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COPR Response to the NRC/IOM Report, "Enhancing
the Vitality of the National Institutes of Health: Organizational Changes
to Meet New Challenges"
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
National Institutes of Health
Bethesda, Maryland 20892
www.nih.gov
Harold T. Shapiro, PbD.
Chairman, Committee on the Organizational Structure of NlH
Woodrow Wilson School of Public and International Affairs
Princeton University
355 Wallace Hall
Princeton, New Jersey 08544
Dear Dr. Shapiro:
I am sending the enclosed report at the request of the National Institutes
of Health (NIH) Council of Public Representatives (COPR). This report
is its response to the Institute of Medicine's report Enhancing the
Vitality of the NIH: Organizational Change to Meet New Challenges.
This January 2004 COPR report follows the December 2002 COPR report submitted
prior to the Institute of Medicine's final deliberations.
COPR is a forum for advising the NIH Director on issues affecting the
broad development of NIH policy, programs, and research goals. It also
advises and assists the NIH Director in enhancing public participation
in NIH activities, increasing public understanding of the NIH, and bringing
important matters of public interest forward for discussion in public
settings. The COPR membership comprises a variety of backgrounds, cultures,
geographic origins; and its members share a vital interest in the work
of the NIH. The enclosed report therefore represents COPR's independent
conclusions and recommendations regarding the organizational structure
and management of the NIH.
I trust you and the Committee will find this report helpful and of interest
to your efforts.
Elias A. Zerhouni, M.D.
Director
The NIH Council of Public Representatives (COPR)
Report to: Elias A. Zerhouni, M.D., Director, National Institutes
of Health
From: NIH Director’s Council of Public Representatives (COPR)
December 1, 2003
Council of Public Representatives:
- James J. Armstrong
- Jim Jensen
- Evelyn Bromet
- Ted Mala
- Ruth C. Browne
- Dawna Torres Mughal
- Nancye W. Buelow
- Rodrigo A. Munoz
- Barbara D. Butler
- William D. Novelli
- Frances J. Dunston
- Lawrence B. Sadwin
- Rafael Gonzalez-Amezcua
- John Schlofrock
- Ellen E. Grant
- Ellen V. Sigal
- Debra S. Hall
- Leonard J. Tamura
- Kimberley Hinton
- Zelda Tetenbaum
- Donald E. Tykeson
INTRODUCTION
In 2001, Congress mandated a study of the organizational structure of
the NIH to determine "whether the current organization and structure
of NIH are optimally configured for the scientific needs of the twenty-first
century." The National Research Council (NRC) and the IOM (Institute
of Medicine) of the National Academies undertook the study and formed
the Committee on the Organizational Structure of the National Institutes
of Health ("IOM Committee").
Chaired by Dr. Harold Shapiro, the IOM Committee focused on whether there
might be any "significant organizational changes…that would
allow NIH to be even more successful in the future" in supporting
the research essential to improving human health. The IOM Committee conducted
an extensive analysis of what it characterized as the complex, highly
decentralized, $27 billion per year structure that the NIH has evolved
into since it was founded in the late 19th century.
The Council of Public Representatives (COPR) was created as a public
voice of the American people, in the broadest and least encumbered sense,
to the Director of the National Institutes of Health (NIH). In December
2002, partially stimulated by the NRC/IOM study, the COPR analyzed a number
of aspects of the structure and function of the NIH, specifically from
the public perspective. The Council's conclusions were contained in the
"Report on the Organizational Structure and Management of the NIH"
("COPR December 2002 Report"), which was sent to the Director,
who forwarded it to the IOM Committee for its consideration.
In July 2003 the IOM Committee released its report entitled "Enhancing
the Vitality of the National Institutes of Health: Organizational Changes
to Meet New Challenges" (the "NRC/IOM Report"), which
represented a detailed and independent examination of the NIH. The NRC/IOM
report contained fourteen specific recommendations:
- Centralization of Management Functions
- Establish a Public Process for Changing the Number of NIH Institutes
or Centers
- Strengthen Clinical Research
- Increase Trans-NIH Strategic Planning and Funding
- Strengthen the NIH Office of the Director (OD)
- Establish a Process for Creating New OD Offices and Programs
- Create a Director's "Special Projects" Program
- Promote Innovation and Risk Taking in the Intramural Research Program
(IRP)
- Standardize Data Management Systems
- Set Term Limits for IC Directors and Establish a IC Director Review
Process
- Set Term Limits for the NIH Director
- Reconsider the Status of the National Cancer Institute
- Reform Advisory Council Activity and Membership Criteria
- Increase Funding for Research Management and Support (RMS)
In this report, prepared for the NIH Director, the COPR responds to these
recommendations, from the public perspective. Although we are confining
our remarks specifically to the recommendations, we note three important
issues:
- We are heartened that that IOM Committee found no compelling reason
to suggest an alternative organizational structure for NIH, and that
the current organizational structure represents a fundamentally useful
response to the legitimate demands made by NIH's various constituencies.
- We raise the question: What is the public process for introducing
the NRC/IOM Report to the public?
- Will there be opportunity for the public to provide input on these
recommendations beyond COPR's response?
DISCUSSION
The IOM Report clearly reflects some of the core issues that COPR raised
in its December 2002 Report. As to the resulting 14 recommendations in
the final NRC/IOM Report, we have identified 6 of the recommendations
as priority areas from the public's perspective. We also provide comment
on 3 additional recommendations and include specific comment on a priority
issue for the COPR, not directly reflected in the NRC/IOM Report recommendations,
all in the spirit of the IOM Committee's mandate "to be of some practical
assistance to all who wish NIH to continue to be an effective—indeed,
outstanding—organization."
Top Priorities
Recommendation 4. Increase Trans-NIH Strategic Planning and
Funding
We strongly support the concept of the Institute and Centers' (ICs)
designating funding toward centrally defined research priorities. In
the implementation of this process, some interested parties may view
the contributions on the part of the IC's as a reduction in the ICs'
individual research capacities. NIH may need to make a concerted effort
to communicate that this initiative is not "taking" something
from IC budgets, but rather it is finding a "convergence of research
priorities," and of developing a trans-institute process for moving
forward into the new century
Recommendation 5. Strengthen the NIH Office of the Director (OD)
The Office of the Director must be equipped with the tools necessary
to facilitate and integrate research on a trans-NIH basis. The budget
of the OD has not kept pace with the growth of the overall NIH research
organization, even as the OD has been expected to take on added responsibilities
that accompany the growth. The OD needs additional funds if the director's
office is to function properly and lead NIH as it addresses the research
needs of the future. (paraphrase of COPR December Report page 5).
Recommendation 7. Create a Director's "Special Projects"
Program
We strongly support this mechanism for funding "the initiation
of high-risk, exceptionally innovative research projects offering high
potential payoff" (NRC/IOM Report page 77). This comports with
our belief that the OD should have discretion to allocate money based
on "shifting priorities and emerging opportunities" (COPR
December Report page 5).
Recommendation 8. Promote Innovation and Risk Taking in the Intramural
Research Program (IRP)
In our opinion the intramural research should complement extramural
research programs. We should strongly encourage the investigators to
test innovative hypotheses that involve intellectual scientific risk.
We also strongly support a multi-disciplinary approach to biomedical
research and agree that this process requires "substantial input
from the scientific community and the public" (NRC/IOM Report page
81).
Recommendation 9. Standardize Data Management Systems
We acknowledge that this will likely be a long and costly process,
but strongly believe that the NIH must establish single, unitary standards
for data collection and integration that apply to all NIH-sponsored
research activity. Failure to implement standardization, and even delay
in doing so, carries a price that is measured in deferred development
of therapy and increased risk in clinical trials that ultimately threaten
patient care and improvements for the health of Americans (COPR December
Report page 6). Moreover, we also regard this as an integral component
of the NIH Roadmap for Medical Research (Roadmap).
Recommendation 14. Increase Funding for Research Management and
Support (RMS)
We consider the need for administrative funding to be an important
area, and support the proposition that if Congress is going to impose
a mandate on the NIH, it should then fund at the appropriate level to
support the enterprise. We view this funding as being separate from
recommendation number 5, and therefore expect that funding for RMS will
not reduce the existing budget of the OD.
Secondary Priorities
Recommendation 2. Establish a Public Process for Changing the Number
of NIH Institutes or Centers
We heartily endorse the idea of establishing a public process to "evaluate
scientific needs, opportunities, and consequences" of proposed
changes in the number of institutes and centers (NRC/IOM Report page
6), but we emphasize our view, expressed in the COPR December 2002 Report
(pages 3 and 4), that the public process should be established to explore
not only changing the number of institutes and centers, but also
consolidating them. The emphasize that public input should be actively
solicited, as early as possible, through a number of notification avenues
and that the window of opportunity for when the public is engaged in
the discussion should be open and transparent.
Recommendation 6. Establish a Process for Creating New OD Offices
and Programs
We note that this recommendation, as written, does not mention a public
process, although we are aware that the IOM Committee stated, "The
public process for evaluating proposals to create organizational units
described in Chapter 4 [regarding changing the number of ICs] should
also be applied to programmatic offices in the OD" (NRC/IOM Report
page 82). At present there is no defined process for creating "Offices,"
which can be triggered by focal pressure from a scientific or public
health standpoint. We endorse the idea of establishing a public process
to "evaluate scientific needs, opportunities, and consequences"
of proposed changes in the number of offices in the Office of the Director.
We recommend that, similar to the process we suggested for recommendation
Number 2 (supra), when discussion is initiated on this issue, a public
process be established to explore the creation or consolidation of OD
offices and programs. In addition, we urge that an appropriate trigger
for initiating this public process be clearly identified and initiated
at the earliest point in the action process. The emphasize that public
input should be actively solicited, as early as possible, through a
number of notification avenues and that the window of opportunity for
when the pubic is engaged in the discussion should be open and transparent.
Recommendation 13a. Advisory Council Activity and Membership Criteria
We provide comment on aspects of this recommendation and include specific
comment on a priority issue for the COPR, not directly reflected in
the NRC/IOM Report Recommendation 13, but directly related to the topic
of advisory council membership and activity. We firmly believe that
the principle of empowering patients and the public as significant partners
in the research process is integral to enhancing transparency in the
research enterprise and to the continuing success of the NIH. Public
members of Advisory Councils need to be actively involved in the priority
setting process and be frequently consulted to provide the public perspective.
We believe that clear identification of public members on each Institute
and Center Advisory Council and a common definition of their roles are
essential to promoting this partnership and transparency in the research
enterprise.
We strongly recommend the following:
- Public members of IC advisory councils are clearly identifiable;
- Public members of IC advisory councils are appointed for the purpose
of bringing the public's perspective to the council and the institute;
- Public members of IC advisory councils are trained and educated,
with their peers (other public members) so they can better
serve in their role as a significant partner in the research process.
- All 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, while taking diversity into account.
Remaining Recommendations
In preparing this report, we considered all of the recommendations put
forth by the IOM Committee. We do not at this time have any comment on
the remaining recommendations (Numbers 1, 3, 10, 11 and 12), but our lack
of comment should not be construed as indicating either acceptance or
rejection. Rather, we have focused our attention on the 9 recommendations
that we feel should be emphasized from the public standpoint.
CONCLUSION
In summary, our prioritization of the recommendations reflects our continuing
belief, as stated in our COPR December 2002 Report, that "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."
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