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7
Policy Overview and Recommendations
SUPPORT FOR HEALTH SCIENCES RESEARCH
Since World War II, U.S. health science policy has led to an unquestion-
ably successful health research enterprise. This growth and development
has been nurtured by a unique mixture of research sponsors: the federal
government, state governments, private foundations and voluntary health
agencies, and corporations. This multifaceted support system has invested
large amounts of resources into building an unequaled health research
infrastructure. Such a diversified system of support has diminished the po-
tential for centralized planning and has encouraged input from a wide range
of views regarding the conduct of health sciences research ensuring that
no one group could impose limitations on what ideas should be pursued
or how the research should be conducted. In effect, this unique research
system has preserved academic freedom and encouraged the creativity of
health scientists allowing them to develop and test their hypotheses for
improving our understanding of human disease processes. The commit-
tee concluded that preserving this broad-based support system is essential to
continue a vigorous US. health sciences research program.
Opportunities in health sciences research appear to be growing almost
exponentially. However, the number of excellent ideas far exceeds the
available funding. In order to maintain the momentum for supporting the
best science resources have to be allocated to the various components of
the research enterprise. The committee emphasizes that the components of
162
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POLICY OVERVIEW AND RECOMMENDATIONS
163
the research infrastructure are highly interrelated and dependent upon one
another, and scientists will not be able to deliver optimum research results
and train young investigators without adequate facilities and equipment.
Likewise, overemphasis on increasing research space will be to no avail
if the buildings are underutilized by scientists and mentors because of
shortages of researchers and research funds. The charge to this committee
was to analyze the entire research infrastructure (people, projects, facilities, and
equipment) in a holistic fashion and develop a coordinated set of policies to
ensure balanced allocations to the components of the research system: people,
projects, and facilities.
Although the committee acknowledges that many of the previous ac-
complishments in the health sciences have been directly attributed to the
magnitude of federal support for health research, the charge to the com-
mittee did not include justifying a basis for increasing congressional ap-
propriations. Undoubtedly, this phase of the allocation process is critically
important to the continued success of the health sciences research enter-
prise. Because of the overwhelming success of previous health research
endeavors, new and heuristic research opportunities are emerging con-
tinuously. However, such opportunities easily could consume substantial
increases in funding. Although this study does not address the process for
increasing congressional appropriations, the committee acknowledges that
the level of future research support from Congress will be related directly
to the potential societal benefits of health research. The primary goal of
this committee in developing a balanced allocation process was to preserve
the creativity of the individual investigator the most valuable asset to the
research enterprise. Beyond the role of the federal government, the committee
believes that better inter-sectoral communication among the government, in-
dusay, and private nonprofit sponsors of health sciences research is necessary
to meet this challenge.
Patterns and Policies of Federal Health Sciences Support
Federal support for basic research has been based on the following
five principles:
1. Stable federal support for research in order to undertake long-range
programs.
2. Peer review for evaluating scientific merit of all research projects paid
for by federal funds.
3. Academically based scientific investigation.
4. Flexible scientific research management policies left to individual
scientists and their institutions.
5. Accountability to the Congress, the President, and the American public.
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FUNDING HEALTH SCIENCES RESEARCH
Although many changes have evolved in the way science is supported
by the federal government, these general principles have stood the test of
time. Many private and nonprofit sponsors of health research have adopted
them as well.
Research Community Perceptions
The committee closely analyzed federal funding trends and policies
for health sciences research over the past two decades. Additionally,
the committee reviewed the limited data available on the contributions
from other governmental sources, private foundations and voluntary health
agencies, and corporate research sponsors. These analyses revealed a
continuous commitment to the support of the health sciences research
enterprise in terms of both absolute and relative dollars. Funding patterns
through 1989 revealed that more investigators and projects are receiving
federal support than ever before, with the highest total allocations since the
system began. Furthermore, despite federal budget cuts in many nonhealth
domestic programs throughout the past decade, health sciences research
has continued to receive annual increases in appropriations through fiscal
year 1990.
Regardless of these gains, there is a strong feeling within the scientific
community that federal support for future health research is unstable and
unpredictable. Much of the concern is based upon two often cited statistics:
(1) the declining number of annual new and competing awards and (2) the
decline in annual award rates (award rate = grants awarded/total approved
applications). Adding to the confusion, NIH and ADAMHA recently have
replaced the former system for awarding grants based upon raw priority
scores with a more complex moving average percentile ranking system.
In the new percentiling system the raw priority scores assigned to grant
applications in the current review cycle of a particular study section are
percentiled with priority scores from the two previous review cycles. In
effect, percentiling diminishes the variance of the priority scores assigned
by a particular study section over three review cycles. Once the slate
of grant applications is presented to the various institutes, the institutes
determine a certain percentile threshold for proposals to be awarded. By
selecting a percentile funding cutoff for awarding grants, the variance
in priority scores among different study sections is normalized. Since its
inception, however, the percentile cut-off generally has been misconstrued
by the scientific community as the award rate. For example, institutes
may be funding to the 12th or 13th percentile but this translates into a
24-25 percent award rate. Thus, the low percentile cutoff has led to a
false impression of "declining" support for health sciences by NIH and
ADAMHA
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POLICY OVERVIEW AND RECOMMENDATIONS
165
Adding to this misperception are other less explicit policy changes
and disturbances within the health research environment reflected in award
rates. For example, the policy to lengthen grant awards, which has increased
the average duration of research grants from 3.2 years to approximately 4
years, implies that about 25 percent fewer grants will need to be renewed
each year to sustain the same overall annual number of research projects
supported by NIH and ADAMHA Since 1976, the number of grant ap-
plications submitted for peer review has continued to outpace the growth
in appropriations. This dramatic growth in the number of investigator-
initiated research project applications reflects, in part, a surge in research
opportunities as well as the growing practice of applying for multiple grant
awards.
Simultaneously, the approval rate for grant applications by study sec-
tions has risen steadily, from 70 percent in the mid 1970s to nearly 95
percent. As a result, the growth in applications, combined with the in-
creasing approval rate, has driven down the award rate throughout the
1980s (Figure 4-8~. Despite recent declines in annual new and competing
awards, the total portfolio of NIH grant awards (competing plus noncom-
peting continuations) has grown every year from the early 1970s until 1988.
Although the total number of awards supported by NIH dropped by 200
In 1989, from 20,867 to 20,681, and further to 20,316 in 1990, the NIH
investment committed to research in real dollar amounts has continued to
grow. The total number of awards is expected to increase slightly by nearly
125 in fiscal year 1991.
These policy changes have created substantial long-term pressures on
the infrastructure of the research enterprise. Despite the overall long-
term upward trend in research funding, these longer-term concerns became
the primary motivation for this study. The committee has analyzed all of
the available data pertaining to the overall level of support for research
projects and has found no evidence to confirm the research community's
perception of declining federal research support. To clarify these issues and
to recommend corrections, the next section summarizes policy decisions,
both implicit and explicit, that have contributed to the current anxieties
within the research community.
A Brief Review of Past Policy Decisions for Resource Allocation
The First 20 Years: Balanced Growth in Research Support
Between 1950 and 1968 NIH underwent rapid growth. Federal policies
combined with growing congressional appropriations fostered considerable
flexibility for funding research, with support being provided for all four
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FUNDING HEALTH SCIENCES RESEARCH
of the interdependent components of the research enterprise: (1) a well
trained pool of researchers, (2) modern facilities, (3) modern equipment
and (4) research project funding.
During this era, various mechanisms for supporting research were
established in an effort to control disease and improve health. While
investigator-initiated research and development (R&D) grants have been
the cornerstone of NIH and ADAMHA extramural programs during the
postwar expansion, other mechanisms for investigator-initiated research
support have included program project grants, center grants, and, more
recently, cooperative agreements. R&D contracts have been yet another
mechanism for supporting research, although contracts commonly are not
investigator initiated. There has also been a strong federal commitment to
train researchers and to build research facilities.
Constrained Growth and Instability in the 1970s
"Stabilization" Policy. Slower budgetary growth in the 1970s along
with a dramatic inflation rate reduced the buying power of research dollars.
One result of these forces was the fluctuating number of annual new and
competing grants awarded in the late 1970s. For example, between 1975
and 1976 the number of new and competing awards dropped from 4,700
to 3,50~a drop of nearly 25 percent and then surged to 5,200 in 1978.
These fluctuations led to uncertainty in the availability of ongoing support
for health research. Consequently, the scientific community began to lose
confidence in the future of federal research support.
In response to these concerns, Congress, NIH, and ADAMHA agreed
to a policy that established a minimum number of new and competing re-
search project grant applications to be funded annually. Beginning in fiscal
year 1981 and ending in 1988, minimum numbers of new and competing
awards were established between NIH/ADAMHA and the congressional
appropriations committees. This decision, in turn, reflected an explicit
NIH/ADAMHA policy that investigator-initiated research project grants
were the highest priority for their current research programs and that
maintaining a minimum level of new awards would stabilize the health
research base. However, the Administration's budget requests for NIH and
ADAMHA also had to conform to the Department of Health and Human
Services (DHHS) budgets. DHHS budgets were, in turn, highly influenced
by budget balancing in the Office of Management and Budget (OMB).
"Downward Negotiation" Policy. Despite added appropriations from
congressional committees, the available funds were inadequate to fund fully
the agreed upon number of awards. Thus, in order to comply, NIH and
ADAMHA were forced into a policy of reducing ongoing research commit-
ments (noncompeting continuing awards from previous years) as well as the
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POLICY OVERVIEW AND RECOMMENDATIONS
167
amounts paid to new and competing awards in what commonly is referred
to as downward negotiation. This is a recent practice for reconciling NIH
and ADAMHA research grant commitments to annual appropriations by
making across-the-board reductions in all grant awards. Downward negoti-
ation is a euphemism, since little if any negotiation actually occurs between
the scientist and NIH or ADAMHA Rather, these decisions concerning
the overall proportions of the previously committed funds to be withheld
in order to fund the required annual level of new and competing awards
are made between NIH/ADAMHA and OMB. This policy has placed addi-
tional burdens on scientists, for they are expected to perform the proposed
research with less than the recommended amount of funding.
The committee concluded that the stabilization policy was a sound strat-
egy to protect the research base. However, the necessary appropriations to
support fully the ongoing research obligations of NIH and ADAMH~4 were not
provided. As a result, NIH and ADAMHA were forced to make arbitrary ad-
ministrative cuts in all grant awards to be able to fund the mandated new and
competing grants. While the overall grant portfolio grew, these cuts contributed
to instability in the research project support system as well as to an imbalance
among support for the other components of the research enterprise.
Further Constraints and Crises in the 1980s
"Extended Duration of Awards" Policy. Although NIH and ADAMHA
were increasing the numbers of new and competing awards through the
stabilization policy, the research community felt that the average 3-year
award period for traditional research project grants (R01) was too short.
Three-year awards do not allow for long-term research program planning,
nor, in many cases, do they allow scientists sufficient time to achieve
research goals. Additionally, these shorter-duration awards require too
much emphasis on grant writing and administrative details.
As competition intensified throughout the 1980s, the number of grant
applications with very high priority scores increased. Nevertheless, despite
high priority scores, any given ongoing research project faced termination if
its score in competitive renewal fell just below the pay line. With interrupted
funding, individual scientists felt they would be forced to reduce staff
below critical levels, and although amended applications might ultimately
restore funding to the program, the research team may by then have been
disbanded. As a consequence of these fears, multiple grant applications,
with renewals in alternate years, were seen by many scientists as a means
of providing continuity of funding for their research programs.
1b address these concerns, NIH and ADAMHA instituted a policy
to increase the length of grant awards gradually. The intended results of
increasing award periods were to provide more stability in research activities
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FUNDING HEALTH SCIENCES RESEARCH
and scientists' careers and, possibly, to discourage the number of multiple
grant applications by individual investigators. Additionally, longer award
periods were viewed as a means to reduce the administrative workload for
NIH and ADAMHA study sections by reducing the number of competitive
renewal applications processed each year.
Although increasing grant duration does have a stabilizing effect on
research careers, it also obligates NIH and ADAMHA appropriations
further into the future. This policy of lengthening award periods, coupled
with the phenomenon of increasing average award size, reduces the funds
available for meeting annual targets of new and competing grant awards.
Despite these problems, the committee believes it is no longer justifiable to
sacrifice the stability of support for productive scientists simply to maintain
a given annual quota of grant awards. To this end, the committee supports
this NIH and ADAMH~4 policy to extend award periods, even if it reduces
the number of new and competing awards in any single year. Despite the
consequence of a sharp reduction in new and competing awards in a correction
year, the system will once again attain a balance in the out years
Peer Review Process and Allocation Policy
The committee also heard testimony from the scientific community
about the effectiveness of the peer review process for evaluating grant
proposals. As the proportion of approved proposals receiving funds has
declined over the past decade, many scientists believe that the peer review
process has favored the "old boy network" of mid to late career investigators
who have been receiving continuous research support at the expense of
young creative scientists just entering the competitive grant system. While
there are data demonstrating that the average age of principal investigators
is increasing, there is no evidence that these older scientists are less creative
or that their grant applications are less meritorious.
It is commonly believed that many scientists are reluctant to submit
innovative or high-risk proposals because the review panels may be averse
to recommending funding for less conventional research. Prevention and
nutrition research are examples of proposals that may not fair well in
the present structure of peer review for various reasons. Because of the
confidentiality of unfunded research grant proposals, no data exist on
the number of "novel" proposals not awarded. However, the committee
acknowledges that a closer examination of the peer review system and its
role in determining the effectiveness and efficiency of expended research
funds may be warranted.
Conclusions on Research Funding
The most disturbing aspect of the scientific communi~'s perception of
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POLICY OVERVIEW AND RECOMMENDATIONS
169
declining research project grant support is that it predisposes against sig-
nificant corrections for other elements of the research base. The committee
concluded that this has led to a climate where federal support for health sci-
ences research has become focused too heavily on projects and not enough on
developing career scientists and fostering creative environments. That is, over
the last decade training, equipment, and facilities have become steadily and
significantly underfunded in relation to research project support. Unfor-
tunately, funding from other nonfederal sources, although substantial, has
not compensated sufficiently for the accumulated loss of federal support
for these long-term investments in the health sciences research enterprise.
Before recommending the steps that can begin to address these accumu-
lated imbalances, the committee reviews briefly in the next section some
of the additional analytic factors that must be considered as propagating
the specific status of the neglected health research components namely,
training, equipment, and facilities.
Support for Training
Many of today's senior health science faculty members in colleges,
universities, and medical centers can trace their careers to the various
training programs underwritten by NIH/ADAMHA between 1950 and 1970.
However, federal funds allocated for training new researchers have not kept
pace with expanding research opportunities. As indicated in Figure 4-9,
NIH support for training as a percent of the extramural budget declined
from 17.2 percent in 1970 to 6.6 percent in 1978 and even further to 4.2
percent in 1988. Furthermore, inflationary pressures have been shrinking
the real dollar value of stipends awarded to trainees and fellows.
The emergence of unexpected health crises, such as AIDS, emphasizes
the importance of maintaining a cadre of highly talented scientific personnel
who can be redirected quickly as needed. According to a recently released
report by the Office of Science and Engineering Personnel of the National
Research Council, Biomedical and Behavioral Research Scientists: Their
Raining and Sup, entrants into health sciences research have increased
slightly while recruitment of Ph.D. scientists by the private sector has
increased markedly. Furthermore, predictions of an increasing attrition
rate among scientists trained during the postwar expansion is cause for
concern about research personnel shortages before the end of this century.
These and other factors will affect the pool of educators and mentors to
train the next generation of scientists, in both academia and industry.
The committee concludes that steps must be taken now to maintain the
pool of career scientists by recruiting and retaining the best possible candi-
dates. Resource allocation policies fostering health research careers will
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FUNDING HEALTH SCIENCES RESEARCH
require long-term investments from a variety of sources. Academia, gov-
ernment, industry, private foundations, and voluntary health agencies need
to play cooperative roles in developing and pursuing effective strategies for
enhancing and renewing the nation's health sciences talent base. These
strategies should not only focus on recruiting individuals into science ca-
reers, but should also nurture these individuals to the level where they
become independent young investigators. New approaches should include
programs targeted at multidisciplinary and interdisciplinary training of sci-
entists who are becoming increasingly necessary for addressing complex
health questions.
The federal government along with the scientific community must ac-
knowledge the need for continued recruitment and take responsibility for
developing new talent to ensure the future vitality of the health sciences
enterprise. This committee acknowledges that funding for talent develop-
ment may not be available from new congressional allocations for NIH and
ADAMHA. The committee is also deeply concerned that any redistribution
of existing funds from research project support will increase pressures on
the funding picture. Nevertheless, the committee believes that the scientific
community must show commitment to the long-term integrity of the overall
system, even if that means short-tern sacrifices to research allocations in order
to reinvigorate Gaining and replenish the scientific talent pool
Support for Equipment and Facilities
The committee concluded that inadequate or unsuitable space and ob-
solete equipment have restricted the number and Apes of research projects
that can be undertaken. Although the extent of the needs for construction,
repair, and renovation of health sciences research facilities is difficult to
determine, estimates run as high as $8 billion. The committee believes the
long-term decline in federal programs for research facility construction and
equipment renewal is partially responsible for deterioration of the nation's
research laboratories. Consequently, the committee believes that these
worsening conditions potentially could have adverse affects on research
training and the productivity level of the nation's scientific work force.
Federal support for research facilities has diminished drastically over
the past two decades. Federal grant programs in the 1960s were very suc-
cessful in expanding the nation's research capabilities, but several factors
caused the NIH and National Science Foundation (NSF) facilities programs
to be eliminated in the early 1970s. For instance, the increasing commit-
ment of resources to the Vietnam War severely strained domestic programs,
including facilities programs at academic institutions. Also, OMB (at that
time known as the Bureau of the Budget) began pressuring NSF and NIH
to justify continuing expansion of the nation's research facilities at a time
when both college enrollments and the growth in federal R&D funds were
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POLICY OVERVIEW AND RECOMMENDATIONS
171
leveling off. This forced a policy of supporting facilities solely through
indirect cost recovery associated with research project grants.
Except for some limited appropriations for AIDS research facilities,
federal funds for health research facilities have been negligible over the past
10 years. This continued neglect comes at a time of escalating maintenance
costs, increasing regulatory standards, increasing technological sophistica-
tion, and a dramatic growth in scientific opportunities. Although some
state governments and the private sector continue to make significant con-
tributions to support the physical infrastructure for health research, they
cannot be expected to meet the total demand. Clearly, there is a need to
establish a national policy for renewal and expansion of the health sciences
research infrastructure.
The committee concluded that despite repeated shoddies calling for in-
creased support for research facilities, no long-term federal strategy exists to
restore the physical infrastructure for health research. There is no consensus
within government or the research community on the need for expanded
versus renovated facilities, the best mechanism for program support, or the
respective roles of the interested sponsoring parties. Additionally, there is
no mechanism to coordinate the various independent contributors support-
ing facilities and equipment. Without a clear set of goals and a cohesive
national policy, U.S. universities and research institutions will continue to
decay and will be forced to seek short-term solutions to their facilities'
needs by soliciting pork barreled appropriations from Congress.
TOWARD A POSITIVE RESEARCH ENVIRONMENT
The committee believes that the goals of health research can be
achieved only by creating a positive research environment for health sci-
ences. This environment should
· identify and encourage young, talented individuals to pursue health
research careers;
· provide stable research support for talented scientists throughout
their careers;
· offer flexibility in allocating resources to foster creativity and meet
changing demands; and
· provide the modern laboratories and equipment necessary for sci-
entific research and training.
These characteristics, in turn, require effective coordination and leadership
from the federal research agencies; competent, objective public and private
sector administration; and responsiveness to the wishes of the American
people through the political process.
When the environment is positive, supportive, and reasonably pre-
dictable, it nurtures innovative research. A congenial environment is
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FUNDING HEAI7H SCIENCES RESEARCH
equally important, for it encourages talented people to seek careers in
health research while fostering the careers of established scientists. The
continued vitality of health sciences research requires a system of stable
support for scientists but with the flexibility to allocate resources in order to
meet changing demands. The committee believes that while the scientific
community must be held accountable for use of federal research funds,
there has to be stable support and flexible policies to promote an optimal
research environment.
General Research Funding Guideline
To place the existing research establishment into an economic perspec-
tive, the committee analyzed each component in terms of capital investment
relative to its productive life expectancy. The committee determined the
following: (1) individual scientists are the most vital long-term investment
in the research system; (2) capital investment in facilities is of a slightly
shorter duration; and (3) individual research projects and the equipment
used by researchers generally are the shortest and the most variable invest-
ment relative to time.
A certain degree of flexibility is necessary for supporting the compo-
nents of the research enterprise. This fundamental principle implies that
support for one component can be reduced for a brief period of time in
order to provide funds to invigorate another component. The committee
ascertained that those elements with the longest survival value (namely
the research workforce and facilities) may be resilient enough to withstand
temporary budget freezes or slight reductions in order to accommodate
the immediate needs of components with shorter investment periods (re-
search projects and equipment). Although short-term exigencies that favor
support for one component over the others may be necessary for brief
periods, continuance of such short-term policies will, in time, undermine
the integrity of the entire system. In practice, emphasis on the short term
needs of the research enterprise has led to underemphasis of funding for
the training pipeline and facilities.
Thecommitteeconcludedthattheg~idingprincipleformaintaininglon~
term balance within the system is a lequ ate support for each component. At any
given level offederal finding, support for each component must be calculated
relative to society 0cpectaiions of the entire research enterprise.
Recommendation 1: The committee recommends that Congress, NIH
and ADAMHA administrators, and scientists employ a priority-setting
framework for allocating funds to meet long- and short-term research
needs in order to correct and maintain the appropriate overall balance
among the individual components of the research establishment (people,
projects' and facilities).
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FUNDING HEALTH SCIENCES RESEARCH
of indirect costs allowable on sponsored research, these sponsors com-
pound IDC recovery problems for colleges and universities. As a result,
institutional funds are consumed to support the indirect costs associated
with these projects. This constraint may force some institutions to refuse
support from these sources if the indirect costs cannot be recouped in a
fair and equitable manner.
Many nonprofit sponsors are very concerned about the high IDC rates
at the top private research institutions. Paying these high IDC rates easily
could consume much of these sponsors' resources available for the direct
costs of performing research. However, if universities are forced to transfer
indirect costs into direct cost categories, the required funding will remain
the same.
Most research buildings become obsolete for conducting sophisticated
research in 20 years, and equipment is often obsolete between 4 to 7
years after purchase. The committee feels that sponsors of health research
should link support for particular facilities with individual research projects
to allow faster recovery of institutional funds used to maintain facilities and
to repay loans used for construction or renovation. In order to accomplish
this, research institutions need to have options available to recoup previous
expenditures for renewing their research physical plant. This could be done
by changing the annual IDC allowance for building amortization from the
present 2 percent to 5 percent and by raising the allowance for equipment
amortization from 6.67 to 20 percent. This would allow research institutions
to depreciate their buildings over 20 years rather than 50 and to depreciate
equipment in 5 years rather than 15.
The committee emphasizes that this policy change must not reduce the
pool of funds available for direct costs and strongly urges universities and
other research organizations to keep down the administrative portions of
overhead. This seems impossible in light of the increasing federal bureau-
cratic regulations, but failing to keep these costs in check will inevitably
lead to IDC caps and subsequent loss of institutional control over these fi-
nances. However, this policy change could allow research institutions more
flexibility in setting their own priorities within their budgets for IDC recov-
ery. The committee also emphasizes that some assurances must be made
on the part of the grantee institutions that these funds be sequestered and
utilized only for facilities and equipment renewal and not for administra-
tive overhead. Inaction now will only exacerbate the growing infrastructure
problems at colleges and universities.
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POLICY OVERVIEW AND RECOMMENDATIONS
Creative Financing
199
Recommendation 5.3: The committee recommends that rules be ad-
justed so that indirect costs can be applied to direct rental costs of leased
facilities.
Alternatives to the traditional forms of capital formation are beginning
to reshape the way academia raises money for capital improvements. State
and local governments are investing in academic facilities for education
and garnering possible economic advantages by providing a sound scientific
base in their locales. Partnerships with industry (although limited) are pro-
viding an alternative method for capital formation. Patenting and licensing
intellectual property also are bringing financial returns that can be invested
in facilities at some institutions as well.
The committee heard suggestions that institutions should attempt to
offset some of the high costs of research facilities and equipment by entering
into cooperative agreements to share resources. Some research institutions
recently have developed innovative approaches to develop research facilities
by creating long-term arrangements with private developers. By combining
off campus IDC rates with direct rental payments, research institutions can
enter into such lease arrangements. It is conceivable that in such cases
rental payment may provide a means of eventually purchasing the proper
by the research institution.
In some cases research institutions may wish to lease land to a devel-
oper who will construct a research facility. The developer may, in turn,
lease the space in the research building back to the research institution.
In such cases maximum flexibility should be provided so that the building
can be leased or purchased through direct or indirect costs associated with
research conducted in the facility. Developer interest in these types of
projects may be predicated upon tax accounting rules, which may require
some accommodation with regard to how rental or overhead funding is
provided.
ESTABLISHING AN ONGOING PROCESS FOR RESEARCH
PROGRAM MANAGEMENT AND OVERSIGHT
Federal priorities for health sciences research are determined by the
federal budget process through a complex system of interactions among
the Executive Branch, Congress, the scientific community, industry, the
public, and special interest groups. Ultimately, the federal agenda is set
by the funds allocated by Congress through its authorizing, budgeting, and
appropriating mechanisms and the recommendations made by Congress
in report language. The committee concluded that the present system is
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FUNDING HEALTH SCIENCES RESEARCH
becoming increasingly stressed by short-term corrective actions whose long-
term consequences have not been Ally assessed.
Growing federal deficits, earmarking of funds to meet specific health
needs, and rigid allocation policies within the health sciences establishment
have reduced flexibility within the system. These problems emphasize
the need to review federal priorities and to coordinate federal health
sciences research efforts. Integration of scientific priorities, as determined
by peer review or other review mechanisms, with sound policy will lead to
more effective resource allocation, thus improving the overall environment
of health sciences research. Although the committee endorses an open
forum for discussing pnorii:ies and manners of addressing the problems facing
health research, it also emphasizes that top~own research directives will be
counterproductive to research.
Priorities in the private sector are determined in equally complex
processes. Whereas many of the larger foundations and voluntary health
agencies have boards, steering committees, or a standardized peer review
mechanism, others may not have a coordinated means of making deci-
sions according to scientific or other objective criteria. Likewise, corporate
R&D decisions are based upon financial determinants in accordance with
directives from the boards of directors and stockholders. The committee
does not believe that corporate sponsors should be forced to subject their
decision making to open peer review, nor would it be possible. However,
foundations and corporations should be able to consult with federal poli-
cymakers in order to arrive at sound decisions that may complement the
federal effort and meet their own needs as well.
Failure to maintain constructive policies that integrate the efforts
of government and private and nonprofit sponsors of research will limit
scientific progress, jeopardize our continued leadership, and imperil our
economic strength. It is imperative that review and oversight of the bal-
ance among the research components be conducted on an ongoing basis.
Therefore, the committee focused on developing mechanisms whereby the
sponsors of health sciences research could work cooperatively to monitor
progress, develop solutions, and make recommendations to address the
problems facing health research highlighted in this report. The objectives
of this process are (1) to optimize the use of resources from all sponsors
of health sciences research; (2) to improve the nation's capacity to respond
to health crises and capitalize on new research opportunities; and (3) to
restore balance in the components of the system and resource allocation
between support for people, projects, and facilities.
Improving Communication Among the Federal Agencies
Recommendation 6.1: The committee recommends that a Federal
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201
Coordinating Council for Science, Engineering, and Technology (FCCSET)
subcommittee for Health Sciences be established to review federal priorities
and coordinate federal health sciences research efforts on a continuing
basis.
.
Because of the impact that health-related decisions have on the Amer-
ican public, the committee believes it is essential to continue having high-
level health sciences research advice available to the President through the
Office of Science and Technology Policy (OSTP). The committee believes
that effective mechanisms are necessary for developing cross-cutting health
science policy among the federal scientific agencies. As such, the FCC-
SET provides an excellent model for interagency coordination. FCCSET is
composed of the science and technology advisor to the President and one
representative from each of the 13 federal agencies sponsoring research.
The FCCSET can establish various committees composed of appropriate
high-level federal agency representatives to provide a direct link among
government agencies, and it can coordinate federal activities.
While the committee believes that the FCCSET will address inter-
agency coordination of research, the White House also needs a formal
mechanism for obtaining broad scientific advice from nongovernmental sci-
entists. The current director of OSTP has established a President's Council
of Advisors on Science and Technology (PCAST), composed of nongovern-
mental science experts. This is the kind of advisory body the committee had
in mind, and it is pleased to note the establishment of PCAST as a means of
providing the President and FCCSET with advice from nonfederal scientists.
The health sciences FCCSET committee should use the framework for
assessing science and technology budgets proposed in a recent Academy
report to evaluate support for health sciences research across federal agen-
cies. The committee should develop guidelines for federal research prior-
ities by considering the following categories from the National Academy
of Sciences report Federal Science and Technology Budget P,ionties: New
Perspectives and Procedures as they apply to the health sciences:
· research related to the sponsoring agency's mission;
· health research activities of individual agencies that contribute to
the overall science and technology enterprise (including the components of
training, fundamental research, and infrastructure);
· cross-cutting research activities of several agencies that contribute
to broad national objectives given priority by the President and/or Congress;
and
activities that constitute significant health research initiatives by
virtue of their considerable cost.
The committee was pleased to note the appointment of a health
scientist last year as the associate director for life sciences within the OSTP
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FUNDING HEALTH SCIENCES RESEAP~H
and recommends that this associate director be chairman of the proposed
FCCSEI' for Health Sciences. The committee also recommends that this
post continue to be held by individuals with experience in health research
and research administration.
Under the chairmanship of the associate director for life sciences,
a special FCCSET committee for health sciences research would bring
together the NIH director; ADAMHA administrator; NSF director, health
research directors in the Departments of Veterans Affairs, Defense, and
Energy; and the heads of the other government agencies sponsoring federal
health sciences research programs. These federal agencies would use the
guidelines provided by FCCSET to set agency priorities as they pertain to
their individual missions. Subsequently, these priorities would be used for
budget development by the agencies. The science advisor, in cooperation
with the President and director of OMB, then would match program
priorities with budget requests to meet the nation's health science research
needs.
The committee believes that advice obtained through this mechanism
will improve intergovernmental coordination for defining national health
sciences research priorities. Ultimately, this will lead to more effective
policies for allocating resources for project support, training, equipment,
and facilities.
Improving Communication Between Federal and Nonfederal Health
Sciences Research Sponsors
Recommendation 6.2: The committee Commends that a forum such
as the Government-University-Industry Research Roundtable (GUIRR) be
established to review the support of health sciences research on a regular
basis and to facilitate communication among the various sectors that
support health sciences research.
The vitality of the health sciences research enterprise depends not
only upon federal government activities but the cooperation of all parties
involved in health sciences research: universities and independent research
institutes, as well as the private sector (foundations, voluntary health or-
ganizations, and corporations). Each must recognize the interdependence
of the various sponsors of health science research in order to maximize its
own contributions. These venous participants should have a mechanism
for open dialogue to facilitate the efficient use of the limited health science
research resources.
The GUIRR provides a model for developing a forum to address these
issues. The GUIRR was established by the National Academy of Sciences,
National Academy of Engineering, and the IOM to address crosscutting
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POLICY OVERVIEW AND RECOMMENDATIONS
2~3
issues that affect all areas of science and technology. It is composed of
scientists, engineers, administrators, and policymakers from all sectors with
the objectives to understand ~sues, to inject imaginative thought into the
system, and to provide a setting for discussion and the seeking of common
ground.
1b ensure that the balance of support among components of health sci-
ences research is reestablished and maintained, this review would include
evaluation of the relationships among support for research projects, the
number of researchers being trained compared to the nation's needs and
scientific opportunities, and the status of research facilities. This proposed
committee should include representation from the executive and legisla-
tive branches of the federal government, pharmaceutical and biotechnology
industries, state governments, academic research institutions, private foun-
dations, and voluntary health agencies.
The committee recommends that such a forum initially identify the
special responsibilities, interests, and contributions of each of these support
sources and explore means to achieve health sciences research goals through
greater interaction. The committee also suggests that this group consider
sponsoring meetings and workshops or holding public hearings on issues
such as
· the special roles and responsibilities of government, industry, and
nonprofit organizations in supporting health sciences research;
the necessity of devising long-term plans to meet next century's
research training needs;
· ways to finance the escalating costs for facilities and equipment;
· the appropriate balance of support for research projects, training,
and facilities;
· the impact of reallocating resources on the various components of
the research enterprise;
· cooperatives among research institutions and the private sector, in-
cluding review of successes and failures in order to improve new initiatives;
· ways to foster communication among scientists, health practitioners,
and corporations to increase technology transfer; and
· long-range planning for health sciences research including formu-
lating a framework to assist establishing 5-, 10- and 20-year goals for
individual participants.
After careful consideration of issues that affect all supporters of health
sciences research, the proposed GUIRR-like forum should be able to pro-
vide information and advice about the needs and activities of the scientific
community and their supporters to the proposed FCCSET committee out-
lined above. This advice would be particularly useful in formulating federal
guidelines that include consideration of the need to balance commitments
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FUNDING HEA17H SCIENCES RESEARCH
to support investigators directly, to restore facilities and equipment, and to
provide training opportunities.
Unresolved Issues to Be Addressed by These Forums
The committee heard a number of complaints about the disease ori-
entation and traditional disciplinary emphasis of federal support for health
sciences research, with too little money available for newer fields such as
nutrition and prevention research as well as for interdisciplinary projects
that do not fit easily into current health research categories. In contrast,
the committee also heard strong support for the current system, with the
belief that some of these other areas could be handled easily within the
existing organizational structure. However, the charge to this committee did
not include an evaluation of the allocation of resources between or among the
many topics within the disciplines of health sciences research.
In a time of intense competition for available resources, where the
potential for a national health crisis exists at any time, choices must be
made where some fields of research receive more support at the expense
of others. Vigorous advocacy by particular special interest groups has had
enormous benefit in our democratic decision-making system. However,
conflicting views by these groups can confuse decision makers in both the
administration and Congress. Such conflicts have made priority setting
among competing scientific initiatives extremely difficult. The committee
recognizes that it would be advantageous to employ formal and explicit
criteria in setting national health priorities and allocating scarce federal re-
sources. Both government science administrators and nonfederal scientific
advisory groups could benefit in their decision-making considerations from
such criteria.
The science advisors in the White House OSTP, along with the pro-
posed health FCCSET, should work closely with P CAST, NIH/ADAMHA
administrators and advisory groups, and the proposed GUIRR-like com-
mittee to determine appropriate criteria for setting priorities among fields
within the health sciences disciplines and for evaluating new initiatives.
This would not be a means to rate competing disciplines but rather to
evaluate scientific initiatives. Procedures should be developed that would
permit scientific advisory committees and peer review panels to compare
competing initiatives and reach unambiguous recommendations about pri-
ority, based on criteria such as scientific significance, breadth of interest,
potential for new discoveries and understanding, possible contributions to
the improvement of health, and the feasibility and logistics of the proposal.
The committee believes that this should not be perceived as an attempt
to empower government administrators to be central planners; rather, it is
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205
the committee's intent to establish a high-level priority-setting process with
a wide range of input from all sponsors and performers of health research.
Many issues were brought before the committee that were outside
of the committee's charge. Many of these dealt with structural aspects
of the Executive Branch that the committee was not able to address.
These included: (1) the role of the research components of ADAMHA
and their relationship to the research institutes in NIH, (2) the role of
the Assistant Secretary for Health in oversight of research sponsored by
NIH and ADAMHA, and (3) the role of federal laboratories in facilitating
technology transfer. The committee believes that these items should be on
the agenda of OSTP and a health FCCSET to encourage open debate.
The committee also deliberated extensively on the issue of 2-year
congressional budget appropriations for the federal agencies that sponsor
R&D. Whereas assessment of research needs would be conducted annually,
including appropriate congressional testimony and progress reports from
the various agencies, a rolling 2-year funding cycle could set minimum bud-
get levels for particular institutes and programs. Under these circumstances,
funding could be initiated at the beginning of each fiscal year without long
delays, and this would lessen researcher anxiety about the priority level
at which grants will be awarded. Such planning would also diminish the
requirement that agencies arbitrarily reduce the level of previous awards
because of unanticipated changes in funding levels. Although Congress
would retain the option to reduce funding in the second year of a 2-year
cycle, the actual history of overall budgetary stability suggests that such de-
creases would be unlikely. Congress is likely to avoid such midcycle changes
in the interest of stability in the research environment. Although there are
many positive aspects to a 2-year budget cycle for federal research agencies,
the committee did not believe it was within its charge to recommend such
a policy change.
Improving Communication and Cooperation Among Research Sponsors
Recommendation 6.3: The committee recommends that sponsors and
researchers explore ways to share facilities and equipment among research
institutions, industry, and government.
The committee also heard suggestions that institutions offset some
of the high costs of research facilities and equipment by entering into
cooperative regional agreements to share these expensive resources. Even
if this cannot be done on a widespread basis, limited cooperation can
further advances in health research and possibly can reduce unnecessary
duplication of capital investments.
As equipment and facilities costs continue to soar, cooperative sharing
should reduce the need to duplicate investment in physical infrastructure.
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FUNDING HEALTH SCIENCES RESEARCH
Understandably, there are difficulties with proprietary rights and maintain-
ing intellectual freedoms. However, the model of cooperation employed by
the National Institute of Standards and Technology sets a precedent for the
success of these types of ventures. This could be achieved by employing
the GUIRR structure proposed. All sponsors and performers of health
research should explore ways to increase sharing of facilities and equip-
ment. Even though conflict of interest must be avoided, the committee is
convinced that cooperative agreements can arise without compromising the
integrity of researchers or institutions.
Foundations and Voluntary Health Agencies
Recommendation 6.4: The committee recommends that foundations
and voluntary health organizations maintain their support for new lines of
investigation and research projects that, for political or structural reasons,
NIH and ADAMHA cannot fund.
Traditionally, foundations and voluntary health agencies have been key
supporters of interdisciplinary or innovative projects or of those projects
that, for political or other reasons, are difficult to support with federal
funds. Although nonprofit organizations will never have the resources to
rival federal funding for health sciences research, they can respond to
new lines of inquiry faster than the government bureaucracy allows. Fur-
thermore, the disease-specific nature of voluntary health agencies provides
them with a greater focus for supporting innovative ideas in specific areas
of investigation as well as for funding trainees.
Although the committee believes that foundations and voluntary health
agencies are integral to the health research enterprise, it emphasizes that
these organizations must not be considered substitutes for federal support.
Rather, these organizations should supplement federal efforts and fill in
gaps in support in specific areas of research.
SCIENTIST RESPONSIBILITIES
Federal health research allocation policies often have emerged piece-
meal out of the continuing political process. Policy decisions largely reflect
scientific, political, and economic influences. The sponsors of health re-
search need to work toward common goals with the research community
in order to provide an optimum environment for health research. The
committee's recommendations to now have focused primarily on the re-
sponsibilities of the sponsors. Little has been said about the role of research
scientists and their responsibilities to the research system. Indeed, the key
to a viable system is the active participation of scientists in all aspects of
the research enterprise, including priority setting and allocation policy.
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POLICY OVERVIEW AND RECOMMENDATIONS
207
The committee concluded that research scientists could take actions
that would help to improve the future success of the enterprise beyond their
own commitment to specific research projects. Scientists should assume a
more active role in the policy decision-making process and should champion
the overall needs of the research establishment. Health research is a long-
term investment, and scientists need to express their views to governmental
representatives so that Congress and the Executive Branch can set national
research priorities. Scientists also have a responsibility to serve on peer
review panels; to review journal articles; and to provide advice on policy
boards of the federal government, private foundations, and charitable
organizations.
The committee believes that scientists should become more involved in
improving the public's understanding of science. Negative publicity about
science and scientists seems to be uppermost in the public consciousness
in recent years. A very small number of highly publicized cases of alleged
scientific misconduct and fraud are cited by some to be the tip of an iceberg
of deception and misconduct pervading the scientific community. On the
other hand, members of the scientific community have argued that the
high degree of methodological reproducibility establishes the sound basis
of scientific observation. Researchers must continue to show high regard
for animal welfare and the proper handling of toxic wastes in order to avoid
negative ramifications on the research establishment.
1b improve the public's opinion of science, the committee believes that
scientists must strive to rid the system of misconduct; they must cooperate
fully with their institutions and research sponsors in cases of suspected
wrongdoing. Also, scientists need to help prevent overreaction to these
unfortunate incidents that could easily stigmatize the field. The committee
endorses the recommendations of a recent IOM study group report, The
Responsible Conduct of Research in the Health Sciences,4 which includes rec-
ommendations that scientists, individually, as well as through professional
societies and other organizations, promote high ethical standards in the
conduct of research. Failing to address these concerns in the rapidly paced
and highly competitive realm of modern biomedical research could have
serious consequences, for each new case of scientific misconduct increases
the possibility of federal regulation. The committee is concerned that leg-
islatively mandated guidelines for ethical conduct and scientific reporting
could impede research activities and increase research costs.
A CALL TO ACTION
Many of the problems, issues, and opportunities considered by this
committee have been tackled before by the scientific community and by
advisors to and within government. Despite numerous recommendations by
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[ENDING HEALTH SCIENCES RESEARCH
those various groups, no decision to act has been made, and the basic prob-
lems therefore have persisted. The present analysis has sought to include
all of the sources of health sciences research support in order to provide
a more comprehensive overview of current trends for all components of
the research establishment The committee concluded that an imbalance
in support among the components of the research enterprise needs to be
addressed immediately to ensure a viable system into the next century.
Effective and longer-term corrections will be made only when those who
are examining the issues have the authority to act on their conclusions as
well. Therefore, the committee believes that in order to begin resolving the
problems discussed in this report and to make the best use of available
research funds, ongoing communication among all research sponsors and
the whole of the scientific community is vitally important. Only in this way
can the wisdom invested in the enterprise be applied in a continuing effort
of self-regulation and success.
REFERENCES
1. National Research Council. 1989. Biomedical and Behavioral Research Scientists:
Their Training and Supply. Washington, D.C.: National Academy Press.
2. Institute of Medicine. 1988. Resources for Clinical Investigation. Washington, D.C.:
National Academy Press.
National Academy of Sciences, National Academy of Engineering, and the Institute of
Medicine. 1989. National Issues in Science and Technology: V. Federal Science and
Technology Budget Priorities, New Perspectives and Procedures. Washington, D.C.:
National Academy Press.
4. Institute of Medicine. 1988. The Responsible Conduct of Research in the Health
Sciences. Washington, D.C.: National Academy Press.
Representative terms from entire chapter:
policy overview
