The relatively brief tenure of Bernadine Healy, who resigned as National
Institutes of Health director on 30 June 1993, was marked by significant
achievements, sharp controversy, and fundamental changes in the organization
and operation of the institutes. Arguably, none of Healy's innovations was
more controversial and bitterly debated than the application of strategic
planning to NIH-sponsored biomedical research. But as she leaves NIH for
the Cleveland Clinic Foundation, strategic planning has become a reality
at NIH and each of its institutes, including the National Institute of Environmental
Health Sciences.
Strategic planning is an organizational management tool with an established
history of application in business and industry. Its basic elements are
simple and straightforward: development of a clear statement of organizational
mission, critical assessment of the strengths and weaknesses of the organization,
evaluation of the strengths and weaknesses of the organization's competitors,
and establishment of goals and objectives for the next three to five years.
Once the organization adopts its strategic plan, progress toward the goals
and objectives is measured. The strategic plan is constantly revised as
market conditions change and the organization changes.
Strategic planning was originally geared to organizations that manufacture
a product or provide a service. Federal government departments were not
quick to embrace the tool. However, at the urging of James O. Mason, assistant
secretary for health in the Bush administration, the agencies of the U.S.
Public Health Service (which include NIH) began adapting strategic planning
concepts to their activities. When Healy came to NIH in early 1991, she
was quick to recognize the potential of strategic planning for redefining
NIH. If successful, an NIH strategic plan would change NIH from a loosely
affiliated cluster of research institutes into an organization devoted to
a unifying mission and dedicated to a set of common goals and objectives.
Healy seized the initiative. She ordered that each of the institutes work
together to develop a strategic plan organized around a list of 11 areas
of biomedical science, human disease and dysfunction, and vulnerable populations.
In addition, the plan as originally conceived addressed certain operational
and policy issues of concern.
Almost from the onset, the notion of strategic planning at the NIH was
controversial. The initial drafts were to be prepared in a collaborative
effort by the staffs of the institutes under the leadership of the Office
of the Director rather than by outside advisers to the director or the advisory
councils for various institutes. This stirred concern not only among the
members of the advisory councils, but also among the vast community of scientists
receiving grants from NIH. The implication that NIH scientists/bureaucrats
might unilaterally redefine research priorities was not well received in
the biomedical research community.
A more fundamental question was whether NIH or anyone else should attempt
to plan a national program of basic biomedical research. The system of investigator-initiated,
federally funded research grants to academic and other private entities
that had been established in the years just after World War II and carefully
nurtured by NIH in the interim seemed to be working well. In addition, a
strong belief is closely held that American preeminence in biomedicine evolved
by allowing individual investigators whose work was esteemed by their peers
to pursue their own lines of scientific inquiry without concern for its
immediate relevance or specific applicability.
While these questions were circulating in the biomedical research community,
NIH staff was hard at work in the summer of 1991 drafting strategic planning
documents. Committees of scientists from each institute were convened to
offer their best ideas for highly promising research directions consistent
with the general research, health and disease, and vulnerable populations
originally set by Healy. These preliminary drafts were to be reviewed by
Healy, the NIH institute directors, and other senior staff in retreats scheduled
during the summer. The idea was for NIH to draft a strategic plan that would
be presented to the larger community of outside scientists in early 1992
in a series of regional meetings.
The NIH senior staff retreats resulted in several fundamental changes
in the outline of the proposed strategic plan. Research areas were redefined
and expanded to include new concepts that evolved in the working committees.
Among these new concepts was a section entitled "basic biology and
the environment," devoted to research into the interactions between
exogenous factors such as man-made environmental agents or diet and cellular,
subcellular, and intercellular entities. By fall 1991, the proposed structure
of the strategic plan and drafts of its sections were being presented at
meetings of the advisory councils of the institutes. In general, these meetings
provided little comfort or resolution to basic concerns that had been circulating
in the community of NIH grantee scientists.
As the February 1992 date for the first public meeting on the NIH strategic
plan neared, another concern was raised about the plan from an unexpected
quarter. Officials in the Department of Health and Human Services, who oversee
the Public Health Service, became wary that the document might be inconsistent
with President Bush's budget request for the NIH, which was scheduled for
release in late January. This higher-level review and approval delayed distribution
of the draft document to the scientists invited to the February meeting.
As a consequence, when the first public meeting opened in San Antonio, Texas
on February 3, few participants had seen the draft they were to review.
The meeting began on schedule, despite the last-minute adjustment necessitated
by the failure to distribute the draft plan. Assistant Secretary Mason affirmed
his support for the concept of strategic planning. Healy gave a vigorous
and unapologetic defense of the need to expand and direct basic biological
research toward the most pressing human health problems. She also spoke
of her determination to carry out her responsibility to manage the NIH efficiently
and effectively and to convince Congress and the American people that funds
directed to biomedical research were being well spent. Healy's arguments
were vigorously rebutted. Still, when working groups met to discuss the
draft strategic plan, they harshly criticized the process but worked diligently
and productively to improve the draft plan. At the close of the meeting,
NIH officials left with many new and innovative ideas to be integrated into
the next draft. Over the following months, in a series of regional meetings,
the debate about the process and the applicability of strategic planning
to biomedical research attenuated, and the focus turned to questions of
what kinds of research should be given greatest emphasis and support in
the plan.
The NIH Strategic Plan began taking final shape in the fall of 1992.
At the same time, it became apparent that President Bush would not be reelected,
and the fate of Healy, his appointee, became much less clear. One fact was
clear: Healy had won the argument over whether strategic planning could
be applied to basic biomedical research supported and conducted by NIH.
Healy brought all of the 20 institutes and other granting organizations
that make up the NIH into the process, gaining their full participation
and support. More than 2000 persons were involved in the development of
the plan, most of whom were scientists from outside NIH. Included in this
group was the National Task Force on the Strategic Plan, composed of the
most respected and accomplished biomedical scientists in the United States.
The plan was released in May 1993 and formally titled "Investment
for Humanity: A Strategic Vision for the National Institutes of Health."
It sets a goal for the NIH of "... pursuing science to expand the fundamental
knowledge about the nature and behavior of living systems; to apply that
knowledge to extend the health of human lives; and reduce the burden resulting
from disease and disability." It sets priority objectives for research
support for critical sciences and technologies and for the application of
these and other scientific tools to human health needs. It also seeks to
assure that the nation's intellectual resources are directed to biomedical
research and that the infrastructure for research is expanded and maintained.
Finally, the plan recognizes and responds to the demands placed on NIH by
its grantees, members of Congress, and the general public to be fastidious
about assuring that new technologies be applied, new information be shared,
and all resources be accounted for.
An obvious question arises: Will the strategic plan have a lasting impact
on NIH? With the change of administration and the departure of Healy, there
may be reason to believe that the answer is no. However, there are signs
that the plan has taken root and will have a strong influence, particularly
in the development of priorities for research directions for the next three
to five years. Each of the individual NIH institutes found that the long
and difficult process of reaching consensus on their contributions to the
NIH plan provided sound ideas that should be explored. Most are now working
with their advisory councils to draft strategic plans.
The National Advisory Institute of Environmental Health Sciences Council
reviewed a first draft of a plan developed from an amalgamation of a council
report on research needs and an analysis of several hundred research proposals
initiated as a part of crafting the "basic biology and the environment"
section of the NIH plan. The heart of the NIEHS strategic approach is the
concept that all human health and disease results from the interaction of
environmental factors, individual genetic susceptibilities, and age or time.
In this context, the broadest definition of environmental factors is used
(e.g., man-made chemicals, physical energy, social and behavioral factors,
diet, and biological agents). NIEHS proposed a research strategy that integrates
the basic biological sciences, modern toxicology, and human studies such
as clinical and epidemiologic research to characterize the environmental
contribution to health and disease with a goal of prevention and intervention.
The draft plan builds on two years of intense interactions among NIEHS scientists,
their colleagues in other NIH institutes and the extramural scientific community.
In addition, partnerships are being forged with health care providers, environmental
groups, community-based organizations, state and local governments, industry,
regulatory agencies, and organized labor to assure that the NIEHS research,
training mission, and objectives are relevant and applicable.
The NIEHS Advisory Council endorsed the conceptual basis of the draft
plan and most of its content. Criticisms of the plan centered on how to
structure the document to make it more forceful, critical areas of environmental
research that might be included, and changes to make the intent and use
of the document clearer. These changes are being made and the NIEHS plan
will be available for review and comment at the end of the summer.
It is now clear that Healy succeeded in her determination to introduce
strategic planning into the very fabric of the NIH process. She responded
to intense criticism and opposition from respected and powerful members
of the biomedical research community with carefully constructed arguments
and successfully enlisted many of her critics in the process. Perhaps the
strongest evidence of Healy's succes regarding strategic planning is the
new requirement that the annual budget submissions from the NIH institutes
be consistent with the critical elements in the NIH plan.
Dan VanderMeer
(Copies of "Investment for Humanity: A Strategic Vision of the National
Institutes for Health" described in this article are available from
the NIH Office of Science Policy and Legislation, National Institutes of
Health, Bethesda, MD 20892 USA. Copies of the NIEHS draft strategy for the
environmental health sciences will be available in the fall and information
on how to obtain copies will be announced in Environmental Health Perspectives.)
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Last Update: August 26, 1998