Large-Scale Biomedical Science Exploring Strategies for Future Research (2003) / Chapter Skim
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4. Funding for Large-Scale Science
4. Funding for Large-Scale Science
Pages 80-129
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From page 80... ...
Potential sources of funding include government agencies, philanthropies and other nonprofit organizations, and industry, each of which has its advantages and limitations. In the United States, the federal government has traditionally been the primary fonder of large-scale projects, as defined in this report, because of the high costs of such activities.
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From page 81... ...
For example, the current, conventional NIH peer review process for vetting most research proposals is not very favorable to large-scale projects, which may not be hypothesis driven and often have nontraditional goals. But such a vetting process is essential for achieving credibility and buy-in by the scientific community.
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From page 82... ...
The first federal support for basic research within universities was initiated by the creation of the Department of Agriculture and the Land Grant Colleges. A series of congressional acts, starting with the Morrill Act of 1862, provided the mechanism by which scientists at universities could propose research projects and obtain federal funding to carry them out.
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From page 83... ...
Yet broad priority setting is generally resisted by the recipients of federal funding because it orders the importance of research investments in ways that groups within the scientific community often do not support (Office of Technology Assessment, 1991; McGeary and Merrill, 1999~. The process is inherently contentious because priority setting creates winners and losers.
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From page 85... ...
Even with these mechanisms in place, however, there is no way to avoid competition among the various claims on federal science funds or to balance the federal research portfolio systematically. As described in more detail below, a variety of unrelated agency budgets could be in competition for the funds available under the jurisdiction of an individual appropriations committee, and no single subcommittee is responsible for all science funding agencies, making it very
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From page 86... ...
The budget contained a component called "Federal Science and Technology," which was meant to represent investment in new knowledge and know-how. This was a break from tradition, but still does not enable priority setting among fields (National Research Council, 2001a)
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From page 87... ...
Many researchers have argued that the results of ongoing basic research cannot be benchmarked or measured (Lekowski, 1999~. A 1999 report addressing the issue of assessing research in compliance with GPRA agreed that basic research cannot be measured directly on an annual basis because its outcomes are unpredictable, and there is generally a significant time delay between the generation of new knowledge and its practical application (National Research Council, l999~.
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From page 88... ...
Although specific budget items may have been outlined by the President, the budget committees, the authorizing committees, and the appropriations committees have the decisive influence over the funds distributed to R&D agencies. Each of the 13 appropriations subcommittees from the House and Senate writes a bill that is submitted back to the respective full committee, and the bills are taken to the House or Senate floor.
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From page 89... ...
Subcommittees: Agriculture Commerce Defense District of Columbia Energy and Water Foreign Operations Homeland Security Interior Labor, HHS, and Education Legislative Military Construction Transportation, Treasury, and Independent Agencies VA, HUD, and Independent House Agencies Floor 1 89 1 1 1 3 Congressional Conference Committees Input from Senate authorizing ~ committees Senat'3 Full ~ * 13 Senate Appropriations _ Appropriations Committee _ Subcommittees | Senate | L: 1 ~ Presidential Approval FIGURE 4-1 Federal budget approval process.
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From page 90... ...
So LARGE-SCALE BIOMEDICAL SCIENCE TABLE 4-1 Selected Congressional Appropriations Committee Jurisdictions Committee Jurisdiction Appropriations Committee or Subcommittee Name Senate House Agriculture 1. Department of Agriculture (except Forest Service)
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From page 91... ...
Department of Energy Water Economic Regulatory (except the Economic Development Administration; Energy Regulatory Administration; Information Administration; Energy Information Strategic Petroleum Reserve; Administration, Office of Naval Petroleum and Oil Shale Hearings and Appeals, Reserves; Emergency Strategic Petroleum Preparedness, Office of Hearings Reserve, Naval Petroleum and Appeals; Fossil Energy and Oil Shale Reserves, Research and Development; Fossil Energy Research and Energy Conservation; Development, Clean Coal Alternative Fuels Production and Technology, Energy Related Matters) Conservation, Alternative 2.
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From page 92... ...
Federal Mine Safety and Handicapped Health Review Commission 9. National Labor Relations Board 9.
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From page 93... ...
7. Consumer Product Safety Agency 12.
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From page 94... ...
For instance, if the National Human Genome Research Institute had been given only 80 percent of its budget, it could still have generated DNA sequence data, but the Human Genome Project would have taken longer because fewer sequencers and staff would have been available for the project. NIH FUNDING The majority of federal funding for biomedical research is allocated through NIH.
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From page 95... ...
Unless NIH develops a specific initiative to solicit large-scale projects for a particular field of research, investigators are likely to find it very difficult to overcome obstacles associated with peer review and restrictions on award sizes in the current system. Many established scientists, in speaking before the National Cancer Policy Board, have borne witness to these difficulties encountered in their own recent attempts to obtain NIH funding for large-scale projects (see Box 4-3~.
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From page 98... ...
The House and Senate appropriations committees also play a major role in NIH priority setting, often appropriating more than the President's budget requests and putting forth specific funding directives (Institute of Medicine, 1998~. 5 "Setting Research Priorities at the National Institutes of Health"; see |
From page 99... ...
The NIH director and DHHS secretary may comment on the NCI bypass budget, but they cannot change the proposal. The NCI director also prepares another budget that goes through the usual channels of review at NIH and DHHS before being transmitted to OMB, and this is generally the budget that becomes the basis for appropriations hearings, but the bypass budget is an independent input to OMB and the appropriators.
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From page 100... ...
of eac labora includ Advisory Committee Members: Advises c to the Directora and integ · NCI director (as chair) , NCI deputy director, programs deputy director for NCI extramural science, director official cl of NCI extramural activities emerging · NCAB, BSC chains)
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From page 101... ...
. Advises, assists, consults with, and makes recommendations to the Secretary of DHHS, the NIH director, and the NCI director with respect to the activities carried out by NCI, including reviewing and recommending for support grants and cooperative agreements, following technical and scientific peer review.
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From page 102... ...
agreement to basic c Director's Consumer Liaison Groupa 15 appointed members who are consumer advocates Provides involved in cancer advocacy and represent a the persF constituency with which they communicate on a variety o regular basis. Appointed by the NCI director to serve channel 3-year terms.
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From page 103... ...
r and are Reviews grant proposals, cooperative agreement applications, contract Held as Biomedical proposals for research projects, and applications for research and necessary ly training activities in broad areas of basic and clinical cancer research. about 60 , on an Advises the NCI director and the director of NCI's Division of per year Cations, Extramural Activities regarding research grant and cooperative ~view.
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From page 104... ...
104 LARGE-SCALE BIOMEDICAL SCIENCE program initiatives; program priorities; previous commitments, such as noncompeting continuations; and other projected needs. Extramural research is funded by NIH through three major mechanisms grants, cooperative agreements, and contracts (see Box 4-5~.
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From page 105... ...
Three peer review cycles or "rounds" per year are offered. NIH funding may be sought by nonprofit and for-profit organizations, institutions of higher education, hospitals, research foundations, governments 7 "The NCI Grants Process, Part II: Process and Administration' nci.nih.gov/admin/gab/98GPB/98GPBp2.htm>.
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From page 106... ...
, whose primary function is to review and evaluate the scientific merit of research grant applications, perform the first level of review. Nineteen chartered IRGs distributed among three review divisions9 within CSR review applications regardless of the NIH Institute assignment.
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From page 107... ...
In contrast, only about 1 percent of the research grant applications reviewed by the CSR require a site visit before the IRG can complete its assessment. For any applications referred to NCI for review that cannot be reviewed by an IRG for reasons of conflict of interest or lack of expertise, special emphasis Panels (SEPs)
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From page 108... ...
Equally important is how decisions are 14 Review Criteria for the Rating of Unsolicited Research Grant and Other Applications, NIH Guide, Volume 26, Number 22, June 27, 1997 ( |
From page 109... ...
Funding Mechanisms for Extramural Research and Solicitation of NIH Grant Applications NIH has many different mechanisms for funding extramural research. Examples of those that are most relevant to a discussion of large-scale science are shown in Box 4-7.
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From page 111... ...
Applications in response to PAs are generally reviewed through the CSR, similar to the process for unsolicited grant applications. Funds for PAs may or may not be set aside, so this is the simplest form of "special attention" to indicate NIH interest.
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From page 112... ...
Thus, investigators must eventually convert successful research programs to more conventional NIH funding mechanisms, which can be risky and lead to delays or loss of funding. For example, if a follow-up grant application has to be submitted as an ROT, it will be reviewed as a new application and the IRG committee reviewing it for the first time may be completely unaware of the history of NCI support for the project, the reason for supporting 17 See |
From page 113... ...
Furthermore, budgets in some of these grant applications tend to be large and this also may raise questions in a review panel that is accustomed to reviewing traditional R01 applications with smaller budgets. Given the power and flexibility of the PA and RFA mechanisms for the solicitation of funding applications, decisions to issue them can be very influential in defining new goals and priorities within NIH.
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From page 114... ...
Currently, the Institute is focusing on sequencing the genomes of other species, but some have suggested that it should branch out into related areas, such as structural biology and proteomics, to ensure its long-term relevance and survival. Furthermore, the number of institutes within NIH has increased from 7 to 24 in the last 40 years, and this growth has been strongly criticized by former NIH director Harold Varmus and others on the grounds of the associated loss of flexibility, managerial capacity, and coordination, and the accompanying increase in administrative burden (Varmus, 2001~.
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From page 115... ...
For example, NCI is still the largest single provider of funds for cancer research, but other NIH Institutes and federal agencies, as well as many other organizations including pharmaceutical and biotechnology companies and nonprofit organizations now contribute about half of the total (McGeary and Burstein, 1999~. The various contributions are difficult to define precisely because the relevance of some research to cancer is not easily identified or predicted.
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From page 116... ...
Often, scientists seek industry funding for projects that are less likely to be funded by NIH because they are risky, very costly, or simply do not fit within NIH's current funding mechanisms or priorities. Once such projects have been established or pilot projects have demonstrated proof of principle, however, scientists are more likely to seek and obtain federal funding.
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From page 117... ...
For example, it established the Merck Genome Research Institute to identify expressed sequence tags and to place them in a publicly accessible database in collaboration with NHGRI and NCI. This initiative was undertaken to prevent private institutions, such as Human Genome Sciences, from retaining patent rights to all expressed sequence tags (ESTs)
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From page 118... ...
Indeed, the largest portion of funding was derived from companies identified as "genomics firms." These companies are devoted exclusively to genomics research, and thus could be construed as private ventures in large-scale science. More than 70 percent of these 270 companies, both publicly traded and privately held firms, are based in the United States.
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From page 119... ...
government Foreign governments non-profits Foreign non-profits FIGURE 4-3 Worldwide funding for genomics research, 2000 (millions of SU.S.~. SOURCE: World Survey of Funding for Genomics and Stanford in Washington Program, http: / /www.stanford.edu/class/siwl98q/websites/genomics.
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From page 120... ...
A: Number of firms with publicly traded stock. B: Growth in market value of genomics firms.
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From page 121... ...
Six Institutes at NIH, including NCI, two companies, and two nonprofit organizations provided $58 million to sequence the genome in 6 months using the whole-genome shotgun approach employed by Celera. The new money was divided among only three sequencing centers two in the United States and one in the United Kingdom to complete the work.
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From page 122... ...
of 1986, federal agencies have been mandated to encourage and facilitate collaboration among federal laboratories, state and local governments, universities, and the private sector in order to assist in the transfer of federal technology to the market place. One vehicle for this collaboration is through a CRADA.
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From page 123... ...
Nonprofit Funding of Large-Scale Biomedical Research Nonprofit organizations, while making a small funding contribution in comparison with private industry and the government, have also played an important role in genomics research and could potentially contribute to other large-scale biology projects. Nonprofit28 organizations come in a variety of different forms, including volunteer organizations, such as the American Cancer Society, that continually raise money to support research; endowed philanthropies, such as HHMI29; and even organizations set up by for-profit companies, such as the SNP Consortium.
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From page 124... ...
1999* Science Name Founded Assets Expenses Research Focus Wellcome Trust 1936 $19.2B $640M Biomedical, no cancer Bill and Melinda 1994 $17.1B $230M Vaccines, reproductive Gates Foundation medicine, public health David and Lucite 1964 $13.5B $84.7M Ocean sciences, computer Packard science, math, natural Foundation science, engineering, interdisciplinary Howard Hughes 1953 $12B $427.7M Biomedical Medical Research Institute Pew Charitable 1948-79 $4.7B $6.95M Biomedical, neuroscience Trusts Rockefeller 1913 $3.5B $20M Reproductive health, Foundation agriculture, vaccines, epidemiology, malaria Andrew W
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From page 125... ...
In most cases, investigators look to federal funding sources to continue a project that was launched successfully in a pilot or proof-of-principle stage using philanthropic sources. Such grant applications may then be viewed as less risky, but investigators may still encounter difficulties in obtaining NIH funds if the projects are very costly and the applications have not been solicited through a PA or RFA.
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From page 126... ...
. The objectives and cultures of these different sources may vary considerably, yet partnerships among diverse funding sources could offer unique opportunities for undertaking large-scale endeavors if the challenges entailed can
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From page 127... ...
Furthermore, former acting NIH director Ruth Kirschstein has noted that while the "bedrock" of the agency's research will continue to be individual investigator-initiated inquiry, the nature of scientific investigation is changing such that current research questions are more likely to require the efforts of multidisciplinary teams working with expensive instruments in specialized facilities (Haley, 2001~. Similarly, current NIH director Elias Zerhouni has remarked that the model of the traditional NIH grant "will evolve into different shapes because multidisciplinary science requires collaborations." But he has also noted that "at the end of the day you also need [principal investigators]
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From page 128... ...
A possible alternative to issuing PAs or RFAs for large-scale projects 3~ Personal communication, Richard Klausner, former NCI director.
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From page 129... ...
One way to reduce this variability is through long-term, Institute-wide strategic planning by the NIH director, as Elias Zerhouni is currently striving to do (Metheny, 2002; Kaiser, 2002~. This planning process incorporates input from Institute and Center directors, as well as from leaders among intramural and extramural scientists in both academia and industry.
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