communicates with researchers through the peer review
process and the conduct of scientific meetings. It is much less effective
in communicating with other partners in the research process, most notably
the general public, in part because it devotes few resources to those
tasks.
There are exceptions to this. For example, the National Library of
Medicine has made a concerted effort to create resources that are accessible
to the general public. As a result, its web site has become one of the
most credible and most visited health sites in the world.
Reorganization must improve the nature, quality, and mechanisms of
communication with the American public so that the public and patients
can become truly informed, active, and equal partners in fulfilling
the NIH mission of improving health.
Unfortunately, the NIH has seldom proactively and effectively reached
out to the broad American public through the medium of television. It
is the single most important vehicle in contemporary America for reaching
both a broad audience and underserved minority populations. Even the
largest Institutes would be hard pressed to exploit this media potential
on their own in a cost effective manner. The smaller Institutes and
Centers cannot even dream of utilizing television.
Recommendation:
- The NIH should greatly expand its communications activities with
the general public and with other targeted partners in biomedical
research, principally through increased use of television and associated
technologies. Most of this increased activity should be on a centralized
basis within the Office of the Director and should emphasize technical
communication skills and external contact. We also recognize the continued
importance of having information officers within Institutes and Centers,
where they are close to the actual work of those bodies and can develop
an understanding of that research, as well as the facility to translate
those research findings into language that all can comprehend.
Clinical Trials: Public concern is that
some Institutes and Centers have insufficient capacity to carry out
the large-scale clinical trials in areas of their responsibility that
are necessary to improve the nation's health. This is particularly true
when it comes to data safety monitoring and other functions of patient
protection.
Recommendation:
- The Office of the Director should establish centralized core management
and safety support for clinical trials for use by those Institutes
and Centers that do not have sufficient scale to adequately support
such activities on their own.
Education and Training: The NIH has invested heavily
in education and training in research. Perhaps best known are post-doctoral
fellowships. But the span of activity is much broader; it includes promoting
state-of-the-art standards of care for medical practitioners through
the Office of Medical Application of Research, stimulating public school
students to consider a career in biomedical research, and recent educational
initiatives to strengthen patient protections in clinical trials. One
element that is missing is investment in the education and training
of the public to better serve their role as a partner in the research
process.
Recommendation:
- A program should be created within the Office of the Director to
further the education and training of the public to better fulfill
its partnership role in the research process. We see this as a broad
mandate embracing public members from the level of the local institutional
review board through COPR. The NIH should undertake this activity
in collaboration with other government agencies, associations, foundations,
and other groups external to the NIH.
FUTURE STEPS
COPR recognizes that the structure and management of NIH is a continuing
matter that will be revisited periodically. We anticipate making further
comments after reviewing the forthcoming IOM report and we will continue
to evaluate all NIH operations in light of the five principles articulated
in this document.
APPENDIX
NIH Staffing Levels
The NIH budget has increased from $4 billion to $27 billion over the
last 20 years. The absolute numbers of grants has increased by 40%;
the value of the average grant has increased three-fold, to $375,000;
and the complexity of research has increased enormously. However, staffing
levels (full-time employees) at the NIH have increased by only about
20%.
This state of affairs raises the very real possibility that the NIH
is understaffed to best administer its program responsibilities. Peer
review can act as one kind of check on poor allocation of resources,
but program review also is necessary. That cannot occur if program officers
are stretched too thin and have neither the time nor the resources for
adequate site visits and interactions with grantees.
Of equal or greater importance to good stewardship of the expenditure
of public resources is the role that NIH program officers can play in
facilitating interaction between grant recipients. They can be catalysts,
stimulating a "cross-pollination" of ideas and collaborations
in what otherwise might be more isolated nodes of research activity.
Crossing the boundaries of disciplines and of geography is increasingly
important. This facilitator role of NIH program administrators often
is not given the recognition and support that it merits.
An internal examination by the NIH, while useful, will always carry
the perception of being self-serving. Staffing levels need to be examined
by a body that is perceived by all to be objective.
Recommendation:
- The adequacy of NIH staffing levels should be examined by an independent
organization. If the IOM committee feels that this issue falls outside
of its current mandate, then we urge that another outside body be
charged with addressing this issue.
Research = Growth
We recognize that health is an important and vibrant part of the nation's
economy-about 14% of gross domestic product by most estimates. Medical
centers have long been engines of local and regional economic growth.
So it is no surprise that biotechnology is seen as not only the cutting
edge of the next generation of improvements in human health, but also
as important for the economic life of the communities that house or
hope to house such operations.
This has created political pressures to direct NIH funding for Centers
of Excellence and other large-scale investments in biomedical research
to locations other than what standards of "the best science"
might indicate. We are not so naïve as to think that these pressures
can be eliminated entirely, nor in many ways should they be. However,
we believe that these opportunities should be leveraged to the greatest
extent possible to build partnerships and attract additional resources
to biomedical research.
Recommendation:
- Mechanisms should be created, either through NIH regulations or,
if necessary, by an act of Congress, to require that projects above
a certain size require a matching commitment of local resources. We
can envision those commitments entailing a combination of efforts
by state and local governments, businesses, and the nonprofit sector,
but we do not pretend to recommend the details of such arrangements.
We believe these mechanisms can be important ones in fostering broader
partnerships in biomedical research.
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