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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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164 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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166 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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168 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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170 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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172 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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198 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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200 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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POLICY OVERVIEW AND RECOMMENDATIONS 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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202 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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204 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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POLICY OVERVIEW AND RECOMMENDATIONS 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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206 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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208 [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.